Sterile connector systems

• US 7,938,454 B2
• Filed: 04/24/2007
• Issued: 05/10/2011
• Est. Priority Date: 04/24/2007
• Status: Active Grant

• Current Assignee: Life Technologies Corporation (Thermo Fisher Scientific Incorporated)
• Original Assignee: Hyclone Laboratories, Inc. (Danaher Corporation)
• Inventors: Bilstad, Arnold C., Dennehey, T. Michael, Buchanan, Bradley H., Bacehowski, David V.
• Primary Examiner(s): BOCHNA, DAVID
• Application Number:
  US11/739,433
• Publication Number:
  US 20080265561A1
• Time in Patent Office: 1,477 Days
• Field of Search: 285/3, 285/417, 285/242, 285/239, 604/905
• US Class Current: 285/239
• CPC Class Codes: A61M 2039/167 with energizing means, e.g. light, vibration, electricity
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: B29C 65/1412 Infrared [IR] radiation
• CPC Class Codes: B29C 65/1435 at least passing through one of the parts to be joined, i.e. transmission welding
• CPC Class Codes: B29C 65/1441 making use of a reflector on the opposite side, e.g. a polished mandrel or a mirror pressing means reflective to electromagnetic radiation B29C66/81268
• CPC Class Codes: B29C 65/1445 heating both sides of the joint
• CPC Class Codes: B29C 65/1467 at the same time, i.e. simultaneous welding
• CPC Class Codes: B29C 65/148 placed at the interface
• CPC Class Codes: B29C 65/16 Laser beams
• CPC Class Codes: B29C 65/7473 using radiation, e.g. laser, for simultaneously welding and severing
• CPC Class Codes: B29C 66/0242 Heating, or preheating, e.g. drying B29C66/3464 takes precedence
• CPC Class Codes: B29C 66/1142 Single butt to butt joints
• CPC Class Codes: B29C 66/1162 Single bevel to bevel joints, e.g. mitre joints
• CPC Class Codes: B29C 66/5221 for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
• CPC Class Codes: B29C 66/5223 for forming corner connections or elbows, e.g. for making V-shaped pieces
• CPC Class Codes: B29C 66/52293 said stop being external
• CPC Class Codes: B29C 66/52296 said socket comprising sealing elements, e.g. gaskets
• CPC Class Codes: B29C 66/52297 said socket comprising slip-off prevention means B29C66/52296 takes precedence
• CPC Class Codes: B29C 66/52298 said socket being composed by several elements
• CPC Class Codes: B29C 66/534 Joining single elements to open ends of tubular or hollow articles or to the ends of bars
• CPC Class Codes: B29C 66/54 : Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29C 66/857 : Medical tube welding machines
• CPC Class Codes: B29K 2027/12 : containing fluorine
• CPC Class Codes: B29K 2027/16 : PVDF, i.e. polyvinylidene fluoride
• CPC Class Codes: B29K 2033/08 : Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2033/12 : Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2023/007 : Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: F16L 13/0236 : having an outer ring
• CPC Class Codes: F16L 2201/44 : sterile
• CPC Class Codes: F16L 47/02 : Welded joints; Adhesive joints
• CPC Class Codes: F16L 47/06 : with sleeve or socket formed by or in the pipe end
• CPC Class Codes: F16L 47/20 : based principally on specific properties of plastics
• CPC Class Codes: Y10S 604/905 : Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A system for forming a fluid connection includes a first connector and a second connector. Both connectors include a tubular body having a membrane mounted on a distal end thereof. A support member facilitates the coupling of the connectors together so that the membranes are abutted together. Radiant energy is applied to the abutted membranes so as to first sterilize the membranes and then melt the membranes so that a passage is formed therethrough.

