CA2440153A1 - System for implanting an implant and method thereof - Google Patents

System for implanting an implant and method thereof Download PDF

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Publication number
CA2440153A1
CA2440153A1 CA 2440153 CA2440153A CA2440153A1 CA 2440153 A1 CA2440153 A1 CA 2440153A1 CA 2440153 CA2440153 CA 2440153 CA 2440153 A CA2440153 A CA 2440153A CA 2440153 A1 CA2440153 A1 CA 2440153A1
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CA
Canada
Prior art keywords
envelope
implant
patient
anatomical site
delivery assembly
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
CA 2440153
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French (fr)
Other versions
CA2440153C (en
Inventor
Barry N. Gellman
Jianmin Li
Armand Morin
Jozef Slanda
Richard Tah
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Boston Scientific Ltd Barbados
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Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2440153A1 publication Critical patent/CA2440153A1/en
Application granted granted Critical
Publication of CA2440153C publication Critical patent/CA2440153C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • 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
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06019—Means for attaching suture to needle by means of a suture-receiving lateral eyelet machined in the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/06076—Needles, e.g. needle tip configurations helically or spirally coiled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06171—Sutures helically or spirally coiled
    • 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

Abstract

A system for implanting an implant and method thereof is disclosed. In general overview, the system includes an implant (10), an envelope (20) enclosing the implant, a delivery assembly (650) and an attachment piece (350) for attaching the envelope or implant to the delivery assembly. The envelope may include a drug coating, positioning aids, and means to ease envelope removal. In one embodiment, the delivery assembly is employed for implant and/or envelope delivery inside the patient's body. In another embodiment, the delivery assembly and an attachment piece are employed to deliver the implant or the envelope inside the patient's body.

Claims (23)

1. A system for implanting an implant at an anatomical site in the body of a patient, comprising:

an envelope comprising an inner surface and an outer surface, said envelope enclosing said implant shaped to substantially fit said anatomical site; and a drug, said drug disposed on at least one of said inner surface or outer surface of said envelope.
2. The system of claim 1 wherein said envelope comprises an absorbent material.
3. The system of claim 1 wherein said implant comprises a mesh shaped to fit the mid-urethra of a female patient.
4. The system of claim 1 wherein said drug comprises an antimicrobial drug.
5. The system of claim 1 wherein said drug is disposed on said inner surface of said envelope.
6. The system of claim 1 wherein said drug is disposed on said outer surface of said envelope.
7. The system of claim 1 wherein said drug is absorbed by said envelope.
8. The system of claim 1 wherein said drug is bonded to the surface of said envelope.
9. The system of claim 1 wherein said envelope comprises one or more apertures.
10. The system of claim 1 wherein said envelope comprises a tearable region, said tearable region enabling said envelope to be opened.
11. The system of claim 10 wherein said tearable region comprises a plurality of apertures.
12. The system of claim 1 wherein said tearable region comprises a tab.
13. The system of claim 12 wherein said tab is adjacent said envelope outer surface.
14. The system of claim 1 wherein said envelope outer surface comprises a visual indication mark.
15. The system of claim 1 wherein said envelope is made from material selected from the group consisting of polypropylene, polyethylene, polyester, polytetrafluoroethylene, TYVEK®, MYLAR®, TEFLON® and co-polymers thereof.
16. The system of claim 15 wherein at least one surface of said envelope further comprises at least one synthetic coating or one natural coating.
17. The system of claim 16 wherein said synthetic coating comprises a hydrophilic agent.
18. The system of claim 16 wherein said synthetic coating comprises a hydrophobic agent.
19. The system of claim 1 wherein said envelope comprises at least two sleeves.
20. The system of claim 19 wherein each sleeve has the same length.
21. The system of claim 19 wherein each sleeve comprises at least one tab.
22. The system of claim 19 wherein each sleeve comprises at least one hinge section.
23. The system of claim 22 wherein a first hinge section of a first sleeve is coupled to a second hinge section of a second sleeve. 24. The system of claim 19 further comprising a spacer, wherein said spacer joins said sleeves.

