Apparatus for fabricating needles via conformal deposition...

Static molds – Including static filling means in contact with mold cavity

Reexamination Certificate

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C249S135000, C164S046000

Reexamination Certificate

active

06375148

ABSTRACT:

BRIEF DESCRIPTION OF THE INVENTION
This invention relates generally to hypodermic needles. More particularly, this invention relates to a technique for fabricating needles via conformal deposition in two-piece molds.
BACKGROUND OF THE INVENTION
Traditional machining techniques, such as, tube drawing, grinding, and polishing are used to fabricate needles. While satisfactory for simple needle designs, these techniques cannot be used to fabricate more sophisticated features and geometries that provide extended functionality. For example, a needle with two fluid channels to allow the simultaneous injection of two fluids to the same area is very difficult to fabricate with traditional needle machining techniques. Electronic circuitry, such as, electrodes and amplification circuitry may be used for charge delivery, electric field sensing, or electrophoretic pumping. Biological sensors to provide, for example, biological assay capability, would be extremely useful. Insertion and extraction limiting barbs are also potentially very useful. Additionally, a pump built into the needle and multiple inlet and outlet ports are highly desirable features. A dual prong needle would allow delivery through one prong and sensing in the other. These features are very difficult to implement with traditional machining.
Recently, silicon microfabrication techniques have been used to construct hypodermic needles. For example, microfabrication processes to produce needles are described in the work by Chen and Wise (J. Chen et al., “A Multichannel Neural Probe for the Selective Chemical Delivery at the Cellular Level”, Solid State Sensor and Actuator Workshop, Hilton Head, S.C., 1994) and also by Linn (Liwei L. Linn, et al., “Silicon Processed Microneedles”,
Technical Digest,
7th International Conference on Solid-State Sensors and Actuators, Transducers '93, Yokohama, Japan, Jun. 7-10, 1993). There are two drawbacks with this early work. First, the disclosed processes are destructive to the wafer from which the needles are produced. Second, the processes do not rely upon a mold. Thus, new wafers must be used each time the process is repeated. This results in considerable added expense.
Single mold processes to make needles are known in the art. For example, the HexSil process invented by Chris Keller (Christopher G. Keller et al., “Nickel-Filled HexSil Thermally Actuated Tweezers”,
Technical Digest,
Transducers 95, Stockholm, Sweden, Jun. 25-29, 1995, pp. 376-379) is a single wafer micromolding process. Unfortunately, the Hexsil process can only form relatively short needles (generally less than a millimeter).
In view of the foregoing, it would be highly desirable to provide an improved technique for fabricating hypodermic needles. Ideally, the technique would allow the fabrication of needles with extended functionality, such as multiple fluid channels, multiple ports, and integrated circuitry. In addition, the technique would preferably avoid prior art problems of limited needle length. Ideally, the technique would provide a re-usable mold process to reduce fabrication expense.
SUMMARY OF THE INVENTION
A method of fabricating a needle via conformal deposition in a two-piece mold includes the step of attaching a top mold member to a bottom mold member such that the top mold member and the bottom mold member define an enclosed, elongated needle trench with a deposition aperture. A conformal substance, such as polysilicon, is then passed through the deposition aperture such that the conformal substance is deposited within the enclosed, elongated needle trench to form a needle. The method is used to form needles with prongs, multiple channels, multiple ports, barbs, strength enhancement features, and circuitry.
The invention constitutes an improved technique for fabricating hypodermic needles. The re-usable mold process reduces fabrication expense. In addition, the mold process of the invention provides for longer needles than available in prior art mold processes.


REFERENCES:
patent: 237619 (1881-02-01), Smith
patent: 3671159 (1972-06-01), Greenberg et al.
patent: 5383512 (1995-01-01), Jarvis
patent: 5407503 (1995-04-01), Matsui et al.
patent: 5591139 (1997-01-01), Lin et al.
patent: 5620639 (1997-04-01), Stevens et al.
Keller et al., “Milli-Scale Polysilicon Structures”, Technical Digest, IEEE Solid-State Sensor & Actuator Workshop, Hilton Head, South Carolina, US, pp. 132-137, Jun. 13-16, 1994.
Chen et al., “A Multichannel Neural Probe For Selective Chemical Delivery At The Cellular Level”, Technical Digest, IEEE Solid-State Sensor & Actuator Workshop, Hilton Head, South Carolina, US, pp. 256-259, Jun. 13-16, 1994.
Keller et al., “Nickel-Filled Hexsil Thermally Actuated Tweezers”, Technical Digest, Transducers 95, Stockholm, Sweden, pp. 376-379, Jun. 25-29, 1995.

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