IP Library Granted Patent US 11,896,201
Granted Patent B2
US 11,896,201 · App. 17/315,072 · Granted Feb 13, 2024

Insertable sleeve for speculum and use thereof

Inventors: Maria Lalli (Portland, OR); Fahti Self (Portland, OR); Darius Naigamwalla (Portland, OR)
Assignee: CEEK WOMEN'S HEALTH, INC.
A61B1/00142A61B1/00135A61B1/00154A61B1/303A61B1/32
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Quick Facts
Patent No.
US 11,896,201
App. No.
17/315,072
Granted
Feb 13, 2024
Kind
B2
Abstract

An insertable sleeve accessory and a method for use is provided. The insertable sleeve includes a cylindrical sleeve body. The cylindrical sleeve body includes an outer surface and an inner surface, the inner surface defining a hollow sleeve channel, and at least one open end. The cylindrical sleeve body is configured to be inserted into a vaginal cavity of a patient. The sleeve body is further configured to receive an insertion portion of a medical speculum in the hollow sleeve channel subsequent to being inserted into the vaginal cavity.

Claims (34)

1. A device for use with a medical speculum, comprising:

an insertable sleeve comprising a sleeve body, the sleeve body comprising:

an outer surface; and

an inner surface defining a hollow sleeve channel having a proximal end and a distal end, the proximal end having an opening, wherein the sleeve body is configured to be inserted into a vaginal cavity of a patient, wherein the sleeve body is configured to receive an insertion portion of the medical speculum in the hollow sleeve channel subsequent to being inserted into the vaginal cavity, wherein the insertion portion of the medical speculum comprises an upper bill and a lower bill, and wherein the sleeve body is configured to expand and conform to the upper bill and the lower bill as a space between the upper bill and the lower bill is increased from a closed position to an open position of the medical speculum,

wherein the proximal end of the sleeve body comprises a gradual broadening of the sleeve body, the gradual broadening of the sleeve body extending beyond the insertion portion of the medical speculum, the gradual broadening of the sleeve body integrally formed with the sleeve body and wherein a portion of the sleeve body has a uniform diameter;

an applicator configured to facilitate insertion and positioning of the sleeve body into the vaginal cavity, the applicator comprising:

a tube configured to carry the sleeve body; and

a plunger extending from the tube, a length of the plunger aligned with a length of the tube, the applicator configured to release the sleeve body from the tube into the vaginal cavity in response to a user depressing the plunger into the tube, wherein a portion of the released sleeve body is adapted for insertion into the vaginal cavity.

2. The device of claim 1 , wherein the uniform diameter of the sleeve body is between 0.25 inches and 4.0 inches.

3. The device of claim 1 , wherein the sleeve body and/or the applicator is disposable.

4. The device of claim 1 , wherein the sleeve body comprises one or more of the following to assist with adherence of the sleeve to the insertion portion: gripping elements positioned on the inner surface of the sleeve body, ribbed details, and a texture difference on the inner surface.

5. The device of claim 1 , wherein the sleeve body comprises one or more of the following: folds, fluting, webbing, and ribs, thereby providing structure to the sleeve body to help during insertion.

6. The device of claim 1 , wherein the sleeve body further comprises an internal tab extending along a length of the inner surface of the sleeve body from the distal end to outside of the opening of the proximal end, the tab configured to add stiffness to the sleeve body, and wherein a portion of the tab extending outside of the opening of the proximal end is configured to be held by the user while inserting the insertion portion of the medical speculum into the sleeve body.

7. The device of claim 1 , further comprising a flap configured to secure the insertable sleeve to the medical speculum by tucking the flap over a top edge of the medical speculum.

8. The insertable sleeve of claim 7 , wherein the sleeve body comprises one or more of the following to assist with adherence of the sleeve to the insertion portion: gripping elements positioned on the inner surface of the sleeve body, ribbed details, and a texture difference on the inner surface.

9. The device of claim 1 , wherein the sleeve body is made of a rubber or a plastic material.

10. The device of claim 9 , wherein the rubber or plastic material is one of a polyisoprene, a polyurethane, a thermoplastic polyurethane, a styrene copolymer, and a thermoplastic elastomer.

11. The device of claim 1 , wherein the sleeve body is coated with at least one of a lubricant, a powder, a surface texture, a bioactive agent, and a therapeutic agent.

12. The device of claim 1 , wherein the proximal end is edged with a ridged finish.

13. The device of claim 1 , wherein the sleeve body is made of a transparent material to allow visibility through the sleeve body.

14. The device of claim 1 , comprising a closed distal end, wherein the closed distal end further comprises an aperture.

15. The device of claim 1 , wherein the applicator is made of a rubber, plastic, or cardboard material.

16. The device of claim 1 , wherein the applicator comprises a gripping element to facilitate grasping of the applicator during insertion of the sleeve body into the vaginal cavity.

17. The device of claim 1 , wherein the device is packaged in a single-product package.

18. A kit comprising:

a speculum comprising a handle and an insertion portion, the insertion portion comprising an upper bill and a lower bill coupled to the handle; and

the device of claim 1 .

19. The kit of claim 18 , further comprising a plurality of speculums, varying in length, width, and expansion capabilities.

20. An insertable sleeve for use with a medical speculum, comprising:

a sleeve body, comprising:

an outer surface;

an inner surface defining a hollow sleeve channel having a proximal end and a distal end, the proximal end having an opening; and

a tab extending along a length of the inner surface of the sleeve body from the distal end to outside of the opening of the proximal end, the tab configured to add stiffness to the sleeve body, wherein the sleeve body is configured to be inserted into a vaginal cavity of a patient without an applicator, wherein the sleeve body is configured to receive an insertion portion of the medical speculum in the hollow sleeve channel subsequent to being inserted into the vaginal cavity, and wherein a portion of the tab extending outside of the opening of the proximal end is configured to be held by a user while inserting the insertion portion of the medical speculum into the sleeve body, the sleeve body configured to expand and conform to an upper bill and a lower bill of the medical speculum as a space between the upper bill and the lower bill is increased from a closed position to an open position,

wherein the proximal end of the sleeve body comprises a gradual broadening of the sleeve body, and wherein a portion of the sleeve body has a uniform diameter from the distal end to the proximal end.

Assignments (1)
SECURITY INTEREST Recorded Mar 16, 2022
From: CEEK WOMEN'S HEALTH, INC.
To: SQUADRON MEDICAL FINANCE SOLUTIONS LLC
Reel/Frame 059279/0385 →
Continuity (5)
Continuation 15393081 · Dec 28, 2016
Provisional Application 62310604 · Mar 18, 2016
Provisional Application 62281694 · Jan 21, 2016
Provisional Application 62272619 · Dec 29, 2015
Related Publication 20220095898A1 · Mar 31, 2022
Cited By (1)
US 12,471,758