Adjustable vaginal splint for pelvic floor support

• US 7,673,631 B2
• Filed: 01/19/2006
• Issued: 03/09/2010
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Astani, Aida, Carey, Marcus P., Peters, Burkhard
• Primary Examiner(s): Bianco; Patricia
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US11/334,966
• Publication Number:
  US 20070089750A1
• Time in Patent Office: 1,510 Days
• Field of Search: 128/885, 128/830, 128/834, 128/836, 128/DIG.25, 600/37, 600/29, 215/319, 220/23.89, 220/287, 119/863, 119/865, 446/4
• US Class Current: 128/834
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2250/0064 Sets comprising a plurality of prosthetic parts of different sizes
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

Vaginal splint assemblies and methods for their use for treating various pelvic floor conditions are provided. One embodiment of a vaginal splint assembly includes a base portion having a connecting portion and first and second sides extending outwardly from first and seconds ends of the connecting portion to first and second free ends respectively. It further includes a plurality of apical sections each of a different size and each having a connecting portion and first and second sides extending outwardly from first and second ends of the connecting portion to first and second free ends respectively, and at least first and second coupling elements. The first coupling element is capable of securing the first free end of the base portion to the first free end of any one of the plurality of apical sections, and the second coupling element is capable of securing the second free end of the base portion to the second free end of the one apical section.

Claims

1. A vaginal splint kit comprising:

a base portion having a connecting portion and first and second sides extending outwardly from first and seconds ends of the connecting portion to first and second free ends respectively;

a plurality of apical sections each of a different size and each having a connecting portion and first and second sides extending outwardly from first and second ends of the connecting portion to first and second free ends respectively; and

at least first and second coupling elements, the first coupling element capable of securing the first free end of the base portion to the first free end of any one of the plurality of apical sections such that the combination of the first side of the base portion and first side of the apical section are aligned free end to free end to form a substantially straight line, and the second coupling element capable of securing the second free end of the base portion to the second free end of said one apical section such that the combination of the second side of the base portion and the second side of the apical section are aligned free end to free end to form a substantially straight line,

wherein a combination of the base portion and any one of the plurality of apical sections forms a vaginal splint adapted for placement within a vagina of a patient to thereby stabilize the vagina, and having a substantially trapezoidal shape defined by the first and second connecting portions and first and second sides of the base portion and the first and second sides of the apical section, said trapezoidal shape having a different size for each of the plurality of apical sections that is so coupled.

2. The assembly according to claim 1, wherein the first and second coupling elements are coupled to, and extend outwardly from the first and second free ends of the base portion to respective distal free ends.

3. The assembly according to claim 2, wherein the first and second free ends of each of the plurality of apical sections have first and second recesses therein configured to receive the respective distal free ends of the first and second coupling elements.

4. The assembly according to claim 3, wherein the distal ends of the first and second coupling elements form an interference fit with the respective first and second recesses.

5. The assembly according to claim 1, wherein each of the plurality of apical sections have first and second coupling elements coupled to and extending outwardly from the first and second free ends thereof respectively.

6. The assembly according to claim 5, wherein the first and second free ends of the base portion have first and second recesses therein configured to receive the distal free ends of the first and second coupling elements of any one of the plurality of apical sections.

7. A vaginal splint kit comprising:

a base portion having a connecting portion and first and second sides extending outwardly from first and seconds ends of the connecting portion to first and second free ends respectively;

a plurality of apical sections each of a different size and each having a connecting portion and first and second sides extending outwardly from first and second ends of the connecting portion to first and second free ends respectively;

at least first and second coupling elements, the first coupling element capable of securing the first free end of the base portion to the first free end of any one of the plurality of apical sections, and the second coupling element capable of securing the second free end of the base portion to the second free end of said one apical section; and

an inflatable member positioned between the first and second sides of the base portion, the inflatable member being inflatable by infusion of fluid or gas therein, and, when in the inflated state, the inflatable member extends outwardly beyond a top and/or bottom surface of the splint.

8. The assembly according to claim 7, wherein the inflatable member is a balloon comprised of a material selected from the group consisting of polyurethane, polyester, silicone and rubber.

9. The assembly according to claim 7, wherein the inflatable member is detachably coupled to the splint assembly.

10. A method for treating a pelvic floor prolapse condition of a patient comprising:

providing a vaginal splint kit including base portion having a connecting portion and first and second sides extending outwardly from first and seconds ends of the connecting portion to first and second free ends respectively, a plurality of apical sections each of a different size and each having a connecting portion and first and second sides extending outwardly from first and second ends of the connecting portion to first and second free ends respectively, and at least first and second coupling elements, wherein the first coupling element is capable of securing the first free end of the base portion to the first free end of any one of the plurality of apical sections, and the second coupling element is capable of securing the second free end of the base portion to the second free end of said one apical section;

determining a size of the patient'"'"'s vagina;

based on the determined size, selecting one of the plurality of apical sections;

coupling the selected apical section to the base portion via the at least first and second coupling elements to form a vaginal splint; and

inserting the vaginal splint into the patient'"'"'s vagina.

11. The method according to claim 10, wherein when any one of the plurality of adjustable apical sections is secured to the base portion, the splint has a substantially trapezoidal overall configuration.

12. The method according to claim 10, wherein the first and second coupling elements are secured to the base portion, and configured such that any one of the plurality of apical sections may be coupled to the base portion via the coupling elements.

13. The method according to claim 12, wherein the first and second coupling elements extend outwardly from the first and second free ends of the base portion to respective distal ends, and wherein the first and second free ends of each of the plurality of apical sections have respective first and second recesses therein configured to removably receive therein the respective distal free ends of the first and second coupling elements.

14. The method according to claim 13, wherein the distal ends of the first and second coupling elements form an interference fit with the respective first and second recesses.

15. The method according to claim 10, wherein the splint assembly further comprises an inflatable member positioned between the first and second sides of the base portion, the method further comprising, following the inserting step, inflating the inflatable member by infusing fluid or gas therein until the inflatable member extends outwardly beyond a top and/or bottom surface of the splint.

16. The method according to claim 15, wherein the inflatable member is a balloon comprised of a material selected from the group consisting of polyurethane, polyester, silicone and rubber.

17. The method according to claim 16, further comprising the step of removing the vaginal splint from the patient after a first time period has elapsed.

18. The method according to claim 17, wherein the inflatable member is detachably coupled to the splint, and wherein the removing step further comprises deflating and removing the inflatable member after a first time period has elapsed, and removing the splint after a second time period has elapsed that is greater than the first time period.