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US5860425A Expired / Lapsed US ⏱️ 0.0 years remaining

Bladder neck suspension procedure

Assignee: Boston Scientific Scimed Inc
•
Filing: 1996-01-26
•
Granted: 1999-01-19
•
Expires: 2016-01-26
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Abstract

Abstract The surgical treatment of stress urinary incontinence is disclosed. The disclosed methods include: 1) a technique of probe passage to avoid injuring the bladder and to provide a more accurate and reproducible capture of the pubocervical fascia lateral to the bladder neck and urethra, 2) anchor fixation of the suspending sutures to the pubic bone to decrease the risk of suture pull through from above and to decrease post-operative pain and 3) a simple and reproducible technique to set a limited tension of the suspending sutures. A description of these methods and results of procedures with some of these methods are disclosed. Novel drill guides, suture passers, suture tensioners, and various related tools and devices for use in the surgical method are also disclosed.

Inventors

  • 👤 Theodore V. Benderev
  • 👤 Neil H. Naves
  • 👤 Mark J. Legome

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 01:44
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/42; A61B17/04; A61B17/0401; A61B17/0469; A61B17/0483; A61B17/06; A61B17/06066; A61B17/06109; A61B17/062; A61B17/064; A61B17/0644; A61B17/10; A61B17/16; A61B17/17; A61B17/1739; A61B17/1796; A61B46/00; A61B46/30; A61B17/0482; A61B17/00234; A61B2017/00349; A61B2017/00743; A61B2017/00805; A61B2017/0409; A61B2017/0414; A61B2017/0446; A61B2017/0461; A61B2017/0462; A61B2017/0472; A61B2017/0496; A61B90/00; A61B90/06; A61B2090/062

