CA2221469A1 - Unitary removal of plaque - Google Patents
Unitary removal of plaque Download PDFInfo
- Publication number
- CA2221469A1 CA2221469A1 CA002221469A CA2221469A CA2221469A1 CA 2221469 A1 CA2221469 A1 CA 2221469A1 CA 002221469 A CA002221469 A CA 002221469A CA 2221469 A CA2221469 A CA 2221469A CA 2221469 A1 CA2221469 A1 CA 2221469A1
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- Canada
- Prior art keywords
- plaque
- artery
- head
- segment
- instrument
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/32075—Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
- A61B2017/00473—Distal part, e.g. tip or head
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00681—Aspects not otherwise provided for
- A61B2017/00685—Archimedes screw
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22094—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B2017/320004—Surgical cutting instruments abrasive
- A61B2017/320008—Scrapers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B2017/320044—Blunt dissectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
Abstract
Novel apparatus (20) and related methods are disclosed by which plaque is connected to the head (34) of a removal instrument (20) for removal of a unitary segment of plaque from an artery intact to increase blood flow through the artery.
Description
W O 96/39084 PCTrUS96/03039 UNITARY REMOVAL OF PLAQUE
Teçhnir~l Field The present invention relates generally to increasing blood flow in arteries and, more particularly, to unitary removal of a segm~nt of plaque from an artery.
Back~round Art Constricted blood flow in human arteries due to build-up of plaque is a commnn m~nt and creates serious risks to the quality of life and, in some cases, e.g., when build-up occurs in CO~ y arteries, to life itself, too frequently at an early age.
Past efforts to address the problem of plaque arc~ml-l~tion in arteries have consisted ~rilll;~;ly of conventional enda~tclc~;Loll~y~ by-pass surgery, ~ tion of the z~Mirt~l arteries using dottering or balloon angioplasty (PTA and PTCA), a~hc,cclon~, and sl~cces~ive severing of thin layers of plaque by reason of repeated passes of a cut~ing or grinding i~Llulllerlt along the plaque region where removal is desired. The plaque-cutting technique also requires that debris, in the form of plaque fragments released into the blood skeam, be collected and removed from the artery to avoid complications (such as embolization and thrombosis). Laser removal of plaque is also known.
Conventional endallclccl l-ly is invasive. By-pass surgery is tr~llm~tic to the tissue, very expensive, very invasive, and creates the ~,ealc~L risk to the patient. Balloon angioplasl:y and/or dottering are often only a temporary or short-term solution, as all of the plaque in the ~fflicte-l artery at the time of tre~frnPnt remains there. Dilation only rearranges plaque and may cause pieces of plaque to break loose into the blood skeam. Additional build-up of plaque at the site of treatment can be prevented or alleviated by exercise and diet control, if patient compliance can be achieved. Atherectomy has ~l~om(~ .aL~d poor long-term results, at least in peripheral vessels.
W O 96/39084 PCT~US96/03039 Repeated cutting of the atheroma using a reciprocated il~iLlulllcll~ offers ~lulllise, but cannot be performed rapidly, may not remove all of the plaque at the tre~tm~nt site, and risks complications when and if plaque fragments are not collected and thus escape to flow with blood to other parts of the cardiovascular system. Laser removal of plaque has also shown poor long-term results in some studies.
All present L..~ exhibit restenosis, a complex, poorly understood process by which the artery becomes re-blocked by material that includes ullcullllolled growth of smooth muscle cells (intimal hyperplasia or myointimal fibroplasia). All present tre~tm~ontc vary in peri-operative measures of desirability, including duration of procedure, degree of invasiveness of procedure, number and size/length of surgical incisions required, length of stay in hospital, recuperation/healing time, time until return to work, degree of an~sth~osi~
(local/general) required, overall procedure risk, and overall Lle~ t cost.
W O 96~9084 PCTrUS96/03039 Disclosure of the Invention In brief ~.. ~.y, the present inve:ntion overcomes or alleviates problems of the prior art. It is believed that a less tr~l~m~tir, lower risk, less eA~ensi~e, less invasive, less time-conellmin~, and more efficacious plaque treatment a~aldlus and related methods are provided by which a unitary segment of plaque is removed intact from an artery.
With the foregoing in mind, it is a primary object to overcome or alleviate problems of the prior art.
A further object of paramount importance is the provision of novel plaque tre~tmPnt ~7~aldtus and related methods.
Another object of value is the provision of a~paldLus and met'nodology by which a unitary segment of plaque is removed intact from an artery.
An additional object of importance is the provision of what is believed to be a ~ignifir;~ntly less Lln,~ ir~ lower risk, less expensive, less invasive, less time-con~--ming, and more efficacious way of treating plaque.
A further object of ~ignific~nre is the provision of a novel plaque removal ap~dldLIls and method having one or more of the following features: (1) applicable for plaque removal in arteries of all sizes including all peripheral, corolldly7 and carotid arteries, (2) which can use one or two relatively small incisions, (3) which is effective with or without pre-loosening of plaque; (4) which is operable with or without a guidewire; (5) which can be placed in the artery of choice either concellLlically or eccentrically; (6) usable alone or in combination without other plaque treating procedures; (7) usable in both partially and totally occluded arteries; and (8) useable in either an open surgical procedure or a percutaneous procedure.
These and other objects and r~alul~is of the present invention will be apparent from the detailed description taken with r~r~ ce to the ~rco~p~..yillg drawings.
W O 96~9084 PCTAUS96/03039 Brief Description of the Drawings Figure 1 is a fr~llle~ y lon~itl~lin~l cross-section of a plaque-co--"eeli-~
i~Llulllent, in tli~m~otrally-co~ ;L~d orientation, disposed in a plaque l~rlton.o~ artery.
Figure 2 is a fr~gm~n1~ry longih--lin~l cross-section illustrating the instrument being pulled while in a radially-e~pan~l~d plaque-cu.-.ucti..g position;
Figure 3 is a transverse cross-section taken along lines 3-3 of Figure 2;
Figure 4 is a fragmlont~ry longihl~lin~l cross-section of a second plaque-colllle~ g h~llu~llent, in a ~ metr~lly-constricted orientation, disposed in a plaque-~ en~od artery.
Figure S is a fragment~ry longit~ in~l cross-section illu~LId~ g the instrument being pulled while in a radially-exp~nllecl plaque-co-",P~Ii"g position;
Figure 6 is a transverse cross-section taken along lines 6-6 of Figure S;
Figure 7 is a fr~j~m~ont~ry l~ngitll~lin~l cross-section of a plaque-col~..Pc~ g il~llui~llent, being pulled while in a hooked position with plaque in an artery;
Figure 8 is a fr~gm~nt~ry loni~ihl~lin~l cross-section similar to Figure 7 showing a segment of plaque being displaced with the conn~octing hlsllulllelll along the length of the artery;
Figure 9 is a transverse cross-section taken along lines 9-9 of Figure 8;
Figure 10 is an elevational view of a segment of plaque removed intact from an artery using the present invention;
Figure 11 is a flow chart depicting various ways of implem~nting the present invenlion; and Figure 12 is a fr~m~nt~ry longib--lin~l cross-section of the plaque-connPcting instrument eccentrically or asymmetrically inserted into an artery, i.e., between the inner arterial wall and the plaque.
