Source: http://www.google.com/patents/US20030143352?dq=7,173,247
Timestamp: 2017-11-21 05:23:40
Document Index: 379799906

Matched Legal Cases: ['art 74', 'art 78', 'art 74', 'art 74', 'art 76', 'art 74', 'art 78', 'art 74']

Patent US20030143352 - Laser weldable flexible medical tubings, films and assemblies thereof - Google Patents
The present invention provides a polymer blend for fabricating a laser-weldable article having a first component of a material not thermally responsive to a laser beam and selected from the group consisting of polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene and lower alkyl substituted...http://www.google.com/patents/US20030143352?utm_source=gb-gplus-sharePatent US20030143352 - Laser weldable flexible medical tubings, films and assemblies thereof
Publication number US20030143352 A1
Application number US 10/251,683
Also published as EP2301620A1, US6913056, US7226649, US7459054, US8146642, US20030141009, US20030141634, US20050173056, US20090054873
Publication number 10251683, 251683, US 2003/0143352 A1, US 2003/143352 A1, US 20030143352 A1, US 20030143352A1, US 2003143352 A1, US 2003143352A1, US-A1-20030143352, US-A1-2003143352, US2003/0143352A1, US2003/143352A1, US20030143352 A1, US20030143352A1, US2003143352 A1, US2003143352A1
Inventors Tahua Yang, Sherwin Shang
Original Assignee Tahua Yang, Sherwin Shang
Patent Citations (99), Referenced by (32), Classifications (97), Legal Events (3)
US 20030143352 A1
The present invention provides a polymer blend for fabricating a laser-weldable article having a first component of a material not thermally responsive to a laser beam and selected from the group consisting of polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene and lower alkyl substituted alkyl acrylate copolymers, ethylene vinyl acetate copolymers, polybutadienes, polyesters, polyamides, and styrene and hydrocarbon copolymers; a second component of a laser responsive material having low solubility in an aqueous medium and present in an amount by weight of from about 20 ppm to about 2000 ppm; and the blend being sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to at melt upon exposure to the laser beam for a short period of time.
1. A polymer blend for fabricating a laser-weldable article comprising:
a first component of a material not thermally responsive to a laser beam and selected from the group consisting of polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene and lower alkyl substituted alkyl acrylate copolymers, ethylene vinyl acetate copolymers, polybutadienes, polyesters, polyamides, and styrene and hydrocarbon copolymers;
a second component of a laser responsive material having low solubility in an aqueous medium and present in an amount by weight of from about 20 ppm to about 2000 ppm; and
the blend being sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to at melt upon exposure to the laser beam for a short period of time.
2. The blend of claim 1, wherein the polyolefin is obtained from a monomer of an α-olefin having from 2 to 20 carbons.
3. The blend of claim 1, wherein the polyolefin is selected from the group of propylene containing polymers and ethylene containing polymers.
4. The blend of claim 1, wherein the polyolefin is selected from the group consisting of homopolymers of polypropylene and copolymers of polypropylene.
5. The blend of claim 4, wherein the homopolymer of polypropylene has a stereochemistry selected from the group consisting of isotactic, syndiotactic, atactic, hemiisotactic and stereoblock.
6. The blend of claim 4, wherein the copolymer of polypropylene is selected from the group consisting of random copolymers and block copolymers.
7. The blend of claim 4, wherein the copolymer of polypropylene is obtained by polymerizing a propylene monomer with an α-olefin having from 2 to 20 carbons.
8. The blend of claim 4, wherein the copolymer of polypropylene is selected from the group of random copolymers with ethylene and block copolymers with ethylene.
9. The blend of claim 1, wherein the polyolefin has a heat of fusion from about 60 joules/g to about 160 joules/g.
10. The blend of claim 9, wherein the polyolefin has a peak melting point temperature of less than about 165° C.
11. The blend of claim 1, wherein the first component is a second blend of a first polypropylene and a styrene and hydrocarbon copolymer.
12. The blend of claim 11, wherein the styrene and hydrocarbon copolymer is selected from the group of random copolymers of styrene and hydrocarbon and block copolymers of styrene and hydrocarbon.
13. The blend of claim 12, wherein the styrene and hydrocarbon block copolymer is selected from the group consisting of di-block copolymers, tri-block copolymers, multi-block copolymers and star block copolymers.
14. The blend of claim 13, wherein the styrene and hydrocarbon block copolymer is oil modified.
15. The blend of claim 11, wherein the second blend includes a second polypropylene, the second polypropylene having a high melt strength.
16. The blend of claim 15, wherein the second blend has from about 10% to about 50% by weight of the sum of the weights of the first polypropylene and the second polypropylene and the styrene and hydrocarbon copolymer constituting the remaining weight portion of the second blend.
17. The blend of claim 1, wherein the polyolefin is selected from the group consisting of homopolymers of ethylene and copolymers of ethylene.
18. The blend of claim 17, wherein the copolymers of ethylene are obtained by polymerizing ethylene monomers with an α-olefin having from 3 to 20 carbons.
19. The blend of claim 17, wherein the copolymers of ethylene are obtained by polymerizing ethylene monomers with an α-olefin having from 4 to 8 carbons.
20. The blend of claim 17, wherein the copolymers of ethylene have a density of less than about 0.915 g/cc.
21. The blend of claim 17, wherein the copolymers of ethylene have a density of less than about 0.900 g/cc.
22. The blend of claim 17, wherein the polyolefin is an ultra-low density polyethylene.
23. The blend of claim 2, wherein the polyolefin is obtained utilizing a single-site catalyst.
24. The blend of claim 2, wherein the polyolefin is obtained utilizing a metallocene catalyst.
25. The blend of claim 1, wherein the first component is a polybutadiene.
26. The blend of claim 1, wherein the laser responsive material has a functional group selected from the group consisting of: polymethine, porphine, indanthrene, quinone, di- and tri-phenylmethane, and metal complexed dithiol dyes.
27. The blend of claim 26, wherein the laser responsive material is a dye,
28. The blend of claim 27, wherein the dye is thermally stable at temperatures reached during extrusion processing of the blend.
29. The blend of claim 28, wherein the dye is present in an amount from about 200 ppm to about 500 ppm.
30. The blend of claim 1, wherein the first component is a third blend of from about 99% to about 50% by weight of a third component selected from the group consisting of: (1) ethylene and α-olefin copolymers having a density of less than about 0.915 g/cc, (2) ethylene and lower alkyl acrylate copolymers, (3) ethylene and lower alkyl substituted alkyl acrylate copolymers and (4) ionic polymers; and from about 50% to about 1% of a fourth component selected from the group consisting of: (1) propylene containing polymers, (2) butene containing polymers, (3) polymethyl pentene containing polymers, (4) cyclic olefin containing polymers and (5) bridged polycyclic hydrocarbon containing polymers.
