Device for treatment of atrioventricular valve regurgitation

• US 20030114901A1
• Filed: 12/19/2001
• Published: 06/19/2003
• Est. Priority Date: 12/19/2001
• Status: Active Grant

• Current Assignee: Trimedyne Incorporated (InnovaQuartz, LLC)
• Original Assignee: Trimedyne Incorporated (InnovaQuartz, LLC)
• Inventors: Loeb, Marvin P., Crawford, L. Dean, Graham, Randy P.
• Granted Patent: US 6,740,107 B2
• Time in Patent Office: Days
• US Class Current: 607/89
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22059 transparent
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/2211 Plurality of fibres
• CPC Class Codes: A61B 2018/2277 with refractive surfaces

Abstract

A catheter device suitable for shrinking chordae tendineae of the human heart is provided having an energy conduit and a positioning device that facilitates the delivery of thermal energy, including coherent (laser) or non-coherent light, RF, microwave or ultrasound energy, to a predetermined region of the chordae tendineae or other collagen-containing tissue, such as the female urethra or the esophagus near the sphincter. The device comprises a tubular catheter containing an energy conduit, such as a fiber optic cable, adapted for delivering thermal energy to the tissue. The tubular catheter also contain a stabilizing device, disposed at its distal end, such as an asymmetrically shaped balloon or a retractable flexible metal hook. With the distal end of the catheter device positioned within a human heart, application of thermal energy to the chordae tendineae results in a shrinkage of the chordae, providing a treatment for primary mitral valve regurgitation.

Claims

1. A catheter device, suitable for shrinking chordae tendineae of the human heart, having a proximal end for connection to a thermal energy source, a tubular body portion, and a distal end adapted for delivering thermal energy to a predetermined region of the chordae tendineae, which catheter device comprises:

(a) a tubular sheath;

(b) an energy conduit within the sheath having a proximal end adapted for attachment to an energy source and a distal end portion adapted for delivering thermal energy to the predetermined region of the chordae tendineae; and

(c) a stabilizer device at a distal end portion of the sheath.

2. A catheter device, suitable for shrinking chordae tendineae of the human heart, having a proximal end for connection to a thermal energy source, a tubular body portion, and a distal end adapted for delivering thermal energy to a predetermined region of the chordae tendineae, which catheter device comprises:

(a) a tubular sheath;

(b) an energy conduit within the sheath and having a proximal end adapted for coupling to an energy source and a distal end portion adapted for delivering thermal energy to the predetermined region of the chordae tendineae;

(c) a source of energy operably coupled to the proximal end of the energy conduit; and

(d) a stabilizer device at or just proximal to the distal end of the sheath.

3. A catheter device, suitable for shrinking collagen in a patient'"'"'s body tissue, having a proximal end for connection to a thermal energy source, a tubular body portion, and a distal end adapted for delivering thermal energy to the tissue, which catheter device comprises:

(a) a hollow catheter defining a first lumen, having a closed distal end and a distal end portion defining an aperture in the first lumen;

(b) an optical fiber within the first lumen of the catheter having a proximal end adapted for attachment to a laser source and a distal end portion situated within the distal end portion of the catheter, opposite the aperture;

(c) an inflatable balloon affixed over the distal end portion of the catheter and covering the aperture therein; and

(d) a hollow, cylindrical handpiece, affixed to the proximal end of the catheter and in open communication with the first lumen, said handpiece defining a port for delivery of an inflation medium to the balloon through the first lumen and aperture;

wherein the distal end portion of the optical fiber is adapted to emit laser energy through the aperture in the distal end portion of the catheter; and

the balloon has an asymmetric shape when inflated, the portion of the balloon facing the aperture being larger in radius than the portion of the balloon on the side opposite to the side of the catheter facing the aperture, such that the laser energy is directionally emitted through a relatively larger portion of the balloon.

4. The catheter device of claim 3 wherein the distal end of the optical fiber is beveled at an angle of about 39 degrees and the distal end portion of the optical fiber is sealed within a glass capillary tube, such that laser energy is emitted at an angle of about 60 to about 100 degrees from the axis of the distal end portion of the fiber when the optical fiber is attached to a laser energy source.

5. The catheter device of claim 3 wherein the distal end portion of the catheter further defines a guide lumen, adapted for acceptance of a guide wire, said guide lumen comprising a tube penetrating the cannula at points spaced proximally and distally to the balloon and extending through the catheter between said points behind the optical fiber.

6. The catheter device of claim 3 further comprising a control wire within the first lumen of the catheter, said control wire having a distal end and a proximal end, the distal end of the control wire being attached to an inner surface of distal end portion of the catheter, said control wire being adapted to manipulate the position and orientation of the distal end portion of the catheter.

7. The catheter device of claim 6 wherein the handpiece comprises a lever within a channel, said lever being operably attached to the control wire, such that movement of the lever within the channel causes the distal end portion of the catheter to bend in response to said lever movement.

8. The catheter device of claim 6 wherein the handpiece contains a reel mechanism comprising a shaft and a knob that is fixedly attached to one end of the shaft, wherein said shaft is pivotally moveable within said handpiece, said shaft being operably attached to the control wire, such that turning the knob causes the distal end portion of the catheter to bend in response to the turning of the knob.

9. The catheter device of claim 3 wherein the catheter further comprises a second lumen, and

(e) a flexible metal rod is slidably disposed within the second lumen, said rod having a permanently curved end portion and a blunt distal end.

10. The catheter device of claim 9 wherein the flexible metal rod comprises a superelastic shape memory alloy of nickel and titanium.

