Isolation thrombectomy catheter system

• US 20080275393A1
• Filed: 08/24/2004
• Published: 11/06/2008
• Est. Priority Date: 08/24/2004
• Status: Abandoned Application

• Current Assignee: Medrad Incorporated (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Le, Hieu V., Bonnette, Michael J.
• Application Number:
  US10/925,113
• Publication Number:
  US 20080275393A1
• Time in Patent Office: Days
• US Class Current: 604/102.01
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving

Abstract

An isolation thrombectomy catheter system where thrombus, clotted material, or the like is isolated by distally and proximally placed inflated occlusive balloons sealing a portion of the vasculature for subsequent removal of thrombus by cross stream jets. An isolation catheter accommodates either a jet assembly for ablation of thrombus and for drug or medication delivery, or accommodates a drug delivery device for introduction of lysing fluids, drugs or medications to a thrombus site. Alternating of lysing fluid delivery and ablation can be incorporated for a combined thrombectomy effort.

Claims

1. A catheter system comprising:

a. an isolation catheter having a proximal end, a distal end, a central lumen with a wall extending from said proximal end to said distal end, an inflation lumen also extending from said proximal end to said distal end, a proximal balloon, and a distal balloon, said proximal balloon and said distal balloon together defining an isolation portion near the distal end of the isolation catheter, said inflation lumen being in fluid communication with said proximal balloon and said distal balloon to provide for inflation of said proximal balloon and said distal balloon in a body vessel or cavity, thereby to isolate a portion of the body vessel or cavity, said isolation portion having at least one opening through said wall of said central lumen;

b. treatment apparatus comprising elongated tubular means having a proximal end and a distal end and manual actuator means coupled to said elongated tubular means proximate said proximal end, said elongated tubular means having a wall and at least one lumen for passage of fluid between said proximal and distal ends, said wall having at least one opening therethrough proximate said distal end; and

,

c. said elongated tubular means being configured so that said manual actuator means can be used to position a portion of said elongated tubular means within said isolation catheter to locate said at least one opening through said wall of said elongated tubular means along said isolation portion so that fluid passing through said at least one opening through said wall of said elongated tubular means interacts with the isolated portion of the body vessel or cavity through said at least one opening through said wall of said central lumen.

2. The catheter system of claim 1, wherein said at least one opening through said wall of said central lumen comprises a plurality of windows.

3. The catheter system of claim 1, further comprising an effluent collector in fluid communication with said central lumen and adapted to receive fluid from said central lumen.

4. An isolation thrombectomy catheter system comprising:

a. an isolation catheter having a proximal end, a distal end, a central lumen with a wall extending from said proximal end to said distal end, and an inflation lumen also extending from said proximal end to said distal end, a proximal balloon, and a distal balloon, said proximal balloon and said distal balloon together defining an isolation portion near the distal end of the isolation catheter, said inflation lumen being in fluid communication with said proximal balloon and said distal balloon to provide for inflation of said proximal balloon and said distal balloon in a body vessel or cavity, thereby to isolate a portion of the body vessel or cavity, said isolation portion having at least one opening through said wall of said central lumen;

b. treatment apparatus comprising elongated tubular means having a proximal end and a distal end and manual actuator means coupled to said elongated tubular means proximate said proximal end, said elongated tubular means having a wall and at least one lumen for passage of fluid between said proximal and distal ends, said wall having at least one opening therethrough proximate said distal end;

c. said elongated tubular means being configured so that said manual actuator means can be used to position a portion of said elongated tubular means within said isolation catheter to locate said at least one opening through said wall of said elongated tubular means along said isolation portion;

d. a fluid source forming part of said treatment apparatus;

e. a fluid pump also forming part of said treatment apparatus; and

,

f. said fluid pump being connectible to said fluid source and to said proximal end of said elongated tubular means and being adapted to pump fluid from said fluid source into said elongated tubular means so that the fluid interacts with the isolated portion of the body vessel or cavity through said at least one opening through said wall of said elongated tubular means and said at least one opening through said wall of said central lumen.

5. The isolation thrombectomy catheter system of claim 4, further comprising an effluent collector in fluid communication with said central lumen and adapted to receive fluid from said central lumen.

6. The isolation thrombectomy catheter system of claim 4, further comprising a hemostatic seal which allows movement of said elongated tubular means in said isolation catheter and which minimizes leakage of blood or fluid between said isolation catheter and said elongated tubular means.

7. The isolation thrombectomy catheter system of claim 6, wherein said hemostatic seal is located proximate the proximal end of said isolation catheter.

8. The isolation thrombectomy catheter system of claim 4, further comprising a tapered tip at the distal end of said isolation catheter.

9. The isolation thrombectomy catheter system of claim 4, wherein said at least one opening through said wall of said central lumen comprises a plurality of windows.

