Single operator exchange fluid jet thrombectomy device

• US 6,755,803 B1
• Filed: 06/25/2001
• Issued: 06/29/2004
• 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: Le, Hieu V., Kozak, Debra M., Bonnette, Michael J., Weisel, Stephen E., Dutcher, Robert G., Morris, John Edward
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/888,455
• Time in Patent Office: 1,100 Days
• Field of Search: 604/19, 604/22, 604/27, 604/35, 604/39, 604/40, 604/43, 604/93.01, 604/48, 604/101.04, 604/118, 604/131, 604/140, 604/149-151, 604/173, 604/268, 604/164.01, 604/165.02, 604/164.08, 604/165.01, 604/164.09, 604/164.11, 604/164.13, 606/159, 606/167, 606/170, 606/127, 606/128, 83/13, 83/24, 83/22
• US Class Current: 604/22
• 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
• CPC Class Codes: Y10T 83/0443 By fluid application
• CPC Class Codes: Y10T 83/0453 By fluid application

Abstract

A single operator exchange fluid jet thrombectomy device having an outer catheter assembly and separable and exchangeable components in the form of an inner catheter assembly allowing functioning as a rheolytic thrombectomy catheter or as a crossflow thrombectomy catheter. Embodiments include an outer catheter assembly common to any mode of usage having a guide catheter having a lumen through which a guidewire and the greater portion of a hypo-tube carrying a flow director are passed and advanced. For use as a rheolytic thrombectomy catheter, thrombus is dislodged, entrained, and broken into pieces by jets and evacuated through the lumen of the guide catheter. For use as a crossflow thrombectomy catheter, a flow director having outflow and inflow orifices is provided.

Claims

1. A single operator exchange fluid jet thrombectomy device, suitable for insertion into a body vessel or other body cavity in order to remove undesirable matter therefrom, the device comprising:

a. an outer assembly including;

(1) a manifold including a proximal end and a distal end; and

,

(2) a first tube extending from the distal end of the manifold, the first tube having a proximal end and an open distal end;

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and be exchanged for a different inner assembly and to pass through the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a high pressure second tube having a proximal end, a distal end, a high pressure lumen, and a geometrically configured distally located jet emanator; and

,

(2) a flow director means attached to the high pressure second tube adjacent to, spaced apart from, and proximal to the jet emanator, the flow director means having a lumen; and

,

c. said flow director means and said first tube of said outer assembly defining an annulus and said flow director means positionable to at least partially restrict the annulus thereby providing a substantial fluid seal means between said flow director means and said first tube of said outer assembly.

2. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the flow director means of the at least one inner assembly includes:

a. an inner body; and

,

b. an expandable exhaust tube having a pressure operated closeable or sealable outwardly directed annular surface for engaging an inwardly directed annular surface of the outer assembly.

3. The single operator exchange fluid jet thrombectomy device of claim 2, wherein the combination of the jet emanator and the inner body and the expandable exhaust tube, together, are characterized by an ability to provide a localized region of low pressure associated with a fluid flow directed generally proximally and into the inner body, into the expandable exhaust tube, and through the first tube of the outer assembly.

4. The single operator exchange fluid jet thrombectomy device of claim 2, wherein lateral positioning of the high pressure second tube of the at least one inner assembly within the first tube of the outer assembly is enabled in a first unpressurized operational mode where the closeable annular surface is not expanded and is prevented in a second pressurized operational mode where the closeable annular surface is expanded to engage the at least one inner assembly to the outer assembly.

5. The single operator exchange fluid jet thrombectomy device of claim 4, wherein during the second pressurized operational mode, jetted saline causes the expandable exhaust tube to expand, thus partially or fully closing, restricting, modifying or eliminating the open annulus to temporarily pressure seal the first tube to the high pressure second tube.

6. The single operator exchange fluid jet thrombectomy device of claim 2, wherein lateral positioning of the high pressure second tube of the at least one inner assembly within the first tube of the outer assembly is enabled in a first unpressurized operational mode where the closeable annular surface is not expanded and remains enabled in a second pressurized operational mode where the closeable annular surface is expanded to slidingly seal and engage the at least one inner assembly to the outer assembly.

7. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the jet emanator at the distal end of the high pressure second tube has a proximal side and at least one jet orifice, wherein the at least one jet orifice has been formed by machining upon the proximal side of the jet emanator, so as to direct fluid from the jet emanator proximally for thrombus ablation and then subsequently through the lumen in the flow director means and through the first tube of the outer assembly.

8. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the at least one inner assembly is capable of passage over a guidewire.

9. The single operator exchange fluid jet thrombectomy device of claim 1, further comprising a variable displacement distance indexing means for enabling a selected positional relationship of the jet emanator to the open distal end of the first tube of the outer assembly.

10. The single operator exchange fluid jet thrombectomy device of claim 9, wherein said indexing means includes:

a. a stop means provided for limiting movement of the high pressure second tube including a hemostasis nut/stop at the proximal end of the manifold of the outer assembly; and

,

b. a high pressure connection/stop assembly projecting outwardly from the proximal end of the high pressure second tube.

11. The single operator exchange fluid jet thrombectomy device of claim 1, further comprising:

a. means for observing the relational spacing between the jet emanator and the open distal end of the first tube of the outer assembly comprising at least one observable component selected from the list consisting of;

radio-opaque marker, inner body, jet cap, flexible tapered tip.

12. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the manifold of the outer assembly includes a “

Y”

adapter, and the first tube of the outer assembly is a standard guide catheter.

13. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the jet emanator distally located on the high pressure second tube includes a loop.

14. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the jet emanator distally located on the high pressure second tube includes a generally toroidal configuration.

15. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the high pressure second tube is a metallic tube.

16. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the high pressure second tube is a plastic tube.

17. The single operator exchange fluid jet thrombectomy device of claim 1, wherein a jet cap is mounted on the jet emanator.

18. The single operator exchange fluid jet thrombectomy device of claim 17, wherein the jet cap functions to shield desirable tissue from trauma during insertion of the at least one inner assembly.

19. The single operator exchange fluid jet thrombectomy device of claim 17, wherein the jet cap functions to shield desirable tissue from trauma from jets of saline during thrombectomy.

20. The single operator exchange fluid jet thrombectomy device of claim 1, wherein:

a. the manifold of the outer assembly further includes a proximally located stationary stop;

b. the high pressure second tube of the at least one inner assembly of the array of inner assemblies further includes a proximally located transitional stop affixed to the high pressure second tube adjacent to the proximal end of the high pressure second tube; and

,

c. said at least one inner assembly is movable axially within the outer assembly such that the proximally located transitional stop engages the proximally located stationary stop to hold the jet emanator in a selected relationship with respect to the open distal end of the first tube of the outer assembly.

21. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the high pressure second tube of the at least one inner assembly of the array of inner assemblies has a length between the proximal and distal ends of the high pressure second tube sufficient to allow the distal end of the high pressure second tube to extend from the open distal end of the first tube of the outer assembly while the proximal end of the high pressure second tube extends from the proximal end of the outer assembly so as to allow connection of the high pressure second tube to a high pressure fluid source.

22. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the high pressure second tube includes a passage allowing the at least one inner assembly to be passed over a standard guidewire.

23. The single operator exchange fluid jet thrombectomy device of claim 1, wherein the first tube of the outer assembly is characterized by an ability to serve as a guide catheter.

24. The single operator exchange waterjet thrombectomy device of claim 1, wherein the jet emanator is a curved jet emanator.

25. The single operator exchange waterjet thrombectomy device of claim 1, wherein the jet emanator includes a jet cap having passages therein.

26. The single operator exchange fluid jet thrombectomy device of claim 1, wherein said annulus is restricted by said flow director means being in close proximity to said first tube of said outer assembly so as to provide a substantial fluid seal between said flow director means and said first tube of said outer assembly.

27. A single operator exchange fluid jet thrombectomy device for removal of deformable undesired matter from a body cavity or vessel, comprising:

a. an outer assembly including;

(1) a manifold including a proximally located stationary stop; and

,

(2) a first tube extending distally from the manifold, the first tube having a lumen with an open distal end;

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and be exchanged for a different inner assembly and to pass through the lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a high pressure second tube and having a proximal end, a distal end, a high pressure lumen, and a geometrically configured distally located jet emanator having one or more proximally directed orifices; and

,

(2) a crossflow director means, attached to the high pressure second tube adjacent to, spaced apart from, and proximal to the jet emanator, the crossflow director means having an outflow orifice and an inflow orifice, the crossflow director means designed for redirecting jet flow emanating from the jet emanator and fluid entrained through the inflow orifice out of the outflow orifice; and

,

c. said crossflow director means and said first tube of said outer assembly defining an annulus and said crossflow director means positionable to at least partially restrict the annulus thereby providing a substantial fluid seal between said crossflow director means and said first tube of said outer assembly.

