WO1999012476A2 - Tissue collector - Google Patents

Tissue collector Download PDF

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Publication number
WO1999012476A2
WO1999012476A2 PCT/IL1998/000386 IL9800386W WO9912476A2 WO 1999012476 A2 WO1999012476 A2 WO 1999012476A2 IL 9800386 W IL9800386 W IL 9800386W WO 9912476 A2 WO9912476 A2 WO 9912476A2
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
plunger
collector
proximal
barrel
Prior art date
Application number
PCT/IL1998/000386
Other languages
French (fr)
Other versions
WO1999012476A3 (en
Inventor
Benny Gaber
Original Assignee
Benny Gaber
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from IL12173497A external-priority patent/IL121734A0/en
Priority claimed from IL12435998A external-priority patent/IL124359A0/en
Application filed by Benny Gaber filed Critical Benny Gaber
Priority to JP2000510378A priority Critical patent/JP2001515747A/en
Priority to EP98938882A priority patent/EP1011454A2/en
Priority to AU87465/98A priority patent/AU8746598A/en
Priority to CA002303204A priority patent/CA2303204A1/en
Priority to BR9811652-5A priority patent/BR9811652A/en
Publication of WO1999012476A2 publication Critical patent/WO1999012476A2/en
Publication of WO1999012476A3 publication Critical patent/WO1999012476A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0291Instruments for taking cell samples or for biopsy for uterus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320004Surgical cutting instruments abrasive
    • A61B2017/320008Scrapers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150045Source of blood for blood from vagina, placenta, colon or mouth

Definitions

  • the present invention relates to gynecological instruments generally, and particularly to a uterine tissue collector which scrapes a uterus and collects scraped uterine material by suction.
  • Obtaining samples of cervical and uterine tissue is normally performed in the art by one of three methods: dilation of the cervix and curettage of the endometrium, known as D & C; suction without dilation of the cervix via a small diameter tube, known as aspiration; or by suction curettage.
  • D & C and suction curettage are capable of collecting as much cervical or uterine material as required, but require anesthesia.
  • Aspiration with a small diameter tube does not normally require anesthesia but is not capable of obtaining amounts of tissue comparable to those obtainable with D & C. In order to obtain amounts of tissue comparable to those obtainable with D & C, aspiration must be performed with a large tube which requires anesthesia.
  • An endometrial suction curette called the Pipelle de Cornier, manufactured by PRODIMED of France, may be used to scrape endometrial material with the distal end of a sheath of the curette.
  • the scraping area is limited by the relatively small diameter of the sheath.
  • U.S. Patent 5,224,488 to Neuffer describes a biopsy needle insertable into a body with a deformable strip which can cut tissue and which protrudes laterally outwards of the needle.
  • the strip does not move back and forth but rather cuts when the user rotates the needle about its axis.
  • the strip is manually pushed laterally outwards of the needle by turning a screw.
  • U.S. Patent 4,895,166 to Farr describes a rotatable cutter for penetrating into and cutting tissue in a lumen (body cavity).
  • the cutting tool includes two spaced external segments of a conical generally hollow portion with cutting surfaces at their edges.
  • a vacuum is applied to remove fragments of cut tissue. Again the cutter cuts by rotating, not by moving back and forth.
  • U.S. Patent 5,217,479 to Shuler describes a rotary surgical cutting instrument which cuts with an inner member rotating inside an outer member.
  • the inner member is provided with two symmetric rows of triangular cutting teeth and the outer member has a distal cutting aperture.
  • the instrument cuts by rotating, not by moving back and forth.
  • U.S. Patent 4,340,066 to Shah describes an endometrial sampling device including a cannula which has a transverse slot with scraping edges and a sharp point, and which is insertable into the cervix. By manually moving the cannula and scraping with the scraping edges, one can collect endometrial tissue. The cutter cuts by manually moving the cannula and scraping material, and not by moving back and forth.
  • U.S. Patent 5,335,671 to Clement describes a surgical assembly for removal of body tissue including a movable cutter inside a cannula which is insertable into a desired location in a patient.
  • the cutter is rigid and cuts by shearing against an aperture in the cannula.
  • a vacuum may be provided for removing cut material.
  • the cutter cuts by shearing in one direction, not by moving back and forth.
  • Applicant/assignee discloses in PCT Patent Application PCT US96/02702 and U.S. Patent Application 08/607,901, the disclosure of which is incorporated herein by reference, a uterine tissue collector including a deformable scraper which is capable of being deformed from an undeformed configuration to a deformed configuration. The scraper scrapes a uterus while moving between the undeformed configuration and the deformed configuration.
  • This uterine tissue collector has already enjoyed much success in clinical trials.
  • the present invention seeks to provide several improvements relating to the uterine tissue collector disclosed in U.S. Patent Application 08/607,901.
  • One of the improvements is a flexible scraper which substantially scrapes the uterus only when moved towards a proximal end (the collection end) of a cannula of the uterine tissue collector.
  • This novel structure ensures that the scraper scrapes and "rakes" the uterine material into the cannula and not away from the cannula.
  • the cannula is constructing as a double lumen.
  • One lumen is used for the deformable scraper and a smaller lumen is used for a wire which is attached to and imparts movement to the scraper.
  • This construction better isolates the wire from the uterine material.
  • the wire lumen has a passageway for permitting a fluid, such as ambient air, to flow towards a distal end of the larger, scraper lumen. This flow of "bleed" air helps create a positive pressure on the distal side of any lump of matter in the vicinity of the scraper. The positive pressure allows a suction device proximal to the lump of matter to efficiently suck and collect the lump of matter.
  • Yet another lumen may be provided as a passageway for a guide wire which can be used to "steer" the cannula.
  • the cannula is flexible or is constructed with notches or a thin-walled section, so that the cannula tip is bendable.
  • the distal end of the guide wire is attached to the cannula near the tip, and the proximal end of the guide wire is attached to a finger or hand controlled lever. By pulling on the lever to the right or left, the tip of the cannula is accordingly bent or flexed, thereby significantly increasing the area which may be scraped and/or raked.
  • Still another improvement is an elastic ball which wipes an inner surface of the scraper lumen, the wiped material being sucked and collected by the suction device, thereby increasing the collection efficiency of the uterine tissue collector.
  • the syringe has a double barrel, a distal barrel which extends from a proximal barrel, the proximal barrel having a larger diameter than the distal barrel.
  • a plunger sealingly slides in the distal barrel like any conventional plunger.
  • the proximal barrel has a larger area than the distal barrel, the amount of material which can be collected with the syringe is significantly greater than a conventional syringe of the prior art which has only one barrel of the size of the distal barrel of the present invention, and yet the smaller diameter of the distal barrel allows entry of the syringe of the present invention into smaller openings than possible with syringes of the prior art which have a single barrel of the size of the proximal barrel.
  • uterine tissue refers to any material in the cervical canal and uterine cavity, e.g. uterine layering, cervical mucosa, gestational products, endometrium or tumoral substances.
  • uterus encompasses the cervical canal and uterine cavity. It is also appreciated that the present invention, although described herein for scraping a uterus, is readily applicable for scraping any tissue.
  • a tissue collector including a deformable scraper which is capable of being deformed from an undeformed configuration to a deformed configuration and which scrapes a tissue while moving between the undeformed configuration and the deformed configuration, a deformer which deforms the deformable scraper, and a suction device which sucks material scraped by the deformable scraper, characterized by the scraper being stiffer when moved towards a proximal end of the collector than when moved towards a distal end of the collector.
