Very low profile medical device system having an adjustable balloon

• US 20050055077A1
• Filed: 12/19/2003
• Published: 03/10/2005
• Est. Priority Date: 09/05/2003
• Status: Abandoned Application

• Current Assignee: D-Crown Limited
• Original Assignee: D-Crown Limited
• Inventors: Kutscher, Tuvia Dror, Marco, Doron
• Application Number:
  US10/741,927
• Publication Number:
  US 20050055077A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Described here is a very low profile medical device system having one or more adjustable length (and, optionally, adjustable diameter) balloons, system accessories, and system components. Also described are methods for using the system and its parts, such as by performing procedures, such as dilatation and other methods clear from the description, and for placing implants such as stents or occlusive members into tubular organs, open regions of the body, and other body sites. The system includes at least one balloon integral with a guide member, which balloons are adjustable in length and optionally in diameter. The system may be used to introduce and to deploy implants of types such as those that maintain the patency of an open anatomical structure, install a graft, occlude a selected volume, isolate a region, treat a region in a lumen with a surgical procedure or medicinal materials, or collect other (desirable or undesirable) occlusive members at a site.

Claims

1. A medical device system having an adjustable-length inflatable member comprising:

a core guide member having at least one inflation area, a proximal end, a distal end, a core passageway that is fluidly connected with the at least one inflation area, and is closable distally of the at least one inflation area;

having at least one inflatable member with a length, the inflatable member surrounding at least a portion of one of the at least one inflation area, and that is sealingly connected to the core guide member to form an inflatable region in fluid connection with the core passageway; and

at least one constraining member longitudinally slidable along the core guide member, having a distal end, and wherein the constraining member is configured to slide upon the inflatable member, to constrain inflation of the inflatable member proximally of the constraining member distal end, and to permit inflation of the inflatable member distally of the constraining member distal end, whereby the longitudinal movement of the constraining member adjusts the length of the inflatable member available for inflation.

2. The medical device system of claim 1 where the inflatable member is sealingly connected to the core guide member proximally and distally of the at least one inflation area.

3. The medical device system of claim 1 where the core passageway extends from the core guide member proximal end to the at least one inflation area.

4. The medical device system of claim 1 where the core passageway is closed distally of the at least one inflation area.

5. The medical device system of claim 1 where the core passageway is at least partially open distally of the at least one inflation area.

6. The medical device system of claim 1 where the core passageway has an opening outside of the at least one inflation area with a size selected to allow a controlled leakdown.

7. The medical device system of claim 1 where the core guide member passageway is in fluid connection with the core guide member exterior outside of the inflation area.

8. The medical device system of claim 1 where the at least one inflatable member comprises elastomeric material.

9. The medical device system of claim 1 where the at least one inflatable member comprises non-elastomeric material.

10. The medical device system of claim 1 where the at least one inflatable member comprises a material selected to permit permeation of inflation fluid through the inflatable member.

11. The medical device system of claim 1 where the at least one inflatable member comprises a plurality of inflatable members mounted radially adjacent each other.

12. The medical device system of claim 11 where the at least one inflatable member further comprises a comparatively lower profile distal inflatable member section.

13. The medical device system of claim 11 where the distal inflatable member section has a diameter no more than about 0.014 inches.

14. The medical device system of claim 11 where the distal inflatable member section has a diameter no more than about 0.018 inches.

15. The medical device system of claim 11 where the plurality of inflatable members has a diameter no more than about 0.035 inches.

16. The medical device system of claim 11 where the distal inflatable member section is a compliant balloon.

17. The medical device system of claim 11 where the distal inflatable member section is a semi-compliant balloon.

18. The medical device system of claim 11 where the distal inflatable member section is a non-compliant balloon.

19. The medical device system of claim 11 further comprising an outer layer comprising an elastic sleeve radially adjacent at least a portion of the distal inflatable member section or the section comprising a plurality of inflatable members, to restore the at least one section to a lower profile.

20. The medical device system of claim 1 where the core guide member further comprises a distally located guide tip.

21. The medical device system of claim 1 wherein the core guide member comprises a metallic material.

22. The medical device system of claim 1 wherein the core guide member comprises a polymeric material.

23. The medical device system of claim 1 wherein the core guide member has a low profile.

24. The medical device system of claim 23 wherein the diameter of the core guide member is less than about 0.100 inches.

25. The medical device system of claim 24 wherein the diameter of the core guide member is less than about 0.030 inches.

26. The medical device system of claim 24 wherein the diameter of the core guide member is less than about 0.014 inches.

27. The medical device system of claim 1 wherein the distal end of the core guide member is closed.

28. The medical device system of claim 1 wherein at least one core guide member passageway is fluidly connected to the inflation area through at least one opening comprising at least one slit in the core guide member.

