Soft cannula subcutaneous injection set

• US 4,755,173 A
• Filed: 06/04/1987
• Issued: 07/05/1988
• Est. Priority Date: 02/25/1986
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Lord, Peter C., Konopka, April A.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/058,067
• Time in Patent Office: 397 Days
• Field of Search: 604/51, 604/117, 604/122, 604/164-180, 128/DIG. 26
• US Class Current: 604/167.02
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2039/0054 Multiple layers
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2205/197 by the seal material
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: Y10S 128/26 Cannula supporters

Abstract

An injection set for delivering a fluid to a subcutaneous injection location in a patient is disclosed which has a soft cannula projecting from a bottom surface of a holding pad. An insertion needle is initially inserted through a septum located between a catheter hub and a retaining cap mounted on the holding pad. The insertion needle extends through a fluid chamber defined by the septum and the catheter hub and then through a lumen of the soft cannula, with the sharpened tip of the insertion needle extending beyond the end of the soft cannula when the insertion needle is fully inserted. The insertion needle, which allows priming of the injection set, may be removed following installation of the injection set without kinking of the soft catheter, and fluid may be supplied to the injection set for delivery to the patient.

Claims

1. A subcutaneous injection set comprising:

a holding pad for placement on the skin of a patient at an injection site, said holding pad having an aperture therein;

a catheter hub mounted on top of said holding pad, said catheter hub having a fluid chamber therein, said catheter hub also having a cylindrical segment extending through said aperture in said holding pad and extending below the bottom surface of said holding pad, said cylindrical segment having an aperture therethrough in communication with said fluid chamber;

self-sealing means for enclosing said fluid chamber on the top of said catheter hub;

means for receiving a desired fluid into said fluid chamber;

a soft cannula mounted in and extending from said cylindrical segment of said catheter hub, said soft catheter having a lumen therethrough, said lumen being in fluid communication with said fluid chamber in said catheter hub;

an insertion needle for removable insertion through said self-sealing means on said top of said catheter hub, said insertion needle passing through said fluid chamber and through said lumen of said soft cannula, said insertion needle having an outside diameter size which tightly fits and passes through the lumen of said soft cannula, a sharpened tip of said insertion needle extending beyond the length of said soft cannula when said insertion needle is fully inserted through said housing, said self-sealing means sealing said top of said catheter hub when said insertion needle is withdrawn therefrom; and

means for removably securing said holding pad to the skin of a patient.

2. An injection set as defined in claim 1, wherein said holding pad comprises:

a central portion from which said soft cannula protrudes; and

two wing portions extending from opposite sides of said central portion, said two wing portions being connected to said central portion by two areas of reduced thickness which act as hinges to allow said two wing portions to move with respect to said central portion, thereby enabling said holding pad to fit to the contour rather well.

3. An injection set as defined in claim 2, wherein said holding pad is molded of flexible PVC.

4. An injection set as defined in claim 1, wherein said first self-sealing means comprises:

a septum layer made from a pierceable, resilient, resealable substance; and

a retaining cap which is affixed to said catheter hub over said septum thereby compressing said septum, said cap having a small aperture therethrough through which said insertion needle may be inserted.

5. An injection set as defined in claim 4, wherein said septum is made of medical grade silicone rubber.

6. An injection set as defined in claim 4, wherein said retaining cap has a raised circular sealing ring located on the inside of the top of said retaining cap and spaced away and around said aperture in said retaining cap, said raised circular sealing ring pressing into the top of said septum to enhance the sealing characteristics of said injection set.

7. An injection set as defined in claim 4, wherein said retaining cap is secured in place on said catheter hub by a raised snap ring which extends around the lower inside edge of the retaining cap, said retaining cap snapping onto said catheter hub.

8. An injection set as defined in claim 1, wherein said receiving means is so arranged and configured to deliver said fluid into said fluid chamber through the side of said catheter hub.

9. An injection set as defined in claim 1, wherein said soft cannula is made of teflon.

10. An injection set as defined in claim 1, wherein said soft cannula is made of hydrogel material.

11. An injection set as defined in claim 1, wherein the end of said soft cannula is tapered to enhance insertion of said soft cannula.

12. An injection set as defined in claim 1, further comprising:

means for priming said injection set when said receiving means is connected to a source of fluid prior to insertion of said insertion needle and said soft cannula into the skin of a patient.

13. An injection set as defined in claim 12, wherein said priming means comprises:

a passage between said sharpened tip of said insertion needle and a section of said insertion needle within said fluid chamber, said passage being in fluid communication with said fluid chamber, whereby all air or other gases within said fluid chamber may escape through said air passage when said sharpened tip of said insertion needle is held so as to point in an upwards direction as fluid is introduced under pressure into said fluid chamber through said receiving means.

14. An injection set as defined in claim 13, wherein said passage comprises:

a bore located within said insertion needle; and

an aperture from the exterior of said insertion needle to said bore, said aperture being located in said fluid chamber at a position near said first side of said housing when said insertion needle is fully inserted through said catheter hub.

15. An injection set as defined in claim 13, wherein said passage comprises a longitudinal groove disposed along the side of said insertion needle.

16. An injection set as defined in claim 15, wherein said receiving means includes a flexible tube in fluid communication with the fluid chamber within said catheter hub, said flexible tube exiting out through the side of said catheter hub at an angle substantially parallel to the skin said mounting pad is placed on.

