Method and apparatus for placement of implantable device adjacent a body lumen

• US 8,926,494 B1
• Filed: 03/26/2009
• Issued: 01/06/2015
• Est. Priority Date: 03/26/2008
• Status: Active Grant

• Current Assignee: Uromedica, Inc
• Original Assignee: Uromedica, Inc
• Inventors: Cook, Timothy C., Burton, John H.
• Primary Examiner(s): Hicks, Victoria J
• Assistant Examiner(s): HARRIS, RAYMOND EUGENE
• Application Number:
  US12/411,806
• Time in Patent Office: 2,112 Days
• Field of Search: 600/29, 600/30, 600/31, 623/23.66, 623/23.77, 604/500, 604/502, 604/509
• US Class Current: 600/30
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes 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 subject matter provides method and apparatus for placement of implantable devices adjacent a body lumen. A method of implanting an implantable device at a target site for controllable coaptation of a patient'"'"'s urethra using an ultrasonic probe inserted into a rectum of the patient comprises inserting a Foley catheter into the urethra, expanding a Foley balloon in the bladder neck, inserting the ultrasonic probe into the rectum of the patient, using the ultrasonic probe to image the urethra and Foley balloon at the bladder neck, placing a small puncture in the perineum, passing a delivery device to the target site under ultra sonic guidance, injecting echogenic fluid at the target site adjacent the urethra, delivering the implantable device to the target site, and adjusting the implantable device to improve coaptation of the urethra.

Claims

1. A method of positioning and implanting an expandable implantable device at a target site for controllable coaptation of a male patient'"'"'s urethra using a biplanar ultrasonic probe inserted into a rectum of the patient, comprising:

inserting a Foley catheter into the urethra;

expanding a Foley balloon in the bladder neck;

inserting the ultrasonic probe into the rectum of the patient;

using the ultrasonic probe to image the urethra and Foley balloon at the bladder neck;

placing a small puncture in the perineum;

passing a delivery device through the puncture to the target site with concurrent delivery of a local anesthetic under guidance of the ultrasonic probe and positioning the delivery device at the target site, using radial and longitudinal views provided by the ultrasonic probe, wherein the target site is proximal to the apex of the prostate or an urethral vesical anastomosis;

expanding the target site using fluid delivered from the delivery device;

delivering the expandable implantable device to the expanded target site; and

adjusting the expandable implantable device to improve coaptation of the urethra,

wherein the amount of the expansion of the expandable implantable device controls the coaptation of the urethra.

2. The method of claim 1, wherein passing a delivery device includes passing a pointed trocar to the target site under ultrasonic guidance.

3. The method of claim 2, further comprising passing a needle through the trocar.

4. The method of claim 3, further comprising injecting echogenic fluid through a channel of the needle to hydrodissect the target area.

5. The method of claim 4, wherein delivering the expandable implantable device includes removing the needle from the trocar.

6. The method of claim 2, wherein passing a pointed trocar includes coupling a syringe to a Luer coupling of the trocar.

7. The method of claim 2, further comprising injecting echogenic fluid through a channel of the trocar to hydrodissect the target area.

8. The method of claim 2, wherein delivering the expandable implantable device includes delivering the expandable implantable device through a channel of the trocar.

9. The method of claim 1, wherein passing a delivery device includes passing a pointed trocar enclosed within a channel of a removable sheath to the target site under ultrasonic guidance.

10. The method of claim 9, further comprising injecting echogenic fluid through a channel of the trocar to hydrodissect the target area.

11. The method of claim 9, further comprising injecting echogenic fluid through a second channel of the sheath to hydrodissect the target area.

12. The method of claim 9, wherein delivering the expandable implantable device includes delivering the expandable implantable device through a channel of the trocar to the target site.

13. The method of claim 9, wherein delivering the expandable implantable device includes removing the trocar from the channel of the sheath before delivering the expandable implantable device to the target site.

14. The method of claim 1, wherein the fluid is an echogenic fluid delivered at the target site adjacent the urethra.

15. The method of claim 14, wherein the echogenic fluid includes water and is delivered via injection.

16. The method of claim 14, wherein injecting includes hydrodissecting the target site with the fluid to create a pocket for the expandable implantable device.

17. The method of claim 1, wherein placing a small puncture includes placing a small puncture in the perineum using a spinal needle.

18. The method of claim 17, further comprising passing the spinal needle through to the target site.

19. The method of claim 1, wherein the local anesthetic is delivered via injection in an echogenic fluid.

20. The method of claim 1, wherein passing a delivery device includes passing a splittable sheath enclosing a trocar to the target site under ultrasonic guidance.

21. The method of claim 1, wherein adjusting the expandable implantable device includes accessing a septum connected to the expandable implantable device with a hypodermic needle to improve coaptation of the urethra.

22. The method of claim 1 wherein the patient has had a transurethral resection of the prostate or a radical prostatectomy.

23. A method of positioning and implanting an expandable implantable device at a target site for controllable coaptation of a patient'"'"'s urethra using a biplanar ultrasonic probe inserted into a rectum of the patient, comprising:

providing a patient having a Foley catheter in the urethra with a Foley balloon expanded in the bladder neck, a biplanar ultrasonic probe in the rectum, and a puncture in the perineum;

passing a delivery device through the puncture in the perineum of the patient towards a target site and positioning the delivery device at the target site, under guidance of the ultrasonic probe using radial and longitudinal views provided by the ultrasonic probe, wherein the delivery device delivers an echogenic fluid having a local anesthesic along the passage;

expanding the target site using hydrodissection;

delivering the expandable implantable device to the expanded target site; and

adjusting the expandable implantable device to improve coaptation of the urethra, wherein the amount of the expansion of the expandable implantable device controls the coaptation of the urethra.