METHOD AND APPARATUS FOR MINIMALLY INVASIVE HEART VALVE PROCEDURES

• US 20110301701A1
• Filed: 12/04/2009
• Published: 12/08/2011
• Est. Priority Date: 12/04/2008
• Status: Active Grant

• Current Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Yoganathan, Ajit P., Padala, Sai Muralidhar
• Granted Patent: US 9,050,189 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00402 Piezo electric actuators
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An apparatus (100) for and a method of delivering and implanting a surgical device on an anatomic structure is through minimally invasive procedures. The method is facilitated by an apparatus including a unitary tube (106) operatively connected to a deployment head (118) controlled by an apparatus controller. The deployment head is configured to deploy suture hooks or similar clips that connect an annuloplasty implant to heart tissue and secondary surgical devices to the annuloplasty implant. The apparatus is further configured to facilitate orientation adjustment or collapsing of the deployment head and surgical devices attached thereto in order to facilitate their passing through an incision smaller than generally required. After the deployment head passes through the incision its orientation is readjusted so that it may be positioned and the annuloplasty implant automatically sutured to a heart valve annulus by the apparatus suturing sub-assembly using the suture hooks.

Claims

1. An apparatus for implantation of an annuloplasty implant into the heart of a patient, the apparatus comprising:

a unitary tube;

an annuloplasty implant guide assembly and a guide assembly controller;

wherein the annuloplasty implant guide assembly is attached to the distal end of the unitary tube, the unitary tube comprises a proximal tube portion, a distal tube portion and a transition region disposed there between;

the unitary tube further comprising an exterior surface defining an outside diameter, an interior surface defining an inside diameter of the unitary tube, wherein the proximal tube portion includes the guide assembly controller which is operatively connected to the annuloplasty implant guide assembly by a control mechanism that extends from the guide assembly controller through the interior of the unitary tube to the annuloplasty implant guide assembly which includes a suturing sub-assembly system configured to deploy a plurality of suture hooks that connect the annuloplasty implant to tissue within the heart.

2. The apparatus of claim 1 wherein each of the plurality of suture hooks is releasably attached to the suturing sub-assembly system and comprised of a first hook arm and a second hook arm, wherein the first and second hook arms are both pivotally connected at a first end by a pivot pin, wherein the second ends of the first and second hook arms are configured to be extended through tissue of an annulus wall within a heart valve and extended through an annuloplasty implant, thereby connecting the annuloplasty implant to the annulus of a valve, the second ends of the first and second hook arms being structured connect in a manner that latches the second ends of the first and second hook arms and thereby creates a substantially continuous closed loop.

3. The apparatus of claim 1 wherein the distal end of the unitary tube includes an orientation member configured to facilitate rotation of the annuloplasty implant guide assembly and the annuloplasty implant in all directions in response to manipulation of the guide assembly controller.

4. The apparatus of claim 1 wherein an incision cover assembly is attached to the exterior surface of the unitary tube, wherein the incision cover comprises a umbrella skeleton covered by a biocompatible incision cover material, wherein the umbrella skeleton is connected to the exterior surface of the unitary tube by a deployment ring positioned around the exterior surface of the unitary tube and configured to slide up and down the unitary tube exterior surface causing the umbrella skeleton and thereby the incision cover to retract and deploy.

5. The apparatus of claim 1 wherein the annuloplasty implant guide assembly has an annular shape and contains a suturing sub-assembly, wherein the suturing sub-assembly includes a plurality of suture hooks configured to detach from the suturing sub-assembly and connect the annuloplasty implant to the inner tissue of the heart cavity into which the apparatus is inserted.

6. The apparatus of claim 1 wherein the annuloplasty implant guide assembly further comprises an external clamping assembly that facilitates resizing of a valve annulus, the clamping assembly comprising a top clamp plate and a bottom clamp plate, wherein a clamping assembly between the top clamp plate and the bottom clamp plate facilitates reduction of spacing between the top clamp plate and the bottom clamp plate.

7. The apparatus of claim 3 wherein the suturing sub-assembly further includes a deployment mechanism extending through the interior surface of the unitary tube, wherein the deployment mechanism facilitates deployment of each of the plurality of suture hooks and thereby connecting the annuloplasty implant to the inner tissue of the heart cavity into which the annuloplasty implant is inserted.

8. The apparatus of claim 1 wherein distal end of the unitary tube includes an orientation member configured to facilitate rotation of implant delivery member in a manner such that its longest side is perpendicular with the plane of the body into which an incision has been made.

9. The apparatus of claim 1 wherein the annuloplasty implant delivery member is comprised of a plurality of arms each of which are attached to the annuloplasty implant being delivered to the heart.

10. The apparatus of claim 1 wherein the annuloplasty implant delivery member is configured to facilitate folding of the annuloplasty implant in order to facilitate passing the annuloplasty implant through an incision having a size smaller than necessary when the annuloplasty implant is not folded.

