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

• US 20060276871A1
• Filed: 05/20/2005
• Published: 12/07/2006
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences III LLC
• Original Assignee: Exploramed Nc2, Inc.
• Inventors: Welch, Jacqueline Nerney, Collinson, Michael, Vidal, Claude, Catanese, Joseph III, Redmond, Russell J., Makower, Joshua, Walke, Amrish Jayprakash, Lamson, Theodore Charles
• Granted Patent: US 7,758,594 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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
• 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
• 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
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00517 : Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00547 : Prostate
• CPC Class Codes: A61B 2018/00589 : Coagulation
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/144 : Wire
• 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 2002/041 : Bile ducts

Abstract

Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Claims

1. A method for treating a condition in a human or animal subject wherein tissue located adjacent to that anatomical structure is exerting undesired pressure on the anatomical structure, said method comprising the step of:

A) implanting at least one tissue compressing device in the body of the subject to compress the tissue so as to relieve at least some of the pressure exerted by the tissue on the anatomical structure.

2. A method according to claim 1 wherein the anatomical structure is the urethra and the tissue comprises the prostate.

3. A method according to claim 2 wherein the prostate is enlarged.

4. A method according to claim 3 wherein the subject suffers from benign prostatic hypertrophy.

5. A method according to claim 1 wherein Step A comprises:

placing a first anchor at a first location on, in or adjacent to the prostate;

placing a second anchor at a second location on, in or adjacent to the prostate; and

placing a connecting member between the first and second anchors, said connecting member drawing at least one of said first and second anchors toward the other thereby compressing at least a portion of the prostate.

6. A method according to claim 5 wherein one of the first and second anchors is placed within the lumen of the urethra adjacent to the prostate.

7. A method according to claim 5 wherein one of the first and second anchors is placed within the wall of the urethra adjacent to the prostate.

8. A method according to claim 5 wherein one of the first and second anchors is placed within the prostate adjacent to the wall of the urethra.

9. A method according to any of claim 6, 7 or 8 wherein the other of said first and second anchors is placed within the prostate.

10. A method according to any of claim 6, 7 or 8 wherein the other of said first and second anchors is placed within the prostate adjacent to the inner surface of the prostatic capsule.

11. A method according to any of claims 6, 7 or 8 wherein the other of said first and second anchors is placed outside of the prostate.

12. A method according to claim 6, 7 or 8 wherein the other of said first and second anchors is placed adjacent to the outer surface of the prostatic capsule.

13. A method according to claim 6, 7 or 8 wherein the other of said first and second anchors is placed on or in a bone.

14. A method according to claim 13 wherein the other of said first and second anchors is placed on or in the pubic bone.

15. A method according to claim 6, 7 or 8 wherein the other of said first and second anchors is placed on or in a muscle.

16. A method according to claim 6, 7 or 8 wherein the other of said first and second anchors is placed on or in fascia.

17. A method according to claim 6, 7 or 8 wherein the other of said first and second anchors is placed at a location selected from the group consisting of:

a location within prostatic lobe;

a location within peripheral zone of prostate;

a location within prostatic capsule;

a location between prostatic capsule and pubic fascia;

a location within the pubic fascia;

a location within the levator ani muscle

a location within the obturator internus muscle;

a location within the pelvic bone;

a location within the periostium of pelvic bone;

a location within the pubic bone;

a location within the periostium of pubic bone;

a location within the symphysis pubica;

a location within the urinary bladder wall;

a location within the ischiorectal fossa;

a location within the urogenital diaphragm; and

a location within the abdominal fascia.

18. A method according to claim 2 wherein Step A comprises advancing an introducer device into the subject'"'"'s urethra and using said introducer device to introduce the tissue compression device.

19. A method according to claim 18 wherein the introducer device comprises an elongate body having a scope lumen through which a scope may be inserted and a working lumen through which the tissue compression device may be introduced.

20. A method according to claim 2 wherein an opening is formed in the urethra adjacent to the prostate and at least a portion of said device is advanced through that opening in the urethra.