29. The medical device system of claim 1 wherein at least one core guide member passageway is fluidly connected to the inflation area through at least one opening comprising more than one slit in the core guide member.

30. The medical device system of claim 29 wherein the at least one slit is helical.

31. The medical device system of claim 1 wherein at least one core guide member passageway is fluidly connected to the inflation area through at least one opening comprising at least one hole in the core guide member.

32. The medical device system of claim 1 further comprising a catheter.

33. The medical device system of claim 1 further comprising at least one stenting structure.

34. The medical device system of claim 33 wherein the at least one stenting structure is placed in contact with the inflatable member.

35. The medical device system of claim 1 further comprising a plurality of stenting structures.

36. The medical device system of claim 1 further comprising a plurality of stenting structures mounted upon a stent delivery sleeve and wherein the stent delivery sleeve comprises at least one sleeve having an interior longitudinal opening and wherein the sleeve is configured to deploy those stenting devices independently without substantially affecting adjacent stenting devices.

37. The medical device system of claim 36 wherein the stent delivery sleeve is slidable upon the at least one constraining member.

38. The medical device system of claim 36 wherein the stent delivery sleeve is slidable beneath the at least one constraining member.

39. The medical device system of claim 36 wherein the sleeve is configured to deploy at least one of those stenting devices independently by inflating the inflatable member in the interior longitudinal opening.

40. The medical device system of claim 36 wherein the sleeve is configured to allow self-deployment of at least one of those stenting devices independently.

41. The medical device system of claim 36 wherein the stent delivery sleeve comprises at least one filamentary sleeve.

42. The medical device system of claim 1 wherein the delivery sleeve comprises at least one sleeve comprising an elastic membrane.

209. A method for adjusting the length of an inflatable member in a medical device system comprising the steps of:

a.) providing the device of claim 1,

b.) placing the inflatable member at a selected site,

c.) sliding a constraining member along the core guide member on the proximal end of the inflatable member until a selected inflatable member length is achieved, and

d.) inflating the inflatable member.

210. The process of claim 209 further comprising the step of deflating the inflatable member.

211. The process of claim 210 further comprising the step of moving the deflated inflatable member to another site in the human body, adjusting the size of the inflatable member by moving the constraining member to a second selected inflatable member size, and inflating inflatable member.

212. The process of claim 211 further comprising the step of deflating the inflatable member.

213. A method for adjusting the length of an inflatable member in a medical device system comprising the steps of:

a.) providing the device of claim 1,

b.) placing the inflatable member at a selected site in the human body,

c.) sliding a constraining member along the core guide member on the proximal end of the inflatable member until a selected inflatable member length is achieved,

d.) sliding a stent delivery sleeve having at least one stenting device on its exterior to the selected site; and

e.) inflating inflatable member to implant the stenting device.

43. A stent delivery sleeve comprising:

at least one filamentary sleeve having an interior longitudinal opening and wherein the filaments are of a size, flexibility, and shape and comprising materials appropriate a.) to support stenting devices and b.) to deploy those stenting devices independently without substantially affecting adjacent stents and

at least one stenting device mounted exterior to the at least one filamentary sleeve.

44. The stent delivery sleeve of claim 43 where the filamentary sleeve further is configured to deploy those stenting devices independently by inflating a inflatable member in the interior longitudinal opening and to return to a pre-deployment shape without substantial plastic deformation.

45. The stent delivery sleeve of claim 43 where the filamentary sleeve has a substantially constant diameter.

46. The stent delivery sleeve of claim 43 where the filamentary sleeve does not have a substantially constant diameter.

47. The stent delivery sleeve of claim 43 where the at least one stenting device comprises more than one stenting device of which at least one is deployable using a inflatable member.

48. The stent delivery sleeve of claim 43 where the at least one stenting device of which at least one is a self-expanding stenting device.

49. The stent delivery sleeve of claim 48 further comprising a removable retainer configured to controllably allow the at least one self-expanding stenting device to individually self-deploy.

50. The stent delivery sleeve of claim 43 where the filaments comprise a super-elastic alloy.

51. The stent delivery sleeve of claim 43 where the filaments comprise nitinol.

52. The stent delivery sleeve of claim 43 where the filaments comprise a stainless steel.

53. The stent delivery sleeve of claim 43 where the filaments comprise wire.

54. The stent delivery sleeve of claim 43 where the filaments comprise ribbon.

55. The stent delivery sleeve of claim 43 where the at least one stenting device comprises more than one stenting device each having substantially the same length.

56. The stent delivery sleeve of claim 43 where the at least one stenting device comprises more than one stenting device and not having substantially the same length.

57. The stent delivery sleeve of claim 43 where the at least one stenting device comprises more than one stenting device and not having substantially the same expanded diameter.

