CA1324552C

CA1324552C - Angioplasty device

Info

Publication number: CA1324552C
Application number: CA000586442A
Authority: CA
Inventors: Harold D. Kletschka
Original assignee: Individual
Current assignee: Individual
Priority date: 1987-06-10
Filing date: 1988-12-20
Publication date: 1993-11-23
Anticipated expiration: 2010-11-23
Also published as: US4794928A; AU611182B2; DE3887896D1; WO1988009683A1; AU1991288A; EP0371986B1; EP0371986A4; EP0371986A1; SU1836115A3

Abstract

ABSTRACT

An angioplasty device is disclosed for treatment of, or for compression and/or removal of an obstruction from, a vessel or vessel-like structure in medical, non-medical and industrial applications.
The device incorporates a trap/barrier for trapping and removing particles that break away from the treatment site with traditional angioplasty devices including but not limited to balloons, cutting rotors, fiber meshes, lasers and the like. The device also provides means for removing the trapped particles from the treated vessel. An angioplasty device is also enclosed that incorporates only the trap/barrier and particles removal elements of the previously described device.
A method for treatment of, or for removal or compression of an obstruction in, a vessel or vessel-like structure is disclosed that utilizes an angioplasty device of the instant invention. A method employing an angioplasty device of the instant invention is also disclosed for preventing particles from escaping from a point of manipulation of a vessel or vessel-like structure.

Description

1324~2 AN ~NGIOP~ DEVIC:E

BAÇK~;ROUND OF THE INVENTION
This invention relates to a new and improved angioplasty device for compressing and/or removing atherosclerotic plaques, thromboses, stenoses. occlusions, clots. potential embolic material and so forth (hereinafter "obstructions"~ from veins, arteries, vessels, ducts and the like (hereinafter "vessels"). The device also has potential for treatment of the following conditions or performance of 0 the following procedures, among others: congenital or acquired stenoses or obstructions; percutaneous aspiration thromboembolectomy; cerebral embolization; congenital or acquired obstruction or stenosis of the aorta, renal, coronary, pulmonary, iliac, femoral, popliteal, peroneal, dorsalis pedis, subclavian, axi11ary, brachlal, radial, ulnar. vertebral, cerebral and/or cerebellar artery or any other accessible artery or their ramifications: congenital or acquired ob~truction or stenosis of the superior vena c~va, inferior vena cava, common lliac, internal iliac, extemal iliac, femoral, greater saphenous, lesser saphenous~ posterior tibial, peroneal, popliteal, pulmonary, coronary, coronary sinus, innominate, brachial, cephalic, basillc, internal Jugular, external ~ugular, cerebral, cerebellar, sinuses of the dura mater and/or vertebral vein or any other accessible vein or their ramifications; atheromatous lesions of any graft or its ramifications; obstructions or stenoses of connections between and among grafts, valns, arterles, organs and ducts; vena caval bleeding:
congenital or acquired intracardiac obstructions. stenoses, shunts and/or aberrant communications: congenital or acquired cardiovascular obstructions. stenoses and/or diseases; lnfusion o~
thrombolytic agents; thromboembolic phenomena; dlagnostic catheterlzation; removal of clots; intrahepatic and/or extrahepatic biliary ductal obstructions (e.g.. ~tones, sediment or strictures);
intra~rascular, intracardiac and/or intraductal forelgn bodies; renal dlalysis; congenital and acquired eisophageal and/or gastro~ntestinal obstructions and/or stenoses; non-organized atheromata: dialysis 3 5 iEistula stenosis; ruptured cerebral aneurysm; arterio-arterlal, ~324~2 arteriovenous and/or veno-venous fistulae; ureteral obstructions obstructlons (e.g., stones, sediment or strictures): fibromuscular dysplasia of the renal artery, carotid arte~ and/or other blood vessels:
and/or atherosclerosis of any accessible artery, veln or their 5 ramiflcations. Such procedures may be performed in both humans and other applications.
As used throughout this speciflca~ion and the claims "angioplasty" shall not be restrictive and shall refer to (1) any of ~he medical and/or veterinaIy procedures and treatments described in the 10 preceding paragraph, (2) procedures and treatments similar to those described in the preceding paragraph, and (3) any other treatment or procedure involving the removal of an obstruction from vessels or vessel-like structures. regardless of whether such structures are part of or associated with a living organism. It may be obvious to those 5 skllled in fields of art apart from the art of angioplast~ devices and procedures that the instant invention could be applied to remove obstructions from "non-living" tubes, tubules, conduits, flbers or other structures (also hereinafter "vessels") in non-medical or Industrial applications. For example, a device of the in~ention could be used to 20 remove an obstruction from a fluid delivery tube w~ a ~nachine under conditions where it would be undesirable for particles of the obstruction to break free and continue down the tube, e.g., lf the machine were still running and particles would ~eopardize continued operation. The term "angioplasty" as used throughout this 2s specification and the appended claims is intended to encompass any such applications.
Prior art devices. representing the traditional angioplasty device, are basically a catheter containing a balloon-like membcr which is inserted into the occluded vessel. Expansion of the balloon at 30 the obstruction site crushes the obstruction against the interior lining of the vessel. When the balloon is retracted. the obstruction remalns pressed against the vessel wall and the effective diameter of the vessel through which fluid may flow is increased at the site of the ~bstructlon. The traditional angioplasty device incorporating a balloon 1324~2 is represented by U.S. Patent Nos. 4,646,742, 4,636,195, 4,587,975 and 4,273,128.
Angioplasty devices have also been developed incorporating expandable meshes or braids, U.S. Patent Nos. 4,650,466 and 4,572,186, drilling or cutting members, U.S. Patent Nos. 4,631,052, 4,589,412 and 4,445, 509, and lasers, U.S. Patent Nos. 4,641,912 and 4,576,177, as the means for crushing or removing an obstruction.
Many problems have been assoclated with all types of angioplasty devices. Perhaps the most significant problem is the creation of 0 particulate matter during the obstruction removal procedure. These particles are released into the fluid flowing through the vessel and can lead to emboli, clots, stroke, kidney failure, heart failure, gangrene, tissue in.~ury, tissue death, emergency bypass surgery, death and other undesirable side effects and complications.
It would be desirable to provide an angioplast~ device that prevents substantially all physiologically significant particles from escaping from the obstruction site, thus preventing the occurrence of unfavorable side effects from angioplasty treatment and procedures.

