Vulnerable plaque modification methods and apparatuses

• US 20060135985A1
• Filed: 12/21/2004
• Published: 06/22/2006
• Est. Priority Date: 12/21/2004
• Status: Abandoned Application

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Tannier, Alan, Kleine, Klaus, Cox, Daniel L., Ellis, Jeffrey T., Lee, Jeong S.
• Application Number:
  US11/022,548
• Publication Number:
  US 20060135985A1
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 2017/22081 Treatment of vulnerable plaque
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1072 : having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A method including introducing an expandable body into a blood vessel at a point coextensive with a vulnerable plaque lesion, and expanding the expandable body from a first diameter to a different second diameter sufficient to modify the shape of an inner diameter of the blood vessel at the point coextensive with the lesion without rupturing the lesion. An apparatus including a cannula having a dimension suitable for insertion into a blood vessel and including an expandable body coupled thereto, the expandable body including a first outer diameter suitable for insertion through the blood vessel and a second outer diameter greater than the first diameter and having a maximum dimension to modify the shape of an inner diameter of the blood vessel and retain a same perimeter. A kit including a cannula including an expandable body and a stent. An expandable framework comprising a polymer material. An apparatus including an expandable body.

Claims

1. A method comprising:

introducing an expandable body into a blood vessel at a point coextensive with a vulnerable plaque lesion; and

expanding the expandable body from a first diameter to a different second diameter sufficient to modify the shape of an inner diameter of the blood vessel at the point coextensive with the lesion without rupturing the lesion.

2. The method of claim 1, wherein one of a shape of an inner diameter of the blood vessel is modified from a non-circular shape to a shape approaching that of a circle.

3. The method of claim 1, further comprising at least one of:

introducing a detectable agent into the blood vessel and wherein expanding comprises expanding the expandable body until the detectable agent is not detectable at a point between the expandable body and the lesion;

introducing a stent into the vessel on the expandable body and deploying the stent within the vessel.

4. The method of claim 3, wherein the method further comprises introducing a detectable agent and wherein at least one of:

the detectable agent is a radiopaque contrast agent; and

introducing a second expandable body distal to the lesion and prior to introducing the detectable agent, expanding the second expandable body to a dimension sufficient to occlude the blood vessel.

5. The method of claim 3, wherein the stent comprises a first expansion characteristic and a second different expansion characteristic, wherein the method comprises:

aligning that portion of the stent with the first expansion characteristic within the vessel corresponding to the point co-extensive with the lesion;

aligning that portion of the stent with the second expansion characteristic within the vessel adjacent to the lesion; and

expanding that portion of the stent with the second expansion characteristic to a diameter corresponding to an interior diameter of the vessel.

6. The method of claim 5, wherein that portion of the stent with the second expansion characteristic is expanded before that portion of the stent with the first expansion characteristic.

7. The method of claim 5, further comprising:

introducing a third expandable body proximal to the first expandable body.

8. A method comprising:

introducing a catheter comprising an expandable body having a first portion bounded by a second portion and a third portion into a blood vessel comprising a vulnerable plaque lesion, wherein the first portion is introduced at a point coextensive with a vulnerable plaque lesion; and

expanding the second portion and the third portion of the expandable body to a diameter greater than a diameter of the first portion.

9. The method of claim 8, wherein one of:

expanding comprises expanding the first portion of the expandable body from a first diameter to a different second diameter sufficient to modify the shape of an inner diameter of the blood vessel and retain a comparable perimeter; and

expanding the first portion independent of the expansion of the second portion and the third portion.

10. The method of claim 8, further comprising:

introducing a stent into the vessel on the expandable body; and

deploying the stent within the vessel.

11. The method of claim 10, wherein the second portion of the expandable body is proximal to the first portion and each of the second portion and the third portion of the expandable body comprises a proximal section and a distal section, and expanding comprises:

expanding the distal section of the second portion of the expandable body at a faster rate than the proximal section; and

expanding the proximal section of the third portion of the expandable body at a faster rate than the distal section.

12. The method of claim 11, wherein the stent comprises a first expansion characteristic and a second different expansion characteristic, wherein the method comprises:

aligning that portion of the stent with the first expansion characteristic within the vessel corresponding to the point coextensive with the lesion;

aligning that portion of the stent with the second expansion characteristic within the vessel adjacent to the lesion; and

expanding that portion of the stent with the second expansion characteristic to a diameter corresponding to an interior diameter of the vessel.