  • the scraper substantially scrapes the uterus only when moved towards the proximal end of the collector.
  • the scraper includes a flexible tongue adjacent and proximal to a generally rigid tongue, wherein the flexible tongue when moved towards the proximal end of the collector flexes towards and abuts against the rigid tongue and when moved towards the distal end of the collector flexes away from and does not abut against the rigid tongue.
  • the flexible tongue protrudes further from a longitudinal axis of the collector than the rigid tongue.
  • the uterine tissue collector includes a cannula having a first lumen and a second lumen, wherein the deformable scraper is disposed in the first lumen and at least a portion of the scraper is protrudable through an aperture formed in the first lumen, and wherein the deformer includes a wire coupled to the deformable scraper, the wire passing through the second lumen.
  • the second lumen has a passageway formed therein for flow therethrough of a fluid towards a distal end of the first lumen.
  • a bleed valve for controlling the flow of the fluid through the passageway.
  • the uterine tissue collector includes a cannula having an inner surface, and a wiping device that wipes particles from the inner surface of the cannula.
  • the suction device imparts a fluid force on the wiping device to propel the wiping device through the cannula.
  • the wiping device includes an elastic ball which is disposed in the cannula and touches the inner surface.
  • the elastic ball is initially attached to the suction device and is detachable from the suction device upon the suction device imparting a fluid force on the elastic ball.
  • a uterine tissue collector including a cannula adapted for insertion into a uterus, the cannula including a flexible distal portion, and at least one guide wire attached to the distal portion of the cannula, wherein movement of the at least one guide wire flexes the distal portion of the cannula.
  • the at least one guide wire is disposed through a lumen formed through the cannula.
  • the lumen constrains movement of the at least one guide wire in a direction generally along a longitudinal axis of the cannula.
  • a proximal portion of the at least one guide wire is pivotally attached about a fulcrum to a lever such that movement of the lever flexes the distal portion of the cannula.
  • the uterine tissue collector includes a pair of guide wires, each guide wire being disposed in a separate lumen formed in the cannula, wherein generally proximal movement of one of the guide wires causes flexing of the distal portion of the cannula in a direction generally opposite to that caused by generally proximal movement of the other guide wire.
  • the at least one guide wire is sufficiently stiff so as to be able to push as well as pull the distal portion of the cannula.
  • a suction device including a syringe including a distal barrel which extends from a proximal barrel, the proximal barrel having a larger diameter than the distal barrel, a plunger element disposed inside the proximal barrel, the plunger element being adapted to sealingly slide inside the proximal barrel, and a plunger that passes through the plunger element, wherein when the plunger is pulled proximally and starts to enter the proximal barrel, a proximal face of a distal end of the plunger is received in a recess formed in the plunger element, such that when the plunger is pulled further proximally, the plunger moves together with the plunger element and the plunger element serves as a new distal end of the plunger during sliding travel in the proximal barrel.
  • Fig. 1 is a simplified, partially sectional illustration of a uterine tissue collector constructed and operative in accordance with a preferred embodiment of the present invention
  • Fig. 2 is a simplified, partially sectional illustration of a scraper used in the uterine tissue collector of Fig. 1;
  • Figs. 3A and 3B are simplified side view illustrations of the operation of the scraper of Fig. 2 in accordance with a preferred embodiment of the present invention, wherein Fig. 3A shows the scraper being moved proximally and scraping a uterine wall and wherein Fig. 3B shows the scraper being moved distally and not scraping the uterine wall;
  • Fig. 4 is a simplified partially sectional illustration of the structure of a lumen through which passes a wire attached to the scraper of Fig. 2 and through which flows fluid to a distal end of the uterine tissue collector in accordance with a preferred embodiment of the present invention
  • Fig. 5 is a simplified, partially sectional illustration of a wiping device constructed and operative in accordance with a preferred embodiment of the present invention and useful in wiping an inner surface of the uterine tissue collector of Figs. 1-4;
  • Figs. 6 A and 6B are simplified illustrations of the operation of the wiping device of Fig. 5, wherein Fig. 6 A illustrates an elastic ball pushed distally into a channel and Fig. 6B illustrates the elastic ball being forced distally in a cannula and wiping an inner perimeter of the cannula;
  • Figs. 7A and 7B are simplified, partially sectional illustrations of a wiping device constructed and operative in accordance with another preferred embodiment of the present invention, wherein Fig. 7A illustrates an elastic ball initially attached to a syringe and Fig. 7B illustrates the elastic ball being detached from the syringe and forced distally in a cannula and wiping an inner perimeter of the cannula;
  • Fig. 8 is a simplified pictorial illustration of a uterine tissue collector constructed and operative in accordance with yet another preferred embodiment of the present invention, the uterine tissue collector including a guide wire which flexes a bendable cannula;
  • Figs. 9 A and 9B are simplified enlarged illustrations of two different configurations of a bendable portion of the cannula of Fig. 8;
  • Figs. 10 A, 10B and IOC are simplified, enlarged sectional illustration of the cannula of Fig. 8, showing three different configurations for passage of guide wires;
  • Fig. 11 is a simplified pictorial illustration of the uterine tissue collector of Fig. 8 being flexed by a user;
  • Fig. 12A is a simplified pictorial illustration of a suction device, useful with any of the uterine tissue collectors of the present invention, constructed and operative in accordance with a preferred embodiment of the present invention
  • Fig. 12B is an enlarged illustration of a distal portion of the suction device of Fig. 12 A.
  • Figs. 13A, 13B and 13C are enlarged simplified pictorial illustrations of the suction with a plunger fully pushed into a distal barrel of a syringe, with the plunger proximally retracted from the distal barrel and moved into a proximal barrel of the syringe, and with the plunger retracted into the proximal barrel, respectively.
  • FIG. 1 illustrates a uterine tissue collector 10 constructed and operative in accordance with a preferred embodiment of the present invention.
  • Uterine tissue collector 10 includes a hollow cannula 12 shaped for insertion into a uterus.
  • Cannula 12 may be straight or bent.
  • Cannula 12 has an aperture 14 and a deformable scraper 16 disposed at a distal portion 18 of cannula 12. The operation of scraper 16 will be described in detail further below with reference to Figs. 2, 3 A and 3B.
  • Uterine tissue collector 10 also comprises a suction device such as a syringe 20 and a deformer, such as an electromagnetic vibrator 22 coupled to scraper 16 by means of a wire 24.
  • a suction device such as a syringe 20
  • a deformer such as an electromagnetic vibrator 22 coupled to scraper 16 by means of a wire 24.
  • the construction and operation of the suction device and deformer are in accordance with the teachings of U.S. Patent Application 08/607,901.
  • syringe 20 and cannula 12 form a disposable assembly. After collection of uterine material and examination thereof, the assembly may be discarded.
  • Scraper 16 preferably includes a flexible tongue 26 adjacent and proximal to a generally rigid tongue 28. Tongues 26 and 28 may be attached to each other and may be formed from a single piece of material, such as plastic. An end 30 of wire 24 is preferably fixedly attached to rigid tongue 28. Flexible tongue 26 is preferably longer than rigid tongue 28, i.e., flexible tongue 26 protrudes further from a longitudinal axis 32 of uterine tissue collector 10 than rigid tongue 28.
  • Figs. 3 A and 3B illustrate the operation of scraper 16.
  • flexible tongue 26 is placed against a uterine wall 34 and is poised for scraping.
  • flexible tongue 26 flexes towards and abuts against rigid tongue 28.