SUMMARY C~F THE T~Nl`ION
In accordance with the instant invention, an angioplasty device is disclosed for use in an angioplas~y procedure or other medical, veterinary, non-medical or industrial applications where re~noval of an obstruction ~om a vessel or vessel-like structure could produce 2 5 particles which, if allowed to remain in sald vessel, could cause undesirable complications and results.
The angioplasty device incorporates an operatlve member, means for controlling the operative member, a trap/barrier, means for expanding the trap/barrier, means for removing particles, and a catheter bundle. The operative member can be one of many known methods or devices for removing and/or crushing an obstmction in a vessel, including but not limited to balloons, cuttin~ rotors, flber meshes and lasers. A g~ven operative member is controlled In a devlce of the Instant invention by the same contrnl means previously known for such de~rice or mech~sm. In the case of a balloon, at least one 132~2 canal through which an expanslon medium could be In]ected would be one approprlate control means. For a laser, the appropriate control means would be a switch that turns the laser on.
The trap/barrier serves as (1) a barr~er preventing physiologically signiflcant particles break~ng away from the obstruction site during an angloplasty procedure or other appllcation of a device of the instant invention from progressing away ~rom the obstructlon slte and creating complications, and (2) a trap that collects particles so that they can be removed from the treatment si~e. The trap/barrier 0 can be impervious to fluid flow wi~hin the vessel or can be a membrane or similar structure having pores through which the vessel iluid can pass. The trap/barrier is expanded into the proper functional position by an expansion means which can be adapted to suit the nature of the trap/barrier. When the trap/balTier is inflatable, the expansion means is at least one canal through which an expansion medium can be in~ected. AlterIlatively, the expansion mean~ can be at least one expansion spring, expansion stent or expansion leaf on or within the trap/barrier. The trap/barrier is expanded as the springs, stents or leaves are pushed outward by the operation of the operative member, flbers, shafts, pods or other rneans.
In some applications, the control means for a balloon operative mem~er and the expansion means of an inflatable member can both be provided by a bl-functional canal through which an expans~on medium can be inlected.
Part~cles are removed from the vessel by at least one part~cle removal aperture and at least one particle removal canal. A pressure differential ls provided between the particle removal canal and the vessel such that particles are pushed or drawn through the particle removal aperture. Alternat~rely, particles may be collected by the trap/barrier and trapped within it when the trap/barrier is retracted and then removed with the devlce.
The catheter bundle is a collection of the varlous canals a~ociated with the vaIious aspects of the device.

.. , . . - - ~ ~

1324~2 Another angloplasty device is also disclosed that incorporates only the trap/barrier. expanslon means, particles removal means and catheter bundle.
The instant invention also involves a method for (13 treatment of, or (2) removal or compression of an obstruction in, a vessel or vessel-like structure using an angloplasty device of the instant invention. The angioplasty device is inserted into the vessel and aligned with the treatment or obstruction site. The device is manlpulated such that the desired treatment. removal or ~ompression is achieved and particles are collected within or removed into the devlce. The device is then retracted and removed from the vessel.
The instant inventlon also provides a method ~or preventing particles from escaping ~rom a point of manipula~ion of a ves~el or vessel-like structure. A device of the instant inventio-l is in~erted into the vessel and expanded at an appropriate point "downstream" or "upstream" ~rom the manipulation ~ite. After the manipulation Is completed, the particles are collected and removed lnto the device.
The device ~s then retracted and removed from the vessel.

BRIEF DE$CRlPIlON OF THE FIGURES
Fig. 1 shows a cross-sectional fragmenta~r diagram of the use of a preferred embodiment of the invention.
Fig.2 ls a cross-sectional diagram of a preferred embodiment of the invention.
Fig. 3 is a pictorial view of the prefeITed embodiment of ~e invention.
Fig. 4 and Fig. 5 are simplified cross-sectional dlagrams of alternative forms of the lnverltion.
Fig. 6 is a pictorial ~ew of an alternative form of the invention.
Fig. 7 is a section taken along line 7-7 of Fig. 5.
Fig. 8 thru 10 are simpl~fied cross-sectlonal diagrams of other alternative ~orms of the invention.
Flg. 11 ls a pictorial v~ew of another alternatlve ~orm of the invention.

