STERILE CONNECTOR SYSTEMS

• US 20100133807A1
• Filed: 04/23/2008
• Published: 06/03/2010
• 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: Woods, Whitt F., Goodwin, Michael E., Bilstad, Arnold C., Dennehey, T. Michael, Larsen, Jeremy K., Buchanan, Bradley H., Bacehowski, David V.
• Granted Patent: US 8,702,129 B2
• Time in Patent Office: Days
• US Class Current: 285/80
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 39/143 both tube ends being sealed by meltable membranes pierced after connection by use of heat, e.g. using radiant energy
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 65/06 using friction, e.g. spin welding non-plastics elements to plastic elements B29C65/645
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• 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 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• 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 66/322 Providing cavities in the joined article to collect the burr
• 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 66/5229 : involving the use of a socket
• CPC Class Codes: B29C 66/52293 : said stop being external
• 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 66/80 : General aspects of machine operations or constructions and parts thereof
• CPC Class Codes: B29C 66/81267 : Transparent to electromagnetic radiation, e.g. to visible light
• 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: B29K 2071/00 : Use of polyethers , e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2101/12 : Thermoplastic materials
• CPC Class Codes: B29K 2995/0025 : Opaque
• CPC Class Codes: B29K 2995/0026 : Transparent
• CPC Class Codes: F16L 2201/44 : sterile
• CPC Class Codes: F16L 29/005 : joints with cut-off devices which can be perforated cut-off devices with a breakable closure member in general F16K13/04

Abstract

A system for forming a fluid connection includes a first connector (12) and a second connector (14). Both connectors include a tubular body (18,18′) having a membrane (19,19′) mounted on a distal end (27) thereof. A support member (16) or other fastener (214,220) facilitates the coupling of the connectors together so that the membranes are abutted together. Radiant or other form of energy is applied to the abutted membranes so as to sterilize the membranes and melt the membranes so that a passage is formed therethrough.

Claims

1. A connector comprising:

a tubular body having an exterior surface extending between a proximal end and an opposing distal end, the proximal end terminating at a proximal end face and the 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;

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 an energy is applied to the membrane and the body, at least a portion of the membrane exposed to the energy melts to form an opening therein and at least a portion of the body exposed to the energy does not melt; and

an alignment stem projecting from the distal end of the tubular body so that at least a portion of the alignment stem is disposed distal of the membrane.

2. The connector as recited in claim 1, wherein the alignment stem projects from the distal end face of the tubular body.

3. The connector as recited in claim 1, wherein the alignment stem projects from the exterior surface of the tubular body.

4. The connector as recited in claim 1, further comprising a barb outwardly projecting from the alignment stem or an opening or recess formed on the alignment stem.

5. The connector as recited in claim 1, further comprising an alignment slot formed on the distal end of the tubular body.

6. The connector as recited in claim 5, wherein the alignment slot comprises a tunnel from the distal end face of the tubular body or the alignment slot is formed on the exterior surface of the tubular body.

7. The connector as recited in claim 1, further comprising:

a plurality of spaced apart alignment stems projecting from the distal end of tubular body; and

a plurality of spaced apart alignment slots formed on the distal end of the tubular body.

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

9. The connector as recited in claim 1, wherein the membrane is welded onto the distal end face of the tubular body.

10. 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.

11. The connector as recited in claim 1, further comprising an annular barb encircling and radially outwardly projecting from the proximal end of the tubular body.

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

13. 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.

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

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

17. The connector as recited in claim 1, wherein 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.

16. (canceled)

18-47. -47. (canceled)

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

a first connector comprising;

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;

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

a first alignment slot formed on the distal end of the tubular first body; and

a first alignment stem projecting from the distal end of the tubular first body;

a second connector comprising;

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 energy;

a second alignment slot formed on the distal end of the tubular second body; and

a second alignment stem projecting from the distal end of the tubular second body; and

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

49. The system for forming a fluid connection as recited in claim 48, 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 first connector and the second connector.

50. The system for forming a fluid connection as recited in claim 49, 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.

52. The system for forming a fluid connection as recited in claim 49, wherein the support member is comprised of a transparent material.

53. The system for forming a fluid connection as recited in claim 48, wherein the membrane is comprised of a fluoropolymer.

56. The system for forming a fluid connection as recited in claim 48, wherein the central longitudinal axis of the first passage intersects with the first membrane so as to form an angle therebetween in a range between about 70°

and about 90°

.

57. The system for forming a fluid connection as recited in claim 48, wherein the central longitudinal axis of the first passage intersects with the first membrane so as to form an angle therebetween in a range between about 20°

and about 70°

.

51. (canceled)

54. (canceled)

55. (canceled)

58-71. -71. (canceled)

72. A method for forming a fluid connection, the method comprising the steps of:

positioning a first membrane closing off a first passage extending through a first tubular connector against or adjacent to a second membrane closing off a second passage extending through a second tubular connector;

applying energy to the first membrane and the second membrane after the step of coupling the support member so as to melt the first membrane and the second membrane and seal the first tubular connector to the a second tubular connector; and

further comprising applying an axial force to the first connector and the second connector that pushes the first membrane against the second membrane when applying the energy to the first membrane and the second membrane.

73. The method as recited in claim 72, coupling a support member to the first tubular connector and the second tubular connector so that the support member holds first tubular connector and the second tubular connector together

74. The method as recited in claim 73, wherein the step of coupling the support member occurs at the same time as positioning a first membrane against or adjacent to a second membrane.

75. The method as recited in claim 73, wherein the step of coupling the support member occurs after the step of positioning a first membrane against or adjacent to a second membrane.

76. The method as recited in claim 73, wherein the support member comprises a tubular sleeve and the step of coupling the support member comprises sliding a distal end of the first tubular connector into a first end of the tubular sleeve and sliding a distal end of the second tubular connector into a second end of the tubular sleeve.

77. The method as recited in claim 73, wherein the step of applying energy to the first membrane and the second membrane causes the support member to be welded to at least the first tubular connector or the second tubular connector.

78. The method as recited in claim 73, wherein the step of applying energy comprises applying a radiant energy, an electrical current or a laser.