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 device for implantation within a body lumen of a human or veterinary subject, said device comprising: 
 an intraluminal member that is implantable in a body lumen to cause occlusion of the body lumen; and    a quantity of a therapeutic substance disposed on, in or near the intraluminal member such that the substance will be delivered to some target tissue for at least some period of time following implantation of the intraluminal member within the body lumen.    
     
     
         2 . A device according to  claim 1  wherein the device is implanted in a fallopian tube or other lumen of the female reproductive tract and is effective to occlude that lumen following implantation.  
     
     
         3 . A device according to  claim 2  wherein the therapeutic substance delivered by the device comprises a contraceptive.  
     
     
         4 . A device according to  claim 2  wherein the therapeutic substance delivered by the device comprises a spermicidal agent.  
     
     
         5 . A device according to  claim 1  where the substance is gradually released over time.  
     
     
         6 . A contraceptive delivery system for delivery of an occluding apparatus into the lumen of a fallopian tube of a human or animal subject, said system comprising: 
 an occluding apparatus sized for placement in a fallopian tube of the subject;    delivery cannula that is insertable through the uterus and into the fallopian tube into which the occluding apparatus is to be placed, said delivery cannula being useable to deliver said occluding apparatus into the fallopian tube, said delivery cannula having at least one length marking which may be utilized to discern the length of the delivery cannula that has been advanced into the fallopian tube; and,    an imaging apparatus useable to view the delivery cannula and said at least one length marking to determine the length of the delivery cannula that has been advanced into the fallopian tube.    
     
     
         7 . A contraceptive delivery system as in  claim 6  wherein the at least one marking comprises a colored area on said delivery cannula.  
     
     
         8 . A contraceptive delivery system as in  claim 6  wherein the imaging apparatus comprises a scope.  
     
     
         9 . A contraceptive delivery system as in  claim 8  wherein the scope comprises a hysteroscope.  
     
     
         10 . A contraceptive delivery system as in  claim 6  wherein the imaging apparatus comprises an ultrasound imaging apparatus.  
     
     
         11 . A contraceptive delivery system as in  claim 6  wherein the imaging apparatus comprises a fluoroscope.  
     
     
         12 . A system for causing contraception in a human or animal subject, said system comprising: 
 an expandable occluding member which is implantable in a reproductive passageway of the subject, said occluding member being a) disposable in a first configuration wherein it is sufficiently compact to allow the occluding member to be advanced into the reproductive passageway and b) subsequently expandable to a second configuration wherein the occluding member engages a wall of the reproductive passageway; and,    a quantity of a contraceptive substance which is delivered from the occluding member in sufficient amount to cause a pharmacologic contraceptive effect in the patient for a period of time following implantation of the occluding member within the reproductive passageway.    
     
     
         13 . A system according to  claim 12  wherein the occluding member is sized and configured to be implanted within the lumen of a fallopian tube.  
     
     
         14 . A system according to  claim 12  wherein the occluding member comprises an expandable frame and a matrix disposed substantially within or on the frame.  
     
     
         15 . A system according to  claim 12  where the substance is gradually released over time.  
     
     
         16 . A system according to  claim 14  wherein said matrix comprises pores and wherein said substance is initially contained within said pores.  
     
     
         17 . A system according to  claim 12  wherein the occluding member causes a reversible occlusion of the reproductive passageway.  
     
     
         18 . A system according to  claim 12  wherein the occluding member provokes an inflammatory response which augments occlusion of the lumen of the reproductive passageway.  
     
     
         19 . A system according to  claim 12  wherein the occluding member further comprises means for securing the occluding member to the wall of the reproductive passageway.  
     
     
         20 . A system according to  claim 19  wherein the means for securing the occluding member to the wall of the reproductive passageway comprises a mechanical securing apparatus.  
     
     
         21 . A system according to  claim 12  wherein the expandable occluding member facilitates tissue or cellular ingrowth into the occluding member.  
     
     
         22 . A method for preventing pregnancy in a human or animal subject having a fallopian tube, said method comprising the steps of: 
 providing a device that i) is implantable in the fallopian tube to cause occlusion of the fallopian tube and ii) delivers a contraceptive or spermicidal substance in an amount that is effective to cause contraception or spermicide for at least a period of time following implantation of the device; and    implanting the device within a fallopian tube.    
     
     
         23 . A method according to  claim 22  wherein the device comprises an expandable frame and a matrix disposed substantially within or on the frame.  
     
     
         24 . A method according to  claim 23  wherein the matrix facilitates tissue ingrowth.  
     
     
         25 . A method according to  claim 23  wherein the substance is initially disposed on or in the matrix.  
     