17. An injection set as defined in claim 1, wherein said means for removably securing said holding pad to the skin of the patient comprises:

an adhesive layer attached to the bottom side of said holding pad, said adhesive layer sticking to the skin of the patient as soon as contact is made between said other side of said adhesive layer and the skin.

18. An injection set as defined in claim 17 wherein said adhesive layer includes thereon an antimicrobial substance on the side of said adhesive layer facing the skin of the patient, which antimicrobial substance reduces the risk of infection as said injection set is used by the patient.

19. An injection set as defined in claim 17, wherein said other side of said adhesive layer is covered with a disposable covering which may be manually removed when said injection set is ready to be affixed to the skin of the patient, said disposable covering having an aperture therein through which said cylindrical portion of said catheter hub, said soft cannula, and said insertion needle pass, said disposable covering also having a slit which passes from said aperture to an outer edge of said disposable covering, said disposable cover further having a finger tab which projects out from said edge adjacent said slit, whereby said disposable covering may be pulled off of said adhesive by pulling said finger tab away from said first side of said housing with a circular motion which does not require lifting or sliding the disposable covering over said soft cannula or said insertion needle.

20. An injection set as defined in claim 17, wherein said means for removably securing said holding pad to the skin of the patient additionally comprises:

a rectangular adhesive patch having an aperture centrally located therein for admitting said catheter hub, said rectangular adhesive patch having removable protective paper backing on the bottom surface thereof, said adhesive patch being placed over said holding pad after said removable protective paper backing has been removed to retain said injection set on the skin.

21. An injection set for injecting a desired fluid from a source of fluid to a subcutaneous delivery location under the skin of a patient, said injection set comprising:

a holding pad for placement on the skin of a patient at an injection site, said holding pad having an aperture therein;

a catheter hub mounted on top of said holding pad, said catheter hub having a fluid chamber therein, said catheter hub also having a cylindrical segment extending through said aperture in said holding pad and extending below the bottom surface of said holding pad, said cylindrical segment having an aperture therethrough in communication with said fluid chamber;

self-sealing means for enclosing said fluid chamber on the top of said catheter hub;

a flexible cannula having a first end affixed within said catheter hub and a second end which protrudes from said cylindrical segment of said catheter hub, said cannula having a lumen therein extending between said first and second ends, said lumen being in fluid communication with said fluid chamber in said catheter hub;

a delivery tube having a first end affixed to said catheter hub, said delivery tube being substantially parallel to the skin of the patient as it approaches and is attached to said catheter hub, a second end of said delivery tube being connectable to said source of fluid;

fluid connection means within said catheter hub for maintaining said first end of said delivery tube in fluid communication with said fluid chamber; and

cannula insertion means for inserting the protruding body portion of the flexible cannula into the subcutaneous fat layer of the skin of the patient as the flat surface of the housing is placed against the skin of the patient.

22. An injection set as defined in claim 21, wherein said cannula insertion means comprises:

an insertion needle tightly inserted into said lumen of said cannula, a sharpened tip of said insertion needle projecting beyond said second end of said cannula when said insertion needle is fully inserted thereinto, said insertion needle having a means for gripping an end thereof opposite said sharpened tip, said means for gripping being accessible from the top of said catheter hub, whereby said sharpened tip of said needle punctures the skin and enters a subcutaneous fat layer of the patient as said holding pad is pushed against the skin of the patient, said second end of said cannula being carried into the subcutaneous fat layer with said needle, said needle being retractable from the lumen of said cannula once said second end of said cannula has been inserted into the subcutaneous fat layer.

23. An injection set for injecting a desired fluid from a source of fluid to a delivery location under the skin and in the subcutaneous fat layer of a patient, comprising:

a holding pad for placement on the skin of a patient at an injection site, said holding pad having a central portion with an aperture therein from which said soft cannula protrudes, said holding pad also having two wing portions extending from opposite sides of said central portion, said two wing portions being hingeably connected to said central portion by two areas of reduced thickness, thereby enabling said holding pad to fit to the contour rather well;

a catheter hub mounted on top of said holding pad, said catheter hub having a fluid chamber therein, said catheter hub also having a cylindrical segment extending through said aperture in said holding pad and extending below the bottom surface of said holding pad, said cylindrical segment having an aperture therethrough in communication with said fluid chamber;

a septum made from a pierceable, resilient, resealable substance, said septum enclosing said fluid chamber on the top of said catheter hub;

a retaining cap which is affixed to said catheter hub over said septum thereby compressing said septum, said cap having a small aperture therethrough through which said insertion needle may be inserted;

a flexible tube in fluid communication with the fluid chamber within said catheter hub, said flexible tube exiting out through the side of said catheter hub at an angle substantially parallel to the skin said mounting pad is placed on;

a soft cannula mounted in and extending from said cylindrical segment of said catheter hub, said soft catheter having a lumen therethrough, said lumen being in fluid communication with said fluid chamber in said catheter hub;

an insertion needle for removable insertion through said self-sealing means on said top of said catheter hub, said insertion needle passing through said fluid chamber and through said lumen of said soft cannula, said insertion needle having an outside diameter size which tightly fits and passes through the lumen of said soft cannula, a sharpened tip of said insertion needle extending beyond the length of said soft cannula when said insertion needle is fully inserted through said housing, said self-sealing means sealing said top of said catheter hub when said insertion needle is withdrawn therefrom; and

means for removably securing said holding pad to the skin of a patient.