Infusion catheter having an atraumatic tip

• US 6,855,136 B2
• Filed: 04/25/2002
• Issued: 02/15/2005
• Est. Priority Date: 04/03/2002
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Dorros, Gerald, Hogendijk, Michael, Bates, Mark C.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US10/134,237
• Publication Number:
  US 20030191434A1
• Time in Patent Office: 1,027 Days
• Field of Search: 604/96.01, 604/101.01, 604/101.03, 604/101.04, 604506-510, 604/104, 604/105, 604/164.13, 604/265, 604/529, 604/266, 604/523, 604/915, 604/264, 604/93.01, 604/524, 606/192, 606/194, 606/198
• US Class Current: 604/508
• 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 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The present invention is directed to apparatus and methods for treating a vascular occlusion by providing an infusion catheter having an atraumatic tip and at least one delivery port configured to infuse fluid into the occlusion. The fluid that is infused dilutes the occlusion and reduces adhesion of the occlusion to an intima of the vessel wall, thereby causing the occlusion to dislodge. Emboli generated in the process are directed into an emboli removal catheter for removal.

Claims

1. Apparatus suitable for disrupting a vascular occlusion adhered to a vessel wall, the apparatus comprising:

an infusion catheter having proximal and distal ends and a lumen extending therebetween, an atraumatic tip disposed at the distal end, and at least one delivery port disposed proximal of the atraumatic tip in fluid communication with the lumen, the at least one delivery port configured to infuse fluid into the occlusion so that the fluid reduces adhesion of the occlusion to an intima of the vessel wall;

an emboli removal catheter having a proximal end, a distal end including an occlusive element, and a lumen extending between the proximal and distal ends, the lumen sized to permit the longitudinal advancement of the infusion catheter therethrough; and

a venous return sheath having proximal and distal ends and a lumen extending therebetween, the venous return sheath in fluid communication with the lumen of the emboli removal catheter and is adapted to be disposed in a patient'"'"'s venous system.

2. The apparatus of claim 1 wherein the atraumatic tip comprises a platinum coil.

3. The apparatus of claim 1 wherein at least one delivery port delivers a jet of fluid that forms an oblique angle relative to a longitudinal axis of the infusion catheter.

4. The apparatus of claim 3 wherein the delivery port causes fluid to be ejected in a proximal direction.

5. The apparatus of claim 1 wherein the delivery port comprises a circular configuration.

6. The apparatus of claim 1 wherein the infusion catheter further comprises at least one radiopaque marker band disposed proximal of the atraumatic tip.

7. The apparatus of claim 6 wherein a first radiopaque marker band is disposed proximal of the delivery port and a second radiopaque marker band is disposed distal of the delivery port.

8. The apparatus of claim 1 wherein the fluid is saline.

9. The apparatus of claim 1 further comprising a removable stylet that is configured to be longitudinally advanced within the lumen of infusion catheter.

10. The apparatus of claim 1 further comprising an infusion pump configured to regulate the flow of fluid infused into the lumen of the infusion catheter.

11. The apparatus of claim 1 wherein the fluid is a drug.

12. The apparatus of claim 1 further comprising a valve disposed between the emboli removal catheter and the venous return sheath, wherein the valve is configured to selectively inhibit fluid communication between the lumen of the emboli removal catheter and the lumen of the venous return sheath.

13. The apparatus of claim 1 further comprising a filter disposed between the emboli removal catheter and the venous return sheath.

14. Apparatus suitable for treating an occlusion adhered to a vessel wall, the apparatus comprising:

an infusion catheter having proximal and distal ends and a lumen extending therebetween, an atraumatic tip disposed at the distal end, and at least one delivery port disposed proximal of the atraumatic tip in fluid communication with the lumen; and

a centering device having proximal and distal ends and a lumen extending therebetween, the centering device comprising a plurality of deployable struts disposed at the distal end, the lumen adapted to permit the infusion catheter to pass therethrough,

wherein the infusion catheter is configured to infuse fluid into the occlusion so that the fluid reduces adhesion of the occlusion to an intima of the vessel wall.

15. The apparatus of claim 14 further comprising an outer sheath having proximal and distal ends and a lumen extending therebetween, the outer sheath being configured to constrain the deployable struts in a contracted state within the outer sheath.

16. The apparatus of claim 14 wherein the deployable struts are sized to engage the vessel wall in a deployed state.

18. The apparatus of claim 14 wherein at least one delivery port delivers a jet of fluid that forms an oblique angle relative to a longitudinal axis of the infusion catheter.

19. The apparatus of claim 18 wherein the delivery port causes fluid to be ejected in a proximal direction.

20. The apparatus of claim 14 wherein the infusion catheter further comprises at least one radiopaque marker band disposed proximal of the atraumatic tip.

21. The apparatus of claim 20 wherein a first radiopaque marker band is disposed proximal of the delivery port and a second radiopaque marker band is disposed distal of the delivery port.

