US20050187489A1 - Electrosurgical specimen-collection system - Google Patents
Electrosurgical specimen-collection system Download PDFInfo
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- US20050187489A1 US20050187489A1 US11/098,963 US9896305A US2005187489A1 US 20050187489 A1 US20050187489 A1 US 20050187489A1 US 9896305 A US9896305 A US 9896305A US 2005187489 A1 US2005187489 A1 US 2005187489A1
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Definitions
- This invention relates generally to the field of acquisition of tissue from a patient, as occurs in a biopsy procedure, in particular to the cuffing and removal of tissue from the biopsy site.
- biopsy In diagnosing and treating certain medical conditions, it is often desirable to perform a biopsy, in which a specimen or sample of tissue is removed for pathological examination, tests and analysis. Typically, it is desired that biopsy material be taken from locations having characteristics indicating the presence of disease. For example, breast biopsies may be taken where a suspicious lump or swelling is noticed in a breast. As is known, obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. The information obtained from these diagnostic tests and/or examinations is frequently used to devise a plan for an appropriate surgical procedure or other course of treatment. Examination of tissue samples taken by biopsy is of particular significance in the diagnosis and treatment of breast cancer.
- a biopsy device having features of the invention has an elongated shaft with an inner bore and an aperture, and an elongated cutting member with a flexible distal portion and a tissue cutting member on the distal end.
- the elongated cutting member is at least in part movably disposed within the bore of the elongated shaft.
- the elongated cutting member is preferably open-ended, and preferably has a guide configured to direct movement of the flexible distal end.
- the shaft may be inserted into a patient's body for removal of tissue, such as a biopsy sample. Distal movement of the elongated cutting member within the bore of the shaft allows the flexible distal end to emerge from the shaft aperture to cut surrounding tissue. Tissue samples may be transported proximally by suction within a hollow elongated cutting member for collection.
- An embodiment of a biopsy device having features of the invention has an elongated shaft with an inner bore, a first guide extending along a distal shaft section which defines at least in part a tissue cutting pathway, and an elongated cutting member which is at least in part movably disposed within the bore of the elongated shaft.
- the elongated cutting member has a proximal section, a flexible distal section with an distal end and a tissue cutting member on the distal end.
- the elongated cutting member is preferably open-ended, with a second guide configured to engage the first guide on a distal section of the elongated shaft.
- the first and second guides cooperate to facilitate the movement of the elongated cutting member along the tissue cutting pathway.
- devices embodying features of the invention include an elongated shaft with an inner bore, and an elongated cutting member configured to move within the bore.
- the elongated cutting member is preferably a hollow tube, termed a tissue extraction tube, with a flexible distal portion, a distal opening, and a cutter disposed around the opening.
- the cutter may be on the rim of the opening, or may be spaced distally from it; preferably, the cutter is spaced away from the rim of the opening.
- the shaft may be relatively stiff in comparison to the elongated cutting member, and preferably has a cutting element on its distal tip to facilitate accessing the tissue site.
- a shaft cutting element may be a sharpened tip, a cutter configured to puncture or cut tissue, a radiofrequency (RF) cutter, or other cutting element.
- the shaft cutting element is preferably spaced a distance away from the distal tip of the shaft.
- the shaft has a first guide, oriented in a substantially longitudinal direction, that is preferably disposed within the bore of the shaft.
- the elongated cutting member is configured to engage with the first guide, preferably with a cooperating second guide disposed on the elongated cutting member to facilitate following the tissue cutting pathway defined by the first guide.
- One of the guides may be, for example, a channel or slot, and the other guide may be, for example, a rail or a series of pins configured to slide within the channel or slot. The guides ensure that the motion of the elongated cutting member follows the desired tissue cutting pathway.
- the shaft also has an aperture in a portion of the distal side wall connecting the shaft bore with a region outside the shaft. Although an opening, the aperture is taken to define an imaginary surface that is the continuation of the shaft wall.
- the shaft internal bore includes a ramp on an inner surface disposed substantially opposite the aperture.
- the ramp rises within the bore from the inner surface towards an imaginary center-line within the shaft, and, in particularly preferred embodiments, past the center-line towards the open aperture, and then descends back to the level of the inner wall surface of the bore.
- a first guide such as a channel, is disposed along at least a portion of the ramp.
- Elongated cutting members embodying features of the invention are preferably configured to slide longitudinally within the bore of a shaft.
- the elongated cutting member will be exemplified by a tissue extraction tube, although it will be understood that any elongated cutting member may be suitable.
- a second guide such as a rail, is attached to at least a distal portion of the tube, and may extend along most or all of the length of the tube.
- the bore includes a ramp with a channel
- the tube has an attached rail engaged with the channel
- longitudinal motion of a tissue extraction tube is guided by and follows the path defined by the channel.
- the flexibility of a tissue extraction tube embodying features of the invention allows it to substantially conform to the topography of the ramp.
- a tube moves distally within a bore having a ramp disposed opposite an aperture
- the distal end of the tube rises, causing at least its distal tip to emerge from the shaft aperture under the guidance of the rail engaged with the channel.
- Further distal movement brings the distal end of the tube back down within the shaft again.
- such distal movement places the distal tip of the hollow tube against the inner wall of the shaft distal tip within a structure termed a “cutting bowl.”
- Vacuum may be applied to a proximal portion of the tissue extraction tube to aspirate tissue specimens through the inner lumen of the tube.
- Systems include a carrier for mounting the shaft and for connecting the shaft and tube to a vacuum source and optionally to a radiofrequency power source.
- Methods for removing a tissue specimen from within a patient's body include placing the shaft adjacent a tissue mass of interest located within a patient's body, advancing the tissue extraction tube, and cutting a tissue sample.
- a RF cutter is activated and tissue is cut with a RF cutter.
- distal advancement of the tissue extraction tube moves the tube distal end and the loop cutter out of, and then back into, the shaft aperture.
- the cutter on the distal tip of the hollow tube cuts a path through the tissue, and severs the separated tissue from the tissue bed in the cutting bowl as it re-enters the shaft bore at the distal end of the ramp. Vacuum may be used to attract and hold tissue against the shaft and tube.
- Vacuum from the same or from a separate source may be applied to the proximal part of the hollow tube to transport the severed tissue specimen proximally to a tissue collection chamber.
- Tissue collection methods also include collection of multiple samples. Multiple samples may be taken at multiple locations distally or proximally along an axis, and may be taken at multiple radial locations around an axis.
- the shaft and tube may be partially rotated about the longitudinal axis of the device by turning a thumbwheel to sever and collect a plurality of specimens about the longitudinal axis of the device.
- the amount of rotation may be an arbitrary amount and may be a preset amount.
- a preset amount of rotation about a longitudinal axis of a device may be, for example, designated by detents.
- tissue sample Is vacuumed into a collection tube as soon as it is cut by a cutter at the opening of the tube.
- biopsy samples may be collected with only a single small incision, thus minimizing trauma to the patient and eliminating the need for a separate vacuum or sample acquisition tube.
- Rotation of the shaft allows biopsy collection from diverse radial locations, thus maximizing the sample collection volume while maintaining the minimal level of patient trauma.
- Radiofrequency cutters such as a radiofrequency cutting loop on the distal end of the hollow tube allow the ready acquisition of tissue with little resistance from or deformation of the tissue during sample acquisition, insuring that the samples are actually taken from the expected locations.
- the primary biopsy site described is generally the human breast, although the invention may be used for collecting biopsy specimens from other parts of the human body and other mammalian body as well.
- FIG. 1 is a perspective view of a system embodying features of the invention shown configured to begin taking a biopsy sample.
- FIG. 2A is a perspective view of a system embodying features of the invention, showing the flexible distal portion of a tissue extraction tube emerging from the aperture.
- FIG. 2B is a detailed perspective view of the distal portion of the shaft and tube of the device shown in FIG. 2A showing the advancing distal end of the flexible tube in cutting position along the tissue cutting pathway defined in part by the ramp.
- FIG. 3A is a perspective view of the device of FIGS. 1 and 2 configured with the tissue extraction tube fully advanced within the shaft, with the distal tip of the flexible tissue extraction tube fully extended past the aperture into the cutting bowl.
- FIG. 3B is a longitudinal cross-sectional view of the distal portion of the shaft and tube of the device shown in FIG. 3A showing the distal end of the flexible tube fully extended along the tissue cutting pathway over the ramp with its distal tip within the cutting bowl at the distal end of the aperture, after it has cut a tissue specimen.
- FIG. 4 is a perspective view of a shaft and of a flexible tissue extraction tube embodying features of the invention shown lying next to each other in positions corresponding to the relative positions taken by these elements when in place in the assembled device.
- FIG. 5A is a side, cross-sectional elevation view of the distal tip and loop electrode of a tissue extraction tube embodying features of the invention.
- FIG. 5B is a side, cross-sectional elevation view of the distal tip and loop electrode of an alternative embodiment of a tissue extraction tube embodying features of the invention.
- FIG. 5C is a side, cross-sectional elevation view of the proximal tip of a tissue extraction tube embodying features of the invention showing a luer lock vacuum connection and a conductor for connecting a radiofrequency electrode connection to a source of radiofrequency power.
- FIG. 5D is a perspective, cross-sectional view of half of the distal tip of a tissue extraction tube embodying features of the invention.
- FIG. 5E is a side, cross-sectional view of the proximal tip of an elongated shaft embodying features of the invention showing a vacuum connection and vacuum port and a radiofrequency electrode connection.
- FIG. 6A is a transverse cross-sectional view of a tissue extraction tube with an attached rail embodying features of the invention taken along line 6 A- 6 A of FIG. 4 .
- FIG. 6B is a transverse cross-sectional view of a shaft embodying features of the invention taken along line 6 B- 6 B of FIG. 4 of the invention, showing vacuum ports, an internal bore and a channel running along the ramp seen distally of the section.
- FIG. 6C is a transverse cross-sectional view of a shaft and a flexible tube taken along line 6 C- 6 C of FIG. 3A with the tube in position along a channel on a ramp within the shaft.
- FIG. 1 is a perspective view of a system 10 embodying features of the invention, including a tissue acquisition assembly 12 , a source of radiofrequency (RF) power 38 and a vacuum source 56 .
- the tissue acquisition assembly 12 has a shaft 14 with a distal tip 16 at the end of distal portion 18 .
- Shaft 14 preferably has a distal tip cutter 20 disposed on the distal tip 16 .
- the shaft 14 is an elongated structure oriented along a longitudinal axis 80 that serves to define distal and proximal directions and a radial direction 82 perpendicular to axis 80 .
- a center line within the shaft lies generally along axis 80 .
- Distal tip cutter 20 has a cutting surface effective to cut through tissue, opening up a path through which distal portion 18 of shaft 14 may be inserted, thus aiding in the placement of shaft 14 within a patient's body.
- a cutting surface may be any surface configured to cut tissue, e.g., by having a sharp edge, by having a thin cross-section, by being hard, by conducting radiofrequency energy, or by any combination of these or other properties.
- a cutter, or equivalently, a cutting element may include supporting surfaces and structures in addition to cutting surfaces and structures.
- Distal tip cutter 20 is preferably spaced away from the shaft distal tip 16 .
- Shaft 14 may have any cross-sectional shape, including round, square, hexagonal, or other shape.
- distal cutter 20 may extend radially to a distance greater than the width, or radius, of a shaft 14 .
- Distal cutter 20 may also be made from multiple cutting elements; e.g., a distal cutter 20 embodying features of the invention may be made from a pair of wires configured to carry RF energy.
- a distal cutter 20 embodying features of the invention may be made from a pair of wires configured to carry RF energy.
- distal cutter 20 may include two curved wires configured to carry RF energy that are separated from, and extend distally from, shaft tip 16 .
- a pair of wires making up a distal cutter 20 are oriented substantially along a plane, most preferably a plane including a diameter of a shaft 14 , so that the wires extend in directions separated by about 180°.
- Cutting elements, such as a wire or wires, making up a distal cutter 20 may be rigidly mounted to a distal tip 16 , or may be flexibly mounted to a distal tip 16 .
- a flexibly mounted cutting element may spring back outwardly to a deployed configuration after having been inwardly compressed within a cannula.
- the shaft distal portion 18 also includes a cutting bowl 22 and a ramp guide 24 , visible through aperture 26 , which provides access to them.
- a ramp guide 24 may be any structure within a shaft 14 having a surface with contours that include tangents not substantially parallel to a shaft longitudinal axis. Such a surface may be termed a non-axial surface. The inner radius of the shaft bore thus changes in a longitudinal direction along the length of a ramp disposed within the bore of the shaft.
