Molecular exchange device

• US 8,790,586 B2
• Filed: 09/28/2007
• Issued: 07/29/2014
• Est. Priority Date: 09/28/2006
• Status: Active Grant

• Current Assignee: Cornel Medical Limited
• Original Assignee: Probe Scientific Limited
• Inventors: O'Connell, Mark Thomas, Block, Stewart Jeffrey
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Kingan, Timothy G
• Application Number:
  US12/443,449
• Publication Number:
  US 20100016779A1
• Time in Patent Office: 2,496 Days
• Field of Search: None
• US Class Current: 422/255
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: B01D 61/243 Dialysis
• CPC Class Codes: G01N 1/40 Concentrating samples
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The present application relates to a molecular exchange device (1) for use with an analysis and control apparatus and a method of manufacturing a molecular exchange device. The molecular exchange device comprises a casing (2), extending from a proximal end (3) to a distal end (4), supporting at least two fluid passageways (7a, 7b) extending from the proximal end to the distal end; the casing comprising at least one exchange aperture (9a, 9b) between the distal end and the proximal end, wherein a portion of the fluid passageway exposed by the exchange aperture is porous

Claims

1. A molecular exchange device comprising:

a casing, extending from a proximal end portion to a distal end portion, supporting at least two fluid conduits extending from the proximal end portion to the distal end portion;

the at least two fluid conduits comprising a first fluid conduit and a second fluid conduit, the first fluid conduit comprising a lumen allowing fluid flow in a first direction from the proximal end portion to the distal end portion of the casing, the second fluid conduit comprising a lumen allowing fluid flow in a second direction, opposite the first direction, from the distal end portion to the proximal end portion of the casing;

the casing comprising at least first and second exchange apertures located between the distal end portion and the proximal end portion, wherein the first fluid conduit comprises a porous portion exposed by the first exchange aperture, and the second fluid conduit comprises a porous portion exposed by the second exchange aperture;

wherein the proximal end portion of the casing is configured to house a proximal end portion of the first fluid conduit and a proximal end portion of the second fluid conduit, and the distal end portion of the casing is configured to house a distal end portion of the first fluid conduit and a distal end portion of the second fluid conduit such that the proximal end portions of the first and second fluid conduits are supported by the casing proximal end portion and the distal end portions of the first and second fluid conduits are supported by the casing distal end portion; and

a separator extending from the proximal end portion of the casing to the distal end portion of the casing, the first and second fluid conduits being arranged on opposite sides of the separator;

wherein the first fluid conduit is spaced from the separator within the first exchange aperture to define a gap between the first fluid conduit and the separator, the gap allowing the porous portion of the first fluid conduit to be exposed to an external fluid around the entire circumference of the porous portion of the first fluid conduit;

wherein the second fluid conduit is spaced from the separator within the second exchange aperture to define a gap between the second fluid conduit and the separator, the gap allowing the porous portion of the second fluid conduit to be exposed to an external fluid around the entire circumference of the porous portion of the second fluid conduit.

2. The molecular exchange device according to claim 1, wherein the separator extends along a central axis of the casing.

3. The molecular exchange device according to claim 1, wherein the porous portion of first fluid conduit comprises a porous membrane bonded with the casing at the proximal and distal ends of the first exchange aperture and the porous portion of the second fluid conduit comprises a porous membrane bonded with the casing at the proximal and distal ends of the second exchange aperture.

4. The molecular exchange device according to claim 3, wherein each porous membrane comprises a dialysis membrane.

5. The molecular exchange device according to claim 1, wherein the first and second fluid conduits are defined by at least one tube that extends from the proximal end portion to the distal end portion of the casing, folds back on itself at the distal end portion and extends from the distal end portion to the proximal end portion of the casing, providing the first and second fluid conduits.

6. The molecular exchange device according to claim 1, wherein each of the first and second fluid conduits has a circular or non-circular shaped cross section or the cross section has one straight edge and or the cross section is D-shaped.

7. The molecular exchange device according to claim 1, wherein each of the first and second exchange apertures is an opening, formed by (a) a cut-away a portion of the casing;

or (b) a porous portion of the casing.

8. The molecular exchange device according to claim 1, wherein more than one exchange aperture exposes the same fluid conduit.

9. The molecular exchange device according to claim 8, wherein the fluid conduit exposed to more than one exchange aperture comprises multiple porous portions having different porosities.

10. The molecular exchange device according to claim 1, wherein the first and second exchange apertures comprise aligned or non- aligned exchange apertures.

11. The molecular exchange device according to claim 1, further comprising a plug in the distal end portion of the casing.

12. The molecular exchange device according to claim 1, wherein the separator extends into the distal end portion of the casing and contains a fluid aperture to allow flow from the first fluid conduit to the second fluid conduit.

13. The molecular exchange device according to claim 1, wherein the distal end portion of the casing is formed as a non-porous tip containing a flow chamber to allow flow from one end of the first fluid conduit into the end of the second fluid conduit.

14. The molecular exchange device according to claim 13, wherein the end of at least one of the fluid conduits extends into the flow chamber.

15. The molecular exchange device according to claim 13, wherein the flow chamber has a sensor arrangement to enable spectrologic measurement.

16. The molecular exchange device according to claim 15, wherein the spectrologic measurement is spectrophotometric measurement.

17. The molecular exchange device according to claim 15, wherein the sensor arrangement is a reflector, wave guide, conductor, photoelectric, electro-active or electrochemical sensor.

