Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
CATHETER TIP DESIGNS AND METHODS FOR IMPROVED STENT CROSSING
Document Type and Number:
WIPO Patent Application WO/1999/044666
Kind Code:
A2
Abstract:
A balloon catheter having a first balloon member and a second distal expandable member. The increased distal profile of the catheter with inflation of the second distal expandable member can deflect the distal-most end away from stent walls and edges. Another catheter has a distal region including longitudinal slits and a pre-stressed body configured to expand upon exposure to warm body fluids. Another catheter has a distal region including a first, inner tube disposed about a second, innermost tube. The inner and innermost tubes are secured at the distal-most end. The distal region includes longitudinal slits through the inner tube, thereby defining flaps between the slits. The innermost tube can be retracted relative to the inner tube disposed about the innermost tube, thereby causing the longitudinal flaps to expand outward, thereby increasing the maximum radial extent of the distal region. In yet another embodiment, a balloon catheter having a first guide wire tube is provided. A second guide wire tube is also provided, adapted to be received within the larger, first guide wire tube.

Inventors:
EIDENSCHINK TRACEE E J
MICKLEY TIMOTHY J
LARSON CHRISTOPHER R
MERTENS STEVEN P
EUTENEUER CHARLES L
Application Number:
PCT/US1999/003438
Publication Date:
September 10, 1999
Filing Date:
February 18, 1999
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
SCIMED LIFE SYSTEMS INC (US)
International Classes:
A61M25/00; A61M25/01; A61F2/958; A61M25/04; (IPC1-7): A61M25/00; A61M25/10
Domestic Patent References:
WO1996003092A11996-02-08
Foreign References:
US5449373A1995-09-12
US5047045A1991-09-10
US5156594A1992-10-20
US4950227A1990-08-21
US5891110A1999-04-06
Attorney, Agent or Firm:
Crompton, David M. (Seager & Tufte LLC Suite 895 331 Second Avenue South Minneapolis, MN, US)
Download PDF:
Claims:
What is claimed is:
1. A catheter tip assembly for crossing both vessel lumen obstructions and placed stents, said tip assembly comprising: (a) an elongate tubular member having a proximal end and a distal end with a guide wire receiving lumen extending therethrough; (b) means for performing a therapeutic procedure proximate the distal end of said elongate tubular member wherein a distal portion of said elongate tubular member extends distally beyond said means for performing a therapeutic procedure to form a catheter tip which defines a leading edge for tracking a guide wire extending therethrough; and, (c) means for reconfiguring said catheter tip from a first configuration for crossing said vessel lumen obstruction to a second configuration for crossing a placed stent.
2. The catheter tip assembly of claim 1, wherein said elongate tubular member comprises at least two segments of tubing joined to form a continuous lumen therethrough.
3. The catheter tip assembly of claim 2, wherein one of said at least two segments forms said catheter tip which defines a leading edge for tracking a guide wire.
4. The tip assembly of claim 1, wherein said means for reconfiguring said catheter tip comprises a severable distalmost tip portion, wherein said severable distalmost tip portion is configured for crossing said vessel lumen obstruction and the remaining tip portion proximal of said severable distalmost tip portion is configured for crossing said placed stent.
5. The tip assembly of claim 4, wherein said tip is perforated at said severable distalmost tip portion.
6. The tip assembly of claim 4, wherein said severable distalmost tip portion has an outside surface that tapers distally to form a generally conical tip for crossing said vessel lumen obstruction.
7. The tip assembly of claim 6, wherein said remaining tip portion has a generally blunt distalmost portion for aiding said catheter in crossing said stent.
8. The tip assembly of claim 6, wherein said remaining tip portion has a generally bulbous distalmost portion for aiding said catheter in crossing said stent.
9. The tip assembly of claim 1, wherein said means for reconfiguring said catheter tip comprises a soft distalmost tip portion configured to roll back onto said tip a predetermined distance to form a bulbous leading edge for aiding in crossing said stent.
10. The tip assembly of claim 9, wherein said distalmost tip portion is skived longitudinally to roll back when in contact with said stent.
11. The tip assembly of claim 1, wherein said means for reconfiguring said catheter tip comprises a retractable distalmost tip portion which retracts from a first position wherein said tip aids in crossing said lumen obstruction to a second position wherein said tip aids in crossing said stent.
12. The tip assembly of claim 11, wherein said retractable distalmost tip portion comprises a sheath slidably disposed within said guide wire lumen.
13. The tip assembly of claim 1, wherein said means for reconfiguring said catheter tip comprises a radial hole in said wall of said tip proximal of the distal end thereof and distal of said means for performing a therapeutic procedure, wherein said guide wire extends through said radial hole to deflect the portion of the tip distal thereto to aid in crossing said placed stent.
