Implantable small percutaneous valve and methods of delivery

• US 7,331,991 B2
• Filed: 02/24/2006
• Issued: 02/19/2008
• Est. Priority Date: 02/25/2005
• Status: Active Grant

• Current Assignee: California Institute of Technology
• Original Assignee: California Institute of Technology
• Inventors: Gharib, Morteza, Kheradvar, Arash, Ravichandran, Guruswami
• Primary Examiner(s): Gartenberg; Ehud
• Assistant Examiner(s): Stroud; Jonathan R
• Application Number:
  US11/361,850
• Publication Number:
  US 20060195180A1
• Time in Patent Office: 725 Days
• Field of Search: 623/1.11, 623/1.22, 623/2.33, 623/2.1, 623/2.12, 623/2.11, 623/2.13, 623/2.14, 623/2.24, 623/2.38, 623/1.23, 623/1.24, 623/1.26, 623/1.3, 623/1.15, 623/1.18, 623/1.19, 623/900, 623/901, 623/902, 623/903, 623/909, 623/915, 128/203.11, 427/2.24
• US Class Current: 623/1.22
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/904 Heart
• CPC Class Codes: Y10S 623/91 Heart

Abstract

An implantable prosthetic valve that is transformable from a first helical pre-implantation configuration to a second valvular functional configuration, and methods of delivery.

Claims

1. A prosthetic valve for implantation in a patient comprising a first helical pre-implantation configuration and a second functional valvular configuration, wherein said first configuration is reversibly transformable to said second configuration, wherein said valve comprises:

a support structure with leaflets mounted thereon, said support structure comprising a circular stent and a plurality of elongate support arms, and wherein a first support arm is splittable into two support beams along a longitudinal axis of said first support arm, said two support beams being subsequently capable of being structurally re-attached to enable a reversible transformation of said second configuration into said first configuration.

2. The prosthetic valve of claim 1, wherein said valve comprises a support structure with leaflets mounted thereon, wherein the leaflets are made from material selected from a group consisting of synthetic material, engineered biological tissue, biological valvular leaflet tissue, pericardial tissue, and crosslinked pericardial tissue.

3. The prosthetic valve of claim 2, wherein the pericardial tissue is selected from a group consisting of bovine, equine, porcine, ovine, and human tissue.

4. The prosthetic valve of claim 2, wherein the crosslinked pericardial tissue is crosslinked with a crosslinking agent selected from a group consisting of formaldehyde, glutaraldehyde, dialdehyde starch, glyceraldehydes, cyanamide, diimides, diisocyanates, dimethyl adipimidate, carbodiimide, epoxy compounds, and mixture thereof.

5. The prosthetic valve of claim 2, wherein at least a portion of the support structure is covered with cloth.

6. The prosthetic valve of claim 5, wherein at least a portion of the leaflets is covered with cloth.

7. The prosthetic valve of claim 6, wherein at least one of said elongate support arms further comprises a hook at a distal end of said one elongate support arm.

8. The prosthetic valve of claim 6, wherein said stent is made of a shape memory material.

9. The prosthetic valve of claim 6, wherein said stent is made of shape memory Nitinol.

10. The prosthetic valve of claim 6, wherein the two support beams are coupled to each other by a magnetic force at the second valvular post-implantation configuration.

11. The prosthetic valve of claim 6, wherein a first of the two support beams is coupled to a second of the two support beams by a suture and cinch technique at the second valvular post-implantation configuration.

12. The prosthetic valve of claim 6, wherein at least a portion of the support structure is covered with cloth.

13. The prosthetic valve of claim 1, wherein said valve comprises a support structure with leaflets mounted thereon, said support structure comprising a circular stent, wherein said circular stent is splittable into a non-circular stent with two ends.

14. The prosthetic valve of claim 13, wherein at least one of said two ends further comprises a hook at a distal end of said at least one end.

15. A prosthetic valve system for implantation in a body channel comprising:

a prosthetic valve having a first helical pre-implantation configuration that is reversibly transformable to a second valvular configuration;

a prosthetic valve for implantation in a patient comprising a first helical pre-implantation configuration and a second functional valvular configuration, wherein said first configuration is reversibly transformable to said second configuration wherein said valve comprises;

a support structure with leaflets mounted thereon, said support structure comprising a circular stent and a plurality of elongate support arms, and wherein a first support arm is splittable into two support beams along a longitudinal axis of said first support arm, said two support beams being subsequently capable of being structurally re-attached to enable a reversible transformation of said second configuration into said first configuration; and

a radially or helically collapsible and expandable crown, the crown including a cylindrical support means for enclosing said prosthetic valve.

16. The prosthetic valve system of claim 15, wherein said crown is expandable by an inflatable balloon technique.

17. The prosthetic valve system of claim 15, wherein said crown in made of a shape memory material.

18. The prosthetic valve system of claim 15, wherein said crown in made of shape memory Nitinol.

19. The prosthetic valve system of claim 15, wherein said prosthetic valve is attached to the cylindrical support means of said crown.

