Minimally obstructive retractor for vaginal repairs

• US 9,907,544 B2
• Filed: 08/25/2014
• Issued: 03/06/2018
• Est. Priority Date: 09/29/2011
• Status: Active Grant

• Current Assignee: Proa Medical, Inc.
• Original Assignee: Proa Medical, Inc.
• Inventors: Nadershahi, Afshin, Jetti, Krishna Mohith, Deshpande, Sudeep
• Primary Examiner(s): GIBSON, ERIC SHANE
• Application Number:
  US14/468,167
• Publication Number:
  US 20140364698A1
• Time in Patent Office: 1,289 Days
• Field of Search: 600201-246
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/008 Articulations
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2017/0038 Simultaneous actuation of two tools by pushing one button or the like
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 90/57 Accessory clamps

Abstract

This application presents minimally-obstructive and structurally-adjustable retractors for vaginal repairs, which afford an open work area of desirable size and enhanced visualization for a surgeon about the perineum and the posterior vaginal wall of the patient. The retractors may be lightweight and compact, and also configured and dimensioned to minimize slippage during use. The retractors may have occluders that may partially or substantially block or absorb fluids, for example, from or around the cervix. The retractors may incorporate built-in light sources. The retractors may retract the engorged labia of the postpartum patient as well as the vaginal walls. The retractor may also be used as a speculum.

Claims

1. A system, comprising

a minimally obstructive retractor having a proximal end, a distal end, an exterior surface, and an interior surface, comprising:

a central body portion,

at least two wings,

two hinges, each configured to affix a different one of the at least two wings to the central body portion, and

a rachet mechanism that releasably locks the wings in an open position; and

an occluder affixed to the retractor,

wherein the wings are rotatable about the hinges when moving from a closed to an open position;

wherein the at least one occluder is positioned underneath the canopy, at the distal end of the retractor, beyond the distal end of the retractor, or a combination thereof;

wherein the wings, the hinges, and the central body portion form a canopy that creates and only partially surrounds an interior space that is not surrounded by any other portion of the retractor when the wings are in the open position;

wherein no portion of the retractor obstructs any portion of the interior space formed by the canopy when the wings are in the open position,

wherein the occluder is configured to at least partially occlude bodily fluid from entering into a volume formed by the at least two wings when spread apart and by tissue surrounding the spread wings, and/or at least to reduce bleeding of a uterus, cervix, and/or vagina.

2. The system of claim 1, wherein the occluder is configured to occlude the bodily fluids by forming a barrier that is partially impermeable to the bodily fluid.

3. The system of claim 1, wherein the occluder is configured to occlude the bodily fluids by forming a barrier that is substantially impermeable to the bodily fluid.

4. The system of claim 1, wherein the occluder comprises a material that is configured to absorb the bodily fluid.

5. The system of claim 1, wherein the occluder comprises a porous material.

6. The system of claim 1, wherein the occluder is movable with respect to the central body portion.

7. The system of claim 1, wherein the retractor further comprises a distal tip and wherein the occluder is attached to the distal tip.

8. The system of claim 1, wherein the occluder comprises an inflatable article.

9. The system of claim 8, wherein the inflatable article does not have more than one balloon.

10. The system of claim 8, wherein the inflatable article does not have more than two balloons.

11. The system of claim 8, wherein the inflatable article is inflatable by a fluid.

12. The system of claim 1, wherein the occluder comprises a single balloon tamponade system, comprising a single balloon.

13. The system of claim 12, wherein the retractor further comprises a docking port to securely and detachably attach the single balloon tamponade system to the retractor.

14. The system of claim 12, wherein the single balloon is positioned at the distal end of the retractor.

15. The system of claim 12, wherein the single balloon is positioned underneath the canopy.

16. The system of claim 12, wherein the single balloon is positioned at the distal end of the retractor and/or beyond the distal end of the retractor.

17. The system of claim 1, wherein the occluder comprises a double balloon tamponade system, comprising two balloons.

18. The system of claim 17, wherein the retractor further comprises a docking port to securely and detachably attach the double balloon tamponade system to the retractor.

19. The system of claim 17, wherein at least one balloon is positioned underneath the canopy.

20. The system of claim 17, wherein at least one balloon is positioned at the distal end of the retractor and/or beyond the distal end of the retractor.

21. The system of claim 17, wherein one balloon is positioned underneath the canopy;

and the other balloon is positioned at the distal end of the retractor and/or beyond the distal end of the retractor.

22. The system of claim 1, wherein the system further comprises a secondary device that is temporarily attachable to the retractor.

23. The system of claim 1, wherein the retractor does not have more than two wings and does not have more than one central body portion.

24. The system of claim 23, wherein the occluder comprises a porous material, and wherein the occluder is movable with respect to the central body portion.

25. The system of claim 23, wherein the system further comprises a secondary device that is detachably attached to the retractor, and wherein the retractor further comprises a docking port that securely attaches the secondary device to the retractor.

26. The system of claim 23, wherein the occluder comprises a double balloon tamponade system, comprising two balloons;

and wherein one balloon of the double balloon tamponade system functions as a uterine tamponade balloon, and wherein the other balloon of the double balloon tamponade system functions as a vaginal tamponade balloon.

27. The system of claim 1, wherein the ratchet mechanism comprises at least one arm that is affixed to an interior surface of at least one of the wings.

28. The system of claim 27, wherein the retractor further comprises two mating grooves, which are integrated within the ratchet mechanism, and two pegs;

and wherein the two mating grooves and the two pegs are configured to effectively restrict rotation of the retractor off axis.

29. The system of claim 28, wherein the retractor further comprises a retractor limiter at the proximal end.

30. The system of claim 29, wherein the retractor limiter further comprises a limiter recess.

31. The system of claim 30, wherein the occluder comprises a single balloon tamponade system, comprising a single balloon.

32. The system of claim 31, wherein the single balloon is positioned at the distal end of the retractor.

33. The system of claim 31, wherein the single balloon is positioned beyond the distal end of the retractor.

34. The system of claim 31, wherein the retractor further comprises a docking port to securely and detachably attach the single balloon tamponade system to the retractor.

35. The system of claim 30, wherein the occluder comprises a double balloon tamponade system, comprising two balloons.

36. The system of claim 35, wherein one balloon is positioned underneath the canopy;

and the other balloon is positioned at the distal end of the retractor, beyond the distal end of the retractor, or a combination thereof.

37. The system of claim 35, wherein one balloon is positioned underneath the canopy;

and the other balloon is positioned beyond the distal end of the retractor.

38. The system of claim 35, wherein the retractor further comprises a docking port to securely and detachably attach the double balloon tamponade system to the retractor.

39. The system of claim 35, wherein one balloon of the double balloon tamponade system functions as a uterine tamponade balloon, and wherein the other balloon of the double balloon tamponade system functions as a vaginal tamponade balloon.

40. The system of claim 1, wherein the system comprises a lever, rod, or switch that allows a user to move the occluder independently of the central body portion, wings, and hinges, after the retractor is inserted into the vagina.

41. A system, comprising:

a vaginal retractor, comprising;

a central body portion;

at least two wings;

two hinges that affix a different one of the at least two wings to the central body portion; and

an occluder attached to a component of the system, wherein the occluder is an occluder that is configured to occlude bodily fluid from entering into a volume formed by the at least two wings when spread apart and by tissue surrounding the spread wings; and

a lever, rod, or switch that allows a user to move the occluder independently of the central body portion, wings, and hinges, after the retractor is inserted into a vagina.