Vascular lumen debulking catheters and methods

• US 7,927,784 B2
• Filed: 01/10/2006
• Issued: 04/19/2011
• Est. Priority Date: 12/20/2000
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: ev3 (Medtronic Plc)
• Inventors: Simpson, John B.
• Primary Examiner(s): Ford; Allison M
• Application Number:
  US11/328,453
• Publication Number:
  US 20060239982A1
• Time in Patent Office: 1,925 Days
• Field of Search: None
• US Class Current: 435/1.1
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records

Abstract

A debulking catheter comprising a tissue debulking assembly for removing a continuous strand of material from a body lumen. Catheters of the present invention generally include a catheter body having proximal and distal portions and a tissue debulking assembly disposed at least partially within the distal portion. The tissue debulking assembly is radially movable to expose at least a portion of the assembly through a window on the catheter body. The catheter is advanced transluminally through the body lumen to contact material in the body lumen and remove a plane of continuous material that has a length that is typically longer than a length of the window on the catheter. The continuous material may be directed into a collection chamber. Thereafter, the material may be removed from the collection chamber and preserved or tested.

Claims

1. A composition, the composition comprising vascular tissue that has been excised in vivo from a subject, wherein the vascular tissue comprises at least one continuous strand of tissue that is removed from an interior wall of a vascular lumen in a living human body, wherein the continuous strand of tissue retains the in vivo structure of the tissue prior to its removal and is at least 2 cm in length along an axis of the vascular lumen.

2. The composition of claim 1 wherein the continuous strand of vascular tissue comprises 5 cm or greater in length.

3. The composition of claim 1 wherein the continuous strand of vascular tissue comprises 7 cm or greater in length.

4. The composition of claim 1 wherein the continuous strand of vascular tissue comprises 10 cm or greater in length.

5. The composition of claim 1 wherein the continuous strand of vascular tissue comprises 15 cm or greater in length.

6. The composition of claim 1 which comprises a plurality of continuous strands.

7. The composition of claim 6, wherein the plurality of strands are collected from a single vascular lumen.

8. The composition of claim 6, wherein the plurality of strands are collected from a single vascular atheroma or plaque.

9. The composition of claim 1 wherein the continuous strand has a mass per length of at least 0.45 mg/mm.

10. The composition of claim 1 wherein the continuous strand has a mass per length of at least 0.50 mg/mm.

11. The composition of claim 1 wherein the continuous strand has a mass per length of at least 0.60 mg/mm.

12. The composition of claim 1 wherein the continuous strand has a mass per length of at least 0.65 mg/mm.

13. The composition of claim 1 wherein the continuous strand has a mass per length of at least 0.70 mg/mm.

14. The composition of claim 1, wherein the vascular tissue comprises tissue excised from the coronary artery.

15. The composition of claim 1, wherein the composition is preserved in such a manner that the vascular tissue retains its in vivo structure.

16. A composition comprising vascular tissue that has been excised in vivo from a subject, wherein the vascular tissue comprises at least one continuous strand of tissue that is removed from an interior wall of a vascular lumen in a living human body, wherein the continuous strand of tissue retains the structure of the tissue prior to its removal, is at least 2 cm in length along an axis of the vascular lumen, and has a depth of at least 0.1 mm, wherein depth is a dimension which is radial to an axis of the lumen.

17. The composition of claim 16 wherein the continuous strand has a depth of at least 0.25 mm wherein depth is a dimension which is radial to the axis of the lumen.

18. The composition of claim 16 wherein the continuous strand has a depth of at least 0.33 mm wherein depth is a dimension which is radial to the axis of the lumen.

19. The composition of claim 16 wherein the continuous strand has a depth of at least 0.5 mm wherein depth is a dimension which is radial to the axis of the lumen.

20. The composition of claim 16 which comprises a plurality of continuous strands.

21. The composition of claim 20, wherein the plurality of strands are collected from a single vascular lumen.

22. The composition of claim 20, wherein the plurality of strands are collected from a single vascular atheroma or plaque.

