Adjustable vaginal splint for pelvic floor support

• US 7,628,156 B2
• Filed: 10/25/2005
• Issued: 12/08/2009
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Astani, Aida, Peters, Burkhard
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US11/258,441
• Publication Number:
  US 20070089751A1
• Time in Patent Office: 1,505 Days
• Field of Search: 128/830, 128/834, 128/832, 128/836, 128/DIG.25, 128/885, 602/67, 602/68, 602/70, 602/72, 600/29, 600/31
• 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 splints and methods for their use for treating various pelvic floor conditions are provided. One embodiment of the vaginal splint includes a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides. The splint further includes an adjustable portion coupled to the base portion and positioned substantially adjacent to and distal of the second connecting portion of the base portion. The adjustable portion is removable by a user to thereby change the size of the splint.

Claims

1. A vaginal splint comprising:

a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides;

an adjustable portion coupled to the base portion and positioned substantially adjacent to and distal of the second connecting portion of the base portion, wherein the adjustable portion is removable by a user to thereby change the size of the splint, and further comprises first and second removable apical sections each comprising a connecting portion and first and second side portions at first and second ends respectively of the connecting portion, wherein the connecting portion of the first removable apical section is positioned substantially adjacent and parallel to the second connecting portion of the base portion and is removably coupled to the base portion by a joining portion capable of being torn or cut by a user to thereby remove the first removable apical section from the base portion, and wherein the second removable apical section is removably coupled to a distal side of the first removable apical section and is positioned substantially adjacent and parallel to the first removable apical section,

wherein the vaginal splint is sized and shaped for insertion within a vagina of a patient so as to thereby stabilize the vagina.

2. The splint according to claim 1, wherein the second removable apical section is removably coupled to the first removable apical section by a second joining portion capable of being torn or cut by a user to thereby remove the second removable apical section from the first removable apical section.

3. A vaginal splint comprising:

a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides;

an adjustable portion coupled to the base portion and positioned substantially adjacent to and distal of the second connecting portion of the base portion, wherein the adjustable portion is removable by a user to thereby change the size of the splint, and wherein the adjustable portion further comprises at least a first removable apical section comprising a connecting portion and first and second side portions at first and second ends respectively of the connecting portion, wherein the connecting portion of the first removable apical section is positioned substantially adjacent and parallel to the second connecting portion of the base portion; and

an inflatable member positioned between the first and second sides and first and second connecting portions of the base portion, the inflatable member being inflatable by infusion of fluid therein between a deflated state wherein it does not extend outwardly beyond a top or bottom side of the combination base portion and adjustable portion, and an inflated stated wherein it does extend outwardly beyond the top and/or bottom side of the combination base portion and adjustable portion,

wherein the vaginal splint is sized and shaped for insertion within a vagina of a patient so as to thereby stabilize the vagina.

4. The splint according to claim 3, wherein the inflatable member is a balloon comprised of a material selected from the group consisting of polyurethane, polyester, silicone and rubber.

5. A method for treating a pelvic floor prolapse condition comprising:

providing a splint sized and shaped for insertion within a patient'"'"'s vagina, the splint including a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides, and an adjustable portion coupled to the base portion, wherein the adjustable portion is adjustable or removable by a user to thereby change the size of the splint;

determining a size of a patients vagina;

based on said determined size, removing or adjusting said adjustable portion if a different size is needed; and

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

6. The method according to claim 5, wherein the adjustable portion further comprises at least a first removable apical section having a connecting portion and first and second side portions at first and second ends respectively of the connecting portion, and wherein the removing or adjusting step further comprises removing the first removable apical section from the base portion.

7. The method according to claim 5, further comprising, following the inserting step, inflating an inflatable member positioned between the first and second sides and first and second connecting portions of the splint to a state at which the inflatable member extends outwardly beyond a top and/or bottom side of the splint.