DEVICES FOR URETHRAL TREATMENT

• US 20140012192A1
• Filed: 03/15/2012
• Published: 01/09/2014
• Est. Priority Date: 03/17/2011
• Status: Active Grant

• Current Assignee: ProArc Medical Ltd.
• Original Assignee: ProArc Medical Ltd.
• Inventors: Feld, Yair, Bar-On, Raz, Shabat, Roni, Golan, Shai, Lengel, Yoav
• Granted Patent: US 10,035,005 B2
• Time in Patent Office: Days
• US Class Current: 604/93.01
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• 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 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

A dilation device (206) for an intra-body lumen, for example, a urethra partially occluded by an enlarged prostate in the form of a resilient curved body configured to be implanted in a cut around the lumen, and a method for dilating such a lumen by implanting a dilation device in a cut around the outside of the lumen. Also, a deployment system (300) including a delivery device for the implant, and a device for dilating the lumen before and while the cut is being made, and a method of using the implant and the deployment system. The implant may be formed of a strip or a coiled wire. The cut may be performed in part by the implant. The cut may be performed by a sharp edge, and/or by application of electrical current to the area being cut, or by a piezoelectric transducer.

Claims

1. An implant for deployment in an intra-body lumen to dilate the lumen, comprising:

a substantially ring-shaped structure formed of a resilient material configured for deployment in a peripheral cut formed in an inner surface of tissue surrounding a lumen,

wherein the implant is configured to be delivered to the deployment site in a compressed condition, and is releasable to at least a partially uncompressed condition after delivery.

3. An implant according to claim 1, wherein the implant is configured to dilate or help maintain dilation of a portion of a urethra that is constricted due to BPH, and to be embedded in a cut formed in the inner surface of a prostate.

5. An implant according to claim 1, wherein the implant is only partially relaxed upon deployment, whereby it applies a radial force in the cut to enable further post-deployment dilation.

6. An implant according to claim 1, configured as:

a) a substantially flat ring,

b) or a substantially flat surfaced closed ring,

c) or a substantially flat surfaced open or closed structure having a generally triangular perimeter formed of three arcuate segments,

d) with or without holes in the flat surfaces,

e) or a wire,

f) the length being selected according to the lumen to be dilated.

7. An implant according to claim 6, having protrusions on its longitudinal edges or on a flat surface thereof.

9. An implant according to claim 1 formed of nitinol, or stainless steel, or chromium-cobalt, or a biodegradable or other biocompatible material.

10. An implant according to claim 1, wherein the implant carries a drug which is released after deployment.

12. An implant according to claim 1, wherein the implant is a flat substantially C-shaped ring, in the range of 0.1 mm to 10 mm wide, and in the range of 0.05 mm to 0.5 mm thick.

2. (canceled)

4. (canceled)

8. (canceled)

11. (canceled)

13. (canceled)

14. A device for dilating a bodily lumen by enlarging the lumen and deploying an implant in tissue surrounding the lumen, comprising:

a carrier to deliver an implant for deployment in a cut in the inner surface of tissue surrounding the area to be dilated;

a cutter attached distally to a carrier

wherein the cutter is configured and positionable by its carrier to form a cut into the inner surface of tissue surrounding the lumen for receiving an implant; and

a release mechanism to separate the implant from its carrier.

15. The device according to claim 14, configured for treatment of BPH by dilation of a urethra and deployment of an implant into the inner surface of a prostate surrounding the urethra.

17. The device according to claim 54, wherein the dilation device or the cutter is the carrier for the implant or the implant is delivered by a carrier separate from the dilation device and the cutter.

19. The device according to claim 54, wherein the dilation device, the cutter, and the implant release mechanism are operable through a tubular shaft by an attached hand-piece accessible from outside the body.

20. The device according to claim 54, wherein the dilation device is comprised of at least one generally cylindrical balloon or at least two balloons that are generally toroidal or generally semi-ellipsoidal, or at least one resilient self-expanding member, and the dilation device is delivered to the area of use in a compressed condition.

23. The device according to claim 14, wherein the cutter is delivered to the implantation site inside a sheath, and is extendable out of the sheath for use.

24. The device according to claim 54, wherein dilation device is a balloon, and the sheath carrying the cutter is located on an outer surface of the balloon or in a sheath inside the balloon and is extendable through a self-sealing area of the balloon for use.

26. The device according to claim 54, wherein the dilation device and the sheath carrying the cutter are delivered to the implantation site as separate units.

28. The device according to claim 14, wherein the cutter and the implant cooperate so that the implant forms at least part of the implant-receiving cut.

30. The device according to claim 14, wherein the cutter is connectable to a source of electric power or to a piezoelectric transducer to form the cut.

36. The device according to claim 14, further including a mechanism for closing the implant-receiving cut by application of an adhesive, or by a clamp, or by a suture.

54. A device according to claim 14, further including an expandable dilation device for expanding the lumen during an implantation procedure.

55. A device according to claim 14, further including an implant.

56. A device according to claim 14, further including a fixation element for anchoring the device in the lumen, wherein the fixation element is a balloon or a plurality of resilient fingers.

16. (canceled)

18. (canceled)

21-22. -22. (canceled)

25. (canceled)

27. (canceled)

29. (canceled)

31-35. -35. (canceled)

37. A method of treatment of an intra-body lumen comprising:

inserting an implant formed of a resilient material into a lumen to be treated;

forming a cut in the inner surface of tissue surrounding the lumen at the area to be treated; and

deploying the implant in the cut.

38. The method according to claim 37, further including delivering the implant to the implantation site in a compressed condition, and deploying the implant in the cut in at least a partially uncompressed condition.

39. The method according to claim 37, wherein the lumen is a constricted portion of a urethra, and the implant is deployed in a cut in the inner surface of the prostate tissue around the constricted area.

41. The method according to claim 37, wherein the cut is formed by a cutter delivered to the implantation site, or by the implant, or by cooperation of a cutter and the implant.

42. The method according to claim 37, wherein the cut is formed by a sharp edge of a cutter and/or the implant, and/or by the action of energy delivered from an electrical source or by a piezoelectric transducer.

43. The method according to claim 42, wherein energy is provided continuously or intermittently during the cutting operation.

46. The method according to claim 37, further including closing the implant-receiving cut after deployment of the implant by application of an adhesive, or by a clamp, or by a suture.

47. The method according to claim 37, wherein the implant is configured substantially as one of:

(a) a flat-surfaced open or closed ring;

(i) with or without holes in the surfaces;

(ii) with or without protrusions on a radially outer surface or on the edges;

(b) as a closed or open ring formed of a wire.

48. The method according to claim 51, wherein the dilation device is a balloon and is expanded by inflation, or is a self-expanding device and is expanded by releasing it from a carrier in which it is delivered to the deployment site.

51. The method according to claim 37, further comprising expanding the lumen using a dilation device before and/or during formation of the cut.

52. The method according to claim 37, further comprising anchoring a delivery/implantation unit for the implant during cutting and deployment of the implant.

53. The method according to claim 47, wherein the open ring is C-shaped.

40. (canceled)

44-45. -45. (canceled)

49-50. -50. (canceled)