Robust System and Methods for Blood Access

• US 20090156975A1
• Filed: 11/30/2008
• Published: 06/18/2009
• Est. Priority Date: 11/30/2007
• Status: Abandoned Application

• Current Assignee: Dan Welsh, Mark Ries Robinson, Mike Borrello
• Original Assignee: Dan Welsh, Mark Ries Robinson, Mike Borrello
• Inventors: Welsh, Dan, Borrello, Mike, Robinson, Mark Ries
• Application Number:
  US12/325,243
• Publication Number:
  US 20090156975A1
• Time in Patent Office: Days
• US Class Current: 604/4.10
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150229 Pumps for assisting the blood sampling
• 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• 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: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2005/1588 : having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2039/0009 : Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation

Abstract

Embodiments of the present invention provide robust systems for the removal and subsequent infusion of blood for measurement purposes, and embodiments of the present invention provide methods of operating such systems and providing capabilities such as predicting and avoiding occlusions and/or bubbles, managing occlusions and/or bubbles if they occur, automatic cleaning of the blood access system, and determining and managing the patency of the blood access site. Such operational challenges can occur during any of several phases of operation of a blood access system. Embodiments of the present invention can effectively incorporate a variety of inputs for the identification of trends consistent with present or pending occlusions. An embodiment of the present invention can be aware of the stage of operation, e.g., withdrawal, infusion, or cleaning, and the prior performance of the system. Embodiments of the present invention can have the ability to identify the location of the problem so that effective procedures can be used to resolve the problem.

Claims

1. A method of determining the patency of a blood access site in use with a blood access system, comprising:

a. Operating the blood access system and determining one or more characteristics of pressure, flow rate, or both, of fluid flow within the blood access system at a plurality of times;

b. Determining from characteristics whether the blood access site is suitable for continued access.

2. A method of managing a blood access site in use with a blood access system, comprising:

a. Determining the patency of the blood access site at a plurality of times, each time according to the method of claim 1;

b. If the determined patency indicates patency decreasing to a value below a predetermined value, or at a rate greater than a predetermined rate, then operating the blood access system to generate access site cleaning actions that enhance patency of the blood access site.

3. A method of managing a blood access site in use with a blood access system, comprising:

a. Determining the patency of the blood access site at a plurality of times, each time according to the method of claim 1;

b. If the determined patency indicates patency decreasing to a value below a predetermined value, or at a rate greater than a predetermined rate, then communicating an alert signal to medical personnel.

4. A method as in claim 1, wherein step b comprises comparing the determined characteristics to a range of characteristics defined for the blood access system, and if the determined characteristics are not within the range then indicating that the blood access site is not suitable for continued access.

5. A method as in claim 1, wherein step b comprises comparing the determined characteristics to a range of characteristics determined from characteristics determined previously for the same patient, and if the determined characteristics are not within the range then indicating that the blood access site is not suitable for continued access.

6. A method as in claim 1, wherein the blood access system comprises one or more of the blood access systems described in the specification.

7. A method as in claim 1, wherein the determined characteristics comprise:

a. “

pressure one”

, defined as the minimum sustained flow rate achieved at a predetermined pressure;

b. “

pressure two”

, defined as the change in pressure one over a plurality of blood access events.

8. A method as in claim 1, wherein the determined characteristics comprise:

a. “

flow one”

, defined as the pressure required to transport fluid through the access site at a predetermined flow rate;

b. “

flow two”

, defined as the change in flow one over a plurality of blood access events.

9. A method as in claim 1, wherein the determined characteristics comprise:

a. “

decay one”

, defined as the decay of pressure when flow is stopped;

b. “

decay two”

, defined as the change in decay one over a plurality of blood access events;

c. “

growth one”

, defined as the increase in pressure when flow is started or increased;

d. “

growth two”

, defined as the change in growth one over a plurality of blood access events.

10. A method as in claim 1, wherein step b) comprises comparing the determined characteristics to a range of characteristics determined from characteristics determined previously for other patients, and if the determined characteristics are not within the range then indicating that the blood access site is not suitable for continued access.

11. A method as in claim 10, wherein the other patients are patients with characteristics similar to the present patient.

12. A method as in claim 11, where the previous patients are patients with similar blood hematocrit as the present patient.

13. A method of automatically cleaning a blood access system, comprising:

a. Configuring the system such that a cleaning fluid can be transported through it without substantial infusion into the patient; and

b. Transporting a cleaning fluid through at least a portion of the system with variable fluid flow rates, or variable fluid flow directions, or both.

14. A method of determining that an occlusion in a blood access system is likely to occur, comprising:

a. Operating the blood access system and sensing pressure or flow at two or more places in the system;

b. Determining the likelihood of an occlusion from the relationship between the two or more sensed values.

15. A method of determining that an occlusion is present in a blood access system having bidirectional flow, comprising:

a. Operating the blood access system and sensing pressure or flow in at least one place in the system, wherein the pressure is at the connection to the patient, system controls flow rate and measures pressure, or pulls at a pump pressure and monitors pressure at the patient;

b. Determining that an occlusion is present when the pressure exceeds a threshold.

16. A method of automatically managing a blood access system in the presence of an actual or predicted occlusion, comprising:

a. Detecting that an occlusion is present or that an occlusion is likely to occur;

b. Controlling pressure or flow to avoid overpressure at patient, reverse flow rate, clean the system, or take residual blood to waste.