Fluid jet PMR

• US 20020111644A1
• Filed: 02/14/2001
• Published: 08/15/2002
• Est. Priority Date: 02/14/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Pearce, Joseph, Guo, Zihong, Johnson, Tim, Shuman, Brandon J.
• Granted Patent: US 6,544,220 B2
• Time in Patent Office: Days
• US Class Current: 606/167
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• 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

Abstract

Devices and methods for performing myocardial revascularization using fluid jets. Devices can include a pressurized fluid source coupled through fluid supply lumens to a distal-most nozzle disposed on the distal end of the catheter. Some devices have separate myocardial revascularization catheters disposed within guide catheters, while other devices have unitary devices including a generally steerable myocardial revascularization catheter shaft. Preferred embodiments include a distally disposed control valve. One valve is controlled using an electrically actuated device, another valve is controlled using a low-pressure control fluid, while yet another device valve is controlled using an axially slidable activation wire. The fluid valve can include a biasing spring to shut the valve and preclude fluid flow, with the bias opposed by a user-applied fluid, mechanical, or electrical force. One device includes a radially expandable distal catheter portion, which expands under pressure to present a significantly larger distal profile. The inflated distal region may be forced against a heart chamber wall, and can provide a larger surface area and improved seal. One catheter includes an intermediate expandable tubular anchor portion. Fluid used in the devices can include saline, revascularization enhancing therapeutic substances, angiogenic promoting substances, and radiopaque contrast media, all of which can be injected at the same time.

Claims

1. A catheter for forming holes in the myocardium of a heart chamber wall, said catheter having a distal region and a proximal region, said catheter comprising:

an elongate tubular shaft having a length, a first lumen therethrough, and a distal nozzle in fluid communication with said first lumen;

a valve disposed along said elongate shaft length for controlling fluid flow through said lumen and being in fluid communication with said lumen; and

means for controlling said valve from said tubular shaft proximal region.

2. A catheter as in claim 1, wherein said valve has an open position and a closed position, further comprising means for biasing said valve in said closed position.

3. A catheter as in claim 1, wherein said valve has an open position and a closed position, further comprising means for closing said valve from said shaft proximal region.

4. A catheter as in claim 1, wherein said nozzle is sufficiently strong to deliver fluids at a pressure of at least about 10 atmospheres.

5. A catheter as in claim 1, wherein said valve includes a valve stem member and a valve seat member for receiving said valve stem member thereagainst.

6. A catheter as in claim 1, wherein said valve includes a valve seat member having an orifice therethrough and a valve stem member for occluding said orifice.

7. A catheter as in claim 6, wherein said means for controlling said valve includes an elongate control member extending from said catheter proximal region and operably coupled to said valve stem member.

8. A catheter as in claim 7, wherein said valve includes a spring for biasing said valve stem in a closed position.

9. A catheter as in claim 1, wherein said valve includes means for controlling said valve with fluid pressure, and said catheter further includes a second lumen for transmitting fluid pressure to said means for controlling said valve with fluid pressure.

10. A catheter as in claim 1, wherein said means for controlling said valve includes means for opening and closing said valve in response to varying fluid pressure.

11. A catheter as in claim 1, wherein said means for controlling said valve includes a temperature sensitive member which changes shape in response to changing temperature, wherein said catheter further includes at least one electrode for providing electrical current to said temperature sensitive member for heating said temperature sensitive member.

12. A catheter as in claim 11, wherein said valve includes a biasing device for biasing said valve in a closed position.

13. A catheter as in claim 1, wherein said catheter shaft includes a shaft wall, wherein said shaft wall is formed of a first portion and a second portion, wherein said second portion is expandable under pressure to a greater degree than said first portion, such that said second portion expands in diameter greater than at least 20 percent.

14. A catheter as in claim 13, wherein said second portion expands in diameter greater than at least about 40 percent.

15. A catheter as in claim 13, wherein said second portion is disposed near said catheter distal region.

16. A catheter as in claim 15, wherein said second portion has a first, unexpanded configuration with a first distal-most profile, and a second, expanded configuration with a second distal-most profile, wherein said catheter second distal-most profile is significantly greater than said first distal-most profile.

17. A catheter as in claim 16, wherein said second distal-most profile is at least twice as large as said first distal-most profile.

