# US 10,503,873 B2 · Medication injection site and data collection system

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- Number: US 10,503,873 B2
- Document ID: US10503873B2
- Status: Granted
- Kind: B2
- Application number: 14/696,771
- Filed: 2015-04-27
- Published: 2015-08-13
- Granted: 2019-12-10
- Earliest claimed: 2009-11-06
- Assignees: CRISI Medical Systems, Inc.
- Applicants: CRISI Medical Systems, Inc.
- Inventors: Stephen M. Prince; Walter J. Bochenko; Shawn W. DeKalb; Winthrop De Childers
- Web page: https://patentgrep.com/patent/US10503873B2

## 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 having a medication port configured to be fluidically 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 from a source other than the medication container that is associated with the administration of the contents of the medication container;
an activation switch extending from an external face of the housing, wherein the activation switch is configured to manually activate the second sensor to detect the information from the 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 transmit the information generated by the first identification sensor and the second sensor to a remote data collection system,
wherein the activation switch is configured to manually activate the second sensor to detect the information from the source other than the medication container when the source other than the medication container is external to the housing and not coupled to the medication port, wherein the activation switch extends from the external face of the housing in a first direction that is directly opposite a second direction in which the medication port extends from the housing, and wherein the activation switch is configured to be activated directly by a first hand of a user, the housing having a size and a shape enabling the housing to be held by the first hand of the user while the user administers the medication from the medication container via the medication port with a second hand of the user.

### Claim 2 (depends on 1)

The system of 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)

The system of 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)

The system of 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)

The system of claim 1, wherein the information detected by the first identification sensor and/or the second sensor comprises one or more of: 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)

The system of claim 1, wherein the information detected by the second sensor characterizes a patient sample.

### Claim 7 (depends on 1)

The system of claim 1, wherein the information detected by the second sensor characterizes a medical device.

### Claim 8 (depends on 7)

The system of claim 7, 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 9 (depends on 1)

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

### Claim 10 (depends on 9)

The system of claim 9, 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 11 (depends on 1)

The system of claim 1, wherein the information detected by the second sensor is selected from the group consisting of a picture of a caregiver associated with the patient, a video of a caregiver associated with the patient, an identification code associated with a caregiver associated with the patient, a password associated with a caregiver associated with the patient, an identification of a caregiver associated with the patient, a name of a caregiver associated with the patient, an affiliation of a caregiver associated with the patient, a responsible clinician associated with a caregiver associated with the patient, and a decision-making authority associated with a caregiver associated with the patient.

### Claim 12 (depends on 1)

The system of 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 13 (depends on 1)

The system of claim 1, wherein the information detected by the second sensor includes at least one of a prescription number, a patient identifier, a formulation, an expiration date, an administration instruction, a precautionary instruction, contraindications, medication reconciliation information, a pharmacy identifier, and a preparer identifier.

### Claim 14 (depends on 1)

The system of claim 1, wherein the information detected by the second sensor includes at least one of a medication administration order, a lab order, a diagnostic testing order, a radiological order, a treatment order, and a therapy order.

### Claim 15 (depends on 1)

The system of 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 16 (depends on 1)

The system of 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 17

A system comprising:
a housing having a medication port configured to be fluidically coupled to a fluid outlet of a manually administrable medication container 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 the medication container when the fluid outlet of the medication container is coupled or being 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 the medication container;
an activation switch extending from an external face of the housing, wherein the activation switch is configured to manually activate the second sensor to detect the identification information on the second portion of the medication container; and
a transmitter disposed within the housing and in communication with the first sensor and the second sensor to transmit data generated by the first sensor and the second sensor to a remote data collection system,
wherein the activation switch is configured to manually activate the second sensor to detect the identification information on the second portion of the medication container when the medication container is external to the housing and not coupled to the medication port, wherein the activation switch extends from the external face of the housing in a first direction that is directly opposite a second direction in which the medication port extends from the housing, and wherein the activation switch is configured to be activated directly by a first hand of a user, the housing having a size and a shape enabling the housing to be held by the first hand of the user while the user administers the medication from the medication container via the medication port with a second hand of the user.

### Claim 18 (depends on 17)

The system of claim 17, 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 19

A system comprising:
a housing having a medication port configured to be fluidically 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 from a source other than the medication container that is associated with the administration of the contents of the medication container;
an activation switch extending from an external face of the housing, wherein the activation switch is configured to manually activate the second sensor to detect the information from the 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 transmit the information generated by the first identification sensor and the second sensor to a remote data collection system,
wherein the first identification sensor comprises a near field communication (NFC) sensor,
wherein the second sensor comprises a camera,
wherein the information from the source other than the medication container that is associated with the administration of the contents of the medication container includes encoded information and non-encoded information, wherein the encoded information includes a barcode or a symbolic code, and wherein the non-encoded information includes a biometric characteristic of the patient,
wherein the activation switch is configured to manually activate the second sensor to detect the information from the source other than the medication container when the source other than the medication container is external to the housing and not coupled to the medication port, wherein the activation switch extends from the external face of the housing in a first direction that is directly opposite a second direction in which the medication port extends from the housing, and wherein the activation switch is configured to be activated directly by a first hand of a user, the housing having a size and a shape enabling the housing to be held by the first hand of the user while the user administers the medication from the medication container via the medication port with a second hand of the user.

### Claim 20 (depends on 19)

The system of claim 19, wherein the second sensor detects the information from a second source different than a first source, wherein the first identification sensor generates the identification information indicative of contents of the medication container from the first source, and wherein the identification information indicative of the contents of the medication container is different than the information detected by the second sensor from the second source.

### Claim 21 (depends on 19)

The system of claim 19, wherein the source other than the medication container resides on or is integrated into at least one of the following: a different medication container than the medication container comprising the medication for administration to the patient, a patient wrist band, an oral solid package, a patient sample container, a medical device, or any combination thereof.