W O 96~9084 PCTrUS96/03039 Best Mode for Carrying out the Invention R~;~e.~nce is now made to the dldwiulgs wherein like mlm~r~l~ are used to de~ign~te like parts throughout. The present invention provides for unitary, intact removal of a segm~nt of plaque from an artery to resolve or alleviate co~ ;eli~/e blood flow problems in human arteries. The invention overcomes or alleviates health risks associated with conventional endarterectomy, by-pass surgery, dottering and balloon angioplasty procedures, atherectomy, reciprocal cutting of layers of plaque, and laser plaque removal. It is believed that intact removal of one or more seg-llel,L~. of plaque, in accord~nce with the principles of the present invention, is less tr~llm~tir7 creates lower risks, is less ~ .ive, is less invasive, less time-co"~ g, and is more efficacious than by-pass surgery, angioplasty, and reciprocal cutting of plaque.
R~fe.e.lce is now made to Figure 11, for the l~ul~ose of providing a description of the present invention which is colllprehel~.ive. Initially, at least one man-made upel~ g and in some cases only one opening is created in the artery, at a readily ~rcessihle site, for which plaque tre~tmtoTlt is desired. This can be done conventir,n~lly, by making a small surgical incision in the artery of no greater size than needed or by making a small puncture in the vessel, such as a percutaneous ~uncLulc;, followed by conventional insertion of a guidewire, which may or may not be followed by sheath insertion including insertion of a sheath particularly suitable to plaque removal.
As a prelimin~ry to intact removal of a unitary segment of plaque, one or more plaque-loosening techniques may be employed, at the discretion of the health care provider.
For example, where one incision or other man-made opening is used, the plaque adjacent thereto may be generally radially and/or circumferentially cut or bluntly ~ sectr~l so as to make removal easier, sure, and predictable. Where two incisions or other man-made W O 96~9084 PCT~US96/03039 openings are made in the length of artery to be treated, the plaque, at both man-made openings, may be generally radially and/or cir~;ul,lre,ellLially cut or blun~ly ~ ecte(l for ease and predictability of plaque segm~nt removal.
If desired, a dottering h~LlulllellL may be inserted and caused to vibrate and/or rotate so as to impact in a sequential fashion upon plaque adhering to the interior wall surface of the length of artery to be treated. The dottering instruments disclosed in pending U.S.
Trademark Application Serial No. 07/943,514, filed November 9, 1992 (owned by the n~e of the present invention), may be utilized to so preliminarily loosen the plaque to be later unitarily removed from the artery. A second ~ul~ose for use of a dottering u~nent is to enlarge the lumen or pa~w~y to permit insertion of the plaque-conntocting Thel~ar~ , a suitable il~lu~e.ll is placed, inserted, or introduced through the man-made opening into the artery, for exannple, although not n.ocess~rjly, along an indwelling guidewire. The insertion can be generally concentric within the plaque-ridden lumen of the artery (see Figure 1, for example) or eccentric, i.e., between the arterial wall and the plaque (see Figure 12, for example).
After il~l~ ent insertion, instrument displacement continues, by exercise of ext~rn~l control, until the head of the instrument has been displaced ltO and located at a desired site adjacent to plaque within the artery, normally removed or remote from the insertion site. A suitable external control, which may be used in practicing the principles of the present invention, is disclosed in co-pending U.S. Patent Application Serial No.
07/973,514, filed November 9, 1992 (owned by the ~si~nPe of the present invention).
When so disposed, positioned, or placed, the head of the instrument is conn~ct~A, on a temporary or releasible basis, to the ~ cent plaque whereby the instrument is tethered to the plaque. The connection may be by grabbing, gripping, compressively holding, clamping, and/or embedding plaque within the head so as to bind together the plaque and the head, grasping, and/or holding the plaque by or at the head. The connection may or may not also .~imnlt~n~ously create a tapering interface between the engaged plaque and neighboring plaque that has not been engaged.
Once the releasible connection has been created b~lweell the head of the instrument and the adjacent plaque, the h~Llulllelll is displaced so as to apply force to the tethered plaque, i.e., the plaque to which the releasible connection has been made. While the primarily force is one of pulling or stretching the plaque along the length of the artery in a direction generally parallel to the lon~itll-lin~l axis of the artery and opposite to the direction of insertion, other motions may also be used. For example, the releasible connection int~rn~lly within the artery may be achieved using at least some rotation and, thereafter, additional rotation may be applied in one or both directions to assist in sep~lldLing a length of plaque from its adhered relation within the artery. Similarly, the head may be advanced and retracted to the same end. In some applications including two-incision situations, the plaque may be engaged and then pushed toward the second incision, rather than being pulled back toward the first incision. The direction of the insertion and force applied is independent of the arterial flow direction, i.e., it may be either antegrade or retrograde to normal blood flow.
The above-mentioned instrument displacement while the head is releasibly connt cte~l to the plaque results in tearing, severing, shearing, separating, and/or peeling instantly or progressively of a segment of plaque as a unit from the artery. The plaque segment can be separated from residual arterial plaque~ including adjacent plaque by tearing or shearing or by radially and/or circumferentially cutting using a suitable instrument.
Plaque nnay also se~alaLt: along a created tapering interface due to the force ~ d through the connPctin3~ plaque as it is manipulated by the Col~..f-C~ h~llull~ lL.
One principle at work here is that a chain is as strong as its weakest link. The force ~r~ d to the plaque eventually produces s~ liom at the plane between tissue layers where the conïlection between the layers is weakest. In practice, this weakest connection generally occurs at the plane between the tii~P~sec~ tissue arld the non~ e~Pd tissue. The we~kn~s~ at this plane is related to the we~kn~ss exploited using blunt dissection in conventional endarterectomy, altnough the physical m.orh~ni~m described herein exploits ~is we~kn~.c.s in quite a different way which in no way employs the blu~t r~ ecti~ n used in conveIltional end~l t~ c~; lomy .
The severed unitary segment of plaque is, finally, l~Llie~,~,d, withdrawn, and removed from the artery through the insertion site along with the ilL~.Llunle.ll head to which the plaque segm~nt is temporarily co".~ ecl, or through another site toward which the head has pulled or pushed the plaque.
While the health care provider can, thereafter, insert a syn~etic or biologically-obtained lining into the treated artery, the present invention comprehends as well termin~ting the pracedure upon withdrawal of the plaque segm.onf and removal head, followed by suitable closing of the one or more man-made openings in the artery.