20. The prosthetic valve system of claim 15, further comprising an elongate delivery apparatus, wherein said prosthetic valve at the first pre-implantation configuration and said crown are collapsibly mounted onto said delivery apparatus.

21. The prosthetic valve system of claim 20, wherein said prosthetic valve at the first pre-implantation configuration is removably mounted onto said delivery apparatus in a helical manner on the elongate delivery apparatus.

22. The prosthetic valve system of claim 21, wherein a profile of said mounted prosthetic valve is about 3 to 12 French diameter.

23. The prosthetic valve system of claim 21, wherein a profile of said mounted prosthetic valve is about 3 to 6 French diameter.

24. The prosthetic valve system of claim 21, wherein an exterior surface of said delivery apparatus comprises a helical groove sized and configured to receive the mounted prosthetic valve.

25. The prosthetic valve system of claim 21, wherein said delivery apparatus is selected from a group consisting of a catheter, a wire, a guidewire, a flexible tubing, and a cannula.

26. The prosthetic valve system of claim 15, wherein said prosthetic valve comprises a support structure with a circular stent, said crown having a series of connected or separated guide grooves for the circular stent to fill in the grooves when the prosthetic valve is transformed from the first helical pre-implantation configuration to the second valvular configuration.

27. The prosthetic valve system of claim 15, wherein said crown is loaded with at least one bioactive agent selected from a group consisting of analgesics/antipyretics, antiasthamatics, antibiotics, antidepressants, antidiabetics, antifungal agents, antihypertensive agents, anti-inflammatories, antineoplastics, antianxiety agents, immunosuppressive agents, antimigraine agents, sedatives/hypnotics, antipsychotic agents, antimanic agents, antiarrhythmics, antiarthritic agents, antigout agents, anticoagulants, thrombolytic agents, antifibrinolytic agents, antiplatelet agents and antibacterial agents, antiviral agents, antimicrobials, anti-infectives, and combination thereof.

28. The prosthetic valve system of claim 15, wherein said crown is loaded with at least one bioactive agent selected from a group consisting of actinomycin D, paclitaxel, vincristin, methotrexate, angiopeptin, batimastat, halofuginone, sirolimus, tacrolimus, everolimus, tranilast, dexamethasone, mycophenolic acid, and stem cells.

29. The prosthetic valve system of claim 15, wherein said prosthetic valve comprises a support structure with a circular stent and at least a hook secured at said support structure sized and configured for piercing into surrounding tissue.

30. The prosthetic valve system of claim 29, wherein at least a portion of the support structure is covered with cloth.

31. A method for implanting a prosthetic valve in a patient, comprising:

a prosthetic valve for implantation in a patient comprising a first helical pre-implantation configuration and a second functional valvular configuration, wherein said first configuration is reversibly transformable to said second configuration, wherein said valve comprises;

a support structure with leaflets mounted thereon, said support structure comprising a circular stent and a plurality of elongate support arms, and wherein a first support arm is splittable into two support beams along a longitudinal axis of said first support arm, said two support beams being subsequently capable of being structurally re-attached to enable a reversible transformation of said second configuration into said first configuration, and a radially or helically collapsible and expandable crown, the crown including a cylindrical support means for enclosing said prosthetic valve, and an elongate delivery apparatus;

mounting said prosthetic valve at the first pre-implantation configuration and said crown at a collapsed configuration onto said delivery apparatus;

delivering said delivery apparatus to a target implant site in the patient;

expanding said crown at the implant site;

deploying said prosthetic valve at the implant site by transforming said prosthetic valve from the first pre-implantation configuration to the second valvular configuration; and

removing the delivery apparatus from the patient.

32. The method of claim 31, wherein the implant site at a body organ or system is selected from a group consisting of a cardiovascular system, a venous system, an esophagus, a stomach, a ureter, a urethral, a biliary passage, and an intestine.

33. The method of claim 31, wherein the delivery step is selected from a group consisting of a percutaneous procedure, a trans-apical catheterization, an endoscopic procedure, a laparoscopic procedure, and an open-chest procedure.

34. A method of delivering at least one bioactive agent to a body channel of a patient, comprising:

providing an implant device loaded with said at least one bioactive agent, wherein a prosthetic valve for implantation in a patient comprising a first helical pre-implantation configuration and a second functional valvular configuration, wherein said first configuration is reversibly transformable to said second configuration, wherein said valve comprises;

a support structure with leaflets mounted thereon, said support structure comprising a circular stent and a plurality of elongate support arms, and wherein a first support arm is splittable into two support beams along a longitudinal axis of said first support arm, said two support beams being subsequently capable of being structurally re-attached to enable a reversible transformation of said second configuration into said first configuration;

delivering said implant device to about said body channel at said first configuration;

deploying said implant device at said body channel by transforming the implant device to said second configuration; and

releasing said at least one bioactive agent.

35. The method of claim 34, wherein said implant device at said first configuration is helically wrapped around an elongate delivery apparatus for delivering to about said body channel of the patient.

36. The method of claim 34, wherein said implant device comprises a carrier for loading said at least one bioactive agent.

37. The method of claim 36, wherein said carrier is biodegradable.