- a ramp guide 24 may have a flat surface, having parallel tangent lines when tangents are taken at various positions along the ramp guide 24 ; such a flat ramp guide 24 may be termed a linear non-axial surface.
- a ramp guide 24 may have a curved surface, having tangent lines that are not parallel when tangents are taken at various positions along the ramp guide 24 .
- a ramp guide 24 having such a curved surface may be termed a non-linear non-axial surface.
- a ramp guide 24 includes non-linear non-axial surface portions.
- the ramp guide 24 shown in FIGS. 2A and 2B has a non-linear non-axial surface.
- the ramp guide 24 is shown rising from within the shaft to a level near that of the level of the aperture 26 .
- the level of an aperture 26 is taken to be the level of the surrounding wall surface extended across the opening of the aperture 26 . Where the surrounding wall is curved, the extension of the curved surface is also taken to have the same curvature.
- a ramp guide 24 may be entirely below the level of the aperture 26 , or may rise to a level equal to, or greater than, the level of the aperture 26 .
- Cutting bowl 22 is bounded proximally by ramp guide 24 and is defined radially by shaft inner wall 84 .
- Aperture 26 is an opening in the wall of shaft 14 , shaft outer wall 86 extending from all directions to the aperture edge 27 .
- Vacuum vents 28 shown here disposed on shaft distal portion 18 near aperture 26 , are useful for pulling and holding tissue against shaft 14 and cutting bowl 22 when a shaft 14 is placed within a patient's body.
- a vacuum inlet connector 30 is disposed on a proximal portion 31 of shaft 14 for connecting to a vacuum line connected to a source of vacuum for providing vacuum to vacuum vents 28 .
- Thumbwheel 32 also disposed on shaft proximal portion 31 , enables an operator to manually rotate shaft 14 around longitudinal axis 80 to orient aperture 26 so that it opens in a variety of radial directions 82 towards body tissue surrounding shaft 14 .
- RF connector 34 provides RF energy to cutting element 20 .
- RF connector 34 may be configured to provide RF power during rotation of the shaft, for example, where RF connector 34 is a conductive ring as shown in FIG. 1 .
- RF cable 36 leads to RF power source 38 .
- Radiofrequency cutters may be monopolar or bipolar; a monopolar cutting surface is connected to one conductor leading to a source of radiofrequency energy, and requires a separate ground or indifferent electrode to be placed in contact with a patient's body in order to cut a patient's body tissue.
- a bipolar radiofrequency cutting surface includes at least two conductors, each connected to different conductors connected to a radiofrequency energy source, so that the bipolar radiofrequency cutting surface does not require a separate ground or indifferent electrode in order to operate.
- RF power source 38 may be connected to conductor 40 and ground pad 42 which may be placed in electrical contact with a patient's body to provide a complete electrical circuit.
- distal cutter 20 is a bipolar RF cutter, conductor 40 and ground pad 42 are not necessary.
- Tissue acquisition assembly 12 also includes a tissue extraction tube 44 configured to slide into shaft 14 .
- An exposed proximal portion 43 of a tissue extraction tube 44 having features of the invention is shown in FIG. 1 .
- RF connection 46 which carries RF energy obtained from an operable electrical connection to RF cable 48 leading to RF power source 38 , provides RF energy to tissue extraction tube 44 .
- Tube 44 has a vacuum connector 50 disposed on its proximal portion 43 that is configured to mate with a complementary vacuum connector 51 which provides an operable connection to vacuum line 52 connected to vacuum source 56 .
- Vacuum line 52 is preferably a flexible vacuum hose.
- Vacuum applied to the tissue extraction tube 44 is effective to draw tissue towards the tube 44 and to transport severed tissue samples within the hollow tissue extraction tube 44 towards the vacuum source 56 .
- a tissue collection chamber 54 may be placed in or near the vacuum line 52 or vacuum source 56 in order to retain tissue samples for analysis.
- a tissue extraction tube 44 is preferably a hollow elongated tubular member with openings at both ends that is configured to sever a sample of tissue from within a body.
- a tissue extraction tube 44 may be used to acquire biopsy samples from a patient and may also be used to transport a tissue sample out of the body to, for example, a tissue collection chamber.
- a center line within a tube 44 lies generally along a local longitudinal axis. The center line of one portion of a straight tube is also a center line for other portions of that straight tube.
- a tissue extraction tube typically has a flexible portion and is capable of assuming a non-linear configuration during use (it may bend or curve), such that at least a portion of the tube wall may approach or cross a center line defined by another portion of the tube.
- the flexible part of a tissue extraction tube may be limited to only a portion, such as a distal portion; alternatively, a tissue extraction tube may be flexible along its entire length.
- a shaft 14 and tissue extraction tube 44 embodying features of the invention may be mounted onto a support frame 58 effective to secure and guide them before, during, and after tissue sample collection.
- the support frame 58 illustrated in FIG. 1 includes a distal brace 60 configured to hold a shaft 14 while allowing its rotation and a proximal brace 62 , configured to hold a tube 44 .
- Braces 60 and 62 are configured to hold shaft 14 and tube 44 while allowing their rotation.
- Braces 60 and 62 may include snap connectors or other mechanisms configured to provide both mechanical support and electrical contact.
- Proximal brace 62 is configured to move longitudinally along support beams 64 while being substantially prevented from lateral (radial) movement.
- vacuum support 66 is configured to move freely along support beams 64 in longitudinal directions but not in radial directions. It will be understood that, in embodiments of the invention, a single support beam 64 , or a plurality of support beams 64 may be used to hold and guide either or both of a brace 62 and a support 66 .
- springs 68 between proximal brace 62 and vacuum support 66
- 69 between distal brace 60 and proximal brace 62
- Springs 68 and 69 are configured to apply forces so that when removal of forward pressure, the tissue extraction tube 44 and proximal brace 62 automatically retract.
- Spring 69 is preferably stronger than spring 68 in order to insure that the connection with vacuum source 56 is maintained while cutting. Spring 68 also cushions contact between proximal brace 62 and vacuum support 66 . Vacuum line 52 , being connected to vacuum support 66 , is carried along by any longitudinal movement of vacuum support 66 , maintaining its operable connection to vacuum source 56 and tissue collection chamber 54 even during movement of the tissue extraction tube 44 .
- shaft 14 and tissue extraction tube 44 may be configured so that distal movement of the vacuum support 66 towards proximal brace 62 brings spring 68 into contact with proximal brace 62 , urging proximal brace 62 distally towards distal brace 60 , to compress spring 69 and to move tissue extraction tube 44 distally within shaft 14 .
- Vacuum vents 28 are disposed along shaft outer wall 86 at locations near the aperture edge 27 adjacent aperture 26 and at locations somewhat removed from aperture 26 . Vents 28 serve to attract and hold tissue near to the distal portion 18 of shaft 14 and to cutting bowl 22 .
- the distal portion of tube 44 includes a loop cutter 72 disposed on the rim 74 of the orifice 76 leading into the hollow interior 92 of tube 44 .
- Loop cutter 72 may be any cutting element, such as a sharp blade; however, loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to a RF power source 38 .
- a loop cutter may be formed from any loop-shaped cuffing surface, such as a wire, band, ribbon or strip of material, shaped as a loop, whether circular, elliptical, polygonal, or irregular in cross-section.
- a loop cutter 72 may be a continuous loop in the shape of a closed loop, or may be discontinuous, in the shape of a partial loop such as a loop with ends that do not fully connect with one another, or be made up of more than one separate cutting elements arrayed about the rim 74 of an orifice 76 in a loop shape. In some embodiments, a loop cutter 72 may be spaced distally from the rim 74 of orifice 76 .
- a cutter support 73 or plurality of cutter supports 73 may connect with a cutter 72 in order to support a cutter 72 at a position distal to the rim 74 of an orifice 76 .
- loop cutter 72 When supplied with RF power, or when it includes a sharp cutting edge, or other cutting element, loop cutter 72 is effective to cut body tissue with which it comes into contact. Insertion of a distal portion 18 of shaft 14 into a patient's body, and the application of suction through vacuum vents 28 and tube orifice 76 , are each effective to bring tissue into contact with a cutting loop 72 disposed outside an aperture 26 . Movement of loop cutter 72 through body tissue is effective to cut a portion of body tissue. The body tissue may be drawn into orifice 76 by action of the forward (distal) motion of tube 44 and by suction from vacuum source 56 applied by vacuum line 52 to vacuum inlet connector 50 and to the hollow interior 92 of tube 44 .
- ramp guide 24 angles upward to a maximum and then descends again into cutting bowl 22 defined proximally by the ramp and radially by shaft inner wall 84 .
- Tube 44 is shown angling upward with its distal tip 74 and orifice 76 positioned approximately mid-way along the ramp guide 24 . This corresponds to a configuration where vacuum tube support 66 and proximal brace 62 are situated approximately mid-way along the extent of their effective longitudinal travel distance on support beams 64 .
- Cutting loop 72 moves through tissue adjacent aperture 26 as tissue extraction tube 44 moves in a distal direction along ramp guide 24 .
- the path taken by cutting loop 72 is determined by the guides of the shaft 14 and of tube 44 , such as channel 106 and rail 96 , which constrain the motion of tube 44 and of cutting loop 72 along a tissue cutting pathway defined by channel 106 , the shaft guide shown in FIG. 2B .
- the orientation of shaft 14 within a patient's body, including the radial orientation of aperture 26 thus determines the point of origin of the tissue samples removed from the patient.
- FIG. 2B also shows guides rail 96 and channel 106 , which are shown in greater detail in later figures.
- Rail 96 is attached to tube 44 , and engages channel 106 so that movement of tube 44 is constrained in radial directions, but not longitudinal directions, by the tissue cutting pathway defined by channel 106 .
- a rail 96 follows the tissue cutting pathway defined by the channel 106 .
- channel 106 lies along ramp guide 24 and along shaft inner wall 84 within shaft 14 , and follows the contours of shaft inner wall 84 and ramp guide 24 ; in particular, in the region of ramp guide 24 , channel 106 defines a non-linear non-axial pathway within shaft 14 .
- a rail 96 may be any elongated element configured to engage a channel 106 .
- a channel 106 is typically much longer than it is wide, its length defining a longitudinal direction and its width defining a radial direction.
- a rail 96 engaged with a channel 106 is able to move readily in a longitudinal direction, while its motion in a radial direction is constrained by the channel 106 . These directions may be applicable to the entire channel 106 , if the channel 106 is straight, or may be merely local directions, if the channel 106 is curved.
- tube 44 is shown advanced to a maximal distal extent.
- Tube 44 follows an arc-like path as it climbs up and then down along the ramp guide 24 .
- vacuum tube support 66 and proximal brace 62 have moved distally to the full extent of their effective longitudinal travel distance on support beam** 64 , pushing tube 44 to its full travel within shaft 14 , out of aperture 26 , and placing at least part of tissue extraction tube distal portion 70 into cutting bowl 22 .
- a ramp embodying features of the invention may have any contour effective to expose a cutting loop 72 to body tissue as a tube 44 moves longitudinally along a tissue cuffing pathway lying on or along the ramp.
- a ramp guide 24 may ascend and descend with little or no transition portion between ascending and descending portions, or may alternatively include an extended level plateau portion between ascending and descending ramp portions.
- a tube 44 assumes a configuration conforming to that ramp profile by angling upward, lying level over the plateau portion, and then angling downward into the cutting bowl 22 at its most distal extent.
- loop cutter 72 advances in a distal direction along ramp guide 24 , cutting a swath of tissue from a tissue bed, a distal, connecting portion of the tissue swath remains attached to the body tissue mass. However, the loop cutter 72 descends into cutting bowl 22 as it advances along the distal, descending portion of ramp guide 24 near its maximal distal travel. As shown in FIG. 3B , within the cutting bowl 22 , the loop cutter 72 is no longer in contact with the tissue bed adjacent the shaft distal portion 18 . The descent of loop cutter 72 into cutting bowl 22 , past aperture edge 27 severs the connecting portion of the tissue swath, freeing the swath of body tissue from the tissue bed and providing an isolated tissue sample. Vacuum within tube 44 draws the tissue sample proximally within the hollow interior 92 of tube 44 into vacuum line 52 and to tissue collection chamber 54 .
- Cutting loop 72 disposed on tube rim 74 is illustrated in cross-section within cutting bowl 22 in FIG. 3B .