58. The stent delivery sleeve of claim 43 where the filamentary sleeve comprises a braid.

59. The stent delivery sleeve of claim 43 where the filamentary sleeve comprises a woven or knitted braid.

60. The stent delivery sleeve of claim 43 further comprising an elongate position control member attached to an end of one of the at least one filamentary sleeve and configured to allow a user to position the sleeve at a selected site.

61. The stent delivery sleeve of claim 43 comprising at least one filamentary sleeve having at least one stenting device joinable to another filamentary sleeve having at least one stenting device.

62. The stent delivery sleeve of claim 43 comprising more than one filamentary sleeve each having at least one stenting device joined to another filamentary sleeve having at least one stenting device.

63. The stent delivery sleeve of claim 60 comprising more than one filamentary sleeve having at least one stenting device joined to another filamentary sleeve having at least one stenting device and further joined to an elongate position control member attached to an end of one of the filamentary sleeves.

64. The stent delivery sleeve of claim 43 where the at least one stenting device further comprises at least one biologically active agent.

65. The stent delivery sleeve of claim 64 where the at least one biologically active agent comprises one or more immunosuppressants.

66. The stent delivery sleeve of claim 65 where the one or more immunosuppressants comprise sirolimus, everolimus, tacrolimus, or their mixtures.

67. The stent delivery sleeve of claim 65 where the one or more immunosuppressants comprise one of cyclosporins, azathioprines, and corticosteroids.

68. The stent delivery sleeve of claim 43 where the at least one stenting device further comprises a releasable biologically active agent selected from the group consisting of anti-proliferation agents, anti-inflammatory agents, antibiotics, and immunosuppressants.

69. The stent delivery sleeve of claim 43 where the at least one stenting device further comprises a releasable biologically active agent selected from the group consisting of paclitaxel, methotrexate, batimastal, doxycycline, tetracycline, rapamycin, actinomycin, dexamethosone, methyl prednisolone, prednisolone, nitroprussides, estrogen, estradiols, and their mixtures.

70. A stenotic incision tool for cutting stenoses found in a vascular lumen, comprising:

a.) an atherotome holding member having a longitudinal axis, comprising;

i.) an inner substrate having a passageway, a radius, and an outer surface, the substrate being adapted to cooperate with a removable inflatable member and expand to extend a plurality of atherotomes in a substantially radial direction when the removable inflatable member is inflated in the passageway,

ii.) an outer member having an outer surface, and

iii.) a plurality of atherotomes having longitudinal axes, fixedly and movably mounted to said inner substrate, and adapted to extend from the outer surface substantially parallel to the holding member longitudinal axis when the removable inflatable member is inflated in the passageway, and

b.) a proximal control member configured to allow a user to place the tool at a selected site in the human body.

71. The stenotic incision tool of claim 70 where the proximal control member has a passageway substantially aligned with the inner substrate passageway, said passageway adapted to allow passage of the removable inflatable member to the passageway of the inner substrate.

72. The stenotic incision tool of claim 70 where outer member outer surface includes slits corresponding substantially to the positions of the atherotomes when the removable inflatable member is inflated in the passageway.

73. The stenotic incision tool of claim 70 where the plurality of atherotomes is exactly two mounted at approximately 180°

to each other with respect to the atherotome holding member longitudinal axis.

74. The stenotic incision tool of claim 70 where the plurality of atherotomes is exactly four mounted at 90°

to each other with respect to the atherotome holding member longitudinal axis.

75. The stenotic incision tool of claim 70 where the inner substrate extends to and comprises the outer member.

76. The stenotic incision tool of claim 70 where the inner substrate is spaced apart from the outer member.

77. A shape control member for controllably limiting the expansion of an expandable, inflatable member to a selected shape comprising:

a.) at least two support members,

b.) a fabric caul having a passageway configured for entry and exit of an expandable, inflatable member, the caul being mounted between a pair of the support members and configured to limit the shape of the inflatable member to a selected expanded shape when the expandable inflatable member is inflated in the fabric caul passageway, and

c.) a proximal control member configured to allow a user to place the tool at a selected site in the human body.

78. The shape control member of claim 77 where the proximal control member comprises a tubular member extending proximally and having a passageway substantially aligned with the fabric caul passageway, and said passageway adapted to allow passage of the removable, expandable inflatable member.

79. The shape control member of claim 77 where the at least two support members are cylindrical.

80. The shape control member of claim 78 where the tubular member comprises a proximal support member.

81. The shape control member of claim 77 where the fabric caul has a substantially cylindrical expanded shape.

82. The shape control member of claim 81 where the substantially cylindrical expanded shape has a preselected diameter.

83. The shape control member of claim 77 comprising a plurality of fabric cauls having substantially cylindrical expanded shapes with preselected diameters.

