Secure perfusion system

• US 9,770,557 B2
• Filed: 10/29/2010
• Issued: 09/26/2017
• Est. Priority Date: 11/05/2009
• Status: Expired due to Fees

• Current Assignee: Centre Hospitalier Universitaire de Toulouse, Centre National De La Recherche Scientifique, Etablissement Francais Du Sang (Government of France), Universite De Franche-Comte
• Original Assignee: Centre Hospitalier Universitaire de Toulouse, Centre National De La Recherche Scientifique, Etablissement Francais Du Sang (Government of France), Universite De Franche-Comte
• Inventors: Pazart, Lionel, Wacogne, Bruno Franois Marcel, Pieralli, Christian Grard Daniel, Boireau, Wilfrid Herv, Morel, Pascal Charles Serge
• Primary Examiner(s): Hayman, Imani
• Application Number:
  US13/508,179
• Publication Number:
  US 20130060228A1
• Time in Patent Office: 2,524 Days
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/609 Biometric patient identification means
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The invention relates to a secure system for the perfusion of a body liquid, enabling a final control of compatibility of a treatment with the patient and/or the medical situation previously diagnosed by a doctor, in a simple, efficient and energy-saving manner. To this end, the system includes a fluidic circuit of a perfusion having a perfusion catheter, a perfusion tubing and a container for the determined perfusion product to be perfused to a patient. The system is also configured to take a body liquid sample from a patient and to analyze and compare the body liquid sample to the determined perfusion product so as to control the flow of the perfusion product.

Claims

1. A system for the secure perfusion of a body fluid, comprising:

a fluid circuit comprising a perfusion catheter, perfusion tubing and a container of given perfusion product to be perfused to a patient;

a sample collection channel comprising a proximal end and a distal end;

a sample collection device configured to be incorporated into the fluid circuit, the sample collection device comprising a tubular structure for connection to the fluid circuit,

the tubular structure comprising a zone of intubation and a holding member, wherein said holding member holds the distal end of the sample collection channel within the zone of intubation of the tubular structure, such that said distal end of the sample collection channel is pointed toward the perfusion catheter, in the flow direction of the perfusion product, from the container of perfusion product to the perfusion catheter,

a sample collection container configured to be connected to, and in fluid communication with the proximal end of the sample collection channel

a means configured for analyzing and comparing the collected body fluid and a sample of given product;

a means configured for fluid connection between the means configured for analyzing and the sample collection container;

a means configured for controlling the flow of the perfusion product in the tubing, the means configured for analyzing being configured to transmit to the means configured for controlling the flow, a comparison information of the collected body fluid and the sample of given product.

2. The secure perfusion system as claimed in claim 1, wherein the means configured for analyzing and comparing is configured to control the means configured for controlling the flow in order to block the flow of the perfusion product if the comparison information indicates that the body fluid and the perfusion product are incompatible, and in order to permit the flow of the perfusion product if the comparison information indicates that the body fluid and the perfusion product are compatible.

3. The secure perfusion system as claimed in claim 1, comprising a display device for displaying the comparison information of the body fluid collected and the sample of given product.

4. The secure perfusion system as claimed in claim 1, wherein the means configured for analyzing is configured to control the means configured for controlling the flow in order to automatically generate the flow of the perfusion product if the body fluid and the perfusion product are compatible, and in order to not generate the flow of the perfusion product if the body fluid and the perfusion product are incompatible.

5. The secure perfusion system as claimed in claim 1, wherein the means configured for analyzing comprises a reaction chamber and means configured for detecting.

6. The secure perfusion system as claimed in claim 1, wherein the intubation zone is arranged to be positioned at a given maximum vertical distance (Dv_max) from the proximal end of the catheter.

7. The secure perfusion system as claimed in claim 6, wherein the given maximum vertical distance (Dv_max) is between 0 cm and 50 cm.

8. The secure perfusion system as claimed in claim 1, wherein a portion comprising the distal end of the sample collection channel is fixed in the tubular structure, and a portion comprising the proximal end of the sample collection channel emerges outside of the tubular structure level with the intubation zone.

9. The secure perfusion system as claimed in claim 1, wherein the intubation zone comprises a means configured for inserting, said means for inserting being suitable for enabling the insertion of the portion of the sample collection channel comprising the distal end, into the tubular structure.

10. The secure perfusion system as claimed in claim 9, wherein the means configured for inserting is chosen from:

a leaktight material remaining leaktight after having been pierced; and

a leaktight connector.

11. The secure perfusion system as claimed in claim 10, wherein said leaktight material is chosen from a silicone polymer selected from the group consisting of polydimethylsiloxane (PDMS), polymethyl methacrylate (PMMA), and polyvinyl chloride (PVC).