Claims

1. A connector comprising:

a tubular body having a proximal end terminating at a proximal end face and an opposing distal end terminating at a distal end face, the tubular body having an interior surface bounding a linear passage extending therethrough between the proximal end face and the opposing distal end face, the passage having a central longitudinal axis extending along the length thereof, the linear passage having a cross sectional area normal to the central longitudinal axis that is substantially constant along the length of the linear passage, an annular barb encircling and radially outwardly projecting from the proximal end of the tubular body; and

a membrane secured to the distal end face of the tubular body so as to seal the passage closed thereat without encircling the tubular body, the membrane being disposed in a plane that orthogonally intersects with the central longitudinal axis of the tubular body, the membrane and the body being configured so that when a radiant energy is applied to the membrane and the body, at least a portion of the membrane exposed to the radiant energy melts to form an opening therein and at least a portion of the body exposed to the radiant energy does not melt.

2. The connector as recited in claim 1, wherein the membrane is mounted directly on the distal end face of the tubular body.

3. The connector as recited in claim 1, further comprising an annular ring having a first side connected to the distal end face of the tubular body and an opposing second side connected to the membrane.

4. The connector as recited in claim 1, further comprising a shoulder radially outwardly projecting from the body at a location between the proximal end face and the distal end face.

5. The connector as recited in claim 1, wherein the membrane has a maximum diameter in a range between about 2 cm and about 5 cm.

6. The connector as recited in claim 1, wherein the membrane is comprised of a thermoplastic.

7. The connector as recited in claim 1, wherein the membrane is comprised of polyvinylidene fluoride.

8. The connector as recited in claim 1, wherein the tubular body comprises:

a tubular liner comprised of a first polymeric material that bounds the linear passage; and

an outer layer comprised of a second polymeric material that encircles the tubular liner, the second polymeric material being different than the first polymeric material.

9. The connector as recited in claim 1, wherein the body has an exterior surface extending between the proximal end face and the distal end face, the membrane terminating at an outside edge of the distal end face so that the membrane does not extend over a portion of the exterior surface of the body.

10. The connector as recited in claim 1, wherein the entire membrane comprises a flat, planar sheet.

11. A system for forming a fluid connection, the system comprising:

a first connector comprising;

a tubular first body having a linear first passage extending therethrough between a proximal end and an opposing distal end, the first passage having a central first longitudinal axis extending along the length thereof; and

a first membrane sealing the first passage closed at the distal end of the first body without encircling the first body, the central first longitudinal axis intersecting with the first membrane so as to form an angle therebetween in a range between about 20° and

about 70°

;

a second connector comprising;

a tubular second body having a linear second passage extending therethrough between a proximal end and an opposing distal end, the second passage having a central second longitudinal axis extending along the length thereof; and

a second membrane sealing the second passage closed at the distal end of the second body, the first membrane and the second membrane being adapted to melt under the application of radiant energy; and

the distal end of the first body being coupled to the distal end of the second body so that the first longitudinal axis is aligned with the second longitudinal axis and the first membrane is disposed against or adjacent to the second membrane.

12. The system for forming a fluid connection as recited in claim 11, further comprising a support member coupling the distal end of the first body to the distal end of the second body, the support member being separable from the first connector and the second connector.

13. The system for forming a fluid connection as recited in claim 12, wherein the support member comprises a tubular sleeve, at least a portion of the distal end of the first body and the distal end of the second body being received within the tubular sleeve.

14. The system for forming a fluid connection as recited in claim 11, wherein the membrane is comprised of a fluoropolymer.

15. The system for forming a fluid connection as recited in claim 11, wherein the membrane is comprised of polyvinylidene fluoride.

16. The system for forming a fluid connection as recited in claim 11, wherein the first connector and the second connector have substantially the same configuration.