84. The shape control member of claim 77 wherein the plurality of fabric cauls are separated by and mounted between support members.

85. The shape control member of claim 83 where the preselected diameters are different.

86. The shape control member of claim 77 where the fabric caul has an expanded shape that is not cylindrical.

87. The shape control member of claim 77 where the inflatable member is elastic.

88. The shape control member of claim 77 where the inflatable member is inelastic.

89. The shape control member of claim 77 where the inflatable member is semi elastic.

90. A drug delivery sleeve member for controllably delivering a drug material to a body lumen by expansion of a removable, expandable, inflatable member, comprising:

a.) at least two support members,

b.) a drug carrier having a passageway configured for entry and exit of a removable, expandable, inflatable member, the carrier being mounted between a pair of the support members and configured to release a drug when the expandable inflatable member is inflated in the drug carrier passageway, and

c.) a proximal control member configured to allow a user to place the drug delivery member at a selected site in the human body.

91. The drug delivery sleeve member of claim 90 where the proximal control member comprises a tubular member extending proximally and having a passageway substantially aligned with the drug carrier passageway, and said passageway adapted to allow passage of the removable, expandable inflatable member.

92. The drug delivery sleeve member of claim 90 where the a drug carrier is configured to release a drug when the expandable inflatable member is inflated in the drug carrier passageway and causes the exterior wall to contact an interior of a body lumen.

93. The drug delivery sleeve member of claim 90 where the proximal control member comprises a proximal support member.

94. The drug delivery sleeve member of claim 90 where the drug carrier comprises a drug contained in a sleeve member having an exterior surface, and adapted to release the drug to the exterior surface upon inflation of the expandable inflatable member.

95. The drug delivery sleeve member of claim 90 where the drug carrier comprises a drug contained in a sleeve member, a stenting implant for supporting the sleeve member, the drug carrier being configured to implant the drug-containing sleeve member and the stenting implant in the body lumen upon inflation of the expandable inflatable member.

96. The drug delivery sleeve member of claim 94 where the drug carrier further comprises an interior member configured to maintain a physical connection between the pair of adjacent support members after the drug-containing sleeve member and the stenting implant have been released in the body lumen after inflation of the expandable inflatable member.

97. The drug delivery sleeve member of claim 90 where the drug carrier comprises a drug contained in a sleeve member and where sleeve member is configured to implant the drug-containing sleeve member in the body lumen upon inflation of the expandable inflatable member.

98. The drug delivery sleeve member of claim 90 comprising a plurality of drug carriers.

99. The drug delivery sleeve member of claim 98 wherein the plurality of drug carrriers are separated by and mounted between support members.

100. The drug delivery sleeve member of claim 90 where the drug carrier has a substantially constant diameter.

101. The drug delivery sleeve member of claim 90 where the drug carrier does not have a substantially constant diameter.

102. A component for controlling the longitudinal expansion of a inflatable member having a longitudinal axis, a proximal end, and a distal end, comprising:

a.) the inflatable member, and

b.) at least one expansion control member located adjacent one of the inflatable member distal or proximal ends, having an axis generally coincident with the longitudinal axis of the inflatable member, an expansion end adjacent the inflatable member, and a second end more remote from the inflatable member than the expansion end, the at least one expansion control member having a stiffness sufficient to allow, as a result of inflatable member expansion, the expansion end to expand in an amount greater than the expansion of the second end, and to direct the expansion of the inflatable member away from the end adjacent the specific expansion control member.

103. The longitudinal expansion control component of claim 102 wherein the inflatable member comprises an elastic material.

104. The longitudinal expansion control component of claim 102 wherein the inflatable member comprises an inelastic material.

105. The longitudinal expansion control component of claim 103 comprising exactly two expansion control members, each one located adjacent one of the elastic inflatable member proximal and a distal ends.

106. The longitudinal expansion control component of claim 102 wherein one of the at least one expansion control members is integral with one of the inflatable member proximal and distal ends.

107. The longitudinal expansion control component of claim 106 wherein one of the at least one expansion control members is integral with the inflatable member distal end.

108. The longitudinal expansion control component of claim 106 wherein one of the at least one expansion control members is integral with the inflatable member proximal end.

109. The longitudinal expansion control component of claim 102 wherein one of the at least one expansion control members is slidable over one of the inflatable member proximal and distal ends.

110. The longitudinal expansion control component of claim 109 wherein one of the at least one expansion control members is slidable over the inflatable member proximal end.

111. The longitudinal expansion control component of claim 109 wherein the at least one slidable expansion control member comprises a inflatable member constraining member configured to constrain inflation of the inflatable member proximally of the expansion control member expansion end, and to permit inflation of the inflatable member distally of the expansion control member expansion end.

