Valve aptation assist device

• US 7,404,824 B1
• Filed: 11/12/2003
• Issued: 07/29/2008
• Est. Priority Date: 11/15/2002
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Bisson, Brad D., Hyde, Gregory M., Asongwe, Gabriel, Webler, William E., Szobota, Stephanie A., Ellis, Jeffrey T., Mourtada, Firas, Breeding, James D.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/712,553
• Time in Patent Office: 1,721 Days
• Field of Search: 623 21- 31, 623 211- 236
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral

Abstract

An apparatus including a tether, and an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, wherein the tether and aptation device are suitable for percutaneous delivery to a patient. An apparatus including a support annulus comprising a length corresponding to a circumference of one of an interior portion of an atrium and an atrioventricular valve annulus; and an aptation device coupled to the support annulus corresponding to a location to contact cusps of an atrioventricular valve during at least one of systole when the support annulus is seated in one of an atrium and an atrioventricular valve annulus, wherein the support annulus and aptation device are suitable for percutaneous delivery to a patient. Also, a method of introducing an aptation device to contact cusps or leaflets of an atrioventricular valve.

Claims

1. An apparatus comprising:

a tether having a length configured for extending through a ventricle of a heart from, at a proximal end, an atrioventricular valve annulus to, at a distal end, one of a wall of a ventricle and a papillary muscle within the ventricle;

an aptation device coupled about an axis of the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, the aptation device comprising a body having a cross-sectional dimension greater than a cross-sectional dimension of the tether and that is deformable in response to forces applied to the aption device by cusps of an atrioventricular valve; and

a fastening member coupled to the tether including a projection capable of anchoring the fastening member to a wall of a ventricle of a heart,

wherein the tether and aptation device are suitable for percutaneous delivery to a patient, and

wherein the tether extends through the aptation device and the distal end of the tether extends beyond a distal end of the aptation device.

2. The apparatus of claim 1, wherein the tether comprises sufficient torsional stiffness to respond in kind at the distal end to a torque applied at the proximal end.

3. The apparatus of claim 1, wherein the fastening member is coupled to a distal end of the tether and the tether comprises sufficient tensile stiffness to withstand an extension of the tether in response to ventricular pressure changes.

4. The apparatus of claim 1, wherein the fastening member is coupled to a distal end of the tether and is adapted to couple the tether to a wall of a ventricle in response to a torque applied to the proximal end of the tether.

5. The apparatus of claim 1, wherein the aptation device is coupled about the tether at a position corresponding to a position between cusps of an atrioventricular valve when the tether is positioned through an atrioventricular valve, and having a size suitable, when placed between cusps of an atrioventricular valve, that the cusps will aptate against the aptation device.

6. The apparatus of claim 5, wherein the aptation device comprises a cylindrical body.

7. The apparatus of claim 5, wherein a proximal end of the aptation device is coupled about an axis of the tether.

8. The apparatus of claim 5, wherein the aptation device comprises an ellipsoid body.

9. The apparatus of claim 1, wherein the aptation device has a size that is less than a commissure of the cusps of the atrioventricular valve.

10. The apparatus of claim 1, wherein the aptation device comprises a material that inhibits thrombosis.

11. The apparatus of claim 1, wherein a coupling point of the aptation device to the tether is adjustable.

12. An apparatus comprising:

a tether having a length suitable for extending through a ventricle of a heart from, at a proximal end, an atrioventricular valve annulus to, at a distal end, one of a wall of a ventricle and a papillary muscle within the ventricle wherein the tether comprises a sheath and a duplex spring, wherein the sheath surrounds the duplex spring about a length of the duplex spring;

an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, the aptation device comprising a body having a cross-sectional dimension greater than a cross-sectional dimension of the tether; and

a fastening member including a projection capable of anchoring the fastening member to a wall of a ventricle of a heart,

wherein the tether and aptation device are suitable for percutaneous delivery to a patient, and

wherein the distal end of the tether extends beyond a distal end of the aptation device.

