# US 9,039,655 B2 · Medication injection site and data collection system

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- Number: US 9,039,655 B2
- Document ID: US9039655B2
- Status: Granted
- Kind: B2
- Application number: 13/777,831
- Filed: 2013-02-26
- Published: 2013-08-29
- Granted: 2015-05-26
- Earliest claimed: 2009-11-06
- Assignees: CRISI Medical Systems, Inc.
- Applicants: CRISI Medical Systems, Inc.
- Inventors: Stephen Michael Prince; Walter John Bochenko; Shawn Wayne DeKalb; Winthrop De Childers
- Web page: https://patentgrep.com/patent/US9039655B2

## CPC

- A61M 5/31: Details
- A61M 39/02: Access sites
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 20/13: delivered from dispensers
- G16H 20/17: delivered via infusion or injection
- G16H 40/67: for remote operation
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61M 2039/0205: {for injecting media}
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/60: with identification means
- A61M 2205/6036: characterised by physical shape, e.g. array of activating switches
- A61M 2205/6054: Magnetic identification systems
- A61M 2205/6063: Optical identification systems
- A61M 2205/6072: Bar codes
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A medication delivery apparatus for use with a medication container includes a housing, a fluid conduit at least partially extending within the housing and configured to deliver medication within the medication container to a patient, a medication port extending from the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being fluidically coupled to the fluid conduit, and at least one sensor disposed within the housing to generate information characterizing administration of the medication for processing by a remote data collection system. The housing can have a size and shape that enables it to be supported by a first hand of a user while the user administers the medication from the medication container via the medication port using a second hand of the user. Related apparatus, systems, and techniques are also described.

## Claims

### Claim 1

A system comprising:
a housing;
a medication port extending from an external face of the housing configured to be fluidically and directly coupled to a fluid outlet of a manually administrable medication container comprising medication for administration to a patient;
a first identification sensor disposed within the housing to generate identification information indicative of contents of the medication container when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port;
a second sensor disposed within the housing to detect information on a source other than the medication container that is associated with the administration of the contents of the medication container; and
a transmitter disposed within the housing and in communication with the first identification sensor and the second sensor to wirelessly transmit the information generated by the first identification sensor and the second sensor to a remote data collection system.

### Claim 2 (depends on 1)

A system as in claim 1, wherein at least one of the first identification sensor and the second sensor comprises: a near field communication (NFC) sensor or a proximity sensor.

### Claim 3 (depends on 1)

A system as in claim 1, wherein the second sensor further detects information on the medication container that is associated with the administration of the contents of the medication container.

### Claim 4 (depends on 1)

A system as in claim 1, wherein the information detected by the first identification sensor and/or the second sensor comprises one or more of: a one dimensional barcode, a two dimensional barcode, symbolic information, an image, magnetic media, a near field communication (NFC) tag, biometric data, RFID encoded information.

### Claim 5 (depends on 1)

A system as in claim 1, wherein the information detected by the first identification sensor and/or the second sensor characterizes one or more of the patient, demographics associated with the patient, a medical record for the patient, a picture of the patient, a video associated with the patient, a biometric patient identifier (ID), a medical record number, physical characteristics of the patient, allergies of the patient, contraindications, and BROSELOW color.

### Claim 6 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes one or more of a patient sample.

### Claim 7 (depends on 6)

A system as in claim 6, wherein the patient sample is selected from a group consisting of: a blood sample, a urine sample, a tissue sample, and a stool sample.

### Claim 8 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes a medical device.

### Claim 9 (depends on 8)

A system as in claim 8, wherein the medical device is selected from a group consisting of: an intravenous (IV) pump, an EKG monitor, a defibrillator, a pulse oximeter, and a blood pressure monitor.

### Claim 10 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes fluids, medications, and food provided to the patient.

### Claim 11 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes bodily waste of the patient.

### Claim 12 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes a diagnostic test or treatment result for the patient.