The present invention comprehends provision of an d~aldLIIs for excising a segment of plaque intact from the artery which colll~lises an h~LlulllenL equipped with a plaque-eng~ging head Colll~liSillg a connector by which the head is temporarily joined to plaque within the artery and by which force is applied to the plaque to loosen and remove a continuous segment thereof. The instrument colllplises a mrrll~ni.cm including an external control by which the il~.LlLlmelll, its head, including its connector, are manipulated to locate W O 96~9084 PCTrUS96/03039 the head a~ cent the plaque to be engaged, which is normally remote from the insertion site, for temporarily or releasibly connPcting the co"lle~lor to the plaque without severing or fr~gmPntin~ the plaque, for applying a force across the co-l"eclor to the conn~ctPd plaque sufficient to sever the segm~ont of plaque intact from the artery and for removing the severed segment of plaque from the artery. A typical length of plaque so removed from an artery is illustrated in Figure 10. The plaque segment can be short or it can be very long, for example 15-18 inches. It is, however, to be appreciated that the present invention is not restricted to any particular type of instrument. Any h~Llu"~"l capable of being connPcted to arterial plaque at a desired site and by which the connPcttod plaque can be unitarily removed intact as a segment from the artery may be used. The form of releasible connection may be binding, snagging, co",p,~ssi~rely holding, taking hold of, grasping, grabbing, hooking, piercing, rotational engagement, clamping, biting, en hed-ling, or in any other suitable way.
Nolwi~ g the foregoing, Figures 1-3, 4-6, and 7-9 illustrate different mPch~nir~l configurations by which an instrument head is temporarily connPct~d to plaque for purposes of unitary removal intact of a plaque segment. With specific reference to Figures 1-3, an i,~ll~l"lent, generally ~lP~ign~t~d 20, is there illustrated as having been inserted through a man-made opening in an artery, generally design~ttorl 22, in a generally conce"L,ic fashion so as to be disposed generally centrally within a lumen 24 of the artery constricted by a surface-irregular deposit of plaque 26. Insertion is illustrated as being achieved conventionally along an indwelling guidewire 28 in a collapsed or diametrically-small configuration. The instrument co~ lises a first relatively large tube 30 through which a smaller tube 32 generally concentrically passes. The instrument 20 comprises a head, W O 96/39084 PCT~US96tO3039 general}y ~l~.ci~n~t~l 34 colnl)lisillg a plurality of plaque connectors, each desi~n~t.od 36, in the form of resili~nt, helically-disposed blades. Each blade 36 is illustrated as being centrally enlarged at 37. The blades are joined at their respective proximal ends to the proximal portion 38 and to a distal tip 40 at their respective distal ends and may o~ may not pivot at their ends relative to proximal portion 38 amd distal tip 40. The tube 32 extends centrally between the blades 36 and is securely non-rotatably f~.~tenlo~ to the proximal portion of the distal tip 40.
Once the head 34, in its constricted position, is disposed at a desired location along the artery 22 adjacent a desired portion of plaque 26, an exterior control, such as the one disclosed in pending U.S. Patent Application Serial No 07/973,514, filed November 9, 1992, is used to lon~ in~11y retract tube 32 and tip 40 in respect to tube 30 causing the plaque-co~ eclol blades 36 to flex from the constricted position of Figure 1 to the radially ~o~r~nflPd position of Figure 2.
Thelcarhr or simlllt~n~ously the.e~ , the head 34 is pulled and/or rotated so as to create a releasible or Lc~ or~ly connection between the head 34 and the plaque engaged by the blades 36, as shown in Figure 3. This grasping, grabbing, clamping, binding or like phenomenon causes the conn~cte~l plaque to move as the instrument head 34 is moved by manipulation of the external control. Thus, the head 34 can be moved back and forth and/or can be rotated in one or the other or both directions so as to radially and/or circumferentially sever or shear the plaque from itself, as illustrated at site 42 in Figure 2. The h~ l.Rnt 20 and its head 34 are retracted in a generally longih-llin~l or axial direction, either alone or in conjunction with back and forth movement as well as selected rotational movement in one or the other, or both directions. This causes the plaque to be sheared, peeled, or be severed from the internal surface 44 of the internal wall 46 of the artery 22, which defines the boundary between the arterial wall and the engaged plaque. It is to be appreciated that as arterial disease progresses, this boundary between the ~ e~eed and nntli~e~c~l arterial wall may be located within the interior layer 46, or between layers 46 and 52, or within layer 52, but does not generally invade layer 50. The severed unitary plaque segment 26' is retrieved together with the conn~cte~l head 34 and removed through the man-made opening in the artery and when removed and disconn~cted from the head has a worm-like appearance as shown in Figure 10. Plaque segment 26' might be called an enda,L~recLol,ly plug. Medically speaking, it is by definition an endarterectomy plug, although the endarterectomy has been achieved by novel, non-conventional techniques.
In m~ l terms, the artery 22 comprises an outside layer 50 known as the tunica adventitia, a central, radially larger interm.o~ te layer 52, known as the tunica media, and the previously mentioned interior layer or wall 46, known as the tunica intima endothelium.
The plaque 26 is typically referred to as atherosclerotic plaque, which in advanced stages of disease such as are typically treated, partially or wholly, engulfs the tunica media.
The present invention, as stated earlier, does not contemplate cutting, grinding, or fragmenting pieces of plaque 26 from the atheroma, but rather is directed to grasping, gripping, clamping, or otherwise releasibly conn.qcting the instrument head to the plaque for intact removal of a segment of plaque and in certain embo-lim~nt~, including the embo-liment.c disclosed herein, contemplates simnl~n~oously creating a tapered interface.
The creation of the tapered interface is advantageous in that, after the treatment when flow is restored, a tapered interface in the upstream direction will help prevent the creation of undesirable flaps of disease being lifted from the vessel wall, as the flow over the tapered disease will press the disease more firmly into the vessel wall, and also reduce flow turbulence at the interface.
W O 96~9084 PCT~US96/03039 ReÇe.~llce is now made to the h~LlulllellL illustrated in FigLres 4-6, which is generally clesi~n~ted 20'. The instrument 20' is conn~oct~d and controlled as is the above-described ill~Llulllent 20. Only dirr~ nces between il~.LlulllellL 20 and instrument 20' need description here. The numerals used in Fi~res 4-6 which are j(1rntir.~l to numerals used in Figures 1-3 identify i~1~ntir~1 o m.ul)~L~llLially i-i.ontir~l parts. The instrumel~t 20' differs from the ilLsL~ument 20 primarily in the configuration of c~ ne-;lor head 34'. Head 34' culll~lises a plurality of spaced, sOllltwllàL longit~ in~lly-ext~n-lin~ blades 36' anchored"~ ecLi~!ely, at the proximal ends 38 thereof to the distal portion of the tube 30 and non-rotatably joined to the tiR 40- Each blade 36' colll~lises a proximally-directed barb 37'. While each barb 37' is illlustrated as being disposed at a slight acute angle in respect to the longit~l~in~l axis of the artery 22, any suitable barb orientation may be used.
When the tube 32 is retracted by the extern~l control in respect to tube 30, tip 40 is displaced toward proximal portion 38, causing the blades 36' of the head or co..l~el~
34' to flex radially ouLwaldly. Withdrawal (retraction) and/or rotation of the head 34' causes the blades 36' to bite into, but not sever away pieces of the plaque 26. Generally lon~ in~l retraction of the instrument 20', inr~ 'ing connPcting head 34' with the plaque 26 bindingly connrcted between the blades 36', accommodates severing or shearing of the plaque at radially-directed site 42 thereby sepa.~ plaque segment 26' from residual arterial plaque 26. This severing or shearing can create a tapered or beveled interface. The retraction of the h~Llul~ent 20' may be accompanied by to and fro longi~l~lin~l movement of the head 34', retraction only and/or rotation in one or the other or both directions ~ sufficien~: to sever, shear, or peel the plaque segment 26' from the annular interface 44 of the inner layer 46 of the artery 22, or at whatever depth the llice~cedlnon-~lice~ce~l interface has progressed, as described earlier.