112. The longitudinal expansion control component of claim 111 wherein the at least one slidable expansion control member is fixedly attached to a proximally extending position control member.

113. The longitudinal expansion control component of claim 112 wherein the proximally extending position control member is tubular.

114. The longitudinal expansion control component of claim 112 wherein the at least one slidable expansion control member comprises a material that has a flexural stiffness higher than the flexural stiffness of the material comprising the inflatable member.

115. The longitudinal expansion control component of claim 114 wherein the at least one slidable expansion control member comprises a material that has a flexural stiffness lower than the flexural stiffness of the material comprising the member extending proximally.

116. The longitudinal expansion control component of claim 102 wherein the at least one expansion control member comprises a material that has a flexural stiffness higher than the flexural stiffness of the material comprising the inflatable member.

117. The longitudinal expansion control component of claim 102 wherein the at least one expansion control member comprises one or more longitudinal stiffeners.

118. The longitudinal expansion control component of claim 102 wherein the at least one expansion control member comprises at least one convoluted limiter ring configured to de-convolute upon expansion and to limit the expansion of the expander end to a determined limit when de-convoluted.

119. The longitudinal expansion control component of claim 118 wherein the at least one convoluted limiter ring is situated between the expander end and the second end.

120. The longitudinal expansion control component of claim 102 wherein the at least one expansion control member comprises at least one cinch ring adjacent the second end configured to substantially prevent the expansion of the second end.

121. The longitudinal expansion control component of claim 102 wherein the at least one expansion control member comprises a plurality of closed slots in the at least one expansion control member configured to allow and to limit the expansion of at least a portion of the expander end to a predetermined limit.

122. A medical inflatable member system comprising:

a core guide member having at least one inflation area, a proximal end, a distal end, a core passageway that is fluidly connected with the at least one inflation area, and is closable distally of the at least one inflation area; and

having at least one inflatable member with a longitudinal axis, a length, and a inflatable member distal end, the inflatable member surrounding at least a portion of one of the at least one inflation areas, and that is sealingly connected to the core guide member to form an inflatable region in fluid connection with the passageway; and

at least one expansion control member located adjacent one of the inflatable member distal or proximal end, having an axis generally coincident with the longitudinal axis of the inflatable member, an expansion end adjacent the inflatable member and a second end more remote from the inflatable member than the expansion end, the at least one expansion control member having a stiffness sufficient to allow, upon expansion of the inflatable member, the expansion end to expand in an amount greater than the expansion of the second end, and to direct the expansion of the inflatable member away from the end adjacent the specific expansion control member.

123. The medical inflatable member system of claim 122 where the inflatable member is elastic.

124. The medical inflatable member system of claim 122 where the inflatable member is inelastic.

125. The medical inflatable member system of claim 122 where the inflatable member is sealingly connected to the core guide member proximally and distally of the at least one inflation area.

126. The medical inflatable member system of claim 122 comprising exactly two expansion control members, each one located at one of the inflatable member proximal and distal ends.

127. The medical inflatable member system of claim 122 wherein one of the at least one expansion control members is integral with one of the inflatable member proximal and distal ends.

128. The medical inflatable member system of claim 127 wherein one of the at least one expansion control members is integral with the inflatable member distal end.

129. The medical inflatable member system of claim 127 wherein one of the at least one expansion control members is integral with the inflatable member proximal end.

130. The medical inflatable member system of claim 122 wherein the at least one expansion control member comprises a material that has a flexural stiffness higher than the flexural stiffness of the material comprising the inflatable member.

131. The medical inflatable member system of claim 122 wherein the at least one expansion control member comprises one or more longitudinal stiffeners.

132. The medical inflatable member system of claim 122 wherein the at least one expansion control member comprises at least one convoluted limiter ring configured to de-convolute upon expansion and to limit the expansion of the expander end to a determined limit when de-convoluted.

133. The medical inflatable member system of claim 132 wherein the at least one convoluted limiter ring is situated between the expander end and the second end.

134. The medical inflatable member system of claim 122 wherein the at least one expansion control member comprises at least one cinch ring adjacent the second end configured to substantially prevent the expansion of the second end.

135. The medical inflatable member system of claim 122 wherein the at least one expansion control member comprises a plurality of closed slots in the at least one expansion control member configured to allow and to limit the expansion of at least a portion of the expander end to a predetermined limit.

