Apparatus and process for making prosthetic suction sleeve

A process for forming a length of a continuous tubular member with an uninterrupted continuous layer of elastomeric resin covering and adhered to one of two opposing sides thereof, comprising:

• continuously feeding a tubular member in a generally longitudinal and vertically downward direction relative to and through a coating zone maintained at a sub-atmospheric pressure;
• while carrying out said feeding step, applying and adhering a continuous, uninterrupted tubular uncured elastomeric resin layer to said one side of said tubular member within said coating zone by applying sub-atmospheric pressure between said elastomeric resin layer and said one side of said tubular member;
• and
• curing said elastomeric resin while it is adhered to said one side of said tubular member.

Apparatus for applying a continuous uninterrupted resin layer on one surface of a continuous tubular substrate, comprising:

• a coating zone including a continuous resin casting device arranged to dispense a continuous, uninterrupted, tubular coating material layer of uncured elastomeric resin into the coating zone;
• said coating zone including a sub-atmospheric chamber arranged so as to provide a sub-atmospheric pressure within the chamber to which said coating material layer is subjected during operation of the apparatus;
• a heating zone located adjacent said coating zone, said heating zone including a heater device;
• and
• a feed mechanism arranged to engage and feed a continuous tubular substrate along a longitudinal direction of the substrate through said sub-atmospheric chamber and coating zone, and said heating zone in the recited order.

A method for molding a distal end cap on an open end of a length of a pre-formed tubular sleeve member formed of an elasticized fabric with a porous tubular reinforcement matrix integrated with said end cap, comprising the steps:

• providing a length of a pre-formed tubular sleeve member formed of elasticized fabric and having an open end;
• securing a length of a tubular reinforcement matrix element formed of interlocked fibers that are arranged so the matrix member is porous and strongly resists elongation in the sleeve longitudinal direction but is readily stretchable in transverse radial directions to an open end of the tubular sleeve member so the sleeve member and matrix element extend generally coaxially;
• twisting the matrix element about its central axis adjacent the open end of the sleeve member to effectively close the open end of the sleeve member by the twisted matrix element;
• providing a female mold having a female mold cavity dimensioned and configured to correspond with a desired outer contour of a distal end cap to be joined to the sleeve member;
• placing a predetermined quantity of an uncured end cap elastomeric resin in the female mold cavity;
• providing a male mold element dimensioned and configured to cooperate with the female mold so that, when the male mold element located in molding relationship with the female mold, a closed mold cavity defining the external contour of a distal end cap is formed;
• locating the portion of the matrix element extending beyond the twisted portion inside the adjacent open end of the tubular sleeve;
• locating the male mold element inside the matrix sleeve portion located inside the tubular sleeve;
• advancing the male mold element, matrix sleeve and tubular sleeve into molding relationship with the female mold so that the twisted portion of the matrix element extends within the closed mold cavity along with the uncured distal end cap resin so that the resin penetrates the porous material of the matrix element and closes the open end of the sleeve member;
• curing the resin in the mold cavity;
• and
• removing the molded distal end cap and reinforcement matrix from the mold cavity, wherein the former open end of the sleeve member is closed by the molded distal end cap and the reinforcement matrix is located concentrically inside the end area of the sleeve adjacent the distal end cap.

A process for forming a sleeve member suitable for prosthetic applications, said sleeve members comprising a tubular elasticized fabric element having a distal end cap attached to and closing one end of the sleeve element, comprising the steps of:

• placing a predetermined quantity of uncured elastomeric resin intended to form said cured elastomer layer in the interior of the closed end of the sleeve member;
• placing the sleeve member and uncured elastomer resin in a female molding die cavity having an interior contour corresponding to the desired outer contour of said sleeve member;
• placing a male mold die member having an outer contour corresponding with the desired inner contour of the sleeve member within the sleeve member and advancing the male mold die member into the sleeve member and female mold die cavity until it reaches a molding position relative to the female mold die cavity, at which position a closed die cavity between the male mold die member and the female mold die cavity is defined, said sleeve is located in the mold cavity adjacent inner walls female mold die and the uncured elastomer resin occupies the remainder of the closed die cavity, said resin having been distributed throughout the closed die cavity and against the interior of the sleeve member by movement of the male mold die member relative to the female mold die cavity and the uncured resin;
• said predetermined quantity of uncured elastomer resin being calculated to fill said closed die cavity;
• curing the elastomer resin in the closed die cavity in bonded relationship with the interior of the sleeve member;
• withdrawing the male mold die member, tubular sleeve member, distal end cap and cured elastomer layer from the female mold die cavity.