28. The single operator exchange fluid jet thrombectomy device of claim 27, wherein the at least one inner assembly of the array further includes a proximally located transitional stop fixed to the high pressure second tube adjacent to the high pressure second tube proximal end, and wherein said at least one inner assembly is movable axially within the outer assembly such that the proximally located transitional stop engages the proximally located stationary stop to hold the jet emanator and crossflow director means in a selected spaced apart relationship with respect to the open distal end of the lumen of the first tube of the outer assembly.

29. The single operator exchange fluid jet thrombectomy device of claim 28, wherein the high pressure second tube of the at least one inner assembly of the array of inner assemblies has a length between the proximal and distal ends of the high pressure second tube sufficient to allow the distal end of the high pressure second tube to extend from the open distal end of the lumen of the first tube of the outer assembly while the proximal end of the high pressure second tube extends from the proximal end of the outer assembly so as to allow connection of the high pressure second tube to a high pressure fluid source.

30. The single operator exchange fluid jet thrombectomy device of claim 29, wherein the high pressure second tube includes a passage allowing the at least one inner assembly to be passed over a standard guidewire.

31. The single operator exchange fluid jet thrombectomy device of claim 28, wherein the jet emanator includes a toroidal loop.

32. The single operator exchange fluid jet thrombectomy device of claim 28, wherein the jet emanator is a curved jet emanator.

33. The single operator exchange fluid jet thrombectomy device of claim 28, wherein the jet emanator includes a jet cap having passages therein.

34. A small profile, rapid exchange device system suitable for insertion into a synthetic or biologic body vessel, cavity or organ in order to treat or diagnose an undesirable condition therein, the device comprising:

a. an outer assembly including;

(1) a manifold; and

,

(2) a first tube extending distally from the manifold and having a lumen with an open distal end;

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and to pass through the manifold and lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a distal emanator for directing energy in close approximation to the undesirable condition in order to treat or diagnose the undesirable condition;

(2) a flow director means; and

,

(3) a means for determining the relationship of the distal emanator of the at least one inner assembly with respect to the open distal end of the lumen of the first tube of the outer assembly such that alternatively;

(a) the lumen of the first tube of the outer assembly functions as a supply lumen for a material to be infused in close approximation to the undesirable condition to act together with the distal emanator to aid in treating or diagnosing the undesirable condition; and

,

(b) the lumen of the first tube of the outer assembly functions as an exhaust lumen for infused materials, lysed tissue or other undesirable materials associated with treating the undesirable condition; and

,

c. said flow director means and said first tube of said outer assembly defining an annulus and said flow director means positionable to at least partially restrict the annulus thereby providing a substantial fluid seal between said flow director means and said first tube of said outer assembly.

35. A small profile, rapid exchange device system suitable for insertion into a synthetic or biologic body vessel, cavity or organ in order to lyse thrombus, tissue or other undesirable matter therein, the device comprising:

a. an outer assembly including;

(1) a manifold; and

,

(2) a first tube extending distally from the manifold and having a lumen with an open distal end;

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and to pass through the manifold and lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a distal emanator for directing energy in close approximation to the undesirable matter in order to aid in disrupting or lysing the undesirable matter;

(2) a flow director means; and

,

(3) a means for determining the relationship of the distal emanator of the at least one inner assembly with respect to the open distal end of the lumen of the first tube of the outer assembly such that a material supplied through the lumen of the first tube of the outer assembly may be infused in close approximation to the undesirable matter in order to act together with the distal emanator to aid in disrupting or lysing the undesirable matter; and

,

c. said flow director means and said first tube of said outer assembly defining an annulus and said flow director means positionable to at least partially restrict the annulus thereby providing a substantial fluid seal between said flow director means and said first tube of said outer assembly.