14. The tip assembly of claim 1, wherein said means for reconfiguring said catheter tip comprises a bend in said tip so that if said tip catches on said stent, said catheter can be rotated with resulting deflection of said tip away from said stent.
15. The tip assembly of claim 1, wherein said means for reconfiguring said catheter tip comprises a collapsible distalmost tip portion wherein if negative pressure is applied to said proximal end of said guide wire receiving lumen, said collapsible distalmost tip portion is drawn down onto said guide wire to aid in crossing said stent.
16. The tip assembly of claim 1, wherein said means for reconfiguring said catheter tip comprises an inflatable cuff surrounding a portion of said tip having an internal volume in fluid communication with said guide wire receiving lumen so that when fluid is infused into said proximal end of said guide wire receiving lumen with a guide wire disposed therein, said inflatable cuff expands to aid in stent crossing.
17. A catheter tip and guide wire assembly for crossing a placed stent, said stent having a wall portion and a lumen extending therethrough, said tip and guide wire assembly comprising: (a) an elongate tubular member having a proximal end and a distal end with a guide wire receiving lumen extending therethrough; (b) means for performing a therapeutic procedure proximate the distal end of said elongate tubular member wherein a distal portion of said elongate tubular member extends distally beyond said means for performing a therapeutic procedure to form a catheter tip which defines a leading edge for tracking a guide wire extending therethrough; (c) a guide wire extending through said guide wire receiving lumen, said guide wire having thereon means for deflecting said tip away from said interior wall of said stent to aid in passing through said lumen of said stent.
18. The catheter tip and guide wire assembly of claim 17, wherein said elongate tubular member comprises at least two segments of tubing joined to form a continuous lumen therethrough.
19. The catheter tip and guide wire assembly of claim 18, wherein one of said at least two segments forms said catheter tip which defines a leading edge for tracking a guide wire.
20. The catheter tip and guide wire assembly of claim 17, wherein said means for deflecting said tip away from said interior wall of said stent comprises an offset axial segment positioned distal of said distalmost portion of said tip, said offset axial segment first contact said stent wall to prevent tip contact therewith.
21. The catheter tip and guide wire assembly of claim 17, wherein said means for deflecting said tip away from said interior wall of said stent comprises a plurality of helical coils formed in said guide wire.
22. The catheter tip and guide wire assembly of claim 17, wherein said means for deflecting said tip away from said interior wall of said stent comprises a single helical coil formed in said guide wire.
23. The catheter tip and guide wire assembly of claim 17, wherein said means for deflecting said tip away from said interior wall of said stent comprises an axial segment of increased diameter along the length of said guide wire.
24. A catheter tip assembly for crossing both vessel lumen obstructions and placed stents, said tip assembly comprising: (a) an elongate tubular member having a proximal end and a distal end with a guide wire receiving lumen extending therethrough; (b) a guide wire extending through said guide wire receiving lumen; and, (c) means for performing a therapeutic procedure proximate the distal end of said elongate tubular member wherein a distal portion of said elongate tubular member extends distally beyond said means for performing a therapeutic procedure to form a catheter tip, said catheter tip including a distalmost portion rotatably secured to the distal end of said elongate tubular member and having a lumen therethrough coincident with said lumen of said elongate tubular member, said distalmost portion configured to rotate in response to axial movement of said elongate tubular member relative to said guide wire.
25. The catheter tip assembly of claim 24, wherein said elongate tubular member comprises at least two segments of tubing joined to form a continuous lumen therethrough.
26. The catheter tip assembly of claim 25, wherein one of said at least two segments forms said catheter tip which defines a leading edge for tracking a guide wire.
27. The catheter tip assembly of claim 24, wherein said lumen of said rotatably secured distalmost portion includes at least one helical projection therein which causes rotation of said distalmost portion due to friction with said guide wire when moved axially relative thereto.
28. A catheter tip assembly for crossing both vessel lumen obstructions or placed stents, said tip assembly comprising: an elongate tubular member having a proximal end, a distal end, and a guide wire receiving lumen and an inflation lumen extending therethrough; an inflatable balloon disposed proximate said distal end of said elongate tubular member, wherein a distal portion of said elongate tubular member extends distally beyond said inflatable balloon to form a catheter tip which defines a leading edge for crossing vessel lumen obstructions or placed stents, wherein said inflatable balloon has an interior in fluid communication with said inflation lumen; and a distal inflatable tip balloon disposed distal of said inflatable balloon, wherein said distal inflatable tip balloon has an interior in fluid communication with said inflatable balloon interior.
