Intradermal delivery device and method

• US 6,971,999 B2
• Filed: 11/14/2002
• Issued: 12/06/2005
• Est. Priority Date: 11/14/2001
• Status: Expired due to Fees

• Current Assignee: Maej, LLC
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Chan, Julian V., Py, Daniel
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/294,926
• Publication Number:
  US 20030093032A1
• Time in Patent Office: 1,118 Days
• Field of Search: 604/65, 604/67, 604/154, 604/189, 604/207, 604/208, 604/209, 604/211, 604/181, 604/136, 604/198, 604/263, 604/192, 604/272, 604/268, 604/264, 604/167, 604/180, 604/244, 604/117, 128/DIG.11, 128/12
• US Class Current: 604/115
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button
• CPC Class Codes: A61M 5/31591 Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

The subject intradermal delivery device provides for penetration to a fixed depth without requiring special expertise by the user. The device consists of a syringe nested inside an inner shell and an outer shell. An elongated annular channel is formed between the inner shell and the outer shell. A housing receives the syringe and concentric shells in a sliding engagement. A first seal on the distal end of the housing forms a variable length channel in communication with the elongated annular channel via a port formed in the outer shell. When the device is applied to the skin, the housing and syringe are slid towards the skin, and the variable length channel generates a vacuum which forces the skin to bulge into the elongated annular channel. As a result, the skin is tensioned across the inner shell to form a substantially planar, taut target area of skin. The taut target area of skin in combination with a stop on the housing determines the insertion depth of the syringe.

Claims

1. A delivery device comprising:

a housing including a base defining a first skin-engaging surface portion forming a needle aperture and defining a substantially planar target penetration region of skin, and a second skin-engaging surface portion extending radially relative to the first skin-engaging surface portion to substantially prevent relative movement of the skin and the base and releasably secure the base to the skin;

a syringe including a syringe body coupled to the housing, a plunger slidably received within the syringe body and a needle in fluid communication with the syringe body, wherein the needle is movable through the needle aperture upon slidably moving the syringe through the housing to thereby insert the needle into the substantially planar target penetration region of the skin and inject a substance contained within the syringe; and

at least one stop surface fixed relative to at least a portion of the first skin-engaging surface and adapted to cooperate with the syringe to limit a depth of insertion of the needle into the substantially planar target penetration region of the skin.

2. A delivery device as defined in claim 1, further comprising a vacuum chamber in fluid communication with the base for drawing a vacuum within the base and, in turn, releasably securing the first and second skin-engaging surfaces to the skin.

3. A delivery device as defined in claim 1, wherein the depth is such that an opening of the needle is located substantially entirely within the skin.

4. A delivery device as defined in claim 1, wherein the needle has an angled needle tip.

5. A delivery device as defined in claim 1, wherein the substantially planar target penetration region is oriented at an acute angle relative to an axis of the delivery device.

6. A delivery device as defined in claim 5, wherein the acute angle is within the range of about 30°

to about 60°

relative to the axis of the intradermal delivery device.

7. A delivery device as defined in claim 1, wherein the housing includes first and second parts, and at least one of the first and second parts is movable relative to the other.

8. A delivery device as defined in claim 1, wherein the base of the housing includes an inner shell defining the first skin-engaging surface and an outer shell surrounding the inner shell defining the second skin-engaging surface.

9. A delivery device as defined in claim 1, further comprising a mechanism associated with the housing for generating vacuum.

10. A delivery device as defined in claim 9, wherein the mechanism for generating vacuum includes an outer shell substantially concentric with an inner shell defining an elongated annular channel therebetween, and the housing defines a sealed channel of variable size in communication with the elongated annular channel such that in a retracted position the shells are placed against a patient'"'"'s skin and the housing slides to increase the sealed channel in size, thereby creating a vacuum within the elongated annular channel and, in turn, tensioning the patient'"'"'s skin across the inner shell such that the substantially planar target penetration region is established.

11. A delivery device as defined in claim 10, further comprising a relief opening for porting the sealed chamber to ambient conditions in an extended position.

12. A delivery device as defined in claim 1, further comprising a stop connected to the housing for controlling a dosage of substance released from the syringe.

27. A delivery device as defined in claim 1, wherein the at least one stop surface is arranged so the the depth of insertion of the needle allows for an intradermal injection.

13. A method for delivering a substance into a patient comprising the steps of:

(a) providing a delivery device including a housing having a base defining a first skin-engaging surface portion forming a needle aperture and defining a substantially planar target penetration region of skin, and a second skin-engaging surface portion extending radially relative to the first skin-engaging surface portion to substantially prevent relative movement of the skin and the base, and releasably secure the base to the skin;

(b) reciprocally mounting a syringe in the housing, the syringe having a syringe body for storing a substance, a plunger slidably received within the syringe body and a needle in fluid communication with the syringe body;

(c) releasably securing the first and second skin-engaging surface portions on the skin of the patient;

(d) forming the substantially planar target penetration region of the skin;

(e) inserting the needle of the syringe into the substantially planar target penetration region of the skin upon slidably moving the syringe through the housing;

(f) controlling a depth of insertion of the needle into the substantially planar target penetration region with at least one stop surface fixed relative to at least a portion of the first skin-engaging surface for determining the depth in cooperation with the syringe; and

(g) injecting the substance from the syringe body through the needle into the patient.

14. A method as defined in claim 13, further comprising the step of creating a vacuum between the first and second skin-engaging surface portions to form the substantially planar target penetration region of the skin.

15. A method as defined in claim 13, further comprising the step of inserting the needle at a predetermined acute angle between the axis of the needle and the substantially planar target penetration region of the skin.

16. A method as defined in claim 13, wherein the step of forming a substantially planar target penetration region on the skin includes tensioning the skin.

17. A delivery device comprising:

first means for defining a substantially planar target region of skin;

second means for releasably securing the first means to the skin and preventing relative movement of the substantially planar target region of the skin and the first means;

third means for storing a substance to be injected into the skin;

fourth means for releasing the substance from the third means;

fifth means in fluid communication with the third means for penetrating the substantially planar target region of the skin and injecting the substance contained within the third means; and

sixth means fixed relative to the first means for limiting a depth of insertion of the fifth means.

18. A delivery device as defined in claim 17, wherein the first means is defined by a first skin-engaging surface portion for engaging the skin and defining the substantially planar target penetration region of skin, and forming an aperture for receiving the fifth means therethrough.

19. A delivery device as defined in claim 17, wherein the second means is defined by a second skin-engaging surface portion extending radially relative to the first means, for engaging the skin and preventing relative movement of the skin and the first means.

20. A delivery device as defined in claim 19, further comprising a vacuum chamber formed adjacent to the second skin-engaging surface portion and connectable in fluid communication with the skin to releasably secure the second skin-engaging surface to the skin.

21. A delivery device as defined in claim 17, wherein the third means is defined by a chamber of a syringe.

22. A delivery device as defined in claim 17, wherein the fourth means is defined by a plunger slidably received within the third means.

23. A delivery device as defined in claim 17, wherein the fifth means is a cannula.

24. A delivery device as defined in claim 17, wherein the sixth means is at least one stop surface sized and configured to limit a depth of insertion of the fifth means.

25. A delivery device as defined in claim 17, wherein the depth of insertion is such that a release aperture of the fifth means is located substantially entirely within the skin.

26. A delivery device as defined in claim 17, wherein the substantially planar penetration region is oriented at an acute angle relative to an axis of the delivery device.