CA2405710A1 - Method and apparatus for creating intrauterine adhesions - Google Patents

Method and apparatus for creating intrauterine adhesions Download PDF

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Publication number
CA2405710A1
CA2405710A1 CA002405710A CA2405710A CA2405710A1 CA 2405710 A1 CA2405710 A1 CA 2405710A1 CA 002405710 A CA002405710 A CA 002405710A CA 2405710 A CA2405710 A CA 2405710A CA 2405710 A1 CA2405710 A1 CA 2405710A1
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CA
Canada
Prior art keywords
implantable device
marker
trauma
uterus
group
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002405710A
Other languages
French (fr)
Other versions
CA2405710C (en
Inventor
Douglas J. Duchon
James Presthus
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Impres Medical Inc
Original Assignee
Impres Medical, Inc.
Douglas J. Duchon
James Presthus
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Filing date
Publication date
Application filed by Impres Medical, Inc., Douglas J. Duchon, James Presthus filed Critical Impres Medical, Inc.
Publication of CA2405710A1 publication Critical patent/CA2405710A1/en
Application granted granted Critical
Publication of CA2405710C publication Critical patent/CA2405710C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B17/4241—Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/12—Devices for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0072—Delivery tools therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

Abstract

An apparatus and method of use or treatment are disclosed for creating intrauterine adhesions resulting in amenorrhea. In particular, the apparatus relates to an easily deployed intrauterine implant that readily and consistently reduces or eliminates abnormal intrauterine bleeding. In addition, the apparatus is also used as a uterine marker device for visualizing endometrial tissue thickness and potential changes. The method o f the present invention serves as a supplement to or a replacement for conventional hysterectomy or ablation/resection procedures used to treat menorrhagia.

Claims (110)