12. The secure perfusion system as claimed in claim 1, wherein the sample collection device additionally comprises:

a means configured for connecting to a proximal end of the perfusion catheter, and

a means configured for connecting to a distal end of the perfusion tubing.

13. The secure perfusion system as claimed in claim 1, wherein the sample collection channel has a length, between the proximal and distal ends, of between 10 cm and 100 cm.

14. The secure perfusion system as claimed in claim 1, equipped with a perfusion catheter comprising:

a distal end configured to be inserted into a patient;

a proximal end configured to be connected with a distal end of the perfusion tubing;

the sample collection device arranged between the distal end and the proximal end, and comprising a tubular structure for connection to the fluid circuit, equipped;

with the zone of intubation of a sample collection channel comprising a distal end; and

with a means configured for holding, in the tubular structure, the portion of the sample collection channel comprising a distal end, so that, in use, said distal end is pointed toward the perfusion catheter, in the flow direction of the perfusion product, from a container of perfusion product to the perfusion catheter.

15. The secure perfusion system as claimed in claim 1, comprising perfusion tubing comprising:

a proximal end configured to be connected to a container of a perfusion product;

a distal end configured to be connected with a proximal end of a perfusion catheter inserted into a patient;

the sample collection device arranged between the distal end and the proximal end, and comprising a tubular structure for connection to the fluid circuit, equipped;

with the zone of intubation of a sample collection channel comprising a distal end; and

with a means configured for holding in the tubular structure, the portion of the sample collection channel comprising a distal end, so that, in use, said distal end is pointed toward the perfusion catheter, in the flow direction of the perfusion product, from a container of perfusion product to the perfusion catheter.

16. The secure perfusion system as claimed in claim 14, wherein the intubation zone is positioned at a given maximum vertical distance (Dv_max) from the proximal end of the catheter.

17. The secure perfusion system as claimed in claim 16, wherein the given maximum vertical distance (Dv_max) is between 0 cm and 50 cm.

18. A process for implementing a secure perfusion system as claimed in claim 1, the sample collection device of which has been previously fitted to a patient, characterized in that it comprises the following steps:

placing the sample collection device, the sample collection container and the means for analyzing and comparing in fluid communication;

bringing the sample collection container to a height below that of the catheter of the patient, so that the body fluid flows into the sample collection channel, toward the sample collection container;

holding the sample collection container at a height below that of the catheter of the patient for a sufficient time to obtain, in the sample collection container, a volume sufficient to constitute a collection of a sample of body fluid;

analyzing and comparing the collected body fluid and the sample of given product;

generating comparison information of the collected body fluid and the sample of given product;

transmitting the comparison information to a means for controlling the flow of the perfusion product;

blocking the flow of the perfusion product if the comparison information indicates that the body fluid and the perfusion product are incompatible, and permitting the flow of the perfusion product if the comparison information indicates that the body fluid and the perfusion product are compatible.

19. The process as claimed in claim 18, comprising, in addition, a step of displaying the comparison information of the collected body fluid and the sample of given product.

20. A process for implementing a secure perfusion system as claimed in claim 1, characterized in that it comprises the following steps:

incorporating the sample collection device into a fluid circuit of a first perfusion previously fitted to a patient equipped with a perfusion catheter, in an outer portion of the fluid circuit relative to the body of the patient;

holding, inside the tubular structure, the portion of the sample collection channel comprising the distal end, so that said distal end is pointed toward the perfusion catheter, in the flow direction of the perfusion product, from a container of perfusion product to the perfusion catheter;

placing the sample collection channel, the sample collection container and the means for analyzing and comparing in fluid communication;

bringing the sample collection container to a height below that of the catheter of the patient, so that the body fluid flows into the sample collection channel, countercurrent compared to the perfusion products, then toward the sample collection container;

holding the sample collection container at a height below that of the catheter of the patient for a sufficient time to obtain, in the sample collection container, a volume sufficient to constitute a collection of a sample of body fluid;

analyzing and comparing the collected body fluid and a sample of given product;

generating comparison information of the collected body fluid and the sample of given product;

transmitting the comparison information to a means for controlling the flow of the product of a second perfusion;

blocking the flow of the product of the second perfusion if the comparison information indicates that the body fluid and the product of the second perfusion are incompatible, and permitting the flow of the product of the second perfusion if the comparison information indicates that the body fluid and the product of the second perfusion are compatible.

21. The process as claimed in claim 20, wherein the sample collection device is arranged so that, in use, the intubation zone is positioned at a given maximum vertical distance (Dv_max) from the proximal end of the catheter.

22. The process as claimed in claim 21, wherein the given maximum vertical distance (Dv_max) is between 0 cm and 50 cm.

23. The process as claimed in claim 20, wherein the distal end of the collection channel is arranged at a given distance from a proximal end of the perfusion catheter, said distance being referred to as the “

butt-joining distance” and

between 0 cm and 20 cm.