11. The apparatus of claim 1 wherein the suturing sub-assembly system includes a plurality of pumps, wherein the pumps comprise at least one of a microfluidic pump and a microelectromechanical pump, wherein each of the plurality of pumps is operatively connected to at least one of the plurality of suture hooks, wherein the pumps control deployment of the suture hooks in a manner connecting the annuloplasty implant to the inner tissue of the heart cavity into which the annuloplasty implant is inserted.

12. The apparatus of claim 1 wherein the suturing sub-assembly system is configured to enable a user to control deployment of the plurality of suture hooks in any manner desired by the user, including deploying each of the plurality of suture hooks individually, deploying each of the plurality of suture hooks in groups and deploying each of the plurality of suture hooks all at once.

13. The apparatus of claim 1 wherein the annuloplasty implant guide assembly includes an adjustable mounting system onto which annuloplasty rings of a plurality of different shapes, rigidity and sizes may be mounted.

14. The apparatus of claim 1, wherein positioning of the annuloplasty implant guide assembly and deployment of suture hooks by the suturing sub-assembly is guided by at least one of a plurality of methods including medical imaging modalities and direct visualization through blood using at least one infrared cameras mounted on the annuloplasty implant guide assembly.

15. The apparatus of claim 1, wherein movement of the annuloplasty implant guide assembly and control of the suturing sub-assembly may be controlled by a software module that allows the user to activate and deactivate components of the apparatus including at least the components comprising the annuloplasty implant guide assembly and the components comprising the suturing sub-assembly.

16. The apparatus of claim 1 wherein the apparatus is integrated with a surgical robot allowing the user to control the apparatus by way of the surgical robot.

17. The apparatus of claim 1, wherein secondary devices, including at least one of artificial heart valves and tissue engineering heart valves, may be delivered to the site of the annuloplasty implant through the unitary tube following implantation of the annuloplasty implant into the heart, wherein the secondary devices may be deployed onto the previously implanted annuloplasty implant using the annuloplasty implant guide assembly already in position as a result of the implantation of the annuloplasty implant.

19. The apparatus of claim 11 wherein the second ends of the first and second hook arms are sharpened.

20. The apparatus of claim 11 wherein the at least one automatic release mechanism includes at least one of a microfluidic pump and a microelectromechanical pump.

18. An automatic suturing apparatus comprising:

a suture apparatus body;

a plurality of suture connectors; and

at least one automatic release mechanism connected to the suture apparatus body and at least one of the plurality of connectors, wherein the at least one automatic release mechanism is configured to release the at least one of the plurality of connectors to which it is connected from the suture apparatus body,

wherein each of the plurality of suture connectors is releasably attached to the suture apparatus body and comprised of a first hook arm and a second hook arm, wherein the first and second hook arms are both pivotally connected at a first end by a pivot pin, wherein the second ends of the first and second hook arms are configured to be extended through tissue of an annulus wall within a heart valve and extended through an annuloplasty implant ring, thereby connecting the annuloplasty implant ring to the annulus of a valve, the second ends of the first and second hook arms are further configured to connect in a manner that locks the first and second hook arms and thereby creates a substantially continuous closed loop.

21. A method of implanting an annuloplasty implant, comprising:

providing an apparatus for implantation of an annuloplasty implant that includes an annuloplasty implant guide assembly configured with at least one annuloplasty implant connector;

connecting the annuloplasty ring to the at least one annuloplasty implant connector of the implant guide assembly;

adjusting the orientation of the implant guide assembly and thereby the orientation of the annuloplasty implant, wherein the adjusted orientation of the annuloplasty implant facilitates passing the annuloplasty implant through an incision on a patient'"'"'s body having a size smaller than necessary when the annuloplasty implant orientation is not adjusted;

extending the orientation adjusted guide assembly and the annuloplasty ring through the incision;

readjusting the orientation of the guide assembly and thereby the orientation of the annuloplasty ring after the orientation adjusted guide assembly extends through the incision;

positioning the annuloplasty ring within a heart valve annulus; and

initiating an automatic suture procedure wherein at least one of a plurality of suture connection rings extends through tissue of the heart valve annulus and the annuloplasty ring thereby connecting the annuloplasty ring to the heart valve annulus.

22. The method of claim 21 wherein the positioning of the annuloplasty implant ring within a heart valve annulus causes a reshaping of the heart valve annulus, wherein reshaping comprises at least one of changing the heart valve geometry and changing the heart valve size.

23. The method of claim 21 wherein the apparatus for implantation of an annuloplasty implant includes a hollow unitary tube connected to the annuloplasty implant guide assembly, wherein the method includes the step of delivering secondary devices through the unitary tube to the implanted annuloplasty ring which serves as a platform that can support implantation of the secondary devices within the heart valve annulus.