METHODS AND DEVICES FOR URETHRAL TREATMENT

• US 20120010645A1
• Filed: 03/21/2010
• Published: 01/12/2012
• Est. Priority Date: 03/20/2009
• Status: Abandoned Application

• Current Assignee: ProArc Medical Ltd.
• Original Assignee: ProArc Medical Ltd.
• Inventors: Feld, Yair
• Application Number:
  US13/257,651
• Publication Number:
  US 20120010645A1
• Time in Patent Office: Days
• US Class Current: 606/192
• 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 lumen.

Claims

1-14. -14. (canceled)

15. Apparatus for implanting a urethral dilation device comprising:

a mounting device configured to carry the dilation device; and

a movable holder attached to the mounting device;

an inflatable urethral expander disposed within the delivery device,

wherein the mounting device and holder are configured to deliver the dilation device to a desired position in a urethra, and to implant the dilation device through a wall of the urethra into an enlarged portion of a prostate to at least partially surround the urethra, with at least part of the dilation device surrounding the urethral expander during implantation.

16. Apparatus according to claim 15, further comprising a delivery sheath configured to receive the dilation device before placement thereof on the mounting device.

18. Apparatus according to claim 15, wherein the dilation device is formed of a resilient material and the mounting device is configured to permit a reduction of a transverse dimension of the dilation device as it passes though a the working channel.

20. Apparatus according to claim 15, wherein said urethral expander is configured to be rotatably coupled to said holder.

22. Apparatus according to claim 15, wherein said urethral expander extends outwardly from one side of said holder when inflated.

23. Apparatus according to claim 15, wherein said urethral expander includes at least one guide channel for said dilation device.

24. Apparatus according to claim 15, wherein said urethral expander is a balloon.

31. Apparatus according to claim 15, further including a cage configured to surround the dilation device during implantation.

32. Apparatus according to claim 31, wherein the cage includes an opening allowing the dilation device to exit for implantation.

33. Apparatus according to claim 31, wherein the cage is configured to compress the dilation device and prevent it from expanding while being delivered for implantation.

59. Apparatus according to claim 15, further including 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.

60. Apparatus according to claim 15, further including a separate delivery wire for each guide pocket.

61. Apparatus according to claim 15, further including a single delivery wire for all the guide pockets.

62. Apparatus according to claim 15, wherein the urethral expander is disposed substantially along a longitudinal axis of a central lumen of the delivery device during delivery.

63. Apparatus according to claim 15, further including a pusher coupled to the holder that is operable to move the implant to a desired location for implantation.

64. Apparatus according to claim 15, including:

a sheath in which the implant is delivered;

wherein the sheath is configured to be screwed into the tissue of the prostate;

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

65. Apparatus according to claim 64, wherein the sheath is configured to be withdrawn by unscrewing it from within the prostate or by pulling it from within the prostate.

66. Apparatus according to claim 15, further comprising a delivery sheath configured to receive the dilation device before placement thereof on the mounting device.

67. Apparatus according to claim 15, wherein at least part of the dilation device surrounds the urethral expander during delivery to the implantation site.

68. Apparatus according to claim 15, wherein the urethral expander includes at least one guide channel from within which the dilation device is implanted so that it at least partially surrounds the urethral expander during implantation.

69. Apparatus according to claim 15, wherein the urethral expander includes a plurality of separate guide channels from within which separate curved segments of a dilation device can be implanted.

17. (canceled)

19. (canceled)

21. (canceled)

25. A dilation device for a urethra that is partially occluded by an enlarged prostate comprising a curved element configured to be implanted circumferentially partially around a urethra in the surrounding tissue of the prostate.

27. A dilation device according to claim 25, comprising a plurality of curved segments each of which is configured to be disposed circumferentially around the urethra when implanted.

28. A dilation device according to claim 25, formed of a resilient material.

35. A dilation device according to claim 25, including a drug coating which is eluted over time, to treat the prostate.

36. A dilation device according to claim 35, wherein the drug is sirolimus or paclitaxel.

37. A dilation device according to claim 25, including a drug coating which is eluted over time, to cause shrinkage or reduce growth of the prostate or to prevent restenosis.

38. A dilation device according to claim 25, made of or coated with a radioactive material, or a material capable of being heated by RF energy.

39. A dilation device according to claim 25, wherein the dilation device includes a sharpened portion to facilitate implantation, and a projection to prevent withdrawal while a delivery device is being removed.

40. A dilation device according to claim 39, wherein the projection is comprised of a barb located at an end of the dilation device which first enters the prostate.

26. (canceled)

29-30. -30. (canceled)

34. (canceled)

41. An implantation system for dilating a urethra at least partially obstructed by an enlarged prostate comprising:

a dilation device configured to be at least partially embedded in an enlarged portion of the prostate; and

a delivery device for the dilation device including;

a mounting device to which the dilation device is removably attached;

a holder for the dilation device that is attached to the mounting device,

wherein the mounting device and the holder are operable to deliver the dilation device to a desired position in a urethra, and to implant the dilation device through a wall of the prostate to circumferentially surround at least part of the urethra; and

an inflatable urethral expander disposed within the delivery device during delivery to the implantation site,

wherein the dilation device at least partially surrounds the urethral expander during implantation.

42. An implantation system according to claim 41, wherein the mounting device, and the holder are disposed around the urethral expander during delivery to the implantation site.

43. An implantation system according to claim 41, further including a pusher coupled to the holder that is operable to move the implant to a desired location for implantation.

44. An implantation system according to claim 41, wherein the delivery device is comprised of a plurality of generally coaxial tubes, and urethral expander is disposed substantially along a longitudinal axis of the innermost tube during delivery to the implantation site.

45. An implantation system according to claim 41, wherein the urethral expander includes at least one guide channel from within which the dilation device is implanted so that the dilation device at least partially surrounds the urethral expander during implantation.

46. An implantation system according to claim 41, wherein the dilation device carries a drug coating which is eluted over time, to treat the prostate.

47. An implantation system according to claim 46, wherein the drug is sirolimus or paclitaxel.

48. An implantation system according to claim 41, 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 restenosis.

49. An implantation system according to claim 41, wherein the dilation device is comprised of one or more curved segments that partially surround the periphery of the urethra when implanted.

50. An implantation system according to claim 41, wherein the dilation device includes a sharpened portion to facilitate implantation, and a projection to prevent withdrawal while the delivery device is being removed.

51. An implantation system according to claim 50, wherein the projection is a barb located at an end of the dilation device which first enters the prostate.

52. An implantation system according to claim 49, further including a plurality of guide channels, each configured to receive a curved section of the dilation device, for guiding implantation of the multiple dilation devices, the guide channels being located at multiple circumferential and/or axial positions on the urethral expander.

53. An implantation system according to claim 52, further including a separate delivery wire for each guide channel.

54. An implantation system according to claim 52, further including a single delivery wire for all the guide channels.

55. An implantation system according to claim 41, including:

a sheath in which the implant is delivered;

wherein the sheath is configured to be screwed into the tissue of the prostate;

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

56. An implantation system according to claim 55, wherein the urethral expander is configured to be withdrawn by unscrewing it from within the prostate or by pulling it from within the prostate.

57. An implantation system according to claim 41, wherein the urethral expander is configured to be expanded by inflation or is self-expanding.

58. An implantation system according to claim 41, wherein the delivery device is configured to implant the dilation device from the outside of the delivery tube.