Device and method for myocardial revascularization

• US 6,695,836 B1
• Filed: 07/03/2000
• Issued: 02/24/2004
• Est. Priority Date: 07/03/2000
• Status: Expired due to Term

• Current Assignee: Radius Medical Technologies, Inc. (Teleflex Incorporated)
• Original Assignee: Radius Medical Technologies, Inc. (Teleflex Incorporated)
• Inventors: DeMello, Richard M., Finlayson, Maureen A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/609,410
• Time in Patent Office: 1,331 Days
• Field of Search: 606/27-29, 606/31-34, 606/41, 606/42, 606/45-50, 607/101, 607/102, 607/98
• US Class Current: 606/28
• 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 2017/00092 using thermocouples
• 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: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

A device and method for treating tissue at a treatment site. The device and method include supplying controlled energy to a heating portion of the device positioned within a tissue wall at the treatment site. The size of the heating portion and energy supplied provides for ablation of the tissue to form a cavity within the tissue wall without ablating the surfaces of the tissue wall. Treatment fluid can then be supplied through the device to the cavity to supplement growth of blood vessels or retard such growth at the treatment site. The device can also be used to create an injury zone at a treatment site without ablating tissue, wherein the injury zone can be injected with treatment fluid. The device and method has use anywhere within the body, especially in the regions of the heart.

Claims

1. A treatment device for body tissue comprising:

a proximal end assembly including a controller and energy generator; and

a distal end assembly connected to the proximal end assembly through a body portion, the distal end assembly including a heating portion located distal of a nonconductive portion, the heating portion being operably connected to the controller and energy generator to receive controlled energy therefrom, and the heating portion and nonconductive portion of the distal end assembly are sized so that the heating portion, when inserted into the myocardium of a human heart, is completely located between the epicardium and endocardium and in contact with the surrounding tissue to be ablated, and the nonconductive portion extends through one of the epicardium and endocardium, and includes a proximal boundary allowing the heating portion to be exposed beyond said proximal boundary whereby energy supplied to the heating portion ablates the surrounding myocardium tissue to form a cavity therein while said proximal boundary of the nonconductive portion substantially prevents the ablating of the entry through the epicardium or endocardium to produce a cavity entry with a smaller diameter than the cavity, and

the proximal end assembly further includes an injection assembly fluidly connected to the distal end assembly so as to allow fluid to be injected through the distal end assembly and into the cavity formed in the myocardium, the injection assembly including a syringe mechanism, with the body portion including a hollow lumen, and the distal end assembly including a hollow portion and exit areas, so that fluid released from the syringe mechanism travels through the hollow lumen, into the hollow portion of the distal end assembly, through the exit areas, and into the cavity formed in the myocardium, and

the distal end assembly includes a heating element in the shape of a coil spring, and the fluid injected into the cavity exits the distal end assembly through gaps in the coil spring.

2. The treatment device according to claim 1, wherein the heating portion of the distal end assembly is approximately two millimeters long.

3. The treatment device according to claim 2, wherein the proximal boundary of the nonconductive portion of the distal end assembly is at least two millimeters long.

4. The treatment device according to claim 1, wherein the distal end assembly includes a heating element having a pointed distal tip, and the nonconductive portion is formed by covering a portion of the heating element with a nonconductive sleeve, while allowing the remaining portion of the heating element to be exposed.

5. The treatment device according to claim 4, wherein the distal end assembly includes a protrusion for limiting the depth of insertion of the heating portion into the myocardium.

6. The treatment device according to claim 4, wherein the energy generator supplies controlled radio requency energy to the heating portion of the distal end assembly.

7. A method for treating tissue within a body comprising the steps of:

inserting a distal end assembly of a tissue treatment device into a tissue wall of the body, said distal end assembly having a heating portion and a nonconductive portion;

providing on said nonconductive portion a proximal boundary allowing insertion into the tissue wall and providing a protective distance between the tissue wall and said heating portion; and

forming a cavity completely within surfaces of said tissue wall and a smaller-diameter entry to the cavity through a selected surface of the tissue wall by supplying controlled energy to the heating portion of the distal end assembly, the energy supplied being sufficient to ablate tissue between the surfaces in contact with the heating portion, with the nonconductive portion being positioned to prevent ablation of the selected surface of the tissue wall.

8. The method for treating tissue according to claim 7, wherein the tissue wall is a wall of a human heart.

9. The method for treating tissue according to claim 7, wherein the insertion step includes locating the heating portion within the tissue wall so that a proximal-most portion of the heating portion is approximately two millimeters from a tissue surface from which the heating portion entered the tissue wall.

10. The method for treating tissue according to claim 9, wherein the energy is supplied from one of a radiofrequency generator, an ultrasound generator and a laser generator.

11. The method for treating tissue according to claim 7, further including the step of injecting a treatment fluid from a proximal end of the tissue treatment device through the distal end assembly and into the cavity formed in the tissue wall.

12. The method for treating tissue according to claim 11, wherein the treatment fluid is a tissue growth factor.

13. The method for treating tissue according to claim 11, wherein the treatment fluid is a tissue anti-growth factor.

14. The method for treating tissue according to claim 7, further including the steps of:

injecting a sealing fluid after injection of the treatment fluid, and

removing the distal end assembly from the tissue wall, the sealing fluid helping to seal the treatment fluid within the cavity when the distal end assembly is removed from the tissue wall.

15. A method for treating tissue within a body comprising the steps of:

inserting a distal end assembly of a tissue treatment device into a tissue wall of the body, until a heating portion of the distal end assembly is positioned between surfaces of the tissue wall and a non-conducting portion of the distal end assembly is in contact with the selected surface of the tissue wall through which the assembly is inserted;

supplying controlled energy to the heating portion of the distal end assembly to heat the tissue wall to produce within the surfaces of the tissue wall a cavity that is larger than the entry to the cavity through the selected surface by ablating the tissue that is in contact with the heating portion; and

injecting a treatment fluid from a proximal end of the tissue treatment device through the distal end assembly and into the cavity in the tissue wall.

16. The method for treating tissue according to claim 15, wherein the tissue wall is a wall of a human heart.

17. The method for treating tissue according to claim 15, further including the step of:

forming a cavity within surfaces of said tissue wall by supplying the controlled energy to the heating portion at a level sufficient to ablate tissue between surfaces of the tissue wall without ablating a surface of the tissue wall.

18. The method for treating tissue according to claim 17, wherein the insertion step includes locating the heating portion within the tissue wall so that a proximal-most portion of the heating portion is approximately two millimeters from a tissue surface.

19. The method for treating tissue according to claim 18, wherein the energy is supplied from one of a radiofrequency generator, an ultrasound generator and a laser generator.

20. The method for treating tissue according to claim 15, further including the step of:

forming an injury zone on the tissue wall by supplying the controlled energy to the heating portion at a level sufficient to cause reversible cell damage without ablating the tissue.

21. The method for treating tissue according to claim 20, wherein the heating portion heats the tissue between 40 and 100 degrees Celsius.