Medical devices and methods of making and using such devices

Abstract

Devices, such as medical devices for inhibiting conception, and methods of using and/or making these devices. In one aspect of the disclosure, a medical device has a delivery system and a first insert, which is removably coupled to the delivery system and which is designed to be deployed within a portion of a first fallopian tube, and a second insert, which is removably coupled to the delivery system and which is designed to be deployed within a portion of a second fallopian tube. Other aspects of the disclosure include, among other things, inserts made from one or more polymers; inserts which are designed to pierce and remain in place; and inserts which are implanted through a fluid delivery system.

1 . A device for inhibiting conception in a patient having a fallopian tube, the device comprising:
 a delivery system;   a structure having a piercing end designed to pierce a portion of the fallopian tube and remain attached to the portion, said structure being detachably coupled to the delivery system and being in a first configuration prior to piercing said portion and forming a second configuration after said piercing;   at least one agent attached to the structure, the agent designed to cause a tissue growth into the fallopian tube.   
     
     
         2 . A device in  claim 1  wherein said structure comprises a shape memory material and has a first shape which is substantially linear and which defines said first configuration and a second shape which is a memorized shape provided by said shape memory material and which defines said second configuration. 
     
     
         3 . A device as in  claim 1  wherein said structure pierces said portion and bends proximally away from said portion in said second configuration. 
     
     
         4 . A device as in  claim 1  wherein said agent comprises polyester fibers. 
     
     
         5 . A device as in  claim 1  wherein said structure pierces said portion and bends distally away from said portion in said second configuration. 
     
     
         6 . A device as in  claim 1  wherein said structure at least partially encircles tissue in a region near said portion. 
     
     
         7 . A device as in  claim 1  wherein said structure has a length of about 1 mm to about 3 mm along a longitudinal axis in said first configuration. 
     
     
         8 . A device as in  claim 7  wherein said agent comprises polyester fibers. 
     
     
         9 . A device as in  claim 1  wherein said delivery catheter comprises:
 an outer sheath;   a tube coaxially disposed within a lumen of said outer sheath;   a push plunger coaxially disposed and slidable within a lumen of said tube, said push plunger capable of pushing said structure out of said delivery catheter.   
     
     
         10 . A device as in  claim 9  wherein said push plunger has a cavity at a distal end, said cavity being sized to receive said agent. 
     
     
         11 . A device as in  claim 1  wherein said structure is a surgical staple. 
     
     
         12 . A method for inhibiting conception in a patient having a fallopian tube, said method comprising:
 introducing a delivery system transcervically into an ostium of a fallopian tube, said delivery system having a structure which has a piercing end designed to pierce a portion of the fallopian tube and remain attached to the portion, said structure being removably coupled to said delivery system and being in a first configuration prior to piercing said portion and forming a second configuration after said piercing, said structure having an agent attached to the structure, said agent designed to cause a tissue growth into said fallopian tube;   expelling said structure from said delivery system, wherein said structure pierces said portion and bends into tissue in said fallopian tube.   
     
     
         13 . A method as in  claim 12  wherein said structure comprises a shape memory material and has a first shape which is substantially linear and a second shape which is a memorized shape provided by said shape memory material and which defines said second configuration. 
     
     
         14 . A method as in  claim 13  wherein said structure pierces said portion and bends proximally away from said portion in said second configuration. 
     
     
         15 . A method as in  claim 13  wherein said structure pierces said portion and bends distally away from said portion in said second configuration. 
     
     
         16 . A method as in  claim 12  wherein said structure at least partially encircles tissue in a region near said portion. 
     
     
         17 . A method for producing an insert for inhibiting conception in a patient having at least one fallopian tube, the method comprising:
 forming an insert which comprises a non-biodegradable polymer and which is designed to be implanted into a fallopian tube, said polymer providing a surface for contacting a wall of said fallopian tube;   inserting said insert into a delivery system.   
     
     
         18 . A method as in  claim 17  wherein said forming comprises molding said polymer in a mold and wherein said insert is substantially comprised of said non-biodegradable polymer. 
     
     
         19 . A method as in  claim 17  wherein said forming comprises extruding said polymer through a die. 
     
     
         20 . A method as in  claim 17  further comprising:
 sterilizing said insert and said delivery system; and   sealing said insert and said delivery system in a kit package.   
     
     
         21 . A method as in  claim 17  wherein said forming comprises insert molding said polymer with a resilient, expandable metal and with an agent which is designed to cause a tissue growth into said fallopian tube. 
     
     
         22 . A method as in  claim 17  wherein said forming comprises:
 forming a first component;   forming a second component;   combining said first and second components to create said insert.   
     
     
         23 . A method as in  claim 21  wherein said agent comprises a polymer. 
     
     
         24 . A method as in  claim 17  wherein said polymer comprises at least one of: a polyurethane; a silicone urethane copolymer; a polyester; a polyethylene; a polycarbonate; a silicone; polypropylene, ABS, acrylic, nylon, Pebax, FEP, PVP, or a ePTFE. 
     
