Lumen occluders made from thermodynamic materials

• US 6,550,480 B2
• Filed: 01/31/2001
• Issued: 04/22/2003
• Est. Priority Date: 01/31/2001
• Status: Expired due to Fees

• Current Assignee: Numed/Tech LLC
• Original Assignee: Numed/Tech LLC
• Inventors: Wang, Wei, Feldman, Tatyana
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Nicolas, Frederick C.
• Application Number:
  US09/773,108
• Publication Number:
  US 20020129819A1
• Time in Patent Office: 811 Days
• Field of Search: 251/11, 128/831, 128/887, 128/898, 128/843, 128/835, 128/840, 604/1, 604/385.17
• US Class Current: 128/831
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61F 11/08 internal, e.g. earplugs
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08L 33/04 Homopolymers or copolymers of esters C08L43/04 takes precedence
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

Disclosed are occluders and methods of their use. The occluders comprise shape-memory polymeric materials which, when heated above their crystalline melting temperatures, may be deformed from a first configuration into a second configuration. The occluder is then held in the deformed shape until it cools to a temperature below its crystalline melting temperature (T_m) whereby it holds the deformed shape of the second configuration by virtue of the recrystallization of the polymeric occluder material. Upon reheating the occluder above its T_m, the occluder will resume its original shape. In this manner, an occluder which has been deformed to reduce its diameter may be inserted into and positioned within a target lumen in the body and then allowed to warm to body temperature whereby it resumes its original diameter and results in the occlusion of the lumen. The occluders, according to preferred embodiments, may be used for reversible sterilization of mammals, among other surgical and non-surgical uses.

Claims

1. A method of occluding a lumen in a living mammal, said lumen having an inner diameter, comprising:

providing an occluder deformed to a diameter equal to or smaller than the inner diameter of said lumen of a living mammal, said occluder comprising a shape memory composition having a glass transition temperature in the range of about −

100°

to about 20°

C. and said composition comprising a crystalline domain structure having a crystalline melting temperature (T_m) in the range of about 0°

to about 37°

C.;

surgically inserting the occluder into the lumen;

allowing the occluder to warm to the body temperature of said mammal thereby becoming elastic and conforming to the size and shape of the lumen;

wherein said lumen is selected from fallopian tubes, blood vessels, vas deferens, and vagina of said mammal.

2. The method according to claim 1, wherein the shape memory composition comprises cis- and trans-poly[methyl(3,3,3-trifluoropropyl)]siloxane with cis- content of about 40% or higher.

3. The method according to claim 1, wherein the shape memory composition comprises poly(stearyl methacrylate).

4. The method of claim 1 wherein the lumen is a fallopian tube.

5. The method according to claim 1, wherein the deformed occluder is formed by a process comprising:

providing an occluder with a diameter equal to or larger than the inner diameter of the lumen;

warming the occluder to a temperature higher than T_m, such that it becomes elastic;

deforming the occluder until the deformed diameter is smaller than the diameter of the lumen;

cooling the deformed occluder to a temperature sufficiently lower than T_m to allow the composition to re-crystallize such that the occluder retains the deformed form.