Anti-stenotic method and product for occluded and partially occluded arteries

• US 5,865,844 A
• Filed: 10/26/1995
• Issued: 02/02/1999
• Est. Priority Date: 08/18/1989
• Status: Expired due to Fees

• Current Assignee: Synectic Ventures III LLC (Synectic Asset Management, Inc.), Synectic Ventures II LLC (Synectic Asset Management, Inc.), Synectic Ventures I LLC (Synectic Asset Management, Inc.)
• Original Assignee: Endovascular Instruments, Inc.
• Inventors: Reger, Vincent A., Plaia, Mark, Nordgren, Gregory N.
• Primary Examiner(s): Clarke, Robert A.
• Application Number:
  US08/548,569
• Time in Patent Office: 1,195 Days
• Field of Search: 623/1, 623/11, 623/12, 604/8, 606/169, 606/170, 606/194, 606/195, 606/198
• US Class Current: 606/159
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• 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 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: Y10S 623/902 : Method of implanting

Abstract

Methods of artificially lining a vessel, especially an artery, of a medical patient to address the existence of a flow-inhibiting atheroma and to significantly alleviate the probability of restenosis, and the resulting products.

Claims

1. A continuous method of treating an artery, comprising the steps of:

separating material comprising plaque from other material within a segment of an artery using no less than a first instrument;

placing a vascular graft at a location within the artery comprising the separating site using no less than a second instrument;

securing the vascular graft as a lining within said artery at the placing site.

2. A method according to claim 1 comprising the step of surgically accessing the artery prior to the separating step.

3. A method according to claim 2 comprising the step of surgically closing an artery access following the securing step.

4. A method according to claim 1 further comprising the step of performing an arteriotomy to access to the artery.

5. A method according to claim 4 wherein the accessing step comprises percutaneously using a needle.

6. A method according to claim 1 wherein the separating step comprises performing an endarterectomy.

7. A method according to claim 1 wherein the separating step comprises separating atheromatous and arterial material from other arterial wall material along an arterial interface of weakness and pulling the separated atheromatous and arterial material from the artery through a site of surgical access.

8. A method according to claim 7 wherein the step of separating atheromatous and arterial material comprises first axially parting and thereafter grasping at least one piece of atheromatous and arterial material and pulling thereon causing the piece to be removed along a natural interface of weakness.

9. A method according to claim 7 wherein the step of separating atheromatous and arterial material comprises bluntly dissecting along the natural interface of weakness.

10. A method according to claim 1 wherein the placing step comprises displacing the vascular graft through a surgical access site under control of the second instrument.

11. A method according to claim 1 wherein the placing step comprises inserting a sheath into the artery, advancing the vascular graft through the sheath into the artery and removing the sheath from the artery.

12. A method according to claim 1 wherein the securing step comprises radially expanding the vascular graft while at the placing site within the artery.

13. A method according to claim 12 wherein the expanding step comprises mechanically spreading the vascular graft.

14. A method according to claim 1 wherein the securing step comprises expanding a stent connected to, advanced with, and disposed within the vascular graft at each of the proximal and distal ends of the vascular graft and the separating step comprises axially separating and thereafter grasping and tearing pieces of plaque from the artery.

15. A method according to claim 1 wherein the securing step comprises expanding a stent connected to, advanced with, and disposed within the vascular graft at each of the proximal and distal ends of the vascular graft.

16. A method according to claim 1 wherein the separating step is preceded by passing a guide wire through the segment of the artery.

17. A method according to claim 16 wherein the passing step comprises first advancing no less than a third instrument into the plaque segment to be separated to create a guide wire receiving passageway therein.

18. A method according to claim 1 wherein the placing step comprises using a balloon catheter as the second instrument to hold the vascular graft and the securing step comprises diametrally expanding the graft by inflating the balloon inside the vascular graft.

19. A method of treating an artery, comprising the steps of:

enlarging the flow path size of a plaque-ridden segment of an artery by performing an atherectomy, in whole or in part and/or an endarterectomy, in whole or in part;

immediately after the enlarging step, placing a vascular lining in a diametrally small state within the artery by grasping the lining with an insertion instrument to position the graft at least in part co-extensive with a portion of the segment;

releasing the graft from the grasp of the insertion instrument;

removing the insertion instrument;

diametrally expanding the graft;

securing the expanded vascular graft within said artery at said location.

20. A method according to claim 19 wherein the enlarging step comprises expanding the flow path within the artery by performing an angioplasty followed by performance of the atherectomy and/or endarterectomy.

21. A method according to claim 19 wherein the enlarging step comprises loosening plaque followed by performance of the atherectomy and/or endarterectomy.