- tube 44 assumes an arc-like configuration along ramp 44 , with a part of distal tube portion 70 within cutting bowl 22 . That position may be achieved by distal movement of cutting loop 72 from a position where orifice 76 is outside aperture 26 to a position where orifice 76 passes aperture edge 27 to assume a position within cutting bowl 22 as shown in the figure. Distal movement of orifice 76 and cutting loop 72 past aperture edge 27 is effective to sever the strip of tissue connecting a tissue swath with the external tissue bed adjacent shaft distal portion 18 .
- FIG. 3B also shows vacuum chamber 88 which supplies vacuum vents 28 . The connection of vacuum chamber 88 to vacuum port 30 , provided by vacuum ports 90 , is illustrated in FIGS. 5D and 6B .
- FIG. 4 shows shaft 14 and tissue extraction tube 44 disposed along side one another.
- Tissue extraction tube 44 is preferably somewhat longer than shaft 14 , so that tube 44 may be inserted within shaft bore 110 with tube distal portion 70 fully extended into cutting bowl 22 and still allow proximal end 43 of tube 44 , with its vacuum connection 50 , to extend proximally beyond the vacuum connection 30 and thumbwheel 32 at shaft proximal portion 31 .
- FIG. 4 also illustrates optional radial indents 94 on RF connector 34 which may be used to help to hold shaft 14 in a desired radial orientation after rotation of the shaft 14 , as by turning thumbwheel 32 . Pins, detents, or other devices may be used to engage indents 94 effective to secure the position of shaft 14 .
- FIG. 4 also shows rail 96 attached to tube 44 .
- rail 96 extends along the length of tube 44 ; however, in other embodiments, a rail 96 may extend along only a distal portion of tube 44 and may be absent along a proximal portion 43 of a tissue extraction tube 44 .
- a rail 96 is securely attached to tube 44 , and in some embodiments of the invention may be an integral part of a tube 44 .
- Control of the movement of a rail 96 is also effective to control the movement of a tube 44 to which is attached or of which it is a part.
- engagement of a rail 96 with a channel 106 is effective to guide the movement of a tube 44 along a ramp guide 24 .
- rail 96 is effective to guide tissue extraction tube 44 into the arc-shaped path lying over ramp guide 24 as illustrated in FIGS. 2A-2B and 3 A- 3 B.
- FIG. 5A A distal portion 70 of a tissue extraction tube 44 embodying features of the invention is shown in FIG. 5A .
- the orifice 76 of tube 44 leads in a proximal direction to tube bore 92 ; loop cutter 72 is disposed on rim 74 of tube 44 and about the orifice 76 in the embodiment shown in FIG. 5A .
- the loop diameter 98 of loop cutter 72 is preferably smaller than the inner diameter 100 of orifice 76 , insuring that the dimensions of a tissue swath cut by loop cutter 72 are small enough to fit within tube bore 92 .
- cutting loop 72 is connected to tube RF connection wire 102 which runs in a longitudinal direction along tube 44 within rail 96 .
- FIG. 5B An alternative tube guide 97 is shown in FIG. 5B .
- a series of pins 97 having heads 99 are disposed in a linear arrangement along a surface of a tube 44 .
- Pins 97 and heads 99 are configured to fir into and engage a shaft guide, such as a channel 106 as illustrated in other Figures, effective to guide movement of a tube 44 along a tissue cutting pathway.
- FIG. 5C A proximal portion 43 of a tissue extraction tube 44 embodying features of the invention is shown in FIG. 5C .
- rail 96 (including RF connection wire 102 ) extends along the entire length of the tube 44 .
- External RF connector 46 which includes a conductive ring around the diameter of tube 44 , is operably connected to RF connection wire 102 as shown, allowing tube 44 to rotate while maintaining effective electrical contact with RF power source 38 .
- FIG. 5C also illustrates a luer lock vacuum connection 50 configured to engage a vacuum connection 51 or vacuum line 52 leading to a vacuum source 56 , effective to supply vacuum to tube bore 92 .
- a cutting bowl 22 within the shaft distal portion 18 has a distal inner wall 108 which serves to limit the distal movement of a tube 44 disposed within a bore 110 of a shaft 14 embodying features of the invention.
- Shaft inner wall 84 forms the remainder of the boundary defining cutting bowl 22
- shaft outer wall 86 extends up to aperture edge 27 to define the outer surface of shaft 14 and the outer perimeter of aperture 26 .
- This figure also shows vacuum chamber 88 which provides vacuum to vacuum vents 28 . Vacuum vents 28 aid in drawing tissue to shaft 14 so that a cutting loop 72 has sufficient nearby tissue from which to cut a tissue sample.
- Vacuum ports 90 within shaft 14 connect vacuum chamber 88 with vacuum source 56 via vacuum connections 50 and 51 and via vacuum line 52 .
- FIG. 5E The proximal portion 31 of a shaft 14 embodying features of the invention is illustrated in FIG. 5E , showing RF connector 34 operably connected to shaft RF wire 114 to provide an electrical connection effective to supply RF power to distal cutter 20 .
- vacuum connector 30 leads to vacuum port 90 so that vacuum provided through connector 30 has access to vacuum port 90 at all radial orientations of shaft 14 .
- O-ring 112 provides a vacuum-tight seal allowing rotation of shaft 14 while maintaining an effective vacuum connection.
- FIGS. 6A-6C Transverse cross-sections of a tube 44 and shaft 14 embodying features of the invention are shown in FIGS. 6A-6C .
- FIG. 6A shows a transverse cross-section of a tube 44 taken along line 6 A- 6 A of FIG. 4 , and illustrates a suitable configuration for the attachment of a rail 96 with a tube 44 .
- Tube electrode wire 102 which supplies cutting loop 72 with RF power, is insulated by the non-conductive material of rail 96 surrounding it, and also provides strength to rail 96 .
- FIG. 6B illustrating a transverse cross-section of a shaft 14 taken along line 6 B- 6 B of FIG.
- vacuum ports 90 and shaft electrode wires 114 may be disposed within the wall of shaft 14 .
- Ramp guide 24 and channel 106 may also be seen in FIG. 6B , which is a view looking in the distal direction.
- FIG. 6C is a transverse cross-sectional view, taken along line 6 C- 6 C of FIG. 3A , of a shaft 14 and a tube 44 engaged together.
- the cross-section of FIG. 6C is taken at a position where the ramp guide 24 has risen to a level near to the level of aperture 26 , exposing tube 44 to a maximal extent to the region outside the shaft 14 .
- tissue extraction tube 44 is shown in cross-section in FIG. 6C at the point of its greatest excursion out of bore 110 outside aperture 26 , at the peak of ramp guide 24 .
- Such radial excursion of the tube 44 outside the aperture 26 is effective to allow loop cutter 72 to cut tissue from regions surrounding shaft 14 .
- FIG. 6C also shows the vacuum chamber 88 disposed below ramp guide 24 and channel 106 . Shaft electrode wires 114 leading to distal cutter 20 are also shown, as are vacuum vents 28 .
- the invention provides assemblies, devices, and systems for obtaining tissue samples from within a patient's body.
- Assemblies 12 include shafts 14 and tissue extraction tubes 44 having features of the invention, with tubes 44 disposed at least in part within shafts 14 for example, as described above.
- Systems 10 include tissue acquisition assemblies 12 in conjunction with some or all of, for example, a support frame 58 , a RF power source 38 , a vacuum source 56 , and a tissue collection chamber 54 . These and other elements may be operably connected together with some or all of, for example, a RF cable 34 or 36 , a vacuum line 52 , and a ground pad 40 and ground cable 42 .
- a suitable source of radiofrequency energy is effective to provide radiofrequency energy of between about 35 W and about 150 W, preferably between about 50 W and about 100 W.
- the radiofrequency energy may suitably have a frequency of between about 0.1 MHz and about 10 MHz, preferably between about 0.3 MHz and about 1.2 MHz.
- a tissue extraction tube 44 embodying features of the invention may be made with any flexible, biocompatible material.
- a tube 14 is preferably made with a flexible, non-conducting biocompatible material.
- Suitable materials include, but are not limited to, silicon rubber, latex and other natural and synthetic rubber materials, nylon, polyethylene block amides (such as Pebax®), thermoplastic elastomers, such as, for example, Kraton and C-Flex, and including thermoplastic polyester elastomers (e.g., Hytrel®), and other polymers, polymer blends and copolymers of polymers, including but not limited to polyacrylonitrile, polyamide, polynitrile, polyolefin, polyurethane, polyvinyl chloride, and other flexible non-conducting materials.
- Tube 44 may include a strengthening filament 78 on or within its wall, shown here as a spiral coil; filament 78 may alternatively be in the configuration of a ring or rings, a braid, multiple longitudinal strips, or other configurations.
- a strengthening filament 78 is effective to add strength to a flexible tube, providing radial strength to prevent vacuum from causing the tube to collapse, and allowing a tube to bend without breaking or tearing.
- a strengthening filament may be any elongated object, such as a cord, band or other thin strip of material, and may be embedded in or attached to the tube wall.
- a strengthening filament may be straight, curved, coiled, ring-shaped, spiral-shaped, braided with other strengthening filaments, another shape or any combination of shapes.
- Strengthening filaments 78 are preferably non-conductive, and may be made from materials including, but not limited to, glass fiber, polymers such as, for example, Kevlar®, polyesters, other polymers, polymer blends and copolymers of polymers, including but not limited to polyacetal, polyacrylonitrile, polyamide, polyethylene including high density polyethylene (HDPE), polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polyurethane, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene fibers, polyvinyl chloride, and other materials such as graphite fibers.
- Strengthening filaments may also be made with filled materials, such as glass or mineral-filled polymers such as glass-filled polyester, mica-filled polysulfone, other filled polymers and other filled materials.
- a rail 96 , series of pins 97 , or other tube guide embodying features of the invention may be made with a durable, biocompatible material, which is preferably non-conducting and may be flexible. Suitable materials include HDPE, polyetheylene, polyacrylonitrile, polyacetal, polyamide, polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene polymers, polyurethane, polyvinyl chloride, Pebax®, Hytrel®, acrylonitrile-butadiene-styrene (ABS), glass- or mineral-filled polymers, such as glass-filled polyester, mica-filled polysulfone, other filled polymers and other filled materials and other biocompatible non-conducting materials. As shown in FIG. 6A , a rail may en
- a shaft 14 may be made of any suitably strong biocompatible material, and preferably a non-conductive material.
- a shaft 14 may be made from a biocompatible polymer, composite, such as a graphite composite and an epoxy-bound braid of glass or nylon; ceramic, or other material.
- polycarbonate is a strong and durable biocompatible material.
- suitable materials include other plastics including thermoplastics and polymers, and co-polymers, polymer alloys and polymer mixtures.
- Suitable materials include HDPE, polyetheylene, polyacrylonitrile, polyacetal, polyamide, polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene polymers, polyurethane, polyvinyl chloride, Pebax®, Hytrel®, acrylonitrile-butadiene-styrene (ABS), glass- or mineral-filled polymers, such as glass-filled polyester, mica-filled polysulfone, other filled polymers and other filled materials and other biocompatible non-conducting materials.
- HDPE high density polyethylene
- polyetheylene polyacrylonitrile
- polyacetal polyamide
- polyethylene terephthalate polyimide
- poly(methyl)methacrylate polynitrile
- polyolefin polypropylene
- a shaft may be made from or include a metal, such as stainless steel.
- a metal may be coated with a ceramic, Teflon®, a polymer such as polyimide, or with any other biocompatible coating.
- a guide, such as a channel 106 disposed on a shaft 14 may be made of the same material as a shaft 14 , may be made of a different material chosen from materials suitable for making a shaft 14 , or may further include other materials or coatings.
- a material or coating having a low coefficient of friction such as Teflon®, may be used in the manufacture of a guide.
- Rail 96 and channel 106 as shown in the Figures and described above are particular examples of guides; other guides configured to cooperate together to guide the motion of a tissue extraction tube 44 along a shaft 14 are also suitable for the practice of the invention.
- suitable guides include any elements configured to engage each other and to guide the movement of a tissue extraction tube along a tissue cutting pathway.
- Guides embodying features of the invention need not be continuous, unitary elements, nor need they extend along the entire length of a shaft or tube embodying features of the invention.
- a guide may be a series of pins or protuberances configured and aligned so as to engage a channel.
- a shaft may have a rail
- a tube may have a channel
- other possible configurations of guides are suitable for the practice of the invention.