1. An implantable device for treating excessive bleeding in a body cavity, comprising:
a biocompatible material deliverable into said body cavity;
said biocompatible material containing an attribute promoting tissue growth that results in adhesion formation within said body cavity;
said attribute defined by at least one of a mechanical component of said biocompatible material and a non-cultured biologic component of said biocompatible material.
2. The implantable device of claim 1 wherein said material is shaped to conform to an internal structure of a body cavity.
3. The implantable device of claim 2 wherein said body cavity is a uterus.
4. The implantable device of claim 1 wherein said material is sterile and flexible.
5. The implantable device of claim 1 wherein said material is substantially rigid.
6. The implantable device of claim 1 wherein said material is selected from the group consisting of mesh, suture, gel, porous, allograft, protein, hydrogel, liquid sealant, glue, cellulose, collagen, sponge, micro-porous, tissue/collagen, thrombin, alginate, tissue, kitosan, particulate, foam and any combination thereof.
7. The implantable device of claim 6 wherein a structure of said mesh is selected from the group consisting of woven, non-woven, braided, spun, knitted and any combination thereof.
8. The implantable device of claim 1 wherein said material is metallic.
9. The implantable device of claim 1 wherein said material is polymeric.
10. The implantable device of claim 1 wherein said material is a bio-material.
11. The implantable device of claim 1 wherein said material has a characteristic selected from the group consisting of non-absorbable, absorbable and resorbable.
12. The implantable device of claim 6 wherein a weave of said mesh selected from the group consisting of plain, open, closed, twill, dutch, reverse dutch, twill dutch, teffeta and any combination thereof.
13. The implantable device of claim 1 wherein said material is a random fiber bundle.
14. The implantable device of claim 13 wherein said material is fabricated from a monofilament.
15. The implantable device of claim 13 wherein said material is fabricated from a multi-filament.
16. The implantable device of claim 6 wherein said porous material is selected from the group consisting of ceramics, alumina, silicon, powdered metals, Nitinol®, stainless steel, titanium, porous polymers and any combination thereof.
17. The implantable device of claim 1 wherein said material is further incorporated into a mesh matrix.
18. The implantable device of claim 6 wherein a pore size of said porous material is less than 10 microns.
19. The implantable device of claim 6 wherein a pore size of said porous material is greater than 75 microns.
20. The implantable device of claim 6 wherein said liquid sealant or glue is one selected from the group consisting of thrombin, collagen-thrombin, polymer, collagen, fibrin-based and any combination thereof.
21. The implantable device of claim 6 wherein said liquid sealant forms a hemostatic solid.
22. The implantable device of claim 6 wherein said protein is configured into a format, whereby said format is selected from the group consisting of small beads, sheets, strips, regular shaped configurations and irregular shaped configurations.
23. The implantable device of claim 6 wherein said material comprises mesh particles.
24. The implantable device of claim 23 wherein said mesh particles are configured into a form selected form the group consisting of atomized micro-particles, semi-rigid foam, suspended aggregate, particulates, powder and any combination thereof.
25. The implantable device of claim 23 wherein said mesh particulates are suspended in a substance selected from the group consisting of liquid, gas, foam and flowable substance.
26. The implantable device of claim 1 wherein said material is encapsulated in a hydrophillic membrane.
27. The implantable device of claim 1 wherein said material is self-expanding.
28. The implantable device of claim 1 further comprising one or more coatings, wherein said coating is imaged using an imaging technique.
29. The implantable device of claim 28 wherein said coating is dissolvable.
30. A method of creating adhesions in a body cavity comprising:
inserting an implantable device within said body cavity; and locating said device at an optimal site within said body cavity, wherein said optimal site promotes effective adhesion formation to control bleeding.
31. The method of claim 30 further comprising determining an optimal site in said body cavity that is a site of excessive bleeding.
32. The method of claim 30 further comprising removing said implantable device after sufficient adhesions have formed.
33. The method of claim 30 further comprising pretreating said body cavity prior to inserting said implantable device within said body cavity.
34. The method of claim 33 wherein said pretreating includes creating trauma to a tissue within said body cavity.
35. The method of claim 34 wherein said trauma includes necrosis of said tissue.
36. The method of claim 34 wherein said trauma is achieved via ablation.
37. The method of claim 34 wherein said trauma is achieved via curettage.
38. The method of claim 34 wherein said trauma is achieved via liquid abrasion.
39. The method of claim 33 wherein said pretreating is performed using a device selected from the group consisting of curette, roller ball electrocautery device, thermal energy device, hot water filled balloon; radio-frequency (RF) energy director, microwave, cryogenic device, cytotoxic agent, intense LASER light, devices capable of imparting trauma to the endometrial lining and any combination thereof.
40. The method of claim 33 wherein said pretreating involves the use of a drug.
41. The method of claim 40 wherein said drug is one selected from the group consisting of hormones, hormone-altering medications and antibiotics.
42. The method of claim 33 wherein said pretreating involves the use of a chemical.
43. The method of claim 33 further comprising timing said pretreating to a patient's normal menstrual cycle.
44. The method of claim 30 further comprising pretreating said body cavity when an endometrium is in an optimal state for adhesion formation.
45. The method of claim 30 further comprising post-treating said body cavity after inserting said implantable device within said body cavity and forming adhesions.
46. The method of claim 45 wherein said post-treating involves the use of a drug.
47. The method of claim 46 wherein said drug is one selected from the group consisting of hormones or chemicals.
48. A pretreatment device for creating trauma to a tissue within a body cavity comprising:
a stem section; and a trauma-inducing section adjacent said stem section.
49. The device of claim 48 wherein said trauma-inducing section consists of bristles.
50. The device of claim 48 wherein said trauma-inducing section consists of spike-like projections.
51. The device of claim 48 wherein said stem section is made of a material selected from the group consisting of rigid polymers, ABS, nylon, PVC, stainless steel, aluminum, metallics and any combination thereof.
52. The device of claim 48 wherein said trauma-inducing section is made of a material selected from the group consisting of semi-rigid polymers, nylon, polyethylene and any combination thereof.
53. The device of claim 48 wherein said trauma-inducing section is configured as a Brillo® pad-like structure capable of scouring tissue.
54. The device of claim 53 wherein said Brillo® pad-like structure is comprised of collagen coated with a sclerosing agent.
55. The device of claim 53 wherein said Brillo® pad-like structure can self-expand when deployed from a catheter.
56. The device of claim 48 wherein said trauma-inducing section comprises a multi-pronged brush.
57. The device of claim 48 wherein said trauma-inducing section comprises a wire with sharp protrusions.
