Insertable sleeve for speculum and use thereof

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.

What is claimed is: 
     
         1 . An insertable sleeve for use with a medical speculum, comprising:
 a cylindrical sleeve body comprising an outer surface and an inner surface, the inner surface defining a hollow sleeve channel, and at least one open end;   wherein the cylindrical sleeve body is configured to be inserted into a vaginal cavity of a patient; and   wherein the sleeve body is configured to receive an insertion portion of a medical speculum in the hollow sleeve channel subsequent to being inserted into the vaginal cavity.   
     
     
         2 . The insertable sleeve of  claim 1 , wherein the sleeve body has a uniform diameter from a distal end to a proximal end. 
     
     
         3 . The insertable sleeve of  claim 2 , wherein the uniform diameter of the sleeve body is between 0.25 and 4.0 inches. 
     
     
         4 . The insertable sleeve of  claim 1 , 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 as a space between the upper bill and the lower bill is increased. 
     
     
         5 . The insertable sleeve of  claim 1 , wherein the sleeve body is disposable. 
     
     
         6 . The insertable sleeve 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. 
     
     
         7 . The insertable sleeve 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 to help during insertion. 
     
     
         8 . The insertable sleeve of  claim 1 , wherein the sleeve body comprises an internal tab configured to add stiffness to the sleeve body. 
     
     
         9 . The insertable sleeve of  claim 1 , further comprising a pocket configured to secure the insertable sleeve to the speculum by tucking the pocket over a top edge of the speculum. 
     
     
         10 . The insertable sleeve of  claim 1 , wherein the sleeve body has a length of at least 50% of a total length of the insertion portion of the medical speculum. 
     
     
         11 . The insertable sleeve of  claim 1 , wherein the sleeve body is made of a rubber or a plastic material. 
     
     
         12 . The insertable sleeve of  claim 11 , wherein the rubber or plastic material is one of a polyisoprene, a polyurethane, a thermoplastic polyurethane, a styrene copolymer, and a thermoplastic elastomer. 
     
     
         13 . The insertable sleeve 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. 
     
     
         14 . The insertable sleeve of  claim 1 , wherein the at least one open end is edged with a ridged finish. 
     
     
         15 . The insertable sleeve of  claim 14 , wherein the ridged finish is formed from one of a rolled bead edge, a ring rolled into the sleeve body and cured, a dip in a material of the sleeve body, a dip in a secondary material attached to the sleeve body, a foam or a sponge ring rolled into the sleeve body, and a portion of the sleeve body naturally biased to a rolled position. 
     
     
         16 . The insertable sleeve of  claim 1 , wherein the sleeve body is made of a transparent material to allow visibility through the sleeve body. 
     
     
         17 . The insertable sleeve of  claim 1 , wherein the sleeve body comprises a plurality of components each made independently by one of the processes in a group consisting of co-molding, injection molding, and dip molding. 
     
     
         18 . The insertable sleeve of  claim 1 , comprising a closed distal end, wherein the closed distal end further comprises an aperture. 
     
     
         19 . The insertable sleeve of  claim 1 , wherein an applicator is configured to carry the sleeve body and facilitate insertion and positioning of the sleeve body into the vaginal cavity. 
     
     
         20 . The insertable sleeve of  claim 19 , wherein the applicator is made of a rubber, plastic, or cardboard material. 
     
     
         21 . The insertable sleeve of  claim 19 , wherein the applicator comprises a gripping element to facilitate grasping of the applicator during insertion of the sleeve body into the vaginal cavity. 
     
     
         22 . The insertable sleeve of  claim 19 , wherein the applicator comprises a release mechanism to release the sleeve body from the applicator. 
     
     
         23 . The insertable sleeve of  claim 22 , wherein the release mechanism is a plunger. 
     
     
         24 . The insertable sleeve of  claim 1 , wherein the insertable sleeve is packaged in a single-product package. 
     
     
         25 . The insertable sleeve of  claim 1 , wherein the insertable sleeve is packaged in a compressed form. 
     
