Vessel remodeling methods and devices for use in a graft device

• US 9,579,224 B2
• Filed: 07/24/2012
• Issued: 02/28/2017
• Est. Priority Date: 07/25/2011
• Status: Active Grant

• Current Assignee: Xeltis AG (Technische Universiteit Eindhoven)
• Original Assignee: Neograft Technologies, Inc.
• Inventors: McGrath, Jon, El-Kurdi, Mohammed S., Soletti, Lorenzo, Flaherty, J. Christopher
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/234,974
• Publication Number:
  US 20140303715A1
• Time in Patent Office: 1,680 Days
• Field of Search: 128/898
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

Methods and devices for treating a vessel for use in a medical procedure are disclosed. A vein or other vessel can be modified in situ, prior to harvesting. Subsequently, at least a portion of the vessel is removed, and subsequently implanted to treat a patient, typically in a bypass procedure in which the vessel portion fluidly connects a source of oxygenated blood to an occluded artery.

Claims

1. A method of performing a medical procedure, the method comprising:

modifying an in situ vessel;

removing at least one segment of the modified in situ vessel;

applying a restrictive member about the at least one removed, modified in situ vessel segment to produce a covered graft device; and

implanting the covered graft device in a patient;

wherein the in situ vessel modification is performed at least one week prior to removing the at least one vessel segment.

2. The method of claim 1 wherein the restrictive member comprises a restrictive fiber matrix.

3. The method of claim 1 wherein the restrictive member comprises a stent.

4. The method of claim 1 further comprising:

fluidly connecting a first portion of the covered graft device to a source of blood flow; and

fluidly connecting a second portion of the covered graft device to an artery.

5. The method of claim 1 wherein the in situ vessel comprises a vein.

6. The method of claim 1 wherein the in situ vessel is selected from the group consisting of:

vein, artery, urethra, intestine, esophagus, trachea, bronchi, ureter, duct, fallopian tube, and combinations of these materials.

7. The method of claim 1 wherein the modification comprises increasing the pressure within the in situ vessel.

8. The method of claim 7 wherein the pressure increase comprises an increase to at least 50 mmHg.

9. The method of claim 7 wherein the pressure increase comprises a pressure that is varied over time.

10. The method of claim 7 wherein the pressure is incrementally increased over time.

11. The method of claim 1 wherein the modification comprises applying a pressure applying cuff to the patient'"'"'s skin proximate the in situ vessel.

12. The method of claim 11 wherein the cuff further comprises an inflatable bladder.

13. The method of claim 12 further comprising intermittently inflating the inflatable bladder such that pressure within the in situ vessel is intermittently elevated.

14. The method of claim 11 wherein the pressure applying cuff causes the pressure within the in situ vessel to increase.

15. The method of claim 1 wherein the modification comprises applying a vacuum around the in situ vessel.

16. The method of claim 1 wherein the modification comprises implanting a mechanical scaffold within the in situ vessel.

17. The method of claim 1 wherein the modification comprises implanting a flow occluding device proximate to the in situ vessel.

18. The method of claim 17 wherein the modification comprises implanting the flow occluding device within a sidebranch proximate the in situ vessel.

19. The method of claim 17 wherein the flow occluding device is constructed and arranged to at least partially occlude flow in a lumen of a vessel.

20. The method of claim 1 wherein the modification comprises ligating at least one vessel sidebranch.

21. The method of claim 1 wherein the modification comprises application of energy to the in situ vessel.

22. The method of claim 21 wherein the energy comprises energy selected from the group consisting of:

radiofrequency, ultrasound, chemical, laser, mechanical, and combinations of these.

23. The method of claim 21 wherein the application of energy promotes angiogenesis.

24. The method of claim 1 wherein the modification comprises modifying one or more valves of the in situ vessel.

25. The method of claim 1 wherein the modification promotes angiogenesis.

26. The method of claim 1 wherein the modification comprises delivering an agent into the in situ vessel.

27. A method of performing a medical procedure, the method comprising:

removing at least one segment of a vessel that has been modified in situ at least one week prior to the removing of the vessel segment;

applying a restrictive member about the at least one vessel segment to produce a covered graft device; and

implanting the covered graft device in a patient.

28. The method of claim 27 wherein the restrictive member comprises a restrictive fiber matrix.

29. The method of claim 27 wherein the restrictive member comprises a stent.

30. The method of claim 27 wherein the in situ vessel comprises a vein.

31. The method of claim 27 wherein the modification comprises increasing the pressure within the in situ vessel.

32. The method of claim 31 wherein the pressure increase comprises an increase to at least 50 mmHg.

33. The method of claim 31 wherein the pressure increase comprises a pressure that is varied over time.

34. The method of claim 31 wherein the pressure is incrementally increased over time.

35. The method of claim 27 wherein the modification comprises applying a pressure applying cuff to the patient'"'"'s skin proximate the in situ vessel.

36. The method of claim 35 wherein the cuff further comprises an inflatable bladder.

37. The method of claim 36 further comprising intermittently inflating the inflatable bladder such that pressure within the in situ vessel is intermittently elevated.

38. The method of claim 35 wherein the pressure applying cuff causes the pressure within the in situ vessel to increase.