Insulin compatible infusion set

• US 4,723,947 A
• Filed: 04/09/1986
• Issued: 02/09/1988
• Est. Priority Date: 04/09/1986
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Konopka, April A.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/849,926
• Time in Patent Office: 671 Days
• Field of Search: 604/282, 604/280, 604/283, 604/272, 156/294
• US Class Current: 604/272
• CPC Class Codes: A61M 39/08 Tubes; Storage means specially adapted therefor

Abstract

An injection set for use with an external infusion source of fluid such as insulin is disclosed which injection set is constructed using multiwall tubing. The interior of the multiwall tubing is made of a material which is completely insulin compatible, while the exterior of the multiwall tubing is made of a material which may be solvent bonded. The multiwall tubing facilitates solvent bonding installation of an insert molded needle assembly and a connector to the ends of the tubing without necessitating the use of and incurring the disadvantages of epoxy bonding.

Claims

1. An injection set for use with an external infusion system to deliver a desired fluid to a subcutaneous injection location under the skin of a patient, comprising:

a segment of flexible tubing having a first end and a second end, said tubing being open on said first and second ends and having a passage therethrough communicating with said first and second ends, said tubing being of multiwall construction and having an inner annular layer defining said passage, said inner annular layer being made of a first material which is compatible with said desired fluid, said tubing also having an outer annular layer which is flexible and solvent bondable;

a connector for facilitating fluid communication with said first end of said tubing, said connector being mechanically connected to said first end of said tubing to supply said desired fluid from said external infusion system to said passage in said tubing;

a needle having a proximal end and a distal end, said needle for insertion by the distal end thereof into said subcutaneous injection location under the skin of said patient; and

a segment which is insert molded onto the proximal end of said needle, the distal end of said needle extending from one end of said segment, said segment having an essentially cylindrical cavity therein in which said proximal end of said needle is located, said cylindrical cavity having an opening therein at the other end of said segment, said second end of said tubing being inserted into said cylindrical cavity in a manner whereby said said inner layer of said tubing at said second end of said tubing is inserted over a portion of said proximal end of said needle with the proximal end of said needle being in fluid communication with said passage in said tubing, and the inner portion of said cylindrical cavity of said segment being mechanically connected to said outer layer of said tubing at said second end of said tubing.

2. An injection set as defined in claim 1, wherein said inner layer of said tubing is made of polyethylene and said outer layer of said tubing is made of flexible PVC.

3. An injection set as defined in claim 1, wherein said tubing has an intermediate layer disposed between said inner layer and said outer layer.

4. An injection set as defined in claim 3, wherein said inner layer is made of polyethylene and said outer layer is made of flexible PVC, said intermediate layer being made of a material which has good adhesion qualities to both polyethylene and flexible PVC.

5. An injection set as defined in claim 4, wherein said intermediate layer is made of EVA.

6. An injection set as defined in claim 3, wherein said inner layer has an inner diameter of 0.01-0.025 inches and a thickness of 0.005-0.012 inches, said intermediate layer has a thickness of 0.0005-0.005 inches, and said outer layer has a thickness of 0.005-0.015 inches.

7. An injection set as defined in claim 1, wherein said segment is made of hard PVC.

8. An injection set as defined in claim 1, wherein said tubing is mechanically connected to said connector and to said segment by solvent bonding.

9. An injection set as defined by claim 8, wherein said solvent bonding is done with a solvent which solvent is a 100% reagent solvent.

10. An injection set as defined in claim 9, wherein said solvent is cyclohexanone.

11. An injection set as defined in claim 1, wherein said connector includes disposed therein a flange having an aperture therethrough, said first end of said tubing being mounted in said connector in abutting relationship with said flange, said aperture in said flange being aligned with the center of said inner layer of said tubing and in fluid communication with said passage.

12. An injection set as defined in claim 11, wherein said desired fluid is insulin.

13. An injection set as defined in claim 1, wherein said connector is a female luer connector.

14. An injection set for use with an external drug infusion pump to deliver insulin supplied by said pump to a subcutaneous injection location under the skin of a patient, comprising:

a segment of said triextruded flexible tubing having a first end and a second end, said tubing being open on said first and second ends, said tubing having an inner annular layer defining a passage therethrough between said first and second ends, said inner annular layer being made of a polyethylene, said tubing having an intermediate annular layer around said inner layer, said intermediate layer being made of EVA, said tubing also having an outer annular layer, said outer layer being made of flexible PVC,

a female luer connector for connection with said first end of said tubing, said connector being made of hard PVC, said connector being solvent bonded to said outer layer of said tubing to supply said desired fluid from said external infusion system to said passage in said tubing;

a needle for insertion by the distal end thereof into said subcutaneous injection location under the skin of said patient; and

a hard PVC segment which is insert molded onto said needle near the proximal end thereof, said segment having a cylindrical cavity therein in which said proximal end of said needle is located, said cylindrical cavity having an opening therein, said second end of said tubing being inserted into said cylindrical cavity in a manner whereby the proximal end of said needle is located inside of the portion of said inner layer of said tubing at said second end thereof, said needle being in fluid communication with said passage in said tubing, the inner portion of said cylindrical cavity of said segment being solvent bonded to said outer layer of said tubing at said second end thereof.

15. An injection set comprising:

a length of multiwall tubing having an inner annular layer of polyethylene and an outer annular layer of flexible PVC, said tubing having a passage therethrough;

a hollow needle having a distal end and a proximal end;

a segment of hard PVC mounted around the proximal end of said hollow needle, said segment having a cavity therein into which one end of said tubing is inserted, the outer layer of said tubing being solvent bonded to the interior of said cavity with said inner layer of polyethylene at said one end of said tubing being located over the proximal end of said needle, said passage being in fluid communication with said proximal end of said needle; and

a hard PVC connector solvent bonded to the other end of said tubing, said passage also being in fluid communication with the interior of said connector.

16. A method of making an injection set, comprising:

providing a length of multiwall tubing having an inner annular layer of polyethylene and an outer annular layer of flexible PVC, said tubing having a passage therethrough;

insert molding a segment of hard PVC around the proximal end of a hollow needle;

inserting one end of said tubing into a cavity in said segment, the outer layer of said tubing being solvent bonded to the interior of said cavity with said passage being in fluid communication with said proximal end of said needle; and

solvent bonding the other end of said tubing to a hard PVC connector, said passage also being in fluid communication with the interior of said connector.