UNSTENTED HEART VALVE WITH FORMED IN PLACE SUPPORT STRUCTURE

• US 20090082857A1
• Filed: 05/05/2005
• Published: 03/26/2009
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Granted Patent: US 8,377,118 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30672 : temporary
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• 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 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0059 : temporary
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

An implantable prosthetic valve (100) has an in situ formable support structure. The valve comprises a prosthetic valve (104), having a base and at least one flow occluder. A first flexible component is incapable of retaining the valve at a functional site in the arterial vasculature. The first component (126) extends proximally of the base of the valve. A second flexible component (128) is incapable of retaining the valve at a functional site in the arterial vasculature. The second component extends distally of the base of the valve. At least one rigidity component (300) combines with at least one of the first and second flexible components to impart sufficient rigidity to the first or second components to retain the valve at the site.

Claims

1. A cardiovascular prosthetic valve, the valve comprising:

an inflatable cuff comprising at least one inflatable channel that forms, at least in part, a distal inflatable toroidal structure and a proximal inflatable toroidal structure, the inflatable cuff also comprising a waist that extends between the distal inflatable toroidal structure and the proximal inflatable toroidal structure; and

a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction.

2. A prosthetic valve for replacing an aortic valve positioned between the left ventricle and the aorta of the heart, the valve comprising:

an inflatable structure comprising a distal end and a proximal end; and

a valve member coupled to the inflatable structure, the valve member being positioned generally between the distal and proximal ends of the inflatable structure;

wherein the distal end of the inflatable structure is configured to be positioned within the left ventricle and the proximal end of the inflatable structure is configured to be positioned within the aorta.

3. A cardiovascular prosthetic valve, the valve comprising:

an inflatable body comprising at least a first inflatable chamber and a second inflatable chamber that is not in fluid communication with the first inflatable chamber, the inflatable body configured to form, at least in part, a generally annular ring;

a valve coupled to the inflatable body, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction;

a first inflation port in communication with the first inflatable chamber; and

a second inflation port in communication with the second inflatable chamber.

4. A cardiovascular prosthetic valve, the valve comprising:

a cuff having a distal end and a proximal end;

an inflatable structure coupled to the cuff and having at least one inflatable channel that forms a toroidal structure; and

a valve coupled to the cuff;

the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction;

wherein the distal end of the cuff has a non-circular cross-section with respect to the flow;

the non-circular cross-section configured to affect the performance of an adjacent valve.

5. A cardiovascular prosthetic valve, the valve comprising:

a flexible cuff having a distal end and a proximal end;

an inflatable structure coupled to the cuff and having at least one inflatable channel that forms a toroidal structure;

a valve mounted to the cuff;

the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction; and

at least anchor that is moveable between a first position in which the anchor extends in a radial direction to engage an adjacent anatomical structure and a second position in which the anchor has a reduced radial profile.

6. A cardiovascular prosthetic valve, the valve comprising:

an inflatable body;

a valve coupled to the body;

the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction; and

at least two control wires that are detachably coupled to the inflatable body.

7. The prosthetic valve as in claim 6, wherein each control wire comprises an outer sleeve and an inner elongated member moveably positioned within the outer sleeve, the outer sleeve including at least one opening through which a portion of the inflatable body extends, the inner elongated member moveable from a first position in which the inflatable body is locked within the at least one opening and a second position in which the inflatable body is disengaged from the second opening.

8. A cardiovascular prosthetic valve, the valve comprising:

an inflatable body comprising at least one inflation channel;

a valve coupled to the body;

the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction;

an inflation port in communication with the at least one inflatable channel;

a plug positioned within the inflation port;

an inflation tube extending through the inflation tube in communication with the at least one inflation channel; and

a balloon coupled to the inflation tube, the balloon configured to expand between a first, inflated position in which the balloon prevents the inflation tube from decoupling from the inflation port and a second, deflated position in which the inflation tube can be decoupled from the inflation port.

9. A method of implanting a prosthetic valve within a heart, the method comprising:

translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart;

inflating a portion of the inflatable structure that is distal to the native valve; and

inflating a portion of the inflatable structure that is proximal to the native annular valve.

10. A method of implanting a prosthetic valve within the heart, the method comprising:

translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart;

inflating a distal portion of the inflatable structure; and

proximally retracting the valve to seat the distal portion of the inflatable structure against a distally facing portion of the native valve.

11. A method of implanting a prosthetic valve within the heart, the method comprising:

translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart; and

inflating a first chamber of the inflatable structure; and

independently inflating a second chamber of the inflatable structure.

