Variable tip catheter

• US 6,582,400 B1
• Filed: 10/24/2000
• Issued: 06/24/2003
• Est. Priority Date: 10/24/2000
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Mickley, Timothy J., Harris, Chad, Hawk, Matthew, Larson, Scott
• Primary Examiner(s): Walberg; Teresa
• Assistant Examiner(s): FASTOVSKY, LEONID M
• Application Number:
  US09/695,527
• Time in Patent Office: 973 Days
• Field of Search: 604/164.01,500,510 606/7,15,167 128/898
• US Class Current: 604/164.01
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/348 Means for supporting the trocar against the body or retaining the trocar inside the body
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Therapeutic catheters for increasing myocardial blood perfusion in procedures including percutaneous myocardial revascularization (PMR), which can include tips for cutting into the myocardium to stimulate a healing response and/or for injecting angiogenic substances. PMR catheters can include an outer shaft slidably housing an inner shaft having a distal therapeutic tip. The outer shaft can be slidably disposed in a guide catheter and have an expandable atraumatic distal tip for presenting an enlarged distal profile against the heart chamber wall. The enlarged atraumatic profile can reduce the likelihood of the outer shaft penetrating undesirably into the myocardium. One expandable distal tip expands radially when forced against the endocardium. Another expandable tip expands when unconstrained by the guide catheter. Yet another expandable tip expands when manipulated by an elongate manipulation member.

Claims

1. A therapeutic catheter for increasing myocardial blood perfusion, having a longitudinal axis and transverse planes transverse to said longitudinal axis, comprising:

an inner shaft having a proximal region and a distal region;

a therapeutic tip disposed on said inner shaft distal region having means for penetrating said myocardium;

an outer shaft having a distal region and having said inner shaft disposed within;

an atraumatic distal tip disposed proximate said outer shaft distal region, said atraumatic distal tip having a first configuration having a first transverse profile and a second configuration having a second transverse profile greater than said first transverse profile; and

means for urging said atraumatic tip from said first configuration to said second configuration.

2. A therapeutic catheter as recited in claim 1, wherein said means for urging said atraumatic tip includes means for expanding said tip transverse profile responsive to means for proximally directing compressive force against said atraumatic tip.

3. A therapeutic catheter as recited in claim 2, wherein said means for proximally directing compressive force includes means for transversely elastically expanding said tip responsive to being forced against an obstacle.

4. A therapeutic catheter as recited in claim 2, wherein said atraumatic tip has a distal end, further comprising a tension member slidably disposed within said outer shaft and having a distal end coupled to said atraumatic tip distal end, wherein said means for proximally directing compressive force includes means for transversely expanding said tip responsive to being longitudinally foreshortened by a proximal directed force applied by said inner tension member to said atraumatic tip distal end.

5. A therapeutic catheter as recited in claim 4, wherein said outer shaft has a distal region and said means for transversely expanding said tip includes regions of preferential folding in said distal region.

6. A therapeutic catheter as recited in claim 1, wherein said means for urging said atraumatic tip includes means for biasing said tip to transversely expand.

7. A therapeutic catheter as recited in claim 6, wherein said means for biasing includes forming at least a portion of said atraumatic tip of a radially expansive shape memory material.

8. A therapeutic catheter as recited in claim 6, wherein said means for biasing includes forming at least a portion of said atraumatic tip of an elastic material biased to expand radially when unconstrained.

9. A therapeutic catheter as recited in claim 1, wherein said means for urging said atraumatic tip includes means for inflatably expanding said tip.

10. A therapeutic catheter as recited in claim 1, wherein said outer shaft has a distal end and said atraumtatic tip includes a cross member pivotally coupled to said outer shaft distal end and able to assume a first orientation and a second orientation, said second orientation having a larger transverse profile than said first orientation, wherein said outer shaft includes a lumen extending therethrough and an elongate manipulation member slidably disposed within said lumen, wherein said means for urging said atraumatic tip includes manipulating said cross member between said first and second orientations by manipulating said slidably disposed manipulation member.

11. A therapeutic catheter as recited in claim 1, wherein said means for penetrating said myocardium is selected from the group consisting of means for forming holes in said myocardium and means for injecting angiogenic substances into said myocardium.