- a shaft and a tube may each, or singly, have multiple guides, such as, for example, a pair of rails configured to engage a pair of channels, or a plurality of pins aligned in a row or rows so as to fit within a slot or slots, or a multitude of parallel runners configured to engage and slide along a multitude of tracks.
- devices embodying features of the invention may have a tube with a rail configured to move within a channel, the tube also having one or more runners configured to slide along a track or tracks.
- a shaft need not have a guide.
- a tissue extraction tube may have a guide configured to direct the movement of the flexible distal portion without engaging with another guide.
- Such embodiments include devices having flexible, curved guides disposed along a distal portion of a tissue extraction tube configured to direct a distal tip of the tissue extraction tube back towards a cutting bowl after the distal tip has been deflected radially out of a shaft aperture during distal movement along a shaft.
- Such flexible, curved guides may be ramp-shaped, and may cause the flexible distal end of a tube to assume a ramp shape as it emerges from an aperture.
- the open distal end 76 of a tissue extraction tube 44 with a ramp-shaped curved guide on its distal portion 70 will emerge from the shaft aperture 26 as the distal portion 70 of the tube 44 moves distally and climbs up a ramp 24 , enabling its loop cutter 72 to cut tissue; further distal movement of the tube 44 guided by the curved guide allows the flexible distal portion 70 to re-enter aperture 26 , to enter cutting bowl 22 , and to partially or completely conform to the ramp 24 when the tube 44 is extended distally along a shaft.
- Such flexible curved guides may be made from previously discussed materials, or other materials, such as memory materials and spring materials.
- Memory materials include, for example, memory metals such as nickel titanium alloys, and spring materials include plastic spring materials and metal spring material, such as, for example, spring steel.
- Aperture 26 is illustrated in the Figures as an uncovered opening through the wall of shaft 14 .
- aperture 26 is covered by a movable aperture cover.
- an aperture cover is in place over an aperture 26 during placement or removal of shaft 14 at or from a desired location within a patient's body, and the cover is moved during collection of a tissue sample so as to expose aperture 26 .
- the systems, assemblies and devices embodying features of the invention are made from materials that are suitable for sterilization, including ultraviolet, chemical and radiation sterilization.
- sterilizable materials include metals, glasses, ceramics, composites, plastics, thermoplastics and thermoplastic elastomers, and other polymers including, but not limited to polyethylene, HDPE, Kevlar®, C-Flex, polypropylene, polyacrylonitrile, polyamide, polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene polymers, polyurethane, polyvinyl chloride, and other biocompatible non-conducting materials and other materials.
- Assemblies, devices and systems embodying features of the invention may be used to cut and to collect tissue samples from within a patient's body.
- a skin incision is typically needed to access a body location to obtain a tissue sample. Skin incisions are often made using scalpels or other sharp cutting tools, although RF cutters may also be used.
- a distal cutter 20 may be used to make an initial skin incision, or, alternatively, another cutting instrument maybe used to cut through a patient's skin.
- a distal cutter 20 is effective to cut through body tissue below the skin to provide a path for the insertion of a shaft 14 into a desired location within a patient's body.
- Methods for removing a tissue specimen from within a body include placing a shaft 14 adjacent a tissue mass of interest located within a patient's body.
- a hollow tube 44 may be in place within the shaft 14 during insertion of a shaft 14 into a patient's body, or may be placed within the shaft after the shaft is inserted into a patient's body.
- Advancing the hollow tube 14 along ramp guide 24 out of a shaft aperture 26 exposes tissue to loop cutter 72 , which is effective to cut tissue surrounding the shaft.
- loop cutter 72 is a RF cutter
- loop cutter 72 is activated with RF energy during advancement outside of the aperture 26 .
- Distal advancement of the loop cutter 72 disposed about orifice 76 is effective to cut a swath of tissue, which may be sucked into orifice 76 by vacuum applied via tube bore 92 originating from a vacuum source 56 . Further distal advancement of loop cutter 72 brings it back into the shaft aperture 26 ; this movement, by bringing loop cutter 72 past aperture edge 27 , is effective to cut any tissue still connecting the tissue swath with the tissue bed. The completely severed tissue sample within tube bore 92 is drawn by vacuum proximally along the length of tube 44 , through vacuum line 52 and into tissue collection chamber 54 .
- one tissue sampling method embodying features of the invention includes placing a shaft 14 adjacent a tissue mass within a body; advancing a tissue extraction tube 44 with a flexible distal portion 70 and a distal cutting element 72 through the shaft bore 110 so that distal cutting element 72 and distal portion 70 advance at least partially out of aperture 26 and advance through tissue, cutting a tissue sample.
- cutting element 72 is a RF cutter, and RF power is applied to cutting element 72 as it advances, effective to cut tissue.
- Application of vacuum draws surrounding tissue towards hollow tube 44 , where it may be cut by the advancing cutting element 72 , providing a tissue sample.
- the above method may further include guiding the tube 44 by engaging the rail 96 with the channel 106 .
- Methods embodying features of the invention may also include guiding a hollow tube 44 out of an aperture 26 while the tube 44 travels over a ramp guide 24 .
- Methods further include activating an RF cutter 72 to cut tissue, and cutting tissue while a hollow tube 44 is guided out of an aperture 26 while the tube 44 travels over the ramp guide 24 .
- Applying vacuum to a proximal part 43 of a hollow tube 44 is effective to transport a tissue specimen proximally to a tissue collection chamber 54 .
- Tissue collection methods also include collection of multiple tissue samples. Multiple tissue samples may be collected from one location or from multiple locations using methods of the present invention.
- a method for collecting multiple tissue samples includes placing a shaft 14 adjacent tissue; advancing a tissue extraction tube 44 in a distal direction so that its distal end 70 and distal cutter 72 advance through tissue for a first time; cutting a first tissue sample; advancing a tissue extraction tube 44 in a distal direction so that its distal end 70 and distal cutter 72 advance through tissue for a second time; and cutting a second tissue sample.
- distal cutter 72 is a RF cutter and RF power is supplied to distal cutter 72 while tissue samples are taken.
- Distal end 70 and distal cutter 72 may be retracted in a proximal direction back within bore 110 between sample acquisitions.
- Preferred methods of collecting multiple samples include rotating the shaft 14 and tube 44 around a longitudinal axis 80 , preferably between collection of a first and a second sample. Such rotation may be accomplished by turning a thumbwheel, preferably to preset locations designated by detents or indentations. Alternatively, a shaft 14 and tube 44 may be rotated by an arbitrary amount. Rotational force may be applied manually, for example, by an operator's hand rotating a thumbwheel 32 , or by mechanical, electrical, or other means of providing rotational force.
- An advantage of this method is that multiple samples may be obtained from a single shaft position by rotating the shaft around a longitudinal axis while it remains inserted within a patient's body. Thus, multiple samples may be recovered from different positions oriented at designated radial positions around an initial biopsy site. In addition, the positions may be known and recorded by clinical operators, so that the locations from which samples were taken may be known.
- a shaft 14 may be moved in a longitudinal direction between sample acquisitions, as well as, or instead of, rotating the shaft between sample acquisitions.
Abstract
Devices, methods and systems for obtaining biopsy tissue samples are provided. Flexible hollow tubes with a rail and a tip cutting element advance within a shaft with an aperture and a bore having a ramp, so that the cutting element emerges from the aperture and cuts tissue as it moves over the ramp. Either or both shaft and bore may have guides, which may engage each other to guide the tube along a tissue cutting pathway. A tube may have a rail and the bore a channel which engages the rail and guides the tube. Cut tissue may be acquired and transported proximally within the tube by suction to a tissue collection chamber. Multiple tissue samples may be obtained from a single insertion point by rotation and/or translation of the shaft between biopsies.
Description
- This application is a continuation-in-part of application Ser. No. 09/619,867, filed Jul. 20, 2000, which is a continuation of application Ser. No. 09/618,685, filed Jul. 18, 2000, now abandoned, which is a continuation-in-part of application Ser. No. 09/159,467, filed Sep. 23, 1998, now U.S. Pat. No. 6,261,241, application Ser. No. 09/196,125, filed Nov. 20, 1998, and application Ser. No. 09/057,303, filed Apr. 8, 1998, now U.S. Pat. No. 6,331,166, which claims benefit of provisional application Ser. No. 60/076,973, filed Mar. 3, 1998; and a continuation-in-part of application Ser. No. 09/717,176, filed Nov. 16, 2000, which is a continuation-in-part of application Ser. No. 09/477,255, filed Jan. 4, 2000, which are all hereby incorporated herein by reference in their entireties, and from all of which priority is hereby claimed under 35 U.S.C. §119(e) and §120.
- This invention relates generally to the field of acquisition of tissue from a patient, as occurs in a biopsy procedure, in particular to the cuffing and removal of tissue from the biopsy site.
- In diagnosing and treating certain medical conditions, it is often desirable to perform a biopsy, in which a specimen or sample of tissue is removed for pathological examination, tests and analysis. Typically, it is desired that biopsy material be taken from locations having characteristics indicating the presence of disease. For example, breast biopsies may be taken where a suspicious lump or swelling is noticed in a breast. As is known, obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. The information obtained from these diagnostic tests and/or examinations is frequently used to devise a plan for an appropriate surgical procedure or other course of treatment. Examination of tissue samples taken by biopsy is of particular significance in the diagnosis and treatment of breast cancer.
- Thus, there is need in the art for devices and methods for collecting specimens from a biopsy site.
- The present invention is directed to collecting tissue samples from a biopsy site within a patient. A biopsy device having features of the invention has an elongated shaft with an inner bore and an aperture, and an elongated cutting member with a flexible distal portion and a tissue cutting member on the distal end. The elongated cutting member is at least in part movably disposed within the bore of the elongated shaft. The elongated cutting member is preferably open-ended, and preferably has a guide configured to direct movement of the flexible distal end. The shaft may be inserted into a patient's body for removal of tissue, such as a biopsy sample. Distal movement of the elongated cutting member within the bore of the shaft allows the flexible distal end to emerge from the shaft aperture to cut surrounding tissue. Tissue samples may be transported proximally by suction within a hollow elongated cutting member for collection.
- An embodiment of a biopsy device having features of the invention has an elongated shaft with an inner bore, a first guide extending along a distal shaft section which defines at least in part a tissue cutting pathway, and an elongated cutting member which is at least in part movably disposed within the bore of the elongated shaft. The elongated cutting member has a proximal section, a flexible distal section with an distal end and a tissue cutting member on the distal end. The elongated cutting member is preferably open-ended, with a second guide configured to engage the first guide on a distal section of the elongated shaft. The first and second guides cooperate to facilitate the movement of the elongated cutting member along the tissue cutting pathway.
- In general, devices embodying features of the invention include an elongated shaft with an inner bore, and an elongated cutting member configured to move within the bore. The elongated cutting member is preferably a hollow tube, termed a tissue extraction tube, with a flexible distal portion, a distal opening, and a cutter disposed around the opening. The cutter may be on the rim of the opening, or may be spaced distally from it; preferably, the cutter is spaced away from the rim of the opening. The shaft may be relatively stiff in comparison to the elongated cutting member, and preferably has a cutting element on its distal tip to facilitate accessing the tissue site. A shaft cutting element may be a sharpened tip, a cutter configured to puncture or cut tissue, a radiofrequency (RF) cutter, or other cutting element. The shaft cutting element is preferably spaced a distance away from the distal tip of the shaft.
- The shaft has a first guide, oriented in a substantially longitudinal direction, that is preferably disposed within the bore of the shaft. The elongated cutting member is configured to engage with the first guide, preferably with a cooperating second guide disposed on the elongated cutting member to facilitate following the tissue cutting pathway defined by the first guide. One of the guides may be, for example, a channel or slot, and the other guide may be, for example, a rail or a series of pins configured to slide within the channel or slot. The guides ensure that the motion of the elongated cutting member follows the desired tissue cutting pathway.
- The shaft also has an aperture in a portion of the distal side wall connecting the shaft bore with a region outside the shaft. Although an opening, the aperture is taken to define an imaginary surface that is the continuation of the shaft wall. In addition, in shafts embodying preferred features of the invention, the shaft internal bore includes a ramp on an inner surface disposed substantially opposite the aperture. In preferred embodiments, as viewed from a proximal-to-distal perspective, the ramp rises within the bore from the inner surface towards an imaginary center-line within the shaft, and, in particularly preferred embodiments, past the center-line towards the open aperture, and then descends back to the level of the inner wall surface of the bore. Preferably, a first guide, such as a channel, is disposed along at least a portion of the ramp.