3 5 Fig. 12 is a picto~ w of an altemative trap/bar~ier.

132~2 Fig. 13a is a pictorial view of another alternative form of the invention.
Fig. 13b Is a cross-sectional diagram of the device of Fig. 13a.
Fig. 14 is a fragmentary pictorial view of an altemative form of the invention.
Fig. 15 is a pictorial view of a mechanlsm for expanding l:he trap/barrier of a device of the instant invention.
Fig. 16 is a perspective view of a component of the mechanism depicted in Fig. 15.
0 Fig. 17 is a pictorial view of the expanded mechar~sm of Fig. 15.
Fig. 18 is a pictorial view of an alternative mechanism for expanding the trap/barrier of the instant invention.
Figs. 19 through 22 are p~ctorial views of all alternative mechanism for expanding the trap/barrier of the instant invention.
Fig. 23 through 25 are pictorial views of an alternative mechanism for expanding the trap/barrier of the instant inventlon.

The angioplasty de~ice of the present invention can take maIly forms, each of which includes a structure that serves as (1) a barrier preventing physiologically significant particles breal~ng away from the obstruction site dur~ng an angloplasty procedure or other application of a device of the instant invention from progressing away irom the 2 5 obstrLlction site and creating complications. and (2) a trap that collect~ physiologically signiflcant particles so that they can bc removed ~rom the treatment site. A partlcle is "physiologically significant" if it could potentially cause damage or other unwanted complication If it were to migrate firom the obstruction site. Par~cles produced from an obstruction or any other partisles breaking away from the interior of a vessel in which. a device of the ~nstant invention is used are hereina~ter gene~cally referred to as "paz~cles".
Fig. 1 shows an exarnple of the use of a preferred embodlment of the instant in~ention. The deviee is inseIted into a vessel 1 according to me~ods well known to those skilled in the art. The dev~ce may be ~324~2 inserted at any polnt in relation to the obstruction slte 3 that ls conslstent with the desired treatment protocol. The balloon 4 ls aligned vvith the site of ~e obs'cruction 3 us~ng methods well known ln the art. The dev~ce is then oriented such that ~he trap/barrier ~, which serves the trap/barrier functions, is sltuated in a retrograde direction, "downstream" in relation to the direction of fluid flow 7, from the obstmction slte 3. l'he embodiment of Fig. 1 allows inser~ion of the balloon 4 before the trap/barrier 6 from a point "downstream"
from the obstruct~on site 3.
lo Fluid, air or other expansion medium is inlected lnto the device through canals in the catheter bundle ~; such that the ~rap/barrier 6 is expanded first, so that it forms a seal against the vessel inner lining :2, ~ollowed by the balloon 4. Alternatively, both the trap/barrier 6 and the balloon 4 could be expanded simultaneously or the balloon ~ could be expanded before the trap/barrier 6. If, however, substantially all of the physiologically signihcarlt particles breaking away from the obstmction site 31 are to be trapped by the ~ap/barrier 6, as is the preferred operation of devices of the invention, the trap/barrier 6 should be fully expanded before the balloon 4 is ~ully expanded.
As the balloon 4 Is expanded t~e obstruction ~ is erushed aga~t the vessel lnner lining 2 ~uch that the effective inner diameter of t~e vessel 1 through which fluid can ilow is increased. Crush~ng of the obstruction 3 creates particles which may break free on either side of the balloon 4.
The balloorl 4 is then partially retracted. The particles o~ the obstruction are then, according to the preferred embodiment, pushed toward the trap/barrier 6 by the fluid pressure in the vessel 1, .or, according to an alternative embodiment, drawn toward the trap/barrler 6 by providing a pressure dlfferential between the vessel and canals within the catheter bundle ~. The particles are either pushed or drawn into thé catheter bundle E!i through a particle removal aperture 14 from which they may be disposed of, or lodged in the trap/barrler ~ such that, when it ls retracted, the particles are trapped inside and removed w~th the trap/barrler 6.
3s , .
, -1324~2 The balloon ln a device of the instant lnventlon serves as an operative member which may be replaced by any means known ln the art, or later developed ln the art, ~or remov~ng or compresslng an obstmction. AS used throughout this speciflcatlon and the claLms, the term "operative member" shall encompass any means for removing or compresslng an obstruction, including but not llm~ted to the means represented by U.S. Patent Nos. 4,646,742, 4,636,195, 4,587,97~, 4,273,128, 4,650,466, 4,572,186, 4,631,052, 4.589,412, 4,445,509, 4,641,912 and 4,576,177, which include balloons. meshes, cutt~ng rotors and lasers. Each ~rpe of operative member will have ~ts unique control mechanlsm that, in the case of a balloon. fllls it or, ln the case of a laser or cutting rotor, turns ~t on. These various mechanisms are referred to herein collectively as "control means." Although the balloon and lts associated fllling or expansion system w~ll be used throughout the speciflcation as an example of an operatlve member and its associated control rneans, it is to be understood that any available operative member and its control means could be substituted in many of the embodiments discu~sed herein. References to "expansion" and "retraction" of the balloon should be understood to, by in~erence, refer to activating and deactivatiIlg whatever operative member is incorporated into a given devlce.
Although the figures depict the trap/barr~er 6 as having a generally conical shape. ~he trap/barr~er 6 can be any shape as long as a seal ~s achieved w~ ~Lhe ~nner lin~ng of the vessel 2 to be treated 2 5 and the shape facili~ates entrapment of the particles. Further, although the flgures depict the trap/barrier 6 and operatiYe means, in most case~ a balloon 4~ as being spatially remote from each other, the trap/barrler S and operat~ve means may be sltuated w~th respect to each other in any configuration that allow~ the trap/barrier 6 to achieve a seal with the inner vessel lining S! and to trap particles when expanded.
Figs. 2 and 3 depict another preferred embodiment of the invention, including detail wlthin the catheter bundle ~S. lln con~rast wlth the preferred embodlment depicted ln Flg 1, the preferred : :
: ~ :: :: :