36. A small profile, rapid exchange device system suitable for insertion into a synthetic or biologic body vessel, cavity or organ in order to lyse thrombus, tissue or other undesirable matter therein, the device comprising:

a. an outer assembly including;

(1) a manifold; and

,

(2) a first tube extending distally from the manifold and having a lumen with an open distal end; and

,

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and be exchanged for a different inner assembly and to pass through the manifold and lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a distal emanator for directing energy in close approximation to the undesirable matter in order to aid in disrupting or lysing the undesirable matter;

(2) a flow director means; and

,

(3) a means for determining the relationship of the distal emanator of the at least one inner assembly with respect to the open distal end of the lumen of the first tube of the outer assembly such that the undesirable matter may be exhausted through the lumen of the first tube of the outer assembly; and

,

c. said flow director means provides a substantial fluid seal between said flow director means and said first tube of said outer assembly.

37. A small profile, rapid exchange device system suitable for insertion into a synthetic or biologic body vessel, cavity or organ in order to lyse thrombus, tissue or other undesirable matter therein, the device comprising:

a. an outer assembly including;

(1) a manifold; and

,

(2) a first tube extending distally from the manifold and having a lumen with an open distal end; and

,

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and be exchanged for a different inner assembly passed within the and lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a distal emanator for directing energy in close approximation to the undesirable matter in order to aid in disrupting or lysing the undesirable matter;

(2) a flow director means; and

,

(3) a means for determining the relationship of the distal emanator of the at least one inner assembly with respect to the open distal end of the lumen of the first tube of the outer assembly such that alternatively;

(a) a material supplied through the lumen of the first tube of the outer assembly may be infused in close approximation to the undesirable matter in order to act together with the distal emanator to aid in disrupting or lysing the undesirable matter; and

,

(b) the undesirable matter together with any infused material may be exhausted through the lumen of the first tube of the outer assembly; and

,

c. said flow director means provides a substantial fluid seal between said flow director means and said first tube of said outer assembly.

38. A small profile, rapid exchange fluid jet thrombectomy device, suitable for insertion into a body vessel or other body cavity in order to remove undesirable matter therefrom, the device comprising:

a. an outer assembly including;

(1) a manifold including a proximally located stationary stop; and

,

(2) a first tube extending distally from the manifold, the first tube having a lumen with an open distal end, the lumen of the first tube having at least a first diameter; and

,

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and to pass through the first diameter of the lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a high pressure second tube having a high pressure lumen and a geometrically configured distally located jet emanator having one or more rearwardly directed jet orifices; and

,

(2) a flow director means attached to the high pressure second tube adjacent to, spaced apart from, and proximal to the jet emanator; and

,

c. a substantial fluid seal between said flow director means and said first tube of said outer assembly.

39. A catheter device for use with an outer assembly having first tubular means for passage of fluid or other material with a proximal end and a distal end and with at least one passage along the length thereof, said catheter device comprising:

a. second tubular means for passage of fluid along the length thereof, with a proximal end and a distal end;

b. jet emanator means for directing at least one fluid jet in the vicinity of said distal end of said second tubular means, said jet emanator means having at least one jet orifice positioned to direct at least one fluid jet in a generally proximal direction, said jet emanator means being in fluid communication with said second tubular means;

c. connection means in fluid connection with said second tubular means located in the vicinity of said proximal end of said second tubular means, said connection means providing for supply of fluid to said second tubular means, and thereby providing for supply of fluid to said jet emanator means so that fluid emanates from said at least one jet orifice to form at least one fluid jet and entrains fluid or other material from the vicinity of said at least one fluid jet;

d. flow director means located in the vicinity of said at least one jet orifice, said flow director means configured to direct flow from at least one of said at least one fluid jet(s) into said distal end of said at least one passage of said outer assembly;

e. said jet emanator means and said flow director means being adapted to entrain material from the vicinity of said at least one fluid jet and drive fluid and entrained material toward said proximal end of said outer assembly;

f. said catheter device being removably insertable into said at least one passage of said outer assembly; and

,

g. said flow director means providing a substantial fluid seal between said flow director means and the first tubular means of outer assembly.

40. The catheter device of claim 39, further comprising:

a. inflow means and outflow means in said flow director means;

b. said inflow means providing passage for fluid and entrained material to be drawn into said flow director means; and

,

c. said outflow means providing passage for at least some of said fluid and entrained material in said flow director means to flow through said outflow means and away from said flow director means.