31. The blend of claim 30, wherein the laser responsive material is present in an amount from about 200 ppm to about 2000 ppm.
32. A laser weldable tubing comprising:
a sidewall having a layer from a polymer blend comprising a first component of a material not thermally responsive to a laser beam and selected from the group consisting of polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene and lower alkyl substituted alkyl acrylate copolymers, ethylene vinyl acetate copolymers, polybutadienes, polyesters, polyamides, and styrene and hydrocarbon copolymers, a second component in an amount by weight of from about 20 ppm to about 500 ppm of a laser responsive material having low solubility in aqueous medium and the layer being sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to melt a portion of the sidewall upon exposure to the laser beam for a short period of time.
33. The tubing of claim 32, wherein the tubing has a monolayer structure.
34. The tubing of claim 32, wherein the tubing has a multiple layer structure.
35. The tubing of claim 34, wherein the layer forms a solution contact layer.
36. The tubing of claim 34, wherein the layer is a core layer.
37. The tubing of claim 34, wherein the layer is a skin layer.
38. The tubing of claim 32, wherein the polyolefin is obtained from a monomer of an α-olefin having from 2 to 20 carbons.
39. The tubing of claim 32, wherein the polyolefin is selected from the group of propylene containing polymers and ethylene containing polymers.
40. The tubing of claim 32, wherein the polyolefin is selected from the group consisting of homopolymers of polypropylene and copolymers of polypropylene.
41. The tubing of claim 40, wherein the homopolymer of polypropylene has a stereochemistry selected from the group consisting of isotactic, syndiotactic, atactic, hemiisotactic and stereoblock.
42. The tubing of claim 40, wherein the copolymer of polypropylene is selected from the group consisting of random copolymers and block copolymers.
43. The tubing of claim 40, wherein the copolymer of polypropylene is obtained by polymerizing a propylene monomer with an (α-olefin having from 2 to 20 carbons.
44. The tubing of claim 40, wherein the copolymer of polypropylene is selected from the group of random copolymers with ethylene and block copolymers with ethylene.
45. The tubing of claim 32, wherein the polyolefin has a heat of fusion from about 60 joules/g to about 160 joules/g joules/g.
46. The tubing of claim 45, wherein the polyolefin has a peak melting point temperature of less than about 165° C.
47. The tubing of claim 32, wherein the first component is a second blend of a first polypropylene and a styrene and hydrocarbon copolymer.
48. The tubing of claim 47, wherein the styrene and hydrocarbon copolymer is selected from the group of random copolymers of styrene and hydrocarbon and block copolymers of styrene and hydrocarbon.
49. The tubing of claim 48, wherein the styrene and hydrocarbon block copolymer is selected from the group consisting of di-block copolymers, tri-block copolymers, and star block copolymers.
50. The tubing of claim 49, wherein the styrene and hydrocarbon block copolymer is oil modified.
51. The tubing of claim 47, wherein the second blend includes a second polypropylene, the second polypropylene having high melt strength.
52. The tubing of claim 51, wherein the second blend has from about 10% to about 50% by weight of the sum of the weights of the first polypropylene and the second polypropylene and the styrene and hydrocarbon copolymer constituting the remaining weight portion of the second blend.
53. The tubing of claim 32, wherein the polyolefin is selected from the group consisting of homopolymers of ethylene and copolymers of ethylene.
54. The tubing of claim 53, wherein the copolymers of ethylene are obtained by polymerizing ethylene monomers with an α-olefin having from 3 to 20 carbons.
55. The tubing of claim 53, wherein the copolymers of ethylene are obtained by polymerizing ethylene monomers with an α-olefin having from 4 to 8 carbons.
56. The tubing of claim 53, wherein the copolymers of ethylene have a density of less than about 0.915 g/cc.
57. The tubing of claim 53, wherein the copolymers of ethylene have a density of less than about 0.900 g/cc.
58. The tubing of claim 53, wherein the polyolefin is an ultra-low density polyethylene.
59. The tubing of claim 58, wherein the ultra-low density polyethylene is obtained utilizing a single-site catalyst.
60. The tubing of claim 58, wherein the ultra-low density polyethylene is obtained utilizing a metallocene catalyst.
61. The tubing of claim 32, wherein the laser responsive material has a functional group selected from the group consisting of: polymethine, porphine, indanthrene, quinone, di- and tri-phenylmethane, and metal complexed dithiol dyes.
62. The tubing of claim 61, wherein the laser responsive material is a dye.
63. The tubing of claim 62, wherein the dye is thermally stable at temperatures reached during extrusion processing of the tubing.
64. The tubing of claim 63 wherein the dye is present in an amount from about 200 ppm to about 500 ppm.
65. A film comprising:
a layer comprising a first blend of a polymeric component and a laser responsive component, wherein the polymeric component is a second blend of from about 99% to about 50% by weight of a first component selected from the group consisting of: (1) ethylene and α-olefin copolymers having a density of less than about 0.915 g/cc, (2) ethylene and lower alkyl acrylate copolymers, (3) ethylene and lower alkyl substituted alkyl acrylate copolymers and (4) ionic polymers; and from about 50% to about 1% of a second component selected from the group consisting of: (1) propylene containing polymers, (2) butene containing polymers, (3) polymethyl pentene containing polymers, (4) cyclic olefin containing polymers and (5) bridged polycyclic hydrocarbon containing polymers; and
wherein the film is sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to at melt upon exposure to the laser beam for a short period of time.
66. The film of claim 65, wherein the α-olefin has from 4 to 8 carbons.
67. The film of claim 66, wherein the ethylene and α-olefin copolymer is obtained using a single-site catalyst.
68. The film of claim 66, wherein the second component is a propylene containing polymer.
69. The film of claim 68, wherein the propylene containing polymer is a homopolymer.
70. The film of claim 68, wherein the propylene containing polymer is a copolymer of propylene and ethylene.
71. The film of claim 70, wherein the second blend includes a third component of a second ethylene and α-olefin copolymer.
72. The film of claim 71, wherein the second ethylene and α-olefin copolymer is obtained using a single-site catalyst.
73. The film of claim 72, wherein the first ethylene and α-olefin copolymer has a density of less than about 0.900 g/cc, and the second ethylene and α-olefin copolymer has a density of higher than about 0.900 g/cc but less than about 0.910 g/cc.