- Elongated cutting members embodying features of the invention, such as tissue extraction tubes, are preferably configured to slide longitudinally within the bore of a shaft. In the following discussion, the elongated cutting member will be exemplified by a tissue extraction tube, although it will be understood that any elongated cutting member may be suitable. A second guide, such as a rail, is attached to at least a distal portion of the tube, and may extend along most or all of the length of the tube. In preferred embodiments, where the bore includes a ramp with a channel, and the tube has an attached rail engaged with the channel, longitudinal motion of a tissue extraction tube is guided by and follows the path defined by the channel. The flexibility of a tissue extraction tube embodying features of the invention allows it to substantially conform to the topography of the ramp. As such a tube moves distally within a bore having a ramp disposed opposite an aperture, the distal end of the tube rises, causing at least its distal tip to emerge from the shaft aperture under the guidance of the rail engaged with the channel. Further distal movement brings the distal end of the tube back down within the shaft again. In preferred embodiments, such distal movement places the distal tip of the hollow tube against the inner wall of the shaft distal tip within a structure termed a “cutting bowl.”
- Vacuum may be applied to a proximal portion of the tissue extraction tube to aspirate tissue specimens through the inner lumen of the tube. Systems include a carrier for mounting the shaft and for connecting the shaft and tube to a vacuum source and optionally to a radiofrequency power source.
- Methods for removing a tissue specimen from within a patient's body include placing the shaft adjacent a tissue mass of interest located within a patient's body, advancing the tissue extraction tube, and cutting a tissue sample. In preferred methods, a RF cutter is activated and tissue is cut with a RF cutter. As described above, distal advancement of the tissue extraction tube moves the tube distal end and the loop cutter out of, and then back into, the shaft aperture. As the hollow tube passes through tissue, the cutter on the distal tip of the hollow tube cuts a path through the tissue, and severs the separated tissue from the tissue bed in the cutting bowl as it re-enters the shaft bore at the distal end of the ramp. Vacuum may be used to attract and hold tissue against the shaft and tube. Vacuum from the same or from a separate source may be applied to the proximal part of the hollow tube to transport the severed tissue specimen proximally to a tissue collection chamber. Tissue collection methods also include collection of multiple samples. Multiple samples may be taken at multiple locations distally or proximally along an axis, and may be taken at multiple radial locations around an axis. For example, the shaft and tube may be partially rotated about the longitudinal axis of the device by turning a thumbwheel to sever and collect a plurality of specimens about the longitudinal axis of the device. The amount of rotation may be an arbitrary amount and may be a preset amount. A preset amount of rotation about a longitudinal axis of a device may be, for example, designated by detents.
- The need for separate collection and vacuum tubes is eliminated in the present invention since a tissue sample Is vacuumed into a collection tube as soon as it is cut by a cutter at the opening of the tube. By cutting and collecting samples with a single flexible tube that emerges from an aperture in the wall of a shaft, biopsy samples may be collected with only a single small incision, thus minimizing trauma to the patient and eliminating the need for a separate vacuum or sample acquisition tube. Rotation of the shaft allows biopsy collection from diverse radial locations, thus maximizing the sample collection volume while maintaining the minimal level of patient trauma. Radiofrequency cutters such as a radiofrequency cutting loop on the distal end of the hollow tube allow the ready acquisition of tissue with little resistance from or deformation of the tissue during sample acquisition, insuring that the samples are actually taken from the expected locations.
- These and other advantages will be further described in the following detailed description of embodiments of the invention. In the foregoing discussion, the primary biopsy site described is generally the human breast, although the invention may be used for collecting biopsy specimens from other parts of the human body and other mammalian body as well.
-
FIG. 1 is a perspective view of a system embodying features of the invention shown configured to begin taking a biopsy sample. -
FIG. 2A is a perspective view of a system embodying features of the invention, showing the flexible distal portion of a tissue extraction tube emerging from the aperture. -
FIG. 2B is a detailed perspective view of the distal portion of the shaft and tube of the device shown inFIG. 2A showing the advancing distal end of the flexible tube in cutting position along the tissue cutting pathway defined in part by the ramp. -
FIG. 3A is a perspective view of the device ofFIGS. 1 and 2 configured with the tissue extraction tube fully advanced within the shaft, with the distal tip of the flexible tissue extraction tube fully extended past the aperture into the cutting bowl. -
FIG. 3B is a longitudinal cross-sectional view of the distal portion of the shaft and tube of the device shown inFIG. 3A showing the distal end of the flexible tube fully extended along the tissue cutting pathway over the ramp with its distal tip within the cutting bowl at the distal end of the aperture, after it has cut a tissue specimen. -
FIG. 4 is a perspective view of a shaft and of a flexible tissue extraction tube embodying features of the invention shown lying next to each other in positions corresponding to the relative positions taken by these elements when in place in the assembled device. -
FIG. 5A is a side, cross-sectional elevation view of the distal tip and loop electrode of a tissue extraction tube embodying features of the invention. -
FIG. 5B is a side, cross-sectional elevation view of the distal tip and loop electrode of an alternative embodiment of a tissue extraction tube embodying features of the invention. -
FIG. 5C is a side, cross-sectional elevation view of the proximal tip of a tissue extraction tube embodying features of the invention showing a luer lock vacuum connection and a conductor for connecting a radiofrequency electrode connection to a source of radiofrequency power. -
FIG. 5D is a perspective, cross-sectional view of half of the distal tip of a tissue extraction tube embodying features of the invention. -
FIG. 5E is a side, cross-sectional view of the proximal tip of an elongated shaft embodying features of the invention showing a vacuum connection and vacuum port and a radiofrequency electrode connection. -
FIG. 6A is a transverse cross-sectional view of a tissue extraction tube with an attached rail embodying features of the invention taken along line 6A-6A ofFIG. 4 . -
FIG. 6B is a transverse cross-sectional view of a shaft embodying features of the invention taken alongline 6B-6B ofFIG. 4 of the invention, showing vacuum ports, an internal bore and a channel running along the ramp seen distally of the section. -
FIG. 6C is a transverse cross-sectional view of a shaft and a flexible tube taken alongline 6C-6C ofFIG. 3A with the tube in position along a channel on a ramp within the shaft. -
FIG. 1 is a perspective view of asystem 10 embodying features of the invention, including atissue acquisition assembly 12, a source of radiofrequency (RF)power 38 and avacuum source 56. Thetissue acquisition assembly 12 has ashaft 14 with adistal tip 16 at the end ofdistal portion 18.Shaft 14 preferably has adistal tip cutter 20 disposed on thedistal tip 16. Theshaft 14 is an elongated structure oriented along alongitudinal axis 80 that serves to define distal and proximal directions and aradial direction 82 perpendicular toaxis 80. A center line within the shaft lies generally alongaxis 80. -
Distal tip cutter 20 has a cutting surface effective to cut through tissue, opening up a path through whichdistal portion 18 ofshaft 14 may be inserted, thus aiding in the placement ofshaft 14 within a patient's body. A cutting surface may be any surface configured to cut tissue, e.g., by having a sharp edge, by having a thin cross-section, by being hard, by conducting radiofrequency energy, or by any combination of these or other properties. A cutter, or equivalently, a cutting element, may include supporting surfaces and structures in addition to cutting surfaces and structures.Distal tip cutter 20 is preferably spaced away from the shaftdistal tip 16.Shaft 14 may have any cross-sectional shape, including round, square, hexagonal, or other shape. Whereshaft 14 has circular cross-section, the width ofshaft 14 is given by the radius of the circle. In further preferred embodiments,distal cutter 20 may extend radially to a distance greater than the width, or radius, of ashaft 14.Distal cutter 20 may also be made from multiple cutting elements; e.g., adistal cutter 20 embodying features of the invention may be made from a pair of wires configured to carry RF energy. For example, as shown inFIG. 1 , and in greater detail inFIG. 2B ,distal cutter 20 may include two curved wires configured to carry RF energy that are separated from, and extend distally from,shaft tip 16. Preferably, a pair of wires making up adistal cutter 20 are oriented substantially along a plane, most preferably a plane including a diameter of ashaft 14, so that the wires extend in directions separated by about 180°. Cutting elements, such as a wire or wires, making up adistal cutter 20 may be rigidly mounted to adistal tip 16, or may be flexibly mounted to adistal tip 16. For example, a flexibly mounted cutting element may spring back outwardly to a deployed configuration after having been inwardly compressed within a cannula. - The shaft
distal portion 18 also includes a cuttingbowl 22 and aramp guide 24, visible throughaperture 26, which provides access to them. Aramp guide 24 may be any structure within ashaft 14 having a surface with contours that include tangents not substantially parallel to a shaft longitudinal axis. Such a surface may be termed a non-axial surface. The inner radius of the shaft bore thus changes in a longitudinal direction along the length of a ramp disposed within the bore of the shaft. Aramp guide 24 may have a flat surface, having parallel tangent lines when tangents are taken at various positions along theramp guide 24; such aflat ramp guide 24 may be termed a linear non-axial surface. Alternatively, aramp guide 24 may have a curved surface, having tangent lines that are not parallel when tangents are taken at various positions along theramp guide 24. Aramp guide 24 having such a curved surface may be termed a non-linear non-axial surface. In preferred embodiments, aramp guide 24 includes non-linear non-axial surface portions. For example, theramp guide 24 shown inFIGS. 2A and 2B has a non-linear non-axial surface. - The
ramp guide 24 is shown rising from within the shaft to a level near that of the level of theaperture 26. The level of anaperture 26 is taken to be the level of the surrounding wall surface extended across the opening of theaperture 26. Where the surrounding wall is curved, the extension of the curved surface is also taken to have the same curvature. Aramp guide 24 may be entirely below the level of theaperture 26, or may rise to a level equal to, or greater than, the level of theaperture 26. - Cutting
bowl 22 is bounded proximally byramp guide 24 and is defined radially by shaftinner wall 84.Aperture 26 is an opening in the wall ofshaft 14, shaftouter wall 86 extending from all directions to theaperture edge 27. Vacuum vents 28, shown here disposed on shaftdistal portion 18 nearaperture 26, are useful for pulling and holding tissue againstshaft 14 and cuttingbowl 22 when ashaft 14 is placed within a patient's body. - A
vacuum inlet connector 30 is disposed on aproximal portion 31 ofshaft 14 for connecting to a vacuum line connected to a source of vacuum for providing vacuum to vacuum vents 28.Thumbwheel 32, also disposed on shaftproximal portion 31, enables an operator to manually rotateshaft 14 aroundlongitudinal axis 80 to orientaperture 26 so that it opens in a variety ofradial directions 82 towards bodytissue surrounding shaft 14.RF connector 34 provides RF energy to cuttingelement 20.RF connector 34 may be configured to provide RF power during rotation of the shaft, for example, whereRF connector 34 is a conductive ring as shown inFIG. 1 .RF cable 36 leads toRF power source 38. Radiofrequency cutters may be monopolar or bipolar; a monopolar cutting surface is connected to one conductor leading to a source of radiofrequency energy, and requires a separate ground or indifferent electrode to be placed in contact with a patient's body in order to cut a patient's body tissue. A bipolar radiofrequency cutting surface includes at least two conductors, each connected to different conductors connected to a radiofrequency energy source, so that the bipolar radiofrequency cutting surface does not require a separate ground or indifferent electrode in order to operate. Wheredistal cutter 20 is a monopolar RF cutter,RF power source 38 may be connected toconductor 40 andground pad 42 which may be placed in electrical contact with a patient's body to provide a complete electrical circuit. Wheredistal cutter 20 is a bipolar RF cutter,conductor 40 andground pad 42 are not necessary. -