W O 96~9084 PCTrUS96/03039 The severed plaque segment 26' is retrieved and removed from the artery through a man-made opening therein as the instrument 20' is removed, the head 34' rem~ining releasibly connPctPd to the plaque segment 26' during retrieval and removal.
Refelcnce is now made to the unitary plaque segment removal instrument, generally ~esign~tP(l 20", illustrated in Figures 7-9. To the extent parts of instrument 20n illustrated in Figures 7-9 are ;clenti~l or substantially i~lenti~l to parts previously described m connection with Figures 1-3, i~1Pntir~l numerals are used and no further description thereof lS l~PCP~ y.
Tube 30 and distal portion 38 thereof do not form a part of the embodiment illustrated in Figures 7-9. Instrument head 34" is non-rotatably secured at the distal end of tube 32 and is inserted into the desired location along guidewire 28. The instrument head 34" is illustrated as m~int~ining a constant lldl~/~.se ~limPn~ional configuration.
Head 34" comprises a plurality of curvilinear blades 36", each of which is illustrated as c,~lyillg a pair of curved hooks 39, which engage the plaque when rotated so as to pierce portions thereof without severing pieces of plaque thererl.lll. Thereafter, by displacing the head 34" to and fro, or by retracting alone and/or rotationally as desired and by primarily retracting the head 34" along the length of the artery 22, plaque segment 26' is loosened, severed, retrieved, and removed from the artery through a man-made opening therein.
Reference is now made to Figure 12, which illustrates the same apparatus as shown in Figures 1-3, illustrating placement of the instrument head 34 into the artety between the plaque 26 and the arterial wall surface or cleavage interface of weakness 44 and advanced along the arterial surface 44 to the desired plaque connection site wiLll~uL prior use of an interface s~al,aLion tool.
W O 96~9084 PCT~US96/03039 The invention may be embodied in other specific forms without departing from the spirit of e~enti~l cha,~.cLe.;sLics thereof. The present embo.~ therefore to be consider.ed in all r~sL,ec~ as illll~tr~tive and are not restrictive, the scope of the invention being in~1ir~trcl by the appended claims rather than by the foregoing description, and all changes which come within the ~ g and range of equivalency of the claims are therefore int~-1ed to be embraced therein.
VVhat is cl~imPcl and desired to be secured by Letters Patent i3:
Teçhnir~l Field The present invention relates generally to increasing blood flow in arteries and, more particularly, to unitary removal of a segm~nt of plaque from an artery.
Back~round Art Constricted blood flow in human arteries due to build-up of plaque is a commnn m~nt and creates serious risks to the quality of life and, in some cases, e.g., when build-up occurs in CO~ y arteries, to life itself, too frequently at an early age.
Past efforts to address the problem of plaque arc~ml-l~tion in arteries have consisted ~rilll;~;ly of conventional enda~tclc~;Loll~y~ by-pass surgery, ~ tion of the z~Mirt~l arteries using dottering or balloon angioplasty (PTA and PTCA), a~hc,cclon~, and sl~cces~ive severing of thin layers of plaque by reason of repeated passes of a cut~ing or grinding i~Llulllerlt along the plaque region where removal is desired. The plaque-cutting technique also requires that debris, in the form of plaque fragments released into the blood skeam, be collected and removed from the artery to avoid complications (such as embolization and thrombosis). Laser removal of plaque is also known.
Conventional endallclccl l-ly is invasive. By-pass surgery is tr~llm~tic to the tissue, very expensive, very invasive, and creates the ~,ealc~L risk to the patient. Balloon angioplasl:y and/or dottering are often only a temporary or short-term solution, as all of the plaque in the ~fflicte-l artery at the time of tre~frnPnt remains there. Dilation only rearranges plaque and may cause pieces of plaque to break loose into the blood skeam. Additional build-up of plaque at the site of treatment can be prevented or alleviated by exercise and diet control, if patient compliance can be achieved. Atherectomy has ~l~om(~ .aL~d poor long-term results, at least in peripheral vessels.
W O 96/39084 PCT~US96/03039 Repeated cutting of the atheroma using a reciprocated il~iLlulllcll~ offers ~lulllise, but cannot be performed rapidly, may not remove all of the plaque at the tre~tm~nt site, and risks complications when and if plaque fragments are not collected and thus escape to flow with blood to other parts of the cardiovascular system. Laser removal of plaque has also shown poor long-term results in some studies.
All present L..~ exhibit restenosis, a complex, poorly understood process by which the artery becomes re-blocked by material that includes ullcullllolled growth of smooth muscle cells (intimal hyperplasia or myointimal fibroplasia). All present tre~tm~ontc vary in peri-operative measures of desirability, including duration of procedure, degree of invasiveness of procedure, number and size/length of surgical incisions required, length of stay in hospital, recuperation/healing time, time until return to work, degree of an~sth~osi~
(local/general) required, overall procedure risk, and overall Lle~ t cost.
W O 96~9084 PCTrUS96/03039 Disclosure of the Invention In brief ~.. ~.y, the present inve:ntion overcomes or alleviates problems of the prior art. It is believed that a less tr~l~m~tir, lower risk, less eA~ensi~e, less invasive, less time-conellmin~, and more efficacious plaque treatment a~aldlus and related methods are provided by which a unitary segment of plaque is removed intact from an artery.
With the foregoing in mind, it is a primary object to overcome or alleviate problems of the prior art.
A further object of paramount importance is the provision of novel plaque tre~tmPnt ~7~aldtus and related methods.
Another object of value is the provision of a~paldLus and met'nodology by which a unitary segment of plaque is removed intact from an artery.
An additional object of importance is the provision of what is believed to be a ~ignifir;~ntly less Lln,~ ir~ lower risk, less expensive, less invasive, less time-con~--ming, and more efficacious way of treating plaque.
A further object of ~ignific~nre is the provision of a novel plaque removal ap~dldLIls and method having one or more of the following features: (1) applicable for plaque removal in arteries of all sizes including all peripheral, corolldly7 and carotid arteries, (2) which can use one or two relatively small incisions, (3) which is effective with or without pre-loosening of plaque; (4) which is operable with or without a guidewire; (5) which can be placed in the artery of choice either concellLlically or eccentrically; (6) usable alone or in combination without other plaque treating procedures; (7) usable in both partially and totally occluded arteries; and (8) useable in either an open surgical procedure or a percutaneous procedure.
These and other objects and r~alul~is of the present invention will be apparent from the detailed description taken with r~r~ ce to the ~rco~p~..yillg drawings.