21. A method according to claim 2 wherein an opening is formed in the urethra and an introducer is advanced through the opening on the urethra to a position where it is used to implant the first anchor.

22. A method according to claim 21 wherein the introducer is then retracted to another position where it is used to implant the second anchor.

23. A method according to claim 20 wherein the opening formed in the urethra is no more than 2 mm in its greatest cross dimension.

24. A method according to claim 20 wherein at least one device is advanced into the urethra and used to i) form the opening in the urethra, ii) place the first anchor, iii) place the second anchor and iii) place the connecting member.

25. A method according to claim 20 wherein at least one device is advanced through the subject'"'"'s lower abdominal wall and used to i) place the first anchor, ii) place the second anchor and ii) place the connecting member.

26. A method according to claim 20 wherein said at least one device is advanced percutaneously to a position adjacent to or within the prostate.

27. A method according to claim 25 wherein at least one device is advanced percutaneously into the subject'"'"'s urinary bladder and through the wall of the urinary bladder to a location adjacent to or within the prostate.

28. A method according to claim 25 wherein the first anchor is placed within the urethra adjacent to the prostate, the second anchor is placed within the bladder adjacent to the wall of the bladder and the connecting member is placed such that it extends through the prostate between the first and second anchors.

29. A method according to claim 2 wherein a first device is advanced transurethrally into the subject'"'"'s urinary balder and at least one other device is then advanced through the wall of the urinary bladder to a location adjacent to or within the prostate where said at least one other device is then used to place at least one of the first and second anchors and the connecting member.

30. A method according to claim 29 wherein the first anchor is placed within the urethra adjacent to the prostate, the second anchor is placed within the bladder adjacent to the wall of the bladder and the connecting member is placed such that it extends through the prostate between the first and second anchors.

31. A method according to claim 2 wherein the connecting member is elastic.

32. A method according to claim 31 wherein the first and second locations are spaced apart such that the elastic connecting member is in a stretched state.

33. A method according to claim 2 wherein the length of the connecting member is adjustable.

34. A method according to claim 33 wherein the wherein the step of placing the connecting member comprises adjusting the length of the connecting member.

35. A method according to claim 34 wherein the method further comprises the step of:

B) subsequently readjusting the length of the connecting member at least one time.

36. A method according to claim 1 wherein the at least one device implanted within the body comprises i) a first anchor, ii) a second anchor and iii) a tensioning member that extends between the first and second anchors, and wherein the method comprises:

causing the first anchor to be anchored at a first location;

causing the second anchor to be anchored at a second location; and

causing the tensioning member to be under sufficient tension to compress tissue between the first and second anchors.

37. A method according to claim 1 wherein Step A comprises placing at least first, second and third anchors at least first second and third locations on, in or adjacent to the prostate and placing at least one connecting member to connect said first second and third anchors and to compress at least a portion of the prostate.

38. A method according to claim 1 wherein Step A causes ischemia of at least a portion of the tissue.

39. A method according to claim 1 further comprising the step of:

forming a lesion within the tissue which subsequently causes shrinkage of the tissue.

40. A method according to claim 39 wherein a coagulative lesion is formed by heating the tissue.

41. A method according to claim 39 wherein the coagulative lesion subsequently becomes resorbed thereby causing the tissue to shrink.

42. A method according to claim 39 wherein the creation of the coagulative lesion within the tissue causes swelling of the tissue and wherein the at least one device is positioned to compress the tissue in a manner that limits the affect of such swelling on the adjacent anatomical structure.

43. A method according to claim 39 wherein the tissue comprises prostate tissue and wherein the coagulative lesion causes the prostate to shrink.

44. A method according to claim 1 wherein the compression created by Step A causes necrosis of at least a portion of the tissue.

45. A method according to claim 2 wherein Step A comprises forming at least one opening in the wall of the urethra and wherein the method further comprises the step of:

treating the opening formed in the urethra to facilitate closure of that opening without substantial constriction or blockage of the lumen of the urethra.

