System and method for stimulation and/or enhancement of myocardial angiogenesis

• US 6,755,821 B1
• Filed: 12/08/1999
• Issued: 06/29/2004
• Est. Priority Date: 12/08/1998
• Status: Expired due to Fees

• Current Assignee: Cardiocavitational Systems Incorporated
• Original Assignee: Cardiocavitational Systems Incorporated
• Inventors: Fry, Stephen M.
• Primary Examiner(s): Shay, David M.
• Application Number:
  US09/457,490
• Time in Patent Office: 1,665 Days
• Field of Search: 604/19, 604/20, 604/22, 606/3, 606/7, 606/10-16, 606/167-170, 606/185, 606/41, 606/45, 606/46
• US Class Current: 606/15
• CPC Class Codes: A61B 17/22022 using electric discharge
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Shock-waves are applied using a combination lithotripsy probe/balloon system, comprising a needle and cannular balloon which can be inserted through the skin at a point between the ribs into the cavity beneath the chest wall and overlying the heart. Alternatively, the shock-wave can be administered extracorporally or via a catheter. A fluid injector is connected to the balloon, allowing it to be inflated with saline or other appropriate fluid to fill the space (for transmission of shock waves and/or to displace tissue—such as lung) and contact the surface of the heart. A shock-wave (acoustic) generator is used to generate shock-waves through the lithotripsy probe, through the fluid and into the myocardial tissue. The fluid provides a uniform medium for transmission of the acoustic energy, allowing precise focus and direction of the shock-wave to induce repeatable cavitation events, producing small fissures which are created by the cavitation bubbles. In this case, channels would not be ‘drilled’ into the heart muscle, minimizing trauma to the tissue while still creating conditions that will stimulate increased expression of angiogenic growth factors.

Claims

1. A system for treatment of coronary disease comprising:

a generator for producing a shock wave for inducing cavitation effect in myocardium functionally connected to

a delivery system comprising an intracorporeal delivery portion for transmitting shockwaves directly to the myocardium;

a fluid-inflatable balloon disposed at a distal end of the delivery portion; and

a means for inflating and deflating the balloon wherein the system produces shockwaves in the myocardium.

2. The system of claim 1, wherein the generator comprises an extracorporeal shock wave lithotrypsy system.

3. The system of claim 1, wherein the generator comprises an electrical power source and a transducer, and the delivery system comprises a shock wave transmitting connector connected to the transducer and extending through to a distal end of an intracorporeal delivery portion wherein the intracoporeal delivery portion is selected from the group consisting of an endoscope, a lithotrispy probe, a hand-held surgical probe, and a catheter.

4. The system of claim 1, wherein the fluid-inflatable balloon is inflated using a saline solution.

5. The system of claim 1, wherein the generator comprises an electrical spark generator and a metal cap, and the delivery system comprises:

a wire connected at a proximal end to the spark generator and at a distal end to the metal cap; and

a delivery portion comprising a device for manipulating a position of the metal cap selected from the group consisting of an endoscope, a lithotripsy probe, a hand held surgical probe, and a catheter.

6. The system of claim 1, wherein the generator comprises an electrical power source and a transducer disposed between the generator and the intracorporeal delivery portion and the delivery system includes a connector for providing electrical power from the power source to the transducer.

7. The system of claim 6, wherein the delivery system further comprises a delivery device selected from the group consisting of an endoscope, an extracorporeal lithotripsy probe, a hand-held surgical probe, and a catheter.

8. The system of claim 1, wherein the generator comprises a laser and an electro-optical transducer for converting laser light into a shock-wave and the delivery system comprises:

an optical fiber extending from an output of the laser to the electro-optical transducer; and

a delivery portion comprising a manipulating device selected from the group consisting of an endoscope, a lithotripsy probe, a hand held surgical probe, and a catheter.

9. The system of claim 1, further comprising means for introducing one or more growth factor modulators either systemically or locally to the heart tissue.

10. A system for treating heart disease in a patient comprising:

an extracorporeal shock-wave generator;

a device for coupling shock waves from the generator to an outer chest wall of the patient; and

a needle/cannula-balloon device for coupling shock waves from the coupling device to the myocardium comprising;

a cannula;

a shock-wave transmitting connector;

a fluid inflatable balloon; and

a channel within the cannula for transmitting fluid to the balloon.

11. The system of claim 10, further comprising a channel for introducing at least one growth factor modulator.