CA2139786A1 - Bailout receptacle for angioplasty catheter - Google Patents

Bailout receptacle for angioplasty catheter

Info

Publication number
CA2139786A1
CA2139786A1 CA002139786A CA2139786A CA2139786A1 CA 2139786 A1 CA2139786 A1 CA 2139786A1 CA 002139786 A CA002139786 A CA 002139786A CA 2139786 A CA2139786 A CA 2139786A CA 2139786 A1 CA2139786 A1 CA 2139786A1
Authority
CA
Canada
Prior art keywords
guidewire
receptacle
catheter
balloon
angioplasty
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
Application number
CA002139786A
Other languages
French (fr)
Inventor
G. David Jang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2139786A1 publication Critical patent/CA2139786A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183Rapid exchange or monorail catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty

Abstract

2139786 9401164 PCTABScor01 A bailout system (10) for procedures involving angioplasty catheters, comprising a receptacle (14) sized to fit inside an angioplasty guiding catheter (62), comprising an elongate tubular shaft (32) having a lumen (42) extending longitudinally therethrough from a proximal end (34) to a distal end (36), a balloon angioplasty catheter (12) extending through the lumen (42), the angioplasty catheter (12) and the receptacle (14) each adapted to slide longitudinally with respect to each other, and a longitudinally movable guidewire (60) extending through the lumen (42) but outside of the angioplasty catheter (12). Also disclosed is a method for using the system.

Description

b -~10 94/01164 1 PC~/US93/OS372 BA}LOUT RECEPTACI.E FOR ANGIOPLASTY CATHETER
BACRGROUND OF THE I~ENTION
The present invention relates to a system for permitting rapid removal and reinsertion of angioplasty catheters, and is particularly usPful in connection with fixed wire coronary balloon angioplasty catheters.
Percutaneous transluminal coronary angioplasty (PTCA) has gained widespread acceptance as a significantly less-invasive alternative to coronary bypass surgery. A similar technique, peripheral angioplasty, i5 useful in treatment of peripheral vascu}ar disease. Unlike bypass surgery, PTCA does not re~uire general anesthesia, cutting of the chest wall, extracorporeal pro~usion, or transfusion of blood.
During PTCA and other balloon angioplast~ procedures, a catheter b~aring an angioplasty balloon at the distal en~ is threaded into a stenosis (restrictio~ of the artery) under fluoroscopic observation. Contrast agent is injected during the positioning process in order to permit real time imaging of the vasculature into which the catheter is inserted.
On~e the catheter is in place in the stenosis, the angioplasty balloon is inflated, dilating the stenosis.
It is important that the inflated diam~ter of the balloon be matched to the native dia~Teter of the stenotic vessel. A
balloon that is too small will produce suboptimal dilation, while a balloon that is too large could result in arterial.
wall damage. Physicians tend ~o err on the side of choosing smaller (rather than larger) angioplasty balloons.
There are numerous occasions in which removal of the 3~ angioplasty catheter and reinsertion of another ca~heter may be required during PTCA. For example, coronary occlusion may occur during angioplasty. Dilation of one vessel may result in re5triction of another, adjacent stenotic vessel.
Furthenmore 9 dissection o~ the arterial wall may occur during angioplasty. In both of these events, placement of a perfusion catheter through the stenotic region may be of utmost importance.

WO94/0ll~ 2 1 3 ~ 7 8 ~ PCT/US93/063~!
-2- :
Furthermore, if the balloon chosen by ~he phvsician turns out to be a hëss than optimal size, removal of the angioplasty catheter and reinsertion of a different angioplasty catheter may be necessary.
One type of angioplasty catheter in widespread use is the over the wire catheter. This catheter has a guidewire lumen through which a st~erable guidewire may be advanced. The guidewire (which extends distally beyond the distal end of the angioplasty catheter) is typically first positioned in the stenosis. Next, the catheter is advanced o~er the guidewire into the stenosis. If catheter exchange is neces~ary, the catheter may be removed from the patient leaving the guidewire in place, and a new catheter may be rapidly advanced over the positioned guidewire into the stenosis.
Another type of angioplas~y catheter in widespread use is the fixed wire catheter. In this catheter, the distal end of the angioplasty balloon is actually bonded to the guidewire.
Thus, the guidewire is "fixed" with respect to the location of the balloon. A ~ajor advantage of the fixed wire catheter is the elimination of the guidewire lumen extending through the balloon, permitting the d~flated fixed wire balloons to have an extremely low profile. However, a significant disadvantage of the fixed wire ca~heter is the inability to rapidly remove the catheter and reinsert a different catheter into the same vasculature location~. ~ When the fixed wire catheter is removed, the guidewire is removed at the same time. Insertion of a new catheter is somewhat time consuming, requiring additional in~ec~ion of contrast material and fluoroscopic observation during positioning of the second catheter. In essence, replacing a catheter with a second fixed-wire catheter is li~e starting the procedure all over again.
Accordingly, there is a substantial need for a system for , bailing out fixed wire angioplasty catheters; that is, a system for permitting the removal of the fixed wire ca~heter and rapid and assured reinsertion of a second catheter into the same vascular location. Similarly, there is a need or a method for accomplishing that result.