22. A method according to claim 19 wherein the enlarging step comprises cutting plaque.

23. A method according to claim 19 wherein the enlarging step comprises chipping plaque.

24. A method according to claim 19 wherein the enlarging step comprises grinding plaque.

25. A method according to claim 19 wherein the enlarging step comprises applying laser energy to the plaque.

26. A method according to claim 19 wherein the enlarging step comprises separating and removing both plaque and a portion of the interior of the artery as one or more pieces.

27. A method according to claim 19 wherein the enlarging step comprises first axially parting the segment from the remaining artery at least in part followed by excising plaque from the artery as elongated units.

28. A method of enlarging the lumen of an artery comprising the steps of:

parting first material from second material in an arterial segment using an endarterotome, an atherotome, a Hall loop, a ring dissector, a Scanlon endarsector, an arterial stripper, a laser and/or ultrasonics;

placing a vascular graft within the segment of the arterial segment as a lining by tethering the graft to a graft-seizing instrument;

untethering the graft from the graft seizing instrument and removing the instrument;

thereafter connecting the vascular graft to tissue within the segment using suturing, stapling and/or a stent.

29. A method of treating a vessel, comprising the steps of:

removing plaque and the like from a length of the vessel;

inserting a graft through a man-made access route into the vessel under control of a graft-engaging instrument releasibly holding the graft;

displacing the graft along the vessel to the plaque removal site under control of the engaging instrument releasibly grasping the graft;

releasing the graft from the engaging instrument at the site;

causing the graft to be contiguously secured to the vessel at the site.

30. A method according to claim 29 further comprising holding the graft with another instrument during at least part of the causing step.

31. A method of treating a vessel comprising the steps of:

anti-stenotically treating a segment of the vessel so as to reduce the quantity of interior plaque at the segment using only one small arteriotomy site;

introducing through the one small arteriotomy site a vascular graft and an instrument coupled to and controlling intravascular displacement of the graft into the vessel;

placing the vascular graft and coupled instrument at the treated segment of the vessel;

uncoupling the vascular graft from the instrument;

removing the instrument from the vessel through said one arteriotomy site;

causing adherence between the vascular graft and the interior of the vessel at the treated segment.

32. A method according to claim 31 further comprising the step of placing a guide wire through the one arteriotomy site and into the vessel.

33. A method according to claim 32 wherein the placing step is preceded by the step of clearing a path through an occluded portion of the vessel.

34. A method according to claim 33 wherein the clearing step is practiced using an instrument selected from the group consisting of a dynamic wire guide and a dynamic disrupter.

35. A method according to claim 31 wherein the anti-stenotic treating step comprises performing an atherectomy, in whole or in part.

36. A method according to claim 31 wherein the anti-stenotic treating step comprises performing an atherectomy, in whole or in part, using an instrument selected from the group consisting of an atherome cutter, a Simpson atherocath, a rotablator, and a Kinsey device.

37. A method according to claim 31 wherein the anti-stenotic treating step comprises performing an atherectomy, in whole or in part, using an instrument selected from the group consisting of a laser instrument, an ultrasonics instrument and an extraction catheter.

38. A method according to claim 31 wherein the anti-stenotic treating step comprises performing an endarterectomy, in whole or in part.

39. A method according to claim 38 wherein the performing of the endarterectomy step comprises removal of a section of intima.

40. A method according to claim 38 wherein the performing of the endarterectomy step comprises removal of a section comprising intima and media.

41. A method according to claim 31 wherein the anti-stenotic treating step comprises performing an endarterectomy, in whole or in part, using an instrument selected from the group consisting of a Hall loop, a Scanlan endarsector, forceps, and an expandable cutter.

42. A method according to claim 31 wherein the anti-stenotic treating step comprises axially separating pieces of atheromatous and arterial material from other arterial material along an interface of weakness and pulling the pieces from the artery through one arteriotomy site.

43. A method according to claim 31 further comprising the step of providing a Dacron sleeve graft.

44. A method according to claim 31 further comprising the step of providing an expanded PTFE sleeve graft.

45. A method according to claim 31 further comprising the step of providing a natural vein graft.

46. A method according to claim 31 further comprising the step of providing a graft comprising synthetic ingrowth material.

47. A method according to claim 31 further comprising the step of providing a sleeve graft comprising synthetic resinous material equipped with at least one position-sustaining stent.

48. A method according to claim 31 further comprising the step of providing a natural vein graft equipped with at least one position-sustaining stent.

49. A method according to claim 31 comprising the step of placing a hollow tubular member at the one arteriotomy site and conducting the displacing and removing steps through the tubular member.

50. A method of treating a vessel comprising a vein or artery comprising the steps of:

anti-stenotically reducing the quantity of plaque in a predetermined segment of the vessel by axial severing and removal;

coupling a vascular graft to an insertion instrument;

displacing the graft along the vessel to the segment under control of the insertion instrument;

uncoupling the instrument;

contiguously securing the graft to segment.