58. The device of claim 48 wherein said trauma-inducing section comprises a cap.
59. The device of claim 48 wherein said trauma-inducing section comprises a collagen plug.
60. The device of claim 48 wherein said trauma-inducing section comprises a wire-formed distal end.
61. The device of claim 60 wherein said distal end is comprised of one or more fibers configured to form an egg-beater design.
62. The device of claim 60 wherein said wires are fabricated from a material selected from the group consisting of Nitinol®, stainless steel, titanium and any combination thereof.
63. The device of claim 60 wherein said trauma-inducing section comprises a balloon having a rough external surface.
64. The device of claim 63 wherein said surface includes fine wires.
65. The device of claim 64 wherein said surface includes small bristles.
66. A pretreatment device for creating trauma to a tissue within a body cavity comprising:
a pretreatment fluid; and a tube housed within a catheter and used to insult said tissue with said pretreatment fluid.
67. The device of claim 66 wherein said fluid is a crystalline salt suspended in a water stream.
68. A method of contraception comprising:
inserting an implantable device within a uterus; and locating said device at an optimal site within said uterus, wherein said optimal site promotes adhesion formation and prevents conception.
69. A tool used to deploy an implantable device within a uterus comprising:
a cervical cap; and a guide located on a proximal end of said cervical cap.
70. The tool of claim 69 wherein said cervical cap includes a one-way valve having one or more slits on said valve.
71. The tool of claim 69 wherein said cervical cap forms a cup-shaped device.
72. The tool of claim 69 wherein said guide comprises a hollow tube.
73. The tool of claim 69 wherein said guide comprises a catheter.
74. The tool of claim 69 wherein said cap includes one or more lumen for dispensing fluid, creating vacuum, delivering tools and deploying said implantable device.
75. The tool of claim 69 further comprising a speculum used to dilate a vagina.
76. A tool used to deploy an implantable device within a uterus comprising:
one or more expanding elements attached to said implantable device;
and one or more manipulator elements.
77. The tool of claim 76 wherein said expanding element is one selected from the group consisting of rigid lumen, elastic membrane, wire, balloon and inflatable tube.
78. The tool of claim 76 wherein said manipulator element is one selected from the group consisting of hook, wire, string, monofilament, spring, hinge and inflation lumen.
79. The tool of claim 76 wherein said expanding element is a wire attached to said implantable device via a one-way barb.
80. A tool used to deploy an implantable device comprising:
a guide directed for placement of said implantable device within a uterus to create adhesions.
81. The tool of claim 80 wherein said guide is permanently implanted within a patient.
82. The tool of claim 80 wherein said guide forms a pathway to a cervix of a patient.
83. The tool of claim 80 wherein said guide comprises a hollow tube.
84. A device for monitoring the tissue of a uterus comprising:
at least one imagable marker;
said marker having a size less than a size of an expanded uterus;
said marker having a surface for adhering said marker to a uterine wall;
said marker composed of a biocompatible material suitable for permanent implantation in said uterus; and said marker detachably disposed on a delivery tool prior to insertion of said marker into said uterus.
85. The device of claim 84 wherein said marker is imagable using an imaging technique selected from the group consisting of ultrasound, magnetic resonance imaging, computed tomography, x-ray and an y combination thereof.
86. The device of claim 84 wherein said marker is incorporated into an implant device.
87. The device of claim 84 wherein said marker is incorporated into a deployment tool.
88. The device of claim 84 wherein said marker is incorporated into a pretreatment device.
89. The device of claim 84 wherein said size is adjustable.
90. The device of claim 84 wherein said size corresponds to one of a predetermined range of uterus sizes.
91. The device of claim 84 further including a shape, wherein said shape is adjustable.
92. The device of claim 91 wherein said shape is selected from the group consisting of sphere, tube, donut, hollow sphere, equilateral triangular shape, curved object and other geometric shapes.
93. The device of claim 84 wherein said marker has a density different from a density of surrounding tissue.
94. The device of claim 84 wherein said material of said marker is selected form the group consisting of polypropylene, ethylene, titanium, urethane, nylon, GORE-TEX®, PTFE, Nitinol®, stainless steel, proteins, or any type of human biologic that is stabile.
95. The device of claim 94 wherein said material is a combination of materials.
96. The device of claim 84 wherein said marker is configured as a solid component.
97. The device of claim 84 wherein said marker is configured as a hollow component.
98. The device of claim 97 wherein said hollow component is filled with a liquid.
99. The device of claim 97 wherein said hollow component is filled with a gas.
100. The device of claim 84 further comprising a substance coated on an exterior portion of said marker.
101. The device of claim 100 wherein said substance is a biological material.
102. The device of claim 101 wherein said substance is reactive to tissues.
103. The device of claim 101 wherein said substance is reactive to cells.
104. The device of claim 100 wherein said biological material prevents liquid/moisture penetration.
105. A method of monitoring tissue of a uterus comprising:
introducing at least one imagable marker into an interior of said uterus;
allowing said at least one marker to become embedded in tissue formed on said interior of said uterus; and using said at least one marker as a reference location to evaluate tissue features on said interior of said uterus.
106. The method of claim 105 wherein at least two imagable markers are introduced into said uterus and wherein said at least two markers provide a two dimensional frame of reference.
107. The method of claim 105 wherein said at least one imagable marker is introduced into said interior during a procedure wherein said uterus is being treated for a condition of menorrhagia.
108. The method of claim 105 wherein said at least one imagable marker is allowed to remain in said uterus for an extended period of time.
109. The method of claim 105 further comprising determining placement of an implantable device, wherein said implantable device is combined with said marker.
110. The method of claim 105 further comprising imaging said marker using common imaging techniques.
CA2405710A 2000-04-25 2001-04-24 Method and apparatus for creating intrauterine adhesions Expired - Lifetime CA2405710C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US19973600P 2000-04-25 2000-04-25
US60/199,736 2000-04-25
US25652900P 2000-12-18 2000-12-18
US60/256,529 2000-12-18
PCT/US2001/013169 WO2001080788A2 (en) 2000-04-25 2001-04-24 Method and apparatus for creating intrauterine adhesions

Publications (2)

Publication Number Publication Date
CA2405710A1 true CA2405710A1 (en) 2001-11-01
CA2405710C CA2405710C (en) 2010-04-20

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Family Applications (1)

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CA2405710A Expired - Lifetime CA2405710C (en) 2000-04-25 2001-04-24 Method and apparatus for creating intrauterine adhesions

Country Status (6)

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US (5) US6708056B2 (en)
EP (1) EP1278480A2 (en)
JP (3) JP4503208B2 (en)
AU (2) AU2001257212B9 (en)
CA (1) CA2405710C (en)
WO (1) WO2001080788A2 (en)

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