W O 96~9084 PCTAUS96/03039 Brief Description of the Drawings Figure 1 is a fr~llle~ y lon~itl~lin~l cross-section of a plaque-co--"eeli-~
i~Llulllent, in tli~m~otrally-co~ ;L~d orientation, disposed in a plaque l~rlton.o~ artery.
Figure 2 is a fr~gm~n1~ry longih--lin~l cross-section illustrating the instrument being pulled while in a radially-e~pan~l~d plaque-cu.-.ucti..g position;
Figure 3 is a transverse cross-section taken along lines 3-3 of Figure 2;
Figure 4 is a fragmlont~ry longihl~lin~l cross-section of a second plaque-colllle~ g h~llu~llent, in a ~ metr~lly-constricted orientation, disposed in a plaque-~ en~od artery.
Figure S is a fragment~ry longit~ in~l cross-section illu~LId~ g the instrument being pulled while in a radially-exp~nllecl plaque-co-",P~Ii"g position;
Figure 6 is a transverse cross-section taken along lines 6-6 of Figure S;
Figure 7 is a fr~j~m~ont~ry l~ngitll~lin~l cross-section of a plaque-col~..Pc~ g il~llui~llent, being pulled while in a hooked position with plaque in an artery;
Figure 8 is a fr~gm~nt~ry loni~ihl~lin~l cross-section similar to Figure 7 showing a segment of plaque being displaced with the conn~octing hlsllulllelll along the length of the artery;
Figure 9 is a transverse cross-section taken along lines 9-9 of Figure 8;
Figure 10 is an elevational view of a segment of plaque removed intact from an artery using the present invention;
Figure 11 is a flow chart depicting various ways of implem~nting the present invenlion; and Figure 12 is a fr~m~nt~ry longib--lin~l cross-section of the plaque-connPcting instrument eccentrically or asymmetrically inserted into an artery, i.e., between the inner arterial wall and the plaque.
W O 96~9084 PCTrUS96/03039 Best Mode for Carrying out the Invention R~;~e.~nce is now made to the dldwiulgs wherein like mlm~r~l~ are used to de~ign~te like parts throughout. The present invention provides for unitary, intact removal of a segm~nt of plaque from an artery to resolve or alleviate co~ ;eli~/e blood flow problems in human arteries. The invention overcomes or alleviates health risks associated with conventional endarterectomy, by-pass surgery, dottering and balloon angioplasty procedures, atherectomy, reciprocal cutting of layers of plaque, and laser plaque removal. It is believed that intact removal of one or more seg-llel,L~. of plaque, in accord~nce with the principles of the present invention, is less tr~llm~tir7 creates lower risks, is less ~ .ive, is less invasive, less time-co"~ g, and is more efficacious than by-pass surgery, angioplasty, and reciprocal cutting of plaque.
R~fe.e.lce is now made to Figure 11, for the l~ul~ose of providing a description of the present invention which is colllprehel~.ive. Initially, at least one man-made upel~ g and in some cases only one opening is created in the artery, at a readily ~rcessihle site, for which plaque tre~tmtoTlt is desired. This can be done conventir,n~lly, by making a small surgical incision in the artery of no greater size than needed or by making a small puncture in the vessel, such as a percutaneous ~uncLulc;, followed by conventional insertion of a guidewire, which may or may not be followed by sheath insertion including insertion of a sheath particularly suitable to plaque removal.
As a prelimin~ry to intact removal of a unitary segment of plaque, one or more plaque-loosening techniques may be employed, at the discretion of the health care provider.
For example, where one incision or other man-made opening is used, the plaque adjacent thereto may be generally radially and/or circumferentially cut or bluntly ~ sectr~l so as to make removal easier, sure, and predictable. Where two incisions or other man-made W O 96~9084 PCT~US96/03039 openings are made in the length of artery to be treated, the plaque, at both man-made openings, may be generally radially and/or cir~;ul,lre,ellLially cut or blun~ly ~ ecte(l for ease and predictability of plaque segm~nt removal.
If desired, a dottering h~LlulllellL may be inserted and caused to vibrate and/or rotate so as to impact in a sequential fashion upon plaque adhering to the interior wall surface of the length of artery to be treated. The dottering instruments disclosed in pending U.S.
Trademark Application Serial No. 07/943,514, filed November 9, 1992 (owned by the n~e of the present invention), may be utilized to so preliminarily loosen the plaque to be later unitarily removed from the artery. A second ~ul~ose for use of a dottering u~nent is to enlarge the lumen or pa~w~y to permit insertion of the plaque-conntocting Thel~ar~ , a suitable il~lu~e.ll is placed, inserted, or introduced through the man-made opening into the artery, for exannple, although not n.ocess~rjly, along an indwelling guidewire. The insertion can be generally concentric within the plaque-ridden lumen of the artery (see Figure 1, for example) or eccentric, i.e., between the arterial wall and the plaque (see Figure 12, for example).
After il~l~ ent insertion, instrument displacement continues, by exercise of ext~rn~l control, until the head of the instrument has been displaced ltO and located at a desired site adjacent to plaque within the artery, normally removed or remote from the insertion site. A suitable external control, which may be used in practicing the principles of the present invention, is disclosed in co-pending U.S. Patent Application Serial No.
07/973,514, filed November 9, 1992 (owned by the ~si~nPe of the present invention).
When so disposed, positioned, or placed, the head of the instrument is conn~ct~A, on a temporary or releasible basis, to the ~ cent plaque whereby the instrument is tethered to the plaque. The connection may be by grabbing, gripping, compressively holding, clamping, and/or embedding plaque within the head so as to bind together the plaque and the head, grasping, and/or holding the plaque by or at the head. The connection may or may not also .~imnlt~n~ously create a tapering interface between the engaged plaque and neighboring plaque that has not been engaged.
Once the releasible connection has been created b~lweell the head of the instrument and the adjacent plaque, the h~Llulllelll is displaced so as to apply force to the tethered plaque, i.e., the plaque to which the releasible connection has been made. While the primarily force is one of pulling or stretching the plaque along the length of the artery in a direction generally parallel to the lon~itll-lin~l axis of the artery and opposite to the direction of insertion, other motions may also be used. For example, the releasible connection int~rn~lly within the artery may be achieved using at least some rotation and, thereafter, additional rotation may be applied in one or both directions to assist in sep~lldLing a length of plaque from its adhered relation within the artery. Similarly, the head may be advanced and retracted to the same end. In some applications including two-incision situations, the plaque may be engaged and then pushed toward the second incision, rather than being pulled back toward the first incision. The direction of the insertion and force applied is independent of the arterial flow direction, i.e., it may be either antegrade or retrograde to normal blood flow.
The above-mentioned instrument displacement while the head is releasibly connt cte~l to the plaque results in tearing, severing, shearing, separating, and/or peeling instantly or progressively of a segment of plaque as a unit from the artery. The plaque segment can be separated from residual arterial plaque~ including adjacent plaque by tearing or shearing or by radially and/or circumferentially cutting using a suitable instrument.
Plaque nnay also se~alaLt: along a created tapering interface due to the force ~ d through the connPctin3~ plaque as it is manipulated by the Col~..f-C~ h~llull~ lL.