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~l~Y 7~
--~VO 94/U1164 PCI`/US93/06372 SUk~RY OF THE I~1VENTION
In accordance with one embodiment of the invention, there is provided a bailout s~stem for procedures involving angioplasty c~theters, comprising a receptacle sized to fit inside an angioplasty guiding catheter, comprising an elongate tubular shaft having a lumen extending longitudinally therethrough ~rom a proximal end to a distal end, a fixed-wire balloon angioplas~y catheter extending through the lumen, the angioplasty catheter and the receptacle each adapted to slide longitudinally with respect to each other, and a longitudinally movable guidewire extending through the lumen but outside of the angioplasty catheter. The system may ~urther comprise a guiding catheter in which the receptacle, the angioplasty catheter, and the guidewire are contained. The angioplasty catheter may be a peripheral angioplas~y catheter, or may be a fixed wire coro~ary balloon angioplasty catheter.
In one preferred system, the diameter of the receptacle shaft is 3.9 French or smaller. The receptacle may advantageously include an enlarged connector at the proximal end thereof Z0 through which the angioplasty catheter extends into the lumen.
The receptacle may also include a side port ~xtending through the shaft and adapted to receive a guidewire extending therethrouqh. The side port is preferably loca~ed toward the proximal end of the receptacle at a point ordinarily outside a patient during use of the system.
In one particularly preferred embodiment, the receptacle further includes a guidewire removihg means for permitting removal of the guidewire laterally through the shaft, the guidewire removing means extending longitudinally along at 0 least a portion of the shaft. The simples~ guidewire remo~ing means comprises a slik. Alternatively, the guidewire remo~ing means i~ adapted to form a slit when lateral removal of the guidawire is desired. The guidewire removing means preferably extends distally along the shaft to within abou~ 40 cm of the distal end of the receptacle. more prefera~ly to within about 30, 25, 20, 15, or 10 cm. In one embodiment, the guidewire removing means extends di~tally along the shaft all the way to w~ g~/oll~ 2 1 3 ~ 7 8 ~ PCT/US93/0637~

the distal end cf the receptacle. When a system includes both a side port and a guidewire removing means, the guidewire removing means preferably extends distally from the side port.
The shaft of the receptacle advantageously has a first proximal segment and a second distal segment, wherein the ~' first segmen~ is more rigid than the second segment. The first segment may be made of a different material than the second segment. The second segment is preferably between about 1 and about 20 cm in length.
10The present invention further includes a bailout system for procedures involving fixed-wire balloon angioplasty catheters, comprising a recep~acle comprisiny an elongate tubular shaft having a lumen extending longitudinally therethrough from a proximal end to a distal end, and a fixed-wire balloon angioplasty catheter extending through the lumen, the angioplasty ca~heter and the receptacle each adapted to slide longitudinally with respect to each other, wherein the balloon angioplasty catheter has an angioplasty balloon having a maximum inflated diameter, and wherein the diameter of the lumen in the receptacle is not greater than the maximum inflated diameter o~;the balloon. This sys~em also includes a guidewire extending through the lumen of the receptacle, and may be contained inside a guiding catheter in a patie~t.
The methods of the invention include a method for ~5 practicing ~alloon angioplasty, comprising the steps of: (a) positioning a baiIout system according to the invention in a patient, so that a deflated angioplasty balloan of the angioplasty catheter is positioned in a stenosis, (b) inflating the balloon to dilate the stenosls, tc) advancing a bailout guidewire through the bailout receptacle and through the lesion, and (d) withdrawing the angioplasty ca~heter from the pa~ient, leaving the bailout guidewire in ~he dilated lesion. In various embodiments, step (b) is performed before step ~c); step (c) is performed before step (b): or step (c) is performed before step (a~. One method further includes the step between steps (b) and (c) of advancing the distal e~d of the bailout receotacle through the stenosis. These methods .