13. A method comprising:

introducing a catheter comprising an expandable body having a first portion bounded by a second portion and a third portion into a blood vessel comprising a vulnerable plaque lesion, wherein the first portion is introduced at a point coextensive with a vulnerable plaque lesion;

introducing a stent on the expandable body, the stent comprising a portion overlying the first portion of the expandable body; and

expanding the second portion and the third portion of the expandable body to a diameter greater than a diameter of the first portion and sufficient to introduce a tensile stress on the portion of the stent overlying the first portion of the expandable body.

14. The method of claim 13, wherein each of the second portion and the third portion comprise a working length including a proximal end and a distal end,

wherein the stent overlies the second portion and the third portion,

wherein introducing the catheter comprises introducing the second portion at a point distal to the lesion and the first portion at a point proximal to the lesion, and

wherein expanding comprises expanding the proximal end of the second portion of the expandable body to a diameter different than the distal end, and expanding the distal end of the third portion to a diameter different than the proximal end.

15. The method of claim 14, wherein a modification in an expansion characteristic of the stent across its length achieves an expansion difference between the proximal portion and the distal portion of each of the second portion and the third portion of the expandable body.

16. The method of claim 13, wherein expanding increases a diameter of the portion of the stent overlying the first portion of the expandable body.

17. The method of claim 16, wherein the diameter of the portion of the stent overlying the first portion of the expandable body comprises a proximal portion and a distal portion having a diameter greater than a medial portion.

18. The method of claim 17, wherein, following expanding, the medial portion of the stent contacts the lesion.

19. The method claim 14, wherein the second portion is at a point in the blood vessel distal to the lesion and the third portion is at a point in the blood vessel proximal to the lesion and expanding the second portion and the third portion to different diameters at respective proximal and distal ends comprises an initial expanding, the method further comprising:

following the initial expanding, subsequently expanding the distal end of the second portion and the proximal end of the third portion to a diameter sufficient to anchor the stent to the blood vessel.

20. A method comprising:

introducing a catheter comprising an expandable body having a working length into a blood vessel comprising a vulnerable plaque lesion, wherein the expandable body is at a point coextensive with a vulnerable plaque lesion; and

expanding the expandable body to a variable diameter along the working length such that at a point coextensive with the lesion the working length has a smallest diameter.

21. The method of claim 20, wherein at least one of:

the working length of the expandable body has a variable expansion property;

the working length of the expandable body is greater than a length dimension of the lesion within the blood vessel and the expandable body is at a point in the blood vessel proximal and distal to the lesion; and

a stent overlies the working length of the expandable body and an expansion property of the stent contributes to the variable diameter to which the expandable body is expanded.

22. An apparatus comprising:

a cannula having a dimension suitable for insertion into a blood vessel and an expandable body coupled thereto, the expandable body comprising a first outer diameter suitable for insertion through the blood vessel and a second outer diameter greater than the first diameter and having a maximum dimension to modify the shape of an inner diameter of the blood vessel and retain a similar perimeter.

23. The apparatus of claim 22, wherein the expandable body comprises a balloon of a material having a compliance greater than a compliance of an angioplasty balloon.

24. The apparatus of claim 23, wherein the balloon comprises a nominal pressure of less than five atmospheres.

25. The apparatus of claim 22, wherein the expandable body comprises a first expandable body, the apparatus further comprising a second expandable body coupled to the cannula at a point distal to the first expandable body, wherein the second expandable body comprises a first outer diameter suitable for insertion through the blood vessel and a second outer diameter greater than the second diameter of the first expandable body.

26. The apparatus of claim 25, wherein the cannula has a length suitable to locate the second expandable body in a blood vessel beyond a vulnerable plaque lesion.

27. The apparatus of claim 26, wherein at least one of:

the first expandable body has a length dimension corresponding to a length dimension of a vulnerable plaque lesion; and

the first expandable body and the second expandable body each comprise a balloon and the balloon of the first expandable body comprises a material having a compliance greater than a compliance of a material of the second expandable body.

28. The apparatus of claim 27, wherein the compliance of the material of the second expandable body is similar to a compliance of an angioplasty balloon,

wherein each of the first portion, the second portion, and the third portion of the expandable body comprises an expansion lumen and an expansion lumen of the first portion is isolated from an expansion lumen of the second portion and the third portion.

29. The apparatus of claim 22, wherein at a distal portion of the cannula, the expandable body is wound around the cannula such that a spacing between adjacent windings is at least as large as a projected length of a vulnerable plaque within the blood vessel.