13245~2 embodiment depicted in Figs. 2 and 3 allows insertion of thetrap/barrler ~; before the balloon 4 ~rom a point "upstream" from the obstruct~on slte 3. By changing the relative location of the trap/barrier and the operative member in a given device. an obstructlon can be treated by approaching from the most advantageous direction ln the 5 vessel. The trap/barrier 6 is expanded by introduction of an expansion medium into the trap/barrier expanslon canal 11 which fills the trap/barrier 6. The balloon 4 is expanded by introductlon of an expansion medium into the balloon expansion canal ~ which fllls the balloon 4 through the balloon expansion aperture 10, thus crushing ~he obstruction 3 agalnst the vessel inner lining 2. When the vessel is living tissue, e.g., a human or anLmal ve~, artery or duct, the balloon 4 is inflated to a pressure ranging pre~erably from appro~mately 3 to 15 atmospheres, or more depending on the application. I`he proper pressure will be dependant on the treatment protocol, the type of 5 organism being treated, the ~Tpe of vessel being treated and the material from which the b~lloon is constructed. Appropriate expansion pressures for a given situation will be obvlous to those skilled in the art.
A~ter the balloon 4 is partially retracted, any particles are ~ pushed toward the trap/barrier 6 by the fluid flow 7 in the vessel. The particle removal aperture 14 and particle removal canal 13 are open and, since the trap/ba~rier ~ is blocking the normal fluid flow 7, the particles and some fluid are pushed through the particle removal aperture 14 and out the particle removal canal 13 for disposal. Those 25 particles not pushed through the particle removal aperture 14 are pushed lnto the apex of the trap/barrier ~ where they can be trapped after the trap/barrier 6 is retracted. As an alternative, the particle removal canal 1:~ can be attached to means for providing a pressure dif~erential between the vessel pressure and the particle removal canal 30 1~ that will actively draw the particles and some fluid from the vessel for disposal. AS another alternative, the device can include as many particle removal apeItures and canals as can be incorporated into the device.

, - ~ ~ . ;., ~32~2 The preferred embodiment also incorporates a flow-through canal 17 which can be used for lntroduetion of medicinal ageIlts, taking samples of fluid, introducing a guide wire to assist insertion of the angioplasty device, or for any other desirable purpose.
Fig. 4 depiets an alternative embodiment of the invention in which the flow-through canal 17 has been eliminated. Fig. 4 and the remaining cross sectional flgures have been simplified in comparlson with Fig. 2 by omission of any indication of the ~hickness of the walls forming the various canals, chambers and members incorporated into 0 the depicted devices.
Fig. 5 and 6 show an embodiment of the invention wherein th particle removal apertures 14 have been incorporated into thl trap/barrier 6. ~e particle removal apertures 14 can be of any shap-and arra:nged in any formation withln the trap/barrler e that allows ~h~
fluid flow in the ve~sel or a provided pressure differentlal to dravi partlcles into the apertures. As many apertures may be used as may be incoTporated into the device while still maintaining functionalit~. A
conical shape of the trap/barrier ~ facilltates introduction of the particles into the particle removal apertures 14, bu$ ls not essential.
Fig. 7 shows an example of orle possible orientation of the particle removal ape~tures 14 wlthin the trap/barrier 6.
Fig. 8 cieplcts an embodiment of the invention w~th a flow-through canal 17 and having ~he particle removal apertures 14 situated in ~he trapSbarrier 6.
Fig. 9 depicts an embodiment of the invenfion wherein both the balloon 4 and the trap/barr~er 6 are expanded by infusion of an expansion medium through a bi-functional expansion canal 1~ e balloon 4, trap/barrier 6 and bi-~unctional expansion canal 1~ ~hould be of proper size, conflguration and design so as to expand the balloon 4 and trap/barrier ~ in the desired order, and such that the balloon ~
can be partlally retracted while leaving the trap/barrler 8 fully expanded so as to allow collection of particles.
Fig. 10 deplcts an embodiment of the invention as shown in Fig.
9 with the additlon of a gulde wlre canal lS ~to which a guide wire ean be inserted to facilitate insertion and positloning of the devlce.

