IP Library Granted Patent US 9,199,044
Granted Patent B2
US 9,199,044 · App. 13/567,921 · Granted Dec 1, 2015

Devices and methods for wearable injection guides

Inventors: Mahalaxmi Gita Bangera (Renton, WA); Edward S. Boyden (Chestnut Hill, MA); Gregory J. Della Rocca (Columbia, MO); Daniel Hawkins (Pleasanton, CA); Roderick A. Hyde (Redmond, WA); Muriel Y. Ishikawa (Livermore, CA); Jordin T. Kare (San Jose, CA); Robert Langer (Newton, MA); Eric C. Leuthardt (St Louis, MO); Stephen L. Malaska (Redmond, WA); Terence Myckatyn (St. Louis, MO); Parag Jitendra Parikh (St. Louis, MO); Dennis J. Rivet (Chesapeake, VA); Joshua S. Shimony (St. Louis, MO); Michael A. Smith (Phoeniz, AZ); Elizabeth A. Sweeney (Seattle, WA); Clarence T. Tegreene (Mercer Island, WA); Sharon L. Wolda (Seattle, WA); Lowell L. Wood, Jr. (Bellevue, WA)
Assignee: Elwha LLC
A61M5/427A61B17/3403A61M5/46G06F17/5086A61B2017/3411A61B2019/5287
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Quick Facts
Patent No.
US 9,199,044
App. No.
13/567,921
Granted
Dec 1, 2015
Kind
B2
Abstract

Wearable injection guides and manufacture and use thereof are described, which include: a rigid material formed to substantially conform in shape to a topography of a body region of an individual, the rigid material substantially impenetrable to an injection needle, and the rigid material including one or more injection needle access regions arranged in a treatment pattern.

Claims (62)

1. A personalized wearable injection guide comprising:

a rigid material fabricated based on a specific topography of a patient's face to substantially conform in shape to contours of the patient's face, the rigid material substantially impenetrable to an injection needle;

one or more injection needle access regions, each of the one or more injection needle access regions including a portion of the rigid material defining an opening, the one or more injection needle access regions arranged in a patient-specific treatment pattern determined by the patient's distribution of facial lines or wrinkles; and

an activatable injection event indicator associated with at least one of the one or more injection needle access regions.

2. The personalized wearable injection guide of claim 1 , wherein at least a portion of the rigid material comprises:

a transparent thermoplastic material.

3. The personalized wearable injection guide of claim 1 , wherein the rigid material includes a needle-depth limiting thickness proximate to or at least partially coincident with at least one of the one or more injection needle access regions and configured to limit a depth to which an injection needle can be injected into the patient.

4. The personalized wearable injection guide of claim 1 , wherein the rigid material includes a first needle-depth limiting thickness proximate to or at least partially coincident with a first of the one or more injection needle access regions and configured to limit injection into the patient to a first depth and a second needle-depth limiting thickness proximate to or at least partially coincident with a second of the one or more injection needle access regions and configured to limit injection into the patient to a second depth.

5. The personalized wearable injection guide of claim 1 , wherein the portion of the rigid material defining the opening includes a portion of the rigid material defining an opening that transects the rigid material at an angle of less than 90 degrees relative to an adjacent surface of the rigid material.

6. The personalized wearable injection guide of claim 1 , wherein the portion of the rigid material defining the opening comprises:

a downward tapered access surface configured to guide an injection needle to a center of the opening.

7. The personalized wearable injection guide of claim 1 , wherein the activatable injection event indicator comprises:

a pressure sensitive dye incorporated into or near the at least one of the one or more injection needle access regions.

8. The personalized wearable injection guide of claim 1 , wherein the activatable injection event indicator comprises:

a flowable dye stored in a needle-penetrable reservoir incorporated into at least one of the one or more injection needle access regions.

9. The personalized wearable injection guide of claim 1 , wherein the activatable injection event indicator comprises:

an oxygen sensitive dye or a moisture sensitive dye stored in a needle-penetrable reservoir incorporated into at least one of the one or more injection needle access regions.

10. The personalized wearable injection guide of claim 1 , wherein the activatable injection event indicator comprises:

a needle-penetrable membrane.

11. The personalized wearable injection guide of claim 1 , further comprising:

one or more fiducials indicative of at least one patient-specific treatment parameter, wherein the at least one patient-specific treatment parameter is part of a treatment regimen.

12. The personalized wearable injection guide of claim 11 , wherein at least one of the one or more fiducials indicative of the at least one patient-specific treatment parameter is positioned proximal to at least one of the one or more injection needle access regions.

13. The personalized wearable injection guide of claim 11 , wherein the one or more fiducials indicative of the at least one patient-specific treatment parameter comprise:

one or more of a color, a number, a letter, a shape, crosshairs, or combinations thereof indicative of the at least one patient-specific treatment parameter.

14. The personalized wearable injection guide of claim 11 , wherein the one or more fiducials indicative of the at least one patient-specific treatment parameter comprise:

one or more fiducials indicative of at least one of a type and a dose of an injectable agent to be injected at at least one of the one or more injection needle access regions.

15. The personalized wearable injection guide of claim 14 , wherein the one or more fiducials are indicative of at least one of a type and a dose of an injectable neurotoxin to be injected at at least one of the one or more injection needle access regions.