10. An isolation thrombectomy catheter system comprising:

a. an isolation catheter having a proximal end, a distal end, a central lumen with a wall extending from said proximal end to said distal end, an inflation lumen also extending from said proximal end to said distal end, a proximal balloon, and a distal balloon, said proximal balloon and said distal balloon together defining an isolation portion near the distal end of the isolation catheter, said inflation lumen being in fluid communication with said proximal balloon and said distal balloon to provide for inflation of said proximal balloon and said distal balloon in a body vessel or cavity, thereby to isolate a portion of the body vessel or cavity, said isolation portion having at least one opening through said wall of said central lumen;

b. treatment apparatus comprising elongated tubular means including a high pressure tube having proximal and distal ends for passage of high pressure fluid between said proximal and distal ends, a fluid jet emanator in fluid communication with said high pressure tube at said distal end, and manual actuator means proximate said proximal end;

c. said high pressure tube and said fluid jet emanator being configured so that said manual actuator means can be used to position said fluid jet emanator within said isolation catheter along said isolation portion;

d. a fluid source forming part of said treatment apparatus;

e. a high pressure fluid pump also forming part of said treatment apparatus; and

,

f. said high pressure fluid pump being connectible to said fluid source and to said proximal end of said high pressure tube and being adapted to pump fluid from said fluid source into said high pressure tube at high pressure so that fluid emanates from said fluid jet emanator to create at least one fluid jet which interacts with the isolated portion of the body vessel or cavity through said at least one opening through said wall of said central lumen.

11. Treatment apparatus comprising:

a. a partial length jet catheter having a proximal end and a distal end;

b. a high pressure tube for passage of high pressure fluid, said high pressure tube having proximal and distal ends;

c. a fluid jet emanator in fluid communication with said high pressure tube at said distal end of said high pressure tube and located within said partial length jet catheter;

d. manual actuator means coupled to said proximal end of said high pressure tube, said partial length jet catheter, said high pressure tube, and said fluid jet emanator being configured so that they can be manipulated by said manual actuator means and therewith be positioned within a lumen of an isolation catheter;

e. high pressure connection means at the proximal end of said high pressure tube connectible to a source of high pressure fluid; and

,

f. said fluid jet emanator being configured to create at least one fluid jet when said high pressure connection means is connected to a source of high pressure fluid.

12. The treatment apparatus of claim 11, wherein said partial length jet catheter has a short effluent lumen having a proximal end and a distal end and providing for flow of effluent fluid from said distal end to said proximal end so that effluent fluid and debris passes from said proximal end of said short effluent lumen proximally along the lumen of the isolation catheter.

13. The treatment apparatus of claim 11, wherein said partial length jet catheter has at least one inflow orifice and at least one outflow orifice, said at least one outflow orifice creating cross stream jets when said fluid jet emanator creates said at least one fluid jet, said cross stream jets being locatable to treat an isolated portion of a body vessel through openings in the isolation catheter.

14. An isolation catheter for isolating a portion of a body vessel or cavity comprising:

a. an elongated device having a proximal end and a distal end and having at least one balloon inflation lumen and a central lumen extending along the length thereof;

b. a proximal balloon and a distal balloon mounted on said elongated device near said distal end and spaced apart and defining an isolation portion of said elongated device therebetween;

c. said balloon inflation lumen being in fluid communication with said proximal balloon and said distal balloon to provide for inflation and deflation of said proximal balloon and said distal balloon in a body vessel or cavity, said proximal balloon and said distal balloon being expandable upon inflation to seal between said elongated device and the walls of the body vessel or cavity, thereby to isolate a portion of the body vessel or cavity at said isolation portion;

d. said central lumen having a wall and at least one opening through said wall at said isolation portion, said central lumen being adapted to receive treatment apparatus;

e. said at least one opening providing fluid communication between said central lumen and the body vessel or cavity so that said treatment apparatus when positioned adjacent to said at least one opening, has fluid communication with the body vessel or cavity to effect treatment of the body vessel or cavity while said proximal balloon and said distal balloon are inflated thereby isolating a portion of the body vessel or cavity.

15. The isolation catheter of claim 14, further comprising sealing means at the distal end of said central lumen to reduce leakage of fluid between said distal end of said central lumen and a distal portion of said treatment apparatus when disposed therein.

16. The isolation catheter of claim 15, wherein said sealing means comprises a tapered distal tip, said tapered distal tip having an inner diameter comprising a distal portion of said central lumen which tapers to form a short portion of close or interference fit against an external distal portion of said treatment apparatus when disposed therein.