### Claim 13 (depends on 12)

A system as in claim 12, wherein the diagnostic test or treatment result are selected from a group consisting of: lab values, radiological images, radiological reports, vital sign trends, EKG strip, and clinical reports.

### Claim 14 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes a caregiver associated with the patient.

### Claim 15 (depends on 14)

A system as in claim 14, wherein the information characterizing the caregiver associated with the patient is selected from a group consisting of: a picture of the caregiver, a video of the caregiver, an identification code associated with the caregiver, a password associated with the caregiver, an identification of the caregiver, a name of the caregiver, an affiliation of the caregiver, a responsible clinician associated with the caregiver, a decision-making authority associated with the caregiver.

### Claim 16 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes one or more of: a person accompanying the patient, a relationship of the person to patient, a companion, a picture of the person, a fingerprint of the person, an affiliation of the patient, a religion of the patient, contact information for the patient, breast milk information associated with the patient, organ donation information for the patient, medical directives associated with the patient, and caregiving instructions associated with the patient.

### Claim 17 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes a pharmacy record.

### Claim 18 (depends on 17)

A system as in claim 17, wherein the information characterizing the pharmacy record is selected from a group consisting of: prescription number, patient identifier, formulation, expiration date, administration instructions, precautions instructions, contraindications, medication reconciliation information, pharmacy identifier, and preparer identifier.

### Claim 19 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes a physician's order.

### Claim 20 (depends on 19)

A system as in claim 19, wherein the information characterizing the physician's order is selected from a group consisting of: medication administrations orders, lab orders, diagnostic testing orders, radiological orders, treatment orders, and therapy orders.

### Claim 21 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes an environmental factor associated with the patient.

### Claim 22 (depends on 21)

A system as in claim 21, wherein the information characterizing an environmental factor associated with the patient is selected from a group consisting of: a room number for the patient, a temperature of the room for the patient, a time, a care transition status, a time of admission of the patient, a time of last bed sheet change for the patient.

### Claim 23 (depends on 1)

A system as in claim 1, wherein the information detected by the second sensor characterizes one or more of: medication type, medication concentration, medication expiration date, medication NDC, and RxNorm code

### Claim 24 (depends on 1)

A system as in claim 1, wherein the medication container is selected from a group consisting of: syringes, vials, fluid bags, ampoules, blood bags, IV tubing sets, medication patches, and auto-injection devices.

### Claim 25 (depends on 1)

A system as in claim 1, wherein the source detected by the second sensor is on one or more of a patient wrist band, an oral solid package, a patient sample container, and a medical device.

### Claim 26 (depends on 1)

A system as in claim 1, wherein the remote data collection system forms part of a barcode medication administration system.

### Claim 27

A system comprising:
a housing;
a medication port extending from an external face of the housing configured to be fluidically and directly coupled to a fluid outlet of one of a plurality of manually administrable medication containers, the manually administrable medication containers having identification information on one or more of a first portion and a second portion and comprising medication for administration to a patient;
a first sensor disposed within the housing to generate data derived from the identification information on a first portion of a medication container coupled to the medication port;
a second sensor disposed within the housing to generate data derived from the identification information on a second portion of a medication container coupled to the medication port; and
a transmitter disposed within the housing and in communication with the first sensor and the second sensor to wirelessly transmit data generated by the first sensor and the second sensor to a remote data collection system.

### Claim 28 (depends on 27)

A system as in claim 27, wherein the first sensor generates the data when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port.

### Claim 29

An apparatus comprising:
a housing;
a fluid port extending from an outer surface of the housing configured to be coupled to a fluid outlet of a fluid container;
an identification sensor disposed within the housing to generate information indicative of contents of the fluid container when the fluid outlet of the medication container is fluidically coupled to the fluid port; and
a transmitter disposed within the housing and in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system;
wherein the housing has a shape and size enabling it to be held by a first hand of a user while the user administers fluid from the fluid container via the fluid port using his or her second hand.

