Cardiac valve leaflet attachment device and methods thereof

• US 7,938,827 B2
• Filed: 03/10/2009
• Issued: 05/10/2011
• Est. Priority Date: 11/15/2001
• Status: Expired due to Term

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalva Incorporated
• Inventors: Hauck, Wallace Neil, Tu, Hosheng, Lichtenstein, Samuel Victor
• Primary Examiner(s): Johnson, III; Henry M
• Assistant Examiner(s): ROANE, AARON F
• Application Number:
  US12/401,551
• Publication Number:
  US 20090270858A1
• Time in Patent Office: 791 Days
• Field of Search: 606/41, 606/45, 606/47, 606 49- 52, 128/898
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00566 fixation of form upon application of vacuum
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00619 Welding

Abstract

A medical device system comprising a guide catheter and a leaflet fastening applicator, the guide catheter having suitable dimensions for deployment and insertion percutaneously into a human heart in a vicinity of a heart valve, the leaflet fastening applicator having a size allowing insertion through the guide catheter and being capable of holding portions of opposing heart valve leaflets, wherein the fastening applicator comprises a pair of grasping-electrodes adapted for holding and engaging the portions of opposing heart valve leaflets together and for applying energy to fasten the portions, in which heart valve leaflets can be captured and securely fastened, thereby improving coaptation of the leaflets and improving competence of the valve.

Claims

1. A method for treating a valvular annulus, comprising:

(a) introducing percutaneously a medical device system into a patient'"'"'s heart in a vicinity of a heart valve needing repair, the medical device system comprising;

a guide catheter configured for delivery through the patient'"'"'s vasculature to the vicinity of the heart valve comprising opposing leaflets and an annulus;

a spiral wire electrode reversibly extendable through the guide catheter that applies non-ablative energy for shrinking the annulus;

a leaflet fastening applicator sized for intravascular delivery and reversibly extendable through the guide catheter to the vicinity of the heart valve, the leaflet fastening applicator comprising;

a first grasping electrode element; and

an opposing second grasping electrode element, wherein the first and second grasping electrode elements are adapted to apply non-ablative energy;

(b) deploying the spiral wire electrode from the guide catheter such that it contacts at least a portion of the annulus;

(c) applying non-ablative energy with the spiral wire electrode to shrink the portion of the annulus contacted by the spiral wire electrode;

(d) engaging portions of the opposing leaflets with the first and second grasping electrode elements of the leaflet fastening applicator to releasably capture and hold close together the portions of the opposing leaflets; and

(e) applying non-ablative energy with the first and second grasping electrode elements to fasten together the portions of the opposing leaflets engaged by the first and second grasping electrode elements.

2. The method of claim 1, wherein applying non-ablative energy with the spiral wire electrode comprises applying non-ablative thermal energy.

3. The method of claim 1, wherein applying non-ablative energy with the spiral wire electrode comprises applying radiofrequency non-ablative energy.

4. The method of claim 1, further comprising injecting a solution through an internal lumen of the guide catheter, wherein the solution for injection is selected from a group consisting of heparin, aspirin, saline, antibiotic solution, anti-inflammatory solution, and anti-septic solution.

5. The method of claim 1, wherein engaging the portions of the opposing leaflets comprises engaging the portions of the opposing leaflets between a plurality of spikes of the first grasping electrode element and a plurality of recesses of the second electrode grasping element.

6. The method of claim 1, wherein releasably capture and hold close together the portions of the opposing leaflets comprises applying suction from a vacuum port of a gripper extending from an internal lumen of the guide catheter.

7. The method of claim 1, wherein applying non-ablative energy with the first and second grasping electrode elements comprises applying non-ablative thermal energy.

8. The method of claim 1, wherein applying non-ablative energy with the first and second grasping electrode elements comprises applying non-ablative radiofrequency energy.

9. The method of claim 1, further comprising an external radiofrequency energy source, wherein radiofrequency energy is provided from the external radiofrequency energy source to the first and second grasping electrode elements.

10. The method of claim 1, wherein applying non-ablative energy with the spiral wire electrode to shrink the portion of the annulus contacted by the spiral wire electrode comprises tightening collagen tissue surrounding the portion of the annulus.