Contraceptive system and method of use

Abstract

A device and method of using the device for contraception or sterilization and particularly for reversible contraception by occluding a reproductive lumen to prevent the passage of reproductive cells through the lumen for a desired period of time until the patient wishes to become fertile again and then be reopened. The occluding member preferably comprises a tubular framework formed from a shape memory material configured to be implanted in a reproductive lumen. The occluding member is implanted within a body lumen, secured to the wall of the reproductive lumen and then collapsed to collapse the wall and occlude the lumen. Alternatively, the occluding member may be collapsed upon a solid plug. The closure of the reproductive lumen may be reversed by introducing a balloon catheter and by a series of inflations of the balloon reexpanding the collapsed occluding member or by removing the plug. The occluding member and the plug may be configured to facilitate endothelialization, to provoke an inflammatory responses or to deliver a drug.

What is claimed is:  
     
         1 . A contraceptive or sterilization system for occluding a reproductive body lumen to prevent the passage of reproductive cells therethrough, comprising: 
 a) an occluding member which is at least in part expandable within the reproductive body lumen from a first configuration to a second larger configuration to facilitate securing the expanded portion of the occluding member to a wall portion which defines at least in part the reproductive body lumen;    b) means to secure the expanded portion of the occluding member to the wall portion; and    c) means to contract the expanded portion of the occluding member so that the wall portion secured thereto likewise contracts to occlude the reproductive body lumen sufficiently to prevent the passage of reproductive cells therethrough.    
     
     
         2 . The contraceptive system of  claim 1  including an expanding means to expand at least a portion of the occluding member.  
     
     
         3 . The contraceptive system of  claim 2  wherein the expanding means is an elongated catheter having an inner lumen extending within the elongated catheter from a proximal portion of the catheter to a location within a distal portion, an inflatable member on a distal portion thereof with an interior in fluid communication with the inner lumen to facilitate the delivery of inflation fluid to the interior of the inflatable member.  
     
     
         4 . The contraceptive system of  claim 1  including a mandrel configured to be disposed within an expanded portion of the occluding member so that the occluding member contracts onto the mandrel to occlude the reproductive body lumen sufficiently to prevent the passage of reproductive cells therethrough.  
     
     
         5 . The contraceptive system of  claim 1  wherein the occluding member has a tubular open-wall structure to facilitate the ingrowth of endothelial cells thereby securing the expanded portion of the occluding member to the wall portion.  
     
     
         6 . The contraceptive system of  claim 5  wherein the tubular structure has an lattice-like framework.  
     
     
         7 . The occluding member of  claim 6  wherein the lattice-like framework comprises a thin walled metallic tube having a pattern of cuts configured to allow the occluding member to be expanded to an open-walled, relatively large diameter configuration.  
     
     
         8 . A contraceptive member formed of shape memory alloy which has a stable martensite phase at body temperature, has a first small dimensioned configuration facilitating the introduction thereof into a lumen of a patient's reproductive system, is expandable to a second larger configuration facilitating securing a least a portion of the contraceptive member to a wall portion defining at least in part the lumen of the patient's reproductive system, has an open lattice-like framework facilitating the ingrowth of endothelial cells thereby securing the expanded portion of the contraceptive member to the wall portion and has a contracted remembered shape in an austenite phase at temperatures higher than body temperature with a remembered configuration having smaller transverse dimensions than the second larger configuration.  
     
     
         9 . An contraceptive system installed within a lumen of the patient's reproductive system comprising a collapsed occluding member having at least a portion thereof which is secured to a body wall portion defining at least in part the lumen of the patient's reproductive system and which occludes the lumen sufficiently to prevent the passage of reproductive cells therethrough.  
     
     
         10 . The installed contraceptive system of  claim 9  wherein the occluding member has a tubular structure.  
     
     
         11 . The installed contraceptive system of  claim 10  wherein the tubular structure of the occluding member has a lattice-like framework.  
     
     
         12 . The contraceptive system of  claim 9  including a mandrel disposed within the collapsed occluding member.  
     
     
         13 . An occluding member for body lumens formed of a shape memory alloy exhibiting a martensitic metallurgical structure at body temperature and an austenitic metallurgical structure at temperatures above body temperature having a remembered reduced diameter configuration, having an expanded open configuration to facilitate securing itself to a wall portion defining the body lumen.  
     
     
         14 . The occluding member of  claim 13  wherein the occluding member comprises a lattice-like framework.  
     
     
         15 . The occluding member of  claim 14  wherein the lattice-like framework comprises a thin walled metallic tube having a pattern of cuts configured to allow the occluding member to be expanded to the open, relatively large diameter configuration.  
     
