Minimally Invasive Repair of Heart Valve Leaflets

Abstract

A method of repairing a heart valve provides intravascular access for repair of a heart valve through a ventricular trans-septal approach. An external guide catheter can be inserted through a vein of a patient into the right ventricle via the right atrium. An internal guide catheter can be inserted through the external guide and can provide access to the septum for a puncture tool to create an opening through the septum to the left ventricle. The internal guide can then be advanced into the left ventricle and used to guide a deployment catheter that deploys a repair device onto the heart valve.

Claims

1-20. (canceled)

21. A method of repairing a heart valve in a beating heart of a patient, comprising: inserting a guide catheter through a vein of a patient and into a right atrium of a heart of the patient; inserting a septal puncture tool through the guide catheter and into the heart; puncturing a septum in the patient's heart to create an opening through the septum; advancing a deployment catheter through the guide catheter and through the septum to a position adjacent a mitral valve leaflet; deploying a suture onto the mitral valve leaflet with the deployment catheter; inserting an anchor catheter through the guide catheter to insert an anchor device adjacent a left ventricle of the heart such that the suture extends from the mitral valve leaflet to the anchor device; adjusting a tension of the suture to achieve proper valve function; and locking the suture at the anchor device at the tension that achieves proper valve function.

22. The method of claim 21, wherein locking the suture at the anchor device at the tension that achieves proper valve function includes engaging a mechanical lock with the suture.

23. The method of claim 22, further comprising withdrawing the anchor catheter from the body with the mechanical lock engaged with the suture in the heart.

24. The method of claim 22, wherein engaging the mechanical lock with the suture includes rotating the mechanical lock with the anchor catheter.

25. The method of claim 21, further comprising inserting the suture through the anchor device prior to inserting the anchor catheter into the body.

26. The method of claim 21, wherein inserting the anchor device adjacent the left ventricle includes advancing the anchor device along the suture to adjacent the left ventricle.

27. The method of claim 21, further comprising inserting a cutting catheter having a cutting tool through the guide catheter to adjacent the anchor device after adjusting the tension of the suture and cutting the suture adjacent the anchor device with the cutting tool.

28. The method of claim 24, wherein the step of deploying a suture onto the mitral valve leaflet with the deployment catheter includes: capturing a heart valve leaflet with a clamping mechanism of the deployment catheter; and inserting the suture through the heart valve leaflet with a needle of the deployment catheter.

29. A method of repairing a heart valve in a beating heart of a patient comprising: intravenously advancing a deployment catheter into a left ventricle of a beating heart of a patient through a septum in the heart; deploying a suture onto a mitral valve leaflet with the deployment catheter; inserting an anchor catheter into the heart to insert an anchor device adjacent the left ventricle such that the suture extends from the mitral valve leaflet to the anchor device; adjusting a tension of the suture to achieve proper valve function; and locking the suture at the anchor device at the tension that achieves proper valve function.

30. The method of claim 29, wherein locking the suture at the anchor device at the tension that achieves proper valve function includes engaging a mechanical lock with the suture.

31. The method of claim 30, further comprising withdrawing the anchor catheter from the body with the mechanical lock engaged with the suture in the heart.

32. The method of claim 30, wherein engaging the mechanical lock with the suture includes rotating the mechanical lock with the anchor catheter.

33. The method of claim 29, further comprising inserting the suture through the anchor device prior to inserting the anchor catheter into the body.

34. The method of claim 29, wherein inserting the anchor device adjacent the left ventricle includes advancing the anchor device along the suture to adjacent the left ventricle.

35. The method of claim 29, further comprising inserting a cutting catheter having a cutting tool into the heart adjacent the anchor device after adjusting the tension of the suture and cutting the suture adjacent the anchor device with the cutting tool.

36. The method of claim 29, wherein the step of deploying a suture onto the mitral valve leaflet with the deployment catheter includes: capturing a heart valve leaflet with a clamping mechanism of the deployment catheter; and inserting the suture through the heart valve leaflet with a needle of the deployment catheter.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0028] The embodiments of the present invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:

[0029] FIG. 1 is a view of a device for venous access into a heart chamber via the femoral vein to facilitate repair of a heart valve leaflet according to an embodiment of the present invention;

[0030] FIG. 2A is a view of a valve leaflet repair device according to an embodiment of the present invention with an internal guide and puncture tool passed into the left ventricle;

[0031] FIG. 2B is a partial view of the valve leaflet repair device depicted in FIG. 2A;

[0032] FIG. 3 is a view of a valve leaflet repair device according to an embodiment of the present invention with an internal guide exiting a side exit guide catheter;