13. The apparatus of claim 12, wherein the sheath of the tether comprises a material that resists thrombosis.

14. An apparatus comprising:

a tether having a length suitable for extending through a ventricle of a heart from, at a proximal end, an atrioventricular valve annulus to, at a distal end, one of a wall of a ventricle and a papillary muscle within the ventricle;

an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, the aptation device comprising a body having a cross-sectional dimension greater than a cross-sectional dimension of the tether; and

a fastening member including a helical anchor coupled to a distal end of the tether having a length that may be completely embedded in a wall of a ventricle,

wherein the tether and aptation device are suitable for percutaneous delivery to a patient, and

wherein the distal end of the tether extends beyond a distal end of the aptation device.

15. The apparatus of claim 14, wherein the helical anchor comprises a barbed coiled spring.

16. An apparatus comprising:

a tether having a length suitable for extending through a ventricle of a heart from, at a proximal end, an atrioventricular valve annulus to, at a distal end, one of a wall of a ventricle and a papillary muscle within the ventricle;

an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, the aptation device comprising a body having a cross-sectional dimension greater than a cross-sectional dimension of the tether; and

a fastening member comprising a projection capable of anchoring the fastening member to a wall of a ventricle of a heart,

wherein the tether and aptation device are suitable for percutaneous delivery to a patient,

wherein the distal end of the tether extends beyond a distal end of the aptation device, and

wherein the distal end of the tether comprises a fastening member adapted to couple the tether to a wall of a ventricle in response to a torque applied to the proximal end of the tether and a patch having a cross-sectional area greater than a cross-sectional area of the tether and coupled about an axis of the tether at a portion proximal to the fastening member.

17. An apparatus comprising:

a tether having a length suitable for extending through a ventricle of a heart from, at a proximal end, an atrioventricular valve annulus to, at a distal end, one of a wall of a ventricle and a papillary muscle within the ventricle;

an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, the aptation device comprising a body having a cross-sectional dimension greater than a cross-sectional dimension of the tether; and

a fastening member including a projection capable of anchoring the fastening member to a wall of a ventricle of a heart,

wherein the tether and aptation device are suitable for percutaneous delivery to a patient,

wherein the distal end of the tether extends beyond a distal end of the aptation device, and

wherein the tether has a length suitable for extending, at a proximal end, through an interatrial septum, the apparatus further comprising a patch having a cross-sectional area greater than a cross-sectional area of the tether and coupled about an axis of the tether at a portion, when the tether is placed through an interatrial septum and coupled at its distal end to a wall of a ventricle, that is proximal to the interatrial septum.

18. The apparatus of claim 17, further comprising a fastening member adapted to fasten a distal side of the patch to the interatrial septum.

19. The apparatus of claim 18, further comprising a stop coupled to the tether at a position on the proximal side of the patch.

20. An apparatus comprising:

a tether having a length suitable for extending through a ventricle of a heart from, at a proximal end, an atrioventricular valve annulus to, at a distal end, one of a wall of a ventricle and a papillary muscle within the ventricle;

an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, the aptation device comprising a body having a cross-sectional dimension greater than a cross-sectional dimension of the tether; and

a fastening member including a projection capable of anchoring the fastening member to a wall of a ventricle of a heart,

wherein the tether and aptation device are suitable for percutaneous delivery to a patient,

wherein the distal end of the tether extends beyond a distal end of the aptation device, and

wherein the aptation device is coupled to the tether at a position corresponding to a position completely within an atrium during systole when the tether is positioned through an atrioventricular valve, such that one or both cusps contact a surface of the aptation device during systole.

21. An apparatus comprising:

a tether having a length suitable for extending through a ventricle of a heart from, at a proximal end, an atrioventricular valve annulus to, at a distal end, one of a wall of a ventricle and a papillary muscle within the ventricle;

an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, the aptation device comprising a body having a cross-sectional dimension greater than a cross-sectional dimension of the tether; and

a fastening member including a projection capable of anchoring the fastening member to a wall of a ventricle of a heart,

wherein the tether and aptation device are suitable for percutaneous delivery to a patient,

wherein the distal end of the tether extends beyond a distal end of the aptation device, and

wherein the tether comprises a conductive lead.