18. A catheter as in claim 17, wherein said second portion is disposed proximal of said distal region, such that said second portion can be disposed within a guide catheter while said distal region is disposed against said heart wall, such that said second portion expands against said guide catheter to stabilize said myocardial revascularization catheter during use.

20. A catheter as in claim 19, wherein said valve has an open position and a closed position, further comprising a biasing device for biasing said valve in said closed position.

21. A catheter as in claim 19, wherein said valve has an open position and a closed position, wherein said valve actuator includes a closing device for closing said valve from said shaft proximal region.

22. A catheter as in claim 19, wherein said nozzle is sufficiently strong to deliver fluids at a pressure of at least about 10 atmospheres.

23. A catheter as in claim 19, wherein said valve includes a valve stem member and a valve seat member for receiving said valve stem member thereagainst.

24. A catheter as in claim 19, wherein said valve includes a valve seat member having an orifice therethrough and a valve stem member for occluding said orifice.

25. A catheter as in claim 24, wherein said valve controller for controlling said valve includes an elongate control member extending from said catheter proximal region and operably coupled to said valve stem member.

26. A catheter as in claim 25, wherein said valve includes a spring for biasing said valve stem in a closed position.

27. A catheter as in claim 19, wherein said valve controller is pressure actuated, and said catheter further includes a second lumen for transmitting fluid pressure to said valve for controlling said valve with fluid pressure.

28. A catheter as in claim 19, wherein said valve controller includes a device for opening and closing said valve acting in response to varying fluid pressure.

29. A catheter as in claim 19, wherein said valve controller includes a temperature sensitive member which changes shape in response to changing temperature, wherein said catheter further includes at least one electrode for providing electrical current to said temperature sensitive member for heating said temperature sensitive member.

30. A catheter as in claim 29, wherein said valve includes a biasing device for biasing said valve in a closed position.

31. A catheter as in claim 19, wherein said catheter shaft includes a shaft wall, wherein said shaft wall is formed of a first portion and a second portion, wherein said second portion is expandable under pressure to a greater degree than said first portion, such that said second portion expands in diameter greater than at least 20 percent under pressure.

32. A catheter as in claim 31, wherein said second portion expands in diameter greater than at least about 40 percent.

33. A catheter as in claim 31, wherein said second portion is disposed near said distal region.

34. A catheter as in claim 33, wherein said expandable second portion has a first unexpanded configuration with a first distal-most profile and a second expanded configuration with a second distal-most profile, wherein said catheter second distal-most profile is significantly greater than said first distal-most profile.

35. A catheter as in claim 34, wherein said second distal-most profile is at least twice as large as said first distal-most profile.

36. A catheter as in claim 35, wherein said second portion is disposed proximal of said distal region, such that said second portion can be disposed within a guide catheter while said distal region is disposed against said heart wall, such that said second portion expands against said guide catheter to stabilize said myocardial revascularization catheter during use.

38. A method for performing myocardial revascularization as in claim 37, wherein said hole forming step includes injecting at least one therapeutic substance into said myocardium in said forming step.

39. A method for performing myocardial revascularization as in claim 37, wherein said method includes providing a catheter having a proximal region, a distal region, a lumen therethrough, and a distal valve in fluid communication with said lumen, wherein said forming step includes ejecting said fluid from said distal valve.

40. A method for performing myocardial revascularization as in claim 39, wherein said method includes controlling said valve from said catheter proximal region.

41. A method for performing myocardial revascularization as in claim 39, wherein said method includes expanding said catheter distal region from a first distal profile to a second, expanded distal profile greater than said first distal profile, wherein said second expanded distal profile is disposed against said heart chamber wall for an improved seal against said heart chamber wall.

42. A method for performing myocardial revascularization as in claim 39, wherein said method includes expanding a catheter intermediate region from a first diameter to a second, expanded diameter greater than said first diameter, wherein said second expanded diameter is disposed within a guide catheter for stabilizing said catheter during fluid injection.

19. A catheter for forming holes in the myocardium of a heart chamber wall, said catheter having a distal region and a proximal region, said catheter comprising:

an elongate tubular shaft having a length, a first lumen therethrough, and a distal nozzle in fluid communication with said lumen;

a valve disposed along said elongate shaft length for controlling fluid flow through said lumen; and

a valve actuator for controlling said valve from said tubular shaft proximal region.

37. A method for performing myocardial revascularization from within a heart chamber having a wall, the method comprising forming holes in the myocardium using at least one fluid jet.