### Claim 30

A method for implementation by an apparatus comprising: a housing, a medication port extending from an external face of the housing configured to be fluidically and directly coupled to a fluid outlet of a manually administrable medication container comprising medication for administration to a patient, a first identification sensor disposed within the housing to generate identification information indicative of contents of the medication container when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port, a second sensor disposed within the housing to detect information on a source other than the medication container that is associated with the administration of the contents of the medication container, and a transmitter disposed within the housing and in communication with the first identification sensor and the second sensor to wirelessly transmit the information generated by the first identification sensor and the second sensor to a remote data collection system, the method comprising:
generating data by the first identification sensor indicative of contents of the medication container when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port;
generating data by the second sensor associated with the administration of the contents of the medication container; and
transmitting the data generated by the first identification sensor and the second sensor to the remote data collection system.

### Claim 31

A method for implementation by one or more data processors comprising:
receiving, by at least one data processor, information from a medication delivery apparatus characterizing administration of medication to a patient;
associating, by at least one data processor, the information with data specifying at least one medication and/or a volume of medication; and
promoting the associated data;
wherein the medication delivery apparatus comprises:
a housing;
a medication port extending from an external face of the housing configured to be fluidically and directly coupled to a fluid outlet of a manually administrable medication container comprising medication for administration to a patient;
a first identification sensor disposed within the housing to generate identification information indicative of contents of the medication container when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port;
a second sensor disposed within the housing to detect information on a source other than the medication container that is associated with the administration of the contents of the medication container; and
a transmitter disposed within the housing and in communication with the first identification sensor and the second sensor to wirelessly transmit the information generated by the first identification sensor and the second sensor to a remote data collection system.

### Claim 32

A system comprising:
a housing;
a medication port extending from an external face of the housing configured to be fluidically and directly coupled to a fluid outlet of a manually administrable medication container comprising medication for administration to a patient;
a first identification sensor disposed within the housing to generate identification information indicative of the contents of a medication container when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port;
a second sensor disposed within the housing to detect information indicative of the contents of a medication container intended for administration to a patient when the medication container is in contact with or proximate to the second sensor; and
a transmitter disposed within the housing and in communication with the first identification sensor and the second sensor to wirelessly transmit the information generated by the first identification sensor or the second sensor to a remote data collection system.

### Claim 33 (depends on 32)

A system as in claim 32, wherein the first identification sensor or the second sensor generates information indicative of the contents of a fluid medication to be administered to the patient through the medication port.

### Claim 34 (depends on 32)

A system as in claim 32, wherein the second sensor generates information indicative of the contents of a medication container to be administered to the patient through a route other than the medication port.

### Claim 35 (depends on 34)

A system as in claim 34, wherein the medication is an IV fluid, subcutaneous fluid, intramuscular fluid, oral solid, oral liquid, topical preparation, transdermal patch, or a suppository.

### Claim 36 (depends on 34)

A system as in claim 34, wherein the medication container is an IV vial, a syringe, an IV bag, an ampoule, a blister pack, a pouch, a packet, a bottle, a dropper, or an applicator.

### Claim 37

A method for implementation by system comprising: a housing, a medication port extending from an external face of the housing configured to be fluidically and directly coupled to a fluid outlet of a manually administrable medication container comprising medication for administration to a patient, a first identification sensor disposed within the housing to generate identification information indicative of the contents of a medication container when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port, a second sensor disposed within the housing to detect information indicative of the contents of a medication container intended for administration to a patient when the medication container is in contact with or proximate to the second sensor, and a transmitter disposed within the housing and in communication with the first identification sensor and the second sensor to wirelessly transmit the information generated by the first identification sensor or the second sensor to a remote data collection system, the method comprising:
generating data by the first identification sensor indicative of contents of the medication container when the fluid outlet of the medication container is fluidically coupled or is being fluidically coupled to the medication port;
generating data by the second sensor associated with the administration of the contents of the medication container; and
transmitting the data generated by the first identification sensor and the second sensor to the remote data collection system.