Claims Analysis

Total Claims: 58
Claim 1
Independent Claim 108 words
A method of suspending a bladder neck, comprising the steps of: (a) securing a first suture to a first bone anchor; (b) positioning said first anchor in a bone without exposing the bone by way of an open surgical procedure; (c) advancing said first suture through a tissue generally adjacent to the bladder neck; (d) providing a first suture support; (e) securing said first suture to said first suture support; (f) positioning said first suture support against the tissue generally adjacent to the bladder neck to increase the effective contact area between said first suture and the tissue; and (g) suspending the bladder neck with said first suture.
Claim 2
Independent Claim 108 words
A method of suspending a bladder neck, comprising the steps of: (a) securing a first suture to a first bone anchor; (b) positioning said first anchor in a bone without exposing the bone by way of an open surgical procedure; (c) advancing said first suture through a tissue generally adjacent to the bladder neck; (d) providing a first suture support; (e) securing said first suture to said first suture support; (f) positioning said first suture support against the tissue generally adjacent to the bladder neck to increase the effective contact area between said first suture and the tissue; and (g) suspending the bladder neck with said first suture.
Claim 3
Dependent Claim 23 words
The method of claim 1, wherein said first suture is secured to said anchor before said first anchor is positioned in the bone.
Claim 4
Dependent Claim 30 words
The method of claim 1, wherein said first suture is advanced through the tissue generally adjacent to the bladder neck before said first suture is secured to said first anchor.
Claim 5
Dependent Claim 29 words
The method of claim 1, wherein said first suture is advanced through the tissue generally adjacent to the bladder neck before said first anchor is positioned in the bone.
Claim 6
Dependent Claim 33 words
The method of claim 1, wherein the step of positioning said first suture support against the tissue generally adjacent to the bladder neck comprises positioning said first suture support against a vaginal wall.
Claim 7
Dependent Claim 26 words
The method of claim 1, wherein said step of securing said first suture to said first suture support comprises securing said first suture to a mesh.
Claim 8
Dependent Claim 71 words
The method of claim 1, further comprising repeating steps (a) through (c), step (e), and step (g) on an opposite side of the bladder neck using a second suture and a second bone anchor, wherein said first suture is secured to a first end of said first suture support and said second suture is secured to a second end of said first suture support to form a bladder neck suspension sling.
Claim 9
Dependent Claim 16 words
The method of claim 1, wherein the step of positioning said first anchor is accomplished percutaneously.
Claim 10
Dependent Claim 27 words
The method of claim 1, wherein the step of positioning said first anchor comprises positioning said first anchor in a generally anterior surface of a pubic bone.
Claim 11
Dependent Claim 26 words
The method of claim 9, wherein the step of positioning said first anchor comprises positioning said first anchor approximately 2 centimeters lateral to a symphysis pubis.
Claim 12
Dependent Claim 22 words
The method of claim 10, wherein the step of positioning said first anchor comprises positioning said first anchor in a pubic tubercle.
Claim 13
Dependent Claim 20 words
The method of claim 1, wherein the suspending step (g) comprises tying said first suture to suspend the bladder neck.
Claim 14
Dependent Claim 31 words
The method of claim 12, further comprising repeating steps (a) through (g) on an opposite side of the bladder neck using a second suture, second bone anchor, and second suture support.
Claim 15
Independent Claim 183 words
A method of suspending a bladder neck in a patient, said method comprising the steps of: (a) securing a first suture to a first bone anchor, said first suture having a first end and a second end; (b) positioning said first anchor in a pubic bone; (c) grasping said first suture with a probe, said probe being able to pierce tissue; (d) advancing said probe and the first end of said first suture behind the pubic bone and through an endopelvic fascia generally adjacent to a urethra at a first point; (e) releasing said first suture within a vaginal cavity; (f) withdrawing said probe through the endopelvic fascia; (g) advancing said probe through the endopelvic fascia at a second point, said second point also being generally adjacent to the urethra; (h) grasping said first suture within the vaginal cavity with said probe; (i) withdrawing said probe and said first end of said first suture through the endopelvic fascia; (j) releasing said first suture from said probe; and (k) tying the first and second ends of said first suture to suspend the bladder neck.
Claim 16
Independent Claim 183 words
A method of suspending a bladder neck in a patient, said method comprising the steps of: (a) securing a first suture to a first bone anchor, said first suture having a first end and a second end; (b) positioning said first anchor in a pubic bone; (c) grasping said first suture with a probe, said probe being able to pierce tissue; (d) advancing said probe and the first end of said first suture behind the pubic bone and through an endopelvic fascia generally adjacent to a urethra at a first point; (e) releasing said first suture within a vaginal cavity; (f) withdrawing said probe through the endopelvic fascia; (g) advancing said probe through the endopelvic fascia at a second point, said second point also being generally adjacent to the urethra; (h) grasping said first suture within the vaginal cavity with said probe; (i) withdrawing said probe and said first end of said first suture through the endopelvic fascia; (j) releasing said first suture from said probe; and (k) tying the first and second ends of said first suture to suspend the bladder neck.
Claim 17
Dependent Claim 42 words