One principle at work here is that a chain is as strong as its weakest link. The force ~r~ d to the plaque eventually produces s~ liom at the plane between tissue layers where the conïlection between the layers is weakest. In practice, this weakest connection generally occurs at the plane between the tii~P~sec~ tissue arld the non~ e~Pd tissue. The we~kn~s~ at this plane is related to the we~kn~ss exploited using blunt dissection in conventional endarterectomy, altnough the physical m.orh~ni~m described herein exploits ~is we~kn~.c.s in quite a different way which in no way employs the blu~t r~ ecti~ n used in conveIltional end~l t~ c~; lomy .
The severed unitary segment of plaque is, finally, l~Llie~,~,d, withdrawn, and removed from the artery through the insertion site along with the ilL~.Llunle.ll head to which the plaque segm~nt is temporarily co".~ ecl, or through another site toward which the head has pulled or pushed the plaque.
While the health care provider can, thereafter, insert a syn~etic or biologically-obtained lining into the treated artery, the present invention comprehends as well termin~ting the pracedure upon withdrawal of the plaque segm.onf and removal head, followed by suitable closing of the one or more man-made openings in the artery.
The present invention comprehends provision of an d~aldLIIs for excising a segment of plaque intact from the artery which colll~lises an h~LlulllenL equipped with a plaque-eng~ging head Colll~liSillg a connector by which the head is temporarily joined to plaque within the artery and by which force is applied to the plaque to loosen and remove a continuous segment thereof. The instrument colllplises a mrrll~ni.cm including an external control by which the il~.LlLlmelll, its head, including its connector, are manipulated to locate W O 96~9084 PCTrUS96/03039 the head a~ cent the plaque to be engaged, which is normally remote from the insertion site, for temporarily or releasibly connPcting the co"lle~lor to the plaque without severing or fr~gmPntin~ the plaque, for applying a force across the co-l"eclor to the conn~ctPd plaque sufficient to sever the segm~ont of plaque intact from the artery and for removing the severed segment of plaque from the artery. A typical length of plaque so removed from an artery is illustrated in Figure 10. The plaque segment can be short or it can be very long, for example 15-18 inches. It is, however, to be appreciated that the present invention is not restricted to any particular type of instrument. Any h~Llu"~"l capable of being connPcted to arterial plaque at a desired site and by which the connPcttod plaque can be unitarily removed intact as a segment from the artery may be used. The form of releasible connection may be binding, snagging, co",p,~ssi~rely holding, taking hold of, grasping, grabbing, hooking, piercing, rotational engagement, clamping, biting, en hed-ling, or in any other suitable way.
Nolwi~ g the foregoing, Figures 1-3, 4-6, and 7-9 illustrate different mPch~nir~l configurations by which an instrument head is temporarily connPct~d to plaque for purposes of unitary removal intact of a plaque segment. With specific reference to Figures 1-3, an i,~ll~l"lent, generally ~lP~ign~t~d 20, is there illustrated as having been inserted through a man-made opening in an artery, generally design~ttorl 22, in a generally conce"L,ic fashion so as to be disposed generally centrally within a lumen 24 of the artery constricted by a surface-irregular deposit of plaque 26. Insertion is illustrated as being achieved conventionally along an indwelling guidewire 28 in a collapsed or diametrically-small configuration. The instrument co~ lises a first relatively large tube 30 through which a smaller tube 32 generally concentrically passes. The instrument 20 comprises a head, W O 96/39084 PCT~US96tO3039 general}y ~l~.ci~n~t~l 34 colnl)lisillg a plurality of plaque connectors, each desi~n~t.od 36, in the form of resili~nt, helically-disposed blades. Each blade 36 is illustrated as being centrally enlarged at 37. The blades are joined at their respective proximal ends to the proximal portion 38 and to a distal tip 40 at their respective distal ends and may o~ may not pivot at their ends relative to proximal portion 38 amd distal tip 40. The tube 32 extends centrally between the blades 36 and is securely non-rotatably f~.~tenlo~ to the proximal portion of the distal tip 40.
Once the head 34, in its constricted position, is disposed at a desired location along the artery 22 adjacent a desired portion of plaque 26, an exterior control, such as the one disclosed in pending U.S. Patent Application Serial No 07/973,514, filed November 9, 1992, is used to lon~ in~11y retract tube 32 and tip 40 in respect to tube 30 causing the plaque-co~ eclol blades 36 to flex from the constricted position of Figure 1 to the radially ~o~r~nflPd position of Figure 2.
Thelcarhr or simlllt~n~ously the.e~ , the head 34 is pulled and/or rotated so as to create a releasible or Lc~ or~ly connection between the head 34 and the plaque engaged by the blades 36, as shown in Figure 3. This grasping, grabbing, clamping, binding or like phenomenon causes the conn~cte~l plaque to move as the instrument head 34 is moved by manipulation of the external control. Thus, the head 34 can be moved back and forth and/or can be rotated in one or the other or both directions so as to radially and/or circumferentially sever or shear the plaque from itself, as illustrated at site 42 in Figure 2. The h~ l.Rnt 20 and its head 34 are retracted in a generally longih-llin~l or axial direction, either alone or in conjunction with back and forth movement as well as selected rotational movement in one or the other, or both directions. This causes the plaque to be sheared, peeled, or be severed from the internal surface 44 of the internal wall 46 of the artery 22, which defines the boundary between the arterial wall and the engaged plaque. It is to be appreciated that as arterial disease progresses, this boundary between the ~ e~eed and nntli~e~c~l arterial wall may be located within the interior layer 46, or between layers 46 and 52, or within layer 52, but does not generally invade layer 50. The severed unitary plaque segment 26' is retrieved together with the conn~cte~l head 34 and removed through the man-made opening in the artery and when removed and disconn~cted from the head has a worm-like appearance as shown in Figure 10. Plaque segment 26' might be called an enda,L~recLol,ly plug. Medically speaking, it is by definition an endarterectomy plug, although the endarterectomy has been achieved by novel, non-conventional techniques.
In m~ l terms, the artery 22 comprises an outside layer 50 known as the tunica adventitia, a central, radially larger interm.o~ te layer 52, known as the tunica media, and the previously mentioned interior layer or wall 46, known as the tunica intima endothelium.
The plaque 26 is typically referred to as atherosclerotic plaque, which in advanced stages of disease such as are typically treated, partially or wholly, engulfs the tunica media.
The present invention, as stated earlier, does not contemplate cutting, grinding, or fragmenting pieces of plaque 26 from the atheroma, but rather is directed to grasping, gripping, clamping, or otherwise releasibly conn.qcting the instrument head to the plaque for intact removal of a segment of plaque and in certain embo-lim~nt~, including the embo-liment.c disclosed herein, contemplates simnl~n~oously creating a tapered interface.
The creation of the tapered interface is advantageous in that, after the treatment when flow is restored, a tapered interface in the upstream direction will help prevent the creation of undesirable flaps of disease being lifted from the vessel wall, as the flow over the tapered disease will press the disease more firmly into the vessel wall, and also reduce flow turbulence at the interface.