74. The film of claim 65 further comprising a laser responsive material in the first blend and wherein the laser responsive material is a dye having a functional group selected from the group polymethine, porphine, indanthrene, quinone, di- and tri-phenylmethane, and metal complexed dithiol dyes.
75. The film of claim 65, wherein the film is a monolayer structure.
76. The film of claim 65, wherein the film is a multiple layer structure.
77. The film of claim 76, wherein the layer is a seal layer.
78. A film comprising:
a layer of a first blend of a polymeric component and a laser responsive component wherein the polymeric component is a second blend comprising by weight of from about 35% to about 45% of a first ethylene and α-olefin copolymer having a density of less than about 0.900 g/cc, from about 20% to about 30% of a second ethylene and α-olefin copolymer having a density of higher than about 0.900 g/cc but less than about 0.910 g/cc, and from about 30% to about 40% of a polypropylene and wherein the film is sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to at melt upon exposure to the laser beam for a short period of time.
79. The film of claim 78, wherein the first ethylene and α-olefin copolymer is obtained using a single-site catalyst.
80. The film of claim 79, wherein the second ethylene and α-olefin copolymer is obtained using a single-site catalyst.
81. The film of claim 80, wherein the polypropylene is a random copolymer of propylene with ethylene.
82. The film of claim 78 further comprising a laser responsive material in the first blend and wherein the laser responsive material is a dye having a functional group selected from the group polymethine, porphine, indanthrene, quinone, di- and tri-phenylmethane, and metal complexed dithiol dyes.
83. A film comprising:
a layer of a blend of an ethylene and α-olefin copolymer and a dye having a functional group selected from the group polymethine, porphine, indanthrene, quinone, di- and tri-phenylmethane, and metal complexed dithiol dyes.
84. The film of claim 83, wherein the ethylene and α-olefin copolymer is obtained using a single-site catalyst.
85. The film of claim 84, wherein ethylene and α-olefin copolymer has a density of less than about 0.915 g/cc.
86. The film of claim 84, wherein ethylene and α-olefin copolymer has a density of less than about 0.900 g/cc.
87. A laser weldable multiple lumen tubing comprising:
a first lumen and a second lumen each having a layer from a polymer blend comprising a first component of a material not thermally responsive to a laser beam and selected from the group consisting of polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene and lower alkyl substituted alkyl acrylate copolymers, ethylene vinyl acetate copolymers, polybutadienes, polyesters, polyamides, and styrene and hydrocarbon copolymers, a second component in an amount by weight of from about 20 ppm to about 2,000 ppm of a laser responsive material having low solubility in aqueous medium and the layer being sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to melt a portion of the sidewall upon exposure to the laser beam for a short period of time.
88. The multiple lumen tubing of claim 87 wherein the first lumen and the second lumen are connected together along peripheral edges.
89. The multiple lumen tubing of claim 88 wherein the first lumen and the second lumen extend in a parallel direction with respect to one another.
90. The multiple lumen tubing of claim 88 wherein the first lumen and the second lumen are helically disposed with respect to one another.
91. The multiple lumen tubing of claim 87 wherein the first lumen and the second lumen are concentrically disposed with respect to one another.
92. The multiple lumen tubing of claim 87 wherein the first lumen defines a passageway and further comprising a third lumen wherein the second lumen and third lumen are disposed in the passageway.
This is a continuation in part of U.S. patent application Ser. No. 10/061,835 filed on Jan. 31, 2002, which is currently pending, and which is hereby incorporated herein by reference and made a part hereof.
It is known to use medical containers with tubing for various medical procedures such as kidney dialysis, intravenous delivery of therapeutic fluids, delivery of nutritional fluids; delivery of blood., blood components, and blood substitutes. Fluid containers and tubing are also widely used in other industries such as the food industry and the chemical industries.
One such device, incorporates a heated wafer or hot knife that physically contacts the tubing to cut it by melting the tube and joining two tubes together or melt-sealing the tube ends. Typically, heated wafer applications involve a “melt and wipe” process. In peritoneal dialysis, for example, a patient must drain spent dialysate or replenish his/her peritoneal cavity with fresh dialysate. To this end, the patient must connect the transfer set tubing to a tube extending from either a drain bag or a bag containing fresh dialysate. In one “melt and wipe” process, the transfer set tubing is bent in a U or V-shape to fit into a U or V-shaped tube holder. Similarly, the bag-side tube is bent in a U or V-shape to fit into another U or V-shaped tube holder adjacent the first tube holder. A heated wafer moves across the space between the two tube holders and physically contacts the tubing at the bend junction of the U-shape or V-shape. As the heated wafer contacts the tubing, it melts the tube at the bend junction of the U-shape or V-shape. The wafer then wipes the melted tubing material and removes the material from the area between the tube holders. The two holders are brought together and two connections are made. In the first connection, the transfer set tubing is connected to the bag-side tube and the dialysis process is ready to begin. In the second connection, the wasted tube material from the transfer set tubing and the bag-side tube is connected together and discarded.
In order to disconnect the patient from the bag, hot knives are used to cut the tube. An example of a known disconnecting process with the hot knife involves two tubes that are placed side by side across two tube holders. One of the tubes is a short tube having two sealed ends. Generally, the tube holders include a ridge at one end of the tube holder to flatten a portion of the tube to stop fluid flow. The hot knife severs each tube into two pieces. After the hot knife cuts the tube, one of the tube holders moves in relation to the other tube holder. The tubing is “swapped,” realigned with one of the cut portions of the short tube, and connected to it—thus, a disconnection is made between the patient and the bag.
The present invention further provides a laser weldable tubing having a sidewall having a layer from a polymer blend having a first component of a material not thermally responsive to a laser beam and selected from the group consisting of polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene and lower alkyl substituted alkyl acrylate copolymers, ethylene vinyl acetate copolymers, polybutadienes, polyesters, polyamides, and styrene and hydrocarbon copolymers. The blend has a second component in an amount by weight of from about 20 ppm to about 500 ppm of a laser responsive material having low solubility in aqueous medium and the layer being sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to melt a portion of the sidewall upon exposure to the laser beam for a short period of time.
The present invention further provides a film having a layer of a first blend. The blend has a polymeric component and a laser responsive component. The polymeric component is a second blend of from about 99% to about 50% by weight of a first component selected from the group consisting of: (1) ethylene and α-olefin copolymers having a density of less than about 0.915 g/cc, (2) ethylene and lower alkyl acrylate copolymers, (3) ethylene and lower alkyl substituted alkyl acrylate copolymers and (4) ionic polymers. The blend has a second component from about 50% to about 1%. The second component is selected from the group consisting of: (1) propylene containing polymers, (2) butene containing polymers, (3) polymethyl pentene containing polymers, (4) cyclic olefin containing polymers and (5) bridged polycyclic hydrocarbon containing polymers. The film is sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to at melt upon exposure to the laser beam for a short period of time.