The method of claim 14, further comprising providing a suture support, securing said first suture to said suture support, and positioning said suture support against the endopelvic fascia to increase the effective contact area between said first suture and the endopelvic fascia.
Claim 18
Dependent Claim 32 words
The method of claim 14, wherein said steps of advancing said probe and withdrawing said probe through the endopelvic fascia comprise advancing said probe and withdrawing said probe through a pubocervical fascia.
Claim 19
Dependent Claim 29 words
The method of claim 14, further comprising repeating steps (a) through (k) on an opposite side of the bladder neck using a second suture and a second bone anchor.
Claim 20
Independent Claim 69 words
A method of suspending a bladder neck from a bone while minimizing invasion of tissue generally adjacent to the bone, comprising the steps of: locating an anchoring site on the bone without exposing the bone in an open surgical procedure; advancing an anchor into the bone through the tissue generally adjacent to the bone; securing the anchor within the bone; and thereafter suspending the bladder neck using the anchor.
Claim 21
Independent Claim 69 words
A method of suspending a bladder neck from a bone while minimizing invasion of tissue generally adjacent to the bone, comprising the steps of: locating an anchoring site on the bone without exposing the bone in an open surgical procedure; advancing an anchor into the bone through the tissue generally adjacent to the bone; securing the anchor within the bone; and thereafter suspending the bladder neck using the anchor.
Claim 22
Dependent Claim 25 words
The method of claim 18, wherein the step of locating an anchoring site on the bone comprises locating an anchoring site on a pubic bone.
Claim 23
Dependent Claim 12 words
The method of claim 18, wherein the locating step is accomplished percutaneously.
Claim 24
Dependent Claim 87 words
The method of claim 20, wherein the locating step is accomplished using a bone anchor implantation device, said bone anchor implantation device comprising a housing, at least one probe mounted to the housing, and a guide channel extending through the housing, the locating step comprising advancing the at least one probe of the bone anchor implantation device through the tissue generally adjacent to the bone to contact the bone so that the guide channel is placed over the bone within which the anchor is to be secured.
Claim 25
Dependent Claim 44 words
The method of claim 21, wherein the step of advancing an anchor further comprises advancing a drill into the bone through the guide channel of the bone anchor implantation device to provide a recess in the bone and advancing the anchor into the recess.
Claim 26
Dependent Claim 18 words
The method of claim 18, further comprising the step of selecting an anchor having a suture secured thereto.
Claim 27
Dependent Claim 21 words
The method of claim 23, further comprising the step of securing said suture to tissue generally adjacent to the bladder neck.
Claim 28
Independent Claim 109 words
A method of suspending a bladder neck, comprising the steps of: (a) securing a first suture to a first bone anchor; (b) locating an anchoring site on a bone without exposing the bone; (c) positioning said first anchor in the bone; (d) advancing said first suture through a tissue generally adjacent to the bladder neck; (e) providing a first suture support; (f) securing said first suture to said first suture support; (g) positioning said first suture support against the tissue generally adjacent to the bladder neck to increase the effective contact area between said first suture and the tissue; and (h) suspending the bladder neck with said first suture.
Claim 29
Independent Claim 109 words
A method of suspending a bladder neck, comprising the steps of: (a) securing a first suture to a first bone anchor; (b) locating an anchoring site on a bone without exposing the bone; (c) positioning said first anchor in the bone; (d) advancing said first suture through a tissue generally adjacent to the bladder neck; (e) providing a first suture support; (f) securing said first suture to said first suture support; (g) positioning said first suture support against the tissue generally adjacent to the bladder neck to increase the effective contact area between said first suture and the tissue; and (h) suspending the bladder neck with said first suture.
Claim 30
Dependent Claim 20 words
The method of claim 25, wherein the suspending step (h) comprises tying said first suture to suspend the bladder neck.
Claim 31
Dependent Claim 31 words
The method of claim 26, further comprising repeating steps (a) through (h) on an opposite side of the bladder neck using a second suture, second bone anchor, and second suture support.
Claim 32
Independent Claim 64 words
A method of suspending a bladder neck from a bone while minimizing invasion of tissue generally adjacent to the bone, comprising the steps of: locating an anchoring site on the bone without exposing the bone; advancing an anchor into the bone through the tissue generally adjacent to the bone; securing the anchor within the bone; and thereafter suspending the bladder neck using the anchor.
Claim 33
Independent Claim 64 words
A method of suspending a bladder neck from a bone while minimizing invasion of tissue generally adjacent to the bone, comprising the steps of: locating an anchoring site on the bone without exposing the bone; advancing an anchor into the bone through the tissue generally adjacent to the bone; securing the anchor within the bone; and thereafter suspending the bladder neck using the anchor.
Claim 34
Dependent Claim 25 words
The method of claim 28, wherein the step of locating an anchoring site on the bone comprises locating an anchoring site on a pubic bone.
Claim 35
Dependent Claim 12 words
The method of claim 28, wherein the locating step is accomplished percutaneously.
Claim 36
Dependent Claim 18 words
The method of claim 28, further comprising the step of selecting an anchor having a suture secured thereto.
Claim 37
Dependent Claim 21 words
The method of claim 31, further comprising the step of securing said suture to tissue generally adjacent to the bladder neck.
Claim 38
Independent Claim 72 words