51. A method of treating a plaque-bearing vessel, comprising the steps of:

removing plaque from a predetermined segment of vessel to enlarge the flow path size thereof;

placing a vascular lining at a location within the vessel at the segment under control of an instrument by which the lining is controllably and releasibly engaged;

securing the vascular lining to the inside of the vessel at said location separate from the instrument.

52. A method of treating a vessel, comprising the steps of:

treating the flow path interior of a segment of the vessel by removing plaque therefrom;

placing a vascular graft, under control of a graft-gripping device, at a location within the vessel at the segment;

securing the vascular graft to the inside of the vessel at said location free from the gripping device.

53. A method of treating a vessel, comprising the steps of:

removing plaque from the vessel;

grabbing a vascular graft with a clamping device;

introducing the vascular graft into the interior of the vessel under control of the clamping device;

placing the vascular graft within the vessel at a predetermined internal site;

causing adherence between the vascular graft and the interior of the vessel at the site free of the clamping device.

54. A method of treating a vessel, comprising the steps of:

creating a man-made passageway into an interior of the vessel;

removing plaque from the interior of the vessel using the passageway;

introducing a graft and a graft-coupling instrument into the vessel through the passageway;

displacing the graft and the instrument to a predetermined site within the interior of the vessel comprising the location where plaque was removed;

adhering the graft to the interior of the vessel at the site;

removing the instrument from the vessel through the passageway.

55. A method according to claim 54 wherein the removing, introducing, and displacing steps are performed using a guide wire.

56. A method according to claim 54 wherein the introducing step is preceded by the step of temporarily suturing the graft to the instrument.

57. A method according to claim 54 comprising the step of radially collapsing the graft and coupling the graft to the instrument before the introducing step and the step of radially expanding the collapsed graft during the adhering step.

58. A method of treating a vessel comprising the steps of:

anti-stenotically treating a segment of the vessel using a first instrument inserted through one arteriotomy site so as to reduce plaque at the segment;

introducing through one arteriotomy site a vascular graft gripped by a second instrument;

controlling intravascular displacement of the graft along the vessel to the treated segment by manipulation of the second instrument;

eliminating the grip between the vascular graft and the second instrument;

removing the second instrument from the vessel and through said one arteriotomy site;

deploying the graft into adherence between the vascular graft and the interior of the vessel at the treated segment using a third instrument introduced into and later removed from the vessel through the one arteriotomy site.

59. A method of treating a vessel comprising the steps of:

anti-stenotically treating a segment of the vessel using no more invasiveness than two arteriotomy sites so as to reduce plaque at the segment;

introducing through one arteriotomy site a vascular graft carried by a mandrel to which the graft is temporarily attached;

controlling intravascular displacement of the graft along the vessel to the treated segment by the manipulation of the mandrel;

detaching the vascular graft from the mandrel;

removing the mandrel from the vessel through said one arteriotomy site;

causing adherence between the vascular graft and the interior of the vessel at the treated segment.

60. A method of treating an artery, comprising the steps of:

parting and removing plaque from within a segment of an artery through a surgical access site;

placing a vascular graft at a location within and as an internal lining for the artery at least co-extensive with the segment by displacing the vascular graft through the surgical access site by releasibly coupling an insertion device to the graft;

securing the vascular graft within said artery at said location.

61. A method of treating an artery, comprising the steps of:

removing plaque from within a segment of an artery through a surgical access site;

placing a vascular graft at a location within and as an internal lining for the artery at least co-extensive with the segment by displacing the vascular graft through the surgical access site by releasibly clamping an insertion device to the graft;

securing the vascular graft within said artery at said location.

62. A method of treating an artery, comprising the steps of:

reducing the quantity of plaque from within a segment of an artery;

placing a vascular graft at a location within and as an internal lining for the artery at least co-extensive with the segment by displacing the vascular graft through a surgical access site using a grasping instrument to releasibly grasp the vascular graft;

securing the vascular graft within said artery at said location.

63. A method of treating an artery, comprising the steps of:

reducing the quantity of plaque from within a segment of an artery;

placing a vascular graft at a location within and as an internal lining for the artery at least co-extensive with the segment by suturing a distal end of the vascular graft to a mandrel, advancing the mandrel and the vascular graft collectively into the artery, unsuturing the vascular graft from the mandrel and removing the mandrel from the artery;

securing the vascular graft within said artery at said location.

64. A method of treating an artery, comprising the steps of:

eliminating at least some plaque from within a segment of an artery;

placing a vascular graft at a location within and as an internal lining for the artery at least partially co-extensive with the segment by displacing the vascular graft through a surgical access site using a forceps to grasp a distal end of the vascular graft;

securing the vascular graft within said artery at said location.

65. A method of treating an artery, comprising the steps of:

reducing the quantity of plaque from within a segment of artery;

placing a vascular graft at a location within and as an internal lining for the artery at least co-extensive with the segment by displacing the vascular graft through a surgical access site;

securing the vascular graft within said artery at said location.