Micro perfusion device

• US 20030050593A1
• Filed: 08/22/2002
• Published: 03/13/2003
• Est. Priority Date: 02/25/2000
• Status: Active Grant

• Current Assignee: Disetronic Licensing Ag (Roche Holding AG)
• Original Assignee: Disetronic Licensing Ag (Roche Holding AG)
• Inventors: Haueter, Ulrich, Diermann, Ulrich
• Granted Patent: US 6,706,009 B2
• Time in Patent Office: Days
• US Class Current: 604/44
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less

Abstract

A micro perfusion device and method for obtaining at least one constituent of a body fluid. The at least one constituent is obtained using a subcutaneously-positioned perfusion catheter into which perfusate is introduced by a supply channel and an injection needle. The perfusate absorbs the at least one constituent as it flows out of the perfusion catheter and through a discharge channel.

Claims

1. A micro perfusion device for obtaining at least one constituent of a body fluid using a subcutaneously positioned perfusion catheter, the device comprising:

a) a casing;

b) a perfusate supply;

c) a hollow injection needle configured to protrude through the casing and having a front needle opening and a rear needle opening, the injection needle configured to be slideable from a front sliding position in which the needle protrudes beyond a distal end of the perfusion catheter to a rear sliding position in which the front needle opening is disposed within the perfusion catheter, wherein the rear needle opening forms a fluid connection from the perfusate supply to the injection needle at least in the rear sliding position of the injection needle;

d) the perfusion catheter which projects from the casing and surrounds the injection needle; and

e) a discharge channel formed in the casing, the discharge channel being fluidly connected to the perfusion catheter for discharging a perfusate.

2. The micro perfusion device of claim 1, wherein the perfusion catheter comprises a catheter surface permeable to the at least one constituent.

3. The micro perfusion device of claim 2, wherein perforation openings of the perfusion catheter are longer in the longitudinal direction of the perfusion catheter than in the circumferential direction of the perfusion catheter.

4. The micro perfusion device of claim 1, wherein a cross-sectional shape of the injection needle and a cross-sectional shape of the perfusion catheter deviate from each other over a length along which the perfusion catheter abuts the injection needle, such that a flow cross-section for the perfusate remains between the injection needle and the perfusion catheter.

5. The micro perfusion device of claim 1, wherein the injection needle comprises an outer surface area which is not circular when seen in cross-section, over a length along which the perfusion catheter abuts the injection needle.

6. The micro perfusion device of claim 1, wherein the perfusion catheter comprises an inner surface area which is not circular when seen in cross-section, over a length along which the perfusion catheter abuts the injection needle.

7. The micro perfusion device of claim 1, wherein the injection needle is fixed to the casing in its rear sliding position.

8. The micro perfusion device of claim 7, wherein the injection needle is fixed to the casing in its rear sliding position by means of a locking connection.

9. The micro perfusion device of claim 1, wherein the rear needle opening is formed in a surface area of the injection needle and wherein the injection needle is slideably locked into the rear sliding position by a sealing ring removeably locked into the rear needle opening.

10. The micro perfusion device of claim 1, wherein the perfusate supply is formed by a supply catheter which is permanently connected to an inner lumen enclosed by the injection needle and can be slid together with the injection needle relative to the casing.

11. The micro perfusion device of claim 1, wherein a sensor configured to measure the concentration of the at least one constituent is disposed within the discharge channel.

12. The micro perfusion device of claim 1, wherein a measuring means for measuring the concentration of the at least one constituent comprises a working electrode and a counter electrode, wherein the counter electrode is formed on a lower side of the casing, the lower side contacting a tissue surface once the device has been positioned.

13. The micro perfusion device of claim 1, wherein a measuring means for measuring the concentration of the at least one constituent comprises a working electrode and a counter electrode, wherein the working electrode is formed in the discharge channel.

