Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-05-01
2004-07-06
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C600S327000
Reexamination Certificate
active
06758835
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a disposable needle assembly. In particular, the present invention is directed to a micro-injection molded disposable needle assembly having more than one passageway formed therein to permit the simultaneous drawing and administering of fluids through separate passageways. The present invention is also directed to a micro-injection molded disposable assembly having one or more sensors disposed therein for measuring and monitoring one or more desired conditions. The present invention is also directed to a method of forming a disposable needle from an elastomeric material using micro-injection molding.
2. Description of Related Art
U.S. Pat. No. 3,610,226 to Albisser discloses a double lumen cannula instrument for the withdrawal of blood over a prolonged period of time. The instrument includes an inner lumen for withdrawing blood and an outer lumen for introducing an anticoagulent diluent. The relative locations of the openings for the inner and outer lumen permit the mixing of the diluent with the withdrawn blood.
U.S. Pat. No. 5,374,245 to Mahurkar discloses an extruded reinforced multiple-lumen catheter for use in medical applications where fluids must flow simultaneously to and from a patient. Blood is withdrawn for a medical procedure (e.g. dialysis) from the patient through one passageway and returned to the patient through another passageway spaced from the first passageway.
U.S. Pat. No. 5,607,401 to Humphrey discloses augmented polymeric hypodermic needles and lancets. The polymeric needles and lancets are stiffened by augmenting means, which includes a slideable guard or foam insert so that they are able to pierce the skin. Without the augmenting means, it is not possible for the polymeric hypodermic lancet to pierce the skin.
U.S. Pat. No. 5,637,399 to Yoshikawa et al. discloses an extruded synthetic resin needle that is reinforced with combustible fibers. The needle provides a single path administering or withdrawing fluids from a patient.
The prior art described above does not provide for a needle assembly that is capable of prolonged insertion in the patient for both the simultaneous administering of intravenous fluids and the withdrawal of blood without mixing the intravenous fluid with the withdrawn blood. Furthermore, these needle assemblies do not permit the monitoring of the patient without the further insertion of additional needle assemblies or sensors into the patient.
Various devices for internally monitoring a patient are known. U.S. Pat. No. 3,490,441 to Curtis discloses an intra-arterial blood pressure transducer, which includes a needle that is inserted into a blood vessel. The patient's blood pressure is measured by measuring the deflection of a sheath surrounding the needle. U.S. Pat. No. 4,665,927 discloses a flexible probe formed from a flexible plastic for sensing and measuring temperature. The probe may take the form of a needle that is inserted into the patient. U.S. Pat. No. 5,568,806 to Cheney et al. discloses a transcutaneous sensor insertion set. The insertion set includes a needle assembly having a sensor assembly for insertion into a patient. Upon insertion, the needle assembly may be withdrawn leaving the sensor assembly in place for monitoring the patient. None of these devices permit the simultaneous insertion and/or withdrawal of fluids while monitoring the patient.
U.S. Pat. No. 6,032,059 to Henning et al. discloses a fluid sampling device having a needle assembly for sampling of blood and measuring an analyte of interest within the blood. The device includes an analysis device that determines the required amount of drug to be injected in response to the measured analyte without removal of the device from the patient's body. In operation, the needle assembly is inserted into a blood vessel of the patient. The blood then flows into the needle to contact the sensor assembly. The blood is analyzed. In response to the analysis, a drug dosage is automatically administered through needle assembly. Although U.S. Pat. No. 6,032,059 discloses a needle assembly connected to a sensor assembly, it does not disclose a needle assembly that permits the simultaneous insertion and withdrawal of fluids from the blood stream while performing a sensing operation. Furthermore, the needle assembly is not designed for prolonged insertion the patient.
OBJECTS OF THE INVENTION
It is an object of the present invention to provide a disposable needle assembly that is capable of drawing and administering fluids from a patient.
It is another object of the present invention to provide a disposable needle assembly that is formed from a non-bioreactive material, which permits implantation in a patient for extended periods of time. The present invention eliminates the need for multiple patient injections.
It is another object of the present invention to provide a disposable needle assembly that permits the simultaneous administering of intravenous fluids and the drawing of blood.
It is another object of the present invention to provide a disposable needle assembly that permits the simultaneous administering of intravenous fluids and the drawing of blood without contaminating the blood with the intravenous fluids.
It is yet another object of the present invention to provide a micro-injection molded disposable needle assembly having a plurality of passageways formed therein, wherein at least one of the passageways is provided to withdraw blood from the patient.
It is another object of the present invention to provide a micro-injection molded disposable needle assembly having a plurality of passageways formed therein, wherein at least one of the passageways is provided to administer an intravenous fluid to the patient.
It is another object of the present invention to provide a disposable needle assembly having a plurality of passageways formed therein, wherein at least one of the passageways is provided to withdraw blood from the patient.
It is another object of the present invention to provide a micro-injection molded disposable needle assembly having a plurality of passageways formed therein having a passageway for administering an intravenous fluid and a passageway to withdraw blood from the patient, wherein the passageway for withdrawing blood is capable of being flushed with intravenous fluid at predetermined times.
It is another object of the present invention to provide a disposable needle assembly having at least one sensor located therein for sensing one or more predetermined conditions including but not limited to, chemical agents in the blood stream, blood flow, pressure, and temperature.
It is another object of the present invention to provide a disposable needle assembly having at least one sensor containing at least one polarographic region for sensing chemical agents in the blood stream.
It is another object of the present invention to provide a disposable needle assembly having at least one electroconductive sensor for sensing at least chemical agents in the blood stream and temperature.
It is another object of the present invention to provide a disposable needle assembly having an optical sensor for sensing chemical agents and/or measuring intravenous pressure.
It is another object of the present invention to provide a disposable needle assembly having a flexible diaphragm for use in connection with the measurement of intravenous pressure.
It is another object of the present invention to provide a disposable needle assembly having a flexible diaphragm for use in connection with the measurement of a patient's pulse.
SUMMARY OF THE INVENTION
In response to the foregoing challenges, applicants have developed a needle assembly for use in connection with treating and monitoring a patient. The needle assembly is capable of administering fluids to the patient and also drawing fluids from the patient. The needle is preferably formed by micro-injection molding and is disposable.
The needle assembly includes an elongated needle shaft having a first end and a seco
Close Benjamin W.
Hall, III Thomas A.
Casler Brian L.
Han Mark K
MedTG, LLC
Pillsbury & Winthrop LLP
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