The present invention further provides a film having a layer of a first blend of a polymeric component and a laser responsive component. The polymeric component is a second blend comprising by weight of from about 35% to about 45% of a first ethylene and α-olefin copolymer having a density of less than about 0.900 g/cc, from about 20% to about 30% of a second ethylene and α-olefin copolymer having a density of higher than about 0.900 g/cc but less than about 0.910 g/cc, and from about 30% to about 40% of a polypropylene. The film is sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to at melt upon exposure to the laser beam for a short period of time.
The present invention further provides a laser weldable multiple lumen tubing having a first lumen and a second lumen each having a layer from a polymer blend. The layer has a first component of a material not thermally responsive to a laser beam and selected from the group consisting of polyolefins, ethylene and lower alkyl acrylate copolymers, ethylene and lower alkyl substituted alkyl acrylate copolymers, ethylene vinyl acetate copolymers, polybutadienes, polyesters, polyamides, and styrene and hydrocarbon copolymers, a second component in an amount by weight of from about 20 ppm to about 2,000 ppm of a laser responsive material having low solubility in aqueous medium and the layer being sufficiently thermally responsive to exposure to a laser beam having a wavelength within a range of wavelengths from about 700 nm to about 1500 nm to melt a portion of the sidewall upon exposure to the laser beam for a short period of time.
[0020]FIG. 1 is a perspective view of a housing of an embodiment of the present invention.
[0021]FIGS. 2A through 2D are perspective views of a connection and disconnection device according to principles of the present invention.
[0022]FIGS. 3A and 3B are perspective views of another tube holder of an embodiment of the present invention.
[0023]FIGS. 4A through 4H are schematic plan views of the device embodiment in FIGS. 2A through 2D.
[0024]FIGS. 5A through 5C are schematic cross-sectional views of an embodiment of a sealed end tube of the present invention.
[0025]FIG. 6 is a schematic plan view of a protective film according to principles of the present invention.
[0026]FIG. 7 is a schematic plan view of another embodiment of the present invention.
[0027]FIG. 8 is a perspective view of an optical assembly of another embodiment of the present invention.
[0028]FIGS. 9A and 9B are schematic plan views of another embodiment of the present invention.
[0029]FIGS. 10A and 10B are perspective views of another embodiment of the present invention.
[0030]FIGS. 11a, 11 b and 11 c are respectively cross-sectional views of a monolayer, non-PVC, laser weldable tubing and a multiple layer tubing having the monolayer tubing as a layer therein and a multilumen tubing.
[0031]FIG. 12 is a cross-sectional view of a capped tubing assembly.
[0032]FIG. 13 is a cross-sectional view of a coupler.
[0033]FIG. 14 is a cross-sectional view of a tubing and coupler assembly.
[0034]FIG. 15 is a plan view of a medical fluids container connected to a non-PVC laser-weldable tubing.
[0035]FIG. 16 is a cross-sectional view of a laser-weldable tubing connected through a coupler device to a tubing from a transfer set.
[0036]FIG. 17 is a cross-sectional view of a dual lumen tubing.
[0037]FIG. 18 is a cross-sectional view of a dual lumen tubing with the individual lumen concentrically disposed with respect to one another.
[0038]FIG. 19 is a cross-sectional view of a multiple lumen tubing.
[0042]FIG. 1 shows a device 10 according to an embodiment of the present invention. The device 10 includes a housing 12 that has a front 14, a back 16, and two sides 18, 20 there between. The housing 12 also includes a bottom 22 and a lid or door 24. The four sides 14, 16, 18, 20 and bottom 22 define an interior area A. Two slots or openings 30, 32 are located at upper ends 34, 36 of two sides 18, 20 of the housing 12. The door 24 is hinged to the back 16 of the housing 12. The door 24 may be hinged in any number of ways to allow it to be easily opened and shut. The door includes a locking mechanism (not shown) to lock the door closed when the device is in operation. In an embodiment, the door 24 also has two slots 38, 40 that align with the slots 30, 32 to create an area (not shown) for loading and unloading tubing 50 which will be described in further detail below.
[0043]FIGS. 2A through 2D show the inside of the device 10 according to an embodiment of the present invention. Inside the housing 12 are two passageways 52, 54. In an embodiment, the passageways 52, 54 are funneled. Each passageway leads to a guide 56, 58. The guides 56, 58 receive the tubing 50 and advance the tubing 50 within the housing 12. The guides are, preferably, pinch rollers, however, various types of guides or threading devices, may be used. In a preferred embodiment, the guides 56, 58 crimp the tubing 50 as it is fed into the device 10. (See FIG. 2A, Ref. No. 58). This crimping purges fluid from a portion 60 of the tube 50 that progresses past the guides 56, 58 into the device.
[0044]FIGS. 2A through 2D also show a pair of tube holders 70, 72 aligned with guides 56, 58 in the housing 12. FIGS. 3A and 3B show an enlarged view of another tube holder 70 of the present invention. As shown in FIGS. 2A through 2D and 3A and 3B, each tube holder 70, 72 has a first part 74, 76 and a second part 78, 80, respectively. Each first and second part 74, 76 and 78, 80 has a recess or groove 82, 84 that corresponds with an outer diameter B of the tubing 50. The first part 74, 78 is movably attached to the second part 76, 80 via a hinge 85 or similar mechanism. When the tube holders 70, 72 are in the closed position, an aperture 90 is formed extending through the holder 70, 72. A diameter C of this aperture 90 is slightly smaller than the outer diameter B of the tube 50. In this way, the tubing 50 is fed through the guides 56, 58 and received in the tube holders 70, 72. In an embodiment, an inside surface of the tube holders 70, 72 is tapered (not shown). The aperture 90 may be slightly tapered toward the center of the device 10. In this example, the diameter C of the aperture 90 facing the inside of the device is smaller than a diameter of the aperture facing the guides 70, 72. When in the closed position, the tube holders 70, 72 close with sufficient force to grip, but not flatten, the tubing. In addition, if necessary, the aperture 90 uniformly compresses the tubing 50 and forces the tubing to maintain a cylindrical shape. This may be necessary if, for example, the tubing 50 is not cylindrical due to storage conditions of the tubing or prior sterilization methods, e.g., steam sterilization or ETO sterilization, which may cause the tubing 50 to coil and not be perfectly round.
