Micro perfusion device

• US 20040153028A1
• Filed: 01/23/2004
• Published: 08/05/2004
• Est. Priority Date: 02/25/2000
• Status: Active Grant

• Current Assignee: Ulrich Diermann, Ulrich Haueter
• Original Assignee: Ulrich Diermann, Ulrich Haueter
• Inventors: Haueter, Ulrich, Diermann, Ulrich
• Granted Patent: US 6,936,026 B2
• Time in Patent Office: Days
• US Class Current: 604/33
• 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 connectable to a perfusate supply and for obtaining at least one constituent of a body fluid, the device comprising:

a casing including a discharge channel;

a perfusion catheter including a proximal end in fluid communication with the discharge channel and a distal end having an intake opening; and

a hollow injection needle including a proximal end in fluid communication with the perfusate supply and a distal end having a discharge opening, wherein said injection needle is slideably displaceable through the casing and the perfusion catheter between a forward position and a rearward position, wherein the injection needle protrudes through and seals the intake opening of the perfusion catheter when the injection needle is in the forward position, wherein the discharge opening of the injection needle resides within the perfusion catheter and the injection needle no longer seals the intake opening of the perfusion catheter when the injection needle is in the rearward position.

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 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.

4. 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.

5. 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.

6. The micro perfusion device of claim 1, wherein the injection needle attaches to the casing in its rearward position.

7. The micro perfusion device of claim 6, wherein the injection needle is attached to the casing in its rearward position by means of a locking connection.

8. The micro perfusion device of claim 1, wherein the injection needle further includes an opening in a proximal surface area of the injection needle, wherein the injection needle is slideably locked into the rearward position by a sealing ring removeably locked into said opening.

9. The micro perfusion device of claim 1, further comprising a supply catheter connected to an inner lumen enclosed by the injection needle, wherein said supply catheter can be slid together with the injection needle relative to the casing, and wherein said supply catheter is adapted to be in fluid communication with the perfusate supply.

10. 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.

11. 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 adapted to contact a tissue surface once the device has been positioned.

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 working electrode is formed in the discharge channel.

13. A micro perfusion device connectable to a perfusate supply and for obtaining at least one constituent of a body fluid, the device comprising:

a perfusion catheter comprising a distal end including an intake opening and a proximal end in fluid communication with a discharge channel; and

a hollow injection needle comprising a distal end including a discharge opening and a proximal end adapted to be placed in fluid communication with the perfusate supply,

wherein said injection needle is slideably displaceable through the perfusion catheter between an extended position and a retracted position,

wherein the injection needle protrudes through the intake opening of the perfusion catheter when the injection needle is in the extended position,

wherein the discharge opening of the injection needle resides within the perfusion catheter when the injection needle is in the retracted position, and

wherein, when the injection needle is in the retracted position and perfusate is flowing from the discharge opening of the injection needle, body fluid is sucked into the perfusion catheter.

14. The micro perfusion device of claim 13, further comprising a supply channel connectable to the perfusate supply, wherein the supply channel is adapted to be in fluid communication with the proximal end of the injection needle when the injection needle is in the retracted position, the supply channel comprising two sealing rings encircling the injection needle, the two sealing rings configured to releasably lock the injection needle into the retracted position.

15. The micro perfusion device of claim 14, wherein the injection needle further comprises an opening in the surface of the proximal end of the injection needle, wherein the two sealing rings releasably lock the injection needle into the retracted position by being partially disposed within said opening in the surface of the proximal end of the injection needle when the injection needle is in the retracted position.

16. The micro perfusion device of claim 13, further comprising a sensor configured to provide information regarding the at least one constituent of the body fluid.

17. The micro perfusion device of claim 16, wherein the sensor is disposed within the discharge channel.

18. The micro perfusion device of claim 16, wherein the sensor is external to the device.

19. The micro perfusion device of claim 18, further comprising:

a supply channel in fluid communication with the proximal end of the injection needle;

a supply catheter in fluid communication with the supply channel and configured to be placed in fluid communication with the perfusate supply;

an external micro pump adapted to force the perfusate through the supply catheter and the supply channel and into the injection needle;

a discharge catheter fluidly connected to the discharge channel and configured to transport the perfusate to the sensor;

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

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.

