Therapeutic agent injection device

• US 10,835,727 B2
• Filed: 05/30/2018
• Issued: 11/17/2020
• Est. Priority Date: 10/14/2013
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Montalvo, Susan McConnell, Chong, Colin A., Lickliter, Hans, Bikovsky, Rafael
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US15/993,289
• Publication Number:
  US 20180272115A1
• Time in Patent Office: 902 Days
• CPC Class Codes: A61M 2005/3022 Worn on the body, e.g. as patches pressure infusion of the skin patch type A61M5/14248
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3007 with specially designed jet passages at the injector's distal end
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A therapeutic agent injection device including an injection device for delivering a therapeutic agent to a patient having a body, the body having a patient face and a port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, the introducer channel being in fluid communication with the injection channel through a cross channel, the injection channel defining an injection axis; a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining an introducer axis and being in fluid communication with the injection port; and a patch, the patch being attached to the patient face and being operable to adhesively attach to the patient; wherein the injection axis is parallel to the introducer axis.

Claims

1. An injection device for delivering a therapeutic agent to a patient, the injection device comprising:

a body having a patient face and a port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, the injection channel defining a single injection axis, a cross channel connecting the introducer channel to the injection channel, the introducer channel being in fluid communication with the injection channel through the cross channel;

a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining a single introducer axis and being in fluid communication with the injection port;

wherein the injection axis is parallel to and does not intersect the introducer axis;

a patch attached to the patient face and operable to adhesively attach to the patient; and

a pop-up indicator disposed in the introducer channel, the pop-up indicator having a normal state when pressure in the introducer channel is normal and an alarm state when pressure in the introducer channel exceeds a predetermined value.

2. The injection device of claim 1, wherein the pop-up indicator includes a self-closing port operable to receive a needle of a needle hub assembly.

3. The injection device of claim 1, wherein the pop-up indicator has a membrane selected from the group consisting of a folded membrane, an accordion membrane, and a deformable membrane.

4. The injection device of claim 1, the cross channel defining a single cross channel axis, wherein the cross channel axis intersects both the injection axis and the introducer axis.

5. The injection device of claim 4, wherein the cross channel axis is substantially perpendicular to both the injection axis and the introducer axis.

6. The injection device of claim 1, wherein the cross channel connects an end of the injection channel that is distal to the injection port and an end of the introducer channel that is proximate to the introducer port.

7. An injection device for delivering a therapeutic agent to a patient, the injection device comprising:

a body having a patient face and a port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, the injection channel defining a single injection axis, a cross channel connecting the introducer channel to the injection channel, the introducer channel being in fluid communication with the injection channel through the cross channel;

a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining a single introducer axis and being in fluid communication with the injection port;

wherein the injection axis is parallel to and does not intersect the introducer axis;

a patch attached to the patient face and operable to adhesively attach to the patient; and

wherein the body has a first body portion including the port face and a second body portion including the patient face, the first body portion and the second body portion being rotatably connected with a flange, the first body portion and the second body portion being independently rotatable about the introducer axis.

8. The injection device of claim 7, the cross channel defining a single cross channel axis, wherein the cross channel axis intersects both the injection axis and the introducer axis.

9. The injection device of claim 8, wherein the cross channel axis is substantially perpendicular to both the injection axis and the introducer axis.

10. The injection device of claim 7, wherein the cross channel connects an end of the injection channel that is distal to the injection port and an end of the introducer channel that is proximate to the introducer port.

11. An injection device for delivering a therapeutic agent to a patient, the injection device comprising:

a body having a patient face and a port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, the injection channel defining a single injection axis, a cross channel connecting the introducer channel to the injection channel, the introducer channel being in fluid communication with the injection channel through the cross channel;

a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining a single introducer axis and being in fluid communication with the injection port;

wherein the injection axis is parallel to and does not intersect the introducer axis;

a patch attached to the patient face and operable to adhesively attach to the patient; and

an injection septum.

12. The injection device of claim 11, the cross channel defining a single cross channel axis, wherein the cross channel axis intersects both the injection axis and the introducer axis.

13. The injection device of claim 12, wherein the cross channel axis is substantially perpendicular to both the injection axis and the introducer axis.

14. The injection device of claim 11, wherein the cross channel connects an end of the injection channel that is distal to the injection port and an end of the introducer channel that is proximate to the introducer port.

15. An injection device for delivering a therapeutic agent to a patient, the injection device comprising:

a body having a patient face and a port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, a cross channel connecting the introducer channel to the injection channel, wherein the cross channel connects an end of the injection channel that is distal to the injection port to an end of the introducer channel that is proximate to the introducer port, the introducer channel being in fluid communication with the injection channel through the cross channel, the cross channel defining a single cross channel axis and the injection channel defining a single injection axis;

a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining a single introducer axis and being in fluid communication with the injection port;

a patch attached to the patient face and operable to adhesively attach to the patient; and

an injection adapter assembly connectable to the injection port, the injection adapter assembly being operable to receive a needleless pen injector;

wherein the injection axis is parallel to and does not intersect the introducer axis; and

wherein the cross channel axis is substantially perpendicular to and intersects both the injection axis and the introducer axis.