Drug delivery and monitoring system

Details Drug delivery and monitoring system Drug delivery and monitoring system

2001-03-21

2004-02-03

Lazarus, Ira S. (Department: 3749)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S200000, C604S208000, C604S030000, C604S028000

Reexamination Certificate

active

06685678

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates in general to the field of drug delivery, and more particularly, to drug delivery and monitoring systems having drug administration information and data storage capability.
An alarming number of adverse drug events occur nationally contributing significantly to morbidity and mortality, as well as immense expense. Major contributing factors include the necessity of health care workers to perfectly identify, prepare and administer medications after properly identifying the patient and remembering allergies, drug—drug interactions, the patient medical conditions and then recalling drugs and dosing for charting on the patient's record.
A number of systems are known for monitoring drug delivery to a patient through an IV injection port. For example, see Martin, U.S. Pat. No. 4,976,687; Abrams, U.S. Pat. No. 4,613,325; Robinson, et al., U.S. Pat. No. 4,559,044; Purcell, et al.; U.S. Pat. No. 4,383,252; and Lundquist, U.S. Pat. No. 4,079,736.
A drug documenting system has been disclosed using optical scanning techniques in Walker, et al., U.S. Pat. No. 5,651,775, the disclosure of which is incorporated herein in its entirety by reference. In Walker, et al., a scanner module includes a reader for entering and storing drug administration information and data on a magnetic card by operation of a microprocessor. The scanner module includes one or more photo sensing electronic detectors for reading machine readable drug administration information provided on a label adhered to a syringe and determining drug volume delivery data in real time. A PCMCIA slot provides system communication through the use of a modem or connection to an area network. The scanner module may be integrated into a system at a fixed location or rendered portable by battery power. By reducing the sensing system size and connecting to wireless communicating devices, added safety and utility can be made available to patients. Notwithstanding the foregoing, there remains the desire for improvements in drug delivery and monitoring systems, which are fulfilled by the system of the present invention.
SUMMARY OF THE INVENTION
The present invention relates to detecting and documenting drug delivery events using a scanner module for patients receiving injectable medications. By digitizing this information, a log of which patient received what medication and how much, can be transferred to a computerized patient record for temporary or permanent storage. Furthermore, when designed as part of a data network, the drug about to be given to a patient can be checked against the patient's database of other medications, allergies and health conditions allowing warning to the health care professional of possible adverse drug events like administering a drug for which the patient is known to be allergic. Thus, the scanner module can be portable, handheld and have wireless data transceiving capabilities, as well as on-board memory and a microcomputer, allowing the module to function as a point-of-care medication delivery documentation device.
In accordance with various aspects of the present invention, an intravenous injection port cradle is provided with a patient identifying bar or similar machine and/or human readable code permanently affixed to the cradle. The injection port cradle can be used not only for aligning with the syringe using a scanner module for intravenous drug administration, but can carry a patient identifier, e.g., bar code, that will be read by the system in conjunction with the syringe which is mounted to a syringe label cradle. This provides the ability to verify that the right drug matches the correct patient, and affords benefits when the patient is moved or transferred in hospital (i.e., radiology, X-ray, etc.). In this regard, the port cradle and patient identifying information goes with the patient throughout their hospital stay. The barcode can either be one dimension barcode or two dimension, which provides more data on the barcode including a patient photo if desired.
A drug container or ampule similarly attached to a drug cradle is designed to cause a syringe similarly mounted to a scanner module to automatically align therewith. The drug cradle also has an area which holds a unique identifying code for the drug which is machine readable. The handheld scanner module can hold the syringe label cradle, drug cradle and/or the patient intravenous port cradle. The scanner module causes the syringe to automatically align with either the patient injection port or the drug supply container. This alignment facilitates the filling of syringes with the medication and subsequent use by the clinician. When the medication container in its cradle is removed from the scanner module, an injection port carried in the port cradle may be advanced into the scanner module and be caused to automatically align with the filled syringe. Depression of the plunger of the syringe causes the medication to be dispensed into the intravenous tubing connected to a patient's vein.
The port cradle is held away from contamination and in a manner which allows easy and accurate alignment with syringes full of medications similarly mounted on matching cradles. The two cradle systems cause alignment of the needle of the syringe with the orifice or center septum of medication supply containers. A syringe filled in this manner and remaining attached to the scanner module can then be dispensed into the IV port which also mounts onto the scanner module. The scanner module allows in-field preparation and use of medications directly from the supply container into the syringe, and then into the patient without removing the syringe from the module. This allows for the digital documentation of the conjoining of these labels and their drug administration information, as well as the movement of the syringe plunger. By temporarily storing this information or by immediately transmitting this information, the medication delivery event can be communicated to an automatic clinical record or hospital information system. By securing the medication supply vials or ampules in the drug cradle, the medications can be organized for storage or deployment in the clinical setting. These drug cradles help mount the medications in a transport tray for easy identification and accounting.
The scanner module according to one aspect of the invention is in the nature of a syringe mounting and sensing device which (1) causes automatic alignment of the needle of the syringe with an injection port of an intravenous tubing connected to a catheter delivering solutions to a patient or (2) directly to the patient by intramuscular or (3) subcutaneous injection routes. The scanner module in one embodiment uses an array of fiber optic conductors to route an image of the syringe plunger to a detector which senses light levels reflecting the position of the dark syringe plunger seal. The position of the plunger thereby sensed is converted into a digital report of the movement of the syringe plunger and when coupled with information about the size of the syringe, the drug in the syringe and concentration, the amount of medication delivered to the patient may be encoded. A second fiber optic array can be used to read information encoded into a barcode on the label portion of the syringe cradle. The drug information and plunger position are transferred to an attached handheld computing device for storage and ultimate uploading to patient information systems. The identity of the patient receiving the medication may likewise be sensed by a barcode attached to the intravenous delivery port cradle or by scanning the patient's identification via a barcode such as a wristband or similar tag.
Fiber optic channels are known to conduct light around curves and may be used to illuminate or transmit areas of light and dark. By closely aligning a linear array of fiber optic channels to the barrel of the syringe and then routing the fiber optic channels to a linear CCD (charged coupled device or similar photosensing electronic

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