Speculum sleeve
The present invention relates to expandable sleeves, expandable sleeve systems, and their methods of use. In certain aspects, the expandable sleeves are compatible with commonly used speculums to enhance visualization and access of an orifice. The expandable sleeves sheathe over the blades of a speculum and form a taut barrier when the blades are opened to hold back the walls of a tissue orifice and cavity. The expandable sleeves include inflatable pouches that further push back the walls of the orifice. In certain aspects, the expandable sleeves are useful in performing pelvic exams, such as in patients having lax vaginal walls or excess surrounding tissue.
1. An expandable sleeve, comprising:
a tubular member having a proximal end and a distal end, the tubular member formed of an expandable material having a length, an internal surface, and an exterior surface; and
opposing inflatable pouches formed of an expandable material laterally positioned lengthwise on the exterior surface of the tubular member, such that each inflatable pouch extends from the proximal end to the distal end of the tubular member;
wherein the sleeve has a cross-sectional area comprising a cross-section of the tubular member and a cross-section of each of the opposing inflatable pouches, and wherein the opposing inflatable pouches are configured to expand the cross-sectional area of the sleeve in only lateral directions.
2. The sleeve of claim 1 , further comprising at least one partition wall connected to the internal surface of the tubular member to form at least two lumens within the tubular member, wherein the opposing inflatable pouches are positioned adjacent to one of the at least two lumens.
3. The sleeve of claim 2 , wherein the at least one partition wall includes an upper partition wall and a lower partition wall each connected to the internal surface off the tubular member to form an upper lumen, a central lumen, and a lower lumen within the tubular member, and wherein the opposing inflatable pouches are positioned adjacent to the central lumen.
4. The sleeve of claim 3 , wherein the upper lumen is configured to receive a top speculum blade and the lower lumen is configured to receive a bottom speculum blade.
5. The sleeve of claim 2 , wherein a first lumen of the at least two lumens is configured to receive a top speculum blade and a second lumen of at least two lumens is configured to receive a bottom speculum blade.
6. The sleeve of claim 1 , wherein the expandable material is a biocompatible material.
7. The sleeve of claim 1 , wherein the expandable material is an elastomer.
8. The sleeve of claim 1 , wherein the expandable material is a thermoplastic elastomer.
9. The sleeve of claim 1 , wherein the expandable material is a United States Pharmacopeia (USP) Class VI Medical Grade Plastic Material.
10. The sleeve of claim 9 , wherein the expandable material is selected from the group consisting of: silicone, latex, nylon, polyethylene, polyethylene terephthalate (PET), urethane, polyurethane, polypropylene, nitrile, fluoroelastomer, ethylene propylene diene monomer (EPDM), styrenic block copolymer, copolyester, polyamide, polyolefin, and combinations thereof.
11. The sleeve of claim 1 , wherein the expandable material comprises a coating.
12. The sleeve of claim 1 , wherein the inflatable pouches have greater elasticity than the tubular member.
13. The sleeve of claim 1 , wherein the inflatable pouches have a textured exterior surface.
14. The sleeve of claim 1 , wherein the inflatable pouches each have a length that is equal to or less than the length of the tubular member.
15. The sleeve of claim 1 , wherein the inflatable pouches are each separately and fluidly connected to a distinct inflation lumen.
16. The sleeve of claim 15 , wherein the inflation lumens merge into a single lumen that terminates in a luer lock connectable to an inflation pump.
17. The sleeve of claim 16 , wherein the luer lock comprises a stopcock or a check valve.
18. The sleeve of claim 16 , wherein the inflation pump is a syringe or a reciprocating pump.
19. The sleeve of claim 16 , wherein the inflation pump pumps a gas or a liquid.