[0049]FIGS. 2A through 2D and 4A through 4H show an optical assembly 202 according to an embodiment of the invention. In this example, the optical assembly 202 includes a collimator 204, and a reflective prism 206. Depending on the characteristics of the laser unit 200, a laser beam may begin to diverge as soon as it leaves the unit 200. In this scenario, the collimator 204 limits the divergence of the laser beam. Specifically, the collimator 204 has a generally flat back surface 207 that faces the laser 200. The collimator 204 also has slightly convex front surface 208. As the laser energy travels through the collimator 204, the collimator refocuses the laser beam to the prism 206. Other applications, for example CO2, may have a small laser beam that can be expanded by using a beam expander. The collimator 204 is, preferably, made from an acrylic material, however, other transparent or translucent materials may be used.
A number of sensors 300, 302, 304, . . . are positioned within the housing 12. It should be understood that the location of the sensors identified in the drawings is just one example. Other acceptable locations for the sensors may be accomplished depending on the layout of the components within the device 10. These sensors detect and confirm different stages of the process, whether it is during the connection or the disconnection processes. For example, during the connection process, a sensor 300 may be employed to identify an object at the funneled pathway 52, 54. If the object is acceptable, e.g. the tubing 50, the sensor 300 will activate the guides 56, 58. If the object is not acceptable, the guides are not activated. Thus, these sensors help to keep out foreign objects, and even fingers. This sensor 300 may be, for example, an absorption sensor. An absorption sensor identifies tubing 50 that has a dye. In this way, not only will the sensor keep out foreign objects but also it will identify if improper tubing is attempting to be loaded. As mentioned above, the patient's catheter (or transfer set connected to the catheter) may be a different color than the tube connected to the fluid or blood to be administered to the patient. In this way, the absorption sensor checks to make sure the patient-side and disposable (or bag-side) sealed end tubes are loaded in the pathways 52, 54. If the user attempts to improperly load two bag-side tubes, the sensor 300 alerts the user and the user must retry the loading procedure. Depending on the application, the sensor may be set to allow certain combinations of tubing to enter the apparatus. Thus, the sensor 300 provides a safety measure to guard against improper loading.
[0064]FIGS. 2A through 2D illustrate the connecting and disconnecting process as follows. Specifically, FIGS. 2A and 2B show the inventive process that connects two tube ends together. FIGS. 2C and 2D show the inventive process that disconnects the tubing. Additionally, FIGS. 4A through 4H show a simplified schematic of the connecting process.
The method of connecting two tube ends will now be described. During the connection process, the lid 24 is closed. As shown in FIGS. 2A and 4A, the user inserts two tubes 50, each having a sealed end 51, into the device 10 via the loading area openings 30, 32, 38, 40. However, it is within the scope of the invention to use at least one tube end 51 that is not sealed, but, open. In applications involving an open tube end, several types of end caps may be used to maintain the necessary sanitation levels at the inside of the tube. One type of end cap may be a sealed “drum head” that covers the end of the tube. The sealed “drum head” may be a piece of film placed over the open end of the tube and sealed around the entire face of the tube. Another example may include an open end with a vented seal over the face of the tube. A vented seal may be, for example, a perforated membrane. In this example, an end cap would be added to cover the vented end for sanitation purposes. The tubing and cap assembly will be discussed in greater detail below.
In FIGS. 4C, the reflective prism 206 is between the tube holders 70, 72. After each tube end 51 is loaded into its respective tube holder 70, 72, the laser unit 200 is activated and energy diverges from the laser source. The collimator 204 refocuses the diverging energy toward the prism lens 206. As the energy/light strikes the reflective prism 206 it reflects into two bundles of energy. In this embodiment, the prism lenses 210, 212 re-direct each bundle of energy at approximately a 90° angle to focus the energy around the tube ends 51. More particularly, a “spot” of energy strikes the tube ends 51 and preferably, slightly exceeds the diameter B of the tube 50 to ensure the tube is covered with adequate radiant energy.
[0071]FIGS. 4D through 4F show the next step of the connecting process. After the laser 200 shuts off, the plate 106 moves to the back 16 of the housing 12. As the plate 106 moves, the collimator 204 moves to the side 18 along track 107. At the same time, the prism 206 moves toward the laser unit 200, and the tube holders 70, 72 come together via track 105. At this point, the now melted and aseptically heated or sterilized tube ends 51 contact each other. A weld-seal W is formed. Typically, the weld W is in the form of a ring as shown in FIG. 5C. The tube holders 70, 72 remain in this position until the weld W has sufficiently cooled. In another embodiment, the laser unit 200 may be energized again (FIG. 4F). As shown in FIG. 4F, the laser beam is directed down the light pipe 220 to the tube ends. In this example, the weld-seal W forms and the laser unit 200 is shut off. In an embodiment, the weld-seal W is a hermetic seal.
[0075]FIGS. 4G and 4H show the weld inspection process. Upon cooling, the first part 74, 78 of the tube holders 70, 72 open and the guides 56, 58 move weld W to the weld detecting sensor 304 for the post process inspection. The inspection process analyzes, for example, the weld thickness and weld height. This data is compared to the profile data for an acceptable or “good” weld. In a preferred embodiment, this sensor 304 is a CMOS image sensor. However, other similar image sensors may be employed. If the post process inspection indicates that the weld is a “good” weld, the lid 24 is unlocked and the guides 56, 58 open. The user is free to open the lid 24 and remove the connected tubing.
[0078]FIGS. 2C and 2D generally illustrate the inventive method for disconnecting and sealing the tube 50. When the user desires to disconnect from the dialysate solution bag, drainage bag, blood bag, or the like, he/she opens the lid 24 of the device 10. When the lid 24 opens, the guides 56, 58 automatically move to the open position. (FIG. 2C, Ref. No. 56). The user places the tube 50 in the groove of the second part 78, 80 of the tube holders 70, 72. In this way, the tube 50 extends along the funneled passageway 52, 54. In this application, it is not necessary for the first part 74, 78 of the tube holders 70, 72 to close. The user closes the lid 24, thus, closing the guides 56, 58 which, in turn, crimp the tubing 50.
