Drug delivery catheter with tip alignment

• US 6,179,809 B1
• Filed: 09/18/1998
• Issued: 01/30/2001
• Est. Priority Date: 09/24/1997
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Murphy-Chutorian, Douglas R., Khairkhahan, Alexander, Horzewski, Michael J., Mueller, Richard L., Harman, Stuart D.
• Primary Examiner(s): Nguyen, A. T.
• Application Number:
  US09/156,964
• Time in Patent Office: 865 Days
• Field of Search: 604/95, 604/523, 604/525, 604/528, 604/530, 604/264, 604/95.01, 604/95.04, 600/139, 600/136, 600/146, 600/149, 600/150, 600/143
• US Class Current: 604/95.04
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A steerable drug delivery catheter and method of use, particularly adapted for percutaneous use. The distal end of the drug delivery catheter is deflectable. The catheter has a relative movement compensation mechanism for maintaining positioning between the distal end of the drug delivery catheter and the distal end of the drug delivery device therein.

Claims

1. A percutaneous drug delivery catheter comprising:

a catheter jacket, having proximal and distal ends, and at least a first lumen;

at least a first drug delivery device within the first lumen of the catheter jacket, the first drug delivery device having proximal and distal ends;

a deflection mechanism at the proximal end of the catheter, the deflection mechanism operatively attached to a deflector device at the distal end of the catheter jacket, the deflection mechanism comprising a groove portion on a deflection actuator which cooperates with a set of thread pins attached to a rotatable inner deflection knob coupled to the catheter jacket, activation of the deflector device by movement of the deflection mechanism deflects the distal end of the catheter jacket and the drug delivery device therein; and

a relative movement compensation mechanism operatively attached to the deflection mechanism and the proximal end of the first drug delivery device, the relative movement compensation mechanism comprising a thread portion on a handle which cooperates with a groove portion on the inner deflection knob,

wherein, during movement of the deflection mechanism, simultaneous movement of the relative movement compensation mechanism occurs whereby the alignment between the distal end of the catheter jacket and the distal end of the first drug delivery device is maintained during the deflection.

2. The catheter of claim 1 further comprising an operative device.

3. The catheter of claim 2 wherein the operative device is an ultrasound ranging device.

4. The catheter of claim 1 further comprising an indexing means for limiting the movement of the deflection mechanism with respect to the relative movement compensation mechanism.

5. The catheter of claim 4 further comprising an actuator radially aligned with the deflection knob, wherein the rotation of the actuator results in corresponding rotation of the inner deflection knob and relative linear movement of the deflection actuator and the handle.

6. The catheter of claim 5 wherein the at least first drug delivery device is attached to a coupling device and translates within an inner tube, said inner tube attached to the handle.

7. The catheter of claim 6 wherein the first drug delivery device is advanceable within the inner tube.

8. The catheter of claim 6 wherein the coupling device is branched with at least a first and second arm, the first drug delivery device is coupled through the first arm and a second drug delivery device is coupled through the second arm of the coupling device.

9. The catheter of claim 6 wherein the distal end of the drug delivery device comprises a drug delivery needle.

10. The catheter of claim 9 further comprising an automated drug delivery module, attached to the actuator, enabling extension of the piercing needle and dispensing of at least one therapeutic agent there through.

11. The catheter of claim 10 wherein the drug delivery device is attached to a fluid reservoir.

12. The catheter of claim 11 wherein the fluid reservoir contains at least one therapeutic agent.

13. The catheter of claim 12 wherein the therapeutic agent is an angiogenesis agent.

14. The catheter of claim 12 wherein the fluid reservoir contains saline.

15. The catheter of claim 4 wherein the deflection mechanism further comprises a pull cable, having proximal and distal ends, the distal end of the pull cable attached to the distal end of the catheter jacket and extended through a pull cable guide within an anchor sleeve, the anchor sleeve coupled to the distal end of the inner tube and attached to the catheter jacket, the pull cable further extended through the catheter base and the deflection actuator and attached proximally to a pull cable stop, at the proximal end of the deflection actuator.

16. The catheter of claim 15 wherein the deflection mechanism further comprises a shim, having proximal and distal ends, the proximal end attached to the anchor sleeve and a spring and the distal end of the shim attached to the distal end of the catheter jacket.

