Intradermal delivery device
First Claim
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1. An injectable substance delivery device comprising:
- at least one needle having a length sufficient to penetrate a skin surface of a patient to an intradermal depth for infusing a substance;
a limiter for controlling a needle insertion depth, wherein said limiter controls a maximum insertion depth of said needle into said skin surface without restricting complete insertion of said needle; and
a rigid stabilizer fixed at a first distance from said limiter for allowing an increased application force of said limiter while preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site such that said needle length and said limiter determine the depth at which said infusion is delivered, wherein said first distance is determined based upon an amount of said substance to be infused and a diameter of said limiter, and wherein said limiter and said rigid stabilizer are fixed having an extension difference comprising a second distance such that said needle, limiter, and stabilizer contact said skin surface in order, wherein said second distance is determined based upon a sharpness of said needle and said diameter of said limiter.
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Abstract
A system and method is provided for an injectable substance delivery device comprising a limiter, shoulder or post, that controls how deep the needle is inserted into the tissue. The limiter is sized in proportions that control the maximum insertion depth of the needle into the tissue without excessively restricting the complete insertion of the needle. The system and method further comprises an normalization or stabilizer ring that prevents distortion of the tissue in the vicinity of the infusion, so that the needle length is the major determining factor as to how deep the infusion is delivered.
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Citations
36 Claims
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1. An injectable substance delivery device comprising:
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at least one needle having a length sufficient to penetrate a skin surface of a patient to an intradermal depth for infusing a substance;
a limiter for controlling a needle insertion depth, wherein said limiter controls a maximum insertion depth of said needle into said skin surface without restricting complete insertion of said needle; and
a rigid stabilizer fixed at a first distance from said limiter for allowing an increased application force of said limiter while preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site such that said needle length and said limiter determine the depth at which said infusion is delivered, wherein said first distance is determined based upon an amount of said substance to be infused and a diameter of said limiter, and wherein said limiter and said rigid stabilizer are fixed having an extension difference comprising a second distance such that said needle, limiter, and stabilizer contact said skin surface in order, wherein said second distance is determined based upon a sharpness of said needle and said diameter of said limiter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. An injectable substance delivery device comprising:
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at least one needle having a length sufficient to penetrate a skin surface of a patient to an intradermal depth for infusing a substance;
a limiter for controlling a needle insertion depth, wherein said limiter controls a maximum insertion depth of said needle into said skin surface without restricting complete insertion of said needle; and
a flexible needle holder comprising an adhesive for securing said device to said skin surface, wherein said flexible needle holder is secured at a first distance from said limiter for preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site such that said needle length and said limiter determine the depth at which said infusion is delivered. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. An injectable substance delivery device comprising:
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at least one needle having a length sufficient to penetrate a skin surface of a patient to an intradermal depth for infusing a substance;
a limiter for controlling a needle insertion depth, wherein said limiter controls a maximum insertion depth of said needle into said skin surface without restricting complete insertion of said needle; and
a needle holder comprising an adhesive for securing said device to said skin surface and providing an enclosed air space about said needle, wherein said needle holder is secured at a first distance from said limiter for preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site such that said needle length and said limiter determine the depth at which said infusion is delivered. - View Dependent Claims (31, 32)
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33. An injectable substance delivery device comprising:
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at least one needle having a length sufficient to penetrate a skin surface of a patient to an intradermal depth for infusing a substance; and
an inclined needle holder, wherein said needle holder is secured to said skin surface and extends said needle at an angle for preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site. - View Dependent Claims (34)
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35. A method for providing an infusion wherein distortion of the tissue in the vicinity of the infusion is minimized, the method comprising the steps of:
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providing a limiter disposed about an infusion needle for contacting a skin surface during needle penetration to limit said needle insertion depth; and
providing a rigid stabilizer ring fixed at a first distance form said limiter for contacting said skin surface after said needle and limiter begin to deform said skin surface, wherein said rigid stabilizer ring minimizes deformation of said skin surface.
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36. A method for providing an infusion wherein distortion of the tissue in the vicinity of the infusion is minimized, the method comprising the steps of:
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providing an intradermal needle to contact a skin surface first for injection and resulting in a tissue deflection, wherein said needle is configured to penetrate said skin surface and generally maintain said degree of tissue deflection;
providing a limiter to subsequently contact said skin surface to limit a penetration depth of said needle;
providing a stabilizer ring to subsequently contact said skin surface over a larger volume of tissue and allow said limiter to be forced against said skin surface to minimize said degree of tissue deflection without allowing said needle to overtravel or become displaced, wherein said stabilizer ring transfers tissue compression away from said needle penetration site allowing proper penetration depth and preventing tissue distortion to minimize leakage at the penetration site.
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Specification