18. The molecular exchange device according to claim 1, further comprising a channel extending through the casing from the proximal end portion of the casing to the distal end portion of the casing, the channel providing access for additional materials to the interior and/or exterior of the distal end of the casing.

19. The molecular exchange device according to claim 18, wherein the channel is integral with the separator.

20. The molecular exchange device according to claim 19, wherein the channel is formed along the central axis of the separator.

21. The molecular exchange device according to claim 18, wherein the channel provides access to or access for an optical, sonic and/or electrical probe.

22. The molecular exchange device according to claim 1, wherein the proximal end portion of the casing is adapted for attachment to a catheter and/or cannular.

23. The molecular exchange device according to claim 1, wherein the proximal end portion of the casing is a lockable-mating arrangement and/or anchoring member for connecting to an invasive port.

24. The molecular exchange device according to claim 1, wherein the proximal end portion of the casing is adapted for attachment to a pump.

25. The molecular exchange device according to claim 1, wherein the proximal end portion of the casing is adapted for attachment to an external device.

26. The molecular exchange device according to claim 1, wherein the distal end portion of the casing comprises a non-porous outer wall completely surrounding the distal end portions of the first and second fluid conduits.

27. The molecular exchange device according to claim 1, wherein the distal end portion of the casing is non-porous and comprises first and second openings on opposite sides of the separator, the first fluid conduit extending through the first opening into the casing distal end portion such that the entire distal end portion of the first fluid conduit is housed within the casing distal end portion, the second fluid conduit extending through the second opening into the casing distal end portion such that the entire distal end portion of the second fluid conduit is housed within the casing distal end portion.

28. The molecular exchange device according to claim 27, wherein the proximal end portion of the casing is non-porous and comprises third and fourth openings on opposite sides of the separator, the first fluid conduit extending through the third opening into the casing proximal end portion such that the entire proximal end portion of the first fluid conduit is housed within the casing proximal end portion, the second fluid conduit extending through the fourth opening into the casing proximal end portion such that the entire proximal end portion of the second fluid conduit is housed within the casing proximal end portion.

29. The molecular exchange device according to claim 28, wherein the separator is integral with the casing distal end portion and the casing proximal end portion.

30. The molecular exchange device according to claim 27, further comprising a seal between the distal end portion of the first fluid conduit and the casing distal end portion within the first opening and another seal between the distal end portion of the second fluid conduit and the casing distal end portion within the second opening.

31. The molecular exchange device according to claim 28, further comprising a seal between the proximal end portion of the first fluid conduit and the casing proximal end portion within the third opening and another seal between the proximal end portion of the second fluid conduit and the casing proximal end portion within the fourth opening.

32. A method of manufacturing a molecular exchange device, wherein the method comprises the steps of:

i) forming of a casing comprising a proximal end portion and a distal end portion;

ii) providing at least two fluid conduits, the at least two fluid conduits comprising a first fluid conduit and a second fluid conduit, the first fluid conduit comprising a lumen allowing fluid flow in a first direction from the proximal end portion to the distal end portion of the casing, the second fluid conduit comprising a lumen allowing fluid flow in a second direction, opposite the first direction, from the distal end portion to the proximal end portion of the casing;

iii) forming of at least first and second exchange apertures in the casing between the distal end portion and the proximal end portion, wherein the first fluid conduit comprises a porous portion exposed by the first exchange aperture, and the second fluid conduit comprises a porous portion exposed by the second exchange aperture;

wherein the proximal end portion of the casing is configured to house a proximal end portion of the first fluid conduit and a proximal end portion of the second fluid conduit, and the distal end portion of the casing is configured to house a distal end portion of the first fluid conduit and a distal end portion of the second fluid conduit such that the proximal end portions of the first and second fluid conduits are supported by the casing proximal end portion and the distal end portions of the first and second fluid conduits are supported by the casing distal end portion; and

iv) providing a separator extending from the proximal end portion of the casing to the distal end portion of the casing, the first and second fluid conduits being arranged on opposite sides of the separator;

wherein the first fluid conduit is spaced from the separator within the first exchange aperture to define a gap between the first fluid conduit and the separator, the gap allowing the porous portion of the first fluid conduit to be exposed to an external fluid around the entire circumference of the porous portion of the first fluid conduit;

wherein the second fluid conduit is spaced from the separator within the second exchange aperture to define a gap between the second fluid conduit and the separator, the gap allowing the porous portion of the second fluid conduit to be exposed to an external fluid around the entire circumference of the porous portion of the second fluid conduit.

33. The method according to claim 32, wherein steps i), ii) and/or iii) occur simultaneously.

34. The method according to claim 32, wherein the casing is formed by moulding.

35. The method according to claim 34, wherein the first and second exchange apertures are formed by the moulding of the casing.

36. The method according to claim 32, wherein the exchange apertures are formed by treating the casing by laser ablation, x-ray, such spark erosion, etching, or oxidation use of salt treatment during an extrusion process or other microfabrication processes, to render the casing porous.

37. The method according to claim 32, wherein the least two fluid conduits are inserted into the casing after forming the exchange apertures.

38. The method according to claim 32, wherein the at least two fluid conduits are inserted into casing after the sealing of the distal end of the casing.

39. The method according to claim 32, wherein at least one of the fluid conduits has a cross-section which is circular or non-circular having one straight edge or is D-shaped, for orientation into the lumen.

40. The method according to claim 32, wherein the distal end of the casing is sealed.

41. The method according to claim 40, wherein the distal end of the casing is sealed by heat sealing, cold sealing, crimping or mechanical methods.