Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
226 words
A sterile catheter assembly adapted to be preformed to substantially any desired configuration by the user dependent upon his immediate need without affecting the sterility of the catheter prior to insertion of the catheter into a body cavity comprising: a plastic catheter of a material capable of being deformed and after being subjected to substantial heating and cooling to retain a desired deformed condition; a malleable forming wire removably positioned within the lumen of the catheter and being adapted to be deformed to substantially any desired configuration while positioned within said catheter and to substantially retain that configuration when released; a flexible, airtight, waterproof envelope enclosing the catheter and the wire and capable of being subjected to substantial heating and cooling thereafter without material effect thereon; said envelope containing a minimum of entrapped air when enclosed about the catheter and the wire and being in substantially close-fitting relation with the catheter and wire; the catheter being deformable to a desired configuration with the malleable wire retaining the catheter in that configuration while the assembly is heated to a substantial degree so that the plastic catheter softens and thereafter cools substantially so that the catheter will harden in the deformed configuration so that when the catheter is removed from the remainder of the assembly including the envelope and the wire, the catheter will retain the desired configuration.
Claim 2
Dependent Claim
226 words
A sterile catheter assembly adapted to be preformed to substantially any desired configuration by the user dependent upon his immediate need without affecting the sterility of the catheter prior to insertion of the catheter into a body cavity comprising: a plastic catheter of a material capable of being deformed and after being subjected to substantial heating and cooling to retain a desired deformed condition; a malleable forming wire removably positioned within the lumen of the catheter and being adapted to be deformed to substantially any desired configuration while positioned within said catheter and to substantially retain that configuration when released; a flexible, airtight, waterproof envelope enclosing the catheter and the wire and capable of being subjected to substantial heating and cooling thereafter without material effect thereon; said envelope containing a minimum of entrapped air when enclosed about the catheter and the wire and being in substantially close-fitting relation with the catheter and wire; the catheter being deformable to a desired configuration with the malleable wire retaining the catheter in that configuration while the assembly is heated to a substantial degree so that the plastic catheter softens and thereafter cools substantially so that the catheter will harden in the deformed configuration so that when the catheter is removed from the remainder of the assembly including the envelope and the wire, the catheter will retain the desired configuration.
Claim 3
Dependent Claim
28 words
A preformable catheter assembly in accordance with claim 1 wherein the malleable forming wire extends beyond the distal end of the catheter to facilitate removal of the wire.
Claim 4
Dependent Claim
24 words
A preformable catheter assembly in accordance with claim 2 wherein the envelope is formed of polyethylene terephthalate resin provided with a coating of polyethylene.
Claim 5
Dependent Claim
16 words
A preformable catheTer assembly in accordance with claim 3 wherein the forming wire is stainless steel.
Claim 6
Dependent Claim
22 words
A preformable catheter assembly in accordance with claim 4 wherein the forming wire has a diameter between 0.021 inch and 0.116 inch.
Claim 7
Dependent Claim
30 words
A preformable catheter assembly in accordance with claim 5 wherein the flexible envelope is heat-sealed about the catheter and forming wire to minimize the amount of entrapped air contained therein.
Claim 8
Dependent Claim
17 words
A preformable catheter assembly in accordance with claim 6 wherein the catheter is formed of radiopaque plastic.
Claim 9
Dependent Claim
150 words
A process of imparting substantially any desired configuration to a plastic catheter while the catheter is enclosed in a flexible, airtight, waterproof envelope and contains a malleable forming wire in the lumen thereof to provide a sterile catheter assembly adapted to be preformed by the user to the desired configuration without affecting the sterility of the catheter prior to insertion of the catheter in a body cavity comprising: bending the catheter assembly to form the catheter and wire within the envelope to the desired configuration; heating the assembly substantially until the plastic catheter softens around the wire; cooling the assembly substantially until the catheter hardens into the desired configuration around the forming wire thereby forming a sterile catheter within the envelope having the desired configuration for use; and removing the catheter from the remainder of the assembly including the envelope and the wire with the catheter retaining the desired configuration.
Claim 10
Dependent Claim
150 words
A process of imparting substantially any desired configuration to a plastic catheter while the catheter is enclosed in a flexible, airtight, waterproof envelope and contains a malleable forming wire in the lumen thereof to provide a sterile catheter assembly adapted to be preformed by the user to the desired configuration without affecting the sterility of the catheter prior to insertion of the catheter in a body cavity comprising: bending the catheter assembly to form the catheter and wire within the envelope to the desired configuration; heating the assembly substantially until the plastic catheter softens around the wire; cooling the assembly substantially until the catheter hardens into the desired configuration around the forming wire thereby forming a sterile catheter within the envelope having the desired configuration for use; and removing the catheter from the remainder of the assembly including the envelope and the wire with the catheter retaining the desired configuration.
Claim 11
Dependent Claim
134 words
A process of imparting a desired curvature to a plastic catheter to be inserted into a body cavity and assembly in the sterilized condition, said assembly comprising the catheter, a malleable forming wire inserted in the lumen of the catheter, and a flexible, airtight, waterproof, sterilized envelope containing a minimum of entrapped air when enclosed about the catheter and wire; including the steps of bending the catheter assembly to a desired curvature, heating the catheter assembly, cooling the catheter assembly, and then removing the catheter from the remainder of the assembly including the wire, whereby the catheter assumes and retains substantially the desired curvature and may be inserted into a body cavity, the catheter assembly being heated to a temperature of about 212* F., and the catheter assembly being cooled to about room temperature.
Claim 12
Dependent Claim
134 words
A process of imparting a desired curvature to a plastic catheter to be inserted into a body cavity and assembly in the sterilized condition, said assembly comprising the catheter, a malleable forming wire inserted in the lumen of the catheter, and a flexible, airtight, waterproof, sterilized envelope containing a minimum of entrapped air when enclosed about the catheter and wire; including the steps of bending the catheter assembly to a desired curvature, heating the catheter assembly, cooling the catheter assembly, and then removing the catheter from the remainder of the assembly including the wire, whereby the catheter assumes and retains substantially the desired curvature and may be inserted into a body cavity, the catheter assembly being heated to a temperature of about 212* F., and the catheter assembly being cooled to about room temperature.
Claim 13
Dependent Claim
19 words
A process in accordance with claim 9 wherein the catheter assembly is heated by means of a water bath.
Claim 14
Dependent Claim
19 words
A process in accordance with claim 10 wherein the catheter assembly is cooled by means of a water bath.