29. A catheter tip assembly as recited in claim 28, wherein said assembly includes a distal inflation lumen in fluid communication with said inflatable balloon interior and in fluid communication with said distal inflatable tip balloon interior.
30. A catheter tip assembly as recited in claim 29, wherein said assembly includes a valve operably disposed within said distal inflation lumen.
31. A catheter tip assembly as recited in claim 30, wherein said valve is a oneway valve, wherein said oneway valve allows a substantially greater rate of flow from said inflatable balloon to said distal inflatable tip balloon than from said distal inflatable tip balloon to said inflatable balloon.
32. A catheter tip assembly as recited in claim 29, further comprising means for slowly releasing fluid from said distal inflatable tip balloon.
33. A catheter tip assembly as recited in claim 31, further comprising an elongate valve control member coupled to said oneway valve.
34. A catheter tip assembly as recited in claim 33, wherein said elongate valve control member extends through said elongate tubular member and can be pulled proximally to open said valve, wherein said valve is biased to close.
35. A catheter tip assembly as recited in claim 33, wherein said elongate valve control member extends through said elongate tubular member and can be pulled proximally to open said valve, and can be pushed distally to close said valve.
36. A catheter tip assembly for crossing both vessel lumen obstructions or placed stents, said tip assembly comprising: an elongate tubular member having a proximal end and a distal end with a guide wire receiving lumen extending therethrough; means for performing a therapeutic procedure proximate said distal end of said elongate tubular member wherein a distal portion of said elongate tubular member extends distally beyond said means for performing a therapeutic procedure to form a catheter tip which defines a leading edge for crossing vessel lumen obstructions or placed stents; and, a distal expandable portion disposed distal of said balloon, wherein said distal expandable portion has a first configuration when at a first temperature and a second configuration when at a second temperature, wherein said first temperature is lower than said second temperature, and said second configuration has a larger maximum radial extent than said first configuration.
37. A catheter tip assembly as recited in claim 36, wherein said elongate tubular member includes a tube wall and said distal expandable portion includes a plurality of slits extending through said wall, said slits defining a plurality of flaps therebetween, wherein at least said flaps are formed of a shape memory material biased to fold when heated to body temperature, wherein said elongate tubular member wall has an unslit portion distal of said slits, such that said unslit distal portion constrains said flaps and said unslit portion must be removed to allow said flaps to expand.
38. A catheter tip assembly as recited in claim 36, wherein said elongate tubular member includes a wall and said distal expandable portion includes a plurality of slits extending through said wall, said slits defining a plurality of flaps therebetween, said slits extending distally to said leading edge, wherein at least said flaps are formed of a shape memory material biased to expand when heated to body temperature.
39. A catheter tip assembly for crossing both vessel lumen obstructions or placed stents, said tip assembly comprising: a first elongate tubular member having a proximal end, a distal end, and a first lumen therethrough; a second elongate tubular member having a proximal end, a distal end, and a guide wire receiving lumen extending therethrough, said second elongate tubular member disposed within said first elongate tubular member lumen; means for performing a therapeutic procedure proximate said distal end of said first elongate tubular member wherein a distal portion of said first elongate tubular member extends distally beyond said means for performing a therapeutic procedure to form a catheter tip which defines a leading edge for crossing a vessel lumen obstruction or placed stent, wherein said first and second elongate tubular members are operably coupled together proximate said leading edge; and means for radially expanding said first elongate tubular member distal of said therapeutic performing means, said means for radially expanding being responsive to proximally pulling said second tubular member relative to said first tubular member.
40. A catheter tip assembly as recited in claim 39, wherein said first tubular member includes a tube wall, wherein said means for radially expanding includes a plurality of slits extending through said tube wall and defining a plurality of flaps therebetween, wherein proximally moving said second tubular member relative to said first tubular member causes said flaps to have a larger radial extent.
41. A therapeutic catheter system comprising: a first elongate tubular member having a proximal end, a distal end, and a first guide wire receiving lumen extending therethrough; means for performing a therapeutic procedure proximate said distal end of said first elongate tubular member; and a second elongate tubular member having a proximal end, a distal end, and a second guide wire receiving lumen extending therethrough, wherein said first and second tubular members are dimensioned such that said second tubular member can be slidably received within said first tubular member, wherein said first elongate tubular member lumen has a first inside diameter, said second elongate tubular member has a second inside diameter, and said second inside diameter is less than said first inside diameter, such that said catheter system can provide better support for a small guide wire when said small guide wire is inserted within said second tubular member inserted within said first tubular member relative to said small guide wire being inserted directly within said first tubular member.