     
         25 . A method as in  claim 17  wherein said insert comprises an agent which is designed to cause a tissue growth into said fallopian tube. 
     
     
         26 . A method as in  claim 17  wherein said forming comprises:
 placing a portion of a resilient, expandable material into a mold;   injecting said polymer into said mold, said polymer bonding to said resilient, expandable material.   
     
     
         27 . A device for inhibiting conception in a patient having a fallopian tube, said device comprising:
 an insert which comprises a non-biodegradable polymer and which is designed to be implanted into a fallopian tube;   a delivery system removably coupled to said insert.   
     
     
         28 . A device as in  claim 27  wherein said polymer is molded in a mold of said insert and wherein said insert is substantially comprised of said polymer and said insert is pre-formed prior to being coupled to the delivery system. 
     
     
         29 . A device as in  claim 27  wherein said polymer is extruded through a die to create at least a portion of said insert. 
     
     
         30 . A device as in  claim 27  wherein said insert further comprises a resilient, expandable metal which is bound to said polymer. 
     
     
         31 . A device as in  claim 27  wherein said insert further comprises an agent which is designed to cause a tissue growth into said fallopian tube. 
     
     
         32 . A device as in  claim 27  wherein said polymer comprises at least one of: a polyurethane; a silicone urethane copolymer; a polyester; a polyethylene; a polycarbonate; a silicone; polypropylene, ABS, acrylic, nylon, Pebax, FEP, PVP or a ePTFE. 
     
     
         33 . A device as in  claim 27  wherein said insert further comprises a resilient, expandable metal which is bound to said polymer and an agent which is designed to cause a tissue growth into said fallopian tube. 
     
     
         34 . A device for inhibiting conception in a patient having a fallopian tube, the device comprising:
 a delivery system;   a lumen coupled to said delivery system;   an insert removably disposed in said lumen, said insert being sized to be deployed in a fallopian tube;   a fluid input port coupled to said lumen, said fluid input port being designed to receive a fluid to expel said insert through an outlet of said lumen.   
     
     
         35 . A device as in  claim 34  wherein said insert comprises a distal end, a proximal end, and a connector which is coupled to said distal end and to said proximal end and wherein said connector prevents axial compression between said distal end and said proximal end. 
     
     
         36 . A device as in  claim 35  further comprising a plurality of fibers disposed between said distal end and said proximal end. 
     
     
         37 . A device as in  claim 35  wherein at least one of said proximal end and said distal end comprises an expandable anchor having a shape memory material and wherein said expandable anchor expands after being expelled through said outlet. 
     
     
         38 . A device as in  claim 35  wherein at least one of said proximal end and said distal end comprises an imaging marker. 
     
     
         39 . A device as in  claim 37  wherein said insert comprises an agent which is designed to cause a tissue growth into said fallopian tube. 
     
     
         40 . A device as in  claim 39  wherein said fluid is one of a gas or a liquid. 
     
     
         41 . A device as in  claim 39  wherein said fluid is a buffered saline solution. 
     
     
         42 . A device as in  claim 35  wherein said proximal end is pushed by said fluid. 
     
     
         43 . A device as in  claim 35  further comprising:
 one of a syringe or a pump coupled to said fluid input port.   
     
     
         44 . A method of delivering an insert into a fallopian tube of a patient, said method comprising:
 positioning a delivery system near a fallopian tube, said delivery system having a lumen disposed in said delivery system and having an insert moveably disposed in said lumen, said insert being sized to be deployed in said fallopian tube;   introducing a fluid into a fluid input port which is coupled to said lumen, said fluid causing said insert to be expelled from an outlet of said lumen.   
     
     
         45 . A method as in  claim 44  wherein said insert is expelled into a portion of said fallopian tube. 
     
     
         46 . A method as in  claim 44  wherein said insert comprises a distal end, a proximal end and a connector which is coupled to said distal end and to said proximal end and wherein said connector prevents axial compression between said distal end and said proximal end. 
     
     
         47 . A method as in  claim 46  further comprising a plurality of fibers disposed between said distal end and said proximal end. 
     
     
         48 . A method as in  claim 46  wherein at least one of said proximal end and said distal end comprises an expandable anchor having a shape memory material and wherein said expandable anchor expands after being expelled through said outlet. 
     
     
         49 . A method as in  claim 46  further comprising:
 viewing an imaging marker disposed on at least one of said proximal end and said distal end.   
     
     
         50 . A method as in  claim 48  wherein said insert comprises an agent which is designed to cause a tissue growth into said fallopian tube. 
     
     
         51 . A method as in  claim 50  wherein said fluid is one of a gas or a liquid. 
     
     
         52 . A method as in  claim 50  wherein said fluid is a buffered saline solution. 
     
     
         53 . A method as in  claim 46  wherein said proximal end is pushed by said fluid.