W O 96~9084 PCT~US96/03039 ReÇe.~llce is now made to the h~LlulllellL illustrated in FigLres 4-6, which is generally clesi~n~ted 20'. The instrument 20' is conn~oct~d and controlled as is the above-described ill~Llulllent 20. Only dirr~ nces between il~.LlulllellL 20 and instrument 20' need description here. The numerals used in Fi~res 4-6 which are j(1rntir.~l to numerals used in Figures 1-3 identify i~1~ntir~1 o m.ul)~L~llLially i-i.ontir~l parts. The instrumel~t 20' differs from the ilLsL~ument 20 primarily in the configuration of c~ ne-;lor head 34'. Head 34' culll~lises a plurality of spaced, sOllltwllàL longit~ in~lly-ext~n-lin~ blades 36' anchored"~ ecLi~!ely, at the proximal ends 38 thereof to the distal portion of the tube 30 and non-rotatably joined to the tiR 40- Each blade 36' colll~lises a proximally-directed barb 37'. While each barb 37' is illlustrated as being disposed at a slight acute angle in respect to the longit~l~in~l axis of the artery 22, any suitable barb orientation may be used.
When the tube 32 is retracted by the extern~l control in respect to tube 30, tip 40 is displaced toward proximal portion 38, causing the blades 36' of the head or co..l~el~
34' to flex radially ouLwaldly. Withdrawal (retraction) and/or rotation of the head 34' causes the blades 36' to bite into, but not sever away pieces of the plaque 26. Generally lon~ in~l retraction of the instrument 20', inr~ 'ing connPcting head 34' with the plaque 26 bindingly connrcted between the blades 36', accommodates severing or shearing of the plaque at radially-directed site 42 thereby sepa.~ plaque segment 26' from residual arterial plaque 26. This severing or shearing can create a tapered or beveled interface. The retraction of the h~Llul~ent 20' may be accompanied by to and fro longi~l~lin~l movement of the head 34', retraction only and/or rotation in one or the other or both directions ~ sufficien~: to sever, shear, or peel the plaque segment 26' from the annular interface 44 of the inner layer 46 of the artery 22, or at whatever depth the llice~cedlnon-~lice~ce~l interface has progressed, as described earlier.
W O 96~9084 PCTrUS96/03039 The severed plaque segment 26' is retrieved and removed from the artery through a man-made opening therein as the instrument 20' is removed, the head 34' rem~ining releasibly connPctPd to the plaque segment 26' during retrieval and removal.
Refelcnce is now made to the unitary plaque segment removal instrument, generally ~esign~tP(l 20", illustrated in Figures 7-9. To the extent parts of instrument 20n illustrated in Figures 7-9 are ;clenti~l or substantially i~lenti~l to parts previously described m connection with Figures 1-3, i~1Pntir~l numerals are used and no further description thereof lS l~PCP~ y.
Tube 30 and distal portion 38 thereof do not form a part of the embodiment illustrated in Figures 7-9. Instrument head 34" is non-rotatably secured at the distal end of tube 32 and is inserted into the desired location along guidewire 28. The instrument head 34" is illustrated as m~int~ining a constant lldl~/~.se ~limPn~ional configuration.
Head 34" comprises a plurality of curvilinear blades 36", each of which is illustrated as c,~lyillg a pair of curved hooks 39, which engage the plaque when rotated so as to pierce portions thereof without severing pieces of plaque thererl.lll. Thereafter, by displacing the head 34" to and fro, or by retracting alone and/or rotationally as desired and by primarily retracting the head 34" along the length of the artery 22, plaque segment 26' is loosened, severed, retrieved, and removed from the artery through a man-made opening therein.
Reference is now made to Figure 12, which illustrates the same apparatus as shown in Figures 1-3, illustrating placement of the instrument head 34 into the artety between the plaque 26 and the arterial wall surface or cleavage interface of weakness 44 and advanced along the arterial surface 44 to the desired plaque connection site wiLll~uL prior use of an interface s~al,aLion tool.
W O 96~9084 PCT~US96/03039 The invention may be embodied in other specific forms without departing from the spirit of e~enti~l cha,~.cLe.;sLics thereof. The present embo.~ therefore to be consider.ed in all r~sL,ec~ as illll~tr~tive and are not restrictive, the scope of the invention being in~1ir~trcl by the appended claims rather than by the foregoing description, and all changes which come within the ~ g and range of equivalency of the claims are therefore int~-1ed to be embraced therein.
VVhat is cl~imPcl and desired to be secured by Letters Patent i3:
Claims (33)
1. A method of excising plaque from an artery comprising the steps of:
inserting an instrument into the artery, the artery having an axis;
placing the instrument adjacent to plaque in the artery;
grasping the plaque with the instrument without material cutting the plaque by the instrument;
maintaining grasp while displacing the instrument along the axis of the artery thereby generally axially dislodging a length of plaque from the artery;
removing the dislodged length of plaque from the artery.
inserting an instrument into the artery, the artery having an axis;
placing the instrument adjacent to plaque in the artery;
grasping the plaque with the instrument without material cutting the plaque by the instrument;
maintaining grasp while displacing the instrument along the axis of the artery thereby generally axially dislodging a length of plaque from the artery;
removing the dislodged length of plaque from the artery.
2. A method of removing arterial plaque comprising the steps of:
grabbing hold of plaque within an artery with a removal instrument;
applying force to the plaque generally along the length of the artery to sever without longitudinal cutting a segment of plaque from a portion of a wall of the artery;
withdrawing the plaque segment from the artery.
grabbing hold of plaque within an artery with a removal instrument;
applying force to the plaque generally along the length of the artery to sever without longitudinal cutting a segment of plaque from a portion of a wall of the artery;
withdrawing the plaque segment from the artery.
3. A method of increasing blood flow in an artery comprising the steps of:
introducing a gripping instrument into an artery through a man-made opening therein;
displacing the gripping instrument along the artery to a site where the artery is obstructed at least in part by plaque;
gripping plaque at the site with the gripping instrument;
tearing plaque from the artery without cutting the plaque along the axis of the artery by displacing the instrument while the instrument is gripping the plaque;
removing the instrument and the gripped plaque through the man-made opening.
introducing a gripping instrument into an artery through a man-made opening therein;
displacing the gripping instrument along the artery to a site where the artery is obstructed at least in part by plaque;
gripping plaque at the site with the gripping instrument;
tearing plaque from the artery without cutting the plaque along the axis of the artery by displacing the instrument while the instrument is gripping the plaque;
removing the instrument and the gripped plaque through the man-made opening.
4. A method of increasing blood flow in an artery comprising the steps of:
tethering arterial plaque to an indwelling instrument at a site within the artery with immaterial axial cutting of tethered plaque, pulling the instrument and plaque along the length of the artery thereby forcibly tearing a segment of plaque, in the direction of the length of the artery, from a portion of the artery and removing the torn plaque segment from the artery.
tethering arterial plaque to an indwelling instrument at a site within the artery with immaterial axial cutting of tethered plaque, pulling the instrument and plaque along the length of the artery thereby forcibly tearing a segment of plaque, in the direction of the length of the artery, from a portion of the artery and removing the torn plaque segment from the artery.