-~W094/011~ 2 1 3 9 7 8 ~ PCT/U~93,06372 . --5--~ay advantageously utilize a catheter havln~ a guidewire removing means and may fur~her comprise the final step of removing the receptacle from the patient while maintaining the position of the distal end of the bailout guidewire in the lesion, so that the bailout guidewire is rapidly removed laterally from the receptacle through the guidewire removing means.
Finally, the invention includes a method for dilating a , bifurcation double lesion, comprising the ordered steps of:
(a) advancing a system accordiny to the present invention into the right or left coronary artery of a human patient having coronary bifurcation lesion disease at a branch of the artery, so that the angioplasty balloon is in a ~irst bifurcation lesion, and advancinq a bailout guidewire through the bailout : 15 receptacle so that the bailout guidewire is extPnding through a second bifurcation lesion, (b) inflating the balloon to dilate the first bifurcation lesion, (c) reversing the respective positions of the balloon ~nd the bailout guidewire, so that the bailou~ guidewire is in the dilated firct bi~urcation lesion a~d the balloon is in the second bifurcation lesion, and (d) inflating the balloon to dilate the second bifurcation lesion.
BRIEF DESCRIPTION OF T~E D~AWINGS
Figure 1 is a side elevation of the system of the present invention, comprislns a bailout receptacle with a fixed~wire balloon angioplasty catheter extending therethrough.
Figure 2 corresponds to,Figure 1, but further illustrates a guidewire removing means-~or removing a guidewire laterally . through the wall of ~he receptacle.
~igure 3 is a longitudinal cross section of the receptacle of Figure 1.
Figure 4 is a longitudinal cross section of the sys~em of Fiyure 1, illustrating both the angioplasty catheter and the ' bailout rec~ptacle in longitudinal cross.section.
~ 35 Flgure 5 is a longitudinal cross s~ction of the bailout ¦ system of the present invention with a bailout guidewire extending through the receptacle along side the angioplasty ,, .

~ 1 ~J rJ 1 ~J l~.i WO9~/011~ PCT/US93/06 ~
-6- ; -catheter, with the entire system being positioned inside. aguiding catheter.
Flgure 6 corresponds to Figure 5, and illustrates the proximal removal of the bailout receptacle and the angioplasty S catheter while maintaining the bailout guidewire in place.
Figure 7, corresponds to Figure 6, except that the bailout system comprising the bailout receptacle and the angioplasty catheter have been completely removed from the guiding catheter and the bailout guidewire.
Figure 8, Panels A-~, illustrate one method of the present invention.
Figure 9, Panels A-D, illustrate a second method for practicing the present invention.
Figure 10, Panels A~D, illustxate yet another method for practicing the present invention.
Figure 11, Panels A-D, illustrate still another method for practicing the present invention.
Figure 12, Panels A-D, illustrate the method of the present invention in use in a bifurcation lesion in a patient.
DETAILED DESCRIPTIO~ OF THE INVE~TION
In the present invention, there is provided a coaxial bailout system romprising a relatively small receptacle in the form of a hollow cathetèr with the fixed wire balloon catheter inside of the receptacle. Unlike the relatively large guiding catheter used in angioplasty procedures, the receptacle of the present invention has a diameter much closer to the diamet~r of a balloon angioplasty catheter. The fixed-wire angioplasty catheter (or other catheter) extending through the bailout receptacle may slide longitudinally in the distal and proximal directions through the receptacle.
With reference now to Fig~re 1, the bailout system 10 of the presenk invention comprises an angioplasty catheter 12 extending through a bailout receptacle 140 The angioplasty catheter 12 may be a ca~heter of any suita~l~ design for performing coronary angioplasty or peripheral angioplas~y.
How~ver, the angioplasty catheter }2 is preferably a fixed wire balloon angioplasty ~akheter.
, -,-7 ~ ~) :: -W094/011~ PCT/US93/06372 The angioplasty catheter 12 comprises a catheter shaft 16 having a proximal end 20 and a distal end 22. An inflatable/deflatable angioplasty balloon of conventional design is mounted on the distal end 22 of the catheter shaft 16. If the angioplasty ca~heter is a conventional fixed wire coronary angiopla~ty catheter, the balloon 24 has a proximal end attached to ~he distal end 22 of the catheter shaft 16.
, A fixed guidewire 26 extends through the balloon 24, and the L distal end of the balloon 24 is attached securely to the fixed guidewire 26. The guidewire tip 30 may advantageously be a shapeable tip of conventional design.
The bailout receptacle 14 comprises a elongated cylindrical shaft 32 with a proximal end 34 and a distal end 36. A proximal.fitting 40, preferably of molded plastic, is ' lS provided on the proximal end 34 of the receptacle 14. A lumen ~2 extends through the receptacle 14 from the proximal end 34 to the distal end 36. The rec~ptacle lumen 42 is sized only slightly larger than the diameter of the angioplasty catheter 12, and is sized so that the angioplasty catheter 12 can slide 2Q proximally and distally through the receptacle lumen 42.
In one preferred embodim~nt, the diameter of the re~eptacle shaft 32 is 3~9 French or smaller (e.g., in the case of a bailout system ~or coronary use). The receptacle ~ shaft will be larger for peripheral angioplasty.
;~ 25 In one preferred embodiment of the system lO, a proximal ~ side port 4~ is provided, extending through the wall ~6 of the i receptacle shaft 320 The proximal side port 44 is sized to ~, .
permit insertion and removal of a distally-extending movable . guidewire (not shown in Figure l).
In a preferred embodiment, as illustrated in Figure 2, the wall 46 of the receptacle shaft 32 is provided with a guidewire removing means 50 extending distally from the general vicinity of the proximal end 34 of the receptacle - ~haft 32. In the embodiment illustrated in Figure 2, the ~!~ ' 35 guidewire removing means 50 extends distally from the proximal side port 44. The guidewire removing means ~0 can extend distally any desired distance, however, in a preferred ~;
i WO94/011~ ~ 7X1 -8- PCT/US93/063~