12. A method of implanting a prosthetic valve within the heart, the method comprising:

translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart; and

inflating the inflatable structure to deploy the prosthetic valve; and

stapling or suturing the prosthetic valve to an adjacent anatomical structure.

13. A method of treating a patient, comprising

translumenally advancing a prosthetic valve a position proximate a native valve of the heart;

and

fully deploying the prosthetic valve at the cardiovascular site;

testing a performance characteristic of the prosthetic valve;

at least partially reversing the deployment of the prosthetic valve;

repositioning the prosthetic valve; and

re-deploying the prosthetic valve.

14. A method of treating a patient, comprising

advancing deployment catheter to a position proximate a native valve of the heart, the deployment catheter comprising an inflation tube and a prosthetic valve comprising an inflatable structure in communication with the inflation tube;

inflating the inflatable structure with the inflation tube;

removing the deployment catheter from the patient while the inflation tube remains coupled to the inflatable catheter;

advancing a removal catheter over the inflation tube;

deflating the inflatable structure;

retracting the prosthetic valve into the removal catheter; and

withdrawing the prosthetic valve and the removal catheter from the patient.

15. A method of treating a patient, comprising

advancing deployment catheter to a position proximate a native valve of the heart, the deployment catheter comprising a prosthetic valve and a linking member coupled to the prosthetic valve;

deploying the prosthetic valve;

removing the deployment catheter from the patient while linking member remains coupled to the prosthetic valve;

advancing a removal catheter over the linking member;

retracting the prosthetic valve into the removal catheter; and

withdrawing the prosthetic valve and the removal catheter from the patient.

16. A method of treating a patient, comprising the steps of:

identifying a patient with a minimum cross-minimum flow area through an aortic valve of no greater than 0.75 square cm;

enlarging the minimum cross-minimum flow area through the valve; and

deploying a prosthetic valve which provides a minimum cross-sectional flow area of at least about 1.75 square cm.

17. A method of treating a patient, comprising the steps of:

inflating an inflatable structure of a temporary valve at a cardiovascular site in fluid communication with a native valve;

translumenally removing at least a portion of the native valve;

deploying a prosthetic valve to compliment or replace a native valve; and

removing the temporary valve.

18. A method of performing a procedure on a beating heart, comprising the steps of:

positioning a temporary valve in series fluid flow with a native valve;

deploying an inflatable prosthetic valve upstream of the temporary valve; and

removing the temporary valve.

19. A temporary heart valve catheter, for enabling minimally invasive procedures on a valve in a beating heart, comprising:

an elongate, flexible catheter body, having a proximal end and a distal end;

a valve on the distal end, the valve comprising an inflatable structure; and

at least one link between the catheter and the valve to prevent detachment of the valve from the catheter.

20. A method of in situ formation of a prosthetic valve support, comprising the steps of:

providing a prosthetic valve, attached to a flexible support component which is incapable of retaining the valve at a functional site in the arterial vasculature, the support component extending both proximally and distally of the base of the valve;

positioning the valve at the site; and

supplementing the flexible support component to increase the rigidity of the support component sufficiently to retain the valve at the site.

21. An implantable prosthetic valve, having an in situ formable support structure, comprising:

a prosthetic valve, having a base and at least one flow occluder;

a first flexible component which is incapable of retaining the valve at a functional site in the arterial vasculature, the first component extending proximally of the base of the valve;

a second flexible component which is incapable of retaining the valve at a functional site in the arterial vasculature, the second component extending distally of the base of the valve; and

at least one rigidity component for combining with at least one of the first and second flexible components to impart sufficient rigidity to the first or second components to retain the valve at the site.

22. An implantable prosthetic valve, having an in situ formable support structure as in claim 21, wherein at least one of the first and second flexible components comprises an inflatable compartment.

23. An implantable prosthetic valve, having an in situ formable support structure as in claim 22, wherein each of the first and second flexible components comprises an inflatable compartment.

24. An implantable prosthetic valve, having an in situ formable support structure as in claim 21, wherein the rigidity component comprises an inflation media.

25. An implantable prosthetic valve, having an in situ formable support structure as in claim 21, wherein the rigidity component comprises at least one elongate filament.

26. An implantable prosthetic valve, having an in situ formable support structure as in claim 21, wherein at least one of the first and second flexible components comprises an elongate tubular channel.

27. An implantable prosthetic valve, having an in situ formable support structure as in claim 26, wherein the elongate tubular channel extends helically around a longitudinal flow axis through the valve.