Sterile coupling

• US 4,432,755 A
• Filed: 05/25/1983
• Issued: 02/21/1984
• Est. Priority Date: 04/06/1982
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Pearson, Stephen
• Primary Examiner(s): Truluck, Dalton L.
• Assistant Examiner(s): Lester, Michelle N.
• Application Number:
  US06/497,963
• Time in Patent Office: 272 Days
• Field of Search: 604/56, 604/403, 604/408, 604/410-416, 604/905, 285/3, 285/260, 141/329, 141/330, 206/219, 206/222
• US Class Current: 141/329
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A sterile coupling enabling the selective establishment of a sterile pathway between two separate receptacles. A preferably injection molded plastic junction is made about at least the end portions of access means to each of the separate receptacles. The junction provides a sterile coupling so as to selectively bring the access means into pathway communication and thereby establish a sterile pathway between the receptacles through the access means. Also disclosed are methods for manufacturing a sterile coupling and methods for establishing a sterile pathway between the receptacles, as well as a method for low pressure injection molding.

Claims

1. A method for establishing and maintaining a sterile relation between the access means of each of two separate receptacles, each access means having an end portion, wherein at least one of the access means includes a piercing element, to provide for the selective establishment of a sterile pathway between the two receptacles, the steps comprising:

(a) maintaining the end portions in predetermined, spaced relation;

(b) injection molding molten material about at least the end portions of both access means;

(c) simultaneously sterilizing the end portions of both access means by heat transfer from the injection molded molten material; and

(d) cooling the molten material into a unitary junction means enclosing the end portions, the junction means maintaining the end portions in sterile relation, wherein the piercing element may be urged through the junction means so as to selectively establish a sterile pathway between the receptacles through both access means.

2. A method for establishing and maintaining a sterile relation between the access means of each of two separate receptacles, each access means having an end portion, wherein at least one of the access means includes a piercing element, to provide for the selective establishment of a sterile pathway between the receptacles, the steps comprising:

(a) biasing the end portions of the access means into abutting relation;

(b) injection molding molten material about at least the end portions of both access means, said injection molding step overcoming said bias and separating the end portions into spaced relation;

(c) simultaneously sterilizing the end portions of both access means by heat transfer from the injection molded molten material; and

(d) cooling the molten material into a unitary junction means enclosing the end portions, the junction means maintaining the end portions in sterile relation, wherein the piercing element may be urged through the junction means so as to selectively establish a sterile pathway between the receptacles through both access means.

3. A method for selectively establishing a sterile pathway between the access means of each of two separate receptacles, each access means having an end portion, wherein one of the access means includes a piercing element, the steps comprising:

(a) maintaining the end portions in predetermined, spaced relation;

(b) injection molding material about at least the end portions of both access means;

(c) simultaneously sterilizing the end portions of both access means by heat transfer from the injection molded molten material;

(d) cooling the molten material into a unitary junction means enclosing the end portions, the junction means maintaining the end portions in sterile relation; and

(e) selectively urging the piercing element through the junction means and the other of the access means thereby establishing a sterile pathway through both access means.

4. A method for selectively establishing a sterile pathway between access means of each of two separate receptacles, each access means having an end portion, wherein one of the access means includes a piercing element, the steps comprising:

(a) biasing the end portions of the access means into abutting relation;

(b) injection molding molten material about at least the end portions of both access means, said injection molding step overcoming said bias and separating the end portions into spaced relation;

(c) simultaneously sterilizing the end portions of both access means by heat transfer from the injection molded molten material;

(d) cooling the molten material into a unitary junction means enclosing the end portions, the junction means maintaining the end portions in sterile relation; and

(e) selectively urging the piercing element through the junction means and other of the access means, thereby establishing a sterile pathway through both access means.