embodiment, the guidewire removing means 50 e~tends distally to within about 40 cm of the distal end 36 of the receptacle 14; pref~rably to within about 30, 25, or 20 cm, and more preferably to within about 10 or 5 cm of the distal end 36 of the recep~acle 14. In one preferred embodiment, the guidewire removing means 50 extends all the way to the distal end 36 of the receptacle 14.
The guidewire removing means illustrated in Figure 2 comprises a simple slit. It will be understood, however, that the guidewire removing means 50 may comprise any other type of structure that will permit removal of a guidewire laterally through the wall 46 of the receptacle 14. Thus, for example, the guidewire removing means 50 may comprise not only a fully formed slit, but an inchoate slit (e.g., a weakened area that readily may be ruptured or slit ko permit lateral removal of the guidewire). Alternatively, the guidewire removing means may comprise an interrupted or perforated slit, a tear-away strip, parallel weakened lines or parallel interrupted slits to permit removal of a strip, and other si~ilar structures.
In a preferred embodiment, the bailout receptacle 14 (like the angioplasty catheter 12) is formed of molded or extruded polymer material. Without intending to limit the : invention, polymer materials having suitable characteristi~s may be selected from polyethylene, polypropylene, polyvinyl chloride, polyvinylidenechloride, polyethylene terephthalate, polysiloxane, and other welI known polymer materials.
Figure 3 illustrates a longitudinal cross section of one preferred embodiment of the bailout receptacle 14 of the present invention. As il1ustrated in Figure 3, the bailout rec~ptacle 14 has a fitting 40 molded to or otherwise attached to the proximal end 34 of the receptacle shaft 32. The f~tting 4Q is preferably annular, and is advantageously formed of relatively rigid material to permit the physician ~o s~curely grip and hold:the proximal end 34 of the receptacle 14 at the fitting 40. Figure 3 more clearly illustrates the lumen 42 extending longitudinally from the proximal end 34 to the distal end 36 of the receptacle 1~. The wall 46 of the :

J v .~W094J~l~ PCT/US~3/06372 _g_ receptacle 1~ has a pro~imal side port 44 formed therein, permitting access from a point normally outside the pa~ient through the outside wall 46 of the receptacle 14 into the lumen 42 of the receptacle 14.
In the embodiment illustrated in Figure 3, the receptacle shaft 32 includes a proximal se~ment 52 and a distal segment 54. The proximal segment 52 and the distal segment 54 may advantageously be made of different materials. Speci~ically, , it is advantageous to form the proximal segment 52 of a more rigid material, an~ to form the distal segment 54 of a more pliable material. Alternatively, the wall thicknesses of the receptacle sha~t 32 may be adjusted so that the distal segmer.t 54 is more pliable or flexible than the proximal segment 52.

~:15 One advantage of having a 2-segment receptacle 14 is that the stiffer proximal segment can provide pushability, whereas the distal segment is sufficiently pliable to easily permit negotiation of coronary arteries without undo rigidity and without causing damage to the arteries. In practice, the distal ~egment may advantageously comprise the portion of the receptacle 14 extending distally from the guiding catheter (not shown in figure 3) and may, therefore, be between about l cm and 20 cm in length, preferably be~ween about 3 cm and about lO or 15 cm in length.
Figure 4 is another longitudinal section of the rece~tacle 14, this time also showing the angioplasty catheter 12 in cross section inside the receptacle 14.
In Figure 4, the angioplasty catheter 12 is a composite catheter, in which the proximal end 20 of the catheter shaft is formed of a rigid materizl (such as stainless steel hypotube~, and the distal end 22 of the catheter shaft is : ! formed of a more flexible material, such as extruded polym~r.
The fixed guidewire 26 in Figure 4 is bonded to the proximal hypotube ~nd 20 of the catheter sha~t, and extends distally from the hypotube through the balloon 24.
Figure 4 illustrates that, deflated, the balloon 24 is sized to fit easily within the receptacle lumen 42 in sliding WO~4/0~l~ 2 1 3 9 7 8 ~ PCT/US93/063~
--lo~
engagement therewith. The proximal-pointing arrow A and the distal-pointing arrow B indicate that the receptacle 14 may be ~; advanced distally (in the direction of arrow B) over the balloon 24j as illustrated in phantom, or alternatively th~t the balloon 24 may be withdrawn inside the receptacle 14.
~; Similarly, the receptacle 14 may be moved proximally in the direction of arrow A with respect to the angioplasty catheter 12.
, In one particularly preferred embodiment of the ~invention, the bailout system lO includes a bailout guidewire 60 inserted into the lumen 42 of the receptacle 14.~ Figure 5 illustrates the bailout;system 10 of the present invention in place in a guiding catheter 62 of conventional design. The guiding catheter 62~ includes a proximal f~itting 64 at the 15 ~ proxlmal end 66 of the guiding catheter, and a distal opening 70 at the distal end 72 of the guiding catheter 62.
With the bailout system 10 of the present invention in place in a patient, the~angioplasty catheter 12 extending through~the bailout receptacle 14! and the bailout receptacle 20~ ~ 14 extending distally into the guiding catheter 62, one;may desire to advance a bailout guidewire 60;distally inside the ailout~receptacl~e 14. ;In this embodiment, the receptacle lumen~42~of the~receptacle 14 is of suf~ficient size to permit ;proximal~a~nd d~ist~al sliding motion of the bailout guidewire 60 25 ~ and~the angioplasty~catheter 12 with respect to the bailout receptacle~l4, while at the same time~the bailou~ recepta~le 14 is~sufficiently~small ~e.g., 3.9 French or smaller for coronary use)~to ~f}t~easily wlthin~a~;~conventional` guidinq athe~er.
30 ~ As ~illustrated in Figure 5, when the baLloon 24 of the angioplasty catheter ~is extending distally from the distal opening 70 of ~he guiding catheter 62 (presumably having been ; positioned e.q., within a coronary artery in a patient), the bailout~guidewi~re 60 may be advanced distally alongside the 35~ balloon 24 and~the ~lxed guidewire~26.~ The arrow B in :Figure 5 indicates distally directed motion of the bailout guldewire : . .