[0033] FIG. 4 is a view of a valve leaflet repair device according to an embodiment of the present invention with a deployment catheter exiting an internal guide and positioned at the mitral valve;

[0034] FIG. 5A is a view of a deployment catheter tip according to an embodiment of the present invention with a moveable catheter jaw and a suture capture needle, with the catheter jaw in the closed position;

[0035] FIG. 5B is a view of the deployment catheter tip of FIG. 5A with the moveable catheter in the open position;

[0036] FIG. 6 is a cross-sectional view of the deployment catheter tip of FIGS. 5A and 5B;

[0037] FIG. 7 is a view of a valve leaflet repair device according to an embodiment of the present invention with several sutures attached to the mitral valve and exiting through an internal guide;

[0038] FIG. 8 is a view of a valve leaflet repair device according to an embodiment of the present invention with ventricular septal seal devices deployed in the septal wall with sutures extending through a center lumen;

[0039] FIG. 9 is a schematic representation of the septal seal device of FIG. 8 in place in the heart;

[0040] FIG. 10 is a perspective view of septal seal types according to embodiments of the present invention;

[0041] FIG. 11 is a partial view of a septal seal device lumen with a seal element for holding a suture in tension showing the suture freed from tension by a catheter that releases the seal element;

[0042] FIG. 12 is a view of a valve leaflet repair device according to an embodiment of the present invention with an anchor device fixing the position of the sutures;

[0043] FIG. 13 is a side cut-away view of the anchor device of FIG. 12 having a fixation catheter with a locking element for mating with seal internal lock features;

[0044] FIG. 14 is a view of a valve leaflet repair device according to an embodiment of the present invention with a cutting device for cutting sutures at the right ventricular side of a septal seal;

[0045] FIG. 15 is a side cross-sectional view of the suture cutting device of FIG. 14;

[0046] FIG. 16 is a view of a completed implant procedure using a valve leaflet repair device according to an embodiment of the present invention;

[0047] FIG. 17 is a flow chart of surgical procedural steps for repair of heart valve leaflets according to an embodiment of the present invention.

[0048] While the present invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the present invention to the particular embodiments described. On the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention.

DESCRIPTION OF EMBODIMENTS

[0049] In the following detailed description of the present invention, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, one skilled in the art will recognize that various embodiments of the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as to not unnecessarily obscure aspects of the present invention.

[0050] One embodiment of the heart valve repair and delivery system will be examined to demonstrate the multiple catheter access steps required to enter the target heart chamber and deliver the repair device. This embodiment performs the repair of mitral valve regurgitation by delivering sutures to repair the defective valve with a deployment catheter that acts to reduce/eliminate mitral valve regurgitation (MR). In other embodiments, the access approach described herein can be used to access the heart for any other type of procedure, such as, for example, a heart valve replacement, repair of another heart structure or delivery of repair devices other than sutures to valve leaflets.

[0051] Embodiments of the present invention can be used as a vascular access system. It can include a standard vascular introducer that 1) eliminates the need for multiple passes of the instrument against the vein wall, 2) minimizes blood loss due to instrument leakage (circular components are more amenable to closer tolerances and sealing capability), and 3) reduces push/pull forces on the vein wall. The introducer contains seals to maintain hemostasis during instrument exchanges. A side exiting external guide catheter 102 can provide access into the right ventricle 10 as shown in FIG. 1. In one embodiment, a distal end of the external guide 102 can include a suction element to ensure that it holds its position in the right ventricle at, for example, the right ventricular apex. The system can include an internal guide catheter 104 disposed in the side exiting external guide catheter 102 design that facilitates the access through the right ventricle 10 to the right ventricular wall. The introducer and/or external guide catheter 102 can therefore function as means for accessing the right ventricle. A standard septal puncture tool 106 with a needle like end can serve as a means for creating an opening in the septum to create the hole in the ventricular septal wall 12 to provide the passageway for the guide catheter 104 through the wall as depicted in FIG. 2A. As used herein, the term catheter can refer to an elongate, generally flexible and tubular medical device that extends along a longitudinal axis and defines a diameter around the longitudinal axis.

[0052] The pre-shaped internal guide catheter 104 is then advanced into the left ventricle 14, as shown in FIG. 3, and positioned to deliver a deployment catheter 108 to properly capture a leaflet 16 of the mitral valve 18 for repair as shown in FIG. 4. The internal guide catheter 104 can therefore function as a means for positioning the deployment catheter 108 in the left ventricle. The deployment catheter 108, as shown in FIGS. 5A-5B and 6, can provide a means for deploying a repair device and can include a clamping mechanism 110 or other means for grasping for capturing the leaflet and a suture deployment mechanism including a suture capture needle 112 or other means for inserting the suture into the leaflet. The deployment catheter 108 can be exchangeable within the guide catheter 104 to permit multiple suture 114 deployments on the valve leaflet as shown in FIG. 7. Alternatively, the deployment catheter 108 can deliver several sutures 114 at one deployment. Note that in some Figures, such as FIG. 7, the external guide catheter 102 is not shown for sake of clarity.