12. A therapeutic catheter for increasing myocardial blood perfusion, having a longitudinal axis and comprising:

an inner shaft having a proximal region and a distal region;

a therapeutic tip disposed on said inner shaft distal region;

an outer shaft having a distal region and having said inner shaft disposed within; and

an atraumatic distal tip disposed proximate said outer shaft distal region, said atraumatic distal tip having said inner shaft distal region disposed within, said atraumatic distal tip having a first configuration having a first radial dimension and a second configuration having a second radial dimension greater than said first radial dimension, said atraumatic distal tip being sufficiently expandable to change from said first configuration to said second configuration in response to a proximally directed longitudinal force against said atraumatic tip, such that said tip is longitudinally foreshortened and radially expanded in response to being longitudinally forced against an obstacle.

13. A therapeutic catheter as recited in claim 12, wherein said inner shaft is slideably disposed within said outer shaft.

14. A therapeutic catheter as recited in claim 12, wherein said therapeutic tip is a sharp tip extending distally from said atraumatic tip when in said second configuration but remaining within said atraumatic tip when in said first configuration.

15. A therapeutic catheter as recited in claim 12, wherein said atraumatic tip has a bulbous shape and is formed of a polymeric material.

16. A therapeutic catheter as recited in claim 12, wherein said atraumatic tip has a distal orifice for receiving said therapeutic tip therethrough.

17. A therapeutic catheter as recited in claim 16, wherein said orifice exists before to being longitudinally forced against said obstacle.

18. A therapeutic catheter as recited in claim 16, wherein said orifice does not exist prior to being longitudinally forced against said obstacle an is formed by puncture of said inner shaft therapeutic tip.

19. A therapeutic catheter for increasing myocardial blood perfusion, having a longitudinal axis and comprising:

an inner shaft having a proximal region and a distal region;

a therapeutic tip disposed on said inner shaft distal region;

an outer shaft having a distal region and having said inner shaft disposed within; and

an atraumatic distal tip disposed proximate said outer shaft distal region, said atraumatic distal tip having said therapeutic tip disposed within, said atraumatic distal tip having a first, unconstrained configuration having a first radial dimension and a second, constrained configuration having a second radial dimension less than said first radial dimension, said atraumatic distal tip being sufficiently flexible and elastic to change from said first configuration to said second configuration in response to a being disposed within a third shaft having an inner diameter less than said first radial dimension, and to change from said second configuration to said first configuration in response to being freed from inside said third shaft.

20. A therapeutic catheter as recited in claim 19, wherein said inner shaft is slidably disposed within said outer shaft.

21. A therapeutic catheter as recited in claim 19, wherein said atraumatic distal tip includes an elastomeric flange.

22. A therapeutic catheter as recited in claim 19, wherein said atraumatic distal tip includes a plurality of discrete radially disposed arms.

23. A therapeutic catheter as recited in claim 19, wherein said atraumatic distal tip includes an elastomeric flange having a substantially continuous surface transverse distal surface.

24. A therapeutic catheter for increasing myocardial blood perfusion, having a longitudinal axis and comprising:

an inner shaft having a proximal region and a distal region;

a therapeutic tip disposed on said inner shaft distal region;

an outer shaft having a distal region, a distal end, and having said inner shaft disposed within;

an inflation lumen disposed within said outer shaft; and

an inflatable atraumatic distal stop disposed proximate said outer shaft distal region and proximal of said outer shaft distal end and having an interior in fluid communication with said inflation lumen, said atraumatic distal stop having a first configuration having a first radial dimension when uninflated and a second configuration having a second radial dimension when inflated, said second radial dimension being greater than said first radial dimension.

25. A therapeutic catheter as recited in claim 24, wherein said inner shaft is disposed within a first lumen within said outer shaft and said inflation lumen is a second lumen within said outer shaft and substantially parallel to said first lumen.

26. A therapeutic catheter as recited in claim 24, wherein said inflation lumen is defined between said inner and outer shafts.