i , ~094/0ll~ PCT/U~93/~372 With the bailout sys~em lo of the present inventlon in I place in a pa~ient, the bailout receptacle 14 may be advanced ~; over the angioplasty catheter 1~2 to a desired posltion, the l~ angioplasty catheter 12 may be removed from the patient, and !,: 5 a new catheter (such as a balloon angioplasty catheter) may be reinsert`ed through the bailout receptacle 14 to the same , position. Alternatively, if a bailout guidewire 60 has been l~ inserted through the bailout receptacle 14 alongside the fixed I ,wire angioplasty catheter 12, one may remove both the }0 angioplasty catheter 12 and the bailout receptacle 14 from the patient while leaving the bailout guidewire 60 in place.
Figure 6 illustrates the removal of the angioplasty catheter 12 and the bailout receptacl~e 14 while maintaining a bailout guidewire 60 in place in the patient.
In the embodiment illustrated in Flgure 6, the bailout receptacle has a guidewire removing means 50 extending dista~lly from the proximal sideport 44. As illustrated in Figure 6, the bailout~receptacle 14 and angloplasty catheter ; 12 are removed proximally in the direction of arrow A. Arrow Z0 ~C~illustrates that the;ballout guidewlre 6~0 is maintained in a ~ixed position ~and does not move proximally with the remainder of the system lO). By holding the bailout guidewire 60~stationary, the bailout guidewire~0 is passed laterally outward through the guidewire removlng~means 50.
2S ~Figure~ 7 illust~rates the completion of the removal process, in whlch~ the angioplasty catheter 12 and the receptacle 14 co~tinue to move proxima~lly in the direction of arrow`A, while ~he~b~ailout guidewlre 60 ~is~heid in a fixed position as illustrated by arrow C.~ The guidewire removing ~ ~means~50 in Figure~;7 extends to the~distal~end of the bailout receptacle 14, so that the bailout re~eptacle 14 may~be removed completely off of the bailout guidewire 60.
Figures 8-12~illustrate di~ferent methods for using the ` bailout system lO~o~ the present invention. ~ ~
`~ 35; ; ~ In the scenarlo illustrated in the four~panels (A-D) of Figure 8, the guiding catheter 62 extends through the aorta to the coronary artery system, with the bailout receptacle 14 , , WO94/0ll~ 2 1 3 9 7 8 ~ PCT/US~3/0637~
-12~ ~
extending distally from the guiding catheter 62. The deflated angioplasty catheter 12 extends distally from the bailout receptacle and is positioned so that the deflated angioplasty balloon 24 is positioned within an arterial lesion 74. In ~: 5 panel B, the angioplasty balloon 24 is inflated to dilate the stenosis or 1.esion 74. Panel C illustrates the bailout guidewire 60 being advanced from the distal end of the bailout 1 receptacle 14, past the deflated balloon 24 and through the i dilated lesion 74. The angioplasty balloon 24 in Panel C is deflated prior ~o:advancing the bailout guidewire 60 past the balloon 24. In Panel D, the angioplasty catheter 12 has been withdrawn into the bailout receptacle 14 and may be removed rom the patient, leaving the bailout guidewire 60 in place in the lesion 74 ln the event another catheter should need to be positioned inside the lesion 74 rapidly and securely.
: Figure 9 is similar to Figure 8, except:that the bailout guidewire 60 i5 advanced through the lesion prior to insertion of the angioplasty balloon 24 in the Iesion 74. Thus, in ;Panel A, the ba~ilout guidewire crosses the lesion 74; in Panel ;20~ B, the balloon 24 of the angioplasty balloon catheter 12 is ;:~; positioned:inside the lesion 74; in Panel C, the balloon 24 is inflated in the stenosis or lesion 74, with the bailout guidewire 6~ also extending through the lesion 74 outside of the:balloon 24; and: in Panel D, the receptacle 14 and the 25~ ~catheter lZ have been removed, leaving the bailaut guidewire 60 in place in the stenosis 74. ~ :
Figure 10 illus~rates yet another embodiment~ of the ~ : method of the present invention. In Panel A, the stenosis has : ~ already be n dilated by the balloon 24, and the balloon 24 has :~ 30 : been deflated. In~Panel B, the angioplasty catheter 12 and ` the receptacle 14 are advanced as a unit through the dilate~
; I lesion 74, and~ then the bailout ~uidewire 60 is advanced through the bailout receptacle 14. Next, in Panel C, the receptacle 14 and the:angisplasty catheter~12 are withdrawn proximal~y while the bailout guidewire 60~is maintained in lts position within the lesion 74. Finally, in-Panel D, the : guidewir~ 60 is in place in the artery while the angloplasty ~, , , :