16. The personalized wearable injection guide of claim 14 , wherein the one or more fiducials are indicative of at least one of a type and a dose of an injectable subcutaneous volume enhancer or an injectable dermal filler to be injected at at least one of the one or more injection needle access regions.

17. The personalized wearable injection guide of claim 11 , wherein the one or more fiducials indicative of the at least one patient-specific treatment parameter comprise:

one or more fiducials indicative of at least one needle injection depth of at least one type of injectable agent to be injected at at least one of the one or more injection needle access regions.

18. The personalized wearable injection guide of claim 1 , further comprising:

at least one agent-containing reservoir associated with the rigid material and configured to store one or more of an analgesic, disinfectant, antiseptic, sterilant, or therapeutic agent.

19. The personalized wearable injection guide of claim 18 , wherein the at least one agent-containing reservoir associated with the rigid material comprises:

at least one agent-containing reservoir incorporated proximal to or coincident with at least one of the one or more injection needle access regions.

20. The personalized wearable injection guide of claim 1 , further comprising:

a means for immobilizing the rigid material on the patient's face.

21. A method of administering an injection treatment to a patient comprising:

inserting one or more injection needles through one or more injection needle access regions of a personalized wearable injection guide, the personalized wearable injection guide including a rigid material fabricated based on a specific topography of a patient's face to substantially conform in shape to contours of the patient's face, the rigid material substantially impermeable to an injection needle, each of the one or more injection needle access regions including a portion of the rigid material defining an opening, the one or more injection needle access regions arranged in a patient-specific treatment pattern determined by a distribution of facial lines or wrinkles on the patient's face, and an activatable injection event indicator associated with at least one of the one or more injection needle access regions;

activating the activatable injection event indicator during insertion of the one or more injection needles through the one or more injection needle access regions of the personalized wearable injection guide; and

injecting at least one injectable agent through the one or more injection needles into an underlying tissue of the patient's face in proximity to at least one of the facial lines or wrinkles on the patient's face.

22. The method of claim 21 , further comprising:

inserting the one or more injection needles through at least one of the one or more injection needle access regions at an angle less than 90 degrees relative to the surface of the personalized wearable injection guide, the at least one of the one or more injection needle access regions including a portion of the rigid material defining an opening that transects the rigid material at an angle less than 90 degrees relative to an adjacent surface of the rigid material.

23. The method of claim 21 , wherein activating the activatable injection event indicator comprises:

activating at least one of a pressure sensitive material.

24. The method of claim 21 , wherein activating the activatable injection event indicator comprises:

activating at least one of an oxygen-sensitive dye or a moisture-sensitive dye.

25. The method of claim 21 , wherein injecting the at least one injectable agent through the one or more injection needles into the underlying tissue of the patient's face in proximity to at least one of the facial lines or wrinkles on the patient's face comprises:

injecting at least one neurotoxin through the one or more injection needles into the underlying tissue of the patient's face in proximity to at least one of the facial lines or wrinkles on the patient's face.

26. The method of claim 21 , wherein injecting the at least one injectable agent through the one or more injection needles into the underlying tissue of the patient's face in proximity to at least one of the facial lines or wrinkles on the patient's face comprises:

injecting at least one of a subcutaneous volume enhancer or a dermal filler through the one or more injection needles into the underlying tissue of the patient's face in proximity to at least one of the facial lines or wrinkles on the patient's face.

27. The method of claim 21 , further comprising:

aligning the personalized wearable injection guide with one or more reference marks placed on a surface of the patient's face.

28. The method of claim 21 , further comprising:

aligning the personalized wearable injection guide with one or more topographical landmarks of the patient's face.

29. The method of claim 21 , further comprising:

immobilizing the personalized wearable injection guide on the patient's face with a reversible adhesive.

30. The method of claim 21 , further comprising:

immobilizing the personalized wearable injection guide on the patient's face with one or more head-encircling pieces.

31. The method of claim 21 , further comprising:

releasing at least one of an analgesic, disinfectant, antiseptic, or therapeutic agent from at least one agent-containing reservoir associated with the rigid material of the personalized wearable injection guide during insertion of the one or more injection needles through the one or more injection needle access regions.

32. The method of claim 21 , further comprising:

altering the temperature of the personalized wearable injection guide to a temperature above or below about 98.6 degrees Fahrenheit.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2012
From: BANGERA, MAHALAXMI GITA; BOYDEN, EDWARD S.; CHIN, HON WAH; DELLA ROCCA, GREGORY J.; HAWKINS, DANIEL; HYDE, RODERICK A.; ISHIKAWA, MURIEL Y.; KARE, JORDIN T.; LANGER, ROBERT; LEUTHARDT, ERIC C.; MALASKA, STEPHEN L.; MYCKATYN, TERENCE; PARIKH, PARAG JITENDRA; RIVET, DENNIS J.; SHIMONY, JOSHUA S.; SMITH, MICHAEL A.; SWEENEY, ELIZABETH A.; TEGREENE, CLARENCE T.; WOLDA, SHARON L.; WOOD, LOWELL L., JR.
To: ELWHA LLC
Reel/Frame 029461/0609 →
Continuity (3)
Continuation In Part 13567995 · Aug 6, 2012
Continuation In Part 13568033 · Aug 6, 2012
Related Publication 20140039451A1 · Feb 6, 2014