25. The system of claim 24 wherein said spacer comprises a bulk material.

26. The system of claim 24 wherein said spacer comprises a balloon.

27. The system of claim 24 wherein said spacer further comprises a pressure sensor.

28. The system of claim 1 wherein said envelope comprises a composite of two or more materials.

29. The system of claim 1 wherein said envelope comprises at least one attachment piece.

30. A method for implanting an implant at an anatomical site in the body of a patient, comprising the steps of:
providing a system comprising an implant and an envelope, said envelope comprising an inner surface and an outer surface, said envelope configured to enclose said implant and said envelope comprising a drug disposed on at least one of said inner surface or said outer surface of said envelope; and implanting said system at an anatomical site in the patient's body.

31. A system for implanting an implant at an anatomical site in the body of a patient, comprising:
an envelope means comprising an inner surface and an outer surface, said envelope means enclosing said implant shaped to substantially fit said anatomical site;
and a drug disposed on at least one of said inner or outer surface of said envelope means.

32. A system for implanting an implant at an anatomical site in the body of a patient, comprising:
an envelope, said envelope comprising at least two sleeves, said sleeves configured to enclose said implant; and a clamp, said clamp coupling said sleeves together.

33. The system of claim 32 wherein said system further comprises at least one tab.

34. The system of claim 32 wherein said system further comprises at least one attachment piece.

35. The system of claim 32 wherein at least one of said sleeves comprises a composite of two or more materials.

36. The system of claim 32, wherein a portion of said sleeves overlap.

37. The system of claim 32 wherein each sleeve is substantially the same length.

38. The system of claim 32 wherein each sleeve further comprises at least one hinge section.

39. The system of claim 38 wherein a hinge comprises a first hinge section of one sleeve coupled to a second hinge section of another sleeve.

40. The system of claim 32 wherein said clamp releasably couples said sleeves.

41. The system of claim 40 wherein said clamp further comprises a pressure sensor.

42. The system of claim 40 wherein said clamp further comprises a spacer.

43. The system of claim 42 wherein said spacer comprises a bulk material.

44. The system of claim 42 wherein said spacer comprises a balloon.

45. The system of claim 32 wherein said envelope comprises at least one tab.

46. The system of claim 32 wherein said envelope comprises at least one attachment piece.

47. The method of implanting an implant at an anatomical site in the body of a patient, comprising the steps of:
providing a system comprising an implant and an envelope, said envelope comprising at least two sleeves, said sleeves configured to enclose said implant, said system further comprising a clamp;
coupling said sleeves with said clamp; and implanting said implant at said anatomical site in the patient's body.

48. The method of implanting an implant of claim 47 further comprising the steps of unfastening said clamp and uncoupling said sleeves; and removing said clamp and said sleeves from the patient's body, said implant positioned at said anatomical site in the patient's body.

49. A system for implanting an implant at an anatomical site in the body of a patient, comprising:
an envelope means, said envelope comprising at least two sleeves, said sleeves configured to enclose said implant; and a clamp means, said clamp means coupling said sleeves together.

50. A system for implanting an implant at an anatomical site in the body of a patient, comprising:

an envelope comprising an inner surface and an outer surface, said envelope configured to enclose said implant; and a spacer disposed on at least one of said inner surface or said outer surface of said envelope, said spacer for positioning said implant at said anatomical site.

51. The system of claim 50 wherein said spacer comprises a bulk material.

52. The system of claim 51 wherein said bulk material comprises polyethylene.

53. The system of claim 51 wherein said bulk material comprises cellulose.

54. The system of claim 51 wherein said bulk material comprises hydrogel.

55. The system of claim 50 wherein said spacer comprises a balloon.

56. The system of claim 55 wherein said balloon contains a gas.

57. The system of claim 55 wherein said balloon contains a liquid.

58. The system of claim 50 wherein said system further comprises a pressure sensor.

59. The system of claim 58 wherein said pressure sensor indicates the tension applied to the envelope.

60. The system of claim 50 wherein said spacer comprises a clamp.

61. The system of claim 60 wherein said clamp comprises:
a first member comprising a proximal end and a distal end, at least a first exterior face extending therebetween, and a first thickness; and a second member comprising a proximal end and a distal end, at least a second exterior face extending therebetween, and a second thickness.

62. The system of claim 61 wherein the first thickness comprises the spacer thickness.

63. The system of claim 61 wherein said clamp further comprises a balloon disposed on said first exterior face of said clamp.

64. The system of claim 61 wherein said clamp further comprises a bulk material disposed on said first exterior face of said clamp.