     
         26 . 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 a handle; and   an insertable sleeve comprising:
 a cylindrical sleeve body comprising an outer surface and an inner surface, the inner surface defining a hollow sleeve channel, and at least one open end; 
 wherein the cylindrical sleeve body is configured to be inserted into a vaginal cavity of a patient; and 
 wherein the sleeve body is configured to receive the insertion portion of the speculum in the hollow sleeve channel subsequent to being inserted into the vaginal cavity; and 
   an applicator configured to carry the sleeve body and facilitate insertion of the sleeve body into the vaginal cavity.   
     
     
         27 . The kit of  claim 26 , further comprising a plurality of speculums, varying in length, width, and expansion capabilities. 
     
     
         28 . The kit of  claim 26 , further comprising a plurality of insertable sleeves, varying in length and width. 
     
     
         29 . The kit of  claim 26 , further comprising one or more accessories related to the needs of a medical procedure. 
     
     
         30 . A method of preparing a speculum for a medical procedure, the method comprising:
 providing an insertable sleeve, the insertable sleeve comprising:
 a cylindrical sleeve body comprising an outer surface, an inner surface, the inner surface defining a hollow sleeve channel, and at least one open end, 
 wherein the cylindrical sleeve body is configured to be inserted into a vaginal cavity of a patient, and, 
 wherein the sleeve body is configured to receive a pair of bills of a medical speculum in the hollow sleeve channel subsequent to being inserted in the vaginal cavity; 
   positioning the sleeve body in the vaginal cavity of the patient; and   positioning the pair of bills of the medical speculum inside the sleeve body positioned within the vaginal cavity of the patient.   
     
     
         31 . The method of  claim 30 , further comprising:
 providing an applicator configured to contain carry the sleeve body and facilitate insertion of the sleeve body into the vagina;   wherein positioning the sleeve body comprises positioning the applicator within the vagina of the patient; and   removing the applicator from the vagina, leaving the sleeve body inserted into the vagina.   
     
     
         32 . The method of  claim 31 , wherein removing the applicator from the vagina comprises using a release mechanism to release the sleeve body from the applicator. 
     
     
         33 . The method of  claim 30 , wherein the insertable sleeve comprises a pocket positioned at one open end, and wherein positioning the sleeve body comprises sliding the pocket over a portion of the speculum to secure the insertable sleeve on the speculum. 
     
     
         34 . The method of  claim 30 , further comprising:
 separating the pair of bills to dilate the vaginal cavity, wherein separating the pair of bills causes the sleeve body surrounding the bills to expand around the pair of bills; and   performing a gynecology procedure on the patient.   
     
     
         35 . The method of  claim 34 , further comprising:
 closing the pair of bills;   removing the speculum from the vaginal cavity;   and removing the sleeve body from the pair of bills.   
     
     
         36 . The method of  claim 34 , wherein the gynecology procedure is one from the group consisting of: a pelvic examination, Pap smear, an IUD insertion or removal, an insemination, an STD testing, tissue collection, and biopsy. 
     
     
         37 . The method of  claim 34 , wherein the gynecology procedure is an electrosurgery, and wherein the sleeve is configured to provide insulation to protect vaginal walls of the patient during the electrosurgery. 
     
     
         38 . A method of performing a vaginal examination or medical procedure on a patient, comprising, providing an insertable sleeve device; inserting the sleeve device into the vagina of the patient; inserting a speculum into an opening in the sleeve device; and performing the examination or medical procedure. 
     
     
         39 . A method of minimizing side wall encroachment or pinching in a vaginal examination or procedure, comprising, providing an insertable sleeve device according to one or more of the embodiments in the specification; inserting the sleeve into the vagina of the patient; inserting a speculum into an opening in the sleeve device; and performing a vaginal examination or medical procedure such that when the speculum is opened or closed, side wall encroachment is minimized, reduced or avoided, or pinching of sidewall tissue is reduced, minimized or avoided during use of the speculum device for an examination or medical procedure.