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Tensioning device and methods for use

Inactive Publication Date: 2011-12-22
KOCATURK OZGUR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]In another embodiment, a locking device for securing two portions of suture together is provided. The locking device comprises an enclosure having an internal cavity and a distal opening at a distal end of the enclosure. A moveable member having a distal end is positioned at least partially within the internal cavity, such that it is moveable within the cavity between a first position and a second position. A snare member having a loop that extends from the distal end of the moveable member is also provided. The loop can extend at least partially out of the distal opening of the enclosure. An effective diameter of the loop is the portion of the loop that extends out of the opening, and the effective diameter of the loop when the moveable member is in the first position is smaller than the effective diameter of the loop when the moveable member is in the second position. In some embodiments, the effective diameter of the loop when the moveable member is in the first position is smaller than the combined diameter of two portions of suture that are to be secured by the locking device. In other embodiments, a biasing member can extend from the moveable member and at least partly engage the enclosure to restrict movement of the moveable member from the first position to the second position. The biasing member can comprise one or more curved Nitinol arms. In other embodiments, the moveable member can comprise an internal cavity and a portion of a handle member can be moveable mounted within the internal cavity. By moving the handle member in the distal direction, the portion of the handle member in the internal cavity can release the biasing member and permit movement of the moveable member from the first position to the second position.
[0007]In another embodiment, a method for treating mitral valve regurgitation includes the acts of forming a loop of suture around a mitral valve annulus and positioning two portions of the suture through a loop of a snare member. The snare member extends from a distal opening in an enclosure and is mounted to a distal end of a moveable member that is mounted at least partially within a cavity of the enclosure. Tension of the suture can be adjusted to reduce mitral valve annulus size by moving the loop of the snare member along the suture. Tension of the suture around the mitral valve annulus can then be locked by moving the moveable member within the cavity and causing a portion of the loop to move into the enclosure through the distal opening, thereby reducing an effective diameter of the portion of the loop that extends out of the distal opening.

Problems solved by technology

Mitral valve regurgitation, however, is characterized by leakage of the blood backwards, i.e., from the left ventricle to the left atrium.
If left untreated, mitral valve regurgitation can weaken the heart over time and lead to heart failure.

Method used

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  • Tensioning device and methods for use
  • Tensioning device and methods for use
  • Tensioning device and methods for use

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0058]This example demonstrates a method for treating mitral valve regurgitation.

Animal Preparation and Inducement of Ischemic Mitral Regurgitation

[0059]Animal procedures are approved by the National Heart, Lung, and Blood Institute Animal Care and Use Committee. A total of sixty-nine (69) swine are used in this experiment. Among them, thirty-eight (38) swine are assigned to the model of ischemic mitral regurgitation. Catheter-based myocardial infarction with intracoronary ethanol injection are employed to induce ischemic mitral regurgitation. Amiodarone (400 mg daily for 5 to 7 days) and atenolol (25 mg daily for 3 days) are given as a pre-procedural medication. Anesthesia is induced with the use of atropine, butorphanol, ketamine, and xylazine and maintained with the use of isoflurane (via inhalation) and mechanical ventilation. Animals receive intravenous heparin (50 U / kg) before transfemoral arterial and venous access.

[0060]The left circumflex (LCx) artery is primarily targeted ...

example 2

[0072]This example demonstrates a method of treating mitral valve regurgitation.

[0073]Eleven (11) animals are prepared and ischemic mitral regurgitation is induced as described in Example 1. The cerclage procedure described in Example 1 is followed, except that the cerclage follows a right atrial (RA) trajectory through the heart, as follows: The guidewire exits the septal vein and extends further posterior through the basal IVS into the right atrium near the coronary sinus.

[0074]It is observed that the tensioning device places well within the right atrium and that the tensioning device maintains the desired tension in place in 8 out of 11 animals (72.7%) in the RA cerclage group. The results are shown in Table 2.

TABLE 2RA Cerclage(n = 11)P valueProcedural success (n, %)8 (72.7%)Procedural failure (n, %)3 (27.2%)P = 0.77Wrong exit (n, %)3 (27.2%)Coronary sinus (CS) dissection / thombosis (n,0%)Fluoroscopic time (min)133.8 ± 84.8P = 0.014Major complications1 (9.1%) P = 0.34Tamponade1Un...

example 3

[0076]This example demonstrates that the method for treating mitral valve regurgitation using the tensioning device according to the invention reduces the septal-lateral dimension of the mitral annulus and reduces left ventricular ejection.

[0077]The animal preparation, inducement of ischemic mitral regurgitation, and cerclage procedures of Examples 1 and 2 are followed. The septal-lateral dimension of the mitral annulus and ventricular volumes are measured. The results are shown in Table 3.

TABLE 3BaselineTensionp valueMitral annulusSeptal-lateral annulardiameter (cm)systole3.1 ± 0.42.5 ± 0.4diastole3.4 ± 0.62.9 ± 0.5Commissural Width (cm)systole2.6 ± 0.32.2 ± 0.80.41diastole2.6 ± 0.42.2 ± 1.00.28Cerclage diameterCerclage diameter (cm)6.2 ± 0.84.5 ± 0.8Left ventriclediastolic LVID (cm)5.4 ± 0.65.3 ± 0.60.40systolic LVID (cm)4.7 ± 0.54.6 ± 0.70.45End-systolic volume (ml)106 ± 43 98 ± 370.22End-diastolic volume (ml)172 ± 55 158 ± 52 0.09Ejection fraction0.39 ± 0.080.34 ± 0.040.04

[0078]...

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Abstract

A tensioning device is provided comprising a locking device. The locking device comprises a locking enclosure comprising a groove and a locking pin comprising teeth. The tensioning device further comprises a suture comprising first and second portions. The first and second portions of the suture and the locking pin are positioned within the groove of the locking enclosure and the locking pin is movable within the groove between a first, outer position in which the teeth are disengaged from the suture so that the locking device is movable along the first and second portions of the suture and a second, inner position in which the teeth are engaged with the suture so that the locking device is not movable along the suture. Methods for treating mitral valve regurgitation are also provided.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of priority of U.S. Provisional Application No. 61 / 157,267, filed Mar. 4, 2009, which is herein incorporated by reference in its entirety.BACKGROUND OF THE INVENTION[0002]Mitral valve regurgitation is a cardiac valve disorder characterized by the abnormal leakage of blood from the left ventricle to the left atrium due to inadequate coaptation of the mitral valve leaflets. Normal blood flow passes from the left atrium to the left ventricle. Mitral valve regurgitation, however, is characterized by leakage of the blood backwards, i.e., from the left ventricle to the left atrium. Mitral valve regurgitation may be caused by any of a variety of injuries or diseases of the cardiovascular system, for example, myocardial infarction, cardiomyopathy, cardiac fibrosis, ischemia, hypertension, myxomatous degeneration of the valve, myocarditis, and enlargement of the mitral annulus and / or left ventricular cavity. If l...

Claims

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Application Information

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IPC IPC(8): A61B17/04
CPCA61B17/0487A61B2017/0409F16G11/04A61B2017/0496A61B2017/0451F16G11/101F16G11/106F16G11/14A61F2/2445A61F2/246A61F2/2466
Inventor KOCATURK, OZGUR
Owner KOCATURK OZGUR
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