Contraceptive transcervical fallopian tube occlusion devices and their delivery

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 imposing a secondary shape on a resilient structure, 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. The resilient structure is then restrained by the walls of the fallopian tube, imposing anchoring forces as it tries to resume the secondary shape.

1 . A method for sterilizing a female patient using an elongated instrument assembly having a distal end, said method comprising: 
 inserting the distal end of the elongated instrument assembly transcervically into the female patient, the distal end of the elongated instrument having a detachable body which includes a non-biodegradable material;    applying energy from the elongated instrument to a surrounding tissue of a fallopian tube of said female patient;    detaching the detachable body from the distal end of the elongated instrument assembly; and    removing a remaining portion of the elongated instrument assembly from the female patient, wherein a scar formation in a region of the surrounding tissue permanently attaches to the detachable body.    
   
   
       2 . The method of  claim 1  wherein the energy comprises electrical energy and wherein the scar formation encapsulates the detachable body.  
   
   
       3 . A method as in  claim 1  wherein said detachable body is resilient and imposes an anchoring force against said surrounding tissue and wherein said detachable body is radially compressed within the elongated instrument assembly before the inserting.  
   
   
       4 . A method as in  claim 1  wherein said elongated instrument assembly comprises a conductive interface which is coupled to a surface assembly which is coupled to said elongated instrument assembly.  
   
   
       5 . A method as in  claim 1  wherein said elongated instrument assembly comprises an elongate body and a shaft which is disposed within said elongate body.  
   
   
       6 . A method as in  claim 1  wherein said applying precedes said detaching of said detachable body.  
   
   
       7 . A method as in  claim 1  wherein said detachable body has a first configuration prior to said detaching and a second configuration after said detaching.  
   
   
       8 . A method as in  claim 7  wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.  
   
   
       9 . A method as in  claim 1  wherein said detachable body comprises a polymer material.  
   
   
       10 . A method comprising: 
 inserting a catheter having an electrically conductive surface assembly mounted on a distal end of the catheter through the vagina and the cervical canal of a patient and into the uterus of the patient;    advancing a detachable assembly, which is coupled to the catheter, into a fallopian tube of the patient, said detachable assembly including a non-biodegradable material;    applying electrical energy to the electrically conductive surface assembly;    detaching the catheter from the detachable assembly, wherein a permanent scar formation in the fallopian tube encapsulates the detachable assembly.    
   
   
       11 . A method as in  claim 10  wherein said detachable assembly is resilient and imposes an anchoring force against the fallopian tube and wherein said detachable assembly is radially compressed within the catheter before the inserting.  
   
   
       12 . A method as in  claim 10  wherein said catheter comprises a conductive interface which is coupled to said electrically conductive surface assembly.  
   
   
       13 . A method as in  claim 10  wherein said catheter comprises an elongate body and a shaft which is disposed within said elongate body.  
   
   
       14 . A method as in  claim 10  wherein said applying precedes said detaching of said detachable assembly.  
   
   
       15 . A method as in  claim 10  wherein said detachable assembly has a first configuration prior to said detaching and a second configuration after said detaching.  
   
   
       16 . A method as in  claim 15  wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.  
   
   
       17 . A method as in  claim 10  wherein said detachable assembly comprises a polymer material.  
   
   
       18 . A method as in  claim 13  wherein said catheter further comprises a lumen through which said shaft is slidable.  
   
   
       19 . A method as in  claim 10  wherein said applying said electrical energy is through a shaft within a lumen of said catheter.  
   
   
       20 . An intrafallopian delivery system for transcervical introduction of a device, the delivery system comprising: 
 a first portion having an elongate body and a shaft for delivering energy;    a second portion detachably coupled to said elongate body, said second portion including a non-biodegradable material and being sized to fit within a fallopian tube and being detachable from said elongate body to remain permanently within said fallopian tube and wherein said energy causes a scar formation, in said fallopian tube, which attaches to said second portion.    
   
   
       21 . A delivery system as in  claim 20  wherein said energy comprises electrical energy and wherein said shaft delivers electrical current.  
   
   
       22 . A delivery system as in  claim 20  wherein said second portion is resilient and imposes an anchoring force against said fallopian tube and wherein said second portion is radially compressed within the elongate body before the elongate body is transcervically introduced.  
   
   
       23 . A delivery system as in  claim 20  wherein said shaft is disposed within a lumen of said elongate body.  
   
   
       24 . A delivery system as in  claim 20  wherein said energy is delivered before said second portion is detached from said elongate body.  
   
   
       25 . A delivery system as in  claim 20  wherein said second portion has a first configuration prior to being detached and a second configuration after being detached.  
   
   
       26 . A delivery system as in  claim 25  wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.  
   
   
       27 . A delivery system as in  claim 20  wherein said second portion comprises a polymer material.  
   
   
       28 . A delivery system as in  claim 20  further comprising an introducer through which said elongate body is inserted.  
   
   
       29 . A delivery system as in  claim 20  wherein said second portion has a surface which attaches to said scar formation.  
   