5. Apparatus for excising a segment of plaque intact from an artery;
an instrument comprising a plaque-engaging head comprising a connector by which the head is temporarily connected to the plaque within an artery for applying force to the plaque;
a mechanism comprising an external control for the instrument, the head and the connector to locate the head adjacent to the plaque to be engaged, for temporarily connecting the connector to the plaque without severing portions of plaque therefrom, for applying a force across the connector to the connected plaque generally along the length of the artery sufficient to sever a segment ofplaque intact from the artery and for removing the severed segment of plaque from the artery.
an instrument comprising a plaque-engaging head comprising a connector by which the head is temporarily connected to the plaque within an artery for applying force to the plaque;
a mechanism comprising an external control for the instrument, the head and the connector to locate the head adjacent to the plaque to be engaged, for temporarily connecting the connector to the plaque without severing portions of plaque therefrom, for applying a force across the connector to the connected plaque generally along the length of the artery sufficient to sever a segment ofplaque intact from the artery and for removing the severed segment of plaque from the artery.
6. A method of treating plaque in an artery having an elongated length to increase blood flow comprising the steps of:
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque without cutting plaque from the artery along its length;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque without cutting plaque from the artery along its length;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
7. A method according to Claim 6 wherein the inserting step is preceded by creating at least one man-made opening in the artery.
8. A method according to Claim 7 wherein the inserting step comprises placing a guidewire through the opening and advancing the head into the artery along the guidewire.
9. A method according to Claim 6 wherein the inserting step is preceded by preliminarily loosening the plaque.
10. A method according to Claim 9 wherein the loosening step comprises making at least one radial cut in the plaque.
11. A method of treating plaque in an artery to increase blood flow comprising the steps of:
preliminarily loosening the arterial plaque by subjecting the plaque to be removed to dottering;
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
preliminarily loosening the arterial plaque by subjecting the plaque to be removed to dottering;
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
12. A method of treating plaque in an artery to increase blood flow comprising the steps of:
preliminarily displacing the plaque by subjecting the plaque to be removed to balloon angioplasty;
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
preliminarily displacing the plaque by subjecting the plaque to be removed to balloon angioplasty;
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
13. A method according to Claim 6 wherein the locating step comprises placing the head within a central lumen of the artery.
14. A method of treating plaque in an artery to increase blood flow comprising the steps of:
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery by placing the head within the artery between the plaque and a wall of the artery so that insertion of the head separates in part the plaque and the artery at the interface between the two;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery by placing the head within the artery between the plaque and a wall of the artery so that insertion of the head separates in part the plaque and the artery at the interface between the two;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
15. A method of treating plaque in an artery to increase blood flow comprising the steps of:
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque by compressively holding the engaged plaque at the head;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque by compressively holding the engaged plaque at the head;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
16. A method according to Claim 6 wherein the removably connecting step comprises taking hold of the plaque by the head.
17. A method according to Claim 6 wherein the removably connecting step comprises grasping the plaque by the head.
18. A method according to Claim 6 wherein the removably connecting step comprises grabbing the plaque by the head.
19. A method according to Claim 6 wherein the removably connecting step comprises engaging the plaque by the head.
20. A method of treating plaque in an artery to increase blood flow comprising the steps of:
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head by stretching the plaque severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head by stretching the plaque severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
21. A method according to Claim 6 wherein the severing step comprises shearing the plaque intact from a wall of the artery.
22. A method of treating plaque in an artery to increase blood flow comprising the steps of:
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery by progressively peeling the plaque intact from a wall of the artery;
retrieving the head and connected severed segment of plaque from the artery.
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery by progressively peeling the plaque intact from a wall of the artery;
retrieving the head and connected severed segment of plaque from the artery.
23. A method according to Claim 6 wherein the retrieving step comprises removing the head and the severed segment of plaque from the artery.
24. A method according to Claim 6 wherein the removably connecting step comprises hooking the plaque with the head.
25. A method according to Claim 6 wherein the removably connecting step comprises piercing the plaque with the head.
26. A method of treating plaque in an artery to increase blood flow comprising the steps of:
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery by both separating the plaque segment from other plaque within the artery and separating the plaque segment from a wall of the artery;
retrieving the head and connected severed segment of plaque from the artery.
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery by both separating the plaque segment from other plaque within the artery and separating the plaque segment from a wall of the artery;
retrieving the head and connected severed segment of plaque from the artery.
27. A method according to Claim 6 wherein the removably connecting step occurs due to rotating the head.
28. A method according to Claim 27 wherein the rotating step comprises causing the head to bindingly bite into the plaque.
29. A method according to Claim 27 wherein the rotating step comprises embedding plaque within the head in binding relation.
30. A method of treating plaque in an artery to increase blood flow comprising the steps of:
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque by clamping the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
inserting a connecting head into an artery;
locating the head adjacent to plaque within the artery;
removably connecting the head to the plaque by clamping the head to the plaque;
pulling on the plaque through the head thereby severing a segment of plaque intact from the artery;
retrieving the head and connected severed segment of plaque from the artery.
31. A method according to Claim 6 wherein the removably connecting step comprises binding the plaque and the head together.
32. A method according to Claim 6 wherein the removably connecting step comprises snagging the plaque with the head.
33. A method according to Claim 6 wherein the locating step comprises advancing the head to an arterial location remote from the insertion site.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/470,805 | 1995-06-06 | ||
US08/470,805 US5571122A (en) | 1992-11-09 | 1995-06-06 | Unitary removal of plaque |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2221469A1 true CA2221469A1 (en) | 1996-12-12 |
Family
ID=23869117
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002221469A Abandoned CA2221469A1 (en) | 1995-06-06 | 1996-02-22 | Unitary removal of plaque |
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US (2) | US5571122A (en) |
EP (1) | EP0836431A4 (en) |
JP (1) | JPH11506031A (en) |
AU (1) | AU697562B2 (en) |
CA (1) | CA2221469A1 (en) |
WO (1) | WO1996039084A1 (en) |
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-
1995
- 1995-06-06 US US08/470,805 patent/US5571122A/en not_active Expired - Lifetime
-
1996
- 1996-02-22 EP EP96908673A patent/EP0836431A4/en not_active Withdrawn
- 1996-02-22 AU AU51838/96A patent/AU697562B2/en not_active Ceased
- 1996-02-22 WO PCT/US1996/003039 patent/WO1996039084A1/en not_active Application Discontinuation
- 1996-02-22 JP JP9500435A patent/JPH11506031A/en active Pending
- 1996-02-22 CA CA002221469A patent/CA2221469A1/en not_active Abandoned
- 1996-07-23 US US08/685,393 patent/US5665098A/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
US5571122A (en) | 1996-11-05 |
AU697562B2 (en) | 1998-10-08 |
US5665098A (en) | 1997-09-09 |
EP0836431A4 (en) | 1999-12-01 |
JPH11506031A (en) | 1999-06-02 |
AU5183896A (en) | 1996-12-24 |
EP0836431A1 (en) | 1998-04-22 |
WO1996039084A1 (en) | 1996-12-12 |
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Legal Events
Date | Code | Title | Description |
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FZDE | Discontinued |