  • Rigid tongue 28 thus arrests the flexure of flexible tongue 26 and flexible tongue 26 is maintained stiff during its proximal scraping motion against uterine wall 34.
  • flexible tongue 26 when flexible tongue 26 is moved by wire 24 towards distal portion 18, flexible tongue 26 flexes away from and does not abut against rigid tongue 28. Because of its flexibility, flexible tongue 26 simply glides over uterine wall 34 during the distal travel and does not substantially scrape wall 34.
  • scraper 16 is stiffer when moved proximally than when moved distally.
  • cannula 12 is formed with a first lumen 40 and a second lumen 42.
  • Scraper 16 is disposed in first lumen 40 and wire 24 passes through second lumen 42.
  • second lumen 42 has a passageway 44 formed therein for flow therethrough of a fluid, such as ambient air, towards a distal portion 18 of cannula 12 and of first lumen 40.
  • a fluid such as ambient air
  • the flow of fluid, such as "bleed” air, through passageway 44 helps create a positive pressure on the distal side of lump 46 to help syringe 20 efficiently suck and collect lump 46.
  • a bleed valve 48 may be provided for controlling flow of the bleed fluid through passageway 44.
  • Wiping device 50 preferably includes an elastic ball 52 snugly fitted into a channel 54.
  • Elastic ball 52 may be made of any elastomer, such as rubber or neoprene.
  • Channel 54 is in fluid communication with both first lumen 40 and syringe 20, such that any matter collected is sucked through first lumen 40 via channel 54 to syringe 20.
  • wiping device 50 After having used the uterine tissue collector to scrape and collect a desired amount of uterine material, the disposable assembly of syringe 20 and cannula 12 is removed from the hand-held piece shown in Fig. 1 that comprises vibrator 22.
  • Syringe 20 typically contains a large amount of collected uterine material, and the syringe plunger is pulled almost, but not completely proximally in syringe 20.
  • the distal end of cannula 12 is then dipped in a setting solution, such as formalin, and the syringe plunger is then pulled completely proximally to suck formalin through cannula 12 and into syringe 20, whereupon the formalin mixes with the collected material.
  • a setting solution such as formalin
  • the mixture of formalin and material is then discharged into a collection vessel, such as a vial.
  • Syringe 20 is then used to draw therein a second amount of formalin. Up to this point, elastic ball 52 has remained out of the path of the formalin and material.
  • Syringe 20 is then used to draw in formalin a second time and about 80- 90% of the formalin-material mixture is discharged into the collection vessel.
  • FIG. 6 A illustrates syringe 20 after having drawn in formalin for the second time and discharged about 80-90% of the mixture.
  • Piston 58 is then pushed in the direction of an arrow 61, thereby pushing elastic ball 52 distally along channel 54 and distally below inlet 56.
  • the plunger of syringe 20 is then pushed distally, thereby applying a fluid force on elastic ball 52 and propelling elastic ball 52 distally through the length of lumen 40 to distal portion 18 of cannula 12.
  • elastic ball 52 As elastic ball 52 moves through lumen 40, it wipes an inner perimeter of lumen 40 and discharges the formalin and other contents of lumen 40 out of distal portion 18 into a collection vial (not shown). Thus elastic ball 52 increases the collection efficiency of the uterine tissue collector.
  • wiping device 60 includes an elastic ball 62 initially attached to a pin 64 fixedly attached to a plunger 66 of syringe 20.
  • the disposable assembly of syringe 20 and cannula 12 is removed from the hand-held piece shown in Fig. 1 that comprises vibrator 22.
  • Syringe 20 typically contains a large amount of collected uterine material, and plunger 66 is pulled almost, but not completely proximally in syringe 20.
  • cannula 12 is then dipped in a setting solution, such as formalin, and plunger 66 is drawn proximally to suck formalin through cannula 12 and into syringe 20, whereupon the formalin mixes with the collected material.
  • a setting solution such as formalin
  • plunger 66 is drawn proximally to suck formalin through cannula 12 and into syringe 20, whereupon the formalin mixes with the collected material.
  • the position of plunger 66 after having sucked in formalin is shown in Fig. 7A. At this point plunger 66 is not completely pulled proximally in syringe 20 and the sucking of formalin adds about 20% to the volume of matter in syringe 20.
  • Fig. 7B plunger 66 of syringe 20 is pushed distally and elastic ball 62 enters inlet 56. Further distal pushing of plunger 66 applies a fluid force on elastic ball 62 thereby dislodging ball 62 from pin 64. Once ball 62 has been dislodged from pin 64, the fluid force propels elastic ball 62 through channel 54 and lumen 40 to distal portion 18 (not shown in Fig. 7B) of cannula 12. As described hereinabove, as elastic ball 62 moves through lumen 40, it wipes an inner perimeter of lumen 40 and discharges the formalin and other contents of lumen 40 out of distal portion 18 into a collection vial (not shown).
  • a collection vial not shown
  • FIG. 7A and 7B uses a wiping device which wipes the inner surface of cannula 12 after one ingress of formalin
  • FIG. 6 A and 6B uses a wiping device which wipes the inner surface of cannula 12 after two ingresses of formalin.
  • Uterine tissue collector 70 like uterine tissue collector 10, includes cannula 12 which is formed with first lumen 40 and second lumen 42 (both seen in Fig. 10). As described hereinabove, scraper 16 (not shown in Figs. 8-11) is disposed in first lumen 40 and wire 24 passes through second lumen 42.
  • Uterine tissue collector 70 differs from uterine tissue collector 10 in that collector 70 includes a third lumen 72 which serves as a passageway for a guide wire 74 which can be used to flex cannula 12. As seen in Fig. 8, the distal end of guide wire 74 is attached to distal portion 18 of cannula 12. Guide wire 74 preferably has sufficient stiffness to push as well as pull distal portion 18. Cannula 12 is preferably constructed of a flexible material. Additionally or alternatively, a portion of cannula 12 may be constructed with a relatively low bending moment to permit easy flexing of distal portion 18 of cannula 12. For example, as seen in Fig.
  • cannula 12 may have a thin-walled section 78, or as seen in Fig. 9B, cannula 12 may be formed with notches 80 so as to make the cannula tip bendable sideways.
  • Thin-walled section 78 and notches 80 may be formed around a portion of the perimeter of cannula 12 or all around the perimeter.
  • guide wire 74 is attached to a lever 82 which is preferably pivotally attached about a fulcrum 83 to a handle 84.
  • Guide wire 74 is preferably bent about an attachment point 86 in lever 82.
  • distal portion 18 of cannula 12 is accordingly bent or flexed generally in the direction of an arrow 92.
  • the flexing action significantly increases the area which may be scraped and/or raked with uterine tissue collector 70.
  • Guide wire 74 is preferably coupled to a motor 93 for automatic flexing. Motor 93 is preferably the same motor used to vibrate deformable scraper 16. Alternatively, lever 82 may be bent with the index finger.
  • guide wire 74 is preferably attached to cannula 12 at a fulcrum point 91.
  • This arrangement causes lever 82 to bend cannula 12 at a buckling pocket 89, thereby significantly increasing the amount that cannula 12 bends.
  • a second guide wire 76 may be used in conjunction with guide wire 74, guide wire 76 being attached to a side of distal portion 18 opposite to guide wire 74.
  • Each guide wire 74 and 76 may be disposed in a separate lumen formed in cannula 12 (Fig. 10 A), or may alternatively be disposed either inside lumen 40 (Fig. 10B) or outside of cannula 12 (Fig. 10C).