11. The catheter device of claim 3 further comprising at least one thermocouple positioned at the distal end portion of the catheter, within the balloon, or on the surface of the balloon, adapted for measuring the temperature of the inflation medium in the balloon or the temperature at the surface of the balloon, respectively.

12. The catheter device of claim 3 further comprising a source of laser energy, operably coupled to the proximal end of the optical fiber.

13. The catheter device of claim 3 wherein the inflation medium is a cooling fluid, capable of cooling a tissue in contact with the balloon.

14. A catheter device, suitable for shrinking the chordae tendineae of the human heart, having a proximal end for connection to a thermal energy source, a tubular body portion, and a distal end adapted for delivering thermal energy to the chordae tendineae, which catheter device comprises:

(a) a tubular sheath having an opening at its distal end;

(b) an energy conducting cable, slidably disposed within the sheath, having a proximal end adapted for attachment to an energy source and a distal end portion adapted for delivering thermal energy to a predetermined region of the chordae tendineae; and

(c) a flexible metal rod slidably disposed within the sheath, having a permanently curved end portion and a blunt distal end.

15. The catheter device of claim 14 wherein the energy conducting cable is a fiber optic bundle comprising at least one optical fiber having a core diameter in the range of about 100 microns to about 600 microns.

16. The catheter device of claim 15 wherein the optical fiber comprises a distal end portion that can be extended up to about 25 millimeters beyond the distal opening of the sheath when the fiber optic bundle is moved distally relative to the sheath.

17. The catheter device of claim 14 wherein the flexible metal rod is composed of a superelastic shape memory alloy comprising nickel and titanium.

18. The catheter device of claim 14 wherein the energy conducting cable contains at least one terminal in a distal end portion comprising a radio frequency electrode.

19. The catheter device of claim 14 wherein the energy conducting cable comprises a pair of leads having a proximal end adapted for connection to an electrical power source and a distal end portion operably connected to an ultrasonic generator.

20. The catheter device of claim 19 wherein the ultrasonic generator is selected from the group consisting of a piezoelectric generator and a magnetostrictive generator.

21. The catheter device of claim 14 wherein the energy conducting cable comprises a pair of leads having a proximal end adapted for connection to an electrical power source and a distal end portion operably connected to a resistive heating loop.

22. The catheter device of claim 14 further comprising a hollow, substantially cylindrical handpiece, attached to the proximal end of the catheter, said handpiece comprising a mechanism for extending the distal end portion of the energy conducting cable beyond the opening at the distal end of the sheath.

23. The catheter device of claim 14 further comprising a source of energy operably coupled to the proximal end of the energy conducting cable.

24. A catheter device, suitable for shrinking the chordae tendineae of the human heart, having a proximal end for connection to a thermal energy source, a tubular body portion, and a distal end adapted for delivering thermal energy to the chordae tendineae, which catheter device comprises:

(a) a tubular sheath defining at least a first lumen and a second lumen, each lumen having an opening at its distal end;

(b) a fiber optic bundle, having a proximal end adapted for attachment to a source of laser energy, comprising a plurality of optical fibers, slidably disposed within the first lumen of the sheath; and

(c) a flexible metal rod having a permanently curved end portion and a blunt distal end, slidably disposed within the second lumen of the sheath.

25. The catheter device of claim 24 wherein the optical fibers have core diameters in the range of about 100 microns to about 600 microns.

26. The catheter device of claim 24 wherein each optical fiber comprises a distal end portion that can be extended up to about 25 millimeters beyond the opening at the distal end of the first lumen of the sheath when the fiber optic bundle is moved distally relative to the sheath.

27. The catheter device of claim 26 wherein the distal end portions of the optical fibers form a substantially conical array when extended beyond the opening at the distal end of the first lumen of the sheath.

28. The catheter device of claim 26 wherein the distal end portions of the optical fibers form a substantially linear array when extended beyond the opening at the distal end of the first lumen of the sheath.

29. The catheter device of claim 26 wherein the distal end portions of the optical fibers form a substantially curved array when extended beyond the opening at the distal end of the first lumen of the sheath.

30. The catheter device of claim 26 wherein the distal end portions of the optical fibers form a substantially v-shaped array when extended beyond the opening at the distal end of the first lumen of the sheath.

31. The catheter device of claim 24 further comprising a source of laser energy operably coupled to the proximal end of the fiber optic bundle.

32. A catheter device, suitable for shrinking the chordae tendineae of the human heart, having a proximal end for connection to a thermal energy source, a tubular body portion, and a distal end adapted for delivering thermal energy to the chordae tendineae, which catheter device comprises:

(a) a tubular sheath defining at least a first lumen and a second lumen, each lumen having an opening at its distal end;

(b) a fiber optic bundle, having a proximal end adapted for attachment to a source of laser energy, comprising a plurality of optical fibers, slidably disposed within the first lumen, each fiber having a distal end portion comprising a flexible curved metal tube, coaxially disposed over and affixed to the end portion of the fiber, such that the distal end of each fiber terminates just proximal to the distal end of the tube; and

(c) a flexible metal rod having a permanently curved end portion and a blunt distal end, slidably disposed within the second lumen of the sheath.

33. The catheter device of claim 32 wherein the optical fibers have core diameters in the range of about 100 microns to about 600 microns.

34. The catheter device of claim 32 wherein the distal end of each tube is beveled in the shape of a syringe needle, the beveled end being capable of penetrating a tissue into which it is extended.

35. The catheter device of claim 39 further comprising a source of laser energy operably coupled to the proximal end of the fiber optic bundle.