[0085]FIG. 6 shows a protective film 400 according to an embodiment of the invention. The protective film 400 covers the plano convex lenses 210, 212, the anvil 112, and the light pipe 220. The protective film 400 is a thin clear material, preferably, a Mylar® or polyethylene material. The film 400 is provided on, for example, a roll 402 that advances after each disconnection application. When the film 400 advances it is stored in another roll 404. After the roll 402 is used both rolls 402 and 404 can be easily discarded. The laser energy does not have any heating effect on the film. The film 400 does not alter the laser beam characteristics. In this way, the film 400 protects the optics assembly 202 and eliminates cleaning of same. It will be appreciated that one could also achieve this purpose by providing a system of advancing disposable lenses. For example, if the optical assembly includes the light pipe 220 as the anvil 112, the optical assembly could be a number of disposable lenses on a cartridge that rotates after each use. Thus, the used optical assembly is discarded and a new optical assembly is used in each application.
[0087]FIG. 7 illustrates another embodiment of the invention in which the prism 206 and light pipe 220 are not between the tube holders 70, 72 but located near the front 14 of the housing 12. For simplification purposes, FIG. 6 shows the anvil 112 between the collimator 204 and the prism 206. However, during the connection process, the anvil 112 is generally not employed. Instead, the anvil 112 is off to one side 18 or 20 in the housing 12. During the disconnection process, the anvil 112 moves in front of the laser 200. Thus, the anvil 112 may be mounted on a tracking system similar to that described above with respect to the collimator 204.
[0090]FIG. 8 shows another embodiment of the invention. In this embodiment, the laser optics assembly incorporates a fiber optics assembly 410. The fiber optics assembly can include a large cylinder rod or multiple optical fibers to transmit the electromagnetic energy to the tube and provide the necessary heating and distribution of the energy. In this embodiment, the fiber optics assembly 410 includes a fixed lens 412 with first and second sides 414, 416 and a front and back end 420, 422. A recess or access slot 430 extends from the front end 420 into the assembly 410. The recess 430 ends at wall 431 within the assembly 410. The wall 431 acts as the anvil during the disconnection process. The fiber optics assembly 410 has a parting line 411 in which the assembly may be opened while the tube is loaded for the disconnection process. After the tube 50 is loaded, the recess 430 receives the hammer 110 and the hammer compresses the tube 50 at wall 431. The laser unit 200 is energized and the laser beam is directed down the fixed lens 412 in a similar manner as the light pipe 220 described above. In this way, the crimping and separation process begins.
[0092]FIGS. 9A and 9B show another embodiment of the invention. In FIG. 9A, an optical assembly 450 is used with the laser unit 200. The optical assembly 450 is adjacent to the laser unit 200 between the laser unit and a plane X that intersects the tubing 50. The optical assembly 450 includes a generally “Y”-shaped optical splitter 452, in which a base 454 of the “Y” is near the output of the laser unit 200. The “Y”-shaped optical splitter extends from the laser unit 200 toward the plane X. The “Y”-shaped optics may be solid fiber optics or individual fibers.
[0094]FIGS. 10A and 10B show another embodiment of the invention. In this example, the laser unit 200 is used without the optics assembly. The tube holders 70, 72 are mounted on a track system 500. During the connection process, the track system 500 moves the tube holders 70, 72 along a predetermined path toward the laser unit 200. (FIG. 8B). In this way, the tube holders 70, 72 manipulate the tubes 50 so that the tube ends 51 are, preferably, parallel to each other and face the laser unit 200. Thus, the tube holders 70, 72 rotate approximately 90 degrees from when they receive the tube ends to the point at which the tube ends 51 face the laser unit 200. However, the tube holders may rotate in the range of 70 to 110 degrees and achieve the same results.
[0097]FIGS. 11a and 11 b show a monolayer tubing 600 and a multiple layer tubing 600 respectively that are suitable for use with the present invention. FIG. 11c shows a multiple lumen tubing which can have two or more fluid passageways. Like the single lumen tubing of FIGS. 11a and 11 b, the multiple lumen tubing of FIG. 11c can be a monolayer structure or a multiple layer structure, and, therefore, it should be understood the following description shall apply to single lumen tubings or multiple lumen tubings.
The monolayer tubing 600 has a sidewall 602 made from a polymeric material and more preferably from a non-PVC containing polymer and most preferably from a non-PVC containing polymer that is capable of heating upon exposure to a laser beam (“laser responsive”). The multiple layer tubing 600 has a first layer or solution contact layer 604 and a second layer 606. At least one of the layers 604 or 606 is composed of a non-PVC containing polymer that is laser responsive. In a preferred form of the invention, the other layer 604 or 606 will also be a non-PVC containing polymer, and more preferably a non-PVC containing polymer that heats upon exposure to a laser beam. However, it may also be desirable to have a solution contact layer 604 that is not laser responsive or does not contain any components that may leach into solution or react with the solution. Of course, it is contemplated that tubing having more than two-layers can be used without departing from the scope of the present invention. The tubing sidewalls define a fluid pathway 608 therethrough.
Suitable homopolymers of polypropylene can have a stereochemistry of amorphous, isotactic, syndiotactic, atactic, hemiisotactic or stereoblock. In a more preferred form of the invention the polypropylene will have a low heat of fusion from about 20 joules/gram to about 220 joules/gram, more preferably from about 60 joules/gram to about 160 joules/gram and most preferably from about 80 joules/gram to about 130 joules/gram. It is also desirable, in a preferred form of the invention, for the polypropylene homopolymer to have a melting point temperature of less than about 165° C. and more preferably from about 130° C. to about 160° C., more preferably from about 140° C. to about 150° C. In one preferred form of the invention the homopolymer of polypropylene is obtained using a single site catalyst.
Suitable copolymers of propylene are obtained by polymerizing a propylene monomer with an α-olefin having from 2 to 20 carbons. In a more preferred form of the invention the propylene is copolymerized with ethylene in an amount by weight from about 1% to about 20%, more preferably from about 1% to about 10% and most preferably from 2% to about 5% by weight of the copolymer. The propylene and ethylene copolymers may be random or block copolymers. The propylene copolymer should have a low heat of fusion of from about 40 joules/gram to about 140 joules/gram, more preferable from about 60 joules/gram to about 90 joules/gram. In a preferred form of the invention, the propylene copolymer is obtained using a single-site catalyst.
Suitable copolymers of ethylene are obtained by polymerizing ethylene monomers with an α-olefin having from 3 to 20 carbons, more preferably 3-10 carbons and most preferably from 4 to 8 carbons. It is also desirable for the copolymers of ethylene to have a density as measured by ASTM D-792 of less than about 0.915 g/cc and more preferably less than about 0.910 g/cc and even more preferably less than about 0.900 g/cc. Such polymers are oftentimes referred to as VLDPE (very low density polyethylene) or ULDPE (ultra low density polyethylene). Preferably the ethylene α-olefin copolymers are produced using a single site catalyst and even more preferably a metallocene catalyst systems. Single site catalysts are believed to have a single, sterically and electronically equivalent catalyst position as opposed to the Ziegler-Natta type catalysts which are known to have a mixture of catalysts sites. Such single-site catalyzed ethylene α-olefins are sold by Dow under the trade name AFFINITY, DuPont Dow under the trademark ENGAGE® and by Exxon under the trade name EXACT. These copolymers shall sometimes be referred to herein as m-ULDPE.