     
         16 . The occluding member of  claim 14  wherein the lattice-like framework comprises a plurality of interconnected closed wire rings.  
     
     
         17 . The occluding member of  claim 14  wherein the lattice-like framework comprises a helical coil of wire.  
     
     
         18 . The occluding member of  claim 14  wherein the lattice-like framework comprises a braid of wire.  
     
     
         19 . The occluding member of  claim 13  wherein the shape memory material comprises a nickel-titanium alloy.  
     
     
         20 . The occluding member of  claim 13  wherein the surface of the occluding member is configured to promote endothelialization.  
     
     
         21 . The occluding member of  claim 13  further comprising a material capable of provoking an inflammatory response.  
     
     
         22 . The occluding member of  claim 21  wherein the inflammatory material comprises copper or copper alloy.  
     
     
         23 . An occluding assembly comprising an occluding member having a tubular metallic framework with an inner lumen extending therein and having a plug within the lumen, wherein the occluding member has a closed configuration about the plug disposed within the inner lumen thereof, so that the occluding member may be expanded to an open, relatively large diameter configuration by removal of the plug, and then may be heated to the transition temperature to cause the occluding member to revert to the closed, minimal-diameter configuration.  
     
     
         24 . The occluding assembly of  claim 23  wherein the occluding member is configured to promote endothelialization.  
     
     
         25 . The occluding assembly of  claim 23  wherein the plug is formed from a material capable of provoking an inflammatory response.  
     
     
         26 . The occluding assembly of  claim 23  wherein the plug has a threaded configuration.  
     
     
         27 . The occluding assembly of  claim 23  wherein the plug comprises a hollow tube and removable core.  
     
     
         28 . A method of contraception comprising the steps of: 
 a) inserting within a desired body lumen an occluding member;    b) expanding the occluding member within the body lumen;    c) securing the expanded occluding member to a wall portion defining at least in part the body lumen; and    d) collapsing the occluding member and the wall portion secured thereto to occlude the body lumen.    
     
     
         29 . The method of  claim 28  further comprising the step of positioning an elongated plug within the expanded occluding member before collapsing the occluding member.  
     
     
         30 . The method of  claim 28  wherein the occluding member comprises a metallic framework of shape memory material having a phase transition from martensite to austenite at a temperature above body temperature and having a remembered shape in the austenite phase which is a collapsed configuration so that the tubular occluding member may be deformed to the open configuration and then reverted to the closed configuration when heated to a temperature at or above the transition temperature.  
     
     
         31 . The method of  claim 28  wherein the expanded occluding member is disposed within the body lumen for sufficient time for it to be endothelialized within the body lumen and thereby secured to the wall portion.  
     
     
         32 . The method of  claim 30  wherein the step of heating the occluding member comprises bathing the occluding member with fluid at a temperature at or above the transition temperature.  
     
     
         33 . The method of  claim 30  wherein the occluded member is heated by one means of the group consisting of inductive heating, RF heating, laser application and ultrasound.  
     
     
         34 . The method of  claim 28  wherein the occluding member has a proximal end and a distal end, further comprising the step of collapsing the occluding member so that the proximal end has a relatively larger diameter than the distal end to facilitate the insertion of a catheter into the lumen of the occluding member.  
     
     
         35 . A kit for performing a reversible sterilization procedure comprising: 
 a) a catheter having an inflatable member; and    b) an occluding member comprising a tubular metallic framework which has a closed, minimal-diameter configuration and is formed from a shape-memory material having a transition temperature above body temperature, so that the occluding member may be expanded to an open, relatively large diameter configuration, and then heated to or above the transition temperature to cause the occluding member to revert to the closed, small diameter configuration within a desired body-lumen.    
     
     
         36 . The kit of  claim 35  further comprising a plug configured to be positioned within the occluding member prior to activation of the occluding member.  
     
     
         37 . The kit of  claim 35  wherein the plug is radioactive.  
     
     
         38 . The kit of  claim 35  wherein the plug is provided with one or more depressions or grooves to minimize damage to tissue lining the reproductive tract.  
     
     
         39 . The kit of  claim 35  wherein the plug is formed of material which produces an inflamatory response within the reproductive tract.  
     
     
         40 . The kit of  claim 39  wherein the plug is formed at least in part of copper or a copper alloy.  
     
     
         41 . The kit of  claim 37  wherein the plug has incorporated therein or coated thereon a drug or other therapeutic agent which infuses out of the plug into the reproductive tract.  
     
     
         42 . The kit of  claim 41  wherein thetherapeutic agent is a growth hormone to promote endothelial cell growth.  
     
     
         43 . The kit of  claim 36  wherein the plug is formed of polymer material selected from the group consisting of fluoropolymers, high density polyethylene and silicone rubber.