136. A sterilized medical device system kit comprising:

a sterilized sealed packaging containing;

a medical device system having an adjustable-length inflatable member comprising;

a core guide member having at least one inflation area, a proximal end, a distal end, a core passageway that is fluidly connected with the at least one inflation area, and is closable distally of the at least one inflation area;

having an inflatable member having a length, surrounding at least a portion of the inflation area, and that is sealingly connected to the core guide member to form an inflatable region in fluid connection with the passageway; and

at least one constraining member longitudinally slidable along the core guide member, having a distal end, and wherein the constraining member is configured to slide upon the inflatable member, to constrain inflation of the inflatable member proximally of the constraining member distal end, and to permit inflation of the inflatable member distally of the constraining member distal end, whereby the longitudinal movement of the constraining member adjusts the length of the inflatable member available for inflation.

137. The sterilized medical device system kit of claim 136 further comprising at least one stenting device implantable from the medical device system.

138. The sterilized medical device system kit of claim 136 further comprising at least one stenting device delivery sleeve having an interior longitudinal opening, a distal end, a proximal end, and of a size, flexibility, and material appropriate to support stenting devices, and to allow deployment of those stenting devices independently without substantially affecting adjacent stenting devices, and at least one stenting device implantable from the medical device system.

139. The sterilized medical device system kit of claim 136 where the at least one stenting device delivery sleeve is filamentary and is further configured to deploy those stenting devices independently by inflating a inflatable member in the interior longitudinal opening and to return to a pre-deployment shape without substantial plastic deformation.

140. The sterilized medical device system kit of claim 138 wherein the at least one stenting device delivery sleeve has a substantially constant diameter.

141. The sterilized medical device system kit of claim 138 wherein the at least one stenting device delivery sleeve does not have a substantially constant diameter.

142. The sterilized medical device system kit of claim 136 further comprising at least one elastic sleeve having an interior longitudinal opening, a distal end, a proximal end, and of a size, flexibility, and material appropriate to support stenting devices, to allow deployment of those stenting devices independently without substantially affecting adjacent stenting devices, an elongate position control member attached to a proximal end of the sleeve, and at least one stenting device.

143. The sterilized medical device system kit of claim 142 where the at least one elastic sleeve is further configured to deploy those stenting devices independently by inflating a inflatable member in the interior longitudinal opening and to return to a pre-deployment shape without substantial plastic deformation.

144. The sterilized medical device system kit of claim 142 where the at least one stenting device is detachably mounted exterior to the sleeve member.

145. The sterilized medical device system kit of claim 138 comprising more than one stenting device, at least one being deployable using a inflatable member.

146. The sterilized medical device system kit of claim 138 comprising more than one stenting device, at least one being self-expanding.

147. The sterilized medical device system kit of claim 145 further comprising a removable retainer configured to controllably allow the more than one self-expanding stenting devices to individually self-deploy.

148. The sterilized medical device system kit of claim 137 further comprising:

a shape control member for controllably limiting the expansion of the inflatable member to a selected shape comprising;

i.) at least two support members,

ii.) at least one fabric caul having a passageway configured for entry and exit of a removable, expandable inflatable member, the caul being mounted between a pair of the support members and configured to limit the shape of the inflatable member to a selected expanded shape when the expandable inflatable member is inflated in the fabric caul passageway, and

iii.) proximal control member configured to allow a user to place the fabric caul member at a selected site in the human body.

149. The sterilized medical device system kit of claim 148 where the proximal control member comprises a tubular member extending proximally from the at least one caul and having a passageway substantially aligned with the fabric caul passageway, and said passageway adapted to allow passage of the removable, expandable inflatable member.

150. The sterilized medical device system kit of claim 149 where the fabric caul has a substantially cylindrical expanded shape.

151. The sterilized medical device system kit of claim 150 where the substantially cylindrical expanded shape has a preselected diameter.

152. The sterilized medical device system kit of claim 148 comprising a plurality of fabric cauls having substantially cylindrical expanded shapes with preselected diameters.

153. The sterilized medical device system kit of claim 152 wherein the plurality of fabric cauls are separated by and mounted between support members.

154. The sterilized medical device system kit of claim 148 where the preselected diameters are different.

155. The sterilized medical device system kit of claim 148 where the fabric caul has an expanded shape that is not cylindrical.

156. The sterilized medical device system kit of claim 148 further comprising at least one expansion control member located adjacent one of the inflatable member distal or proximal ends, having an axis generally coincident with the longitudinal axis of the inflatable member, an expansion end adjacent the inflatable member, and a second end more remote from the inflatable member than the expansion end, the at least one expansion control member having a stiffness sufficient to allow, during inflation of the inflatable member, the expansion end to expand in an amount greater than the expansion of the second end, and to direct the expansion of the inflatable member away from the end adjacent the specific expansion control member.

157. The sterilized medical device system kit of claim 156 comprising exactly two expansion control members, each one located at one of the elastic inflatable member proximal and a distal ends.

158. The sterilized medical device system kit of claim 156 wherein one of the at least one expansion control members is integral with one of the inflatable member proximal and distal ends.