17. A method of treating a segment of a blood vessel or other body cavity, comprising the steps of:

a. providing an isolation catheter having a central lumen, an inflation lumen, a proximal balloon, a distal balloon, and an isolation portion between the proximal balloon and the distal balloon, the isolation portion having at least one opening through a wall of the central lumen;

b. introducing the isolation catheter into a blood vessel or other body cavity and positioning the isolation catheter at a portion of the blood vessel or other body cavity to be treated;

c. inflating the proximal balloon and the distal balloon of the isolation catheter to isolate a segment of the blood vessel or other body cavity;

d. providing treatment apparatus having a portion adapted to be inserted into the central lumen and having manual actuator means, the portion adapted to be inserted into the central lumen including a distal end and a lumen for passage of fluid to said distal ends, the lumen having a wall, and at least one opening through the wall of the lumen proximate the distal end;

e. introducing into the central lumen the portion of the treatment apparatus adapted to be inserted into the central lumen and advancing it to the isolation portion so that the at least one opening through the wall of the lumen is proximate the at least one opening through the wall of the central lumen; and

,

f. passing fluid in the lumen so that fluid passing through the at least one opening through the wall of the lumen interacts with the isolated segment of the blood vessel or other body cavity through the at least one opening through the wall of the central lumen.

18. A method of treating unwanted material in a segment of a blood vessel or other body cavity, comprising the steps of:

a. providing an isolation catheter having a central lumen, an inflation lumen, a proximal balloon, a distal balloon, and an isolation portion between the proximal balloon and the distal balloon, the isolation portion having at least one opening through a wall of the central lumen;

b. introducing the isolation catheter into a blood vessel or other body cavity and positioning the isolation catheter at a portion of the blood vessel or other body cavity to be treated;

c. inflating the proximal balloon and the distal balloon of the isolation catheter to isolate a segment of the blood vessel or other body cavity;

d. providing a jet assembly comprising a high pressure tube having proximal and distal ends for passage of high pressure fluid between the proximal and distal ends, a fluid jet emanator in fluid communication with the high pressure tube at the distal end, and manual actuator means proximate the proximal end;

e. introducing the distal end of the high pressure tube and the fluid jet emanator into the central lumen of the isolation catheter using the manual actuator means and positioning the fluid jet emanator proximate the isolation portion using the manual actuator means;

f. providing a fluid source and a high pressure fluid pump;

g. connecting the high pressure fluid pump to the fluid source and the high pressure tube;

h. actuating the high pressure fluid pump to pump fluid from the fluid source into the high pressure tube at high pressure so that fluid emanates from the fluid jet emanator to create at least one fluid jet; and

,

i. using the fluid jet(s) to treat unwanted material in the isolated segment of the blood vessel or other body cavity via fluid communication through the at least one opening through the wall of the central lumen.

19. The method of treating unwanted material of claim 18, wherein the provided jet assembly has inflow and outflow orifices and further comprising the step of using the inflow and outflow orifices to create cross stream jets which create recirculation through the at least one opening through the wall of the central lumen.

20. The method of treating unwanted material of claim 18, further comprising the steps of:

a. providing an effluent collector; and

,

b. using the isolation catheter, the jet assembly, and the effluent collector to remove unwanted material from the isolated segment of the blood vessel or other body cavity.

21. The method of treating unwanted material of claim 18, further comprising the step of using the manual actuator means to move the fluid jet emanator proximate a plurality of windows in the wall of the central lumen to enhance maceration of unwanted material.

22. A method of treating a segment of a blood vessel or other body cavity, comprising the steps of:

a. providing an isolation catheter having a central lumen, an inflation lumen, a proximal balloon, a distal balloon, and an isolation portion between the proximal balloon and the distal balloon, the isolation portion having at least one opening through a wall of the central lumen;

b. introducing the isolation catheter into a blood vessel or other body cavity and positioning the isolation catheter at a portion of the blood vessel or other body cavity to be treated;

c. inflating the proximal balloon and the distal balloon of the isolation catheter to isolate a segment of the blood vessel or other body cavity;

d. providing a medication delivery device adapted to be inserted into the central lumen of the isolation catheter and having a proximal end and a distal end, a lumen for passage of medication between the proximal and distal ends, and at least one opening in the wall of the lumen proximate the distal end;

e. introducing the medication delivery device into the central lumen of the isolation catheter and positioning the medication delivery device to locate the at least one opening in the lumen of the medication delivery device proximate the at least one opening through the wall of the central lumen in the isolation portion of the isolation catheter;

f. providing a medication source and a medication pump;

g. connecting the medication pump to the medication source and to the medication delivery device;

h. actuating the medication pump to pump medication from the medication source into the medication delivery device so that medication passes from the lumen of the medication delivery device through the at least one opening and through the at least one opening through the wall of the central lumen in the isolation portion of the isolation catheter; and

,

i. using the medication to treat the isolated segment of the blood vessel or other body cavity.