  • generally proximal movement of one of the guide wires causes flexing of distal portion 18 in a direction generally opposite to that caused by generally proximal movement of the other guide wire.
  • FIGs. 12A-13C illustrate a suction device 100, useful with a uterine tissue collector such as any of the uterine tissue collectors of the present invention, constructed and operative in accordance with a preferred embodiment of the present invention.
  • the details of the construction of suction device 100 are best seen in Figs. 13A-13C.
  • Suction device 100 comprises a two-stage syringe 102.
  • Syringe 102 preferably includes a distal barrel 104 which extends from and is in fluid communication with a proximal barrel 106, proximal barrel 106 having a larger diameter than distal barrel 104.
  • Distal barrel 104 is preferably none other than cannula 12.
  • a plunger 108 having a distal end 110, sealingly slides in distal barrel 104 like any conventional plunger.
  • the body of plunger 108 passes through a plunger element 112 disposed in proximal barrel 106.
  • Plunger element 112 is sized to sealingly slide in proximal barrel 106.
  • Plunger element 112 preferably has a recess 113 formed in a distal end thereof, recess 113 being sized to snugly receive therein distal end 110 of plunger 108.
  • a proximal end of plunger 108 is preferably provided with a small handle 1 17.
  • handle 117 may be used to pull plunger 108 proximally in the direction of an arrow 114.
  • distal end 110 of plunger 108 snugly seats in recess 113.
  • plunger element 112 may now be pulled proximally in the direction of arrow 114, and plunger 108 now moves together with plunger element 112.
  • plunger element 112 now acts as a new tip of plunger 108 in its travel in proximal barrel 106.
  • proximal barrel 106 has a larger area than distal barrel 104, the amount of material which can be collected with syringe 102 is significantly greater than a conventional syringe of the prior art which has only one barrel of the size of the distal barrel of the present invention, and yet the smaller diameter of distal barrel 104 allows entry of syringe 102 into smaller openings than possible with syringes of the prior art which have a single barrel of the size of proximal barrel 106.
  • Material collected with syringe 102 may be discharged by distally pushing plunger element 112 together with plunger 108 in the direction opposite to arrow 114.
  • plunger element 112 Once plunger element 112 is pushed back to abut against a distal face 119 of proximal barrel 106 (the position shown in Fig. 13B), handle 117 may now be used to distally push plunger 108 so that distal end 110 of plunger 108 becomes dislodged from plunger element 112 and is free to be pushed further into distal barrel 104. Plunger 108 may then be further pushed to completely discharge the collected material.

Abstract

A tissue collector (70) comprising a cannula (12) adapted for insertion into a uterus, the cannula (12) including a flexible distal portion (18), and at least one guide wire (74) attached to the distal portion (18) of the cannula (12), wherein movement of the at least one guide wire (74) flexes the distal portion (18) of the cannula (12). There is also provided a suction device (100) comprising a syringe (102) including a distal barrel (104) which extends from a proximal barrel (106), the proximal barrel (106) having a larger diameter than the distal barrel (104), a plunger element (112) disposed inside the proximal barrel (106), the plunger element (112) being adapted to sealingly slide inside the proximal barrel (106), and a plunger (108) that passes through the plunger element (112), wherein when the plunger (108) is pulled proximally and starts to enter the proximal barrel (106), the plunger (108) is received in a recess (113) formed in the plunger element (112), such that when the plunger (108) is pulled further proximally, the plunger (108) moves together with the plunger element (112) and the plunger element (112) serves as a new distal end of the plunger (108) during sliding travel in the proximal barrel (106).

Description

TISSUE COLLECTOR FIELD OF THE INVENTION
The present invention relates to gynecological instruments generally, and particularly to a uterine tissue collector which scrapes a uterus and collects scraped uterine material by suction.
BACKGROUND OF THE INVENTION
Obtaining samples of cervical and uterine tissue is normally performed in the art by one of three methods: dilation of the cervix and curettage of the endometrium, known as D & C; suction without dilation of the cervix via a small diameter tube, known as aspiration; or by suction curettage. D & C and suction curettage are capable of collecting as much cervical or uterine material as required, but require anesthesia. Aspiration with a small diameter tube does not normally require anesthesia but is not capable of obtaining amounts of tissue comparable to those obtainable with D & C. In order to obtain amounts of tissue comparable to those obtainable with D & C, aspiration must be performed with a large tube which requires anesthesia.
An endometrial suction curette, called the Pipelle de Cornier, manufactured by PRODIMED of France, may be used to scrape endometrial material with the distal end of a sheath of the curette. However, the scraping area is limited by the relatively small diameter of the sheath.
There are several instruments in the patent literature for scraping a uterus and/or collecting scraped material. U.S. Patent 5,224,488 to Neuffer describes a biopsy needle insertable into a body with a deformable strip which can cut tissue and which protrudes laterally outwards of the needle. The strip does not move back and forth but rather cuts when the user rotates the needle about its axis. The strip is manually pushed laterally outwards of the needle by turning a screw.
U.S. Patent 4,895,166 to Farr describes a rotatable cutter for penetrating into and cutting tissue in a lumen (body cavity). The cutting tool includes two spaced external segments of a conical generally hollow portion with cutting surfaces at their edges. A vacuum is applied to remove fragments of cut tissue. Again the cutter cuts by rotating, not by moving back and forth.
U.S. Patent 5,217,479 to Shuler describes a rotary surgical cutting instrument which cuts with an inner member rotating inside an outer member. The inner member is provided with two symmetric rows of triangular cutting teeth and the outer member has a distal cutting aperture. Here, too, the instrument cuts by rotating, not by moving back and forth.
U.S. Patent 4,340,066 to Shah describes an endometrial sampling device including a cannula which has a transverse slot with scraping edges and a sharp point, and which is insertable into the cervix. By manually moving the cannula and scraping with the scraping edges, one can collect endometrial tissue. The cutter cuts by manually moving the cannula and scraping material, and not by moving back and forth.
U.S. Patent 5,335,671 to Clement describes a surgical assembly for removal of body tissue including a movable cutter inside a cannula which is insertable into a desired location in a patient. The cutter is rigid and cuts by shearing against an aperture in the cannula. A vacuum may be provided for removing cut material. The cutter cuts by shearing in one direction, not by moving back and forth.
Applicant/assignee discloses in PCT Patent Application PCT US96/02702 and U.S. Patent Application 08/607,901, the disclosure of which is incorporated herein by reference, a uterine tissue collector including a deformable scraper which is capable of being deformed from an undeformed configuration to a deformed configuration. The scraper scrapes a uterus while moving between the undeformed configuration and the deformed configuration. This uterine tissue collector has already enjoyed much success in clinical trials.
SUMMARY OF THE INVENTION
The present invention seeks to provide several improvements relating to the uterine tissue collector disclosed in U.S. Patent Application 08/607,901. One of the improvements is a flexible scraper which substantially scrapes the uterus only when moved towards a proximal end (the collection end) of a cannula of the uterine tissue collector. This novel structure ensures that the scraper scrapes and "rakes" the uterine material into the cannula and not away from the cannula.
Another improvement is constructing the cannula as a double lumen. One lumen is used for the deformable scraper and a smaller lumen is used for a wire which is attached to and imparts movement to the scraper. This construction better isolates the wire from the uterine material. In addition, the wire lumen has a passageway for permitting a fluid, such as ambient air, to flow towards a distal end of the larger, scraper lumen. This flow of "bleed" air helps create a positive pressure on the distal side of any lump of matter in the vicinity of the scraper. The positive pressure allows a suction device proximal to the lump of matter to efficiently suck and collect the lump of matter.
