Rheolytic thrombectomy catheter and method of using same

• US 6,224,570 B1
• Filed: 11/09/1998
• Issued: 05/01/2001
• Est. Priority Date: 02/06/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Kozak, Debra M., Bonnette, Michael J., Le, Hieu V., Dutcher, Robert G., Setum, Cindy M., Morris, John Edward, Wiesel, Steven E.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/188,633
• Time in Patent Office: 904 Days
• Field of Search: 604/19, 604/22, 604/35, 604/165.01, 604/500, 604/508-509, 604/510, 604/164.01, 604/164.03, 604/164.09, 604/164.1, 604/164.11, 604/164.13 , 604/165.02, 604/165.04, 604/167.06, 604/170.01, 604/170.02, 604/264, 604/523-525, 604/529, 604/533-536, 604/177, 604/174, 604/165.03, 606/167.01
• US Class Current: 604/165.02
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself

Abstract

A rheolytic thrombectomy catheter and method of using same to remove thrombus from a body vessel or other body cavity. Several embodiments are disclosed. All embodiments include an outer catheter having a lumen and an inner high pressure tube of a size to enable it to be passed through the lumen of the catheter. The distal end of the inner high pressure tube extends beyond the distal end of the catheter and carries a jet cap for directing one or more jets of saline proximally toward the distal end of the catheter. In some embodiments, the catheter has a distally located inwardly directed stationary stop and the inner high pressure tube includes a distally located outwardly directed transitional stop for engaging the inwardly directed stationary stop to thereby position the jet cap at a defined distance from the distal end of the catheter. In other embodiments, a stationary stop is located at the proximal end of the catheter and a transitional stop is carried on the proximal end of the inner high pressure tube. In the embodiments having the stationary and transitional stops located proximally, the inner high pressure tube includes a flow director at its distal end. In use, thrombus is dislodged, entrained, and broken into pieces by the saline jets and evacuated proximally through the lumen of the catheter.

Claims

1. A rheolytic thrombectomy catheter for the removal of thrombus from a body vessel, said rheolytic thrombectomy catheter comprising:

a. an evacuation tube containing a longitudinally positionable high pressure hypo-tube and flow director with a jet cap at the distal end thereof directing a solution backwards towards the distal end of said evacuation tube;

b. an exhaust tube portion, affixed to said longitudinally positionable high pressure hypo-tube; and

,

c. said exhaust tube portion permitting rotational and longitudinal movement of said hypo-tube relative to said evacuation tube.

2. A rheolytic thrombectomy catheter for the removal of thrombus from a body vessel, said rheolytic thrombectomy catheter comprising:

a. an evacuation tube containing a longitudinally positionable high pressure hypo-tube with a jet cap at the distal end thereof directing a solution backwards towards the distal end of said evacuation tube;

b. an expandable exhaust tube portion, affixed to said hypo-tube;

c. said expandable exhaust tube portion permitting rotational and longitudinal movement of said hypo-tube relative to said evacuation tube when in the relaxed, unexpanded state and engaging said evacuation tube to seal said hypo-tube in engagement with said exhaust tube when in the expanded state, while still providing movement relative to each other; and

,

d. means for causing said expandable exhaust tube to expand and engage said evacuation tube.

3. The catheter of claim 2, wherein jet pressure expands said expandable exhaust tube.

4. The catheter of claim 2, wherein said means for causing said expandable exhaust tube to expand comprises an aperture at a distal end portion of said expandable exhaust tube for receiving fluid emitted from said jet cap.

5. The catheter of claim 4, wherein said jet cap contains a rearwardly facing orifice opposite said aperture for directing a flow of said high pressure fluid into said expandable exhaust tube.

6. The catheter of claim 2, further including flexible guidewire means affixed to, and extending outwardly from, in axial alignment with the distal end of said jet cap.

7. The catheter of claim 6, wherein said flexible guidewire means comprises a coil spring and a tapered core.

8. The catheter of claim 7, wherein said tapered core is of a thickness of about 0.010 inches to 0.004 inches on proximal end to 0.004 inches to 0.002 inches on distal end.

9. The catheter of claim 2, wherein said hypo-tube carries said solution at an infusion pressure in a range of 500 to 15,000 psi.

10. A rheolytic thrombectomy catheter for removing material from a body cavity, the rheolytic thrombectomy catheter comprising:

a. an outer assembly including a proximally located manifold, a distally extending evacuation catheter, and means to manipulate the evacuation catheter interposed between the manifold and the evacuation catheter; and

,

b. an inner assembly including a hypo-tube catheter, the hypo-tube catheter having a distally located let cap means to form a proximally directed jet from a high pressure flow of liquid from the hypo-tube catheter, and a flow director, adjacent to but proximally spaced apart a desired distance from the jet cap to receive at least a portion of the proximally directed jet, means of providing a flow of high pressure liquid to the hypo-tube catheter, the hypo-tube catheter being movable within the outer assembly when high pressure liquid is not flowing into the hypo-tube catheter, means to manipulate the hypo-tube catheter proximally coupled to the hypo-tube catheter, and means to limit maximum distal movement of the inner assembly relative to the outer assembly coupled to the hypo-tube catheter.