[0053] As can be seen in FIG. 4, embodiments of the present invention provide a tri-catheter approach for accessing a heart valve to deploy a repair device onto a portion of the valve, such as a valve leaflet. The tri-catheter approach can include the external guide catheter 102, internal guide catheter 104 received within the external guide catheter 102 and deployment catheter 108 received within the internal guide catheter 104. In some embodiments, as depicted in FIG. 4, the tri-catheter arrangement can define a generally S-shaped access configuration to the valve with the catheters defining a first curve in the right atrium to access the right ventricle and a second curve where the internal guide 104 exits the external guide 102 to cross the septum and access the heart valve in the left ventricle. In one embodiment, the external guide 102 defines a curvature of about 130 degrees and the internal guide 104 has a generally U-shaped distal end that angles towards the valve to define the generally S-shaped configuration. Both external guide 102 and internal guide 104 may be given various curvatures to match the anatomy of a given patient. In one embodiment, the external guide 102 has a diameter of between 12 and 16 French and the inner guide 104 has approximately 2 French sizes smaller than the external guide 102. The delivery catheter 108 and other catheters inserted into the internal guide 104 can have a diameter that is approximately 2 French sizes smaller than the internal guide 104.

[0054] The deployment catheter 108 can alternatively or additionally deliver an additional medical repair device such as a leaflet extension or a passive valve occlusion device. A medical repair device is a device that is permanently implanted for the repair treatment or a device that supports the primary repair treatment. Such medical repair devices can be suture materials, biomatrix materials used to support or augment a tissue structure, or devices that would provide repair treatment by device assisted coaptation of one of the cardiac valves. In one embodiment, deployment catheter 108 can deliver a pledget, such as described in commonly owned, copending U.S. patent application Ser. No. 13/339,865, which is incorporated by reference herein. In another embodiment, deployment catheter 108 can deliver a replacement valve or a device that seats in the valve annulus and has a portion extending down between the valve leaflets that is anchored to the heart.

[0055] After the desired number of sutures 114 is deployed, the sutures 114 are threaded through a lumen of a septal seal device 117. The septal sealing device 117 is then advanced down the guide catheter 104 with a seal catheter and into the right ventricle 10. The device 117 is positioned to have right side and left side seal elements 116, depicted in FIG. 9, positioned on opposite sides of the septal wall 12. The sealing elements 116 are deployed to provide a means for sealing the opening in the septum with the sealing device 117 and the catheter withdrawn as shown in FIG. 8. In one embodiment, seal device 117 comprise a pre-shaped wire frame having tensioned flanges on opposing sides that abut the opposing sides of the septal wall 12 to hold the seal elements 116 in place and an internal lumen 118 extending through the device. In one embodiment, the wire frame is comprised of Nitinol.

[0056] The sutures 114 can now be tensioned from a location external of the heart to have a desired tension that provides for proper valve function. The internal lumen 118 of the septal sealing device 117 can have one or more seals 126 that provide pressure on the sutures to prevent them from easily moving to maintain the set tension on the sutures 114 and provide a means for setting the tension. Seals 126 can also serve to maintain the integrity of the lumen 118. The seal can be similar to a silicone slit seal 122 or a flap seal 120, as shown in FIG. 10, both of which facilitate release of the suture 114 position using a catheter 128 or other means for re-tensioning if desired to allow for re-tensioning, as shown in FIG. 11.

[0057] After tension of the sutures 114 is confirmed via trans-esophageal echo cardiography, for example, the sutures 114 can be fixed to the sealing device 117 for permanent anchoring of the sutures 114. The sutures 114 are threaded through a lumen in an anchoring catheter 130 to provide coaxial positioning of a locking element 132 or anchoring device that can function as a means for anchoring the sutures at the sealing device 117. Fixation can be accomplished with the anchoring catheter 130 with the releasable locking element 132 that interfaces with internal lock features 134 in the right side sealing element 116 of the sealing device 117 and locks the sutures 114 in position and permanently fixes to the sealing device 117 as shown in FIGS. 12 and 13. The locking mechanism 132 can be a rotational cam lock or a screw in element.