159. The sterilized medical device system kit of claim 156 wherein one of the at least one expansion control members is integral with the inflatable member distal end.

160. The sterilized medical device system kit of claim 156 wherein one of the at least one expansion control members is integral with the inflatable member proximal end.

161. The sterilized medical device system kit of claim 156 wherein one of the at least one expansion control members is slidable over one of the inflatable member proximal and distal ends.

162. The sterilized medical device system kit of claim 156 wherein one of the at least one expansion control members is slidable over the inflatable member proximal end.

163. The sterilized medical device system kit of claim 161 wherein the at least one slidable expansion control member comprises a inflatable member constraining member configured to constrain inflation of the inflatable member proximally of the expansion control member expansion end, and to permit inflation of the inflatable member distally of the expansion control member expansion end.

164. The sterilized medical device system kit of claim 162 wherein the at least one slidable expansion control member is fixedly attached to a tubing member extending proximally.

165. The sterilized medical device system kit of claim 162 wherein the at least one slidable expansion control member comprises a material that has a flexural stiffness higher than the flexural stiffness of the material comprising the inflatable member.

166. The sterilized medical device system kit of claim 162 wherein the at least one slidable expansion control member comprises a material that has a flexural stiffness lower than the flexural stiffness of the material comprising the tubing member extending proximally.

167. The sterilized medical device system kit of claim 156 wherein the at least one expansion control member comprises a material that has a flexural stiffness higher than the flexural stiffness of the material comprising the inflatable member.

168. The sterilized medical device system kit of claim 156 wherein the at least one expansion control member comprises one or more longitudinal stiffeners.

169. The sterilized medical device system kit of claim 156 wherein the at least one expansion control member comprises at least one limiter ring adjacent the expander end configured to limit the expansion of the expander end to a determined limit.

170. The sterilized medical device system kit of claim 156 wherein the at least one expansion control member comprises at least one cinch ring adjacent the second end configured to substantially prevent the expansion of the second end.

171. The sterilized medical device system kit of claim 156 wherein the at least one expansion control member comprises a plurality of closed slots in the at least one expansion control member configured to allow and to limit the expansion of the expander end to a determined limit.

172. A sterilized stent delivery sleeve kit comprising:

sterilized sealed packaging containing;

at least one filamentary sleeve having an interior longitudinal opening and wherein the filaments are of a size, flexibility, and shape and comprising materials appropriate a.) to support stenting devices and b.) to deploy those stenting devices independently without substantially affecting adjacent stents and

at least one stenting device mountable exterior to the at least one filamentary sleeve.

173. The sterilized stent delivery sleeve kit of claim 172 where the filamentary sleeve further is configured to deploy those stenting devices independently by inflating a inflatable member in the interior longitudinal opening and to return to a pre-deployment shape without substantial plastic deformation.

174. The sterilized stent delivery sleeve kit of claim 172 where the at least one stenting device comprises more than one stenting device of which at least one is deployable using a inflatable member.

175. The sterilized stent delivery sleeve kit of claim 172 where the at least one stenting device of which at least one is a self-expanding stenting device.

176. The sterilized stent delivery sleeve kit of claim 172 further comprising a removable retainer configured to controllably allow the at least one self-expanding stenting device to individually self-deploy.

177. The sterilized stent delivery sleeve kit of claim 172 comprising more than one filamentary sleeve each having at least one stenting device joinable to another filamentary sleeve having at least one stenting device.

178. The sterilized stent delivery sleeve kit of claim 172 comprising more than one filamentary sleeve having at least one stenting device joinable to another filamentary sleeve having at least one stenting device and further joined to an elongate position control member attached to an end of one of the filamentary sleeves.

179. The sterilized medical device system kit of claim 172 wherein the at least one filamentary sleeve has a substantially constant diameter.

180. The sterilized medical device system kit of claim 172 wherein the at least one filamentary sleeve sleeve does not have a substantially constant diameter.

181. The sterilized stent delivery sleeve kit of claim 172 comprising more than one stenting device each having substantially the same length.

182. The sterilized stent delivery sleeve kit of claim 172 comprising more than one stenting device not having substantially the same length.

183. The sterilized stent delivery sleeve kit of claim 172 comprising more than one stenting device not having substantially the same expanded diameter.

184. The sterilized stent delivery sleeve kit of claim 172 comprising an elongate position control member joinable to an end of a filamentary sleeve.

185. The sterilized stent delivery sleeve kit of claim 172 where the at least one stenting device further comprises at least one biologically active agent.

186. The sterilized stent delivery sleeve kit of claim 172 where the at least one stenting device further comprises a releasable biologically active agent selected from the group consisting of anti-proliferation agents, anti-inflammatory agents, antibiotics, and immunosuppressants.