Yet another lumen may be provided as a passageway for a guide wire which can be used to "steer" the cannula. The cannula is flexible or is constructed with notches or a thin-walled section, so that the cannula tip is bendable. The distal end of the guide wire is attached to the cannula near the tip, and the proximal end of the guide wire is attached to a finger or hand controlled lever. By pulling on the lever to the right or left, the tip of the cannula is accordingly bent or flexed, thereby significantly increasing the area which may be scraped and/or raked.
Still another improvement is an elastic ball which wipes an inner surface of the scraper lumen, the wiped material being sucked and collected by the suction device, thereby increasing the collection efficiency of the uterine tissue collector.
Another improvement is constructing the suction device as a two-stage syringe. The syringe has a double barrel, a distal barrel which extends from a proximal barrel, the proximal barrel having a larger diameter than the distal barrel. A plunger sealingly slides in the distal barrel like any conventional plunger. When the plunger is completely pulled proximally through the distal barrel and enters the proximal barrel, the distal tip of the plunger is pulled into engagement with a plunger element so that the plunger element is fixed to the distal tip of the plunger. The plunger element now acts as a new tip of the plunger in its travel in the proximal barrel. Since the proximal barrel has a larger area than the distal barrel, the amount of material which can be collected with the syringe is significantly greater than a conventional syringe of the prior art which has only one barrel of the size of the distal barrel of the present invention, and yet the smaller diameter of the distal barrel allows entry of the syringe of the present invention into smaller openings than possible with syringes of the prior art which have a single barrel of the size of the proximal barrel.
It is noted that throughout the specification and claims, the term "uterine tissue" refers to any material in the cervical canal and uterine cavity, e.g. uterine layering, cervical mucosa, gestational products, endometrium or tumoral substances. In the specification and claims, the term "uterus" encompasses the cervical canal and uterine cavity. It is also appreciated that the present invention, although described herein for scraping a uterus, is readily applicable for scraping any tissue.
There is thus provided in accordance with a preferred embodiment of the present invention a tissue collector including a deformable scraper which is capable of being deformed from an undeformed configuration to a deformed configuration and which scrapes a tissue while moving between the undeformed configuration and the deformed configuration, a deformer which deforms the deformable scraper, and a suction device which sucks material scraped by the deformable scraper, characterized by the scraper being stiffer when moved towards a proximal end of the collector than when moved towards a distal end of the collector.
In accordance with a preferred embodiment of the present invention the scraper substantially scrapes the uterus only when moved towards the proximal end of the collector. Further in accordance with a preferred embodiment of the present invention the scraper includes a flexible tongue adjacent and proximal to a generally rigid tongue, wherein the flexible tongue when moved towards the proximal end of the collector flexes towards and abuts against the rigid tongue and when moved towards the distal end of the collector flexes away from and does not abut against the rigid tongue.
Still further in accordance with a preferred embodiment of the present invention the flexible tongue protrudes further from a longitudinal axis of the collector than the rigid tongue.
Additionally in accordance with a preferred embodiment of the present invention the uterine tissue collector includes a cannula having a first lumen and a second lumen, wherein the deformable scraper is disposed in the first lumen and at least a portion of the scraper is protrudable through an aperture formed in the first lumen, and wherein the deformer includes a wire coupled to the deformable scraper, the wire passing through the second lumen.
In accordance with a preferred embodiment of the present invention the second lumen has a passageway formed therein for flow therethrough of a fluid towards a distal end of the first lumen. Preferably there is also provided a bleed valve for controlling the flow of the fluid through the passageway.
In accordance with a preferred embodiment of the present invention the uterine tissue collector includes a cannula having an inner surface, and a wiping device that wipes particles from the inner surface of the cannula. Preferably the suction device imparts a fluid force on the wiping device to propel the wiping device through the cannula.
Further in accordance with a preferred embodiment of the present invention the wiping device includes an elastic ball which is disposed in the cannula and touches the inner surface.
Still further in accordance with a preferred embodiment of the present invention the elastic ball is initially attached to the suction device and is detachable from the suction device upon the suction device imparting a fluid force on the elastic ball.
There is also provided in accordance with a preferred embodiment of the present invention a uterine tissue collector including a cannula adapted for insertion into a uterus, the cannula including a flexible distal portion, and at least one guide wire attached to the distal portion of the cannula, wherein movement of the at least one guide wire flexes the distal portion of the cannula. Preferably the at least one guide wire is disposed through a lumen formed through the cannula. Preferably the lumen constrains movement of the at least one guide wire in a direction generally along a longitudinal axis of the cannula. In accordance with a preferred embodiment of the present invention a proximal portion of the at least one guide wire is pivotally attached about a fulcrum to a lever such that movement of the lever flexes the distal portion of the cannula.
Further in accordance with a preferred embodiment of the present invention the uterine tissue collector includes a pair of guide wires, each guide wire being disposed in a separate lumen formed in the cannula, wherein generally proximal movement of one of the guide wires causes flexing of the distal portion of the cannula in a direction generally opposite to that caused by generally proximal movement of the other guide wire.
Still further in accordance with a preferred embodiment of the present invention the at least one guide wire is sufficiently stiff so as to be able to push as well as pull the distal portion of the cannula.
There is also provided in accordance with a preferred embodiment of the present invention a suction device including a syringe including a distal barrel which extends from a proximal barrel, the proximal barrel having a larger diameter than the distal barrel, a plunger element disposed inside the proximal barrel, the plunger element being adapted to sealingly slide inside the proximal barrel, and a plunger that passes through the plunger element, wherein when the plunger is pulled proximally and starts to enter the proximal barrel, a proximal face of a distal end of the plunger is received in a recess formed in the plunger element, such that when the plunger is pulled further proximally, the plunger moves together with the plunger element and the plunger element serves as a new distal end of the plunger during sliding travel in the proximal barrel.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
Fig. 1 is a simplified, partially sectional illustration of a uterine tissue collector constructed and operative in accordance with a preferred embodiment of the present invention;
Fig. 2 is a simplified, partially sectional illustration of a scraper used in the uterine tissue collector of Fig. 1;
Figs. 3A and 3B are simplified side view illustrations of the operation of the scraper of Fig. 2 in accordance with a preferred embodiment of the present invention, wherein Fig. 3A shows the scraper being moved proximally and scraping a uterine wall and wherein Fig. 3B shows the scraper being moved distally and not scraping the uterine wall;
Fig. 4 is a simplified partially sectional illustration of the structure of a lumen through which passes a wire attached to the scraper of Fig. 2 and through which flows fluid to a distal end of the uterine tissue collector in accordance with a preferred embodiment of the present invention;
Fig. 5 is a simplified, partially sectional illustration of a wiping device constructed and operative in accordance with a preferred embodiment of the present invention and useful in wiping an inner surface of the uterine tissue collector of Figs. 1-4;
Figs. 6 A and 6B are simplified illustrations of the operation of the wiping device of Fig. 5, wherein Fig. 6 A illustrates an elastic ball pushed distally into a channel and Fig. 6B illustrates the elastic ball being forced distally in a cannula and wiping an inner perimeter of the cannula;
Figs. 7A and 7B are simplified, partially sectional illustrations of a wiping device constructed and operative in accordance with another preferred embodiment of the present invention, wherein Fig. 7A illustrates an elastic ball initially attached to a syringe and Fig. 7B illustrates the elastic ball being detached from the syringe and forced distally in a cannula and wiping an inner perimeter of the cannula;
Fig. 8 is a simplified pictorial illustration of a uterine tissue collector constructed and operative in accordance with yet another preferred embodiment of the present invention, the uterine tissue collector including a guide wire which flexes a bendable cannula;
Figs. 9 A and 9B are simplified enlarged illustrations of two different configurations of a bendable portion of the cannula of Fig. 8;
Figs. 10 A, 10B and IOC are simplified, enlarged sectional illustration of the cannula of Fig. 8, showing three different configurations for passage of guide wires;
Fig. 11 is a simplified pictorial illustration of the uterine tissue collector of Fig. 8 being flexed by a user;
Fig. 12A is a simplified pictorial illustration of a suction device, useful with any of the uterine tissue collectors of the present invention, constructed and operative in accordance with a preferred embodiment of the present invention;
Fig. 12B is an enlarged illustration of a distal portion of the suction device of Fig. 12 A; and
Figs. 13A, 13B and 13C are enlarged simplified pictorial illustrations of the suction with a plunger fully pushed into a distal barrel of a syringe, with the plunger proximally retracted from the distal barrel and moved into a proximal barrel of the syringe, and with the plunger retracted into the proximal barrel, respectively.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT Reference is now made to Fig. 1 which illustrates a uterine tissue collector 10 constructed and operative in accordance with a preferred embodiment of the present invention.
