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WO1998034565B1 - Treating urinary and other body strictures - Google Patents

Treating urinary and other body strictures

Info

Publication number
WO1998034565B1
WO1998034565B1 PCT/US1998/002190 US9802190W WO9834565B1 WO 1998034565 B1 WO1998034565 B1 WO 1998034565B1 US 9802190 W US9802190 W US 9802190W WO 9834565 B1 WO9834565 B1 WO 9834565B1
Authority
WO
WIPO (PCT)
Prior art keywords
mass
collagen
tissue
stricture
effective
Prior art date
Application number
PCT/US1998/002190
Other languages
French (fr)
Other versions
WO1998034565A1 (en
Filing date
Publication date
Priority claimed from US08/795,656 external-priority patent/US6338726B1/en
Application filed filed Critical
Priority to DE69828553T priority Critical patent/DE69828553T2/en
Priority to AT98903924T priority patent/ATE286688T1/en
Priority to EP98903924A priority patent/EP0900062B1/en
Publication of WO1998034565A1 publication Critical patent/WO1998034565A1/en
Publication of WO1998034565B1 publication Critical patent/WO1998034565B1/en

Links

Abstract

The invention provides a method and system for treatment of body strictures to restore luminal diameter to within a normal diameter range, in which the stricture is dilated to stretch its lumen to a desired diameter, collagen is exuded near to existing tissue of the stricture so as to be absorbed by that tissue or adhered to that tissue, making a collagen-enhanced tissue structure, and energy is emitted to affect the collagen-enhanced tissue, such as by ablation or by hardening. Ablation and hardening may be repeated so as to create a set of layers of hardened collagen in the form of a supporting frame, preferably having a hollow cylindrical shape. Dilation of the stricture is achieved by expanding one or more balloons, or by the pressure of exuded collagen, until the stricture is larger than a normal diameter range. When energy is emitted into the collagen, the stricture contracts back to the normal diameter range, either by ablation of excess tissue or by plating of the stricture wall. The stricture's tissue is also isolated by a set of balloons at either or both ends of the stricture, so as to isolate the stricture and restrict the collagen to the sticture's tissue. The stricture's tissue is also supported by a stent, which is preferably tack-welded onto the stricture's tissue using collagen. Collagen adheres to the stent, which supports the stricture's tissue until the stent is absorbed into that tissue.