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

a microprocessor for the evaluation component, the microprocessor adapted for location separate from the micro perfusion device; and

a battery configured to provide power to the device, the battery also located for location separate from the micro perfusion device.

21. The micro perfusion device of claim 13, further comprising a working electrode configured to provide information regarding the at least one constituent of the body fluid.

22. The micro perfusion device of claim 21, further comprising a casing and a working electrodle, wherein the hollow injection needle is slideably displaceable through the casing, wherein the casing is connected to the proximal end of the perfusion catheter, wherein the working electrode is located within the casing on an inner wall of the discharge channel, and wherein an adhesive patch on a lower side of the casing is configured to serve as a counter electrode to the working electrode.

23. The micro perfusion device of claim 13, wherein the injection needle is configured to provide support to the perfusion catheter.

24. The micro perfusion device of claim 23, 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.

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

providing a perfusion catheter comprising a proximal end in fluid communication with a discharge channel and a distal end including an intake opening;

providing a hollow injection needle slideably displaceable in the perfusion catheter and including a proximal end capable of being placed in fluid communication with a perfusate and a distal end including a discharge opening;

sealing the intake opening in the distal end of the perfusion catheter by extending the distal end of the injection needle through said intake opening; and

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

26. The method of claim 25, further comprising retracting the injection needle until the discharge opening of the injection needle is within the perfusion catheter.

27. The method of claim 26, wherein retracting the injection needle establishes a fluid connection with the perfusate.

28. The method of claim 26, further comprising causing perfusate to flow through the injection needle, out the discharge opening of the injection needle, and into the perfusion catheter.

29. The method of claim 28, wherein the perfusate flows in the direction of the discharge channel in a lumen defined between the injection needle and the perfusion catheter.

30. The method of claim 29, further comprising absorbing the at least one constituent from the body fluid into the perfusate through at least one opening 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 discharge opening in the distal end of the injection needle.

31. The method of claim 30, further comprising causing the perfusate and the at least one constituent to flow out of the lumen through the discharge channel.

32. The method of claim 26, further comprising providing a sensor to ascertain information about the at least one constituent, the sensor being placed downstream of the perfusion catheter.

33. The method of claim 26, further comprising providing a working electrode in the discharge channel and providing a counter electrode to the working electrode.

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

providing a perfusion catheter comprising a proximal end in fluid communication with a discharge channel and a distal end including an intake opening;

providing a hollow injection needle slideably displaceable in the perfusion catheter and including a proximal end capable of being placed in fluid communication with a perfusate and a distal end including a discharge opening;

extending the distal end of the injection needle through the intake opening;

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

retracting the injection needle until the discharge opening of the injection needle resides within the perfusion catheter; and

causing perfusate to flow from said discharge opening into the perfusion catheter.

35. The method of claim 34, wherein the flowing perfusate causes body fluid to be sucked into the perfusion catheter.

36. The method of claim 35, wherein the perfusate flows in the direction of the discharge channel in a lumen defined between the injection needle and the perfusion catheter.

37. The method of claim 34, further comprising absorbing the at least one constituent from the body fluid into the perfusate through at least one opening 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 discharge opening in the distal end of the injection needle.

38. The method of claim 37, further comprising causing the perfusate and the at least one constituent to flow out of the lumen through the discharge channel.

39. The method of claim 34, further comprising sealing the intake opening in the distal end of perfusion catheter by extending the distal end of the injection needle through said intake opening.

40. The method of claim 34, further comprising providing a sensor to ascertain information about the at least one constituent, the sensor being placed downstream of the perfusion catheter.

41. The method of claim 34, further comprising providing a working electrode in the discharge channel and providing a counter electrode to the working electrode.