41. A catheter system for use in a body vessel or cavity for diagnosing or treating a condition comprising:

a. an outer catheter with a proximal end and a distal end and at least a first passage along the length thereof;

b. an inner assembly with a proximal end and a distal end and at least one tube with at least a second passage along the length thereof, and a jet emanator near the distal end thereof, said second passage being connectable to a source of fluid so that when so connected, fluid emanates from said jet emanator to form at least one fluid jet;

c. a flow director means in the vicinity of said jet emanator, said flow director means being attached to said inner assembly, said flow director means having an extent that is substantially shorter than said outer catheter;

d. said inner assembly being insertable into and removable from said outer catheter;

e. said flow director means providing a substantial fluid seal between said flow director means and said first passage; and

,

f. said inner assembly being positionable in said outer catheter to a position in which said flow director means causes at least some flow to pass along said first passage.

42. The catheter system of claim 41, further comprising at least one alternate inner assembly insertable into said outer catheter, said at least one alternate inner assembly being useable to aid in diagnosing or treating a condition in a body vessel or cavity.

43. The catheter system of claim 41, further comprising an alternate inner assembly having a dilation balloon, said alternate inner assembly being insertable into said outer catheter.

44. The catheter system of claim 41, further comprising means for indexing an appropriate positional and variable relationship of said flow director means with respect to said distal end of said outer catheter.

45. A multi-part catheter device comprising:

a. an outer catheter with a proximal end and a distal end and at least a first passage extending between said proximal end and said distal end;

b. an inner assembly with a proximal end and a distal end;

c. said inner assembly being longer than said outer catheter, and being removably insertable into said outer catheter so that said distal end of said inner assembly can extend past said distal end of said outer catheter while said proximal end of said inner assembly extends past said proximal end of said outer catheter;

d. a flow director means with a proximal end and a distal end and at least one passage extending between said proximal end and said distal end, said flow director means being attached to said inner assembly and being located near said distal end of said inner assembly and being substantially shorter than said inner assembly;

e. said inner assembly being positionable in said outer catheter so that said flow director means extends at least in part past said distal end of said outer catheter;

f. said flow director means being in close proximity to said outer catheter so as to provide a substantial fluid seal between said flow director means and said outer catheter; and

,

g. said proximal end of said flow director means being configured to communicate with said first passage of said outer catheter to allow fluid or other matter to pass between said flow director means and said outer catheter.

46. A fluid jet thrombectomy device, suitable for insertion into a body vessel or other body cavity in order to remove undesirable matter therefrom, the device comprising:

a. an outer assembly including;

(1) a manifold including a proximally located stationary stop; and

,

(2) a first tube extending distally from the manifold, the first tube having a lumen with an open distal end, the lumen of the first tube having at least a first diameter; and

,

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and to pass through the first diameter of the lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a high pressure second tube having a high pressure lumen and a distally located jet emanator;

(2) a proximally located transitional stop; and

,

(3) a flow director means attached to the high pressure second tube; and

,

c. said flow director means being in close proximity to said first tube of said outer assembly so as to provide a substantial fluid seal between said flow director means and said first tube of said outer assembly.

47. The fluid jet thrombectomy device of claim 46, wherein said flow director means comprises a crossflow director means.

48. A single operator exchange fluid jet thrombectomy device, suitable for insertion into a body vessel or other body cavity in order to remove undesirable matter therefrom, the device comprising:

a. an outer assembly including;

(1) a manifold including a proximal end and a distal end; and

,

(2) a first tube extending from the distal end of the manifold, the first tube having a proximal end and an open distal end;

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and be exchanged for a different inner assembly and to pass through the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a high pressure second tube having a proximal end, a distal end, a high pressure lumen, and a geometrically configured distally located jet emanator, said jet emanator comprising a jet cap having passages therein; and

,

(2) a flow director means attached to the high pressure second tube adjacent to, spaced apart from, and proximal to the jet emanator, the flow director means having a lumen.

49. A fluid jet thrombectomy device, suitable for insertion into a body vessel or other body cavity in order to remove undesirable matter therefrom, the device comprising:

a. an outer assembly including;

(1) a manifold including a proximally located stationary stop; and

,

(2) a first tube extending distally from the manifold, the first tube having a lumen with an open distal end, the lumen of the first tube having at least a first diameter; and

,

b. at least one inner assembly, each inner assembly characterized by an ability to separate from the outer assembly and to pass through the first diameter of the lumen of the first tube of the outer assembly, and wherein at least one inner assembly includes;

(1) a high pressure second tube having a high pressure lumen and a distally located jet emanator, said jet emanator comprising a jet cap having passages therein;

(2) a proximally located transitional stop; and

,

(3) a flow director means attached to the high pressure second tube.