Claims

AMENDED CLAIMS
[received by the International Bureau on 12 August 1998 (12.08.98); original claims 36-40, 42-52, 59 and 68-69 amended; original claims 1-35, 41, 53-58, 60-67 and 70-76 cancelled; new claims 77-100 added (9 pages)]
36. Apparatus for treatment of a stricture within the body, said apparatus including: a multi-lumen catheter; a catheter tip housing at a distal end of said catheter with at least one radiology marker; means for inserting said catheter into said stricture; a first inflatable balloon located at a distal end of said housing and a second inflatable balloon located at a proximal end of said housing, both said first and second balloons coupled to a first structure within said catheter and disposed for delivery of a fluid, said first and second balloons when inflated by said fluid being effective to achieve at least one seal against a surface of said stricture, effective to confine a portion of said stricture located between said first and second balloons, and effective to stabilize a position of said catheter during said treatment; a second structure disposed in said catheter and located between said first and second balloons, said second structure being disposed for exuding a first mass of substantially opaque collagen into said stricture, whereby said exuded first mass of collagen is confined between said first and second balloons under a first pressure and for a first time, said first pressure and time being effective to dilate said stricture and to cause at least a portion of said first mass of collagen to be absorbed, in response to said first pressure and time, into at least a portion of a mass of existing tissue of said stricture confined between said first and second balloons; at least one ring electrode contained in said catheter tip housing coupled to said conductor, said electrode being effective to emit RF energy in a frequency range between about 450 Kilohertz and about 600 Kilohertz and being effective to raise a temperature in said region of tissue substantially proximate to said electrode to at least about 100 degrees Celsius for a time
20 effective to couple at least a portion of said mass of absorbed collagen into a unified matrix with at least a portion of said mass of existing tissue.
37. Apparatus as in claim 36, wherein said seal is fluid-tight.
38. Apparatus as in claim 36, wherein said seal gas-tight.
39. Apparatus as in claim 36, wherein said seal is both fluid-tight and gas-tight.
40. Apparatus as in claim 36, wherein said electrode emits an amount of RF energy effective to ablate only a portion of said mass of existing tissue substantially proximate to said housing.
42. Apparatus as in claim 36, wherein said electrode emits an amount of RF energy effective to harden at least a portion of said unified matrix of absorbed collagen coupled to at least a portion of said mass of existing tissue.
43. Apparatus as in claim 36, wherein said electrode emits an amount of RP energy effective to ablate, substantially proximate to said catheter tip housing only, a portion of said hardened unified matrix of absorbed collagen coupled to at least a portion of said mass of existing tissue.
44. Apparatus as in claim 36, wherein said first mass of collagen is exuded under a second pressure and for a second amount of time, said second pressure and said time being effective to cause said stricture to expand, in response to said second pressure and second time, to a diameter larger than normal range for said stricture and to cause at least a portion of said first mass of exuded collagen to be absorbed, in response to said second pressure and said second time, into at least a portion of a mass of existing tissue of said expanded stricture confined between said first and second balloons.
21
45. Apparatus as in claim 36, wherein said electrode emits an amount of RP energy effective to couple at least a portion of said mass of absorbed collagen into a unified matrix with at least a portion of said mass of existing tissue of said expanded stricture.
46. Apparatus as in claim 36, wherein said electrode emits an amount of RF energy effective to harden at least a portion of said unified matrix of absorbed collagen coupled to said mass of existing tissue of said expanded stricture.
47. Apparatus as in claim 36, wherein said electrode emits an amount of RP energy effective to ablate, substantially proximate to said housing only, a portion of said unified matrix of absorbed collagen coupled with said mass of existing tissue of said expanded stricture to contract to within said normal diameter range.
48. Apparatus as in claim 36, wherein said second structure for exuding said first mass of collagen includes at least one port located between said first and second balloons.
49. Apparatus as in claim 36, wherein said second structure for exuding said first mass of collagen includes a third inflatable balloon with a microporous membrane, said third balloon being located between said first and second balloons and being inflated by said first or second pressure of said exuded first mass of collagen.
50. Apparatus as in claim 36, wherein said second structure for exuding said first mass of collagen is effective to exude a second mass of collagen, whereby said second mass of collagen adheres to at least a portion of said first mass of collagen and said second mass of collagen is effective to create a layer of collagen about one (1) mil in thickness.
51. Apparatus as in claim 36, wherein said electrode emits an amount of RF energy effective to harden at least a portion of said second mass of collagen adhered to at least a portion of said first mass of collagen.
22
52. Apparatus as in claim 50, wherein said electrode emits an amount of RF energy effective to ablate, substantially proximate to said catheter tip housing only, a portion of said hardened second mass of collagen adhered to at least a portion of said first mass of collagen.
59. Apparatus as in claim 36, including a stent; means for inserting said stent into said stricture whereby said stent is operative to retard collapse of said stricture.
68. Apparatus as in claim 36, wherein said second structure for exuding collagen includes means for exuding a mass of hardenable substance.