:: , ~,, . . ; . : , - . . ~ - : - ..

1324~2 Flg. 11 depicts an embodlment of the invention wlth a bi-functional expansion canal l~i for the balloon 4 and the trap/barr~er 6.
The bi-functional expanslon canal 15 has been blfurcated. The embodiment of Flg. 11 also has a different type of particle removal S aperture 14 which ~s not situated in the trap/barrier ~;. Finally, the depicted embodiment incorporates a ilow-thro~gh canal 17.
Fig. 12 depicts another embodiment of the invention wherein the trap/barrier is a trap/barrier membrane 23. lhe conflguratlon of particle removal apertures and canals normally associated with the trap/barrier is not included. ~he trap/barrier membrane 23 has one or more pores 24 through whlch fluid, substances in the fluid and physiologically insignificant particles can pass. WheIl ~e balloon 4 is partially retracted, fluid flow 7 and its associated pressure will resume and the trap~barrier membrane 23 will act as a sieve, collecting all physiologically significant particles that were released. When the trap/barrier membrane 23 is retracted, the trapped part~des are held and can be removed with the angioplas~ device.
The size of the pores 24 can be varied depending upon the use of the device. The pores 24 should be small enough to trap all physiologically signiflcant particles. The location of the obstruction site relative to areas where renegade particles could cause undesirable complications will determine what si~e particle is physiologically signiflcant. In a traditlonal angloplasl~ procedure, the pore size could be approxlmately 2~L in diarneter. ~ 211 pore would trap any particle 2 s large enough to block capillaries (diameter approximately 3-4~).
Larger pore sizes may be appropriate in other medical or non-medical applications of the device of the invention. The appropriate pore size for a g~en application should be obvious to those skilled ln var~ous flelds of art to which the invention could be applied.
A trap/barrier could also be substituted for the trap/barrler membrane 23 in an embodiment like that of Fig. 12. The device would not include any particle removal apertures or canals. Particles would be pushed into the trap/barrier where they could be trapped when ~he device is retracted and removed. In such ~n embodiment the conical shape of the trap/barrier would be v~ry important. Bl~nd : . ' . ' :

':

f -~324~2 pockets or slnuses could also be incorporated into the trap/barrier or the side of the catheter bundle to facilltate the lodgement of the debris in a favorable position to be sequestered ~rom belng swept awa~
as the trap/barrier is retracted and removed. As the trap/barrier is 5 retracted, it would cover over the particles, enclosing them. Similar ifeatures could a~so be incorporated with a trap/barIier membrane.
Fig. 13 depicts an embodiment of the lnvention incorporating only the trap/barrier 6, catheter bundle 5, trap/barrier expansion canal 11, trap/b~rrier interior chamber l:ib, particle removal apertures 0 14 and parti~le removal canal 13. This embodiment could be used wlth many angioplasty devices currently in use, which would provide the means for compressing or removing an obstructlon. The trap/barrier devlce of this embodlment could be inserted through a central canal in a traditional ~gloplast~ device such that it can be 5 expanded "downstream" ~rom the obstruction slte. Obviously, the trap/barrier membrane 23 could be substituted fo~ the trap/barrier in this embodiment.
The embodiment depicted in Flg. 13 and slmilar embodiments could be used as a trap and trap/barrier in any situation where it is 20 possible to create partic~es, not necessarily from an obstruction, which could cause undesirable complications if not removed. For example, in any procedure that involves clamping of a blood vessel, particle~ can break free from materlals that have accumulated within but do not appreciably obstruct the vessel. Those particles could cause the same 25 complications associated with renegade particles breaking away from an obstruction during a traditional angioplas~ procedure. A device like that in Fig. 13 could be inserted "downstream" or "upstream" from the clamp site to trap and remove any particles that break free.
Although this type of application involves no operatiYe means as herein 30 deflned, such an appliea$ion and similar applications, lncluding medical, veterinary, non-medical and industrial applications, are ~ntended to be encompassed by the ~erm "angioplasty" as used throughout this speclflcatlon and the appended clalms. Moreover, many cf the characteristics and features described throughout tlhe 3s ; ,, . :, . . . . . ~ ~ .

. , . . . . ,; ~

-13245~2 speciflcation could also be incorporated into a devlce ~r ~uch applications.
It ~s important to note that, in any embodimen~ of the invent~on, th~ various canals contained within the catheter bundle ~ can either S be arranged ( 1) concentrically, such that they all share the same central a~ds, (21 separately, such that each canal is independent of all the others, or (3) some combination of concentrlc and separate canal structures. The collection of canals, whether arranged concentrically, separately or both, is referred to throughout this specification and the 0 appended claims as the catheter bundle 5.
The trap/barrier 6 or trap/barrier membrane 2 3 in any ernbodiment of the invent~on may be designed or expanded in any manner that will achieve a shape that forms a seal with with the interior lining of the vessel 2 to be treated. By using methods known 15 to those s~cilled in the art of manufacturing similar devices and components, the manner in which the trap/barrier 6 or trap/barrier membrane 23 ls manufactured can cause the trap/barrier 8 or trap/barrier membrane 2~ to expand so as to achleve the desired shape and seal without any underlying supporting expansion 2 o mechanism.
Alternatively, the trap/barrier ~; or trap/barrier membrane 23 can be expanded w~th a supporting expanslon mechanism. Flgs. 14 through 18 depict some possible supporting expansion mechanisms.
Fig. 14 depicts a plurality of expansion springs 18 that expand the 25 trap/barrier 6. The expans~on springs 18 could be manufactured from plastic, metal or any other material that could be manufactured to hold the desired shape of the trap/bar~er &. The exRanded position would be the "natural" position of the expansion springs 18. I~e device would also incorporate means for pulling the springs into a retracted 30 position for insertion and removal of the devlce from the vessel. The retraction means could be fibers that extend back from the expansion springs 18, a sheath t~at covers the spr~ngs and holds them down un~il expans~on, or other means which w~ll be obvious to those skllled in the art.