23. The composition of claim 16 wherein the continuous strand has a mass per length of at least 0.45 mg/mm.

24. The composition of claim 16 wherein the continuous strand has a mass per length of at least 0.50 mg/mm.

25. The composition of claim 16 wherein the continuous strand has a mass per length of at least 0.60 mg/mm.

26. The composition of claim 16 wherein the continuous strand has a mass per length of at least 0.65 mg/mm.

27. The composition of claim 16 wherein the continuous strand has a mass per length of at least 0.70 mg/mm.

28. The composition of claim 16, wherein the vascular tissue comprises tissue excised from the coronary artery.

29. The composition of claim 16, wherein the composition is preserved in such a manner that the vascular tissue retains its in vivo structure.

30. A composition of excised vascular tissue comprising at least one continuous strand of tissue that is removed from a vascular lumen in a living human body, wherein the tissue is removed by

providing a catheter;

inserting the catheter into an unhealthy region of a vascular lumen of the living human body;

advancing the catheter within the vascular lumen in such a manner so as to excise vascular tissue there from to produce excised vascular tissue; and

preserving the excised vascular tissue;

wherein the excised vascular tissue comprises a continuous strand of tissue that retains the in vivo structure of the tissue prior to its removal from the living human body, has a length of at least 2 cm along the axis of vascular lumen, and further comprises both plaque and diseased tissue.

31. The composition of claim 30 wherein the continuous strand has a mass per length of at least 0.50 mg/mm.

32. The composition of claim 30 wherein the continuous strand has a mass per length of at least 0.55 mg/mm.

33. The composition of claim 30 wherein the continuous strand has a mass per length of at least 0.60 mg/mm.

34. The composition of claim 30 wherein the continuous strand has a mass per length of at least 0.65 mg/mm.

35. The composition of claim 30 wherein the continuous strand has a mass per length of at least 0.70 mg/mm.

36. The composition of claim 30 which comprises a plurality of continuous strands.

37. The composition of claim 30 wherein the plurality of strands are collected from a single vascular lumen.

38. The composition of claim 30 wherein the plurality of strands are collected from a single vascular atheroma or plaque.

39. The composition of claim 30, wherein the vascular tissue comprises tissue excised from the coronary artery.

40. A composition, the composition comprising vascular tissue that has been excised in vivo from a subject, wherein the vascular tissue has a first depth and being debulked from an interior wall of a vascular lumen having a second depth, wherein the depth of the excised vascular tissue is less than the depth of the wall of the vascular lumen, and wherein the vascular tissue comprises at least one continuous strand of tissue having a length of at least 2 cm along the axis of the vascular lumen.

41. The composition of claim 40, wherein the excised vascular tissue reflects the structural integrity of an in vivo tissue of the vascular lumen.

42. The composition of claim 41, wherein the excised vascular tissue has a depth selected from the group consisting of at least 0.1 mm, at least 0.25 mm, at least 0.33 mm, and at least 0.5 mm.

43. The composition of claim 40, wherein the excised vascular tissue was debulked from an interior wall of a vascular lumen in a body by use of a catheter,

wherein the catheter comprises a catheter body, wherein the catheter body comprises:

(a) a proximal portion and a distal portion, wherein the distal portion is deflectable with respect to the proximal portion and the distal portion further comprises a window,

(b) a tissue debulking assembly comprising a tissue cutter, wherein the tissue debulking assembly is configured for being exposed through the window when the distal portion is deflected with respect to the proximal portion, and

(c) a collection chamber positioned relative to the window such that the window opens up into the collection chamber;

and wherein the excised vascular tissue comprises at least one continuous strand of tissue which continuous strand of tissue is at least 2 cm in length along an axis of the vascular lumen.

44. The composition of claim 43, wherein the excised vascular tissue further comprises diseased tissue excised from an unhealthy region of the vascular lumen.

45. A library comprising a plurality of systematically archived samples, wherein the samples comprise vascular tissue that has been excised in vivo from a subject, each sample containing at least one continuous strand of tissue that is removed from a vascular lumen in a living human body, wherein the continuous strand retains the in vivo structure of the tissue prior to its removal and is at least 2 cm in length along an axis of the vascular lumen.

46. The library of claim 45 wherein the samples are preserved so as to maintain the continuous strand intact.

47. The library of claim 45 wherein the samples are maintained in liquid nitrogen.

48. The library of claim 45 wherein the samples are maintained in paraffin.

49. The library of claim 45 wherein clinical information regarding patients from whom the samples were excised is maintained with the library.

50. The library of claim 45, wherein the vascular tissue further comprises diseased tissue excised from an unhealthy region of the vascular lumen.