69. Apparatus as in claim 36, wherein said second structure for exuding collagen includes means for exuding a first mass of flowable substance from a source into said body, whereby at least a portion of said first mass of flowable substance is absorbed into at least a portion of said mass of existing tissue of said stricture; and said electrode emits an amount of RP energy effective to couple at least a portion of said first mass of flowable substance to at least a portion of said mass of existing tissue of said stricture.
77. Apparatus as in claim 69, wherein said electrode emits an amount of RP energy effective to harden at least a portion of said first mass of flowable substance coupled to at least a portion of said mass of existing tissue.
78. Apparatus as in claim 69, wherein said electrode emits an amount of RP energy effective to ablate, substantially proximate to said catheter tip housing only, a portion of said hardened first mass of flowable substance coupled to said mass of existing tissue.
23
79. Apparatus as in claim 69, wherein said first mass of flowable substance is exuded under a second pressure and for a second amount of time, said second pressure and said time being effective to cause said stricture to expand, in response to said second pressure and second time, to a diameter larger than a normal range for said stricture and to cause at least a portion of said first mass of flowable substance to be absorbed, in response to said second pressure and said second time, into at least a portion of said mass of existing tissue of said stricture confined between said first and second balloons.
80. Apparatus as in claim 69, wherein said electrode emits an amount of RP energy effective to ablate, substantially proximate to said catheter tip housing only, at least a portion of said mass of existing tissue of said expanded stricture coupled with said first mass of absorbed flowable substance to contract to within said normal diameter range.
81. Apparatus as in claim 69, wherein said second structure for exuding said first mass of flowable substance includes at least one port located between said first and second balloons.
82. Apparatus as in claim 69, wherein said second structure for exuding said first mass of flowable substance includes a third inflatable balloon with a microporous membrane, said third balloon being located between said first and second balloons and being inflated by said pressure of said exuded first mass of flowable substance.
83. Apparatus as in claim 69, wherein said second structure for exuding said first mass of flowable substance is effective to exude a second mass of flowable substance, whereby said second mass of flowable substance adheres to at least a portion of said first mass of flowable substance and said second mass of flowable substance is effective to create a layer of flowable substance about one (1) mil in thickness.
24
84. Apparatus as in claim 83 wherein said electrode emits an amount of RP energy effective to harden at least a portion of said layer of flowable substance.
85. Apparatus as in claim 36, wherein said second structure for exuding a mass of collagen includes means for exuding a fluid for medical treatment of said body.
86. Apparatus as in claim 85, whereby at least a portion of said fluid for medical treatment is absorbed into at least a portion of said region of tissue in said body.
87. Apparatus as in claim 85, wherein said electrode emits an amount of RP energy effective to couple at least a portion of said absorbed fluid for medical treatment to at least a portion of said region of tissue in said body.
88. Apparatus as in claim 85, wherein said electrode emits an amount of RP energy effective to harden at least a portion of said fluid for medical treatment coupled to at least a portion of said region of tissue.
89. Apparatus as in claim 85, wherein said electrode emits an amount of RP energy effective to ablate only substantially proximate to said housing a portion of said hardened fluid for medical treatment coupled to said region of tissue.
90. Apparatus as in claim 85, wherein said electrode emits an amount of RP energy effective to ablate only substantially proximate to said housing a portion of said region of tissue which has absorbed said fluid for medical treatment.
91. Apparatus as in claim 85, wherein said electrode emits an amount of RP energy effective to ablate only substantially proximate to said housing a portion of said region of tissue which has absorbed and coupled with said fluid for medical treatment.
25
92. Apparatus as in claim 85, wherein a second pressure is exerted by said exuded and confined fluid for medical treatment for a second amount of time effective to cause said region of tissue to also expand to a diameter larger than a normal range for said constricted lumen; said fluid for medical treatment is exuded under a second pressure and for a second amount of time, said second pressure and said time being effective to cause said region of tissue to expand, in response to said second pressure and second time, to a diameter larger than a normal range for said constricted lumen and to cause at least a portion of said fluid for medical treatment to be absorbed, in response to said second pressure and said second time, into at least a portion of a mass of tissue of said constricted lumen confined between said first and second balloons.
93. Apparatus as in claim 92, wherein said electrode emits an amount of RF energy effective to ablate only substantially proximate to said housing at least a portion of said region of tissue expanded to said diameter of larger than normal range and coupled with said absorbed fluid for medical treatment to contract to within said normal diameter range.
94. Apparatus as in claim 92, wherein said second structure for exuding said fluid for medical treatment includes at least one port located between said first and second balloons.
95. Apparatus as in claim 92, wherein said second structure for exuding said fluid for medical treatment includes a third inflatable balloon with a microporous membrane, said third balloon being located between said first and second balloons and being inflated by said pressure of said exuded fluid for medical treatment.
96. Apparatus as in claim 92, wherein said second structure for exuding fluid for medical treatment is effective to exude a second amount of said fluid for medical treatment, whereby said second amount of fluid for medical treatment adheres to at least a portion of said