11. The rheolytic thrombectomy catheter of claim 10, wherein the flow director includes an expandable exhaust tube, said expandable exhaust tube having a proximal aperture, a distal aperture, and a passage therebetween and the distal aperture includes a ramped annular surface.

12. The rheolytic thrombectomy catheter of claim 11, wherein the ramped annular surface tapers inwardly proximally.

13. The rheolytic thrombectomy catheter of claim 11, wherein the expandable exhaust tube further includes a distally located radio-opaque marker.

14. The rheolytic thrombectomy catheter of claim 10, wherein the hypo-tube catheter further includes a distally located radio-opaque marker.

15. The rheolytic thrombectomy catheter of claim 10, wherein the hypo-tube catheter further includes a distally located guidewire coil.

16. The rheolytic thrombectomy catheter of claim 10, wherein the inner assembly is separable from the outer assembly and insertable into the outer assembly.

17. The rheolytic thrombectomy catheter of claim 10, wherein the flow director includes a longitudinally oriented expandable exhaust tube, movable within the evacuation catheter in the absence of a jet from the jet cap and temporarily expandedly sealed within the evacuation catheter in response to the presence of a jet from the jet cap.

18. The rheolytic thrombectomy catheter of claim 10, wherein impingement of the jet on the evacuation lumen creates sufficient stagnation pressure to allow evacuation of debris with no need for additional suction on the proximal end of the evacuation lumen.

19. A rheolytic thrombectomy catheter for the removal of thrombus from a body vessel, the rheolytic thrombectomy catheter comprising:

a. an evacuation tube containing a longitudinally positionable high pressure hypo-tube with a jet cap at the distal end thereof directing a solution backwards towards the distal end of said evacuation tubes

b. a flow director carried by the longitudinally positionable high pressure hypo-tube, the flow director located adjacent to but spaced apart from the jet cap by a predetermined distance;

c. the flow director having an expandable exhaust tube, the expandable exhaust tube having a lumen in fluid communication with the fluid directed backwards from the jet cap and expandable in response to high pressure associated with the fluid directed backward from the jet cap such that expandable exhaust tube expands to seal against the inner surface of the evacuation tube by closing an annulus defined between the inner surface of the evacuation tube and the outer surface of the expandable exhaust tube; and

,

d. wherein the pressurized flow director temporarily limits longitudinal movement of said hypo-tube relative to the evacuation tube and prevents leakback at the annulus.

20. The rheolytic thrombectomy catheter of claim 19, wherein the hypo-tube passes through the flow director.

21. The rheolytic thrombectomy catheter of claim 19, wherein said flow director includes a distal ramped annular surface.

22. The rheolytic thrombectomy catheter of claim 21, wherein the ramped annular surface tapers inwardly proximally.

23. The rheolytic thrombectomy catheter of claim 19, further including flexible guidewire means affixed to, and extending outwardly from, in axial alignment with the distal end of said jet cap.

24. The catheter of claim 23, wherein said guidewire is short and tapered, whereby said short tapered guidewire means is usable for directing and positioning the catheter in the vasculature.

25. A rheolytic thrombectomy catheter for the removal of thrombus from a body vessel, the rheolytic thrombectomy catheter comprising:

a. an evacuation tube containing a longitudinally positionable high pressure hypo-tube with a jet cap at the distal end thereof directing a solution backwards towards the distal end of said evacuation tube;

b. an exhaust tube portion, affixed to said hypo-tube, adjacent to but spaced apart from said jet cap; and

,

c. said exhaust tube portion permitting rotational and longitudinal movement of said hypo-tube relative to said evacuation tube.

26. The rheolytic thrombectomy catheter of claim 25, wherein the exhaust tube portion has an inner surface and an outer surface and the hypo-tube is affixed to the inner surface of the exhaust tube portion.

27. The rheolytic thrombectomy catheter of claim 25, wherein the exhaust tube portion has an inner surface and an outer surface and the exhaust tube portion expands in response to pressure against the inner surface to engage the evacuation tube and prevent movement relative to said evacuation tube.

28. The rheolytic thrombectomy catheter of claim 25, wherein the exhaust tube portion has an inner surface and an outer surface and the exhaust tube portion expands in response to pressure against the inner surface to seal the outer surface against the evacuation tube.

29. A rheolytic thrombectomy catheter for the removal of thrombus from a body vessel, the rheolytic thrombectomy catheter comprising:

a. an evacuation tube containing a longitudinally positionable high pressure hypo-tube with a jet cap at the distal end thereof directing a solution backwards towards the distal end of said evacuation tube;

b. an expandable exhaust tube portion, affixed to said hypo-tube adjacent to, yet spaced apart from, said jet cap;

c. said expandable exhaust tube portion permitting rotational and longitudinal movement of said hypo-tube relative to said evacuation tube when in a relaxed, unexpanded state and engaging said evacuation tube to seal said hypo-tube in engagement with said exhaust tube when in an expanded state; and

,

d. means for causing said expandable exhaust tube to expand and engage said evacuation tube.