46. A method according to claim 20 further comprising the step of:

implanting an epithelialization promoter to facilitate epithelialization over the anchor placed within the urethra without substantial constriction or blockage of the lumen of the urethra.

47. A method according to claim 5 wherein one of said first and second anchors is placed substantially within the lumen of the urethra.

48. A method according to claim 5 wherein one of said first and second anchors is placed substantially within the wall of the urethra.

49. A method according to claim 20 further comprising the step of:

implanting a substance that prevents or deters the formation of adhesion, scars or tissue within the lumen of the urethra.

50. A method according to claim 46 wherein the step of implanting an epithelialization promoter comprises seeding or sodding the wall of the urethra with epithelial cells.

51. A method according to claim 2 wherein said method further comprises the step of:

B) incising the capsule of the prostate.

52. A method according to claim 51 wherein Step B comprises inserting a cutting device transurethrally, advancing the cutting device through an opening formed in the wall of the urethra and using the cutting device to incise the capsule of the prostate.

53. A method according to claim 51 wherein Step B comprises inserting a cutting device percutaneously, advancing the cutting device to allocation within or near the prostate and using the cutting device to incise the capsule of the prostate.

54. A method according to claim 51 wherein Step B comprises inserting a cutting device percutaneously into the urinary bladder, advancing the cutting device through the wall of the urinary bladder to a location within or near the prostate and using the cutting device to incise the capsule of the prostate.

55. A method according to claim 51 wherein Step B comprises inserting a cutting device percutaneously into the rectum, advancing the cutting device through the wall of the rectum to a location within or near the prostate and using the cutting device to incise the capsule of the prostate.

56. A method according to claim 51 wherein Step B comprises inserting a cutting device percutaneously through the perineum, advancing the cutting device through the wall of the urinary bladder to a location within or near the prostate and using the cutting device to incise the capsule of the prostate.

57. A method according to claim 1 further comprising the step of:

B) delivering a therapeutic substance to a location within or near the tissue.

58. A method according to claim 57 wherein the therapeutic substance comprises a substance that weakens or modifies tissue.

59. A method according to claim 57 wherein the substance is selected from the group consisting of:

hemostatic agents;

antimicrobial agents;

antibiotics;

antifungals;

antiprotozoals;

antivirals;

antimicrobial metals;

hemostatic and/or vasoconstricting agents;

pseudoephedrine;

xylometazoline;

oxymetazoline;

phenylephrine;

epinephrine;

cocaine;

local anesthetic agents;

lidocaine;

cocaine;

bupivacaine;

hormones;

anti-inflammatory agents;

corticosteroids;

non-steroidal anti-inflammatory agents;

hormonally active agents;

agents that enhance potency;

substances that dissolve, degrade, cut, break, weaken, soften, modify or remodel connective tissue or other tissue;

enzymes;

collagenase;

trypsin;

EDTA;

trypsin combined with EDTA;

hyaluronidase;

tosyllysylchloromethane (TLCM));

chemotherapeutic or antineoplastic agents;

substances that prevent adhesion formation;

hyaluronic acid gel;

space occupying substances;

substances that promote desired tissue ingrowth into an anchoring device or other implanted device;

substances that promote or facilitate epithelialization;

substances that create a coagulative lesion which is subsequently resorbed causing the tissue to shrink, substances that cause the prostate to decrease in size;

phytochemicals that cause the prostate to decrease in size;

alpha-1a-adrenergic receptor blocking agents;

5-alpha-reductase inhibitors;

smooth muscle relaxants and agents that inhibit the conversion of testosterone to dihydrotestosterone.

60. A method according to claim 1 comprising:

providing a system that comprises i) an introducer that is insertable to a position within or near the prostate gland, ii) an implantable device for compressing the prostate gland and iii) delivery apparatus advanceable through the introducer and useable to implant the implantable device such that it compresses the prostate gland;

inserting the introducer to a position within or near the prostate gland;

advancing the delivery apparatus through the introducer; and

using the delivery apparatus to implant the implantable device such that the implantable device compresses the prostate gland.

