Devices, systems and methods for treating benign prostatic hyperplasia and other conditions

• US 10,195,014 B2
• Filed: 03/14/2013
• Issued: 02/05/2019
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences III LLC
• Original Assignee: NeoTract, Inc. (Teleflex Incorporated)
• Inventors: Lamson, Theodore C., Cheng, Floria, Catanese, III, Joseph
• Primary Examiner(s): Anderson, Gregory
• Application Number:
  US13/830,811
• Publication Number:
  US 20130253662A1
• Time in Patent Office: 2,154 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00792 Plastic surgery
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/0451 : Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 : Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2018/00547 : Prostate
• CPC Class Codes: A61F 2/0022 : placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/04 : Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/047 : Urethrae
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

Extra-urethral implants and methods of use are disclosed. Implants can treat disorders or diseases of the prostate by, for example, enlarging the lumen of the prostatic urethra.

Claims

1. A system for enlarging a lumen of a prostatic urethra comprising:

a delivery tool;

an implant carried by the delivery tool, the implant shaped to at least partially circumscribe the prostatic urethra; and

a depth guide removably fastened to and situated along one side of the implant and configured to dissect and displace tissue and set a depth of penetration of the implant within peri-urethral tissue planes and thereby enlarge the lumen of the prostatic urethra.

2. The system of claim 1 wherein the delivery tool has a sharp surface configured to penetrate the urethral wall.

3. The system of claim 1 wherein the delivery tool delivers energy to prostatic tissue.

4. The system of claim 1 wherein the implant has a sharp surface configured to penetrate the urethral wall.

5. The system of claim 1 wherein the implant is carried externally to at least part of the delivery tool.

6. The system of claim 1 wherein the implant is carried internally to at least part of the delivery tool.

7. The system of claim 1 further comprising a pusher coupled to the implant.

8. The system of claim 7 further comprising a locking mechanism coupled to at least one of the delivery tool, the implant, or the pusher.

9. The system of claim 1 wherein the implant includes a first section and a second section, wherein the first section is comparatively more flexible than the second section.

10. The system of claim 1 wherein the implant is self expanding.

11. The system of claim 1 wherein the delivery tool and the implant each have a radius of curvature and the delivery tool radius of curvature is greater than the implant radius of curvature.

12. The system of claim 1 wherein the implant includes a first section and a second section, wherein the first section is frictionally-engaged with the second section.

13. The system of claim 12 wherein the implant is configured to be deployed by overcoming the frictional engagement.

14. A method for enlarging a lumen of a prostatic urethra comprising:

advancing a delivery unit to a site within the lumen of the prostatic urethra, wherein the delivery unit comprises a delivery tool, an implant, and a depth guide;

penetrating the wall of the prostatic urethra with the delivery unit;

advancing the implant with respect to the delivery tool, wherein the depth guide is removably fastened to and situated along one side of the implant and configured to dissect and displace tissue and set a depth of penetration of the implant within peri-urethral tissue planes; and

retracting the delivery unit wherein the implant is left deployed within peri-urethral tissue planes.

15. The method of claim 14 wherein the wall of the prostatic urethra is penetrated using a sharp feature on the delivery tool.

16. The method of claim 14 wherein the delivery tool delivers energy to prostatic tissue.

17. The method of claim 14 wherein the wall of the prostatic urethra is penetrated using a sharp feature on the implant.

18. The method of claim 14 wherein delivery tool and the implant each have a radius of curvature and the delivery tool radius of curvature is greater than the implant radius of curvature.

19. The method of claim 14 wherein the implant expands to a greater diameter after advancing with respect to the delivery tool.

20. The method of claim 14 wherein the delivery unit further comprises an expanding member and the method further comprises expanding the implant using the expanding member.

21. The method of claim 14 wherein the implant is advanced from at least partially within the delivery tool.

22. The method of claim 14 wherein the implant is advanced from at least partially outside the delivery tool.