Permission-based material dispenser

• US 20060270997A1
• Filed: 05/18/2006
• Published: 11/30/2006
• Est. Priority Date: 05/19/2005
• Status: Abandoned Application

• Current Assignee: Vasogen Ireland Ltd.
• Original Assignee: Vasogen Ireland Ltd.
• Inventors: Chen, Hao, Matsuura, David G., Simpson, Philip J., Chancellor-Maddison, Kathleen, Costa, Mark, Lim, Bernard C.B., Kanbergs, Davis A.R.
• Application Number:
  US11/435,981
• Publication Number:
  US 20060270997A1
• Time in Patent Office: Days
• US Class Current: 604/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 5/178 : Syringes

Abstract

A syringe includes a releasable lock means for allowing discharge of a treated biological fluid sample to the patient in response to a release signal to the releasable lock means. The release signal is issued following a positive outcome from a verification process dependent upon temporal data from certain events in the collection, treatment and delivery of the biological fluid sample, and identity data of the patient and the syringe with the treated biological fluid.

Claims

1. A syringe for use with a patient in a biological fluid treatment system, the patient having a patient identifier, the syringe comprising:

a syringe inlet;

a syringe chamber for receiving the treated biological fluid;

a syringe outlet in communication with the chamber via a passage;

a syringe outlet valve to control the discharge of the treated biological fluid via the syringe outlet;

an incremental counter for recording temporal data corresponding to biological fluid treatment events, treated biological fluid events and delivery events;

a unique identifier associated with the syringe, the unique identifier correlatable to the patient identifier;

a releasable lock to operate the syringe outlet valve between a plurality of states;

a computer readable medium for storing the unique identifier, the patient identifier, temporal data, and data related to biological fluid treatment events, treated biological fluid events and delivery events;

a processor for comparing the unique identifier to the patient identifier to confirm the correlation between same; and

for receiving the temporal data to determine at least one time delay between the events and for determining whether the at least one time delay is within a predefined range;

a release signal generator for issuing a release signal in response to an outcome from the processor, the release signal to operate the releasable lock.

2. The syringe of claim 1 wherein the syringe inlet is operable to form a first fluid coupling with a biological fluid treatment chamber outlet.

3. The syringe of claim 2 wherein the syringe outlet is operable to form a second fluid coupling with a medical accessory.

4. The syringe of claim 1 wherein the releasable lock being operable in response to a release signal to operate the syringe outlet valve between an open state and a closed state.

5. The syringe of claim 1 wherein the releasable lock is opened upon positive confirmation of the correlation between the patient identifier and the unique identifier, and provided that the at least one time delay is within a predefined range.

6. The syringe of claim 4 wherein the releasable lock is operable to place the outlet valve in an irreversible closed state.

7. The syringe of claim 2 wherein the syringe outlet includes a coupler engageable with a complementary coupler included with the medical accessory.

8. The syringe of claim 7 wherein the releasable lock includes a pivoted pawl member having a limited range of motion, interconnected slots corresponding to the locked state, the open state and an irreversible locked state, a first resilient member having a flange engaging the interconnected slots, and a second resilient member in cooperation with the first resilient member to control the range of motion, wherein the flange is restricted to travel within the interconnected slots.

9. The syringe of claim 8 wherein the first resilient member is spring made from a fuse material which temporarily changes consistency under the presence of the release signal.

10. The syringe of claim 9 wherein the fuse material is nickel titanium naval ordinance laboratory intermetallic material (NITINOL).

11. The syringe of claim 10 wherein the second resilient member forces the flange into a slot corresponding to the irreversible closed state of the outlet valve.

12. The syringe of claim 11 wherein the complementary coupler and the coupler can only form second coupling with the releasable lock in an open position.

13. The syringe of claim 12 wherein the outlet valve comprises a valve element portion and a valve seat portion, and an actuator for translating the valve element portion relative to the valve seat portion to open the syringe outlet valve, the actuator linked to the coupler and being actuable upon engaging the coupler with the complementary coupler.

14. A syringe for use with a patient in a biological fluid treatment system, the patient having a patient identifier, the syringe comprising:

a syringe inlet;

a syringe chamber for receiving the treated biological fluid;

a syringe outlet in communication with the chamber via a passage;

a syringe outlet valve to control the discharge of the treated biological fluid via the syringe outlet;

a releasable lock to operate the syringe outlet valve between a closed state, an open state and a permanently closed state;

an incremental counter for recording temporal data corresponding to biological fluid treatment events, treated biological fluid events and delivery events;

a unique identifier associated with the syringe, the unique identifier correlatable to the patient identifier;

a release signal generator for issuing a release signal to operate the releasable lock following acceptability of the temporal data and the correlation of the patient identifier and the unique identifier;

the releasable lock including;

a pivoted pawl member;

interconnected slots corresponding to the closed state, the open state and the permanently closed state;

a first resilient member having a flange restricted to travel within the interconnected slots, wherein the first resilient member is spring made from a fuse material which temporarily changes consistency under the presence of the release signal, the position of flange within the interconnected slots dictating the state of the outlet valve.

15. The syringe of claim 14 wherein the fuse material is nickel titanium naval ordinance laboratory intermetallic material (NITINOL).

16. The syringe of claim 15 wherein the releasable lock includes a second resilient member to force the flange into a slot corresponding to a permanently closed state.

17. The syringe of claim 16 including a channel portion having electronic circuitry for transmitting, receiving and storing data related to the syringe and/or its contents or the patient;

the circuitry comprising a transmitter, a receiver, an antenna, processor, computer readable medium, a timing circuit for maintaining temporal data related to the treatment process, a power source and input/output devices.

18. The syringe of claim 16 wherein the electronic circuitry includes an RFID tag.

19. The syringe of claim 18 wherein the RFID tag is active, semi-active or passive.

20. The syringe of claim 17 wherein outlet valve comprises a filter in the passage for expelling one or more gas constituents in the treated sample.