Subcutaneous injection set tubing with solvent bonding

• US 20020055722A1
• Filed: 08/30/2001
• Published: 05/09/2002
• Est. Priority Date: 11/06/2000
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Sterling Medivations, Inc. (Guided Therapeutics, Inc.)
• Inventors: Nomvra, Hiroshi, Douglas, Joel Sterling, Hueo, Robert Louis
• Granted Patent: US 6,673,440 B2
• Time in Patent Office: Days
• US Class Current: 604/272
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: B29C 59/142 of profiled articles, e.g. hollow or tubular articles
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/484 Moisture curing adhesives
• CPC Class Codes: B29C 66/112 Single lapped joints
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/1222 comprising at least a lapped joint-segment
• CPC Class Codes: B29C 66/1224 comprising at least a butt joint-segment
• CPC Class Codes: B29C 66/131 Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/5344 said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends B29C66/5346 takes precedence
• CPC Class Codes: B29C 66/612 Making circumferential joints
• 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: B29K 2023/06 PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/0633 LDPE, i.e. low density polyethylene
• CPC Class Codes: B29K 2023/12 PP, i.e. polypropylene
• CPC Class Codes: B29K 2027/06 PVC, i.e. polyvinylchloride
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2069/00 Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7544 : Injection needles, syringes
• CPC Class Codes: C08J 2323/06 : Polyethene
• CPC Class Codes: C08J 2327/18 : Homopolymers or copolymers of tetrafluoroethylene
• CPC Class Codes: C08J 5/122 : using low molecular chemically inert solvents, swelling or softening agents
• CPC Class Codes: Y10T 428/139 : Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/265 : 1 mil or less
• CPC Class Codes: Y10T 428/31544 : Addition polymer is perhalogenated
• CPC Class Codes: Y10T 428/3192 : Next to vinyl or vinylidene chloride polymer
• CPC Class Codes: Y10T 428/31928 : Ester, halide or nitrile of addition polymer
• CPC Class Codes: Y10T 428/31935 : Ester, halide or nitrile of addition polymer

Abstract

The infusion set comprises of a connecting tube of polyethylene which is treated to form a wetable surface or treated with a primer and then bonded to a PVC hub by using solvent adhesive to solvent bond the low density polyethylene tubing or Teflon tubing to a PVC hub. The surface treatment methods include a methane plasma surface that is applied to tubing in a continuous manner and alternatively a primer that is applied locally and dried prior to applying the adhesive. Both techniques form a strong and resilient bond for the infusion needle and tube when assembled to the PVC hubs.

Claims

1. A subcutaneous injection set comprising:

a hub, a tube connected to the hub and forming therewith a hub-tube joint, and a needle connected to the hub and forming therewith a needle-hub joint, the hub including a socket;

wherein said hub is molded of a plastic selected from the group consisting of PVC and PC;

wherein the tube is formed of a material selected from the group consisting of polyethylene and polypropylene and includes a polymer layer formed by plasma treating with methane and oxygen gas;

wherein solvent adhesive is applied to the needle-hub joint;

wherein solvent adhesive is applied to the hub-tube joint; and

wherein the tube has an outer diameter, and the hub has a minimum area to seal, a socket length, and a fully effective length which satisfy at least one of the relationships selected from the group consisting of

the minimum area to seal=outer diameter of the tube/6.25;

the minimum socket length=1 * outer diameter of the tube; and

the hub fully effective length is 1.6 * outer diameter of the tube.

2. An infusion set as claimed in claim 1, wherein the tube is formed of polypropylene.

3. An infusion set as claimed in claim 1, wherein the plasma polymer layer of methane has a thickness between about 10 Å

and about 2000 Å

.

4. A subcutaneous injection set comprising:

a hub, a tube connected to the hub and forming therewith a hub-tube joint, and a needle connected to the hub and forming therewith a needle-hub joint, the hub including a socket;

wherein said hub is molded of a plastic selected from the group consisting of PVC and PC;

wherein the tube is formed of a material selected from the group consisting of polyethylene and polypropylene, and the tube includes a primer;

wherein solvent adhesive is applied to the needle-hub joint;

wherein solvent adhesive is applied to the hub-tube joint; and

wherein the tube has an outer diameter, and the hub has a minimum area to seal, a socket length, and a fully effective length which satisfy at least one of the relationships selected from the group consisting of

the minimum area to seal=outer diameter of the tube/16.67;

the minimum socket length=2 * outer diameter of the tube; and

the fully effective length is 2.6 * outer diameter of the tube.

5. An infusion set as claimed in claim 4, where the tube is formed of polypropylene.

6. An infusion set as claimed in claim 4, wherein the plasma polymer layer of methane has a thickness between about 10 Å

0 and about 2000 Å

.

7. A subcutaneous injection set comprising:

a hub, a tube connected to the hub and forming therewith a hub-tube joint, and a needle connected to the hub and forming therewith a needle-hub joint, the hub including a socket;

wherein said hub is molded of a plastic selected from the group consisting of PVC and PC;

where the tube is formed of polytetrafluoroethylene includes a polymer layer formed by plasma treating with methane and oxygen gas;

wherein the tube has an outer diameter, the hub has a minimum socket length, the solvent adhesive is applied to the needle-hub joint, and the solvent adhesive satisfies at least one of the relationships selected from the group consisting of

the minimum area to seal=outer diameter of the tube/3.33; and

the minimum socket length=1.9 * outer diameter of the tube; and

the fully effective length is 2.8* outer diameter of the tube.

8. An infusion set as claimed in claim 7, wherein the plasma polymer layer of methane has a thickness between about 10 Å

and about 2000 Å

.

9. A solvent bondable joint comprising:

a LDPE part having a plasma deposited layer of methane and oxygen gas;

a solvent adhesive applied to the joint;

a solvent bondable piece in communication with the solvent adhesive; and

wherein the plasma polymer layer of methane is at least 10 Å

thick but not greater than 2000 Å

.

10. A solvent bondable joint comprising:

a polytetrafluoroethylene part having a plasma deposited layer of methane and oxygen gas;

a solvent adhesive applied to the joint;

a solvent bondable piece in communication with the solvent adhesive; and

wherein the plasma polymer layer of methane is at least 10 Å

thick but not greater than 2000 Å

.

11. A solvent bondable joint comprising:

a LDPE part having a plasma deposited layer of methane and oxygen gas;

a solvent adhesive applied to the joint;

a LDPE part having a plasma deposited layer of methane and oxygen gas in communication with the solvent adhesive; and

wherein the plasma polymer layer of methane is at least 10 Å

thick but not greater than 2000 Å

.

12. A solvent bondable joint comprising:

a polytetrafluoroethylene part having a plasma deposited layer of methane and oxygen gas

a solvent adhesive applied to the joint;

a polytetrafluoroethylene part having a plasma deposited layer of methane and oxygen gas in communication with the solvent adhesive; and

wherein the plasma polymer layer of methane is at least 10 Å

thick but not greater than 2000 Å

.

13. A solvent bondable joint comprising:

a LDPE part having a plasma deposited layer of methane and oxygen gas;

a solvent adhesive applied to the joint;

a polytetrafluoroethylene part having a plasma deposited layer of methane and oxygen gas in communication with the solvent adhesive; and

wherein the plasma polymer layer of methane is at least 10 Å

thick but not greater than 2000 Å

.