30. A kit comprising:

a cannula having a dimension suitable for insertion into a blood vessel and comprising an expandable body coupled thereto, the expandable body comprising a first outer diameter suitable for insertion through the blood vessel and a second outer diameter greater than the first diameter and the second diameter has a maximum dimension to modify the shape of an inner diameter of the blood vessel and retain a same perimeter; and

a stent having a diameter suitable for deployment on the expandable body through a blood vessel.

31. The kit of claim 30, wherein the expandable body comprises a first expandable body, the apparatus further comprising a second expandable body coupled to the cannula at a point distal to the first expandable body, wherein the second expandable body comprises a first outer diameter suitable for insertion through the blood vessel and a second outer diameter greater than the second diameter of the first expandable body and wherein the stent comprises a length corresponding to a working length of the first expandable body.

32. The kit of claim 31, wherein the stent comprises a first portion having a length corresponding to a length of the first expandable body and second portion extending over a portion of the second expandable body, wherein the second portion has an expansion characteristic different from an expansion characteristic of the first portion.

33. The kit of claim 32, wherein the expansion characteristic of the second portion of the stent has a greater tendency to expand than the expansion characteristic of the first portion.

34. The kit of claim 33, wherein the first expandable body and the second expandable body each comprise a balloon and the balloon of the first expandable body comprises a material having a compliance greater than a compliance of a material of the second expandable body.

35. The kit of claim 30, wherein at a distal portion of the cannula, the expandable body is spiraled around the cannula such that a spacing between adjacent peaks of the expandable body is at least as large as a projected length of a vulnerable plaque within the blood vessel.

36. An apparatus comprising:

an expandable framework having an expanded diameter suitable for placement in a blood vessel and comprising a first end and a second end and a polymeric material disposed between the first end and the second end and defining a lumen therethrough.

37. The apparatus of claim 36, wherein the framework comprises a plurality of circumferentially disposed rings disposed a distance from one another, wherein each of the plurality of rings comprises a plurality of struts.

38. The apparatus of claim 37, wherein at least one of:

the first end comprises a first circumferentially disposed ring comprising a metal material;

the second end comprises a second circumferentially disposed ring comprising a metal material;

the polymeric material encapsulates the metal material; and

the polymeric material is patterned into a framework comprising at least one of struts and suspension elements.

39. The apparatus of claim 36, wherein the polymeric material comprises a non-bioerodable polymeric material.

40. The apparatus of claim 39, wherein a portion of the polymeric material comprises one of a drug and a cellular component.

41. The apparatus of claim 40, wherein the one of the drug and the cellular component is coated on a surface of the polymeric material.

42. The apparatus of claim 37, wherein the polymeric material comprises a mesh or weave overlying the metal material.

43. An apparatus comprising:

an expandable body having a diameter suitable for insertion into a blood vessel and capable of being modified from a first folded diameter to a second larger unfolded diameter in response to an inflation pressure less than two atmospheres and, following modification, being non-compliant at an inflation pressure less than two atmospheres.

44. The apparatus of claim 43, wherein at least one of:

in an unfolded state a diameter of the expandable body approximates a diameter of the blood vessel; and

the expandable body comprises a polymer having one of a two percent secant modulus less than 60,000 psi or a flexural modulus less than 36,000 psi.

45. The apparatus of claim 43, further comprising a cannula shaft wherein the expandable body is coupled to the cannula shaft.

46. An apparatus comprising:

an expandable body having a diameter suitable for insertion into a blood vessel and capable of being modified from a first diameter to a second larger diameter in response to an inflation pressure, wherein the second diameter is less than an inside diameter of the blood vessel and, following modification, being less compliant at an increased inflation pressure.

47. The apparatus of claim 46, further comprising a cannula shaft wherein the expandable body is coupled to the cannula shaft.

48. An apparatus comprising:

a balloon expandable intralumenal framework comprising a first end and a second end defining a length dimension longer than a length of a vulnerable plaque, the framework comprising axially-oriented anchor portions at the first end and the second end capable of anchoring to a blood vessel and supporting a medial portion between the ends without anchoring the medial portion to the blood vessel.

49. The apparatus of claim 48, wherein at least one of:

in an expanded state, the first end has a first diameter and the medial portion has a variable diameter that is less than or equal to the first diameter across its length;

an expansion of the medial portion depends on the expansion of the anchor portions; and

an expansion of the anchor portions from a first diameter to a larger second diameter increases a tensile strain on the medial portion.