Tissue acquisition assembly 12 also includes atissue extraction tube 44 configured to slide intoshaft 14. An exposedproximal portion 43 of atissue extraction tube 44 having features of the invention is shown inFIG. 1 .RF connection 46, which carries RF energy obtained from an operable electrical connection toRF cable 48 leading toRF power source 38, provides RF energy totissue extraction tube 44.Tube 44 has avacuum connector 50 disposed on itsproximal portion 43 that is configured to mate with acomplementary vacuum connector 51 which provides an operable connection tovacuum line 52 connected to vacuumsource 56.Vacuum line 52 is preferably a flexible vacuum hose. Vacuum applied to thetissue extraction tube 44 is effective to draw tissue towards thetube 44 and to transport severed tissue samples within the hollowtissue extraction tube 44 towards thevacuum source 56. Atissue collection chamber 54 may be placed in or near thevacuum line 52 orvacuum source 56 in order to retain tissue samples for analysis. - Thus, a
tissue extraction tube 44 is preferably a hollow elongated tubular member with openings at both ends that is configured to sever a sample of tissue from within a body. Atissue extraction tube 44 may be used to acquire biopsy samples from a patient and may also be used to transport a tissue sample out of the body to, for example, a tissue collection chamber. A center line within atube 44 lies generally along a local longitudinal axis. The center line of one portion of a straight tube is also a center line for other portions of that straight tube. A tissue extraction tube typically has a flexible portion and is capable of assuming a non-linear configuration during use (it may bend or curve), such that at least a portion of the tube wall may approach or cross a center line defined by another portion of the tube. The flexible part of a tissue extraction tube may be limited to only a portion, such as a distal portion; alternatively, a tissue extraction tube may be flexible along its entire length. - A
shaft 14 andtissue extraction tube 44 embodying features of the invention may be mounted onto asupport frame 58 effective to secure and guide them before, during, and after tissue sample collection. Thesupport frame 58 illustrated inFIG. 1 includes adistal brace 60 configured to hold ashaft 14 while allowing its rotation and aproximal brace 62, configured to hold atube 44.Braces shaft 14 andtube 44 while allowing their rotation.Braces Proximal brace 62 is configured to move longitudinally along support beams 64 while being substantially prevented from lateral (radial) movement. Similarly,vacuum support 66 is configured to move freely along support beams 64 in longitudinal directions but not in radial directions. It will be understood that, in embodiments of the invention, asingle support beam 64, or a plurality of support beams 64 may be used to hold and guide either or both of abrace 62 and asupport 66. In preferred embodiments, and as illustrated inFIG. 1 , springs 68 (betweenproximal brace 62 and vacuum support 66) and 69 (betweendistal brace 60 and proximal brace 62) aid in proper positioning of components at rest and during use.Springs tissue extraction tube 44 andproximal brace 62 automatically retract.Spring 69 is preferably stronger thanspring 68 in order to insure that the connection withvacuum source 56 is maintained while cutting.Spring 68 also cushions contact betweenproximal brace 62 andvacuum support 66.Vacuum line 52, being connected to vacuumsupport 66, is carried along by any longitudinal movement ofvacuum support 66, maintaining its operable connection to vacuumsource 56 andtissue collection chamber 54 even during movement of thetissue extraction tube 44. - As illustrated in
FIG. 1 ,shaft 14 andtissue extraction tube 44 may be configured so that distal movement of thevacuum support 66 towardsproximal brace 62 bringsspring 68 into contact withproximal brace 62, urgingproximal brace 62 distally towardsdistal brace 60, to compressspring 69 and to movetissue extraction tube 44 distally withinshaft 14. - As illustrated in
FIG. 2A and 2B , longitudinal movement of atissue extraction tube 44 within ashaft 14 causes thedistal portion 70 oftube 44 to travel alongramp guide 24 and to emerge fromaperture 26. Vacuum vents 28 are disposed along shaftouter wall 86 at locations near theaperture edge 27adjacent aperture 26 and at locations somewhat removed fromaperture 26.Vents 28 serve to attract and hold tissue near to thedistal portion 18 ofshaft 14 and to cuttingbowl 22. - The distal portion of
tube 44 includes aloop cutter 72 disposed on therim 74 of theorifice 76 leading into thehollow interior 92 oftube 44.Loop cutter 72 may be any cutting element, such as a sharp blade; however,loop cutter 72 is preferably a RF cutter, such as a loop of conducting wire operably connected to aRF power source 38. A loop cutter may be formed from any loop-shaped cuffing surface, such as a wire, band, ribbon or strip of material, shaped as a loop, whether circular, elliptical, polygonal, or irregular in cross-section. Aloop cutter 72 may be a continuous loop in the shape of a closed loop, or may be discontinuous, in the shape of a partial loop such as a loop with ends that do not fully connect with one another, or be made up of more than one separate cutting elements arrayed about therim 74 of anorifice 76 in a loop shape. In some embodiments, aloop cutter 72 may be spaced distally from therim 74 oforifice 76. Acutter support 73 or plurality of cutter supports 73 may connect with acutter 72 in order to support acutter 72 at a position distal to therim 74 of anorifice 76. - When supplied with RF power, or when it includes a sharp cutting edge, or other cutting element,
loop cutter 72 is effective to cut body tissue with which it comes into contact. Insertion of adistal portion 18 ofshaft 14 into a patient's body, and the application of suction through vacuum vents 28 andtube orifice 76, are each effective to bring tissue into contact with a cuttingloop 72 disposed outside anaperture 26. Movement ofloop cutter 72 through body tissue is effective to cut a portion of body tissue. The body tissue may be drawn intoorifice 76 by action of the forward (distal) motion oftube 44 and by suction fromvacuum source 56 applied byvacuum line 52 to vacuuminlet connector 50 and to thehollow interior 92 oftube 44. Thus, when ashaft 14 holding atissue extraction tube 44 is disposed within a patient's body, forward motion oftube 44 alongramp guide 24 bringing cuttingloop 72 into contact with body tissue adjacent shaftdistal portion 18 is effective to cut a swath or strip of tissue from within a patient's body. - As shown in
FIG. 2B , viewed from a proximal to distal direction, ramp guide 24 angles upward to a maximum and then descends again into cuttingbowl 22 defined proximally by the ramp and radially by shaftinner wall 84.Tube 44 is shown angling upward with itsdistal tip 74 andorifice 76 positioned approximately mid-way along theramp guide 24. This corresponds to a configuration wherevacuum tube support 66 andproximal brace 62 are situated approximately mid-way along the extent of their effective longitudinal travel distance on support beams 64. - Cutting
loop 72 moves through tissueadjacent aperture 26 astissue extraction tube 44 moves in a distal direction alongramp guide 24. The path taken by cuttingloop 72 is determined by the guides of theshaft 14 and oftube 44, such aschannel 106 andrail 96, which constrain the motion oftube 44 and of cuttingloop 72 along a tissue cutting pathway defined bychannel 106, the shaft guide shown inFIG. 2B . The orientation ofshaft 14 within a patient's body, including the radial orientation ofaperture 26, thus determines the point of origin of the tissue samples removed from the patient. -
FIG. 2B also shows guides rail 96 andchannel 106, which are shown in greater detail in later figures.Rail 96 is attached totube 44, and engageschannel 106 so that movement oftube 44 is constrained in radial directions, but not longitudinal directions, by the tissue cutting pathway defined bychannel 106. Thus, when engaged with achannel 106, arail 96 follows the tissue cutting pathway defined by thechannel 106. As shown inFIG. 2B ,channel 106 lies alongramp guide 24 and along shaftinner wall 84 withinshaft 14, and follows the contours of shaftinner wall 84 andramp guide 24; in particular, in the region oframp guide 24,channel 106 defines a non-linear non-axial pathway withinshaft 14. The engagement betweenrail 96 andchannel 106 is effective to guidetube 44 up the ascending portion oframp guide 24 and down the descending portion oframp guide 24 astube 44 moves in a distal direction past the position shown inFIG. 2B . In general, arail 96 may be any elongated element configured to engage achannel 106. Achannel 106 is typically much longer than it is wide, its length defining a longitudinal direction and its width defining a radial direction. Arail 96 engaged with achannel 106 is able to move readily in a longitudinal direction, while its motion in a radial direction is constrained by thechannel 106. These directions may be applicable to theentire channel 106, if thechannel 106 is straight, or may be merely local directions, if thechannel 106 is curved. - In
FIGS. 3A and 3B ,tube 44 is shown advanced to a maximal distal extent.Tube 44 follows an arc-like path as it climbs up and then down along theramp guide 24. As shown inFIG. 3A ,vacuum tube support 66 andproximal brace 62 have moved distally to the full extent of their effective longitudinal travel distance on support beam** 64, pushingtube 44 to its full travel withinshaft 14, out ofaperture 26, and placing at least part of tissue extraction tubedistal portion 70 into cuttingbowl 22. A ramp embodying features of the invention may have any contour effective to expose acutting loop 72 to body tissue as atube 44 moves longitudinally along a tissue cuffing pathway lying on or along the ramp. Aramp guide 24 may ascend and descend with little or no transition portion between ascending and descending portions, or may alternatively include an extended level plateau portion between ascending and descending ramp portions. In such alternative configurations, atube 44 assumes a configuration conforming to that ramp profile by angling upward, lying level over the plateau portion, and then angling downward into the cuttingbowl 22 at its most distal extent. - As
loop cutter 72 advances in a distal direction alongramp guide 24, cutting a swath of tissue from a tissue bed, a distal, connecting portion of the tissue swath remains attached to the body tissue mass. However, theloop cutter 72 descends into cuttingbowl 22 as it advances along the distal, descending portion oframp guide 24 near its maximal distal travel. As shown inFIG. 3B , within the cuttingbowl 22, theloop cutter 72 is no longer in contact with the tissue bed adjacent the shaftdistal portion 18. The descent ofloop cutter 72 into cuttingbowl 22,past aperture edge 27 severs the connecting portion of the tissue swath, freeing the swath of body tissue from the tissue bed and providing an isolated tissue sample. Vacuum withintube 44 draws the tissue sample proximally within thehollow interior 92 oftube 44 intovacuum line 52 and totissue collection chamber 54. - Cutting
loop 72 disposed ontube rim 74 is illustrated in cross-section within cuttingbowl 22 inFIG. 3B . In that figure,tube 44 assumes an arc-like configuration alongramp 44, with a part ofdistal tube portion 70 within cuttingbowl 22. That position may be achieved by distal movement of cuttingloop 72 from a position whereorifice 76 isoutside aperture 26 to a position whereorifice 76passes aperture edge 27 to assume a position within cuttingbowl 22 as shown in the figure. Distal movement oforifice 76 and cuttingloop 72past aperture edge 27 is effective to sever the strip of tissue connecting a tissue swath with the external tissue bed adjacent shaftdistal portion 18.FIG. 3B also showsvacuum chamber 88 which supplies vacuum vents 28. The connection ofvacuum chamber 88 to vacuumport 30, provided byvacuum ports 90, is illustrated inFIGS. 5D and 6B . -
FIG. 4 showsshaft 14 andtissue extraction tube 44 disposed along side one another.Tissue extraction tube 44 is preferably somewhat longer thanshaft 14, so thattube 44 may be inserted within shaft bore 110 with tubedistal portion 70 fully extended into cuttingbowl 22 and still allowproximal end 43 oftube 44, with itsvacuum connection 50, to extend proximally beyond thevacuum connection 30 andthumbwheel 32 at shaftproximal portion 31.FIG. 4 also illustrates optional radial indents 94 onRF connector 34 which may be used to help to holdshaft 14 in a desired radial orientation after rotation of theshaft 14, as by turningthumbwheel 32. Pins, detents, or other devices may be used to engageindents 94 effective to secure the position ofshaft 14. -
FIG. 4 also showsrail 96 attached totube 44. As illustrated in this figure,rail 96 extends along the length oftube 44; however, in other embodiments, arail 96 may extend along only a distal portion oftube 44 and may be absent along aproximal portion 43 of atissue extraction tube 44. Arail 96 is securely attached totube 44, and in some embodiments of the invention may be an integral part of atube 44. Control of the movement of arail 96 is also effective to control the movement of atube 44 to which is attached or of which it is a part. Thus, engagement of arail 96 with achannel 106 is effective to guide the movement of atube 44 along aramp guide 24. For example,rail 96 is effective to guidetissue extraction tube 44 into the arc-shaped path lying overramp guide 24 as illustrated inFIGS. 2A-2B and 3A-3B. - A
distal portion 70 of atissue extraction tube 44 embodying features of the invention is shown inFIG. 5A . Theorifice 76 oftube 44 leads in a proximal direction to tube bore 92;loop cutter 72 is disposed onrim 74 oftube 44 and about theorifice 76 in the embodiment shown inFIG. 5A . Theloop diameter 98 ofloop cutter 72 is preferably smaller than theinner diameter 100 oforifice 76, insuring that the dimensions of a tissue swath cut byloop cutter 72 are small enough to fit within tube bore 92. As illustrated inFIG. 5A , cuttingloop 72 is connected to tubeRF connection wire 102 which runs in a longitudinal direction alongtube 44 withinrail 96. - An