[0058] Once the sutures 114 are permanently fixed to the sealing element 116, the sutures 114 can be threaded through the end of a cutting catheter 136 which is advanced until it contacts the sealing element 116 as shown in FIG. 14. The sutures 114 can then be cut at the sealing element 116 with a cutting device or tool 138 in the cutting catheter 136, also shown in FIG. 15, which is then withdrawn. The intervention is then complete and the guide catheters and introducers can be withdrawn leaving behind the anchored sutures 114 as shown in FIG. 16. The access site can then be closed.

[0059] FIG. 17 depicts a flowchart of surgical steps 200 that can be taken to repair a heart valve leaflet according to an embodiment of the present invention. At step 202, the femoral or jugular vein is accessed via a cut down or Seldinger technique and an introducer with a hemostasis valve is inserted into the vein. In one embodiment, the outer diameter of the introducer is a maximum of 24 french. At step 202, access is gained to the right atrium 20 using a guide wire and an external guide catheter 102 is advanced over the guide wire to the ventricular apex. In one embodiment, the external guide catheter 102 is a side-exiting catheter. An internal guide catheter 104 is inserted into the external guide catheter following removal of the guide wire until it exits the external guide. At step 206, proper positioning of the internal guide catheter for puncture of the ventricular septal wall 12 is confirmed and a septal puncture device 106 is inserted into the internal guide 104 and advanced to the desired position at the septal wall 12 to puncture the septal wall 12. A guide wire can then be advanced through the internal guide 104 to maintain position in the left ventricle 14. The puncture tool 106 can be withdrawn and a dilator can be used to facilitate passage of the internal guide catheter 104 into the left ventricle 14 and then withdrawn.

[0060] At step 208, a suture deployment catheter 108 can be inserted into the internal guide catheter 104 and advanced in the left ventricle 14. The deployment catheter 108 can be positioned near the leaflet 16, capture the leaflet 16 with a moveable jaw 110, advance a suture needle 112 through the leaflet 16, withdraw the needle 112 back through the leaflet 16 and into the catheter 108, release the leaflet 16 and be withdrawn. In one embodiment, proper capture of the valve leaflet 16 is confirmed prior to advancing the needle 112 through the leaflet 16. In one embodiment, this can be done with a fiber optic visualization system. In one embodiment, deployment catheter 108 can be reinserted to deploy additional sutures 114 onto leaflet 16. In another embodiment, leaflet capture and suture deployment can be aided with an augmented reality navigation system utilizing magnetic tracking such as is disclosed in commonly owned, copending U.S. Provisional Application No. 61/565,795, which is hereby incorporated by reference. In some embodiments, deployment catheter 108 can deploy multiple sutures 114 onto leaflet 16 in a single insertion.

[0061] At step 210, the sutures 114 are threaded through a lumen 118 of a ventricular septal sealing device 117, which is then advanced to the ventricular septal wall 12 puncture site with a septal sealing catheter. The septal seal device 117 can have seal elements 116 deployed to seal the puncture and the septal sealing catheter is withdrawn, leaving the sutures 114 in the sealing device 117 and extending outward through the body. At step 212, the sutures 114 can be tensioned to a desired level for proper valve leaflet function. In one embodiment, proper tensioning of sutures 114 and valve leaflet function can be confirmed via transesophogeal echo. In one embodiment, tension of the sutures 114 can be released using a catheter 128 and readjusted.

[0062] At step 214, the sutures 114 are inserted into a lumen of an anchoring catheter 130, which is advanced through the internal guide 104 to the septal sealing device 117. An anchoring element 132 can then be deployed into the sealing device 117 to fix the sutures 114 in position in the sealing device 117 and the anchoring catheter 130 can be withdrawn. At step 216, a suture cutting catheter 136 is inserted into the guide catheter and used to cut the sutures adjacent the septal sealing device 117 with a cutting element 138. The cutting catheter 136, guide catheters 102, 104 and introducers can then all be withdrawn and the access site can be closed to complete the procedure.

[0063] Although the system and method described herein are primarily described in connection with intravenous access for a ventricular septal approach, it should be understood that the devices and methods described can be adapted for use with various other approaches. For example, the system can also provide venous access to the atrial septal wall for a trans-septal puncture that provides access to the left atrium. In addition, the system can be used to provide venous access to the left ventricle through the aortic valve.

[0064] It should further be noted that although the system and method described herein are primarily described with reference to repairing a heart valve leaflet, other tissue structures can be targeted for repair as well. For example, the papillary muscle, heart wall or any other intra-cardiac structure can be targeted for repair or anchoring.

[0065] In various embodiments, a heart valve repair system as described herein can be provided as a kit including the various catheters and devices described herein and instructions for repairing a heart valve of a patient as described herein. In one embodiment, the present application comprises the instructions. In another embodiment, an FDA required Instructions for Use can comprise the instructions.

[0066] Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the present invention. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, implantation locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the invention.