42. A therapeutic catheter system as recited in claim 41, wherein said first tubular member has a first length, wherein said first lumen has a distal orifice, wherein said second tubular member has a second length, wherein said first and second lengths allow a portion of said second tubular member to extend distally from said first tubular member distal orifice when said second tubular member is fully distally inserted within said first tubular member.
43. A method for advancing a therapeutic catheter comprising the steps of : providing a therapeutic catheter including a first elongate tubular member having a proximal end, a distal end, and a first guide wire receiving lumen extending therethrough, means for performing a therapeutic procedure proximate the distal end of said first elongate tubular member, and a second elongate tubular member having a proximate end, a distal end, and a second guide wire receiving lumen extending therethrough, wherein said first and second tubular members are dimensioned such that said second tubular member can be slidably received within said first tubular member; providing a first guide wire having an outside diameter small enough to be slidably received by said second lumen; inserting said first guide wire through said second lumen; advancing said first guide wire into a body vessel; advancing said catheter, with said second tubular member slidably disposed within said first tubular member, over said first guide wire; retracting said first guide wire; and, removing said first guide wire from said first lumen.
44. A method for advancing a therapeutic catheter as recited in claim 43, further comprising the steps of : providing a second guide wire having an outside diameter small enough to be slidably received by said first lumen; removing said second tubular member from said first lumen; inserting said second guide wire into said first lumen; and, further advancing said catheter over said second guide wire.
45. A method for advancing a therapeutic catheter as recited in claim 43, wherein said first and second tubular members have distal tips, wherein said first and second tubular members have lengths allowing said second tubular member distal tip to extend distally past said first tubular member distal tip, further comprising advancing said second tubular member distal tip distally past said first tubular member distal tip.
46. A method for advancing a therapeutic catheter across a stent placed within a body vessel comprising the steps of : providing a catheter including an elongate tubular member having a proximal end, a distal end, and a guide wire receiving lumen and an inflation lumen extending therethrough, an inflatable balloon disposed proximate said distal end of said elongate tubular member, said inflatable balloon having a maximum inflated radial extent, wherein a distal portion of said elongate tubular member extends distally beyond said inflatable to form a catheter tip which defines a leading edge for crossing a vessel obstruction or placed stent, wherein said inflatable balloon interior is in fluid communication with said inflation lumen, a distal inflatable member disposed distal of said balloon, wherein said distal inflatable member has an interior in fluid communication with said balloon interior, wherein said distal inflatable member has a maximum inflated radial extent that is less than said balloon maximum inflated radial extent, and a oneway valve in fluid communication with, and disposed between, said inflatable balloon interior and said distal inflatable member, wherein said oneway valve allows a substantially greater rate of flow from said balloon to said distal inflatable member than from said distal inflatable member to said balloon; advancing said catheter into a body vessel; providing inflation fluid to said inflatable balloon; inflating said inflatable balloon and said distal inflatable member, such that said catheter distal region is radially expanded; allowing said inflatable balloon to at least partially deflate; and advancing said catheter distal inflatable member through said stent.
47. A method for advancing a therapeutic catheter across a stent placed within a body vessel comprising the steps of : providing a therapeutic catheter including an elongate tubular member having a proximal end, a distal end, and a guide wire receiving lumen extending therethrough, means for performing a therapeutic procedure proximate said distal end of said elongate tubular member, wherein a distal portion of said elongate tubular member extends distally beyond said means for performing a therapeutic procedure to form a catheter tip which defines a leading edge for tracking a guide wire extending therethrough, and a distal expandable member disposed distal of said balloon, wherein said distal expandable member has a first configuration when at a first temperature and a second configuration when at a second temperature, wherein said first temperature is lower than said second temperature, and said second configuration has a larger maximum radial extent than said first configuration, wherein said elongate tubular member includes a wall and said distal expandable member includes a plurality of slits extending through said wall, said slits defining a plurality of flaps therebetween, wherein said flaps are formed of a shape memory material biased to expand when heated to body temperature, wherein said elongate tubular member wall has an unslit portion distal of said slits, such that said unslit distal portion constrains said flaps from expanding; severing said unslit portion from said catheter, such that said slits extend to said leading edge; advancing said catheter through said body vessel to said stent; allowing said body vessel to sufficiently warm said flaps and cause said flaps to expand said maximum radial extent; and advancing said distal expandable member expanded distal portion through said stent.
