Transurethral needle ablation system with flexible catheter tip

• US 7,335,197 B2
• Filed: 10/13/2004
• Issued: 02/26/2008
• Est. Priority Date: 10/13/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Swoyer, John M., Christopherson, Mark A., Sage, Shahn S., Elmouelhi, Ahmed
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/963,971
• Publication Number:
  US 20060079880A1
• Time in Patent Office: 1,231 Days
• Field of Search: 606/41, 606 48- 50, 607/101, 607/102
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing

Abstract

A one-piece, single-use disposable device for transurethral needle ablation (TUNA) of prostate tissue to alleviate BPH is disclosed. The device may include a flexible catheter tip including a rigid core and a flexible tip. The device may also include a single use lockout to help ensure that the device is used to perform only one ablation procedure on a single patient. The device may further include a simplified needle deployment mechanism and/or an automatic needle retraction mechanism.

Claims

1. A transurethral ablation device, comprising:

a transurethral catheter insertable into a urethra of a patient;

a catheter tip, wherein the catheter tip comprises;

a rigid core positioned at a distal end of the catheter;

a substantially elbow shaped flexible tip positioned at a distal end of the rigid core; and

support structures extending partially within the flexible tip; and

at least one ablation needle extendable from the rigid core of the catheter tip to penetrate prostate tissue of the patient and to deliver ablation energy to the prostate tissue.

2. The device of claim 1, wherein the rigid core comprises at least one needle exit port from which the ablation needle is extendable.

3. The device of claim 1, wherein the rigid core comprises a fluid delivery lumen connected to receive fluid from the transurethral catheter.

4. The device of claim 3, wherein the flexible tip includes a notch positioned to receive the fluid from the fluid delivery lumen and deliver the fluid to the urethra.

5. The device of claim 4 wherein the notch is positioned on a side the ablation needle extends from the rigid core.

6. The device of claim 4, wherein the fluid cools the urethra.

7. The device of claim 1, further comprising at least one guide tube extending from a proximal end of the catheter to the exit port of the rigid core.

8. The device of claim 1, further comprising a thermocouple to monitor temperature inside the urethra.

9. The device of claim 8, wherein the thermocouple is attached to an outside wall of the guide tube proximate the exit port.

10. The device of claim 8, wherein the thermocouple monitors the temperature inside the urethra via thermal conduction.

11. The device of claim 1, wherein the rigid core has a Shore A hardness of at least 70.

12. The device of claim 1, wherein the rigid core is constructed of a thermoplastic elastomer.

13. The device of claim 1, wherein the flexible tip has a Shore A hardness of between 30 and 70.

14. The device of claim 10, wherein the flexible tip is constructed of a thermoplastic elastomer.

15. The device of claim 1, further including a lockout to store device usage information, and wherein delivery of the ablation energy is controlled based on the stored device usage information.