65. A method for implanting an implant at an anatomical site in the body of a patient, comprising the steps of:
providing a system comprising an envelope comprising an inner surface and an outer surface, said envelope configured to enclose said implant, and a spacer disposed on at least one of said inner or said outer surface of said envelope;
implanting said implant at said anatomical site in the body of a patient; and removing said envelope from said patient.

66. A system for implanting an implant at an anatomical site in the body of a patient, comprising:

an envelope means comprising an inner surface and an outer surface, said envelope means configured to enclose said implant; and a spacer means disposed on at least one of said inner surface or said outer surface of said envelope means, said spacer means for positioning said implant at said anatomical site.

67. A system for implanting an implant at an anatomical site in the body of a patient, comprising:
an envelope comprising a lumen sized to enclose said implant, and a first end and a second end, said first end and said second end disposed at opposite ends of the longitudinal axis of said envelope; and a tab, said tab being joined to one of said first end and said second end of said envelope, wherein said tab is grasped by said operator for positioning said implant in said body.

68. The system of claim 67 wherein said tab comprises a positioning member for positioning said envelope inside the body of a patient.

69. The system of claim 67 wherein said envelope comprises a visual indication mark disposed along a longitudinal axis of said envelope.

70. The system of claim 67 wherein said envelope comprises at least two sleeves.

71. The system of claim 70 wherein each sleeve has the same length.

72. The system of claim 70 wherein said at least two sleeves overlap to enclose said implant.

73. The system of claim 70 wherein said at least two sleeves comprise at least one tab.

74. The system of claim 70 wherein each sleeve comprises at least one hinge section.

75. The system of claim 74 wherein a first hinge section of one sleeve is coupled to a first hinge section of the other sleeve.

76. The system of claim 70 further comprising a clamp.

77. The system of claim 76 wherein said clamp comprises a balloon.

78. The system of claim 76 wherein said clamp comprises a bulk material.

79. The system of claim 76 wherein said clamp comprises a pressure sensor.

80. The system of claim 67 wherein said envelope comprises a tearable region.

81. The system of claim 80 wherein said tearable region comprises a tab.

82. The system of claim 81 wherein at least one tab is positioned on an outer surface of said envelope.

83. The system of claim 82 wherein said envelope comprises a plurality of cuts.

84. The system of claim 80 wherein said tearable region comprises a plurality of apertures.

85. The system of claim 80 wherein said envelope is made from a tearable material.

86. The system of claim 85 wherein said envelope is made from a material with a linear molecular orientation.

87. A method for implanting an implant at an anatomical site in the body of a patient, comprising the steps of:

providing a system comprising an envelope, said envelope comprising a lumen sized to enclose said implant, said envelope further comprising a first end and a second end, said first end and said second end disposed at opposite ends of said envelope, and a tab, said tab being joined to one of said first end and said second end of said envelope; and implanting said system at said anatomical site in the patient's body.

88. A system for implanting an implant at an anatomical site in the body of patient, comprising:
an envelope means comprising a lumen sized to enclose said implant, said envelope means further comprising a first end and a second end, said first end and said second end disposed at opposite ends of the longitudinal axis of said envelope means; and a tab means, said tab means joined to one of said first end and said second end of said envelope means, wherein said tab means is grasped by said operator for implanting said implant in said body.

89. An attachment piece for joining an implant to a delivery assembly, comprising:
a first member, said implant bonded to said first member, said first member engageable with a dilator tube, wherein said first member is seated within said dilator tube to join said implant to said delivery assembly.

90. The attachment piece of claim 89 wherein said first member comprises an appendage, said implant being bonded to said appendage.

91. The attachment piece of claim 90 wherein said appendage is positioned between a first portion and a second portion of said first member.

92. The attachment piece of claim 91 wherein said second portion of said first member is sized and shaped to fit within a lumen of said dilator tube.

93. The attachment piece of claim 89 wherein said first member comprises a first end, said first end comprising at least one slit.