   
       30 . An intrafallopian catheter system for transcervical introduction of an intrafallopian device, said catheter system comprising: 
 an elongate body having a shaft for delivering electrical energy;    a detachable body which is detachably coupled to said elongate body, said detachable body including a non-biodegradable material and being sized to fit within a fallopian tube and being detachable from said elongate body to remain permanently within said fallopian tube and wherein said electrical energy causes a scar formation, in said fallopian tube, which encapsulates said detachable body.    
   
   
       31 . A catheter system as in  claim 30  wherein said detachable body is resilient and imposes an anchoring force against said fallopian tube and wherein said detachable body is radially compressed within the elongate body is transcervically introduced.  
   
   
       32 . A catheter system as in  claim 30  wherein said shaft is disposed within a lumen of said elongate body.  
   
   
       33 . A catheter system as in  claim 30  wherein said electrical energy is delivered before said detachable body is detached from said elongate body.  
   
   
       34 . A catheter system as in  claim 30  wherein said detachable body has a first configuration prior to being detached and a second configuration after being detached.  
   
   
       35 . A catheter system as in  claim 34  wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.  
   
   
       36 . A catheter system as in  claim 30  wherein said detachable body comprises a polymer material.  
   
   
       37 . A catheter system as in  claim 30  further comprising an introducer through which said elongate body is inserted.  
   
   
       38 . A catheter system as in  claim 30  wherein said detachable body has a surface which attaches to said scar formation.  
   
   
       39 . A method for sterilizing a female patient, said method comprising: 
 delivering a body transcervically into the female patient, said body including a non-biodegradable material;    delivering energy to a surrounding tissue of a fallopian tube of said female patient;    wherein a scar formation in a region of the surrounding tissue permanently attaches to the body.    
   
   
       40 . The method of  claim 39  wherein the energy comprises electrical energy and wherein the scar formation encapsulates said body.  
   
   
       41 . A method as in  claim 39  wherein said body is resilient and imposes an anchoring force against said surrounding tissue and wherein said body is radially compressed within a delivery device before delivering said body transcervically.  
   
   
       42 . A method as in  claim 39  wherein an elongated instrument assembly delivers said body and is detachably coupled to said body.  
   
   
       43 . A method as in  claim 39  wherein said body is not expelled from said fallopian tube.  
   
   
       44 . A method as in  claim 39  wherein said body comprises a polymer material.  
   
   
       45 . A method as in  claim 39  wherein said body has a first configuration prior to said delivering and a second configuration after said delivering.  
   
   
       46 . A method as in  claim 45  wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.  
   
   
       47 . A method as in  claim 39  wherein said body comprises an open outer wall which allows tissue ingrowth into said body.  
   
   
       48 . An intrafallopian delivery system for transcervical introduction of a device, the delivery system comprising: 
 a first portion having an elongate body;    a second portion detachably coupled to said elongate body, said second portion including a non-biodegradable material and being sized to fit within a fallopian tube in an area exposed to energy to damage tissue in said fallopian tube and being detachable from said elongate body to remain permanently within said fallopian tube and wherein said energy causes a scar formation, in said fallopian tube, which attaches to said second portion.    
   
   
       49 . A delivery system as in  claim 48  wherein said energy comprises electrical energy.  
   
   
       50 . A delivery system as in  claim 48  wherein said second portion is resilient and imposes an anchoring force against said fallopian tube and wherein said second portion is radially restrained within said elongated body before the elongate body is transcervically introduced.  
   
   
       51 . A delivery system as in  claim 48  wherein said energy is delivered before said second portion is detached from said elongate body.  
   
   
       52 . A delivery system as in  claim 48  wherein said second portion has a first configuration prior to being detached and a second configuration after being detached.  
   
   
       53 . A delivery system as in  claim 52  wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.  
   
   
       54 . A delivery system as in  claim 48  wherein said second portion comprises a polymer material.  
   
   
       55 . A method as in  claim 1  wherein the detachable body includes a metallic material comprising at least one of: copper alloy; copper; alloy of beryllium and copper; beryllium; zinc; stainless steel; platinum; Nitinol.  
   
   
       56 . A method as in  claim 10  wherein the detachable assembly includes a metallic material comprising at least one of: copper alloy; copper; alloy of beryllium and copper; beryllium; zinc; stainless steel; platinum; Nitinol.  
   
   
       57 . A delivery system as in  claim 20  wherein the second portion includes a metallic material comprising at least one of: copper alloy; copper; alloy of beryllium and copper; beryllium; zinc; stainless steel; platinum; Nitinol.  
   
   
       58 . A catheter system as in  claim 30  wherein the detachable body includes a metallic material comprising at least one of: copper alloy; copper; alloy of beryllium and copper; beryllium; zinc; stainless steel; platinum; Nitinol.  
   
   
       59 . A method as in  claim 39  wherein the body includes a metallic material comprising at least one of: copper alloy; copper; alloy of beryllium and copper; beryllium; zinc; stainless steel; platinum; Nitinol.  
   
   
       60 . A delivery system as in  claim 48  wherein the second portion includes a metallic material comprising at least one of: copper alloy; copper; alloy of beryllium and copper; beryllium; zinc; stainless steel; platinum; Nitinol.