22. The apparatus of claim 14 further comprising an emboli removal catheter having proximal and distal ends and a lumen extending therebetween, and further comprising an occlusive element disposed at the distal end, wherein the lumen of the emboli removal catheter is sized to permit the longitudinal advancement of the centering device.

17. The apparatus of 14 wherein the deployable struts comprise a nickel-titanium alloy.

23. A method for treating an occlusion adhered to a vessel wall, the method comprising:

providing an infusion catheter having proximal and distal ends, a lumen extending therebetween, an atraumatic tip disposed at the distal end, and at least one delivery port disposed proximal of the atraumatic tip in fluid communication with the lumen;

providing a centering device having proximal and distal ends, a lumen extending therebetween, and a plurality of deployable struts disposed at the distal end in a contracted state;

positioning the centering device at a location proximal of the occlusion;

deploying the plurality of deployable struts; and

advancing the infusion catheter through the lumen of the centering device to advance the atraumatic tip through the occlusion;

positioning the delivery port at a desired location within the occlusion; and

infusing fluid into the occlusion via the delivery port so that the fluid reduces adhesion of the occlusion to an intima of the vessel wall.

24. The method of claim 23 wherein positioning the delivery port at a desired location within the occlusion comprises:

providing at least one radiopaque marker band disposed on the infusion catheter at a location proximal of the atraumatic tip; and

using the radiopaque marker band to determine the position of the delivery port within the occlusion.

25. The method of claim 23 wherein fluid is infused into the occlusion at a controlled rate using an infusion pump.

26. The method of claim 23 further comprising:

providing an emboli removal catheter having proximal and distal ends and a lumen extending therebetween, and further comprising an occlusive element disposed at the distal end, wherein the lumen of the emboli removal catheter is sized to permit the longitudinal advancement of the infusion catheter;

deploying the occlusive element at a position proximal of the centering device to occlude antegrade flow in a vessel;

establishing retrograde flow through the lumen of the emboli removal catheter to influence flow characteristics in a treatment vessel; and

causing emboli generated during the infusion of fluid into the occlusion to be directed into the emboli removal catheter.

27. The method of claim 23 wherein fluid is infused into the occlusion in a proximal direction.

28. The method of claim 23 wherein deploying the plurality of deployable struts comprises proximally retracting an outer sheath that is used to constrain the deployable struts in the contracted state.

29. A method for treating an occlusion adhered to a wall of a patient'"'"'s vessel, the method comprising:

providing an emboli removal system having a proximal end adapted to be inserted in a patient'"'"'s venous system, distal end including an occlusive element, and a lumen extending between the proximal and distal ends;

providing an infusion catheter having proximal and distal ends, a lumen extending therebetween, an atraumatic tip disposed at the distal end, and at least one delivery port disposed proximal of the atraumatic tip in fluid communication with the lumen;

advancing the distal end of the emboli removal system through the vessel to a position proximal of the occlusion;

deploying the occlusion element to occlude antegrade flow through the vessel;

inserting the proximal end of the emboli removal system into the patient'"'"'s venous system;

advancing the infusion catheter so that the atraumatic tip penetrates the occlusion;

positioning the delivery port at a desired location within the occlusion;

infusing fluid into the occlusion via the delivery port to reduce adhesion of the occlusion to an intima of the vessel wall, dislodge the occlusion and generate emboli;

aspirating emboli-laden blood through the emboli removal system;

filtering emboli-laden blood aspirated through from the vessel to remove emboli; and

re-infusing filtered blood into the patient'"'"'s venous system.

30. The method of claim 29 wherein positioning the delivery port at a desired location within the occlusion comprises:

providing at least one radiopaque marker band disposed on the infusion catheter adjacent to the delivery port; and

using the radiopaque marker band to determine the position of the delivery port within the occlusion.

31. The method of claim 29 wherein infusing fluid into the occlusion further comprises infusing fluid into the occlusion at a controlled rate using an infusion pump.

32. The method of claim 29 further comprising, prior to advancing the infusion catheter, establishing retrograde flow through the vessel.

33. The method of claim 29 wherein infusing fluid into the occlusion further comprises infusing fluid into the occlusion in a proximal direction.

34. The method of claim 29 further comprising:

providing a centering device having proximal and distal ends, a lumen extending therebetween, and a plurality of deployable struts disposed at the distal end in a contracted state;

prior to advancing the infusion catheter, inserting the centering device through the lumen of the emboli removal system to position the centering device at a location proximal of the occlusion and distal of the occlusive element;

deploying the plurality of deployable struts; and

wherein advancing the infusion catheter comprises advancing the infusion catheter through the lumen of the centering device.

35. The method of claim 34 wherein deploying the plurality of deployable struts comprises proximally retracting an outer sheath that is used to constrain the deployable struts in the contracted state.