Uterine tissue collector 10 includes a hollow cannula 12 shaped for insertion into a uterus. Cannula 12 may be straight or bent. Cannula 12 has an aperture 14 and a deformable scraper 16 disposed at a distal portion 18 of cannula 12. The operation of scraper 16 will be described in detail further below with reference to Figs. 2, 3 A and 3B.
Uterine tissue collector 10 also comprises a suction device such as a syringe 20 and a deformer, such as an electromagnetic vibrator 22 coupled to scraper 16 by means of a wire 24. The construction and operation of the suction device and deformer are in accordance with the teachings of U.S. Patent Application 08/607,901. In a preferred embodiment of the present invention, syringe 20 and cannula 12 form a disposable assembly. After collection of uterine material and examination thereof, the assembly may be discarded.
Reference is now made to Fig. 2 which illustrates more clearly scraper 16. Scraper 16 preferably includes a flexible tongue 26 adjacent and proximal to a generally rigid tongue 28. Tongues 26 and 28 may be attached to each other and may be formed from a single piece of material, such as plastic. An end 30 of wire 24 is preferably fixedly attached to rigid tongue 28. Flexible tongue 26 is preferably longer than rigid tongue 28, i.e., flexible tongue 26 protrudes further from a longitudinal axis 32 of uterine tissue collector 10 than rigid tongue 28.
Reference is now made to Figs. 3 A and 3B which illustrate the operation of scraper 16. In Fig. 3 A, it is seen that flexible tongue 26 is placed against a uterine wall 34 and is poised for scraping. As flexible tongue 26 is moved by wire 24 proximally in the direction of an arrow 36, flexible tongue 26 flexes towards and abuts against rigid tongue 28. Rigid tongue 28 thus arrests the flexure of flexible tongue 26 and flexible tongue 26 is maintained stiff during its proximal scraping motion against uterine wall 34. In contrast, as shown in Fig. 3B, when flexible tongue 26 is moved by wire 24 towards distal portion 18, flexible tongue 26 flexes away from and does not abut against rigid tongue 28. Because of its flexibility, flexible tongue 26 simply glides over uterine wall 34 during the distal travel and does not substantially scrape wall 34. Thus, scraper 16 is stiffer when moved proximally than when moved distally.
Referring again to Fig. 2, it is seen that cannula 12 is formed with a first lumen 40 and a second lumen 42. Scraper 16 is disposed in first lumen 40 and wire 24 passes through second lumen 42.
Reference is now made to Fig. 4 which further illustrates the structure of second lumen 42. Preferably second lumen 42 has a passageway 44 formed therein for flow therethrough of a fluid, such as ambient air, towards a distal portion 18 of cannula 12 and of first lumen 40. When cannula 12 is pressed against uterine wall 34 (Fig. 3 A), there is substantially zero or negative pressure inside cannula 12 during suction applied by syringe 20 (Fig. 1). As seen in Fig. 4, if a lump 46 of matter is lodged inside cannula 12 in the vicinity of scraper 16, and a vacuum or near- vacuum exists on the distal side of lump 46, syringe 20 may have difficulty in pulling lump 46 through cannula 12. The flow of fluid, such as "bleed" air, through passageway 44 helps create a positive pressure on the distal side of lump 46 to help syringe 20 efficiently suck and collect lump 46. A bleed valve 48 may be provided for controlling flow of the bleed fluid through passageway 44.
Reference is now made to Fig. 5 which illustrates a wiping device 50 constructed and operative in accordance with a preferred embodiment of the present invention. Wiping device 50 preferably includes an elastic ball 52 snugly fitted into a channel 54. Elastic ball 52 may be made of any elastomer, such as rubber or neoprene. Channel 54 is in fluid communication with both first lumen 40 and syringe 20, such that any matter collected is sucked through first lumen 40 via channel 54 to syringe 20.
Initially elastic ball 52 is lodged in channel 54 above, or more precisely, out of the way of an inlet 56 between channel 54 and syringe 20. Thus, in this position matter is free to flow to syringe 20. Elastic ball 52 in this position abuts against a piston 58 which is slidable in channel 54.
The operation of wiping device 50 will now be described. After having used the uterine tissue collector to scrape and collect a desired amount of uterine material, the disposable assembly of syringe 20 and cannula 12 is removed from the hand-held piece shown in Fig. 1 that comprises vibrator 22. Syringe 20 typically contains a large amount of collected uterine material, and the syringe plunger is pulled almost, but not completely proximally in syringe 20. The distal end of cannula 12 is then dipped in a setting solution, such as formalin, and the syringe plunger is then pulled completely proximally to suck formalin through cannula 12 and into syringe 20, whereupon the formalin mixes with the collected material. The mixture of formalin and material is then discharged into a collection vessel, such as a vial. Syringe 20 is then used to draw therein a second amount of formalin. Up to this point, elastic ball 52 has remained out of the path of the formalin and material. Syringe 20 is then used to draw in formalin a second time and about 80- 90% of the formalin-material mixture is discharged into the collection vessel.
Reference is now made to Figs. 6A and 6B which illustrate how elastic ball 52 is employed. Fig. 6 A illustrates syringe 20 after having drawn in formalin for the second time and discharged about 80-90% of the mixture. Piston 58 is then pushed in the direction of an arrow 61, thereby pushing elastic ball 52 distally along channel 54 and distally below inlet 56. As seen in Fig. 6B, the plunger of syringe 20 is then pushed distally, thereby applying a fluid force on elastic ball 52 and propelling elastic ball 52 distally through the length of lumen 40 to distal portion 18 of cannula 12. As elastic ball 52 moves through lumen 40, it wipes an inner perimeter of lumen 40 and discharges the formalin and other contents of lumen 40 out of distal portion 18 into a collection vial (not shown). Thus elastic ball 52 increases the collection efficiency of the uterine tissue collector.