14. A micro perfusion device for obtaining at least one constituent of a body fluid using a subcutaneously positioned perfusion catheter, the device comprising:

a) a casing;

b) the perfusion catheter projecting from the casing;

c) a hollow injection needle slideably disposed within the perfusion catheter in a position ranging from a front sliding position to a rear sliding position, the injection needle in the front sliding position being configured to protrude from a distal end of the perfusion catheter such that a distal end of the injection needle is external to the perfusion catheter;

d) a supply channel fluidly connected to the injection needle in the rear sliding position through a rear needle opening in the injection needle, the rear sliding position being configured to allow a perfusate to flow from the supply channel through the injection needle and into the perfusion catheter; and

e) a discharge channel formed in the casing, the discharge channel being connected to the perfusion catheter for discharging the perfusate.

15. The micro perfusion device of claim 14, wherein the supply channel comprises two sealing rings encircling the injection needle, the two sealing rings configured to releasably lock the injection needle into the rear sliding position.

16. The micro perfusion device of claim 15, wherein the two sealing rings releasably lock the injection needle into the rear sliding position by being partially disposed within the rear needle opening of the injection needle when the injection needle is in the rear sliding position.

17. The micro perfusion device of claim 14, further comprising a sensor configured to provide information regarding the at least one constituent of the body fluid.

18. The micro perfusion device of claim 17, wherein the sensor is disposed within the casing in the discharge channel.

19. The micro perfusion device of claim 17, wherein the sensor is external to the device.

20. The micro perfusion device of claim 19, further comprising:

(a) a supply catheter fluidly connected to the supply channel;

(b) an external micro pump forcing the perfusate through the supply catheter and the supply channel and into the injection needle;

(c) a discharge catheter fluidly connected to the discharge channel, the discharge catheter configured to transport the perfusate to the sensor;

(d) a collecting container configured to collect the perfusate for disposal; and

(e) an evaluation component electronically connected to the sensor, the evaluation component configured to ascertain information regarding the at least one constituent and display the information on a display.

21. The micro perfusion device of claim 20, wherein the device is located on an arm of a patient.

22. The micro perfusion device of claim 20, further comprising:

(a) a microprocessor for the evaluation component, the microprocessor located on a belt separate from the device located on the arm of the patient; and

(b) a battery configured to provide power to the device, the battery located on the belt.

23. The micro perfusion device of claim 14, further comprising a working electrode configured to provide information regarding the at least one constituent of the body fluid.

24. The micro perfusion device of claim 23, wherein the working electrode is located within the casing on an inner wall of the discharge channel, wherein an adhesive patch on a lower side of the casing is configured to serve as a counter electrode to the working electrode.

25. The micro perfusion device of claim 14, wherein the injection needle is configured to provide support to the perfusion catheter.

26. The micro perfusion device of claim 25, wherein the injection needle and the perfusion catheter are in contact for a full length of the injection needle within the perfusion catheter, the injection needle and the perfusion catheter providing a flow path configured to allow fluid passage.

27. A method of obtaining at least one constituent of a body fluid, comprising:

(a) providing a hollow injection needle slideably disposed in a casing, the casing being configured to be placed against skin of a patient;

(b) providing a perfusion catheter configured to encompass the injection needle;

(c) inserting the perfusion catheter into a tissue containing the at least one constituent when a distal end of the injection needle is protruding from a distal end of the perfusion catheter;

(d) retracting the injection needle until a fluid connection is established between a supply channel and the injection needle;

(e) causing perfusate to flow through the supply channel and the injection needle and out of a distal opening in the injection needle into a lumen between the injection needle and the perfusion catheter;

(f) absorbing the at least one constituent from the body fluid into the perfusate through openings in the perfusion catheter, wherein the at least one constituent is pulled into the lumen across a concentration gradient created as the perfusate is guided away from the distal opening in the injection needle; and

(g) causing the perfusate and the at least one constituent to flow out of the lumen through a discharge channel.

28. The method of claim 27, further comprising providing a sensor to ascertain information about the at least one constituent, the sensor being placed downstream of the perfusion catheter.

29. The method of claim 27, further comprising providing a working electrode in the discharge tunnel and providing a counter electrode to the working electrode.