.

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~, , ~ "
132~2 Figs. 15 through 17 depict an assembly comprising a plurali~ of expansion stents 19 and a stent ring 2~ situated inslde the retracted trap/balTier 6. ~e stents can again be made of plastic, metal or any other material of sultable character to give the trap/barrier 6 the desired shape. Each expansion stent 1~ is attached to the stent ring 20 by a stent hinge :2~2 which allows movement of the expansion stent 1~ to the expanded position without mov~ng circumferentially around the stent ring 20. Fig. 17 depicts the expanded position of the stent assembly.
0 Fig. 18 depicts another supporting expanslon mechanism. The assembly contains a plurality of expansion s~ents 19 whieh are attached to a stent ring 20. Centered within the stent ring 2û is an expansion shaft 25 havlng an expansion node X6 and a retraction node 27. lhe expansion shaf~ 25 extends back through the catheter bundle 5 such that it may be manipulated. When the expansion shaft 25 is pulled away ~rom the trap/bar~er 6, the expanslon node 26 engages the expansion stents 19 and pushes them outward, thus expandlng the trap/barrier 6. When the expansion sh~t 2~ is pushed toward the trap/barrler 6, the retraction node 27 engage~ the exp~nsion stents 10 and pushes them inward, thus retracting the trap/barrier 6. A
canal could be lncluded through the expan~ion shaft 25 for insertion of a guide wire.
If properly situated with respect to the ballnon 4, the trap/barrier 6 could also be expanded and retracted by the action of the bal~oon ~ as the balloon 4 is expanded and retracted. Flgs. 19 through 22 depict an expansion means comprised of a plurality o:f expansion leaves 28 and shroud lines 2g. l~e expansion leaves as should be made from a formable material that w~ll g~ve support to the trap/barrier ~;, yet assume any position or shape lnto which it ls forrned. In Figs. 19 through 22, the expansion leaves 28 are attached at one end to the tip of the trap/barrier 6. The other end rests on or near the retracted balloon 4. AS the balloon 4 is expanded, it pu~hes the expan~ion leaves 2 8 into a position where they brlng the trap/barrier ~ into contact with the i~er vessel lirling 2 as showrl ln Flg. 20. The shroud lines 2~1 are slack. A~ter the obstructlon is : . ~ ,. .. .