Reference is now made to Figs. 7A and 7B which illustrate a wiping device 60 constructed and operative in accordance with another preferred embodiment of the present invention. In this embodiment, wiping device 60 includes an elastic ball 62 initially attached to a pin 64 fixedly attached to a plunger 66 of syringe 20. As described hereinabove, after having used the uterine tissue collector to scrape and collect a desired amount of uterine material, the disposable assembly of syringe 20 and cannula 12 is removed from the hand-held piece shown in Fig. 1 that comprises vibrator 22. Syringe 20 typically contains a large amount of collected uterine material, and plunger 66 is pulled almost, but not completely proximally in syringe 20. The distal end of cannula 12 is then dipped in a setting solution, such as formalin, and plunger 66 is drawn proximally to suck formalin through cannula 12 and into syringe 20, whereupon the formalin mixes with the collected material. The position of plunger 66 after having sucked in formalin is shown in Fig. 7A. At this point plunger 66 is not completely pulled proximally in syringe 20 and the sucking of formalin adds about 20% to the volume of matter in syringe 20.
In Fig. 7B, plunger 66 of syringe 20 is pushed distally and elastic ball 62 enters inlet 56. Further distal pushing of plunger 66 applies a fluid force on elastic ball 62 thereby dislodging ball 62 from pin 64. Once ball 62 has been dislodged from pin 64, the fluid force propels elastic ball 62 through channel 54 and lumen 40 to distal portion 18 (not shown in Fig. 7B) of cannula 12. As described hereinabove, as elastic ball 62 moves through lumen 40, it wipes an inner perimeter of lumen 40 and discharges the formalin and other contents of lumen 40 out of distal portion 18 into a collection vial (not shown). Thus, preferably the embodiment of Figs. 7A and 7B uses a wiping device which wipes the inner surface of cannula 12 after one ingress of formalin, whereas the embodiment of Figs. 6 A and 6B uses a wiping device which wipes the inner surface of cannula 12 after two ingresses of formalin.
Reference is now made to Figs. 8-11 which illustrate a uterine tissue collector 70 constructed and operative in accordance with yet another preferred embodiment of the present invention. Uterine tissue collector 70, like uterine tissue collector 10, includes cannula 12 which is formed with first lumen 40 and second lumen 42 (both seen in Fig. 10). As described hereinabove, scraper 16 (not shown in Figs. 8-11) is disposed in first lumen 40 and wire 24 passes through second lumen 42.
Uterine tissue collector 70 differs from uterine tissue collector 10 in that collector 70 includes a third lumen 72 which serves as a passageway for a guide wire 74 which can be used to flex cannula 12. As seen in Fig. 8, the distal end of guide wire 74 is attached to distal portion 18 of cannula 12. Guide wire 74 preferably has sufficient stiffness to push as well as pull distal portion 18. Cannula 12 is preferably constructed of a flexible material. Additionally or alternatively, a portion of cannula 12 may be constructed with a relatively low bending moment to permit easy flexing of distal portion 18 of cannula 12. For example, as seen in Fig. 9A, cannula 12 may have a thin-walled section 78, or as seen in Fig. 9B, cannula 12 may be formed with notches 80 so as to make the cannula tip bendable sideways. Thin-walled section 78 and notches 80 may be formed around a portion of the perimeter of cannula 12 or all around the perimeter.
Referring to Fig. 8, it is seen that the proximal end of guide wire 74 is attached to a lever 82 which is preferably pivotally attached about a fulcrum 83 to a handle 84. Guide wire 74 is preferably bent about an attachment point 86 in lever 82. As seen in Fig. 11, by pushing guide wire 74 with lever 82 in the direction of an arrow 90, distal portion 18 of cannula 12 is accordingly bent or flexed generally in the direction of an arrow 92. The flexing action significantly increases the area which may be scraped and/or raked with uterine tissue collector 70. Guide wire 74 is preferably coupled to a motor 93 for automatic flexing. Motor 93 is preferably the same motor used to vibrate deformable scraper 16. Alternatively, lever 82 may be bent with the index finger.
It is seen in Fig. 11 that guide wire 74 is preferably attached to cannula 12 at a fulcrum point 91. This arrangement causes lever 82 to bend cannula 12 at a buckling pocket 89, thereby significantly increasing the amount that cannula 12 bends.
Alternatively, a second guide wire 76 may be used in conjunction with guide wire 74, guide wire 76 being attached to a side of distal portion 18 opposite to guide wire 74. Each guide wire 74 and 76 may be disposed in a separate lumen formed in cannula 12 (Fig. 10 A), or may alternatively be disposed either inside lumen 40 (Fig. 10B) or outside of cannula 12 (Fig. 10C). In such an embodiment, generally proximal movement of one of the guide wires causes flexing of distal portion 18 in a direction generally opposite to that caused by generally proximal movement of the other guide wire.
Reference is now made to Figs. 12A-13C which illustrate a suction device 100, useful with a uterine tissue collector such as any of the uterine tissue collectors of the present invention, constructed and operative in accordance with a preferred embodiment of the present invention. The details of the construction of suction device 100 are best seen in Figs. 13A-13C.
Suction device 100 comprises a two-stage syringe 102. Syringe 102 preferably includes a distal barrel 104 which extends from and is in fluid communication with a proximal barrel 106, proximal barrel 106 having a larger diameter than distal barrel 104. Distal barrel 104 is preferably none other than cannula 12. A plunger 108, having a distal end 110, sealingly slides in distal barrel 104 like any conventional plunger. The body of plunger 108 passes through a plunger element 112 disposed in proximal barrel 106. Plunger element 112 is sized to sealingly slide in proximal barrel 106. Plunger element 112 preferably has a recess 113 formed in a distal end thereof, recess 113 being sized to snugly receive therein distal end 110 of plunger 108. A proximal end of plunger 108 is preferably provided with a small handle 1 17.
As seen in Fig. 13B, handle 117 may be used to pull plunger 108 proximally in the direction of an arrow 114. Upon sufficient proximal pulling, distal end 110 of plunger 108 snugly seats in recess 113. As seen in Fig. 13C, plunger element 112 may now be pulled proximally in the direction of arrow 114, and plunger 108 now moves together with plunger element 112. Thus, plunger element 112 now acts as a new tip of plunger 108 in its travel in proximal barrel 106.
Since proximal barrel 106 has a larger area than distal barrel 104, the amount of material which can be collected with syringe 102 is significantly greater than a conventional syringe of the prior art which has only one barrel of the size of the distal barrel of the present invention, and yet the smaller diameter of distal barrel 104 allows entry of syringe 102 into smaller openings than possible with syringes of the prior art which have a single barrel of the size of proximal barrel 106.
Material collected with syringe 102 may be discharged by distally pushing plunger element 112 together with plunger 108 in the direction opposite to arrow 114. Once plunger element 112 is pushed back to abut against a distal face 119 of proximal barrel 106 (the position shown in Fig. 13B), handle 117 may now be used to distally push plunger 108 so that distal end 110 of plunger 108 becomes dislodged from plunger element 112 and is free to be pushed further into distal barrel 104. Plunger 108 may then be further pushed to completely discharge the collected material.
It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.

Claims

C L A I M S What is claimed is:
1. A tissue collector (70) comprising: a deformable scraper (16) which is capable of being deformed from an undeformed configuration to a deformed configuration and which scrapes a tissue while moving between said undeformed configuration and said deformed configuration; a deformer (22) which deforms said deformable scraper (16); and a suction device (20, 100) which sucks material scraped by said deformable scraper (16); characterized by said scraper (16) being disposed in a cannula (12) comprising a flexible distal portion (18), and wherein at least one guide wire (74) is attached to the distal portion (18) of the cannula (12), wherein movement of said at least one guide wire (74) flexes the distal portion (18) of said cannula (12).