23. The method of claim 22, further comprising the steps of:

a. providing sealing means proximate the distal end of said central lumen to reduce leakage of fluid between said distal end of said central lumen and the distal end of the medication delivery device disposed therein; and

,

b. actuating the distal seal prior to delivering medication.

24. The method of claim 22, further comprising the steps of:

a. removing the medication delivery device from the isolation catheter;

b. providing a jet assembly comprising a high pressure tube having proximal and distal ends for passage of high pressure fluid between the proximal and distal ends, a fluid jet emanator in fluid communication with the high pressure tube at the distal end, and manual actuator means proximate the proximal end;

c. introducing the distal end of the high pressure tube and the fluid jet emanator into the central lumen of the isolation catheter using the manual actuator means and positioning the fluid jet emanator proximate the isolation portion using the manual actuator means;

d. providing a fluid source and a high pressure fluid pump;

e. connecting the high pressure fluid pump to the fluid source and the high pressure tube;

f. actuating the high pressure fluid pump to pump fluid from the fluid source into the high pressure tube at high pressure so that fluid emanates from the fluid jet emanator to create at least one fluid jet; and

,

g. using the fluid jet(s) to treat unwanted material in the isolated segment of the blood vessel or other body cavity via fluid communication through the at least one opening through the wall of the central lumen.

25. The method of claim 24, further comprising the steps of:

a. providing an effluent collector; and

,

b. using the effluent collector to receive fluid from the central lumen and thereby remove unwanted material.

26. A method of treating a segment of a blood vessel or other body cavity, comprising the steps of:

a. providing an isolation catheter having a central lumen, an inflation lumen, a proximal balloon, a distal balloon, and an isolation portion between the proximal balloon and the distal balloon, the isolation portion having at least one opening through a wall of the central lumen;

b. introducing the isolation catheter into a blood vessel or other body cavity and positioning the isolation catheter at a portion of the blood vessel or other body cavity to be treated;

c. inflating the proximal balloon and the distal balloon of the isolation catheter to isolate a segment of the blood vessel or other body cavity;

d. providing a plurality of treatment apparatuses each adapted to be advanced into the central lumen of the isolation catheter; and

,

e. introducing into the central lumen of the isolation catheter each of the provided treatment apparatuses one at a time, operating adjacent to the at least one opening in the isolation portion each of the introduced treatment apparatuses one at a time, and removing each of the introduced treatment apparatuses one at a time.

27. A method of treating unwanted material in a blood vessel or other body cavity, comprising the steps of:

a. providing an isolation catheter having a central lumen, an inflation lumen, a proximal balloon, a distal balloon, and an isolation portion between the proximal balloon and the distal balloon, the isolation portion having at least one opening through a wall of the central lumen;

b. introducing the isolation catheter into a blood vessel or other body cavity and positioning the isolation catheter at a portion of the blood vessel or other body cavity to be treated;

c. inflating the proximal balloon and the distal balloon of the isolation catheter to isolate a portion of the blood vessel or other body cavity;

d. providing a jet assembly comprising a high pressure tube having proximal and distal ends for passage of high pressure fluid between the proximal and distal ends, a fluid jet emanator in fluid communication with the high pressure tube at the distal end, and manual actuator means proximate the proximal end;

e. introducing the distal end of the high pressure tube and the fluid jet emanator into the central lumen of the isolation catheter using the manual actuator means and positioning the fluid jet emanator past the distal end of the central lumen of the isolation catheter and beyond the isolated portion of the blood vessel or other body cavity;

f. providing a fluid source and a high pressure fluid pump;

g. connecting the high pressure fluid pump to the fluid source and the high pressure tube;

h. actuating the high pressure fluid pump to pump fluid from the fluid source into the high pressure tube at high pressure so that fluid emanates from the fluid jet emanator to create at least one fluid jet; and

,

i. using the fluid jet(s) to treat unwanted material in the blood vessel or other body cavity while the isolation balloons are isolating a portion of the blood vessel or other body cavity.

28. The method of treating unwanted material of claim 27, wherein the jet assembly comprises inflow and outflow orifices and further comprising the steps of:

a. providing an effluent collector;

b. using the inflow and outflow orifices to create cross stream jets to enhance break up of unwanted material in the blood vessel or other body cavity; and

,

c. using the isolation catheter, the jet assembly, and the effluent collector to remove unwanted material from beyond the isolated portion of the blood vessel or other body cavity.

29. An isolation thrombectomy catheter system comprising:

a. an isolation catheter having openings in an isolated portion;

b. a jet assembly including a fluid jet emanator and a manual actuator;

c. a fluid source;

d. a high pressure pump; and

,

e. an effluent collector.