Minimally invasive valve replacement system

• US 20050075584A1
• Filed: 10/06/2003
• Published: 04/07/2005
• Est. Priority Date: 10/06/2003
• Status: Abandoned Application

• Current Assignee: Douglas S. Cali
• Original Assignee: Douglas S. Cali
• Inventors: Cali, Douglas S.
• Application Number:
  US10/680,733
• Publication Number:
  US 20050075584A1
• Time in Patent Office: Days
• US Class Current: 600/587
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0028 cooled
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

Methods and systems for minimally invasive replacement of a valve. The system includes a collapsible valve and anchoring structure, devices and methods for expanding the valve anchoring structure, adhesive means to seal the valve to the surrounding tissue, a catheter-based valve sizing and delivery system, native valve removal means, and a temporary valve and filter assembly to facilitate removal of debris material. The valve assembly comprises a valve and anchoring structure for the valve, dimensioned to fit substantially within the valve sinus.

Claims

1. A valve sizing apparatus, comprising;

a catheter having a distal end, a proximal end, and a central lumen adapted to fit through a body cavity,

a guidewire, an intravascular ultrasound catheter, and a balloon catheter comprising a balloon having a distal end, a proximal end, and an outer wall circumferentially surrounding a portion of the catheter at its distal portion;

a transducer positioned on the intravascular ultrasound catheter with the ability to emit and receive a signal;

a sizing window positioned over the transducer; and

an auxiliary processor for processing the ultrasonic signals operatively connected to the transducer.

2. The valve sizing apparatus of claim 1, wherein the central lumen comprises multiple lumens.

3. The valve sizing apparatus of claim 1, wherein the outer wall is compliant or non-compliant.

4. The valve sizing apparatus of claim 1, wherein the balloon is inflated to a pressure whereby the outer wall portion of the balloon with the greatest radius from the center is in contact with the body cavity.

5. The valve sizing apparatus of claim 1, wherein the balloon is proximal to the distal portion of the catheter.

6. The valve sizing apparatus of claim 1, wherein the balloon is inflated with saline.

7. The valve sizing apparatus of claim 1, wherein the transducer is positioned centrally to the balloon such that an ultrasonic sound may be emitted from the transducer in a perpendicular direction to the longitudinal axis of the intra vascular catheter and reflected by the outer wall back to the transducer.

8. The valve sizing apparatus of claim 1, wherein the balloon is inflated with gas.

9. The valve sizing apparatus of claim 1, wherein the transducer is positioned centrally to the balloon such that an infrared light may be emitted from the transducer in a perpendicular direction to the longitudinal axis of the intra vascular ultrasound catheter and reflected by the outer wall back to the transducer.

10. The valve sizing apparatus of claim 1, wherein the signal received by the transducer is processed by the auxiliary processor to determine the diameter of the inflated balloon and the body cavity.

11. A method for determining a diameter of a body cavity, comprising the steps of:

emitting a signal from a transducer through a sizing window, said transducer positioned on an intravascular ultrasound catheter guided through a body cavity by a guidewire, the intravascular catheter and guidewire share the lumen of a catheter with a balloon catheter, said balloon catheter comprising a balloon, said balloon having an outer wall circumferentially surrounding a portion of the catheter;

reflecting the signal off the outer wall of the balloon;

receiving the signal through the transducer through the sizing window positioned directly over the transducer;

transmitting data received by the transducer to an auxiliary processor for calculating the diameter of the body cavity.

12. The method of claim 11, wherein the central lumen comprises multiple lumens.

13. The method of claim 11, wherein the outer wall is compliant or non-compliant.

14. The method of claim 11, wherein the balloon is proximal to the distal portion of the catheter.

15. The method of claim 11, wherein the balloon is inflated to a pressure whereby the outer wall portion of the balloon with the greatest radius from the center is in contact with the body cavity.

16. The method of claim 11, wherein the balloon is inflated with saline.

17. The method of claim 11, wherein the transducer is positioned centrally to the balloon such that an ultrasonic sound may be emitted from the transducer in a perpendicular direction to the longitudinal axis of the intravascular ultrasound catheter and reflected by the outer wall back to the transducer.

18. The method of claim 11, wherein the balloon is inflated with gas.

19. The method of claim 11, wherein the transducer is positioned centrally to the balloon such that an infrared light may be emitted from the transducer in a perpendicular direction to the longitudinal axis of the intra vascular ultrasound catheter and reflected by the outer wall back to the transducer.

20. The method of claim 11, wherein the signal received by the transducer is processed by the auxiliary processor to determine the diameter of the inflated balloon and the body cavity.