INTRADERMAL INJECTION ADAPTER

• US 20120123386A1
• Filed: 07/23/2010
• Published: 05/17/2012
• Est. Priority Date: 07/23/2009
• Status: Active Grant

• Current Assignee: Sid Technologies LLC
• Original Assignee: Sid Technologies LLC
• Inventors: Tsals, Izrail
• Granted Patent: US 9,089,655 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 5/321 Means for protection against accidental injuries by used needles
• CPC Class Codes: A61M 5/3216 Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
• 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 5/46 having means for controlling depth of insertion

Abstract

An intradermal injection assembly for injecting a medicament into skin could form an intradermal needle with an adapter, an intradermal syringe with an adapter or an adapter for a merger with a syringe with a cannula. The intradermal adapter in these devices has a body having a longitudinal axis, a central portion having a cannula channel and a distal protrusion extending generally parallel to the longitudinal axis. The distal protrusion of the adapter has a first skin contacting surface extending generally parallel to the longitudinal axis. At least a portion of the distal protrusion is generally transparent such that the portion of the cannula that extends distally relative to a demarcation plane can be viewed through the distal protrusion during insertion of the cannula into a patient'"'"'s skin.

Claims

1. A syringe assembly for delivery of intradermal injections, the syringe assembly comprising:

a syringe barrel having a proximal end and a distal end,

a cannula connected to the distal end of the syringe barrel; and

a protrusion connected to the distal end of the syringe barrel, the protrusion having a first skin contacting surface spaced from and generally parallel to the cannula, wherein at least a portion of the protrusion proximate a distal end of the cannula is generally transparent to allow the cannula to be visible upon insertion into a patient'"'"'s skin.

2. The syringe assembly of claim 1, further comprising:

an adapter having a body with a proximal end and a distal end, wherein the proximal end of the body is connectable to the distal end of the syringe barrel, the cannula is connected to the distal end of the body and the protrusion is connected to the distal end of the body.

3. The syringe assembly of claim 1, further comprising:

an adapter having a body with a proximal end and a distal end, wherein the body is connectable to the distal end of the syringe barrel and the protrusion is rotatably connected to the body.

4. The syringe assembly of claim 3, wherein the protrusion includes a cannula support element to align the cannula to be generally parallel with the first skin contacting surface.

5. The syringe assembly of claim 1, further comprising:

an adapter having a body with a proximal end and a distal end, wherein the body is connectable to the distal end of the syringe barrel, the protrusion is connected to the distal end of the body, a second skin contacting surface is connected to the distal end of the body, the cannula extends distally between the protrusion and the second skin contacting surface and at least one support element is connected to the body to align the cannula to be generally parallel with the first skin contacting surface.

6. An intradermal injection adapter having a cannula for making an intradermal injection, the adapter comprising:

a body having a longitudinal axis;

a central portion located distally relative to the body along the longitudinal axis, the central portion having a cannula channel therethrough extending generally parallel to the longitudinal axis, the cannula channel defining a cannula channel edge; and

a distal protrusion having a first skin contacting surface extending generally parallel to the longitudinal axis, the first skin contacting surface spaced from the cannula such that a distal portion of the cannula extends generally parallel to the first skin contacting surface, the distal protrusion being generally transparent distally relative to a demarcation plane defined where the cannula extends across the cannula channel edge such that the distal portion of the cannula can be viewed through the distal protrusion during insertion of the cannula into a patient'"'"'s skin.

7. The adapter of claim 6 wherein a tip of the cannula is positioned approximately three to seven millimeters (3-7 mm) from the demarcation plane, the distal protrusion and central portion being generally opaque proximally relative to the demarcation plane.

8. The adapter of claim 6 wherein the cannula is fixed to the central portion and the body is integrally formed with a barrel of a syringe.

9. The adapter of claim 6 wherein the distal protrusion is movable between an aspiration position and an assembled configuration.

10. The adapter of claim 9 wherein the distal protrusion is pivotably mounted to the body.

11. The adapter of claim 10 further comprising:

a pivot arm attached to the central portion including a pivot shaft; and

a pivot hub attached to the body, the pivot shaft pivotably engaged by the pivot hub.

12. The adapter of claim 10 wherein the distal protrusion is pivotably mounted to the body by a living hinge.

13. The adapter of claim 9 wherein the distal protrusion is fixed relative to the body in an assembled configuration after the distal protrusion is moved from the aspiration position to the assembled configuration.

14. The adapter of claim 6 further comprising:

a positioning wall defined at an end portion of a syringe channel in the body, the syringe channel receiving a barrel of a syringe in an assembled configuration, the positioning wall engaged with a narrowed distal portion of the barrel in the assembled configuration.

15. An intradermal injection assembly for injecting a medicament into a dermal skin layer, the assembly comprising:

a syringe including a cannula, a hub, a barrel and a plunger, the barrel having a generally cylindrical configuration and a hollow internal cavity adapted to receive the medicament therein; and

an adapter having a body with a syringe channel, a central portion with a cannula channel defining a cannula channel edge, a distal protrusion with a distal nose, a proximal end portion and a longitudinal axis extending between the proximal end portion and the distal nose, the distal protrusion includes a first skin contacting surface positioned generally parallel to the longitudinal axis, a distal portion of the cannula spaced from the first skin contacting surface at a cannula gap distance in the assembled configuration, a tip of the cannula being positioned distally relative to the cannula channel edge in an assembled configuration.

