Sterilization device and method

• US 8,231,619 B2
• Filed: 01/22/2010
• Issued: 07/31/2012
• Est. Priority Date: 01/22/2010
• Status: Expired due to Fees

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Callaghan, David, LaPlaca, Matthew, Model, Jeffrey, Putnam, Mark, Duronio, James
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US12/692,057
• Publication Number:
  US 20110180073A1
• Time in Patent Office: 921 Days
• Field of Search: 128/898, 606/28, 606 41- 50, 607/138
• US Class Current: 606/41
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Sterilization devices and methods for deploying porous implants within the fallopian tubes are disclosed. The devices include a catheter component including an external electrode sheath containing at least two deployable implants and a positioning member. Sliding the external sheath proximally disposes the implants within the fallopian tubes, while sliding both the positioning member and external electrode sheath distally reloads a second implant into the external electrode sheath. The devices further includes a handle component, which houses a chassis, external electrode sheath carrier, reciprocating shaft, positioning member carrier and first and second engaging members. The reciprocating shaft may be operated by a motor to slide distally and proximally along a long axis. The reciprocating shaft, external electrode sheath and its carrier, upon selective actuation, move together proportionally to deploy and reload the implants to facilitate occlusion of the fallopian tubes and complete sterilization.

Claims

1. A device configured for insertion into a fallopian tube, comprising:

a distal end and a proximal end having a handle thereon;

an external electrode sheath having a lumen sized for housing a first porous implant at the distal end and along a long axis thereof, the external electrode sheath configured to slide distally and proximally along its long axis relative to the handle and including at least one ring electrode disposed about its outer diameter for wounding an epithelial layer of a fallopian tube;

an internal sheath longitudinally disposed within the lumen of the external electrode sheath at its distal end and having a lumen sized for housing a second porous implant along the long axis thereof; and

a positioning member slideably disposed within the lumen of the internal sheath proximal to the first and second porous implants along the long axis, the positioning member configured to slide relative to the handle and toward the distal end of the catheter;

wherein sliding at least one of the external electrode sheath or the positioning member relative to one another disposes the first porous implant within a first fallopian tube and disposes the second porous implant within a second fallopian tube.

2. The device of claim 1, wherein the first and second implants at least one of (i) have pore sizes averaging approximately 40 to 200 microns and (ii) have an overall length between approximately 3 mm and approximately 5 mm.

3. The device of claim 1, wherein the first porous implant at least one of (i) is slid toward the distal end, at least partially, by the second porous implant sliding toward the distal end;

and (ii) is slid toward the distal end, at least partially, by the positioning member sliding toward the distal end.

4. The catheter of claim 1, wherein sliding the external electrode sheath toward the proximal end disposes the first porous implant within the first fallopian tube at a position where wounding via the at least one ring electrode occurred.

5. The device of claim 4, wherein simultaneously sliding the external electrode sheath and the positioning member toward the distal end of the catheter reshrouds the internal sheath and positions the second porous implant within the distal end of the external electrode sheath ready for deployment into a second fallopian tube at a position where wounding via the ring electrodes occurred.

6. The device of claim 1, further comprising at least one of (i) at least one pad electrode disposed about the outer surface of the external electrode sheath and (ii) at least one optical member disposed about the outer surface of the external electrode sheath.

7. The device of claim 1, wherein at least one of the first and second porous implants comprises an inner layer and an outer layer surrounding the inner layer.

8. The device of claim 7, wherein the outer layer is comprised, by volume, of approximately 100% Silicon, and the inner layer is comprised, by volume, of approximately 85% Silicon and approximately 15% Tantalum.

9. A catheter device configured for insertion into a fallopian tube, comprising:

a distal end and a proximal end having a handle thereon;

an external electrode sheath having a lumen sized for housing two porous implants at the distal end and along a long axis thereof and configured to slide distally and proximally along its long axis relative to the handle; and

a positioning member disposed within the lumen of the external electrode sheath proximal to the two porous implants along the long axis, the positioning member configured to slide relative to the handle;

wherein sliding the external electrode sheath toward the proximal end of the catheter disposes at least one of the two porous implants within a fallopian tube.

