Minimally invasive surgical stabilization devices and methods

• US 7,918,863 B2
• Filed: 06/24/2005
• Issued: 04/05/2011
• Est. Priority Date: 06/24/2005
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Stout, Christopher A., Nguyen, Mimi, Bailey, Philip Albert, Aldridge, Elisa Janine, Aguilar, Rosendo, Swann, Betsy
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): Patel; Tarla R
• Application Number:
  US11/165,733
• Publication Number:
  US 20060293560A1
• Time in Patent Office: 2,111 Days
• Field of Search: 128830-831, 128/840, 424/422, 600101-183, 604/70, 604/95.1, 604/158, 604/161, 604/163, 604/164.01, 604/167.03, 604/171, 604/523, 604/164.07, 604/164.08, 604/164.09, 604/164.11, 604/164.05, 604/165.01, 604/264, 604538-539, 604/164.02, 604/515, 604/517, 604/164.1, 606/28, 606/108, 606/46, 606/135, 606/151
• US Class Current: 606/135
• CPC Class Codes: A61B 1/0014 Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/0034 adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61F 6/06 for use by females A61F6/20 takes precedence
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
• CPC Class Codes: A61F 6/225 transcervical
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10

Abstract

The various embodiments of the present inventions provide stabilization devices and methods for use of the stabilization devices with minimally invasive gynecological procedures such as methods of preventing pregnancy by inserting intrafallopian contraceptive devices into the fallopian tubes.

Claims

1. A medical stabilization device, comprising:

a sleeve having a lumen diameter extending longitudinally through the sleeve; and

a duckbill valve and an O-ring at a proximal end of the sleeve to couple the stabilization device to a device for an intrafallopian contraceptive procedure, the duckbill valve extending into the lumen diameter of the sleeve;

wherein the lumen diameter is configured to fit around a catheter that extends from the device for an intrafallopian contraceptive procedure;

wherein a distal end of the sleeve is insertable into an endoscope; and

wherein the medical stabilization device is configured to be coupled to the endoscope to maintain a fixed longitudinal distance between a control device of the device for an intrafallopian contraceptive procedure and the endoscope.

2. The medical stabilization device of claim 1, wherein the device for the intrafallopian contraceptive procedure comprises an intrafallopian contraceptive delivery device.

3. The medical stabilization device of claim 2, wherein the intrafallopian contraceptive device promotes tissue ingrowth around the intrafallopian contraceptive device.

4. The medical stabilization device of claim 1, wherein the O-ring and duckbill valve couple the medical stabilization device to the control device.

5. The medical stabilization device of claim 1, wherein the endoscope comprises a device that provides a transcervical pathway.

6. The medical stabilization device of claim 5, wherein the device that provides a transcervical pathway comprises a hysteroscope.

7. The medical stabilization device of claim 6, wherein the medical stabilization device is configured to be inserted into a distention valve of the hysteroscope.

8. The medical stabilization device of claim 6, wherein the medical stabilization device is permanently coupled to the hysteroscope.

9. The medical stabilization device of claim 6, wherein the medical stabilization device further comprises a distention valve, the distention valve is configured to fit onto a working channel of the hysteroscope.

10. The medical stabilization device of claim 1, wherein the medical stabilization device comprises an arm.

11. A kit, comprising:

an intrafallopian contraceptive delivery device comprising a control device, a catheter extending from the control device, and an intrafallopian device coupled to the catheter;

a stabilization device comprising a sleeve having a lumen extending between a first end and a second end of the stabilization device, the first end of the stabilization device comprising a means for coupling the stabilization device to the intrafallopian contraceptive delivery system; and

a hysteroscope comprising a means for coupling the stabilization device to the hysteroscope;

wherein the second end of the stabilization device is insertable into the hysteroscope past the means for coupling the stabilization device to the hysteroscope to maintain a fixed longitudinal distance between the control device and the hysteroscope.

12. The kit of claim 11, wherein the stabilization device is a sleeve, wherein the first end comprises a connector adapted to lock onto the control device of the medical device and the second end is adapted to lock into the hysteroscope.

13. The kit of claim 12, wherein the sleeve further comprises a port for the insertion of a catheter to deliver a topical anesthetic and a syringe loaded with a topical anesthetic.

14. The kit of claim 11, further comprising a syringe comprising a first barrel and a second barrel, wherein the first barrel is loaded with a topical anesthetic and the second barrel is loaded with a carrier, and a static mixer adapted to be coupled to a syringe.

