Contraceptive transcervical fallopian tube occlusion devices and methods

Abstract

The invention provides intrafallopian devices and non-surgical methods for their placement to prevent conception. The efficacy of the device is enhanced by forming the structure at least in part from copper or a copper alloy. The device is anchored within the fallopian tube by a lumen-traversing region of the resilient structure which has a helical outer surface, together with a portion of the resilient structure which is biased to form a bent secondary shape, the secondary shape having a larger cross-section than the fallopian tube. The resilient structure is restrained in a straight configuration and transcervically inserted within the fallopian tube, where it is released. Optionally, permanent sterilization is effected by passing a current through the resilient structure to the tubal walls.

1 . A contraceptive device, comprising a tubular body in a first radially restrained configuration having a first outer diameter, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger outer diameter than the first configuration to engage a wall of said lumen, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.  
     
     
         2 . The contraceptive device of  claim 1  wherein the tubular body is formed of a helical wire.  
     
     
         3 . The contraceptive device of  claim 1  wherein the tubular body is formed of a helical coil.  
     
     
         4 . The contraceptive device of  claim 1  wherein the tubular body has an open proximal end and an open distal end.  
     
     
         5 . The contraceptive device of  claim 1  wherein the tubular body is enlarged at least partially by self-enlarging.  
     
     
         6 . The contraceptive device of  claim 1  wherein the tubular body is formed at least in part of a nickel-titanium alloy.  
     
     
         7 . The contraceptive device of  claim 1  wherein the tubular body in the second configuration is restrained by the patient's reproductive lumen, whereby the tubular body substantially conforms to inner transverse dimensions of the patient's reproductive lumen at an expansion site therein.  
     
     
         8 . The contraceptive device of  claim 1  wherein the tubular body is configured at least in part to retain the second configuration for sufficient time for tissue to grow into and around at least a portion of the tubular body.  
     
     
         9 . The contraceptive device of  claim 1  wherein the tubular body is configured to be restrained by the patient's reproductive lumen in the second configuration and thereby substantially conform to the inner transverse dimensions of the patient's reproductive lumen and to at least in part retain substantially the second configuration for sufficient time for tissue to grow into and around at least a portion of the tubular body.  
     
     
         10 . The contraceptive device of  claim 1  wherein the enlarging of the tubular body to the second configuration secures at least a portion of the tubular body at an expansion site within the patient's reproductive lumen.  
     
     
         11 . The contraceptive device of  claim 1  wherein at least part of the tubular body is configured to be retained in the second configuration.  
     
     
         12 . The contraceptive device of  claim 1  wherein tissue growth facilitates substantial occlusion of the patient's reproductive lumen.  
     
     
         13 . The contraceptive device of  claim 1  wherein the member at least partially within the tubular body promotes tissue growth and is substantially formed of copper.  
     
     
         14 . The contraceptive device of  claim 1  wherein contraception is aided by a contraceptive agent.  
     
     
         15 . The contraceptive device of  claim 14  wherein the contraceptive agent is copper.  
     
     
         16 . A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body in a first radially restrained configuration having a first outer diameter, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger outer diameter than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body from the first radially restrained configuration having the first outer diameter to the second configuration having the second, larger outer diameter which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.  
     
     
         17 . The method of  claim 16  wherein the step of inserting at least a portion of the contraceptive device within the patient's reproductive lumen further comprises using a catheter to introduce at least the portion of the contraceptive device into the patient's reproductive lumen.  
     
     
         18 . The method of  claim 16  wherein the tubular body is formed of a helical wire.  
     
     
         19 . The method of  claim 16  wherein the tubular body is formed of a helical coil.  
     
     
         20 . The method of  claim 16  wherein the tubular body has an open proximal end and an open distal end.  
     
     
         21 . The method of  claim 16  wherein the tubular body is enlarged at least partially by self-enlarging.  
     
     
         22 . The method of  claim 16  wherein the tubular body is formed at least in part of a nickel-titanium alloy.  
     
     
         23 . The method of  claim 16  wherein the tubular body is configured at least in part to retain the second configuration for sufficient time for tissue to grow into and around at least a portion of the tubular body.  
     
     
         24 . The method of  claim 16  wherein the enlarging of the tubular body to the second configuration secures at least a portion of the tubular body at an expansion site within the patient's reproductive lumen.  
     
     
         25 . The method of  claim 16  wherein at least part of the tubular body is configured to be retained in the second configuration.  
     
     
         26 . The method of  claim 16  wherein tissue growth facilitates substantial occlusion of the patient's reproductive lumen.  
     
     
         27 . The method of  claim 16  wherein the member at least partially within the tubular body promotes tissue growth and is substantially formed of copper.  
     
     
         28 . The method of  claim 16  wherein contraception is aided by a contraceptive agent.  
     
     
         29 . The method of  claim 28  wherein the contraceptive agent is copper.  
     
     
         30 . A contraceptive device, comprising a tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from a first configuration to a second configuration having larger transverse dimensions than the first configuration to engage a wall of said lumen, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.  
     
     
         31 . A contraceptive device, comprising a tubular body in a first radially restrained configuration having a first cross-section, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger cross-section than the first configuration to engage a wall of said lumen, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.  
     
     
         32 . A contraceptive device, comprising a tubular body in a first radially restrained configuration having a longitudinal axis, said tubular body at least in part configured to enlarge in a direction transverse to the longitudinal axis within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having larger transverse dimensions than the first configuration, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.  
     
     
         33 . A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from a first configuration to a second configuration having larger transverse dimensions than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body from the first configuration to the second configuration having larger transverse dimensions than the first configuration which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.  
     
     
         34 . A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body in a first radially restrained configuration having a first cross-section, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger cross-section than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body from the first radially restrained configuration having the first cross-section to the second configuration having the second, larger cross-section which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.  
     
     
         35 . A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body in a first radially restrained configuration having a longitudinal axis, said tubular body at least in part configured to enlarge in a direction transverse to the longitudinal axis within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having larger transverse dimensions than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body in a direction transverse to the longitudinal axis from the first radially restrained configuration to a second configuration having larger transverse dimensions than the first configuration which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.