Self-flowing measuring system

• US 9,167,997 B2
• Filed: 11/16/2010
• Issued: 10/27/2015
• Est. Priority Date: 11/16/2009
• Status: Active Grant

• Current Assignee: Maquet Critical Care AB (Getinge AB)
• Original Assignee: Maquet Critical Care AB (Getinge AB)
• Inventors: Karlsson, Anton, Falkn, Henrik, Liska, Jan, sterdahl, Gabriel
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US13/509,939
• Publication Number:
  US 20120289795A1
• Time in Patent Office: 1,806 Days
• Field of Search: 600/309, 600/364, 600/365, 600/573, 600/582, 600/583, 294/28
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• 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 5/14528 invasively
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The invention relates to a method and arrangement for continuously measuring substances in a pressurised body fluid. A probe (202) for enabling continuous measurement of the concentration of one or more substances in a pressurized body fluid is provided. The probe is adapted to be inserted into the pressurized body fluid, and comprises an interface and an outlet lumen. Furthermore, the probe is configured so that a continuous and spontaneous fluid flow is established from the body fluid through the interface to the outlet lumen. The fluid flow from the outlet may be analyzed by a sensor.

Claims

1. A probe adapted for insertion into an artery of a patient, comprising an essentially cylindrical elongated body having a proximal part, a distal part, and at least one chamber part at an outer cylindrical surface of the body and covered by a membrane, wherein the probe is provided with a single flow lumen, wherein the chamber part is in fluid connection with the flow lumen, and the flow lumen is operable to transport a spontaneous flow of fluid, continuously obtained from the artery through the membrane into the chamber part, from the distal part of the body to the proximal part of the body for subsequent measurement of the concentration of one or more substances present in the artery, wherein the membrane has a liquid permeability of about 5-50*10⁻

4 cm/(bar*s).

2. A probe according to claim 1 devoid of any other flow lumen.

3. The probe according to claim 1, wherein the chamber part is in fluid connection with the flow lumen via at least one through-hole provided from the chamber part to the single flow lumen.

4. The probe according to claim 1 wherein the chamber part is essentially annular and covered by the membrane and wherein a single through-hole connects the chamber part with the single flow lumen.

5. A probe according to claim 1, wherein the membrane has a surface area of about 5-500 mm².

6. A probe according to claim 1, wherein the membrane has a thickness of 30-80 μ

m.

7. A probe according to claim 1, wherein the single flow lumen has an internal diameter of about 0.05-0.3 mm and the probe has a length of about 5-60 cm.

8. A probe according to claim 1, wherein the membrane has a surface area of 30-200 mm² and a thickness of 30-80 μ

m.

9. A probe according to claim 8 with a length of about 50-250 mm;

an external diameter of about 0.7-1.4 mm;

an internal flow lumen of about 0.1-0.3 mm; and

a membrane of a hollow-fibre type having an outer diameter of about 0.9-1.6 mm, a wall thickness of about 30-80 μ

m, a surface area of about 30-100 mm² and a liquid permeability of about 20-50*10<sup>−

4</sup> cm/(bar*s).

10. A probe according to claim 1, wherein the probe is adapted for continuous measurement.

11. A probe according to claim 1, further comprising at least one additional lumen that provides direct access to the artery.

12. A self-flowing system for measuring the concentration of one or more substances in an artery, said system comprising:

a) a probe according to claim 1; and

b) a sensor adapted to receive the fluid and analyze said fluid, the sensor being connected to an outlet of the flow lumen.

13. A probe according to claim 1, comprising one or more inoperable flow lumens.

14. A probe according to claim 1, wherein the probe is adapted for collection of at least one sample.

15. A probe according to claim 1, wherein the membrane has a surface area of about 30-200 mm².

16. A probe according to claim 1, wherein the single flow lumen has an internal diameter of about 0.15 mm, and the probe has a length of about 5-60 cm.

23. A method for measuring the concentration of one or more substances in an artery, comprising the steps of:

a) inserting a probe according to claim 1 in an artery,

b) establishing a spontaneous fluid flow through the membrane of the probe,

c) transporting at least a part of said fluid flow to a sensor adjacent to a probe outlet, and

d) continuously detecting a substance present in the artery.

24. A method according to claim 23, comprising establishing a spontaneous fluid flow through the membrane of about 1-50 μ

l/min.

25. A method according to claim 23, comprising establishing a spontaneous fluid flow through the membrane of about 2-10 μ

l/min.

17. A method of manufacturing a probe adapted for insertion into an artery, that ascertains a continuous fluid flow through a membrane contacting arterial blood and is provided with a flow lumen extending from a distal part of the probe to a proximal part of the probe for sampling or sensing of one more compounds in the arterial blood, comprising the steps of:

a) providing an elongated probe body having an internal flow lumen connected to a chamber part, wherein the chamber part is at an outer cylindrical surface of the body and is coverable with a membrane;

b) estimating at least one of the systolic pressure and the diastolic pressure in the artery in a selected body site;

c) selecting a membrane which at the estimated arterial pressure provides a spontaneous fluid flow of about 1-50 μ

l/min in the single flow lumen following contact with the arterial blood; and

d) attaching the membrane to sealingly cover the probe chamber part.

18. A method according to claim 17, comprising providing the elongated probe body with an internal single flow lumen and a single through-hole connecting the chamber part and the single flow lumen.

19. A method according to claim 17, comprising providing an elongated probe body with one or more additional inoperable internal flow lumens.

20. A method according to claim 17, wherein the membrane is selected from a kit of membranes, and wherein each membrane in the kit has a liquid permeability, area and thickness adapted to an arterial pressure or pressure range.

21. A method according to claim 17, wherein the selecting step comprises selecting a membrane which at the estimated arterial pressure provides a spontaneous fluid flow of about 2-10 μ

l/min in the single flow lumen following contact with the arterial blood.

22. A method according to claim 17, wherein the selecting step comprises selecting a membrane which at the estimated arterial pressure provides a spontaneous fluid flow of about 3-7 μ

l/min in the single flow lumen following contact with the arterial blood.