alternative tube guide 97 is shown inFIG. 5B . A series ofpins 97 havingheads 99 are disposed in a linear arrangement along a surface of atube 44.Pins 97 and heads 99 are configured to fir into and engage a shaft guide, such as achannel 106 as illustrated in other Figures, effective to guide movement of atube 44 along a tissue cutting pathway. - A
proximal portion 43 of atissue extraction tube 44 embodying features of the invention is shown inFIG. 5C . In this embodiment, rail 96 (including RF connection wire 102) extends along the entire length of thetube 44.External RF connector 46, which includes a conductive ring around the diameter oftube 44, is operably connected toRF connection wire 102 as shown, allowingtube 44 to rotate while maintaining effective electrical contact withRF power source 38.FIG. 5C also illustrates a luerlock vacuum connection 50 configured to engage avacuum connection 51 orvacuum line 52 leading to avacuum source 56, effective to supply vacuum to tube bore 92. - As illustrated in
FIG. 5D , a cuttingbowl 22 within the shaftdistal portion 18 has a distalinner wall 108 which serves to limit the distal movement of atube 44 disposed within abore 110 of ashaft 14 embodying features of the invention. Shaftinner wall 84 forms the remainder of the boundary defining cuttingbowl 22, while shaftouter wall 86 extends up toaperture edge 27 to define the outer surface ofshaft 14 and the outer perimeter ofaperture 26. This figure also showsvacuum chamber 88 which provides vacuum to vacuum vents 28. Vacuum vents 28 aid in drawing tissue toshaft 14 so that a cuttingloop 72 has sufficient nearby tissue from which to cut a tissue sample.Vacuum ports 90 withinshaft 14 connectvacuum chamber 88 withvacuum source 56 viavacuum connections vacuum line 52. - The
proximal portion 31 of ashaft 14 embodying features of the invention is illustrated inFIG. 5E , showingRF connector 34 operably connected toshaft RF wire 114 to provide an electrical connection effective to supply RF power todistal cutter 20. As shown,vacuum connector 30 leads to vacuumport 90 so that vacuum provided throughconnector 30 has access tovacuum port 90 at all radial orientations ofshaft 14. O-ring 112 provides a vacuum-tight seal allowing rotation ofshaft 14 while maintaining an effective vacuum connection. - Transverse cross-sections of a
tube 44 andshaft 14 embodying features of the invention are shown inFIGS. 6A-6C .FIG. 6A shows a transverse cross-section of atube 44 taken along line 6A-6A ofFIG. 4 , and illustrates a suitable configuration for the attachment of arail 96 with atube 44.Tube electrode wire 102, which supplies cuttingloop 72 with RF power, is insulated by the non-conductive material ofrail 96 surrounding it, and also provides strength to rail 96. As shown inFIG. 6B , illustrating a transverse cross-section of ashaft 14 taken alongline 6B-6B ofFIG. 4 ,vacuum ports 90 and shaft electrode wires 114 (which provide RF power to distal cutter 20) may be disposed within the wall ofshaft 14.Ramp guide 24 andchannel 106 may also be seen inFIG. 6B , which is a view looking in the distal direction. -
FIG. 6C is a transverse cross-sectional view, taken alongline 6C-6C ofFIG. 3A , of ashaft 14 and atube 44 engaged together. The cross-section ofFIG. 6C is taken at a position where theramp guide 24 has risen to a level near to the level ofaperture 26, exposingtube 44 to a maximal extent to the region outside theshaft 14. Thus,tissue extraction tube 44 is shown in cross-section inFIG. 6C at the point of its greatest excursion out ofbore 110outside aperture 26, at the peak oframp guide 24. Such radial excursion of thetube 44 outside theaperture 26 is effective to allowloop cutter 72 to cut tissue fromregions surrounding shaft 14.Rail 96 remains engaged withchannel 106 during longitudinal movement oftube 44, and such engagement is effective to guide distal portions oftube 44 down a distal portion oframp guide 24 into cuttingbowl 22.FIG. 6C also shows thevacuum chamber 88 disposed belowramp guide 24 andchannel 106.Shaft electrode wires 114 leading todistal cutter 20 are also shown, as are vacuum vents 28. - The invention provides assemblies, devices, and systems for obtaining tissue samples from within a patient's body.
Assemblies 12 includeshafts 14 andtissue extraction tubes 44 having features of the invention, withtubes 44 disposed at least in part withinshafts 14 for example, as described above.Systems 10 includetissue acquisition assemblies 12 in conjunction with some or all of, for example, asupport frame 58, aRF power source 38, avacuum source 56, and atissue collection chamber 54. These and other elements may be operably connected together with some or all of, for example, aRF cable vacuum line 52, and aground pad 40 andground cable 42. - A suitable source of radiofrequency energy is effective to provide radiofrequency energy of between about 35 W and about 150 W, preferably between about 50 W and about 100 W. The radiofrequency energy may suitably have a frequency of between about 0.1 MHz and about 10 MHz, preferably between about 0.3 MHz and about 1.2 MHz.
- A
tissue extraction tube 44 embodying features of the invention may be made with any flexible, biocompatible material. Such atube 14 is preferably made with a flexible, non-conducting biocompatible material. Suitable materials include, but are not limited to, silicon rubber, latex and other natural and synthetic rubber materials, nylon, polyethylene block amides (such as Pebax®), thermoplastic elastomers, such as, for example, Kraton and C-Flex, and including thermoplastic polyester elastomers (e.g., Hytrel®), and other polymers, polymer blends and copolymers of polymers, including but not limited to polyacrylonitrile, polyamide, polynitrile, polyolefin, polyurethane, polyvinyl chloride, and other flexible non-conducting materials. -
Tube 44 may include a strengtheningfilament 78 on or within its wall, shown here as a spiral coil;filament 78 may alternatively be in the configuration of a ring or rings, a braid, multiple longitudinal strips, or other configurations. A strengtheningfilament 78 is effective to add strength to a flexible tube, providing radial strength to prevent vacuum from causing the tube to collapse, and allowing a tube to bend without breaking or tearing. A strengthening filament may be any elongated object, such as a cord, band or other thin strip of material, and may be embedded in or attached to the tube wall. A strengthening filament may be straight, curved, coiled, ring-shaped, spiral-shaped, braided with other strengthening filaments, another shape or any combination of shapes. Strengtheningfilaments 78 are preferably non-conductive, and may be made from materials including, but not limited to, glass fiber, polymers such as, for example, Kevlar®, polyesters, other polymers, polymer blends and copolymers of polymers, including but not limited to polyacetal, polyacrylonitrile, polyamide, polyethylene including high density polyethylene (HDPE), polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polyurethane, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene fibers, polyvinyl chloride, and other materials such as graphite fibers. Strengthening filaments may also be made with filled materials, such as glass or mineral-filled polymers such as glass-filled polyester, mica-filled polysulfone, other filled polymers and other filled materials. - A
rail 96, series ofpins 97, or other tube guide embodying features of the invention may be made with a durable, biocompatible material, which is preferably non-conducting and may be flexible. Suitable materials include HDPE, polyetheylene, polyacrylonitrile, polyacetal, polyamide, polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene polymers, polyurethane, polyvinyl chloride, Pebax®, Hytrel®, acrylonitrile-butadiene-styrene (ABS), glass- or mineral-filled polymers, such as glass-filled polyester, mica-filled polysulfone, other filled polymers and other filled materials and other biocompatible non-conducting materials. As shown inFIG. 6A , a rail may enclose aRF connection wire 102. - A
shaft 14 may be made of any suitably strong biocompatible material, and preferably a non-conductive material. Thus, ashaft 14 may be made from a biocompatible polymer, composite, such as a graphite composite and an epoxy-bound braid of glass or nylon; ceramic, or other material. For example, polycarbonate is a strong and durable biocompatible material. Other suitable materials include other plastics including thermoplastics and polymers, and co-polymers, polymer alloys and polymer mixtures. Suitable materials include HDPE, polyetheylene, polyacrylonitrile, polyacetal, polyamide, polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene polymers, polyurethane, polyvinyl chloride, Pebax®, Hytrel®, acrylonitrile-butadiene-styrene (ABS), glass- or mineral-filled polymers, such as glass-filled polyester, mica-filled polysulfone, other filled polymers and other filled materials and other biocompatible non-conducting materials. A shaft may be made from or include a metal, such as stainless steel. A metal may be coated with a ceramic, Teflon®, a polymer such as polyimide, or with any other biocompatible coating. A guide, such as achannel 106 disposed on ashaft 14, may be made of the same material as ashaft 14, may be made of a different material chosen from materials suitable for making ashaft 14, or may further include other materials or coatings. For example, a material or coating having a low coefficient of friction, such as Teflon®, may be used in the manufacture of a guide. -
Rail 96 andchannel 106 as shown in the Figures and described above are particular examples of guides; other guides configured to cooperate together to guide the motion of atissue extraction tube 44 along ashaft 14 are also suitable for the practice of the invention. Thus, it will be understood that suitable guides include any elements configured to engage each other and to guide the movement of a tissue extraction tube along a tissue cutting pathway. Guides embodying features of the invention need not be continuous, unitary elements, nor need they extend along the entire length of a shaft or tube embodying features of the invention. For example, as illustrated inFIG. 5B , a guide may be a series of pins or protuberances configured and aligned so as to engage a channel. It will be understood that a shaft may have a rail, and a tube may have a channel, and that other possible configurations of guides are suitable for the practice of the invention. It will further be understood that a shaft and a tube may each, or singly, have multiple guides, such as, for example, a pair of rails configured to engage a pair of channels, or a plurality of pins aligned in a row or rows so as to fit within a slot or slots, or a multitude of parallel runners configured to engage and slide along a multitude of tracks. In further embodiments, devices embodying features of the invention may have a tube with a rail configured to move within a channel, the tube also having one or more runners configured to slide along a track or tracks. - In addition, it will be understood that in embodiments of the invention, a shaft need not have a guide. In such embodiments, a tissue extraction tube may have a guide configured to direct the movement of the flexible distal portion without engaging with another guide. Such embodiments include devices having flexible, curved guides disposed along a distal portion of a tissue extraction tube configured to direct a distal tip of the tissue extraction tube back towards a cutting bowl after the distal tip has been deflected radially out of a shaft aperture during distal movement along a shaft. Such flexible, curved guides may be ramp-shaped, and may cause the flexible distal end of a tube to assume a ramp shape as it emerges from an aperture. For example, the open
distal end 76 of atissue extraction tube 44 with a ramp-shaped curved guide on itsdistal portion 70 will emerge from theshaft aperture 26 as thedistal portion 70 of thetube 44 moves distally and climbs up aramp 24, enabling itsloop cutter 72 to cut tissue; further distal movement of thetube 44 guided by the curved guide allows the flexibledistal portion 70 to re-enteraperture 26, to enter cuttingbowl 22, and to partially or completely conform to theramp 24 when thetube 44 is extended distally along a shaft. Such flexible curved guides may be made from previously discussed materials, or other materials, such as memory materials and spring materials. Memory materials include, for example, memory metals such as nickel titanium alloys, and spring materials include plastic spring materials and metal spring material, such as, for example, spring steel. -
Aperture 26 is illustrated in the Figures as an uncovered opening through the wall ofshaft 14. In some embodiments of the devices of the invention,aperture 26 is covered by a movable aperture cover. In some methods of collecting tissue samples embodying features of the invention, an aperture cover is in place over anaperture 26 during placement or removal ofshaft 14 at or from a desired location within a patient's body, and the cover is moved during collection of a tissue sample so as to exposeaperture 26. - Preferably, the systems, assemblies and devices embodying features of the invention are made from materials that are suitable for sterilization, including ultraviolet, chemical and radiation sterilization. Such sterilizable materials include metals, glasses, ceramics, composites, plastics, thermoplastics and thermoplastic elastomers, and other polymers including, but not limited to polyethylene, HDPE, Kevlar®, C-Flex, polypropylene, polyacrylonitrile, polyamide, polyethylene terephthalate, polyimide, poly(methyl)methacrylate, polynitrile, polyolefin, polypropylene, polystyrene, polysulfone, polytetrafluoroethylene (Teflon®) and other fluorinated ethylene polymers, polyurethane, polyvinyl chloride, and other biocompatible non-conducting materials and other materials.