2. The tissue collector (70) according to claim 1 wherein said at least one guide wire (74) is disposed through a lumen (72) formed through said cannula (12).
3. The tissue collector (70) according to claim 2 wherein said lumen (72) constrains movement of said at least one guide wire (74) in a direction generally along a longitudinal axis (32) of said cannula (12).
4. The tissue collector (70) according to claim 1 wherein a proximal portion of said at least one guide wire (74) is pivotally attached about a fulcrum (83) to a lever (82) such that movement of said lever (82) flexes the distal portion (18) of said cannula (12).
5. The tissue collector (70) according to claim 1 and comprising a pair of said guide wires (74, 76), wherein generally proximal movement of one of said guide wires (74) causes flexing of said distal portion (18) of said cannula (12) in a direction different to that caused by generally proximal movement of the other guide wire (76).
6. The tissue collector (70) according to claim 5 and wherein each said guide wire (74, 76) is disposed in a separate lumen formed in said cannula (12).
7. The tissue collector (70) according to claim 1 and wherein said at least one guide wire (74) is sufficiently stiff so as to be able to push distally as well as pull proximally the distal portion (18) of said cannula (12).
8. The tissue collector (70) according to claim 1 and wherein said at least one guide wire (74) is attached to said cannula (12) at a fulcrum point (91), thereby causing said cannula (12) to bend at a buckling pocket (89) when said at least one guide wire (74) pushes distally the distal portion (18) of said cannula (12).
9. The tissue collector (10, 70) according to claim 1 and comprising: a syringe (102) comprising a distal barrel (104) which extends from a proximal barrel (106), said proximal barrel (106) having a larger diameter than said distal barrel (104); a plunger element (112) disposed inside said proximal barrel (106), said plunger element (112) being adapted to sealingly slide inside said proximal barrel (106); and a plunger (108) that passes through said plunger element (112), wherein when said plunger (108) is pulled proximally and starts to enter said proximal barrel (106), said plunger (108) is received in a recess (113) formed in said plunger element (112), such that when said plunger (108) is pulled further proximally, said plunger (108) moves together with said plunger element (112) and said plunger element (112) serves as a new distal end of said plunger (108) during sliding travel in said proximal barrel (106).
10. A tissue collector (10, 70) comprising: a deformable scraper (16) which is capable of being deformed from an undeformed configuration to a deformed configuration and which scrapes a tissue while moving between said undeformed configuration and said deformed configuration; a deformer (22) which deforms said deformable scraper (16); and a suction device (100) which sucks material scraped by said deformable scraper
(16); characterized by said suction device (100) comprising a syringe (102) comprising a distal barrel (104) which extends from a proximal barrel (106), said proximal barrel (106) having a larger diameter than said distal barrel (104); a plunger element (112) disposed inside said proximal barrel (106), said plunger element (112) being adapted to sealingly slide inside said proximal barrel (106); and a plunger (108) that passes through said plunger element (112), wherein when said plunger (108) is pulled proximally and starts to enter said proximal barrel (106), said plunger (108) is received in a recess (113) formed in said plunger element (112), such that when said plunger (108) is pulled further proximally, said plunger (108) moves together with said plunger element (112) and said plunger element (112) serves as a new distal end of said plunger (108) during sliding travel in said proximal barrel (106).
11. The tissue collector (70) according to claim 1 and characterized by said scraper (16) being stiffer when moved towards a proximal end of said collector (10) than when moved towards a distal end of said collector (10).
12. The tissue collector (10, 70) according to claim 10 and characterized by said scraper (16) being stiffer when moved towards a proximal end of said collector (10) than when moved towards a distal end of said collector (10).
13. A tissue collector ( 10) comprising: a deformable scraper (16) which is capable of being deformed from an undeformed configuration to a deformed configuration and which scrapes a uterus while moving between said undeformed configuration and said deformed configuration; a deformer (22) which deforms said deformable scraper (16); and a suction device (20, 100) which sucks material scraped by said deformable scraper (16); characterized by said scraper (16) being stiffer when moved towards a proximal end of said collector (10) than when moved towards a distal end of said collector (10).
14. The tissue collector (10) according to claim 13 wherein said scraper (16) substantially scrapes said uterus only when moved towards said proximal end of said collector (10).
15. The tissue collector (10) according to claim 13 and wherein said scraper (16) comprises a flexible tongue (26) adjacent and proximal to a generally rigid tongue (28), wherein said flexible tongue (26) when moved towards said proximal end of said collector (10) flexes towards and abuts against said rigid tongue (28) and when moved towards said distal end of said collector (10) flexes away from and does not abut against said rigid tongue (28).
16. The tissue collector (10) according to claim 15 and wherein said flexible tongue (26) protrudes further from a longitudinal axis (32) of said collector (10) than said rigid tongue (28).
17. The tissue collector (10) according to claim 13 and also comprising a cannula (12) having a first lumen (40) and a second lumen (42), wherein said deformable scraper (16) is disposed in said first lumen (40) and at least a portion of said scraper ( 16) is protrudable through an aperture (14) formed in said first lumen (40), and wherein said deformer (22) comprises a wire (24) coupled to said deformable scraper (16), said wire (24) passing through said second lumen (42).
18. The tissue collector (10) according to claim 17 and wherein said second lumen (42) has a passageway (44) formed therein for flow therethrough of a fluid towards a distal portion (18) of said cannula (12).
19. The tissue collector (10) according to claim 18 and comprising a bleed valve (48) for controlling said flow of said fluid through said passageway (44).
20. The tissue collector (10) according to claim 13 and also comprising: a cannula (12) having an inner surface; and a wiping device (50, 60) that wipes particles from said inner surface of said cannula (12).
21. The tissue collector (10) according to claim 20 and wherein said suction device (20) imparts a fluid force on said wiping device (50, 60) to propel said wiping device (50, 60) through said cannula (12).
22. The tissue collector (10) according to claim 20 and wherein said wiping device (50, 60) comprises an elastic ball (52, 62) which is disposed in said cannula (12) and touches said inner surface.
23. The tissue collector (10) according to claim 22 wherein said elastic ball (62) is initially attached to said suction device (20) and is detachable from said suction device (20) upon said suction device (20) imparting a fluid force on said elastic ball (62).
PCT/IL1998/000386 1997-09-10 1998-08-17 Tissue collector WO1999012476A2 (en)

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JP2000510378A JP2001515747A (en) 1997-09-10 1998-08-17 Tissue collector
EP98938882A EP1011454A2 (en) 1997-09-10 1998-08-17 Tissue collector
AU87465/98A AU8746598A (en) 1997-09-10 1998-08-17 Tissue collector
CA002303204A CA2303204A1 (en) 1997-09-10 1998-08-17 Tissue collector
BR9811652-5A BR9811652A (en) 1997-09-10 1998-08-17 Tissue collector

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IL121734 1997-09-10
IL12173497A IL121734A0 (en) 1997-09-10 1997-09-10 Uterine tissue collector
IL12435998A IL124359A0 (en) 1998-05-07 1998-05-07 Tissue collector
IL124359 1998-05-07

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WO1999012476A3 (en) 1999-05-06
BR9811652A (en) 2002-09-24
EP1011454A2 (en) 2000-06-28
AU8746598A (en) 1999-03-29
CN1278154A (en) 2000-12-27
JP2001515747A (en) 2001-09-25
CA2303204A1 (en) 1999-03-18

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