15. A kit, comprising:

a stabilization device comprising a sleeve having a lumen extending between a proximal end and a distal end of the stabilization device; and

a hysteroscope comprising a means for coupling the stabilization device to the hysteroscope;

wherein the proximal end of the stabilization device comprises a means for coupling the stabilization device to a medical device for a minimally invasive gynecological procedure, and wherein the distal end of the stabilization device is insertable into the hysteroscope past the means for coupling the stabilization device to the hysteroscope to maintain a fixed longitudinal distance between a control device of the medical device and the hysteroscope.

16. The kit of claim 15, further comprising a syringe pre-loaded with a topical anesthetic.

17. The kit of claim 15, further comprising a syringe pre-loaded with a contrast media comprising a gel having microbubbles.

18. A method, comprising:

inserting a distal end of a stabilization device inside a hysteroscope, the stabilization device comprising a sleeve and a lumen;

coupling the stabilization device to the hysteroscope;

inserting a catheter into a proximal end of the stabilization device and through the lumen, the catheter extending from a device for an intrafallopian contraceptive procedure;

coupling the stabilization device to the device for an intrafallopian contraceptive procedure; and

performing an intrafallopian contraceptive procedure, wherein the stabilization device maintains a fixed longitudinal distance between a control device of the device for an intrafallopian contraceptive procedure and the hysteroscope during the intrafallopian contraceptive procedure.

19. The method of claim 18, wherein coupling the stabilization device to a device for an intrafallopian contraceptive procedure comprises coupling the stabilization device to an intrafallopian contraceptive delivery device.

20. A method, comprising:

inserting a distal end of a stabilization device inside a hysteroscope, the stabilization device comprising a sleeve and a lumen;

coupling the stabilization device to the hysteroscope

inserting a catheter into a proximal end of the stabilization device, through the lumen, and into the hysteroscope, the catheter extending from an intrafallopian contraceptive delivery device;

positioning the intrafallopian contraceptive delivery device to deploy a fallopian tube insert;

coupling the stabilization device to the intrafallopian contraceptive delivery device; and

deploying the fallopian tube insert, wherein the stabilization device maintains a fixed longitudinal distance between a control device of the intrafallopian contraceptive delivery device and the hysteroscope while deploying the fallopian tube insert.

21. The method of claim 20, further comprising feeding a corewire of the intrafallopian contraceptive delivery device forward by a predetermined distance after coupling the stabilization device to the hysteroscope.

22. The method of claim 20, wherein coupling the stabilization device to the hysteroscope comprises inserting the stabilization device into the hysteroscope past a ball valve and closing the ball valve on the stabilization device.

23. The method of claim 20, wherein coupling the stabilization device to the hysteroscope comprises friction fitting the stabilization device into a working channel of the hysteroscope and wherein coupling the stabilization device to the intrafallopian contraceptive delivery device comprises fiction fitting the stabilization device to the control device of the intrafallopian contraceptive delivery device.

24. The method of claim 20, wherein coupling the stabilization device to the intrafallopian contraceptive delivery device comprises mechanically fitting by fitting the proximal end of the stabilization device to an adaptor and fitting the adaptor to the control device.

25. The method of claim 20, wherein coupling the stabilization device to the intrafallopian contraceptive delivery device comprises coupling the stabilization device to a delivery catheter of the intrafallopian contraceptive delivery device.

26. The method of claim 20, further comprising inserting an anesthetic delivery catheter into a port on the stabilization device and into the hysteroscope and mixing an anesthetic with a carrier at a point of use before injecting the mixture through the anesthetic delivery catheter using a static mixer.

27. The method of claim 20, wherein positioning the intrafallopian contraceptive delivery device to deploy the fallopian tube insert comprises positioning the intrafallopian contraceptive delivery device using ultrasound, radiography, or fluoroscopy.

28. A method, comprising:

inserting a distal end of a stabilization device inside a hysteroscope, the stabilization device comprising a sleeve and a lumen;

providing an intrafallopian contraceptive delivery device comprising a control device, a fallopian tube insert delivery catheter having a proximal end and a distal end wherein the proximal end is coupled to the control device, and a fallopian tube insert at the distal end of the delivery catheter;

inserting the fallopian tube insert delivery catheter into the lumen of the stabilization device and into the hysteroscope;

positioning the fallopian tube insert for deployment;

coupling the stabilization device to the hysteroscope to maintain a fixed longitudinal distance between the control device and the hysteroscope; and

deploying the fallopian tube insert.

29. The method of claim 28, wherein coupling the stablization device to the hysteroscope increases the control over a position at which the insert is deployed.