-~32~52 cn~shed, as shown in Fl,g. 21, the balloon 4 is partia~ly retracted such that fluid ilow 7 and its associated pressure is partlally restored and pushes the particles toward the trap/barrier ~ for removal as prevlously discussed. Slnce the expansion leaves 28 are made of a formable material, they maintain the shape into whlch they were pushed by the balloon 4 and maintain the seal with the inner vessel lining 2. The shroud lines 29 remain slack. When the partlcles have been collected and/or removed as previously discussed, the balloon 4 is retracted further such that the shroud lines 2~ become taut and lo retract the expansioIl leaves 2~3 as shown ln Fig. 22. Features from other expansion means could also be combined with an expansion leaf/shroud line configuration to provide the appropriate degree of control over expansion and retractio1l of the trap/barrier. The degree to which the balloon 4 should be expanded or retracted to cause the expansion means to properly funct~on will be dependant upon the speciflc des~gn of ~he device and should be obvic?us to those skilled in the art once a device design has been chosen, and developed.
Alternatively, the expanslon leaves 28 could be constructed from a material that is rigld and not signiflcantly formable similar to materials that could be used to make the expansion springs 18 of Fig.
14. The expansion leaves 28 are, however, manufactured such that their natural shape would retain the trap/barrier ~; ~n its re~racted position. The e~ansion leaves 28 do not dlrectly make contact wlt~
the balloon 4. Each expansion leaf 28 is fltted with a pod 30 that rests on the surface of the balloon 4 as shown in Fig. 23. Alternatively, the pod could fit into a recess in the side of the cathe~er such ~at the expansion leaf lies flush against ~he catheter when in the retracted state, thus allowing smoother insertlon of the catheter. The pod 30 is attached to the expansion leaf 28 by a flexible pod arm 31. As the balloon 4 expands, the pod 30 moves along the surface of the balloon 4 and the trap/barrier 6 is pushed into ~ts e~panded positian as shown in Fig. 24. When the balloon 4 is fully expanded, the pod arm 31 would be bent such that the pod :~ is pressed toward the expansion leaf 213 out of ~ts natural position as shown 2n Flg. 24. AS the balloon is retracted, the pod arm 31 will return toward its natural position ~3~5~2 while keeping the expansion leaf 28 in contact with the inner vessel lining 2 as shown in Flg. 25. Fluld flow 7 and its assoclated pressure will be partially restored and particles can be trapped and dlsposed of as previously discussed. When the balloon 4 is retracted further, the 5 pod arm 31 completely returns to its natural position and the expansion leaf 28 will return to its natural position, as shown in Fig.
23, thus retracting the trap/barrier 6. The degree to which the balloon 4 should be expanded or retracted to cause the expansion means to properly function wlll be dependant upon the spec~ic design o of the device and should be obvlous to those skilled in the art once a specifle device design has been chosen and developed.
Alternatively, the pod arm 31 could be el~ninated and the pod 30 could be attached to the balloon 4. A~ the balloon 4 is expanded, the pod 30 pushes the expansion leaf 28 into an expanded position.
5 The pod 30 should be placed on the balloon surface such that the balloon 4 ean be partially retracted without breaking the seal between the trap/ba~rier 6 and the vessel inner lining 2, thus allowing particles to be collected. Methods for chooslng proper placement of the pod 30 on the balloon 4 w~ll be obvious to those skilleci in the ar~ when 20 considering the type and form of the balloon used in a given devlce.
Variat~ons of these examples anà other means for using the balloon 4 as the ~orce driving an expansion means for the trap/barrier will be obvious to those skilled ~n the art and are intended to be lncluded within the bounds of the instant invention as defined by the 2 5 appended claims. Particularly, the expansion stents, expansion springs and expansion leaves described herein can be made of, ~or example, 11) a deformable material so that they have no "natural"
shape and can be freely pushed into desired shapes, (2) a formed material having a "natural" shape that holds the trap/barrier in an 30 expanded position, or (3) a formed material ha~ring a "natural" shape that holds the trap/barrier in a retracted position. These and other pes of materials may be appropriate and will be obviou~ to those skllled in the art.
As the preceding discussion of the preferred and alternative 3 5 embodiments diselo~es, there are many different structures, .,. . , ~
.. . . . . . . ..

. .
~, ; , .
.

132~1~52 conflguratlons and characterlst~cs of the vaIious embodlments of the lnstant inven'don. each of whlch can be Indl~rldually comblned with any of the others to create a devlce that has the deslred characteristlcs for the deslred appllcatlon. All of the flgures and embodlments part~cularly descrtbed hereln are meant to be ~llustrative of the wlde range of separate characteristlcs which can each be indlvldually ~ncorporated into a de~lce of the lnstant inventlon and not to in any way restrlct comb~natlon of such features in devices not p~cularly described hereln.
From the forego~ng, It will be obvlous to those s~cllled In the art that varlous modlflcations ln the above descfibed methods can be made wlthout departing from the splrlt and scope of the inventlon.
Accordlngl~, the Invention may be embod~ed In other speclflc forms wl~hout departlng from the splrlt or essentlal characterlstlcs thereof.
P~esent embod~ents. ~herefore. are to be consldered ~n al1 respects as Illustsat~Ye and not restrlctive, the scope of the Invention belng ~nd~cated by the appended claims rather than by the foregolng descript~on, and all changes whlch come wlthln the meanlng and range of equivalency of the claims are there~ore intended to be embraced therein.

3(~

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Claims

1. An angioplasty device for removing an obstruction from a vessel or vessel-like structure comprising:
a. a catheter bundle for insertion into said vessel;
b. an operative member, for removal or compression of said obstruction, connected to said catheter bundle;
c. control means, connected to said operative member, for manipulating said operative member;
d. a trap/barrier connected to said catheter bundle;
e. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and f. at least one particle removal aperture situated within said trap/barrier for removal of particles.

2. The angioplasty device of claim 1 wherein said operative member is a balloon.

3. The angioplasty device of claim 2 wherein said control means comprises an expansion canal situated within said catheter bundle and connected to said operative member by an expansion aperture.

4. The angioplasty device of claim 1 wherein said expansion means comprises an expansion canal situated within said catheter bundle and connected to said trap/barrier.

5. The angioplasty device of claim 1 wherein said control means and said expansion means comprise a bi-functional expansion canal connected to both said operative member and said trap/barrier.

6. The angioplasty device of claim 1 wherein said expansion means comprises a supporting expansion mechanism for expansion of said trap/barrier.

7. The angioplasty device of claim 6 wherein said supporting expansion mechanism comprises at least one expansion stent situated within or on said trap/barrier such that, when the trap/barrier is expanded, said trap/barrier establishes a seal against the inner lining of the vessel.

8. The angioplasty device of claim 7 wherein said supporting expansion mechanism additionally comprises an expansion shaft. situated within said catheter bundle, having an expansion node and a retraction node such that, when said shaft is moved, said expansion node and said retraction node expand and retract, respectively, said trap/barrier.

9. The angioplasty device of claim 2 wherein said expansion means comprises:
i. at least one expansion leaf situated on or within said trap/barrier; and ii. at least one shroud line connecting said expansion leaf and said balloon, such that expansion and retraction of said balloon expands and retracts said trap/barrier, respectively, and such that upon partial retraction of said balloon physiologically significant particles are moved toward said trap/barrier by pressure within said vessel.

