Inflatable prosthetic cardiovascular valve for percutaneous transluminal implantation of same

• US 5,554,185 A
• Filed: 07/18/1994
• Issued: 09/10/1996
• Est. Priority Date: 07/18/1994
• Status: Expired due to Term

• Current Assignee: Direct Flow Medical, Inc.
• Original Assignee: Anderson W. Earl, David G. Atteridge, Peter C. Block
• Inventors: Anderson, W. Earl, Atteridge, David G., Block, Peter C.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/276,663
• Time in Patent Office: 785 Days
• Field of Search: 623/2, 623/12, 623/900, 606/195
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

An inflatable prosthetic cardiovascular valve which is constructed so as to be initially deployable in a deflated "collapsed" configuration wherein the valve may be passed through the lumen of a cardiovascular catheter and subsequently inflated to an "operative" configuration so as to perform its intended valving function at its intended site of implantation within the cardiovascular system. The inflated valve may be held in place by mechanical means (e.g., hooks, projections), by chemical adhesive or through biological assimilation by the heart tissue.

Claims

1. An inflatable cardiovascular valve initially deployable in a collapsed deflated configuration and subsequently inflatable to a non-collapsed operative configuration, said valve comprising:

a) an inflatable valve support body which, when fully inflated, comprises a generally annular ring defining a central passageway through which blood may flow;

b) at least one leaflet occluder attached to said inflatable valve support body and configured to move back and forth between;

i. an open position wherein blood may flow in a first direction through said central passageway; and

ii. a closed position whereby blood is prevented from backflowinq through said central passageway in a second direction, said second direction being opposite said first direction;

c) an inflation port formed on said inflatable valve support body to facilitate inflation thereof; and

d) at least one pin protruding outwardly from said valve and configured to engage said adjacent anatomical structure when said inflatable valve body is inflated.

2. The prosthetic cardiovascular valve of claim 1 wherein said at least one pin member comprises:

a series of pin members positioned around said annular ring so as to penetrate and engage surrounding anatomical tissue when said valve is inflated.

3. An inflatable cardiovascular valve initially deployable in a collapsed deflated configuration and subsequently inflatable to a non-collapsed operative configuration, said valve comprising:

a) an inflatable valve support body which, when fully inflated, comprises a generally annular ring defining a central passageway through which blood may flow;

b) at least one leaflet occluder attached to said inflatable valve support body and configured to move back and forth between;

i. an open position wherein blood may flow in a first direction through said central passageway; and

ii. a closed position whereby blood is prevented from backflowing through said central passageway in a second direction, said second direction being opposite said first direction;

c) an inflation port formed on said inflatable valve support body to facilitate inflation thereof; and

d) a gelatinous inflation substance disposed within said inflatable valve body in sufficient quantity to maintain said valve body in said inflated operative configuration.

4. An inflatable cardiovascular valve initially deployable in a collapsed deflated configuration and subsequently inflatable to a non-collapsed operative configuration, said valve comprising:

a) an inflatable valve support body which, when fully inflated, comprises a generally annular ring defining central passageway through which blood may flow;

b) at least one leaflet occluder attached to said inflatable valve support body and configured to move back and forth between;

i. an open position wherein blood may flow in a first direction through said central passageway; and

ii. a closed position whereby blood is prevented from backflowing through said central passageway in a second directions, said second direction being opposite said first direction;

c) an inflation port formed on said inflatable valve support body to facilitate inflation thereof; and

d) a solidified inflation substance disposed within said inflatable valve body to maintain said valve body in said inflated operative configuration.

5. The prosthetic cardiovascular valve of claim 4 wherein said solidified inflation substance is formed within said inflatable valve body by the process comprising the steps of:

providing at least one solidifying fluid which will form said solidified substance;

passing said solidifying fluid into said inflatable valve body so as to cause inflation of said valve body and subsequently allowing said at least one fluid to solidify within said valve body.

6. An inflatable cardiovascular valve initially deployable in a collapsed deflated configuration and subsequently inflatable to a non-collapsed operative configuration, said valve adapted for permanent implantation in a patient, said valve comprising:

a) an inflatable valve support body which, when fully inflated, comprises a generally annular ring comprising a first side and a second side, said annular ring defining a central passageway through which blood may flow;

b) at least one leaflet occluder attached to said inflatable valve support body and configured to move back and forth between;

i. an open position wherein blood may flow in a first direction through said central passageway; and

ii. a closed position whereby blood is prevented from backflowing through said central passageway in a second direction, said second direction being opposite said first direction;

c) an inflation port formed on said inflatable valve support body to facilitate inflation thereof; and

d) a plurality of strut members extending from one of said sides of said inflated ring member.

7. The prosthetic cardiovascular valve of claim 6 wherein said strut members are inflatable along with said ring member and wherein each said strut member defines a hollow inflation space therewithin consistent with the inflation space defined within said ring member.

8. The prosthetic cardiovascular valve of claim 6 further comprising at least one anchoring member formed on said valve and configured to engage an adjacent anatomical structure when said valve is inflated.

9. The prosthetic cardiovascular valve of claim 6 further comprising a check valve apparatus associated with said inflation port to prevent leakage of inflation fluid out of said inflation port after said valve has been inflated.

10. The prosthetic cardiovascular valve of claim 6 further comprising an elongate inflation tube connected to said inflation port to facilitate inflation of said inflatable valve body.

11. The prosthetic cardiovascular valve of claim 10 wherein said elongate inflation tube is detachably connected to said inflation port such that said inflation tube may be detached from said valve body and removed after said valve body has been inflated.

12. The prosthetic cardiovascular valve of claim 11 further in combination with a check valve apparatus which is operative to prevent the backflow of inflation fluid out of said inflation port after said detachable inflation tube has been detached therefrom.

13. The prosthetic cardiovascular valve of claim 6 wherein said inflatable valve support body and said at least one leaflet occluder are configured and constructed such that, when said valve is in the deflated, collapsed configuration, said valve will be sufficiently compact to be passable through a catheter lumen of approximately 4-7 mm in diameter.

14. The prosthetic cardiovascular valve of claim 6 further in combination with a quantity of inflation fluid disposed within said inflatable valve body to maintain said valve body in said inflated operative configuration.

15. The prosthetic cardiovascular valve of claim 6 wherein said inflatable valve body comprises a continuous inflatable annular ring.

16. The prosthetic cardiovascular valve of claim 6 wherein said inflatable valve body comprises a split inflatable annular ring comprising separated first and second ends such that when said valve body is deflated, said valve body is extendable into a linearly extended configuration and which, when inflated, is configurable in a generally round, annular configuration.

17. An inflatable cardiovascular valve initially deployable in a collapsed deflated configuration and subsequently inflatable to a non-collapsed operative configuration, said valve comprising:

a) an inflatable valve support body which, when fully inflated, comprises a generally annular ring defining a central passageway through which blood may flow, and wherein said inflatable valve support body comprises separated first and second ends such that when said valve body is deflated, said valve body is extendable into a linearly extended configuration and which, when inflated, is configurable in a generally round, annular configuration;

b) at least one leaflet occluder attached to said inflatable valve support body and configured to move back and forth between;

i. an open position wherein blood may flow in a first direction through said central passageway; and

ii. a closed position whereby blood is prevented from backflowing through said central passageway in a second direction, said second direction being opposite said first direction; and

,

c) an inflation port formed on said inflatable valve support body to facilitate inflation thereof.