Microneedles for minimally invasive drug delivery
First Claim
1. A minimally invasive drug delivery system for transdermally delivering a medicinal fluid into a patient, comprising:
- (a) a handheld control unit comprising a housing, a processor, a display electrically coupled to said processor, a keypad electrically coupled to said processor, a memory electrically coupled to said processor;
a medicinal fluid reservoir;
a medicinal fluid outlet in fluid communication with said medicinal fluid reservoir, and an actuator that develops pressure to force the medicinal fluid from the medicinal fluid reservoir and through the medicinal fluid outlet for infusion into the patient, said actuator being electrically coupled to and controlled by the processor;
(b) a disposable cartridge, said disposable cartridge comprising a housing, and an array of microneedles through which the medicinal fluid is infused into the patient; and
(c) a fluid line having a distal end and a proximal end, said proximal end being connected to said medicinal fluid outlet, and said distal end being coupled with said disposable cartridge to provide fluid communication between the medicinal fluid outlet and the disposable cartridge;
(d) wherein each individual microneedle of said array comprises;
(i) a generally conical-shaped body having a beveled, non-coring tip, said tip being sharp and able to pierce tissue;
(ii) said conical body further having a broad base formed of a substrate at an opposite end from the tip; and
(iii) a fluid channel extending through the conical-shaped body, providing fluid communication between said broad base and said tip.
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Accused Products
Abstract
The present invention provides a microneedle incorporating a base that is broad relative to a height of the microneedle, to minimize breakage. The microneedle further includes a fluid channel and a beveled non-coring tip. Preferably arrays of such microneedles are fabricated utilizing conventional semiconductor derived micro-scale fabrication techniques. A dot pattern mask is formed on an upper surface of a silicon substrate, with each orifice of the dot pattern mask corresponding to a desired location of a microneedle. Orifices are formed that pass completely through the substrate by etching. A nitride pattern mask is formed to mask all areas in which a nitride layer is not desired. A nitride layer is then deposited on the bottom of the silicon substrate, on the walls of the orifice, and on the top of the silicon substrate around the periphery of the orifice. The nitride layer around the periphery of the orifice is offset somewhat, such that one side of the orifice has a larger nitride layer. Anisotropic etching is used to remove a substantial portion of the substrate, creating a plurality of angular, blunt, and generally pyramidal-shaped microneedles. A subsequent removal of the nitride layer, followed by an isotropic etching step, softens and rounds out the blunt angular microneedles, providing generally conical-shaped microneedles. The uneven nitride layer adjacent the orifice ensures that the microneedles will include a beveled tip. Such microneedle arrays are preferably incorporated into handheld diagnostic and drug delivery systems.
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Citations
14 Claims
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1. A minimally invasive drug delivery system for transdermally delivering a medicinal fluid into a patient, comprising:
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(a) a handheld control unit comprising a housing, a processor, a display electrically coupled to said processor, a keypad electrically coupled to said processor, a memory electrically coupled to said processor;
a medicinal fluid reservoir;
a medicinal fluid outlet in fluid communication with said medicinal fluid reservoir, and an actuator that develops pressure to force the medicinal fluid from the medicinal fluid reservoir and through the medicinal fluid outlet for infusion into the patient, said actuator being electrically coupled to and controlled by the processor;(b) a disposable cartridge, said disposable cartridge comprising a housing, and an array of microneedles through which the medicinal fluid is infused into the patient; and (c) a fluid line having a distal end and a proximal end, said proximal end being connected to said medicinal fluid outlet, and said distal end being coupled with said disposable cartridge to provide fluid communication between the medicinal fluid outlet and the disposable cartridge; (d) wherein each individual microneedle of said array comprises; (i) a generally conical-shaped body having a beveled, non-coring tip, said tip being sharp and able to pierce tissue; (ii) said conical body further having a broad base formed of a substrate at an opposite end from the tip; and (iii) a fluid channel extending through the conical-shaped body, providing fluid communication between said broad base and said tip. - View Dependent Claims (2, 3)
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4. A minimally invasive drug delivery system for transdermally delivering a medicinal fluid into a patient, comprising:
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(a) a handheld control unit comprising a housing, a processor, a display electrically coupled to said processor, a keypad electrically coupled to said processor, a memory electrically coupled to said processor, a medicinal fluid reservoir, a medicinal fluid outlet in fluid communication with said medicinal fluid reservoir, and an actuator that develops pressure to force the medicinal fluid from the medicinal fluid reservoir and through the medicinal fluid outlet for infusion into the patient, said actuator being electrically coupled to and controlled by the processor; (b) a disposable cartridge, said disposable cartridge comprising a housing, and an array of microneedles through which the medicinal fluid is infused into the patient; and (c) a fluid line having a distal end and a proximal end, said proximal end being connected to said medicinal fluid outlet, and said distal end being coupled with said disposable cartridge to provide fluid communication between the medicinal fluid outlet and the disposable cartridge; (d) a data cable, said data cable having a proximal end and a distal end, said proximal end of the data cable being connected to said handheld control unit, such that said data cable is electrically coupled to said processor, said distal end of the data cable being electrically coupled to said disposable cartridge; and (e) said disposable cartridge further including an ultrasonic transducer array that produces an ultrasonic signal directed into target region within a body of a patient and receives a reflected ultrasonic signal from within the body of the patient, producing an output signal indicative of a condition of the target region, said ultrasonic transducer array being electrically coupled to said data cable through which the output signal is conveyed, said processor responding to the output signal and indicating to a user on the display that said disposable cartridge is disposed adjacent to a desired region within the body of the patient. - View Dependent Claims (5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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Specification