Particularly useful hydrogenated block copolymers are the hydrogenated block copolymers of styrene-isoprene-styrene, such as a styrene-(ethylene/propylene)-styrene block polymer. When a polystyrene-polybutadiene-polystyrene block copolymer is hydrogenated, the resulting product resembles a regular copolymer block of ethylene and 1-butene (EB). As noted above, when the conjugated diene employed is isoprene, the resulting hydrogenated product resembles a regular copolymer block of ethylene and propylene (EP). One example of a commercially available selectively hydrogenated is KRATON G-1652 which is a hydrogenated SBS triblock comprising 30% styrene end blocks and a midblock equivalent is a copolymer of ethylene and 1-butene (EB). This hydrogenated block copolymer is often referred to as SEBS. Other suitable SEBS or SIS copolymers are sold by Kurrarry under the tradename SEPTON® and HYBRAR®.
When using oil modified SEBS it may be desirable, though not critical, to use a high melt strength polypropylene as a blend component. Suitable polypropylene and SEBS containing blends include: (1) precompounded blends of PP and SEBS sold by Wittenburg under the trade name CAWITON and particularly grades PR 3670E and PR4977; (2) from 90-98% by weight KRATON G2705 with 2-10% Basell PROFAX PF 611 high melt strength polypropylene; (3) 75% KRATON G2705 with 23% Basell PROFAX SA 861random copolymer of propylene and ethylene with 2% Basell PROFAX PF-611 which is high melt strength PP; and (4) precompounded blend of PP/SEBS sold by J-Von under grade 70585 E.
In another preferred form of the invention, the tubing will be fabricated from a single m-ULDPE resin or a blend of m-ULDPE resins. One particularly suitable m-ULDPE resin is sold by DuPont-Dow under the trademark ENGAGE® and even more particularly ENGAGE® 8003 (density 0.885 g/cc). It is also contemplated blending more than one m-ULDPE resins. Such resins and tubings and film made therefrom are more fully set forth in U.S. Pat. No. 6,372,848 which is incorporated in its entirety herein by reference and made a part hereof.
[0132]FIG. 12 shows the tubing 600 with an end cap 610 hermetically sealed thereto. The end cap film 610 is a monolayer or multiple layer polymeric film that has a tubing contacting surface 611 that is adhesively compatible with the tubing 600. The end cap film can be formed by any suitable polymer processing technique including extrusion, coextrusion, extrusion lamination, lamination, injection molding and the like. The end cap film 610, in a preferred form of the invention, is attached with sufficient strength to an end surface of tubing to withstand a burst strength of 30 psi. Burst strength is measured by applying pressurized air through a tubing flowpath 613 to pressurize the tubing until the tubing or end cap ruptures or leaks. The end cap 610 can be dimensioned to exceed the dimension of the end of the tubing and excess material is wrapped around the tubing end where it is attached to the tubing sidewalls 602 to form the drum embodiment referred to above. It is also possible to dimension the cap 610 as shown in FIG. 12 to match the dimension of the end of the tubing and be attached only to the end portion of the tubing without any significant amount of excess material.
The end cap 610 can be fabricated from single polymers such as the m-ULDPE resins described above. Such and end cap made from m-ULDPE are particularly well suited for use with m-ULDPE tubing containing blends. The end cap 610 can also be fabricated from polymer blends having at least a first component and a second component. The first component is selected from: (1) ethylene and α-olefin copolymers having a density of less than about 0.915 g/cc, (2) ethylene and lower alkyl acrylate copolymers, (3) ethylene and lower alkyl substituted alkyl acrylate copolymers and (4) ionic polymers, commonly referred to as ionomers. The term “ionomer” is used herein to refer to metal salts of the acrylic acid copolymers having pendent carboxylate groups associated with monovalent or divalent cations such as zinc or sodium. The first component is present in an amount from about 99% to about 50% by weight of the blend, more preferably from about 85%-50% and most preferably from about 70%-50%.
The second component is selected from the group consisting of: (1) propylene containing polymers, (2) butene containing polymers, (3) polymethyl pentene containing polymers, (4) cyclic olefin containing polymers and (5) bridged polycyclic hydrocarbon containing polymers. The second component is present in an amount by weight of the blend from about 50% to about 1%, more preferably from about 50%-15% and most preferably from about 30%-50%. These polymer blends for the end cap are particularly well suited for use with the tubings made from blends of polyolefin and styrene and hydrocarbon copolymers.
[0141]FIG. 13 shows a coupler 620 having opposed tubing mounting portions 622, a tubing stop 624 and a fluid pathway 626 therethrough. As shown in FIG. 14, the coupler can be used to connect a first tubing to a second tubing even when the first and second tubings are incompatible with one another. The assembly shown in FIG. 14 will be discussed in greater detail below. The tubing mounting portions 622 can have a tapered portion at its distal end for ease of mounting a tubing thereto. The surface of the coupler 620 can be textured or have a matte finish for ease of mounting of the tubing. The tubing mounting portions 622 are shown to have relatively the same length but could have different lengths without departing from the scope of the present invention. It is also contemplated the tubing mounting portions 622 can have ridges or other protuberances for heat concentrating or enhancing an interference fit between the tubing and the tubing mounting portions 622.
In another preferred form of the invention the polymer blend has three components. The first component is a polyolefin and more preferably a propylene containing polymer in an amount by weight of from about 25% to about 35% such as those sold by Solvay under the trade name FORTILENE and most particularly FORTILENE grade KS 490. The second component is a polyester and more preferably a polyester elastomer such as those sold by DuPont under the tradename HYTREL® and in an amount by weight of the blend of from about 35% to about 45%. The second component can also be a polyurethane. The third component is an ethylene vinyl acetate copolymer having a vinyl acetate content of from about 8% VA to about 40% vinyl acetate, and more preferably a carboxylic acid modified EVA or a carboxylic acid anhydride modified EVA. The EVA is present in an amount by weight of the blend of from about 25% to about 35%. The present invention further contemplates acid modifying or carboxylic acid anhydride modifying the propylene first component instead of or in addition to such modification to the EVA. The coupler 620 can be made by polymer processing techniques such as injection molding.