16. The assembly of claim 15 wherein a tip of the cannula is located approximately one to six millimeters (1-6 mm) from the distal nose in the assembled configuration.

17. The assembly of claim 15 wherein the distal protrusion is generally transparent distally relative to a demarcation plane defined where the cannula crosses the cannula channel edge in the assembled configuration, the distal protrusion and central portion of the adapter being generally opaque proximally relative to the demarcation plane.

18. The assembly of claim 15 wherein the distal nose curves away from the longitudinal axis.

19. The assembly of claim 15 wherein the adapter further includes a cannula channel located in the central portion, the cannula positioned at least partially within the cannula channel in the assembled configuration.

20. The assembly of claim 15 further comprising:

an elastomeric cap removably mountable over the adapter and to a portion of the barrel such that a tip of the cannula is positioned within a distal head portion of the elastomeric cap in a storage position.

21. The assembly of claim 15 wherein the tip of the cannula is spaced an exposed length from a demarcation plane defined by the cannula channel edge.

22. The assembly of claim 21 wherein the exposed length is approximately one and one-half millimeters to ten millimeters (1.5-10 mm).

23. A method of injecting a medicament into a dermal skin layer of a patient'"'"'s skin utilizing an adapter and syringe assembly including a distal protrusion having a relatively transparent portion distally relative to a demarcation plane defined where a cannula crosses a cannula channel edge and a relatively opaque portion proximally relative to the demarcation plane, the adapter also including a first skin contacting surface positioned generally parallel to a distal portion of the cannula, a central portion and a longitudinal axis, the method comprising the steps of:

a) placing the adapter proximate the patient'"'"'s skin such that the longitudinal axis is generally parallel to the users skin;

b) applying a force to the assembly toward the skin and generally parallel to the skin to slide the adapter and syringe assembly along the patient'"'"'s skin and insert the cannula into the patient'"'"'s skin;

c) visually monitoring the insertion of the cannula into the users skin and the positioning of the patient'"'"'s skin relative to the first skin contacting surface through the relatively transparent portion of the distal protrusion;

d) confirming that the cannula is at least partially positioned within the patient'"'"'s skin in an injection position; and

e) injecting the medicament into the dermal skin layer.

24. The method of injecting of claim 23 comprising the further steps of:

f) withdrawing the adapter and syringe assembly away from the patient'"'"'s skin to remove the cannula from the patient'"'"'s skin; and

g) discarding the adapter and syringe assembly.

25. The method of injecting of claim 23 comprising the further step of:

f) engaging the syringe with the adapter prior to step (a) by inserting a barrel of the syringe into a syringe channel of the adapter such that a narrowed distal portion of the syringe is in facing engagement with a positioning wall of the adapter.

26. The method of injecting of claim 23 comprising the further steps of:

f) aspirating the medicament into the syringe prior to step (a); and

g) pivoting the distal protrusion and central portion of the adapter into alignment with the cannula following step (f).

27. The method of injecting of claim 23 comprising the further steps of:

f) removing an elastomeric cap from engagement with the adapter and syringe assembly prior to step (a).

28. An intradermal injection adapter for mounting to a syringe having a cannula for making an intradermal injection, the adapter comprising:

a body having a longitudinal axis and a syringe channel configured to receive at least a portion of the syringe therein;

a central portion having a cannula channel extending generally parallel to the longitudinal axis, the cannula channel defining a cannula channel edge; and

a distal protrusion extending generally parallel to the longitudinal axis, the distal protrusion having a first skin contacting surface extending generally parallel to the longitudinal axis, the first skin contacting surface spaced from the longitudinal axis and being generally continuous between an area adjacent a tip of the cannula and an area adjacent the cannula channel edge in an assembled configuration, the distal protrusion being generally transparent distally and generally opaque proximally relative to a demarcation plane defined where the cannula extends over the cannula channel edge, the demarcation plane being generally perpendicular the longitudinal axis, the tip being positioned distally relative to the demarcation plane in the assembled configuration.

29. The adapter of claim 28 further comprising:

a side opening extending along an entire length of the adapter generally parallel to the longitudinal axis, the opening permitting selective insertion and removal of the syringe therein.

30. The adapter of claim 28 further comprising:

a first alignment ramp positioned within the cannula channel and configured to orient a distal portion of the cannula generally parallel with the first skin contacting surface in the assembled configuration.

31. The adapter of claim 28 further comprising:

a second alignment ramp positioned within the cannula channel configured to orient the distal portion of the cannula, in cooperation with the first alignment ramp, generally parallel to the first skin contacting surface in the assembled configuration, the first and second alignment ramps including an upslope surface, an apex surface and a downslope surface.

32. The adapter of claim 28 further comprising:

a lateral cannula wall extending generally parallel to the longitudinal axis; and

an alignment wall extending generally parallel to the longitudinal axis, the cannula channel defined by the first skin contacting surface, the lateral cannula wall and the alignment wall, the cannula positioned adjacent the lateral cannula wall in the assembled configuration.

33. The adapter of claim 32 further comprising:

first and second alignment ramps located on the alignment wall within the cannula channel, the first and second alignment ramps including a downslope surface adjacent the lateral wall, the cannula positioned adjacent the downslope surfaces and the lateral wall in the assembled configuration.