Infusion catheter having an integrated doppler transducer

• US 20040122354A1
• Filed: 09/03/2003
• Published: 06/24/2004
• Est. Priority Date: 09/05/2002
• Status: Abandoned Application

• Current Assignee: Genentech, Inc. (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Semba, Charles P.
• Application Number:
  US10/655,277
• Publication Number:
  US 20040122354A1
• Time in Patent Office: Days
• US Class Current: 604/66
• 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 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Preferred embodiments disclosing an infusion catheter having an integrated Doppler transducer are provided which advance the field by providing improved structures for the real time monitoring of blood flow for use in such fields as thrombolytic therapy. Method of practicing therapy using preferred embodiments of the present invention are also provided.

Claims

1. An infusion system comprising:

a hollow catheter body having infusion ports therein;

a transducer wire of sufficient length to allow placement of the transducer wire proximate to a desired location within a patient, the transducer wire being partially located inside the hollow catheter body, the remainder of the transducer wire being located outside of the catheter hollow body, a transducer wire distal tip portion removably adjoining the hollow catheter body so as to allow the selective insertion of the transducer wire through the hollow catheter body;

an ultrasound transducer joined to the transducer wire distal tip portion, the transducer being configured, when inserted into blood surrounding the infusion catheter body, to protrude sufficiently to allow the detection of the presence of a Doppler signal based on an ultrasound signal generated by the transducer, the transducer being further configured to produce an output signal based on the degree of blood movement when surrounding by blood; and

an output device being configured to allow a health care practitioner to interpret the transducer based signal in order to gain information about the degree of blood movement proximate to the ultrasound transducer; and

a signal transfer wire, a portion of the wire being located inside the transducer wire, the signal transfer wire being configured to transfer the output signal from the ultrasound transducer to the output device.

2. The infusion system of claim 1, wherein the catheter system is configured for thrombolytic therapy.

3. The infusion system of claim 1, further comprising a port assembly, the port assembly having an attachment end to which the catheter body is removably attached, the transducer wire partially being located within the port assembly, a transducer wire access hole being located opposite the attachment end.

4. The infusion system of claim 3, further comprising a therapeutic agent entry port located on the port assembly.

5. The infusion system of claim 1, wherein the ultrasound transducer protrudes from a distal tip of the hollow catheter body.

6. The infusion system of claim 1, wherein the ultrasound transducer protrudes from a tapered tip of the hollow catheter body.

7. The infusion system of claim 1, wherein the ultrasound transducer is configured to detect a Doppler signal when the blood surrounding the transducer is flowing.

8. The infusion system of claim 7, wherein the output device is an acoustic output device comprising a speaker, a power supply, and appropriate amplification circuitry to allow the output signal generated by the ultrasound transducer to be heard by a human ear when the blood surrounding the transducer is flowing.

9. The infusion system of claim 8, further including a port assembly to which the catheter body is removably attached, wherein the hollow catheter body, the port assembly, and the transducer wire are configured to be inserted into a human blood vessel.

10. The infusion system of claim 7, wherein the output device is a visual output device which produces a visual indicator based on the intensity of the detected Doppler signal.

11. A method of infusion therapy comprising:

locating an infusion catheter and a transducer wire proximate to a treatment site within a blood transferring vessel of a patient, the transducer wire being partially located inside of the infusion catheter, the transducer wire having an integrated ultrasound transducer tip configured to protrude from the infusion catheter into blood surrounding the infusion catheter, when inserted into a blood vessel having blood therein;

infusing a therapeutically effective amount of a therapeutic agent into an area proximate the infusion catheter;

emitting ultrasound energy from the transducer;

detecting the intensity of a Doppler signal produced by the degree of blood flow surrounding the transducer;

determine the degree of blood flow surrounding the transducer through interpreting the intensity of the Doppler signal; and

taking appropriate medical action based on the degree of blood flow.

12. The method of claim 11, wherein locating the infusion catheter and transducer wire proximate to a treatment site within a blood transferring vessel of a patient comprises:

inserting a manipulating guidewire proximate to the treatment site;

passing the infusion catheter over the manipulating guidewire to proximate the treatment site, the catheter having an opening at both ends;

removing the manipulating guidewire from inside of the infusion catheter by removing the guidewire from both of the infusion catheter openings;

guiding a transducer wire, having a Doppler transducer attached to a distal tip portion of the wire, inside the hollow infusion catheter so that the transducer protrudes from the end of the infusion catheter into the surrounding blood.

13. The method of claim 12, further including removing the catheter in response to the Doppler signal.

14. The method of claim 12, wherein the infused therapeutic agent is a lytic agent.

15. The method of claim 14, wherein the lytic agent is a thrombolytic agent selected from the group consisting of tissue plasminogen activator (t-PA), T103N, N117Q, KHRR(296-299)AAAA t-PA, steptokinase, urokinase, reteplase (133-L-serine-174-L-tyrosine-175-L-glutamine-173-527 t_PA), and staphylokinase.

16. The method of claim 15, wherein the thrombolytic agent is native human tissue plasminogen activator (ht-PA) or a variant thereof.

17. The method of claim 16, wherein the tissue plasminogen activator is recombinant native human tissue plasminogen activator (rht-PA).

18. The method of claim 16, wherein the tissue plasminogen activator is T103N, N117Q, KHRR(296-299)AAAA t-PA (tenecteplase).

19. The method of claim 16, wherein the tissue plasminogen activator is co-administered with heparin.

20. The method of claim 19, wherein the heparin is a low molecular weight heparin.

21. The method of claim 12, wherein the infused therapeutic agent is a nucleic acid encoding a polypeptide capable of modifying blood flow proximate an occluded vessel.

22. The method of claim 12, wherein the infused therapeutic agent is an angiogenic factor.

23. The method of claim 22, wherein the angiogenic factor is recombinant human vascular endothelial growth factor (rhVEGF).