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213!J786 .W~94/0~l~ P~T/US~3/0~372 catheter 12 (and, optiona lly, the bailout receptacle 1~) have been removed proximally out of the patient. Another catheter may then be advanced over the guidewire 60 through the lesion.
In the scenario of Figure 11, the fi~ed~wire balloon angioplasty catheter 12 is positioned with the angioplasty balloon 24 inside the stenosis 74 and the receptacle 14 : extending to wi~hin close proximity of the balloon 24. The balloon ~4 is then inflated in the stenosis 74 to dilate the stenosis 74. In Pane~l B, the balloon is deflated, and in ~:;::10 Panel C, the receptacIe 14 is advanced throuqh the dilated lesion 7~ and over the ~alloon of the angiopla5ty catheter 12.
~ .
The:bailout guidewire 60 is then advanced through the bailout .~ ;receptacle~14, extending through the dilated lesion 74. The balloon catheter 12 and the bailout receptacle 14 are then 15~ withdrawn, as shown in Panel D, leaving the bailout guidewire . ~ .
60 extending through the:dilated lesion 74.
Figure 12 illustrates~use of the present invention in a :bifurcation doubl~ lesion. In a patient suffering from : bi~urcation/double lesion coronary disease, the patient has 20. lesions near the:branching point of a coronary artery. The scenario of Figure 12 is~a partioularly difficult scenario for ba:lloon angioplasty, because dilation of a ~lrst lesion 76 may te:nd .to close the second lesion 80, and ~ice versa. Thus, before attempting angioplasty on the dou~le Iesions 76, 80, 25~: the physician must pro~ide a guidewire through~he lesion not being dilated at that moment as a safety precaution.
Wit~ reference~ to Panel A in Figure 12, the deflated ailoon 24 is placed in the first lesion 76, wikh the:b2ilo~t guidewire 60 positioned through the second lesion 80. Then, ~ as shown in Panel B~ the balloon 24 is inflated to dilate the first stenosis 76, with the bailout guidewire extending out of the di~tal end of~the bailout receptacle 14 and through the second lesion 80.
The positions of the angioplasty balloon ~4 and the ~ ~bailout guidewire 60 are then switched, so that the bailout guidewire 60 extends through the dilated first lesion 7:~, and ehe angioplasty balloon is positioned in the second stenosis WO94/011~ PCT/US93/0637 80, as shown in Panel C. The balloon 2~ is inflated to dilate the second stenosis. The angioplasty catheter 12 may then be l withdrawn with the receptacle 14, leaving the bailout ¦~ guidewire 60 in the first vessel extending through the first lesion 76.
It will be appreciated that the method of the invention may also be practiced without a bailout guidewire 60 by posi~ioning the bailout receptacle 14 inside the dilated site (as illustrated in Panel B of Figure lO). The angioplasty catheter 12 is then withdrawn from the patien~ and a new ca~heter may be inserted through ~he bailout receptacle 14 and through the lesion 74 of Figure lO, Panel B.
Although the apparatus and method of the present ; invention~have been~ described in the context of particular embodiments, it will be appreciated that the present invention may be pract-ced with catheters other than balloon angioplasty catheters. It will also be appreciated that ;the catheter reinserted into the patient utilizing the present invention may be any suitable ~ype of catheter, including another 20~ ~ bal~loon angioplasty catheter (either fixed wire or over-the-wirej,~an atherectomy catheter, a laser catheter, a perfusion catheter, other vascular catheter.
Furthermore, it will be appreciated that numerous modifications and variations of the preferred embodiments are 25~ possible, while;remaining w1thin the~ scope of the intended invention. Accordingly, the claims that follow are not to be ` limlted to any~particular disclosed em~odiment, but instead should~be entitl~ed to~their full literal scope, together with reasonable equivalents.
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Claims (39)