Description:
INTERNATIONALSEARCHREPORT Intema"nal ApplicationNo | PCIS 99/03438 C.(Continuation)DOCUMENTSCONSIDEREDTOBERELEVANT CategoryCitation of documentwithindication,whereappropriate,oftherelevantpassage sRelevanttoclaimNo. AUS4725264A(GLASSMAN)4 16February1988(1988-02-16) column3,line10-line24 figures4,6 AUS4122591A(KRAMANNETAL.)9 31October1978(1978-10-31) column4,line6-line63 figures1-3 AUS5114403A(CLARKEETAL.)24 19May1992(1992-05-19) column1,line19-column2,line15 column9,line22-line45 figures1,14 ACH671883A(SARCEMS.A.)28 13October1989(1989-10-13) abstract figure1 AUS5395341A(SLATER)36 7March1995(1995-03-07) abstract 1 Im...,ational applicationNo. INTERNATIONALSEARCHREPORTPCT/US99/03438 Box IObservationswherecertainclaimswerefoundunsearchable(Continu ationofitem1offirstsheet) ThisInternationalSearchReporthasnotbeenestablishedinrespecto fcertainclaimsunderArticle17(2)(a)forthefollowingreasons: 1.FX]Claims Nos.:43-47 becausetheyrelatetosubjectmatternotrequiredtobesearchedbythi sAuthority,namely: Rule39.1(iv)PCT-Methodfortreatmentofthehumanoranimalbodyby surgery 2.Claims Nos.: becausetheyrelatetopartsoftheInternationalApplicationthatdon otcomplywiththeprescribedrequirementstosuch anextentthatnomeaningfulInternationalSearchcanbecarriedout,s pecifically: 3.Claims Nos.: becausetheyaredependentclaimsandarenotdraftedinaccordancewit hthesecondandthirdsentencesofRule6.4(a). Box11Observationswhereunityofinventionislacking(Continuation ofitem2offirstsheet) ThisInternationalSearchingAuthorityfoundmultipleinventionsin thisinternational application,asfollows: 1. As a ! !requiredadditionalsearchfeesweretimelypaidbytheapplicant,th isInternationalSearchReportcoversall searchable claims. 2.2 As all searchable claims could besearchedwithouteffortjustifyinganadditionalfee,thisAuthori tydidnotinvitepayment ofanyadditionalfee. 3. As onlysomeoftherequiredadditionalsearchfeesweretimelypaidbythe applicant,thisInternationalSearchReport covers onlythoseclaimsforwhichfeeswerepaid,specifically claimsNos.: 4.baNorequiredadditionalsearchfeesweretimelypaidbytheapplica nt.Consequently,thisInternationalSearchReportis restrictedtotheinventionfirstmentionedintheclaims;itiscovere dbyclaimsNos.: 1-16,24-40 RemarkonProtest2 The additionalsearchfeeswereaccompaniedbytheapplicant'sprotest. g Noprotestaccompaniedthepaymentofadditionalsearchfees. FURTHERINFORMATION CONTINUEDFROMPCT/ISA/210 1.Claims:1-16,24-40 Acahtetertipassempyhavingmeansforreconfigurationof thecathetertipfromafirstconfigurationforcrossinga vessellumenobstructiontoasecondconfigurationfor crossingaplacedstent. 2.Claims:17-23 Acathetertipandguidewireassemblyforcrossingaplaced stent,saidguidewirehavingmeansfordeflectingthe cathetertipawayfromtheinteriorwallofthestent. 3.Claims:41,42 Atherapeuticcathetersystemhavingfirstandsecond elongatetubularmembersprovidingabettersupportfora smallguidewire. INTERNATIONALSEARCHREPORT Inter--' :-3, nal Awlication No rmtion on patent famify rtbmbsrs t PLIIJS 99/03438 PatentdocumentPublicationPatentfamilyPubiication citedinsearch report datemember(s)date WO9639219A12-12-1996US5645528A08-07-1997 AU5939696A24-12-1996 CA2222236A12-12-1996 EP0840633A13-05-1998 US3631848A04-01-1972NONE US5591129A07-01-1997NONE US4725264A16-02-1988NONE US4122591A31-10-1978DE2421294A04-12-1975 AT346459B10-li-1978 AT333075A15-03-1978 BE828649A30-10-1975 CH587061A29-04-1977 DK187075A,B,03-11-: i975 FR2269355A28-11-1975 GB1482873A17-08-1977 IE41029B10-10-1979 IT1037554B20-11-1979 IT1037726B20-11-1979 JP929721C17-10-1978 JP50149171A29-11-1975 JP53008146B25-03-1978 LU72384A13-08-1976 NL7505048A,B,04-11-1975 US4043345A23-08-1977 YU111075A27-04-1983 DE2538709A11-11-1976 US5114403A19-05-1992NONE CH671883A13-10-1989NONE US5395341A07-03-1995NONE