26 one amount of fluid for medical treatment and said second mass of fluid for medical treatment is effective to create a layer of flowable substance about one (1) mil in thickness.
97. Apparatus as in claim 92 wherein said electrode emits an amount of RP energy effective to harden at least a portion of said layer of fluid for medical treatment
98. Apparatus as in claim 92, wherein said fluid for medical treatment is operative to ablate at least a portion of said confined region of tissue.
99. Apparatus as in claim 92, wherein said fluid for medical treatment is inert until activated by an effective amount of RP energy emitted by said electrode.
100. Apparatus as in claim 36, wherein said second structure for exuding a mass of collagen includes means for evacuating, from said confined portion of said constricted lumen, one or more of the following: an excess portion of said mass of collagen; a detritus resulting from said ablation of said portion of said region of tissue substantially proximate to said housing; a detritus resulting from said ablation of only a portion of said coupled mass of absorbed collagen and existing tissue; a detritus resulting from said ablation of only a portion of said coupled and hardened mass of absorbed collagen and existing tissue; a detritus resulting from said ablation of only a portion of said region of tissue expanded to said diameter of larger than normal range and coupled with said mass of absorbed collagen to contract to within a normal diameter range. an excess portion of said mass of hardenable substance; a detritus resulting from ablation of said coupled hardenable substance and
existing tissue.
27 a detritus of coupled hardenable substance and region of tissue
a detritus of coupled and hardened hardenable substance and existing
tissue. an excess portion of said flowable substance; a detritus resulting from ablation of only a portion of said coupled flowable substance and region of tissue; a detritus resulting from ablation of only a portion of said coupled and hardened flowable substance and region of tissue; an excess portion of said fluid for medical treatment; a remaining portion of said fluid for medical treatment after said medical treatment is complete; and, a detritus resulting from ablation by means of said fluid for medical treatment.
28 STATEMENT UNDER ARTICLE 19(1)
Those claims for which the International Search Report determined that WO 95 08289 A (hereinafter "Dl") and WO 98 01087 (hereinafter "D2") were in category X, as well as other claims, have been amended to more clearly indicate the subject matter of the invention.
Per the application, the invention uses two balloons to fix the location of a catheter at, and to seal and confine a portion of, a stricture in a lumen of the body. The invention then exudes collagen or other treatment substance into the stricture under a pressure and for a time effective to dilate the stricture and cause the collagen or other treatment substance to be absorbed into the existing tissue of the lumen wall at the location of the stricture. Finally the invention applies RP energy to couple the absorbed collagen and existing tissue into a unified matrix, harden it, and ablate any excess collagen, existing tissue, or combination of collagen and existing tissue.
Dl exudes collagen into a lumen through a single balloon and deposits it in one or more layers on the inner surface of the lumen wall, molds the collagen by inflating the balloon, and hardens the collagen using light or chemical energy. D2 exudes collagen into a lumen through a single balloon, deposits the collagen in one or more layers on the inner surface of the lumen wall, applies RP energy to alternately soften and harden the collagen, then slides and/or twists the balloon to smooth the inner surface of the deposited layer(s) of collagen.
Neither Dl nor D2 show or suggest at least the following differences provided by the invention:
—separate balloons for sealing the distal and proximal ends of the catheter and confining the portion of the stricture to be treated;
—absorption of collagen into existing tissue while the catheter is still in place in response to a pressure maintained for a period of time;
—application of energy to couple and harden the absorbed collagen and existing tissue into a unified matrix; and,
—application of RF energy to ablate excess collagen, existing tissue, or combination thereof.
Although Dl shows a balloon with enlarged portions at its distal and proximal ends to stabilize the catheter and seal a portion of a lumen to be treated, because it uses a single balloon the enlarged portions cannot be separately inflated to different diameters under different pressures, thus limiting Dl 's ability to conform to, seal and confine a portion of a lumen.
29 The single balloon of D2 has no provision whatsoever for sealing and confining a portion of a lumen, and D2's movement of a single balloon to smooth the inner surface of the applied layer(s) of collagen teaches away from the invention's two stabilizing balloons. Also, D2 teaches away from the invention's use of pressure of exuded collagen to dilate a stricture, since such pressure would increase the risk of bursting the already weakened lumen wall tissue which caused the aneurysm.
30
PCT/US1998/002190 1997-02-06 1998-02-05 Treating urinary and other body strictures WO1998034565A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
DE69828553T DE69828553T2 (en) 1997-02-06 1998-02-05 DEVICE FOR TREATING HARN PATIENTS AND OTHER BODY STENOSES
AT98903924T ATE286688T1 (en) 1997-02-06 1998-02-05 DEVICE FOR THE TREATMENT OF URINARY TRACT AND OTHER BODY STENOSES
EP98903924A EP0900062B1 (en) 1997-02-06 1998-02-05 Device for treating urinary and other body strictures

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/795,656 US6338726B1 (en) 1997-02-06 1997-02-06 Treating urinary and other body strictures
US08/795,656 1997-02-06
CA002250603A CA2250603C (en) 1997-02-06 1998-10-16 Treating urinary and other body strictures

Publications (2)

Publication Number Publication Date
WO1998034565A1 WO1998034565A1 (en) 1998-08-13
WO1998034565B1 true WO1998034565B1 (en) 1998-10-08

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US (1) US6338726B1 (en)
EP (1) EP0900062B1 (en)
CA (1) CA2250603C (en)
WO (1) WO1998034565A1 (en)

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