187. The sterilized stent delivery sleeve kit of claim 172 where the at least one stenting device further comprises a releasable biologically active agent selected from the group consisting of paclitaxel, prednisolone, methotrexate, batimastal, doxycycline, tetracycline, rapamycin, actinomycin, dexamethosone, methyl prednisolone, nitroprussides, estrogen, estradiols, and their mixtures.

188. A stent delivery sleeve comprising:

at least one elastic sleeve having an interior longitudinal opening, a distal end, a proximal end, and of a size, flexibility, and material appropriate to support stenting devices, to allow deployment of those stenting devices independently without substantially affecting adjacent stenting devices;

an elongate position control member attached to a proximal end of the sleeve, and

more than one stenting device detachably mounted exterior to the sleeve member.

189. The stent delivery sleeve of claim 188 wherein the at least one elastic sleeve has a substantially constant diameter.

190. The stent delivery sleeve of claim 188 wherein the at least one elastic sleeve does not have a substantially constant diameter.

191. The stent delivery sleeve of claim 188 where the stenting devices are each deployable using an inflatable member.

192. The stent delivery sleeve of claim 188 where the stenting devices are self-expanding.

193. The stent delivery sleeve of claim 192 further comprising a removable retainer configured to controllably allow the self-expanding stenting devices to individually self-deploy.

194. The stent delivery sleeve of claim 188 where the stenting devices comprise stenting devices each having substantially the same length.

195. The stent delivery sleeve of claim 188 where the stenting devices comprise stenting devices not having substantially the same length.

196. The stent delivery sleeve of claim 188 where the stenting devices comprise stenting devices not having substantially the same expanded diameter.

197. The stent delivery sleeve of claim 188 where at least one of the stenting devices further comprises at least one biologically active agent.

198. A sterilized stent delivery sleeve kit comprising:

sterilized sealed packaging containing;

a stent delivery sleeve comprising;

at least one elastic sleeve having an interior longitudinal opening, a distal end, a proximal end, and of a size, flexibility, and material appropriate to support stenting devices, to allow deployment of those stenting devices independently without substantially affecting adjacent stenting devices;

an elongate position control member attached to a proximal end of the sleeve, and

more than one stenting device detachably movable exterior to the sleeve member.

199. The sterilized medical device system kit of claim 198 wherein the at least one elastic sleeve has a substantially constant diameter.

200. The sterilized medical device system kit of claim 198 wherein the at least one elastic sleeve sleeve does not have a substantially constant diameter.

201. The sterilized stent delivery sleeve kit of claim 198 comprising more than one stenting device each having substantially the same length.

202. The sterilized stent delivery sleeve kit of claim 198 comprising more than one stenting device not having substantially the same length.

203. The sterilized stent delivery sleeve kit of claim 198 comprising more than one stenting device not having substantially the same expanded diameter.

204. The sterilized stent delivery sleeve kit of claim 198 comprising more than one elastic sleeve having at least one stenting device joinable to another elastic sleeve having at least one stenting device.

205. The sterilized stent delivery sleeve kit of claim 198 comprising an elongate position control member joinable to an end of a elastic sleeve.

206. The sterilized stent delivery sleeve kit of claim 198 where the at least one stenting device further comprises at least one biologically active agent.

207. The sterilized stent delivery sleeve kit of claim 198 where the at least one stenting device further comprises a releasable biologically active agent selected from the group consisting of anti-proliferation agents, anti-inflammatory agents, antibiotics, and immunosuppressants.

208. The sterilized stent delivery sleeve kit of claim 198 where the at least one stenting device further comprises a releasable biologically active agent selected from the group consisting of paclitaxel, prednisolone, methotrexate, batimastal, doxycycline, tetracycline, rapamycin, actinomycin, dexamethosone, methyl prednisolone, nitroprussides, estrogen, estradiols, and their mixtures.

214. The procedure of 213 further comprising the steps of:

a.) deflating the inflatable member,

b.) proximally withdrawing the stent delivery sleeve from the selected site,

c.) positioning the inflatable member at a selected portion of the implanted stent;

d.) selecting the size of the inflatable member by moving the constraining member,

e.) inflating the inflatable member to reform the shape of the implanted stenting device, and

f.) deflating the inflatable member.

215. The procedure of step 213 further comprising the step of deflating the inflatable member.

216. The procedure of 215 further comprising the steps of:

a.) deflating the inflatable member,

b.) placing the inflatable member at a second selected site in the human body,

c.) sliding a constraining member along the core guide member on the proximal end of the inflatable member until a selected inflatable member length is achieved,

d.) sliding the stent delivery sleeve having at least one stenting device on its exterior to the selected site; and

e.) inflating inflatable member to implant the stenting device.

217. The procedure of step 215 further comprising the step of deflating the inflatable member.