System and method for heart valve replacement

• US 20070244558A1
• Filed: 04/04/2007
• Published: 10/18/2007
• Est. Priority Date: 04/14/2006
• Status: Active Grant

• Current Assignee: Venkat R. Machiraju
• Original Assignee: Venkat R. Machiraju
• Inventors: Machiraju, Venkat R.
• Granted Patent: US 7,727,276 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14

Abstract

A prosthetic heart valve replacement system and method aim to reduce the time duration of the patient on the heart-lung machine during surgery. In one embodiment, the invention uses a two rings (e.g., of Titanium) comprising a first outer anchoring ring installed in a first step in the patient annulus, e.g., by stapling (e.g., using Nitinol® staples), and a second inner valve ring which has apertures and to which the sewing cuff of prosthetic heart valve (e.g., of Dacron) is sutured around the sewing cuff. The suturing is expediently completed outside of the patient'"'"'s body, parallel with the stapling of the anchoring ring in the patient annulus. The inner valve ring may have circumferential resiliency. The inner valve ring along with the fastened/sutured prosthetic valve is installed snugly (in a second step) to be captively retained concentrically within the already installed outer anchoring ring, to complete the heart valve replacement.

Claims

1. A prosthetic heart valve replacement system for valve replacement in a patient'"'"'s valve annulus during surgery, enabling a reduction of time duration that the patient is subjected to a heart-lung machine during the prosthetic heart valve replacement, comprising:

a first outer anchoring ring which is separately fastened to the patient'"'"'s heart valve annulus during surgery, and a second inner valve ring to which the prosthetic heart valve is attached outside of the patient, such as by suturing;

the second inner valve ring being configured to be assembled to be captively and snugly held concentrically inside of said first outer anchoring ring.

2. The prosthetic heart valve replacement system as in claim 1, wherein said first outer anchoring ring is stapled to the patient'"'"'s annulus during surgery, such as by using a stapling device.

3. The prosthetic heart valve replacement system as in claim 1, wherein said first outer anchoring ring and said second inner valve ring are made of material which remains noncorrosive even when subjected to prolonged use inside of the patient'"'"'s heart, and wherein the first outer anchoring ring and the second inner valve ring each have a generally tubular configuration with a horizontal inwardly projecting flange at one end, the second inner valve ring being configured to be circumferentially resilient when compressed radially inwards, so as to be captively held within the first outer anchoring ring upon assembly.

4. The prosthetic heart valve replacement system as in claim 3, wherein the material of the first outer anchoring ring and the second inner valve ring comprises Titanium.

5. The prosthetic heart valve replacement system as in claim 4, wherein the material of the first outer anchoring ring and the second inner valve ring comprises Titanium with a coating of Tantulum porous metal.

6. The prosthetic heart valve replacement system as in claim 3, wherein the first outer anchoring ring has an L shaped cross section with a vertical shelf, the vertical shelf being provided at the L shaped cross-section-bottom with a plurality of apertures circumferentially disposed along a lower end of the shelf, said outer anchoring ring being stapled to the patient'"'"'s annulus using staples which pass through said apertures, said staples having a memory characteristic and being preformed for being dispensed by a mechanical stapling device.

7. The prosthetic heart valve replacement system as in claim 2, wherein the first anchoring ring, the second inner valve ring and the staples comprise nonmagnetic material, and wherein said second inner valve ring is provided with notches in its configuration to provide radially inward resiliency.

8. The prosthetic heart valve replacement system as in claim 5, wherein said inwardly projecting flange of the first outer anchoring ring has an undersurface which is uneven to be conducive in use to hug the patient'"'"'s valve annulus tissue tightly.

9. The prosthetic heart valve replacement system as in claim 6, wherein the first outer anchoring ring is provided with a second set of apertures which may be used for sutures for providing added fastening of the first anchoring ring to the patient'"'"'s annulus in addition to the fastening provided by the staples.