     
         26 . A device for implantation within a body lumen of a human or veterinary subject, said device comprising: 
 an intraluminal member that is implantable in a body lumen to cause occlusion of the body lumen, wherein the intraluminal member is configured to facilitate tissue or cellular ingrowth into the intraluminal member; and    a quantity of a therapeutic substance disposed on, in or near the intraluminal member such that the substance will be delivered to some target tissue for at least some period of time following implantation of the intraluminal member within the body lumen.    
     
     
         27 . A device according to  claim 26  wherein the device is implantable in a body lumen comprising a fallopian tube or other lumen of the female reproductive tract and is effective to occlude that lumen following implantation.  
     
     
         28 . A device according to  claim 27  wherein the therapeutic substance delivered by the device comprises a contraceptive.  
     
     
         29 . A device according to  claim 27  wherein the therapeutic substance delivered by the device comprises a spermicidal agent.  
     
     
         30 . A device according to  claim 26  where the substance is gradually released over time.  
     
     
         31 . A contraceptive delivery system for delivery of an occluding apparatus into the lumen of a fallopian tube of a human or animal subject, said system comprising: 
 an occluding apparatus sized for placement in a fallopian tube of the subject and configured to facilitate tissue or cellular ingrowth into the occluding apparatus;    delivery cannula that is insertable through the uterus and into the fallopian tube into which the occluding apparatus is to be placed, said delivery cannula being useable to deliver said occluding apparatus into the fallopian tube, said delivery cannula having at least one length marking which may be utilized to discern the length of the delivery cannula that has been advanced into the fallopian tube; and,    an imaging apparatus useable to view the delivery cannula and said at least one length marking to determine the length of the delivery cannula that has been advanced into the fallopian tube.    
     
     
         32 . A contraceptive delivery system as in  claim 31  wherein the at least one marking comprises a colored area on said delivery cannula.  
     
     
         33 . A contraceptive delivery system as in  claim 31  wherein the imaging apparatus comprises a scope.  
     
     
         34 . A contraceptive delivery system as in  claim 33  wherein the scope comprises a hysteroscope.  
     
     
         35 . A contraceptive delivery system as in  claim 31  wherein the imaging apparatus comprises an ultrasound imaging apparatus.  
     
     
         36 . A contraceptive delivery system as in  claim 31  wherein the imaging apparatus comprises a fluoroscope.  
     
     
         37 . A system for causing contraception in a human or animal subject, said system comprising: 
 an expandable occluding member which is configured to facilitate tissue or cellular ingrowth into the expandable occluding member and which is implantable in a reproductive passageway of the subject, said occluding member being a) disposable in a first configuration wherein it is sufficiently compact to allow the occluding member to be advanced into the reproductive passageway and b) subsequently expandable to a second configuration wherein the occluding member engages a wall of the reproductive passageway; and,    a quantity of a contraceptive substance which is delivered from the occluding member in sufficient amount to cause a pharmacologic contraceptive effect in the patient for a period of time following implantation of the occluding member within the reproductive passageway.    
     
     
         38 . A system according to  claim 37  wherein the occluding member is sized and configured to be implanted within the lumen of a fallopian tube.  
     
     
         39 . A system according to  claim 37  wherein the occluding member comprises an expandable frame and a matrix disposed substantially within or on the frame.  
     
     
         40 . A system according to  claim 37  where the substance is gradually released over time.  
     
     
         41 . A system according to  claim 39  wherein said matrix comprises pores and wherein said substance is initially contained within said pores.  
     
     
         42 . A system according to  claim 37  wherein the occluding member causes a reversible occlusion of the reproductive passageway.  
     
     
         43 . A system according to  claim 37  wherein the occluding member is configured to provoke an inflammatory response to augment occlusion of the lumen of the reproductive passageway.  
     
     
         44 . A system according to  claim 37  wherein the occluding member further comprises means for securing the occluding member to the wall of the reproductive passageway.  
     
     
         45 . A system according to  claim 44  wherein the means for securing the occluding member to the wall of the reproductive passageway comprises a mechanical securing apparatus.  
     
     
         46 . A system according to  claim 37  wherein the expandable occluding member facilitates tissue or cellular ingrowth into the occluding member.  
     
     
         47 . A method for preventing pregnancy in a human or animal subject having a fallopian tube, said method comprising the steps of: 
 providing a device that i) is implantable in the fallopian tube to cause occlusion of the fallopian tube, ii) facilitates tissue or cellular ingrowth into the device and iii) delivers a contraceptive or spermicidal substance in an amount that is effective to cause contraception or spermicide for at least a period of time following implantation of the device; and    implanting the device within a fallopian tube.    
     
     
         48 . A method according to  claim 47  wherein the device comprises an expandable frame and a matrix disposed substantially within or on the frame.  
     
     
         49 . A method according to  claim 48  wherein the matrix facilitates tissue ingrowth.  
     
     
         50 . A method according to  claim 48  wherein the substance is initially disposed on or in the matrix.