61. A method according to claim 60 wherein the introducer has a scope lumen and a working lumen and wherein a scope is inserted into the scope lumen and the delivery apparatus is advanced through the working lumen.

62. A method according to claim 61 further comprising the step of using the scope to view at least a portion of the performance of the method.

63. A method according to claim 60 wherein the introducer comprises a scope and a working lumen and wherein the delivery apparatus is advanced through the working lumen and the scope is used to view at least a portion of the performance of the method.

64. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises inserting the introducer percutaneously through the abdominal wall.

65. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises inserting the introducer percutaneously through the perineum.

66. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises inserting the introducer percutaneously through the abdominal wall, through the wall of the urinary bladder and to a position within the urinary bladder.

67. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises inserting the introducer into the urethra and advancing the introducer to a position within the urethra where the urethra is substantially surrounded by the prostate gland.

68. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises inserting the introducer into the urethra and advancing the introducer to a position within the urethra distal to the prostate gland.

69. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises inserting the introducer into the urethra and advancing the introducer into the urinary bladder.

70. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises percutaneously inserting the introducer through the abdominal wall and though an opening formed in a bone of the pelvis.

71. A method according to claim 60 wherein the step of inserting the introducer to a position within or near the prostate gland comprises inserting the introducer into the rectum and advancing either the introducer or the delivery device through an opening formed in the rectal wall.

72. A method according to claim 71 wherein the method further comprises closing the opening formed in the rectal wall.

73. A method according to claim 60 wherein the introducer is positioned within the urethra and wherein the step of using the delivery apparatus to implant the implantable device such that the implantable device compresses the prostate gland comprises advancing either the introducer or the delivery apparatus though an opening formed in the wall of the urethra.

74. A method according to claim 73 wherein the opening formed in the wall of the urethra is no greater than 2 mm in its greatest cross-dimension.

75. A method according to claim 72 further comprising the step of closing the opening formed in the urethra.

76. A method according to claim 72 wherein the delivery device is advanced outwardly through the capsule of the prostate gland to a position outside the prostate gland.

77. A method according to claim 60 wherein the introducer is positioned within the pelvic cavity outside of the prostate gland and wherein the step of using the delivery apparatus to implant the implantable device such that the implantable device compresses the prostate gland comprises advancing either the introducer or the delivery apparatus through the capsule of the prostate gland.

78. A method according to claim 77 wherein the delivery device is advanced through the wall of the urethra to a position within the urethra.

79. A method according to claim 60 wherein the implantable device comprises a first anchor, a second anchor and a tensioning member that extends between the first anchor and the second anchor.

80. A method according to claim 79 wherein the step of using the delivery apparatus to implant the implantable device such that the implantable device compresses the prostate gland comprises:

advancing the delivery apparatus to a first location and causing the first anchor to be implanted at said first location;

moving the delivery device to a second location and causing the second anchor to be implanted at the second location; and

causing the tensioning member to be under sufficient tension to cause compression of prostate tissue between the first anchor and the second anchor.

81. A method according to claim 80 wherein the step of causing the tensioning member to be under sufficient tension to cause compression of prostate tissue between the first anchor and the second anchor comprises causing the distance between the first location and the second location to be sufficient to result in said sufficient tension on said tensioning member.

82. A method according to claim 80 wherein the step of causing the tensioning member to be under sufficient tension to cause compression of prostate tissue between the first anchor and the second anchor comprises shortening the tensioning member after the first and second anchors have been implanted.

83. A method according to claim 80 wherein the step of causing the tensioning member to be under sufficient tension to cause compression of prostate tissue between the first anchor and the second anchor comprises cinching at least one of the first and second anchors to the tensioning member.

84. A method according to claim 80 further comprising the step of adjusting the tension on the tensioning member at least one time subsequent to implantation of the implantable device.

85. A method according to claim 83 wherein the tension on the tensioning member is adjustable by non-invasive means and wherein the step of adjusting the tension on the tensioning member at least one time subsequent to implantation of the implantable device is carried out by non-invasive means.

85-248. -248. (canceled)