WHAT IS CLAIMED IS:
1. A bailout system for procedures involving angioplasty catheters, comprising:
a guiding catheter;
a receptacle of a substantially constant diameter extending longitudinally through the guiding catheter, comprising an elongate tubular shaft having a lumen extending longitudinally therethrough from a proximal end to a distal end;
a balloon angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to slide longitudinally with respect to each other; and a longitudinally movable guidewire extending through said lumen, wherein said guidewire is outside of said angioplasty catheter along the entire length of the catheter.
2. The system of Claim 1, wherein said angioplasty catheter is a peripheral angioplasty catheter.
3. The system of Claim 1, wherein said angioplasty catheter is a fixed wire coronary balloon angioplasty catheter.
4. The system of any one of Claims 1-3, wherein the diameter of said receptacle shaft is 3.9 French or smaller.
5. The system of any one of Claims 1-4, wherein said receptacle further comprises an enlarged connector at the proximal end thereof through which said angioplasty catheter extends into said lumen.
6. The system of any one of Claims 1-5, wherein said receptacle includes a side port extending through said shaft and adapted to receive a guidewire extending therethrough.
7. The system of Claim 6, wherein said side port is located toward the proximal end of said receptacle at a point ordinarily outside a patient during use of said system.
8. The system of any one of Claims 1-7, wherein said receptacle further includes a guidewire removing means for permitting removal of the guidewire laterally through said shaft, said guidewire removing means extending longitudinally along at least a portion of said shaft.
9. The system of Claim 8, wherein said guidewire removing means comprises a slit.
10. The system of Claim 8, wherein said guidewire removing means is adapted to form a slit when lateral removal of said guidewire is desired.
11. The system of any one of Claims 8-10, wherein said guidewire removing means extends distally along said shaft to within about 40 cm of the distal end of said receptacle.
12. The system of any one of Claims 8-10, wherein said guidewire removing means extends distally along said shaft to the distal end of said receptacle.
13. The system of any one of Claims 8-11, wherein said shaft further includes a side port adapted to receive a guidewire extending therethrough into said lumen, said side port located at a point ordinarily outside the body during use, and; wherein said guidewire removing means extends distally from said side port.
14. The system of any one of Claims 1-13, wherein said shaft has a first proximal segment and a second distal segment, and wherein said first segment is more rigid than said second segment.
15. The system of Claim 14, wherein said first segment is made of a different material than said second segment.
16. The system of Claim 14 or 15, wherein said second segment is between about 1 and about 20 cm in length.
17. A bailout system for procedures involving balloon angioplasty catheters, comprising:
a receptacle comprising an elongate tubular shaft having a lumen of a substantially constant diameter extending longitudinally therethrough from a proximal end to a distal end, said receptacle being adapted to extend longitudinally through a guiding catheter; and a balloon angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to freely slide longitudinally with respect to each other, wherein the balloon angioplasty catheter has an angioplasty balloon having a maximum inflated diameter, and wherein the diameter of the lumen in the receptacle is not greater than the maximum inflated diameter of the balloon; and a longitudinally movable guidewire extending through said lumen, wherein said guidewire is outside of said catheter along the entire length of said catheter.
18. The system of Claim 17, wherein said angioplasty catheter is a peripheral angioplasty catheter.
19. The system of Claim 17, wherein said angioplasty catheter is a fixed wire coronary balloon angioplasty catheter.
20. The system of any one of Claims 17-19, wherein said receptacle further comprises an enlarged connector at the proximal end thereof through which said angioplasty catheter extends into said lumen.
21. The system of any one of Claims 17-20, wherein said receptacle includes a side port extending through said shaft and adapted to receive a guidewire extending therethrough.
22. The system of Claim 21, wherein said side port is located toward the proximal end of said receptacle at a point ordinarily outside a patient during use of said system.
23. The system of any one of Claims 17-22, wherein said receptacle further includes a guidewire removing means for permitting removal of the guidewire laterally through said shaft, said guidewire removing means extending longitudinally along at least a portion of said shaft.
24. The system of Claim 23, wherein said guidewire removing means comprises a slit.
25. The system of Claim 23, wherein said guidewire removing means is adapted to form a slit when lateral removal of said guidewire is desired.
26. The system of any one of Claims 23-25, wherein said guidewire removing means extends distally along said shaft to within about 40 cm of the distal end of said receptacle.