[0147]FIG. 14 shows a tubing assembly 628 having a first laser weldable tubing 600 and a second tubing 630 which are connected together and placed in fluid communication by the coupler 620. The second tubing 630 is made from a material incompatible with the material of tubing 600. What is meant by incompatible is the materials are not capable of being directly joined together in a secure fashion utilizing conductive or inductive heat sealing techniques. This assembly 628 is particularly well suited for joining a PVC tubing 630 from a fluid delivery set or peritoneal dialysis set with the laser weldable, non-PVC tubing 600 described above. The laser weldable tubing 600 can be connected to a transfer set of a patient using the laser welding device 10 discussed above.
The first and second tubing 600, 630 can be connected to the coupler by sliding the fluid pathway 608 of the tubings over the tubing mounting portions 622 until an end portion of the tubing contacts the tubing stop 624. The tubings 600 and 630 are then fixedly attached to the coupler by heat sealing such as with a ring-shaped die, radio frequency heat sealing, solvent bonding, adhesive bonding, or by heating the tubing and coupler in an autoclave during a steam sterilization process (i.e., 121° C. for 1 hour) or other suitable techniques. When heat sealing a mandrel may be employed to maintain the shape of the coupler and tubing assembly.
[0149]FIG. 15 shows a fluid container 640 such as a therapeutic fluid container for storing a dialysate solution, a drain bag of a peritoneal dialysis set, an I.V. container, a blood container, a blood component container a blood substitute container or the like, in fluid communication with a laser weldable tubing 600.
[0150]FIG. 16 shows the laser-weldable tubing 600 connected to a tubing 650 from a peritoneal dialysis transfer set. The tubing connection is made with the device 10 as described in detail above.
[0151]FIG. 17 shows a laser-weldable dual lumen tubing 660 having first and second fluid passageways 662 and 664 and first and second lumen 666 and 668 attached together. It is contemplated that more than two lumen, such as three, four or five or more, could be attached together without departing from the scope of the present invention. The first and second lumen are connected along peripheral edges and can extend parallel with respect to one another along a length of the tubing or the first and second lumen can be helically disposed with respect to one another or otherwise braided.
[0152]FIG. 18 shows another embodiment of a laser-weldable dual lumen tubing 670 having a first and second lumen 672 and 674 having, respectively, first and second fluid passageways 676 and 678. The first and second lumen 672 and 674 are concentrically disposed with respect to one another. It is contemplated that more than two lumen could be concentrically mounted without departing from the present invention.
[0153]FIG. 19 shows yet another embodiment of a laser-weldable, multiple lumen tubing 680 having a primary lumen 682 and four secondary lumen 684 each having a fluid passageway 686. The term “multiple” is meant to include 2 or more so a dual lumen tubing is a multiple lumen tubing. The area 688 between the secondary lumen 684 can be a fluid passageway or can be material such as packing material to hold the secondary lumen in position. While four secondary lumen are shown it is contemplated that two or more secondary lumen could be provided without departing from the present invention. Also, while the secondary lumen 684 are shown spaced apart from one another one or more of these secondary lumen can be attached together. The secondary lumen 684 can extend in a direction parallel to one another or be helically disposed with respect to one another or otherwise braided together.
A coupler was injection molded from a two component polymer blend of 50% HYTREL® 5556 WITH 50% BYNEL 1123. The blend components were pellitized with a 1½ inch David Standard twin screw extruder and injected molded with a 25 ton Arburg injection molding machine. A first tubing of PVC was slid over a first tubing mounting portion and attached to the coupler by radio frequency sealing. A second tubing was fabricated as set forth in Example 2. The second tubing was slid over a second tubing mounting portion of the coupler and then autoclaved at 121° C. for one hour. The assembly was allowed to cool and the first tubing and the second tubing were pulled until the tubing broke or until it became detached from the coupler and the force required to do so was measured respectively at 29.3 lbf and 29.4 lbf.
A coupler was injection molded as set forth in Example 4 from a three-component polymer blend of 30% polypropylene (Solvay KS 490), 40% polyester elastomer (HYTREL® 5556) and 30% anhydride modified EVA (BYNEL 3810). As in example 4, a first tubing of PVC was slid over a first tubing mounting portion and sealed thereto using radio frequency sealing. A second tubing was fabricated as set forth in Example 2 and was slid over a second tubing mounting portion. The assembly was autoclaved at 121° C. for one hour. The assembly was allowed to cool and the first tubing and the second tubing were pulled until the tubing broke or until it became detached from the coupler and the force required to do so was measured respectively at 48.2 lbf and 34.3 lbf.
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U.S. Classification 428/36.9, 156/158
International Classification A61M25/16, A61M5/14, A61M1/28, A61M39/02, A61L29/00, C08L101/00, C08J5/00, A61M39/14, B29C65/02, B29C65/78, B29C65/16, B23K26/067, B29C65/00, B29C65/20, B23K26/28
Cooperative Classification B29C66/723, B29C66/712, B29C66/71, B29C66/81267, A61M39/146, B29C66/73921, B23K26/0619, B23K26/282, B29C66/1312, B29C66/857, B29C66/961, Y10T156/1313, Y10T156/12, Y10T428/1352, Y10T428/1393, Y10T428/139, Y10T428/1397, B29C65/7841, Y10S138/07, B29C66/8226, B29K2023/0616, B29C66/5221, B29C66/91218, B29K2023/0633, B29C66/73115, B23K26/067, B29C65/1687, B29K2023/065, B29C65/1616, B29C65/1632, B29C66/82263, A61M2205/6081, B29C66/1142, B29C66/91216, B29C66/137, B29C66/636, B29K2023/0641, B23K2201/06, B29C65/1619, B29C65/2046, B29K2009/06, B29C65/7802, A61M1/28, B29K2023/083, B29L2023/007, B29K2031/04, B29K2023/0608, B29C65/2061, B29C65/1664, B29C65/1674, B29C66/9131, B29C66/91221, B29C66/91212, B29C66/9121, B29C66/91431, B29C66/91411, B29C66/9161
European Classification B29C65/78D, B29C66/8226, B29C66/636, B29C66/82263, B29C66/71, B29C66/91216, B29C66/91218, B29C66/1142, B29C66/1122, B29C66/522, B29C65/16, B29C65/20D, B29C66/5221, B29C65/02, B29C66/137, B29C65/16D2, B29C65/16D10B2, B29C65/16H, B29C65/16A6B, A61M39/14D, B23K26/067, B23K26/28B, B23K26/06A6
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SHANG, SHERWIN;YANG, TAHUA;REEL/FRAME:013576/0813