A method of suspending a bladder neck comprising the steps of: securing a suture to a bone anchor; positioning said anchor in a bone without exposing the bone by way of an open surgical procedure; positioning a suture support secured to said suture against the tissue generally adjacent to the bladder neck to increase the effective contact area between said suture and the tissue; and suspending the bladder neck with said suture.
Claim 39
Independent Claim 72 words
A method of suspending a bladder neck comprising the steps of: securing a suture to a bone anchor; positioning said anchor in a bone without exposing the bone by way of an open surgical procedure; positioning a suture support secured to said suture against the tissue generally adjacent to the bladder neck to increase the effective contact area between said suture and the tissue; and suspending the bladder neck with said suture.
Claim 40
Dependent Claim 34 words
The method of claim 33, wherein said step of positioning a suture support comprises positioning a suture support comprising a web of biocompatible material having a plurality of apertures therein for facilitating tissue ingrowth.
Claim 41
Dependent Claim 22 words
The method of claim 34, wherein said step of positioning a suture support comprises positioning a mesh made of a biocompatible material.
Claim 42
Dependent Claim 30 words
The method of claim 35, wherein said step of positioning a suture support comprises positioning a mesh made of a material selected from the group consisting of metal and plastic.
Claim 43
Dependent Claim 23 words
The method of claim 35, wherein said step of positioning a suture support comprises positioning a mesh having said suture integrally molded thereto.
Claim 44
Dependent Claim 28 words
The method of claim 33, wherein said step of positioning a suture support comprises positioning a suture support comprising an outer ring and a plurality of inner spokes.
Claim 45
Dependent Claim 31 words
The method of claim 38, wherein said step of positioning a suture support comprises positioning a suture support made of a material selected from the group consisting of metal and plastic.
Claim 46
Dependent Claim 24 words
The method of claim 38, wherein said step of positioning a suture support comprises positioning a suture support having said suture integrally molded thereto.
Claim 47
Dependent Claim 28 words
The method of claim 33, wherein said step of positioning a suture support comprises positioning a suture support comprising a plurality of spokes radiating from a central hub.
Claim 48
Dependent Claim 31 words
The method of claim 41, wherein said step of positioning a suture support comprises positioning a suture support made of a material selected from the group consisting of metal and plastic.
Claim 49
Dependent Claim 24 words
The method of claim 41, wherein said step of positioning a suture support comprises positioning a suture support having said suture integrally molded thereto.
Claim 50
Dependent Claim 78 words
The method of claim 33, wherein said step of positioning a suture support comprises: positioning a suture support comprising a biocompatible plate having two surfaces, said biocompatible plate sized for use in bladder neck suspension procedures and adapted for distributing a biasing force exerted on a suture over a larger surface area of soft tissue, said suture support also comprising a suture tab centrally connected to one surface of said plate and defining a loop with said plate.
Claim 51
Dependent Claim 31 words
The method of claim 44, wherein said step of positioning a suture support comprises positioning a suture support made of a material selected from the group consisting of plastic and metal.
Claim 52
Independent Claim 65 words
A method of suspending a bladder neck comprising the steps of: securing a suture to a bone anchor; positioning said anchor in a bone without exposing the bone; positioning a suture support secured to said suture against the tissue generally adjacent to the bladder neck to increase the effective contact area between said suture and the tissue; and suspending the bladder neck with said suture.
Claim 53
Independent Claim 65 words
A method of suspending a bladder neck comprising the steps of: securing a suture to a bone anchor; positioning said anchor in a bone without exposing the bone; positioning a suture support secured to said suture against the tissue generally adjacent to the bladder neck to increase the effective contact area between said suture and the tissue; and suspending the bladder neck with said suture.
Claim 54
Dependent Claim 34 words
The method of claim 46, wherein said step of positioning a suture support comprises positioning a suture support comprising a web of biocompatible material having a plurality of apertures therein for facilitating tissue ingrowth.
Claim 55
Dependent Claim 22 words
The method of claim 47, wherein said step of positioning a suture support comprises positioning a mesh made of a biocompatible material.
Claim 56
Dependent Claim 28 words
The method of claim 46, wherein said step of positioning a suture support comprises positioning a suture support comprising an outer ring and a plurality of inner spokes.
Claim 57
Dependent Claim 28 words
The method of claim 46, wherein said step of positioning a suture support comprises positioning a suture support comprising a plurality of spokes radiating from a central hub.
Claim 58
Dependent Claim 78 words
The method of claim 46, wherein said step of positioning a suture support comprises: positioning a suture support comprising a biocompatible plate having two surfaces, said biocompatible plate sized for use in bladder neck suspension procedures and adapted for distributing a biasing force exerted on a suture over a larger surface area of soft tissue, said suture support also comprising a suture tab centrally connected to one surface of said plate and defining a loop with said plate.

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2002-01-18 2002-07-20 2003-01-19 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2006-01-18 2006-07-20 2007-01-19 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2010-01-18 2010-07-20 2011-01-19 $7700.00 Window Closed / Lapsed

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