10. The angioplasty device of claim 2 wherein said expansion means comprises:
i. at least one expansion leaf situated on or within said trap/barrier;
ii. at least one pod, said pod being (A) attached to said expansion leaf and in contact with or attached to said balloon, or (B) attached to said balloon and in contact with or attached to said expansion leaf, such that expansion and retraction of said balloon expands and retracts said trap/barrier, respectively, and such that upon partial retraction of said balloon physiologically significant particles are moved toward said trap/barrier by pressure within said vessel.

11. The angioplasty device of claim 1 wherein said trap/barrier comprises a membrane with at least one pore through which no physiologically significant particles can pass.

12. The angioplasty device of claim 1 further comprising a particle removal canal contained within said catheter bundle and wherein said at least one particle removal aperture is connected to said particle removal canal.

13. The angioplasty device of claim 12 wherein said particle removal aperture is integrated into said trap/barrier.

14. The angioplasty device of claim 12 or 13 wherein said particle removal aperture is connected to means for providing a pressure differential between the fluid in said vessel and said particle removal aperture such that fluid containing particles moves into said aperture.

15. The angioplasty device of claim 1 additionally comprising at least one additional canal situated within said catheter bundle, said additional canalbeing selected from the group of guide wire canals and flow-through canals.

16. An angioplasty device for removing an obstruction from a vessel or vessel-like structure comprising:
a. a catheter bundle for insertion into said vessel;
b. a trap/barrier connected to said catheter bundle;
c. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and d. at least one particle removal aperture situated within said trap/barrier for removal of particles.

17. The angioplasty device of claim 16 wherein said expansion means comprises an expansion canal situated within said catheter bundle and connected to said trap/barrier.

18. The angioplasty device of claim 16 wherein said expansion means comprises a supporting expansion mechanism for expansion of said trap/barrier.

19. The angioplasty device of claim 18 wherein said supporting expansion means comprises at least one expansion stent situated on or within said trap/barrier such that, when the trap/barrier is expanded, said trap/barrier establishes a seal against the inner lining of the vessel.

20. The angioplasty device of claim 19 wherein said supporting expansion means additionally comprises an expansion shaft, situated within

21 said catheter bundle, having an expansion node and a retraction node such that, when said shaft is moved, said expansion node and said retraction node expand and retract, respectively, said trap/barrier.

21. The angioplasty device of claim 16 wherein said trap/barrier comprises a membrane with at least one pore through which no physiologically significant particles can pass.

22. The angioplasty device of claim 16 further comprising a particle removal canal contained within said catheter bundle and wherein said at least one particle removal aperture is connected to said particle removal canal.

23. The angioplasty device of claim 22 wherein said particle removal aperture is integrated into said trap/barrier.

24. The angioplasty device of claim 22 or 23 wherein said particle removal aperture is connected to means for providing a pressure differential between the fluid in said vessel and said particle removal aperture such that fluid containing particles moves from the vessel into said aperture.

25 The angioplasty device of claim 16 additionally comprising at least one additional canal situated within said catheter bundle, said additional canalbeing selected from the group of guide wire canals and flow-through canals.

26 A method for in vitro treatment of, or for removal or compression of an obstruction in, a vessel or vessel-like structure comprising:
a. inserting an angioplasty device into said vessel;
b. aligning said device with the site of treatment or the site of the obstruction;
c. manipulating said device such that the desired treatment, removal or compression is achieved;
d. removing any resulting panicles through or to within said device;
e. retracting said device; and f. removing said device from said vessel carrying any collected particles therewith, said device comprising:

i. a catheter bundle for insertion into said vessel;
ii. an operative member, for removal or compression of said obstruction, connected to said catheter bundle;
iii. control means, connected to said operative member, for manipulating said operative member;
iv. a trap/barrier connected to said catheter bundle;
v. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and vi. at least one particle removal aperture situated within said trap/barrier for removal of particles.

27 A method for n vitro treatment of, or for removal or compression of an obstruction in, a vessel or vessel-like structure comprising:
a. inserting an angioplasty device into said vessel;
b. aligning said device with the site of treatment or the site of the obstruction;
c. expanding said device such that the desired treatment, removal or compression is achieved;
d. removing any resulting particles through or to within said device;
e. retracting said device; and f. removing said device from said vessel, said device comprising:
i. a catheter bundle for insertion into said vessel;
ii. a trap/barrier connected to said catheter bundle;
iii. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and iv. at least one particle removal aperture situated within said trap/barrier for removal of particles.

28 An in vitro method for preventing particles from escaping from a point of manipulation of a vessel or vessel-like structure comprising:
a. inserting an angioplasty device into said vessel;
b. positioning said device in said vessel;
c. expanding said device;
d. removing any particles resulting from said manipulation of said vessel through or to within said device;

e. retracting said device; and f. removing said device from said vessel, said device comprising:
i. a catheter bundle for insertion into said vessel;
ii. a trap/barrier connected to said catheter bundle;
iii. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and iv. at least one particle removal aperture situated within said trap/barrier for removal of particles.