30. The catheter of claim 29, wherein jet pressure expands said expandable exhaust tube.

31. The catheter of claim 29, wherein said means for causing said expandable exhaust tube to expand comprises an aperture at a distal end portion of said expandable exhaust tube for receiving fluid emitted from said jet cap.

32. The catheter of claim 31, wherein said jet cap contains a rearwardly facing orifice opposite said aperture for directing a flow of said high pressure fluid into said expandable exhaust tube.

33. The catheter of claim 31, wherein said aperture includes a ramped annular surface.

34. The catheter of claim 29, further including flexible guidewire means affixed to, and extending outwardly from, in axial alignment with the distal end of said jet cap.

35. The catheter of claim 34, wherein said guidewire means comprises a coil spring and a tapered core.

36. The catheter of claim 35, wherein said tapered core is of a thickness of about 0.010 inches to 0.004 inches on proximal end to 0.004 inches to 0.002 inches on distal end.

37. The catheter of claim 29, wherein said solution in said longitudinally positionable high pressure hypo-tube is supplied at an infusion pressure in a range of 500 to 15,000 psi.

38. A method of removing material from a body cavity, the method comprising the steps of:

a. providing an outer assembly including a proximally located manifold, a distally extending evacuation catheter, and means to manipulate the evacuation catheter;

b. providing an inner assembly including a hypo-tube catheter, the hypo-tube catheter being movable within the outer assembly, means to manipulate the hypo-tube proximally coupled to the hypo-tube, and the hypo-tube having a distally located jet cap means to form a proximally directed jet from a high pressure flow of liquid in the hypo-tube, and a flow director, adjacent to but proximally spaced apart from the jet cap to receive at least a portion of the proximally directed jet, wherein the flow director includes a longitudinally oriented exhaust tube, movable within the evacuation catheter in the absence of a jet from the jet cap;

c. providing a guidewire;

d. advancing the guidewire percutaneously through vasculature to the material to be removed from the body cavity;

e. advancing the outer assembly over the guidewire to place the distal end of the outer assembly adjacent the material;

f. withdrawing the guidewire from within the outer assembly;

g. advancing the inner assembly within the outer assembly to extend the jet cap past the distal end of the outer assembly at a predetermined distance;

h. providing a high pressure liquid flow to the inner assembly to form a jet directed toward the expandable exhaust tube of the flow director of the inner assembly; and

,

i. allowing the formed jet to expand the expandable exhaust tube to seal against the outer assembly and entrain material to be removed into a proximally directed flow through the expandable exhaust tube and thence further proximally through the outer assembly and further to allow the impingement of the jet on the evacuation lumen to create sufficient stagnation pressure to allow evacuation of debris with no need for additional suction on the proximal end of the evacuation lumen.

39. A method of removing material from a body cavity, the method comprising the steps of:

a. providing an outer assembly including a proximally located manifold, a distally extending evacuation catheter, and means to manipulate the evacuation catheter interposed between the manifold and the evacuation catheter;

b. providing an inner assembly including a hypo-tube catheter, the hypo-tube catheter of the inner assembly being movable within the evacuation catheter, the manifold and the means to manipulate the evacuation catheter of the outer assembly, means to manipulate the hypo-tube proximally coupled to the hypo-tube, the means to manipulate the hypo-tube and means to limit maximum distal movement of the inner assembly relative to the outer assembly, both situated proximal to the manifold of the outer assembly, and the hypo-tube having a distally located jet cap means to form a proximally directed jet from a high pressure flow of liquid in the hypo-tube, and a flow director, adjacent to but proximally spaced apart a desired distance from the jet cap to receive a portion of the proximally directed jet, wherein the flow director includes a longitudinally oriented expandable exhaust tube, movable within the evacuation catheter in the absence of a jet from the jet cap and temporarily expandedly sealed within the evacuation catheter in response to the presence of a jet from the jet cap;

c. providing a guidewire;

d. advancing the guidewire percutaneously through vasculature to the material to be removed from the body cavity;

e. advancing the outer assembly over the guidewire to place the distal end of the outer assembly adjacent the material;

f. withdrawing the guidewire from within the outer assembly;

g. advancing the inner assembly within the outer assembly to extend the jet cap past the distal end of the outer assembly at a predetermined distance;

h. providing a high pressure liquid flow to the inner assembly to form a jet directed toward the expandable exhaust tube of the flow director of the inner assembly; and

,

i. allowing the formed jet to expand the expandable exhaust tube to seal against the outer assembly and entrain material to be removed into a proximally directed flow through the expandable exhaust tube and thence further proximally through the outer assembly.