WO 94/01164 PCT/US93/0637?
27. The system of and one of Claims 23-25, wherein said guidewire removing means extends distally along said shaft to the distal end of said receptacle.
28. The system of any one of Claims 23-27, wherein said shaft further includes a proximal side port adapted to receive a guidewire extending therethrough into said lumen, and wherein said guidewire removing means extends distally from said side port.
29. The system of any one of Claims 17-28, wherein said shaft has a first proximal segment and a second distal segment, and wherein said first segment is more rigid than said second segment.
30. The system of Claim 29, wherein said first segment is made of a different material than said second segment.
31. The system of Claim 29 or 30, wherein said second segment is between about 1 and about 20 cm in length.
32. A method for practicing balloon angioplasty, comprising the steps of:
a. providing a bailout system, said bailout system comprising:
a receptacle comprising an elongate tubular shaft having a lumen of a substantially constant diameter extending longitudinally therethrough from a proximal end to a distal end, said receptacle being adapted to extend longitudinally through a guiding catheter; and a balloon angioplasty catheter having a proximal end and a distal end and an angioplasty balloon at or near the distal end of the catheter, said balloon in communication with a balloon inflation lumen and said balloon further having a maximum inflated diameter, said angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to freely slide longitudinally with respect to each other, and wherein the diameter of the lumen in the receptacle is not greater than the maximum inflated diameter of the balloon;
b. positioning the bailout system according to Claim 17 in a patient, so that the angioplasty balloon of the angioplasty catheter is positioned in a stenoisis;
c. inflating and deflating the balloon to dilate the stenoisis;
d. advancing a guidewire through the bailout receptacle and through the lesion, such that the guidewire is outside of said catheter along the entire length of said catheter; and e. withdrawing the angioplasty catheter from the patient, leaving the guidewire in the dilated lesion.
33. The method of Claim 32, wherein step (c) is performed before step (d).
34. The method of Claim 32, wherein step (d) is performed before step (c).
35. The method of Claim 32, additionally comprising a step before step (b) of advancing a guidewire into the vasculature of a patient and wherein, in step (b), the system is positioned over the guidewire such that the guidewire is outside of said catheter along the entire length of said catheter, said guidewire extending through said receptacle and wherein step (d) is omitted.
36. The method of Claim 33, further comprising the step between steps (c) and (d) of advancing the distal end of the bailout receptacle through the stenosis.
37. The method of Claim 32, wherein said receptacle further comprises guidewire removing means for permitting removal of a guidewire laterally through the shaft, said guidewire removing means extending longitudinally along at least a portion of the shaft, further comprising the final step of removing the receptacle from the patient while maintaining the position of the bailout guidewire in the lesion, so that the bailout guidewire is removed laterally from the receptacle through the guidewire removing means.
38. A method for dilating a bifurcation double lesion, comprising the ordered steps of:
(a) providing a bailout system, said bailout system comprising:
a receptacle comprising an elongate tubular shaft having a lumen of a substantially constant diameter extending longitudinally therethrough from a proximal end to a distal end, said receptacle;
being adapted to extend longitudinally through a guiding catheter; and a balloon angioplasty catheter having a proximal end and a distal end and an angioplasty balloon at or near the distal end of the catheter, said balloon in communication with a balloon inflation lumen and said balloon further having a maximum inflated diameter, said angioplasty catheter extending through said lumen, said angioplasty catheter and said receptacle each adapted to freely slide longitudinally with respect to each other, and wherein the diameter of the lumen in the receptacle is not greater than the maximum inflated diameter of the balloon;
(b) advancing the system into the coronary artery of a human patient having coronary bifurcation lesion disease at a branch of said artery, so that the angioplasty balloon is in à
first bifurcation lesion, and advancing a guidewire through said bailout receptacle so that the guidewire is extending through a second bifurcation lesion, such that the guidewire is outside of said catheter along the entire length of said catheter;
(c) inflating and deflating the balloon to dilate the first bifurcation lesion;
(d) reversing the respective positions of the balloon and the bailout guidewire, so that the guidewire is in the dilated first bifurcation lesion and the balloon is in the second bifurcation lesion; and (e) inflating and deflating the balloon to dilate the second bifurcation lesion.
39. The method of Claim 38, comprising, in addition to steps (a)-(d), the step of withdrawing the balloon catheter from the second dilated lesion, and allowing the guidewire to remain in one of the two dilated lesions for bailout purposes.
CA002139786A 1992-07-10 1993-07-06 Bailout receptacle for angioplasty catheter Abandoned CA2139786A1 (en)

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US07/911,779 US5342297A (en) 1992-07-10 1992-07-10 Bailout receptacle for angioplasty catheter
US07/911,779 1992-07-10
PCT/US1993/006372 WO1994001164A1 (en) 1992-07-10 1993-07-06 Bailout receptacle for angioplasty catheter

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AU4665993A (en) 1994-01-31
WO1994001164A1 (en) 1994-01-20
EP0649324A4 (en) 1995-08-30
US5342297A (en) 1994-08-30

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