10. A two-ring prosthetic heart valve replacement system for valve replacement in a patient'"'"'s heart valve annulus during surgery, enabling a reduction of time duration that the patient is subjected to a heart-lung machine during the prosthetic heart valve replacement, comprising:

a first outer anchoring ring with a tubular configuration with a shelf at one end and a radially inwardly projecting flange integrally formed at the other end of the tubular configuration, said first outer ring being separately stapled, fastened and installed in the patient'"'"'s heart valve annulus during surgery; and

,

a second inner valve ring which is also provided with an open tubular configuration and an integrally formed radially inwardly extending apertured flange configured for attachment to the prosthetic heart valve such as by suturing which is done outside of the patient;

said second inner valve ring being permanently sutured to the prosthetic heart valve and being configured to be resilient radially inwards to facilitate assembly thereof concentrically inside of the first outer anchoring ring for being captively and snugly held therein.

11. The prosthetic heart valve replacement system as in claim 10, wherein the outer anchoring ring and the valve ring are made of material which remains noncorrosive even when subjected to prolonged use inside of the patient'"'"'s heart, said second inner valve ring being provided with “

v”

shaped grooves at its open end, said tubular configuration of the second inner valve ring being shaped to taper down towards its said radially inwardly projecting flange.

12. The prosthetic heart valve replacement system as in claim 11, wherein the material of the first outer anchoring ring and the second inner valve ring comprises Titanium.

13. The prosthetic heart valve replacement system as in claim 12, wherein the material of the first outer anchoring ring and the second inner valve ring comprises Titanium with a coating of Tantulum porous metal.

14. The prosthetic heart valve replacement system as in claim 11, wherein the outer anchoring ring is provided with apertures for being stapled to the patient'"'"'s annulus using staples which have a memory characteristic and are preformed for being dispensed by a mechanical stapling device.

15. The prosthetic heart valve replacement system as in claim 14, wherein the first outer anchoring ring, the second inner valve ring and the staples comprise nonmagnetic material.

16. The prosthetic heart valve replacement system as in claim 14, wherein the staples have memory and are each provided with two legs having bent tips which face each other, the staples being configured for being dispensed using a powered stapling device.

17. The prosthetic heart valve replacement system as in claim 10, wherein the inwardly extending flange of the first anchoring ring has an undersurface which is uneven to be conducive to hug the patient'"'"'s valve annulus tissue tightly in assembly.

18. The prosthetic heart valve replacement system as in claim 14, wherein the tubular configuration of the first outer anchoring ring is provided with a radially inward step to captively accommodate in assembly, the end the inner valve ring which is provided with said “

v”

grooves, the first outer anchoring ring being also provided with a second set of apertures which may be used for sutures for providing added fastening of the first anchoring ring to the patient'"'"'s annulus in addition to the fastening provided by the staples.

19. A method of implanting a prosthetic heart valve in a patient'"'"'s annulus using first and second permanently placed tubular rings each tubular ring portion having a first end and a circumferential flange extending radially inwards at their bottom end away from, comprising the steps of:

excising a defective natural heart valve from an annulus area of the patient and sizing the patient'"'"'s annulus for establishing a selected size of the first and second tubular rings and the prosthetic heart valve;

in a first step, permanently installing and fastening the first selected sized tubular ring as the first outer anchoring ring with its circumferential flange tightly resting in the patient'"'"'s annulus;

preparing a chosen prosthetic valve by permanently suturing the prosthetic valve outside of the patient'"'"'s body to a selected suitably sized second inner valve ring by using a desired number of threads of suturing material; and

,

in a second step, installing the second tubular ring as the second inner valve ring along with the sutured prosthetic valve concentrically inside of the first outer anchoring ring in a captive manner to be snugly held and retained therein.

20. The method as in claim 19, including the step wherein said first outer anchoring ring is provided with apertures, and wherein the step of permanently fastening includes stapling the first outer anchoring ring to the patient'"'"'s annulus using staples which have a memory characteristic and are preformed for being dispensed through said apertures by a mechanical stapling device;

wherein the first outer anchoring ring, the second inner valve ring and the staples comprise nonmagnetic material, and including the step of providing notches at the first end of the inner second valve ring to impart circumferential resilience in a radially inward direction to the inner second valve ring;

and providing a taper to the tubular ring portion of the second inner valve ring such that the taper narrows towards the bottom end of the tubular ring portion to facilitate insertion of the second inner valve ring into the permanently installed first outer annular ring.