Drug delivery device with vacuum assisted securement and/or feedback

Patent metadata

Field	Value
Publication number	US-10583245-B2
Application number	US-201615544488-A
Country	US
Kind code	B2
Filing date	Feb 17, 2016
Priority date	Feb 17, 2015
Publication date	Mar 10, 2020
Grant date	Mar 10, 2020

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 bottom wall, and at least one side wall connecting the top wall and the bottom wall;
a primary container disposed in the housing for containing a medicament;
a needle for delivering the medicament from the primary container to a patient; and
at least one pressure communication channel defined as at least one elongated groove extending along an outer surface of the bottom wall of the housing, wherein the at least one pressure communication channel is operative for distributing a negative fluid pressure across the outer surface of the bottom wall, the negative fluid pressure drawing the body tissue toward the bottom wall;
wherein the at least one pressure communication channel comprises one or more of the following:
(a) a spiral-shaped groove having a first end disposed at a central area of the base and a second end disposed at a peripheral area of the bottom wall,
(b) two or more concentric grooves, or
(c) a plurality of separate grooves.

2. The drug delivery device of claim 1 , further comprising:
an adhesive layer disposed over at least a portion of the bottom wall, the adhesive layer for adhesively attaching the device to body tissue, wherein the at least one pressure communication channel is operative for distributing the negative fluid pressure across the adhesive layer, the negative pressure across the adhesive layer drawing the body tissue against the adhesive layer.

3. The drug delivery device of claim 1 , wherein the adhesive layer comprises at least one of: (a) a porous adhesive layer, (b) an adhesive layer that is disposed over the at least one pressure communication channel, and (c) an adhesive layer that is resilient.

4. The drug delivery device of claim 1 , further comprising a port having an opening through the outer surface of the bottom wall in fluid communication with the at least one pressure communication channel, the port for applying the negative pressure to the at least one pressure communication channel.

5. The drug delivery device of claim 1 , further comprising a negative pressure source in fluid communication with the at least one pressure communication channel.

6. The drug delivery device of claim 5 , wherein the negative pressure source comprises one of (a) a vacuum pump, (b) a syringe, (c) an oxygen absorber, or (d) an air chamber that expands in volume from a minimum volume state to generate the negative pressure.

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

8. The drug delivery device of claim 6 , including the air chamber, wherein the air chamber comprises a biasing element for expanding the air chamber from the minimum volume state.

9. The drug delivery device of claim 6 , including the air chamber and further comprising a user actuated first lever connected to the housing, the first lever for collapsing the air chamber.

10. The drug delivery device of claim 9 , further comprising a second lever which facilitates movement of the first lever in the first direction by the user pinching the first and second levers together.

11. The drug delivery device of claim 6 , including the air chamber and further comprising a plunger and a cylinder movably disposed relative to one another, wherein the air chamber is formed between the plunger and cylinder.

12. The drug delivery device of claim 6 , including the air chamber, wherein the air chamber includes a valve or vent that allows air contained within the air chamber to pass therethrough when the air chamber is collapsed to the minimum volume state and which does not allow air to pass therethrough when the chamber is expanded from the minimum volume state.

13. The drug delivery device of claim 1 , further comprising a controller for controlling the amount of the negative pressure.

14. The drug delivery device of claim 1 , further comprising a fluid pressure distribution structure for distributing fluid pressure to the at least one pressure communication channel.

15. The drug delivery device of claim 14 , wherein the fluid pressure distribution structure comprises one of (a) a serial structure having a primary fluid pressure delivery conduit and two or more secondary fluid pressure delivery conduits extending from the primary fluid pressure delivery conduit, or (b) a parallel structure comprising a plurality of fluid pressure delivery conduits extending from a source of fluid pressure.

16. The drug delivery device of claim 14 , further comprising one or more valves disposed in the fluid pressure distribution structure.

17. The drug delivery device of claim 1 , further comprising a sealing ring disposed around an injection needle entry site, or partially embedded in or disposed on, the base of the housing and surrounding an opening through which an injection needle of the device can extend through during needle insertion.

18. A method for attaching the drug delivery device of claim 1 to a patient, the method comprising:
placing the device above body tissue of the patient at a selected drug delivery site;
applying a negative fluid pressure to the at least one pressure communication channel extending along the outer surface of the bottom wall of the housing of the device, the at least one pressure communication channel distributing the negative fluid pressure across the outer surface of the bottom wall; and
drawing the body tissue of the patient against the bottom wall with the negative pressure.

19. The method of claim 18 , further comprising applying a positive fluid pressure to the at least one pressure communication channel, the at least one pressure communication channel distributing the positive fluid pressure across the bottom wall at the end of injection to indicate dose delivery completion.

20. The drug delivery device of claim 1 , further comprising a pressure sensor for sensing the proximity of the body tissue to the device, or whether there is negative fluid pressure drawing the body tissue against the bottom wall.

21. A drug delivery device comprising:
a housing including a top wall, a bottom wall, and at least one side wall connecting the top wall and the bottom wall;
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 pressure communication channel defined as at least one groove extending along an outer surface of the bottom wall of the housing, wherein the at least one pressure communication channel is operative for distributing a negative fluid pressure across the outer surface of the bottom wall, the negative fluid pressure drawing the body tissue toward the bottom wall; and
a source of a positive fluid pressure, wherein the at least one pressure communication channel is further operative for distributing the positive fluid pressure across the bottom wall at the end of injection to indicate dose delivery completion.

22. A drug delivery device comprising:
a housing including a top wall, a base, and at least one side wall connecting the top wall and the 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; and
at least one pressure communication channel or aperture defined by the base, wherein the at least one pressure communication channel or aper

Assignees

• Amgen Inc

Inventors

• Mccullough Adam B
• Ring Lawrence S

Classifications

• A61M2205/3344

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

• A61M2005/14252

  with needle insertion means · CPC title

• A61M2205/3306

  Optical measuring means · CPC title

• A61M2005/1586

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

• A61M5/14248 Primary

  of the skin patch type · CPC title