METHODS AND DEVICES FOR URETHRAL TREATMENT

• US 20160096009A1
• Filed: 12/13/2015
• Published: 04/07/2016
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: ProArc Medical Ltd.
• Original Assignee: ProArc Medical Ltd.
• Inventors: FELD, Yair
• Granted Patent: US 10,406,333 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61F 2002/048 Ureters
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A dilation device for an intrabody lumen, for example, a urethra partially occluded by an enlarged prostate in the form of a curved element configured to be implanted around the lumen and add resilience to the lumen, and a method for dilating such a lumen by implanting a dilation device around the outside of the lumen with at least part of the dilation device embedded in surrounding, thereby preventing clinically significant compression of the lumen. Also, an implantation device for such a dilation device in the form of a mounting device configured to carry the dilation device; and a releasably attached movable holder, with the mounting device and holder configured to deliver the dilation device though a working channel to a desired position in a lumen, and to implant the dilation device through a wall of the lumen to a position surrounding the lume.

Claims

1. A delivery device for a urethral dilation device for treating constriction of a urethra due to an enlarged prostate comprising:

a mounting device configured to carry the dilation device to a region of treatment for implantation in the inner surface of the tissue of the prostate surrounding the constriction;

a movable holder attached to the mounting device; and

a urethral expander configured and operable to enlarge the urethra during and/or before implantation,

the mounting device, the holder, and the urethral expander all being configured to be delivered to the implantation site through a working channel inserted within the urethra wherein;

the mounting device is rotatable, and configured and positionable to implant the dilation device into the tissue of the prostate from inside the constricted region.

2. A delivery device according to claim 1, wherein the urethral expander is inflatable or self-expanding.

3. A delivery device according to claim 1, wherein the mounting device is configured to maintain the dilation device in a reduced transverse dimension configuration during delivery to an implantation site.

4. A delivery device according to claim 1, wherein said holder and said urethral expander are configured to be rotatable during implantation or only said holder is rotatable during implantation.

5. A delivery device according to claim 1, wherein said urethral expander extends outwardly from one side of said holder when expanded.

6. A delivery device according to claim 1, configured to implant the dilation device so that a portion of the urethra is not surrounded by the dilation device.

7. A delivery device according to claim 6, configured to implant the dilation device so that the portion of the urethra at the bottom is not surrounded by the dilation device.

8. A delivery device according to claim 1 further including a cage configured to surround the dilation device during delivery, wherein the cage includes an opening allowing the dilation device to exit for implantation.

9. A delivery device according to claim 8, wherein the cage is configured to compress the dilation device and prevent it from expanding while being delivered for implantation.

10. A delivery device according to claim 1 further including:

(a) a guide channel configured to receive a dilation device, for guiding implantation of said dilation devices;

or

a plurality of guide channels, each configured to receive a dilation device, for guiding implantation of multiple dilation devices, the guide channels being located at multiple circumferential and/or axial positions on the urethral expander.

11. A delivery device according to claim 10, further including a separate delivery wire for each guide channel or a single delivery wire for all the guide channels.

12. A delivery device according to claim 1, wherein the mounting device is configured and positionable to implant the dilation device through a cut formed by the dilation device itself.

13. A delivery device according to claim 1, further including a pusher coupled to the holder that is operable to move the dilation device to a desired location for implantation.

14. A delivery device according to claim 1, further comprising:

a delivery sheath configured to receive the dilation device before placement thereof on the mounting device; and

a pushing device operable to expel the dilation device from the sheath, and to hold it in place while the sheath is withdrawn.

15. A delivery device according to claim 14, wherein the sheath is configured to be withdrawn by unscrewing it from within the prostate or by pulling it from within the prostate.

16. A delivery device according to claim 1, wherein at least part of the dilation device surrounds the urethral expander during delivery to the implantation site.

17. A delivery device according to claim 1, wherein the urethral expander is configured to expand a plastically deformable dilation device to a deployment configuration when the urethral expander is expanded.

18. A delivery device according to claim 1, wherein the urethral expander is a balloon.

19. A delivery device according to claim 1, wherein the urethral expander is at the same general axial location as the holder for the dilation device.

20. An implantation system for dilating a urethra constricted by an enlarged prostate comprising:

a delivery device for a urethral dilation device as described in claim 1; and

a dilation device configured to be implantable around a constricted region of a urethra substantially entirely through the surface of the enlarged portion of the prostate surrounding the constricted region of said urethra;

wherein the delivery device is configured and operable to deliver the dilation device to a desired position in a urethra and to implant the dilation device through the wall of the prostate surrounding the constricted portion of the urethra.

21. An implantation system according to claim 20, wherein the urethral expander is at least partially surrounded by the dilation device during delivery.

22. An implantation system according to claim 20, wherein the mounting device is configured and positionable to implant the dilation device through a cut formed by the dilation device itself.

23. An implantation system according to claim 20, further including a pusher coupled to the holder that is operable to move the dilation device to a desired location for implantation.

24. An implantation system according to claim 20, wherein the urethral expander includes:

(a) a guide channel from within which a dilation device is implanted;

or

(b) a plurality of guide channels from within which a plurality of dilation devices respectively are implanted.

25. An implantation system according to claim 20, wherein the dilation device carries a drug coating which is eluted over time, to cause shrinkage or reduce growth of the prostate or to prevent re-stenosis.

26. An implantation system according to claim 25, wherein the drug is sirolimus or paclitaxel.

27. A system according to claim 20, wherein the dilation device is plastically deformable and is expanded from a delivery configuration to a deployment configuration by expansion of the urethral expander.

28. An implantation system according to claim 20, wherein the dilation device is comprised of one or more curved segments configured to partially surround the periphery of the urethra when implanted.

29. An implantation system according to claim 20, wherein the dilation device includes a sharpened portion to facilitate implantation, and a projection to prevent withdrawal while the delivery device is being removed.

30. An implantation system according to claim 29, wherein the projection is a barb located at an end of the dilation device which first enters the prostate.

31. An implantation system according to claim 24, wherein the plurality of guide channels are located at multiple circumferential and/or axial positions on the urethral expander.

32. An implantation system according to claim 24, further including a separate delivery wire for each guide channel or a single delivery wire for all the guide channels.

33. An implantation system according to claim 20, wherein the delivery device includes:

a sheath in which the dilation device is delivered; and

a pushing device operable to expel the dilation device from the sheath, and hold it in place while the sheath is withdrawn.

34. An implantation system according to claim 20, wherein the urethral expander is configured to be withdrawn by unscrewing it from within the prostate or by pulling it from within the prostate.

35. An implantation system according to claim 20, wherein the urethral expander is configured to be expanded by inflation or is self-expanding.

36. An implantation system according to claim 20, wherein the size of the dilation device is such that, upon implantation, a portion of the urethra is not surrounded.

37. A system according to claim 36, wherein the mounting device and the holder are configured and operable to implant the dilation device so that the portion of the urethra at the bottom is not surrounded by the dilation device.

38. A system according to claim 20, wherein the dilation device is elastically deformable and is carried on the mounting tube in a compressed delivery configuration and wherein the system further includes a release mechanism that releases the dilation device to assume a deployment configuration that has a larger transverse dimension than the delivery configuration.

39. A delivery device according to claim 20, wherein the urethral expander is at the same general axial location as the holder for the dilation device.

40. A method for dilating a urethra constricted by an enlarged prostate, comprising:

implanting a generally C-shaped dilation device peripherally around a constricted region of the urethra in a surface of the portion of the prostate causing the constriction, with the dilation device substantially completely embedded in tissue of the prostate.