94. The attachment piece of claim 89 wherein said first member comprises a cylinder.
95. The attachment piece of claim 90 wherein said appendage comprises a free end, said free end of said appendage bonded to an implant.
96. The attachment piece of claim 95 wherein said implant comprises a sling.
97. The attachment piece of claim 96 wherein said sling is used for the treatment of female urinary incontinence.
98. The attachment piece of claim 95 wherein said free end is heat bonded to said implant.
99. The attachment piece of claim 95 wherein said free end is adhesive bonded to said implant.
100. The attachment piece of claim 89 wherein materials used to manufacture said appendage and said first member comprise polyethylene or polyethylene copolymer.
101. A method for delivering an implant to an anatomical site in a patient, comprising the steps of:
providing an attachment piece comprising:
a first member, said implant bonded to said first member, said first member engageable with a dilator tube, wherein said first member is seated within said dilator tube to join said implant to a delivery assembly; and delivering said implant at said anatomical site in said patient.
102. An attachment piece for joining an implant to a delivery assembly and delivering the implant to an anatomical site in a patient, the attachment piece comprising:
a first member means, said implant bonded to said first member means, said first member means engageable with a dilator tube, wherein said first member means is seated within said dilator tube to join said implant to said delivery assembly.
103. An attachment piece for joining an envelope for enclosing an implant to a delivery assembly, comprising:
a first member, said first member bonded to said envelope, said first member engageable with a dilator tube, wherein said first member is seated within said dilator tube to join said envelope to said delivery assembly.
104. A delivery assembly for delivering an implant to an anatomical site in the body of a patient, comprising:

a retractable point;
a delivery handle comprising a proximal button and a distal button;
said proximal button and said distal button operatively joined to the retractable point wherein each of the proximal button and the distal button move the retractable point in a plurality of positions.
105. The delivery assembly of claim 104 further comprising a cannula and a cannula lumen.
106. The delivery assembly of claim 105 wherein said cannula comprises an arc.
107. The delivery assembly of claim 105 wherein in one of said plurality of positions, said retractable point is positioned in said cannula lumen.
108. The delivery assembly of claim 104 further comprising a dilator tube.
109. The delivery assembly of claim 108 further comprising an extender button.
110. The delivery assembly of claim 109 wherein said extender button extends the dilator tube from the distal end of the handle and retracts the dilator tube into the handle.
111. The delivery assembly according to claim 108 wherein said dilator tube comprises a hollow member and a conical tip.
112. The delivery assembly according to claim 111 wherein said hollow member is configured whereby an attachment piece for joining said implant to said delivery assembly is seated in said hollow member.
113. The delivery assembly according to claim 111 further comprising a hinge for attaching said conical tip to said hollow member.
114. The delivery assembly according to claim 111 wherein said conical tip is positioned at a tissue piercing end of said delivery assembly.
115. The delivery assembly according to claim 111 wherein said conical tip further comprises an aperture.
116. The delivery assembly according to claim 108 wherein said dilator tube is actuateable by said delivery handle.
117. The delivery assembly according to claim 111 wherein said hollow member further comprises a rigid ring attached to the wall of the hollow member.

118. A method for delivering an implant to an anatomical site in the body of a patient, comprising:
providing a delivery assembly comprising a retractable point and a delivery handle comprising a proximal button and a distal button, said proximal button and said distal button operatively joined to the retractable point wherein each of the proximal button and the distal button move the retractable point in a plurality of positions;
moving the retractable point to an extended position; and delivering said implant to said anatomical site in the body of the patient.
119. A delivery assembly for delivering an implant to an anatomical site in the body of a patient, comprising:
a handle means;
a retractable point;
a distal button means; and a proximal button means;
said proximal button means and said distal button means operatively joined to the retractable point wherein each of the proximal button means and the distal button means move the retractable point from a first position to a second position.
CA2440153A 2001-03-09 2002-03-07 System for implanting an implant and method thereof Expired - Fee Related CA2440153C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US27484301P 2001-03-09 2001-03-09
US60/274,843 2001-03-09
US28686301P 2001-04-26 2001-04-26
US60/286,863 2001-04-26
PCT/US2002/007076 WO2002071953A2 (en) 2001-03-09 2002-03-07 System for implanting an implant and method thereof

Publications (2)

Publication Number Publication Date
CA2440153A1 true CA2440153A1 (en) 2002-09-19
CA2440153C CA2440153C (en) 2011-09-20

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ID=38779879

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2440153A Expired - Fee Related CA2440153C (en) 2001-03-09 2002-03-07 System for implanting an implant and method thereof

Country Status (7)

Country Link
US (1) US7025772B2 (en)
EP (1) EP1365688B1 (en)
JP (1) JP4181410B2 (en)
AU (2) AU2006222727B9 (en)
CA (1) CA2440153C (en)
DE (1) DE60239188D1 (en)
WO (1) WO2002071953A2 (en)

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