17. A system for forming a fluid connection, the system comprising:

a first connector comprising;

a tubular first body having a first passage extending therethrough between a proximal end and an opposing distal end, the first passage having a first longitudinal axis extending along the length thereof; and

a first membrane sealing the first passage closed at the distal end of the first body without encircling the first body, the first longitudinal axis intersecting with the first membrane so as to form an angle therebetween in a range between about 20° and

about 70°

;

a second connector comprising;

a tubular second body having a second passage extending therethrough between a proximal end and an opposing distal end, the second passage having a second longitudinal axis extending along the length thereof; and

a second membrane sealing the second passage closed at the distal end of the second body, the first membrane and the second membrane being adapted to melt under the application of radiant energy; and

a support member coupling the distal end of the first body to the distal end of the second body, the support member being separable from the first connector and the second connector.

18. The system for forming a fluid connection as recited in claim 17, wherein the support member comprises a tubular sleeve, at least a portion of the distal end of the first body and the distal end of the second body being received within the tubular sleeve.

19. The system for forming a fluid connection as recited in claim 17, further comprising a slot formed on the support member, a tab projecting from the first body being received within the slot of the support member.

20. The system for forming a fluid connection as recited in claim 17, wherein the support member comprises a tubular sleeve having a substantially C-shaped transverse cross section with an elongated slot that extends between a first end and an opposing second end, at least a portion of the distal end of the first body and the distal end of the second body being received within the tubular sleeve.

21. The system for forming a fluid connection as recited in claim 17, wherein the support member is comprised of a transparent material.

22. The system for forming a fluid connection as recited in claim 17, wherein the membrane is comprised of a fluoropolymer.

23. The system for forming a fluid connection as recited in claim 17, wherein the membrane is comprised of polyvinylidene fluoride.

24. A connector comprising:

a tubular body having a proximal end terminating at a proximal end face and an opposing distal end terminating at a distal end face, the tubular body having an interior surface bounding a linear passage extending therethrough between the proximal end face and the opposing distal end face, the passage having a central longitudinal axis extending along the length thereof, the tubular body comprising;

a tubular liner comprised of a first polymeric material that bounds the linear passage; and

an outer layer comprised of a second polymeric material that encircles the tubular liner, the second polymeric material being different than the first polymeric material; and

a membrane secured to the distal end of the tubular body so as to seal the passage closed thereat, the membrane being disposed in a plane that orthogonally intersects with the central longitudinal axis of the tubular body, the membrane and the body being configured so that when a radiant energy is applied to the membrane and the body, at least a portion of the membrane exposed to the radiant energy melts to form an opening therein and at least a portion of the body exposed to the radiant energy does not melt.

25. A system for forming a fluid connection, the system comprising:

a first connector comprising;

a tubular first body having a first passage extending therethrough between a proximal end and an opposing distal end, the first passage having a first longitudinal axis extending along the length thereof; and

a first membrane sealing the first passage closed at the distal end of the first body;

a second connector comprising;

a tubular second body having a second passage extending therethrough between a proximal end and an opposing distal end, the second passage having a second longitudinal axis extending along the length thereof; and

a second membrane sealing the second passage closed at the distal end of the second body, the first membrane and the second membrane being adapted to melt under the application of radiant energy; and

a support member coupling the distal end of the first body to the distal end of the second body, a slot formed on the support member, a tab projecting from the first body being received within the slot of the support member, the support member being separable from the first connector and the second connector.

26. A system for forming a fluid connection, the system comprising:

a first connector comprising;

a tubular first body having a first passage extending therethrough between a proximal end and an opposing distal end, the first passage having a first longitudinal axis extending along the length thereof; and

a first membrane sealing the first passage closed at the distal end of the first body;

a second connector comprising;

a tubular second body having a second passage extending therethrough between a proximal end and an opposing distal end, the second passage having a second longitudinal axis extending along the length thereof; and

a second membrane sealing the second passage closed at the distal end of the second body, the first membrane and the second membrane being adapted to melt under the application of radiant energy; and

a support member coupling the distal end of the first body to the distal end of the second body, the support member comprising a tubular sleeve having a substantially C-shaped transverse cross section with an elongated slot that extends between a first end and an opposing second end, at least a portion of the distal end of the first body and the distal end of the second body being received within the tubular sleeve, the support member being separable from the first connector and the second connector.