10. The catheter of claim 9, wherein the external electrode sheath further comprises ring electrodes disposed about its outer diameter for wounding an epithelial layer of a first fallopian tube, wherein a first porous implant is disposed within a first fallopian tube at the position where wounding of the epithelial layer of the first fallopian tube via the ring electrodes occurred.

11. The catheter of claim 9, wherein the handle further comprises:

a chassis cradled within the handle;

an external electrode sheath carrier seated within the chassis and defining a long axis, wherein a distal end of the external electrode sheath carrier is coupled to the external electrode sheath, wherein the external electrode sheath extends from the distal end of the handle;

a reciprocating shaft coupled to the external electrode sheath carrier at its proximal end and adapted to move the external electrode sheath carrier proximally and distally relative to the handle;

an internal sheath mounted to the chassis and disposed within a lumen of the external electrode sheath;

a positioning member carrier disposed within the external electrode sheath carrier and slideable along the long axis of the external electrode sheath carrier, wherein the positioning member carrier is coupled to the positioning member, and wherein the positioning member is disposed within a lumen of the internal sheath;

a first engaging member coupled to the external electrode sheath carrier and defining at least one arm adapted to releaseably engage the positioning member carrier to enable or prevent movement of the positioning member carrier relative to the external electrode sheath carrier; and

a second engaging member coupled to the push rod carrier and defining at least one arm adapted to releaseably engage the chassis to enable or prevent movement of the positioning member carrier relative to the external electrode sheath carrier;

wherein the reciprocating shaft drives the external electrode sheath carrier proximally and distally relative to the chassis to deploy the implants and selectively actuate the positioning member carrier via engagement with one or both of the engaging members.

12. The catheter of claim 9, wherein the external electrode is configured to slide within a range of about 5 mm and 25 mm.

13. The catheter of claim 9, wherein the positioning member is positioning member is configured to slide within a range of about 2 mm to 10 mm.

14. A method for occluding two fallopian tubes using a single catheter containing two porous implants, comprising:

inserting a catheter into a first fallopian tube, wherein the catheter comprises;

a distal end and a proximal end having a handle thereon;

an external electrode sheath having a lumen sized for housing two porous implants at the distal end and along a long axis thereof, the external electrode sheath having ring electrodes disposed about its outer diameter for wounding an epithelial layer of a fallopian tube; and

a positioning member disposed within the lumen of the external electrode sheath proximal to the two porous implants along the long axis, the positioning member configured to slide relative to the handle;

wounding an epithelial layer of a first fallopian tube using the ring electrodes on the external electrode sheath;

sliding the external electrode sheath toward the proximal end of the catheter to dispose a first porous implant within a first fallopian tube where wounding occurred;

removing the catheter from the first fallopian tube and inserting the catheter into a second fallopian tube;

wounding an epithelial layer of a second fallopian tube using the ring electrodes on the external electrode sheath; and

sliding the external electrode sheath toward the proximal end of the catheter to dispose a second porous implant within a second fallopian tube where wounding occurred.

15. The method of claim 14, wherein the catheter further comprises an internal sheath longitudinally disposed within the lumen of the external electrode sheath and having a lumen sized for housing the second porous implant along the long axis thereof;

wherein simultaneously sliding the external electrode sheath and the positioning member toward the distal end of the catheter reshrouds the internal sheath after deployment of the first porous implant to position the second porous implant at the distal end of the catheter within the external electrode sheath.

16. The method of claim 15, wherein sliding the positioning member pushes at least one of the two porous implants out of the internal sheath.

17. The method of claim 14, further comprising sliding the positioning member pushes at least one of the two porous implants toward the distal end of the catheter.

18. The method of claim 14, further comprising sliding the external electrode sheath toward the proximal end of the catheter to dispose the second porous implant within the second fallopian tube while the positioning member is stationary.

19. The method of claim 14, further comprising sliding the positioning member distally to position the second porous implant for deployment within the second fallopian tube.