Methods and devices for intradermal injection
First Claim
1. An adapter (100, 200, 310, 410, 510) for use with a syringe (50, 80, 350) provided with a needle cannula (55, 85, 345, 431, 531) for intradermal injection of a medicament into the skin of a patient comprising:
- a body sized to receive in sliding engagement the needle cannula for movement of the needle cannula relative to the body between a first position and a second position;
a first primary skin contacting surface (104, 204, 323) positioned at a distal end of the body and containing an opening sized to receive the needle cannula;
a second primary skin contacting surface (105, 205, 311) positioned at the distal end of the body and further positioned at an angle (123, 223, 324) to the first skin contacting surface between approximately 120 degrees and approximately 165 degrees, the second primary skin contacting surface being fixed with respect to the first primary skin contacting surface and the second primary skin contacting surface being positioned distally with respect to the first primary skin contacting surface; and
a proximal contact surface extending proximally from a proximal end of the first primary skin contacting surface,wherein;
in the first position, the needle cannula is positioned relative to the body such that at least a tip of the needle cannula is retracted within the opening and a longitudinal axis of the needle cannula extends at an angle of greater than 0° and
less than 180°
with respect to a plane defined by the proximal contact surface;
in the second position, the tip of the needle cannula extends through the opening and the tip of the needle cannula extends outside of the body and exterior to the second skin contacting surface;
in the second position, the needle cannula extends axially in a direction substantially parallel to at least a portion of the second primary skin contacting surface.
1 Assignment
0 Petitions
Accused Products
Abstract
Devices and methods for intradermal (ID) administration of diagnostic and therapeutic agents, vaccines and other compounds into the dermal layer of the skin are disclosed. The devices and the methods simplify the ID injection process and increase the consistency of the placement of the needle tip in the dermal space close to the skin surface allowing for a shallow cannula placement in the dermis. Furthermore, the devices and methods broaden the number of sites suitable for ID injection and make the ID injection possible with limited training.
61 Citations
33 Claims
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1. An adapter (100, 200, 310, 410, 510) for use with a syringe (50, 80, 350) provided with a needle cannula (55, 85, 345, 431, 531) for intradermal injection of a medicament into the skin of a patient comprising:
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a body sized to receive in sliding engagement the needle cannula for movement of the needle cannula relative to the body between a first position and a second position; a first primary skin contacting surface (104, 204, 323) positioned at a distal end of the body and containing an opening sized to receive the needle cannula; a second primary skin contacting surface (105, 205, 311) positioned at the distal end of the body and further positioned at an angle (123, 223, 324) to the first skin contacting surface between approximately 120 degrees and approximately 165 degrees, the second primary skin contacting surface being fixed with respect to the first primary skin contacting surface and the second primary skin contacting surface being positioned distally with respect to the first primary skin contacting surface; and a proximal contact surface extending proximally from a proximal end of the first primary skin contacting surface, wherein; in the first position, the needle cannula is positioned relative to the body such that at least a tip of the needle cannula is retracted within the opening and a longitudinal axis of the needle cannula extends at an angle of greater than 0° and
less than 180°
with respect to a plane defined by the proximal contact surface;in the second position, the tip of the needle cannula extends through the opening and the tip of the needle cannula extends outside of the body and exterior to the second skin contacting surface; in the second position, the needle cannula extends axially in a direction substantially parallel to at least a portion of the second primary skin contacting surface. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method of making an intradermal injection into the skin comprising the steps of:
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providing an intradermal needle assembly comprising a needle cannula with a forward needle tip and an integral adapter surrounding the needle cannula, the adapter having a first skin contacting surface, a second skin contacting surface, and a proximal contact surface extending proximally from a proximal end of the first skin contacting surface, the needle cannula being in fluid communication with a drug delivery device, a longitudinal axis of the needle cannula extending at an angle of greater than 0° and
less than 180°
with respect to a plane defined by the proximal contact surface, the first and second skin contacting surfaces being positioned at a distal end of the assembly, the second skin contacting surface being positioned distally with respect to the first skin contacting surface;engaging the first and second skin contacting surfaces and the proximal contact surface with the skin; inserting the needle cannula into the dermis layer of the skin through an opening in the first skin contacting surface, wherein the needle cannula is further inserted in the dermis generally parallel to the second skin contacting surface; expelling a fluid from the drug delivery device into the dermis; and removing the intradermal needle assembly from the skin. - View Dependent Claims (25, 26, 27, 28)
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29. A method of making an intradermal injection into the skin comprising the steps of:
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providing an intradermal needle assembly having a forward needle tip and an integral adapter surrounding the needle cannula, the adapter having two surfaces for contacting the skin and the needle cannula being in fluid communication with a drug delivery device; engaging the contact surfaces of the adapter with the skin and maintaining contact of the skin with both adapter contact surfaces; slightly turning a needle hub counterclockwise as defined by a hub pin position to enable distal travel of the hub; inserting the needle into the dermis layer of the skin through an opening in one of the contact surfaces, wherein the needle cannula enters the dermis through the first surface and is further inserted in general parallel to the skin surface; expelling the compound from the drug delivery device into the dermis; and
removing, shielding, and discarding the needle assembly. - View Dependent Claims (30)
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31. A method of making an intradermal injection into the skin comprising the steps of:
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providing an intradermal needle assembly having a forward needle tip, an integral adapter surrounding the needle cannula and a dermis sensor, the adapter having two surfaces for contacting the skin and the needle cannula being in fluid communication with a drug delivery device; engaging the contact surfaces of the adapter with the skin and maintaining contact of the skin with both adapter contact surfaces; activating the dermis sensor while contacting the skin and maintaining the contact; inserting the needle into the dermis layer of the skin through an opening in one of the contact surfaces, wherein the needle cannula enters the dermis through the first surface and is further inserted generally parallel to the skin surface; expelling the compound from the drug delivery device into the dermis; and removing and shielding the cannula whereby the assembly is permanently disabled for safe discard. - View Dependent Claims (32)
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33. A method for providing an intradermal injection, comprising:
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contacting a skin surface with first and second skin contacting surfaces and a proximal contact surface of an adapter device having a drug delivery device mounted in an internal cavity, the first and second skin contacting surfaces being arranged at an angle of less than 180°
relative to one another, the first and second skin contacting surfaces being positioned at a distal end of the assembly, the second skin contacting surface being positioned distally with respect to the first skin contacting surface, the proximal contact surface extending proximally from a proximal end of the first skin contacting surface;inserting a needle cannula of the drug delivery device through an opening in the adapter device and into the skin, a longitudinal axis of the needle cannula extending at an angle of greater than 0° and
less than 180°
with respect to a plane defined by the proximal contact surface; andextending the needle cannula into the dermal layer along a path generally parallel to and below the second skin contacting surface.
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Specification