Transdermal introducer assembly

• US 5,779,665 A
• Filed: 05/08/1997
• Issued: 07/14/1998
• Est. Priority Date: 05/08/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Minimed, Inc. (Medtronic Plc)
• Inventors: Lemos, Richard, Mastrototaro, John J., Van Antwerp, Nannette M., Halili, Edgardo C.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/848,476
• Time in Patent Office: 432 Days
• Field of Search: 604/51, 604/53, 604/118, 604/158, 604/164, 604/48, 604/111, 604/160, 604/166, 604/168, 604/264, 604/272, 604/280, 604/900, 606/167, 606/181, 606/182, 128/635
• US Class Current: 604/506
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

Abstract

A transdermal introducer assembly is provided for quick and easy transcutaneous placement of a medical tube on a patient with reduced patient discomfort. The introducer assembly comprises a medical tube segment defining a hollow lumen extending between a distal end for placement into the subcutaneous tissue and a proximal end disposed outside the patient. The tube segment is assembled in side-by-side relation with a hollow introducer needle, and includes an elongated introducer thread at the distal end thereof folded back for slide-fit reception into the open distal end of the introducer needle. In use, the introducer needle is deployed to pierce the patient'"'"'s skin at a selected placement site and to carry the tube segment to the desired transcutaneous position, after which the introducer needle can be withdrawn and slidably separated from the introducer thread to leave the tube segment and thread in place on the patient. A window is formed in the tube segment near the distal end thereof and, in a preferred form, exposes a transcutaneous sensor carried within the tube segment to patient body fluids.

Claims

1. A transdermal introducer assembly, comprising:

a tube segment defining a hollow lumen extending between a distal end for placement into the subcutaneous tissue of a patient, and a proximal end for placement outside the patient, said tube segment including means for permitting passage of fluid into said lumen at least at the distal end thereof;

an elongated flexible introducer thread connected to the distal end of said tube segment; and

a hollow introducer needle having an open distal end sized for slide-fit reception of said introducer thread, said thread permitting said tube segment to be folded back to extend along said introducer needle in close fitting side-by-side relation, whereby manipulation of the introducer needle to pierce the patient'"'"'s skin carries said tube segment to a transcutaneous position, said introducer needle being slidably withdrawable from said introducer thread to leave said introducer thread and said tube segment transcutaneously positioned on the patient.

2. The transdermal introducer assembly of claim 1 wherein said introducer needle has a hub mounted on a proximal end thereof.

3. The transdermal introducer assembly of claim 1 wherein said tube segment is formed from a resilient material.

4. The transdermal introducer assembly of claim 1 wherein said means for permitting fluid passage into said lumen comprises a window formed in said tube segment generally at the distal end thereof.

5. The transdermal introducer assembly of claim 4 wherein said window formed in said tube segment is radially open.

6. The transdermal introducer assembly of claim 1 wherein said introducer thread is formed integrally with said tube segment.

7. The transdermal introducer assembly of claim 6 wherein said introducer thread comprises an extrusion drawn from the distal end of said tube segment.

8. The transdermal introducer assembly of claim 1 wherein said introducer thread has a cross sectional size substantially less than the cross sectional size of said tube segment.

9. The transdermal introducer assembly of claim 1 wherein said introducer thread has a sufficient length so that a distal end thereof extends out of the patient'"'"'s skin when said introducer needle is slidably separated therefrom.

10. The transdermal introducer assembly of claim 1 further including a biological sensor mounted within said tube segment lumen for exposure to patient body fluid.

11. A transdermal introducer assembly, comprising:

a medical device for placement into the subcutaneous tissue of a patient;

an introducer thread connected to said medical device; and

an introducer needle including means for slide-fit threaded engagement with said introducer thread, said thread when engaged with said introducer needle permitting said medical device to be positioned in close fitting side-by-side relation with said needle in a position trailing a distal end of said needle, whereby manipulation of said introducer needle to pierce the patient'"'"'s skin carries said medical device to a subcutaneous position, said introducer needle being slidably withdrawable from the patient'"'"'s skin for slide-off separation from said introducer thread to leave said thread and said medical device on the patient.

12. The transdermal introducer assembly of claim 11 wherein said medical device comprises a tube segment defining a lumen for transcutaneous placement of the patient'"'"'s skin.

13. The transdermal introducer assembly of claim 11 wherein said introducer thread and said medical device are integrally formed.

14. The transdermal introducer assembly of claim 11 wherein said introducer thread has a sufficient length so that a distal end thereof extends out of the patient'"'"'s skin when said introducer needle is slidably separated therefrom.

15. The transdermal introducer assembly of claim 11 wherein said needle means for slide-fit threaded engagement with said introducer thread comprises a hollow bore formed in said introducer needle.

16. A transdermal introducer assembly, comprising:

a tube segment defining a hollow lumen extending between a distal end for placement into the subcutaneous tissue of a patient, and a proximal end for placement outside the patient, said tube segment having a radially open window formed therein generally at the distal end thereof;

an elongated flexible introducer thread connected to the distal end of said tube segment, said introducer thread being formed integrally with said tube segment as an extruded extension at the distal end thereof; and

a hollow introducer needle having an open distal end sized for slide-fit reception of said introducer thread, said thread permitting said tube segment to be folded back to extend along said introducer needle in close fitting side-by-side relation, whereby manipulation of the introducer needle to pierce the patient'"'"'s skin carries said tube segment to a transcutaneous position, said introducer needle being slidably withdrawable from said introducer thread to leave said introducer thread and said tube segment transcutaneously positioned on the patient.

17. A method of placing a medical device into the subcutaneous tissue of a patient, said method comprising the steps of:

providing the medical device with an elongated introducer thread connected thereto;

theadably coupling the introducer thread with an introducer needle;

piercing the patient'"'"'s skin with the introducer needle, with the introducer thread coupled thereto, to carry the introducer thread and the medical device to a subcutaneous position on the patient; and

withdrawing the introducer needle from the patient'"'"'s skin to slidably separate the introducer needle from the introducer thread and thereby leave the introducer thread and the medical device on the patient.

18. The method of claim 17 wherein said providing step comprises forming the medical device as a tube segment with a hollow lumen formed therein.

19. The method of claim 18 wherein said providing step further comprises forming the introducer thread by extruding the distal end of the tube segment, and forming an open window in the tube segment generally at the distal end thereof.

20. The method of claim 17 wherein said threadably coupling step comprises slide-fit reception of the introducer thread into a hollow bore formed in the introducer needle.

21. The method of claim 17 wherein said providing step further comprises forming the introducer thread with a sufficient length so that a distal end thereof extends out of the patient'"'"'s skin when said introducer needle is slidably separated therefrom.