Drug delivery device with vacuum assisted securement and/or feedback

Patent metadata

Field	Value
Publication number	US-11517663-B2
Application number	US-202016782532-A
Country	US
Kind code	B2
Filing date	Feb 5, 2020
Priority date	Feb 17, 2015
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

Abstract

A drug delivery device includes a housing with at least one pressure communication channel or aperture, which distributes a negative fluid pressure across its base to draw tissue against the device. The device can also include a porous, adhesive layer over the channel(s) or aperture(s), for attaching to tissue. The device can also include a pressure sensor for determining whether there is proper attachment. Further, a bladder may be used instead of the adhesive layer for attaching the device. The bladder, in a partially inflated state, can apply constant pressure across a contact surface causing a flexible adhesive layer attached to the bladder to confirm and adhere to the tissue. Subsequent evacuation of the bladder causes it to deflate and collapse or retract, thereby causing the flexible adhesive layer to pull and stretch the tissue toward the base.

First claim

What is claimed is:

1. A drug delivery device comprising:
a housing including a top wall, a base, and at least one side wall connecting the top wall and base;
a primary container disposed in the housing for containing a medicament;
a needle for delivering the medicament from the primary container to a patient;
at least one bladder disposed over the base; and
an adhesive layer disposed over the at least one bladder and being flexible, the adhesive layer for adhesively attaching the device to body tissue;
wherein the at least one bladder in a partially inflated state conforms to the contour of the body tissue when the device is applied thereto with an application force, the application force thereby being distributed across the surface area of the adhesive layer; and
wherein collapsing the at least one bladder against the base, after the device is applied to the body tissue, causes the adhesive layer to pull the body tissue toward the base, thereby stretching the body tissue.

2. The drug delivery device of claim 1 , further comprising a valve, and wherein the application force creates an increase in pressure of the at least one bladder until it reaches a desired minimum application pressure, and the valve opens to empty and allow the at least one bladder to collapse in response to reaching the desired minimum application pressure.

3. The drug delivery device of claim 1 , further comprising:
a positive pressure source for applying positive fluid pressure to the at least one bladder to partially inflate the at least one bladder, the positive pressure source being separate from the device or integrated with the device; and
a negative pressure source for applying negative fluid pressure to the at least one bladder to deflate and collapse the at least one bladder, the negative pressure source being separate from the device or integrated with the device.

4. The drug delivery device of claim 3 , wherein the positive pressure source comprises a positive pressure pump.

5. The drug delivery device of claim 3 , wherein the negative pressure source comprises a vacuum pump.

6. The drug delivery device of claim 5 , further comprising a valve for adjusting the negative fluid pressure supplied by the vacuum pump.

7. The drug delivery device of claim 5 , further comprising a user-selectable negative fluid pressure selector, which allows a user to select the negative fluid pressure supplied by the vacuum pump.

8. The drug delivery device of claim 3 , wherein the negative pressure source comprises an oxygen absorber for applying the negative fluid pressure.

9. The drug delivery device of claim 3 , wherein the negative and positive pressure sources comprise an air chamber that collapses in volume to a minimum volume state to generate the positive fluid pressure and that expands in volume from the minimum volume state to generate the negative fluid pressure.

10. The drug delivery device of claim 9 , further comprising a user actuated first lever connected to the housing, the first lever for collapsing the air chamber to generate the positive fluid pressure.

11. The drug delivery device of claim 10 , wherein the air chamber comprises a biasing element for expanding the air chamber from the minimum volume state, and the first lever compresses the biasing element when the user moves the first lever in a first direction.

12. The drug delivery device of claim 9 , further comprising a plunger and a cylinder, the plunger and cylinder movably disposed relative to one another, wherein the air chamber is formed between the plunger and the cylinder.

13. The drug delivery device of claim 12 , wherein one of the plunger and the cylinder is movable by a user, the air chamber comprises a biasing element for expanding the air chamber from the minimum volume state, and the one of the plunger and the cylinder compresses the biasing element when pressed by the user.

14. The drug delivery device of claim 11 , wherein activation of the device by a user releases the first lever from the air chamber to allow the biasing element to decompress and expand the air chamber thereby generating the negative fluid pressure.

15. The drug delivery device of claim 13 , wherein releasing the one of the plunger and the cylinder allows the biasing element to decompress and expand the air chamber thereby generating the negative fluid pressure.

16. The drug delivery device of claim 3 , further comprising a controller for controlling the amount of at least one of the positive and negative fluid pressures applied to the at least one bladder by the negative and positive pressure sources.

17. The drug delivery device of claim 1 , wherein the needle comprises either a rigid injection needle or a soft cannula.

18. The drug delivery device of claim 1 , wherein the medicament is selected from the group consisting of TNF inhibitors, antibodies to the calcitonin gene-related peptide receptor, colony stimulating factors, erythropoiesis stimulating agents, apelin receptor agonists, anti-thymic stromal lymphopoietin antibodies,anti-thymic stromal lymphopoietinreceptor antibodies, antibodies that bind human Proprotein Convertase Subtilisin/Kexin Type 9and tissue inhibitors of metalloproteinases.

19. The drug delivery device of claim 1 , further comprising a sealing ring partially embedded in or disposed on the adhesive layer and surrounding an opening through which the needle can extend through during needle insertion.

20. A method for attaching a drug delivery device to a patient, the method comprising:
providing a drug delivery device comprising: a housing including a top wall, a base, and at least one side wall connecting the top wall and base; a primary container disposed in the housing and containing a medicament; a needle for delivering the medicament from the primary container to a patient; at least one bladder disposed over the base; and an adhesive layer disposed over the at least one bladder and being flexible;
placing the drug delivery device on body tissue of the patient at a selected drug delivery site with an application force, the at least one bladder being in a partially inflated state to conform to the contour of the body tissue so that the application force is distributed across the surface area of the adhesive layer, thereby causing the adhesive layer to adhere to the body tissue; and
collapsing the at least one bladder against the base to cause the adhesive layer to pull the body tissue toward the base, thereby stretching the body tissue.

21. The drug delivery device of claim 1 , further comprising a source of a positive fluid pressure for applying positive fluid pressure between the device and the body tissue at the end of injection to indicate dose delivery completion.

22. The method of claim 20 , further comprising applying a positive fluid pressure between the device and the body tissue at the end of injection to indicate dose delivery completion.

Assignees

• Amgen Inc

Inventors

• Mccullough Adam B
• Ring Lawrence S

Classifications

• A61M2205/13

  with means for the detection of operative contact with patient, e.g. lip sensor · CPC title

• A61M2205/3344

  Measuring or controlling pressure at the body treatment site · CPC title

• A61M2205/3306

  Optical measuring means · CPC title

• A61M2005/1586

  Holding accessories for holding infusion needles on the body · CPC title

• A61M2005/14252

  with needle insertion means · CPC title