- Assemblies, devices and systems embodying features of the invention may be used to cut and to collect tissue samples from within a patient's body. A skin incision is typically needed to access a body location to obtain a tissue sample. Skin incisions are often made using scalpels or other sharp cutting tools, although RF cutters may also be used. A
distal cutter 20 may be used to make an initial skin incision, or, alternatively, another cutting instrument maybe used to cut through a patient's skin. Adistal cutter 20 is effective to cut through body tissue below the skin to provide a path for the insertion of ashaft 14 into a desired location within a patient's body. Methods for removing a tissue specimen from within a body include placing ashaft 14 adjacent a tissue mass of interest located within a patient's body. Ahollow tube 44 may be in place within theshaft 14 during insertion of ashaft 14 into a patient's body, or may be placed within the shaft after the shaft is inserted into a patient's body. Advancing thehollow tube 14 alongramp guide 24 out of ashaft aperture 26 exposes tissue toloop cutter 72, which is effective to cut tissue surrounding the shaft. Whereloop cutter 72 is a RF cutter,loop cutter 72 is activated with RF energy during advancement outside of theaperture 26. Distal advancement of theloop cutter 72 disposed aboutorifice 76 is effective to cut a swath of tissue, which may be sucked intoorifice 76 by vacuum applied via tube bore 92 originating from avacuum source 56. Further distal advancement ofloop cutter 72 brings it back into theshaft aperture 26; this movement, by bringingloop cutter 72past aperture edge 27, is effective to cut any tissue still connecting the tissue swath with the tissue bed. The completely severed tissue sample within tube bore 92 is drawn by vacuum proximally along the length oftube 44, throughvacuum line 52 and intotissue collection chamber 54. - Thus, one tissue sampling method embodying features of the invention includes placing a
shaft 14 adjacent a tissue mass within a body; advancing atissue extraction tube 44 with a flexibledistal portion 70 and adistal cutting element 72 through the shaft bore 110 so thatdistal cutting element 72 anddistal portion 70 advance at least partially out ofaperture 26 and advance through tissue, cutting a tissue sample. Preferably, cuttingelement 72 is a RF cutter, and RF power is applied to cuttingelement 72 as it advances, effective to cut tissue. Application of vacuum draws surrounding tissue towardshollow tube 44, where it may be cut by the advancing cuttingelement 72, providing a tissue sample. The above method, whereshaft 14 has a guide such as achannel 106 andtube 44 has a guide such as arail 96, may further include guiding thetube 44 by engaging therail 96 with thechannel 106. Methods embodying features of the invention may also include guiding ahollow tube 44 out of anaperture 26 while thetube 44 travels over aramp guide 24. Methods further include activating anRF cutter 72 to cut tissue, and cutting tissue while ahollow tube 44 is guided out of anaperture 26 while thetube 44 travels over theramp guide 24. Applying vacuum to aproximal part 43 of ahollow tube 44 is effective to transport a tissue specimen proximally to atissue collection chamber 54. - Tissue collection methods also include collection of multiple tissue samples. Multiple tissue samples may be collected from one location or from multiple locations using methods of the present invention. A method for collecting multiple tissue samples includes placing a
shaft 14 adjacent tissue; advancing atissue extraction tube 44 in a distal direction so that itsdistal end 70 anddistal cutter 72 advance through tissue for a first time; cutting a first tissue sample; advancing atissue extraction tube 44 in a distal direction so that itsdistal end 70 anddistal cutter 72 advance through tissue for a second time; and cutting a second tissue sample. In preferred methods of collecting multiple samples,distal cutter 72 is a RF cutter and RF power is supplied todistal cutter 72 while tissue samples are taken.Distal end 70 anddistal cutter 72 may be retracted in a proximal direction back withinbore 110 between sample acquisitions. Preferred methods of collecting multiple samples include rotating theshaft 14 andtube 44 around alongitudinal axis 80, preferably between collection of a first and a second sample. Such rotation may be accomplished by turning a thumbwheel, preferably to preset locations designated by detents or indentations. Alternatively, ashaft 14 andtube 44 may be rotated by an arbitrary amount. Rotational force may be applied manually, for example, by an operator's hand rotating athumbwheel 32, or by mechanical, electrical, or other means of providing rotational force. - An advantage of this method is that multiple samples may be obtained from a single shaft position by rotating the shaft around a longitudinal axis while it remains inserted within a patient's body. Thus, multiple samples may be recovered from different positions oriented at designated radial positions around an initial biopsy site. In addition, the positions may be known and recorded by clinical operators, so that the locations from which samples were taken may be known. A
shaft 14 may be moved in a longitudinal direction between sample acquisitions, as well as, or instead of, rotating the shaft between sample acquisitions. - It will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described herein primarily in terms of an electrosurgical specimen-collection system, various modifications can be made without departing from the spirit and scope of the invention. Moreover, those skilled in the art will recognize that features shown in one embodiment may be utilized in other embodiments. Terms such a “element”, “member”, “device”, “sections”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6), unless the following claims expressly use the terms “means” or “step” followed by a particular function without specific structure or action.
- While particular forms of the invention have been illustrated and described, it should be apparent that various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
Claims (29)
1. (canceled)
2. The tissue extraction system of claim 77 , wherein at least part of said tissue cutting surface is an electrode.
3. The tissue extraction member of claim 2 , wherein at least part of said flexible distal portion is formed of a non-conductive material.
4. The tissue extraction system of claim 2 , wherein said tissue cutting surface is a loop-shaped electrode.
5. The tissue extraction system of claim 77 , further comprising a longitudinal bore therethrough configured to receive tissue.
6. The tissue extraction system of claim 5 , wherein said proximal portion is configured to operably connect with a vacuum source.
7. The tissue extraction system of claim 6 , wherein said longitudinal bore has an inner diameter, and said loop-shaped cutting surface has a loop diameter smaller than said inner diameter.
8. The tissue extraction system of claim 6 , wherein said elongated shaft comprises an elongated hollow tube with a tube wall comprising a strengthening filament.
9. The tissue extraction system of claim 8 , wherein said strengthening filament forms a coil.
10. The tissue extraction system of claim 8 , comprising a plurality of strengthening filaments forming a braid.
11. The tissue extraction system of claim 3 , wherein said non-conductive material is selected from the group consisting of natural and synthetic rubbers, thermoplastic elastomers, polyether block amides, NYLON®, HYTREL®, high density polyethylene (HDPE), polyvinyl chloride, poly(esters), poly(amides), poly(ester-amides), poly(carbonates), poly(urethanes), poly(ester urethanes), and copolymers, polymer alloys, polymer mixtures, and combinations thereof.
12. The tissue extraction system of claim 11 , wherein said non-conductive material comprises a thermoplastic elastomer.
13. The tissue extraction system of claim 77 , wherein said tissue cutting surface is spaced away from said distal end.
14. The tissue extraction system of claim 2 , wherein said tissue cutting surface is spaced away from said distal end.
15. The tissue extraction system of claim 77 , wherein said tissue extraction member is configured to move and said guide is configured to direct movement of said flexible distal shaft portion.
16. The tissue extraction system of claim 15 , wherein said guide is configured to engage another guide effective to direct movement of said flexible distal shaft portion.
17-43. (canceled)
44. A system for obtaining a tissue specimen from within a body, comprising:
a. a tissue extraction device comprising:
an elongated shaft having a proximal shaft portion, a distal shaft portion with a distal tip having a shaft cutting element, an inner bore, an aperture on said shaft distal portion connected with said bore; and
an elongated cutting member which is at least in part movably disposed within the bore of the elongated shaft and which has a proximal portion, a flexible distal portion with a distal open end, a tissue cutting member on the distal open end, a guide on the flexible distal portion configured to direct movement of the tissue cutting member out of said shaft aperture effective to cut tissue disposed about said shaft;
b. a vacuum source operably connected to said tissue extraction device; and
c. a source of radiofrequency energy operably connected to said tissue extraction device.
45. A system for obtaining a tissue specimen from within a body, comprising:
a tissue extraction device comprising:
an elongated shaft having a proximal portion, a distal portion with a distal tip having a shaft cutting element, an inner bore, an aperture on said shaft distal portion connected with said bore, and a first guide extending along said distal portion to define a tissue cutting pathway comprising at least in part a non-axial pathway; and
a tissue extraction member movably disposed at least in part within said shaft inner bore, comprising an elongated hollow tube having a tube proximal portion, a flexible tube distal portion, a tube distal end having a longitudinal bore connecting with a tissue receiving port with a rim, a tissue cutting surface disposed about at least a portion of said rim, and a second guide configured to engage said first guide and follow said tissue cutting pathway;
a vacuum source operably connected to said tissue extraction device; and
a source of radiofrequency energy operably connected to said tissue extraction device.
46. The system of claim 45 , wherein said source of radiofrequency energy is effective to provide radiofrequency energy of between about 35 W and about 150 W.
47. The system of claim 46 , wherein said source of radiofrequency energy is effective to provide radiofrequency energy of between about 50 W and about 100 W.
48. The system of claim 45 , wherein said source of radiofrequency energy is effective to provide radiofrequency energy of between about 0.1 MHz and about 10 MHz.
49. The system of claim 48 , wherein said source of radiofrequency energy is effective to provide radiofrequency energy of between about 0.3 MHz and about 1.2 MHz.
50. The system of claim 45 , wherein said tissue extraction member is configured to move to at least one position wherein said tube distal end is disposed at least in part outside said aperture.
51. The system of claim 45 , wherein said elongated shaft further comprises a plurality of radial positions, and a non-axial ramp surface located at a first radial position on said inner bore within said shaft distal portion, said ramp surface having portions, said first guide being disposed on said non-axial ramp surface, said aperture being located at a second radial position along said shaft, wherein said first radial position and said second radial position are separated by about 180° effective that at least a portion of said ramp extends substantially towards said aperture.
52-75. (canceled)
76. A system for obtaining a tissue specimen from within a body, comprising:
a tissue extraction device comprising:
an elongated shaft having a proximal portion, a distal portion with a distal tip having a cutting means, an inner bore, an aperture on said shaft distal portion connected with said bore, and a first guide means extending along said distal portion to define a tissue cutting pathway; and
a tissue extraction member disposed at least in part within said shaft inner bore, comprising an elongated hollow tube having a longitudinal bore, a proximal portion, a flexible distal portion, a tube distal end having a tissue receiving port with a rim, a tissue cutting means disposed about at least a portion of said rim, and a second guide means configured to engage said first guide means;
a vacuum-providing means operably connected to said tissue extraction device; and
a radiofrequency energy source-means operably connected to said tissue extraction device.
77. An elongated tissue extraction system, comprising:
a. an elongated shaft having a proximal shaft portion, a distal shaft portion and a guide on the distal shaft portion configured to define a non-axial tissue cutting pathway; and
b. an elongated cutting member which is at least in part movably disposed within the bore of the elongated shaft and which has a proximal portion, a flexible distal portion with a distal end, a tissue cutting surface on the distal end, a guide follower on the flexible distal portion configured to follow the non-axial tissue cutting pathway defined by the guide on the distal shaft portion to cut tissue disposed about said shaft;
78. The extraction system of claim 77 wherein a vacuum source is operably connected to the proximal shaft portion of the elongated shaft.
Priority Applications (1)
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US11/098,963 US20050187489A1 (en) | 1998-03-03 | 2005-04-04 | Electrosurgical specimen-collection system |
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US7697398P | 1998-03-03 | 1998-03-03 | |
US09/057,303 US6331166B1 (en) | 1998-03-03 | 1998-04-08 | Breast biopsy system and method |
US09/159,467 US6261241B1 (en) | 1998-03-03 | 1998-09-23 | Electrosurgical biopsy device and method |
US09/196,125 US6454727B1 (en) | 1998-03-03 | 1998-11-20 | Tissue acquisition system and method of use |
US61868500A | 2000-07-18 | 2000-07-18 | |
US09/619,867 US6517498B1 (en) | 1998-03-03 | 2000-07-20 | Apparatus and method for tissue capture |
US10/136,700 US6875182B2 (en) | 1998-03-03 | 2002-04-30 | Electrosurgical specimen-collection system |
US11/098,963 US20050187489A1 (en) | 1998-03-03 | 2005-04-04 | Electrosurgical specimen-collection system |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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Also Published As
Publication number | Publication date |
---|---|
WO2003092472A2 (en) | 2003-11-13 |
AU2003259025A1 (en) | 2003-11-17 |
US6875182B2 (en) | 2005-04-05 |
WO2003092472A3 (en) | 2004-03-18 |
AU2003259025A8 (en) | 2003-11-17 |
US20020120211A1 (en) | 2002-08-29 |
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