27. A therapeutic catheter for increasing myocardial blood perfusion, having a longitudinal axis and comprising:

an outer elongate shaft having a longitudinal axis, a distal end, and a lumen therethrough;

an inner elongate shaft disposed within said outer shaft lumen and having a therapeutic distal tip;

a plurality of expandable members affixed to said outer shaft distal end, said expandable members having a first, unexpanded position having a first transverse profile and a second, expanded position having a second transverse profile greater than said first transverse profile; and

means for urging said expandable members from said first position to said second position.

28. A therapeutic catheter as recited in claim 27, wherein said means for urging said expandable members includes a means for biasing said members to expand to said second position when unconstrained.

30. A therapeutic catheter as recited in claim 28, further comprising means for urging said expanded members to said first position.

31. A therapeutic catheter as recited in claim 28, wherein said urging means includes retracting said expanded members into a third shaft lumen having a lumen inner diameter less than said expanded members transverse profile.

29. A therapeutic catheter as recited in claim as in 27, wherein said means for urging said expandable members includes forming said members of a shape memory material having said second position near body temperature.

32. A therapeutic catheter as recited in claim 29, further comprising means for urging said expanded members to said first position.

33. A therapeutic catheter as recited in claim 32, wherein said urging means includes retracting said expanded members into a third shaft lumen having a lumen inner diameter less than said expanded members transverse profile.

34. A therapeutic catheter for increasing myocardial blood perfusion, having a longitudinal axis and comprising:

a first, outer shaft having a first lumen therethrough, a distal region, a distal end region distal of said distal region, and a distal most end distal of said distal end region, said distal end region being weaker in compression than said distal region, said distal end region having a first transverse profile when not in compression and a second transverse profile when in compression, said second profile being greater than said first profile; and

a second, inner shaft disposed within said first lumen and having a distal end secured to said first shaft distal most region, such that retracting said inner shaft proximally retracts said first shaft distal most end and compresses said distal region to increase said transverse profile from said first position to said second position.

35. A therapeutic catheter as recited in claim 34, wherein said distal end region has a length and includes longitudinal slots for weakening said distal end region, said slots forming longitudinal wings therebetween, such that said wings expand radially in compression, forming a greater profile in said second position than in said first position and forming a shorter distal end region length in said second position than in said first position.

36. A therapeutic catheter for increasing myocardial blood perfusion, having a longitudinal axis and transverse planes transverse to said longitudinal axis, comprising:

a shaft having a proximal region and a distal region;

a therapeutic tip disposed on said shaft distal region and having means for penetrating said myocardium; and

an atraumatic distal tip disposed proximate said shaft distal region, said atraumatic distal tip having a first configuration having a first transverse profile and a second configuration having a second transverse profile greater than said first transverse profile.

37. A therapeutic catheter for increasing myocardial blood perfusion as in claim 36, wherein said atraumatic distal tip is sufficiently expandable to change from said first configuration to said second configuration in response to a proximally directed longitudinal force against said atraumatic tip, such that said atraumatic tip is longitudinally foreshortened and radially expanded in response to being longitudinally forced against an obstacle.

38. A therapeutic catheter as recited in claim 37, wherein said atraumatic tip has a bulbous shape and is formed of a polymeric material.

39. A therapeutic catheter for increasing myocardial blood perfusion as in claim 36, wherein said atraumatic distal tip being sufficiently flexible and elastic to change from said second configuration to said first configuration in response to a being disposed within a second shaft having an inner transverse profile less than said atraumatic tip second transverse profile, and to change from said first configuration to said second configuration in response to being freed from inside said second shaft.

40. A therapeutic catheter for increasing myocardial blood perfusion as in claim 39, wherein said atraumatic distal tip includes an elastomeric flange.

41. A therapeutic catheter for increasing myocardial blood perfusion as in claim 36, wherein said atraumatic distal tip includes an elastically coiled spring coiled about said shaft, said coiled spring being sufficiently elastic to change from said second configuration to said first configuration in response to a being disposed within a second shaft having an inner transverse profile less than said second transverse profile, and to change from said first configuration to said second configuration in response to being freed from inside said second shaft.

42. A therapeutic catheter for increasing myocardial blood perfusion as in claim 41, wherein said coil is a helical coil.