17. The catheter of claim 4 further comprising a depth stop threaded to external helical threads of a back tube, the back tube slidably disposed in the handle.

18. The catheter of claim 4 further comprises a sealing member between the back tube and a front tube.

19. A method of treatment within a body using a percutaneous drug delivery catheter, the steps of the method comprising:

a) providing a percutaneous drug delivery catheter that includes, a catheter jacket having proximal and distal ends, at least a first drug delivery device disposed within the catheter jacket, the drug delivery device having proximal and distal ends, a deflection mechanism at the proximal end of the catheter jacket causing deflection of the distal end of the catheter jacket, the deflection mechanism comprising a groove portion on a deflection actuator which cooperates with a set of thread pins attached to a rotatable inner deflection knob coupled to the catheter jacket, and a relative movement compensation mechanism operatively attached to the deflection mechanism and the proximal end of the first drug-delivery device, the relative movement compensation mechanism comprising a thread portion on a handle which cooperates with a groove portion on the inner deflection knob, whereby alignment between the distal end of the catheter jacket and the distal end of the drug delivery device attached to the relative compensation mechanism is maintained during deflection;

b) positioning the catheter for performance of a drug delivery procedure in the body;

c) deflecting the distal end of the catheter jacket with movement of the deflection mechanism causing simultaneous compensating movement of the relative movement compensation mechanism; and

d) effectuating delivery of at least one therapeutic agent.

20. The method of claim 19 wherein in step b) the catheter is positioned within a body cavity.

21. The method of claim 19 wherein in step b) the catheter is positioned within the left ventricle.

22. The method of claim 19 step b) further including a guide wire for advancing the device through the vasculature and into position within the body.

23. A steerable percutaneous drug delivery catheter for treating internal body surfaces the apparatus comprising:

a catheter jacket having proximal and distal ends, and at least a first lumen;

at least a first drug delivery device within the first lumen of the catheter jacket, the drug delivery device having proximal and distal ends;

a deflection mechanism, comprising a groove portion on a deflection actuator which cooperates with a set of thread pins attached to a rotatable inner deflection knob, said inner deflection knob operatively coupled to the catheter jacket; and

a relative movement compensation mechanism operatively attached to the drug delivery device, the compensation mechanism comprising a thread portion on a handle which cooperates with a groove portion on the inner deflection knob;

whereby movement of the deflection mechanism causes simultaneous compensating movement of the relative movement compensation mechanism.

24. A percutaneous drug delivery catheter comprising:

a catheter jacket, having proximal and distal ends, and at least a first lumen;

at least a first drug delivery device within the first lumen of the catheter jacket, the first drug delivery device having proximal and distal ends;

a deflection mechanism at the proximal end of the catheter, the deflection mechanism operatively attached to a deflector device at the distal end of the catheter jacket, the deflection mechanism comprising a groove portion on a deflection actuator which cooperates with a set of thread pins attached to a rotatable inner deflection knob coupled to the catheter jacket, activation of the deflector device by movement of the deflection mechanism deflects the distal end of the catheter jacket and the drug delivery device therein; and

a relative movement compensation means operatively connected to the deflection mechanism and the proximal end of the first drug delivery device for maintaining alignment between the catheter jacket and the drug delivery device, the relative movement compensation means comprising a thread portion on a handle which cooperates with a groove portion on the inner deflection knob, whereby movement of the deflection mechanism causes simultaneous movement of the relative movement compensation means.

25. A catheter with tip alignment comprising:

a catheter jacket having proximal and distal ends, and at least a first lumen;

at least a first drug delivery device within the first lumen of the catheter jacket, the drug delivery device having proximal and distal ends;

a deflection mechanism at the proximal end of the catheter operatively attached to a deflector device at the distal end of the catheter jacket, activation of the deflector device by movement of the deflection mechanism deflects the distal end of the catheter jacket and the drug delivery device therein; and

a tip alignment mechanism operatively attached to the deflection mechanism and the proximal end of the drug delivery device, the tip alignment mechanism comprising at least one relative movement compensation mechanism selected from the group consisting of a rotatable differential screw mechanism, a gear mechanism, a cam mechanism, a threaded mechanism, and a grooved mechanism,

wherein movement of the deflection mechanism causes simultaneous compensating movement of the relative movement compensation mechanism.