External functional means, blood treatment apparatus for receiving an external functional means in accordance with the invention, and method

• US 9,808,566 B2
• Filed: 04/23/2010
• Issued: 11/07/2017
• Est. Priority Date: 04/23/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Gronau, Soeren, Guenther, Goetz, Haecker, Juergen, Lauer, Martin, Manke, Joachim, Nikolic, Dejan, Weis, Manfred
• Primary Examiner(s): Scherbel, Todd J
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US12/766,424
• Publication Number:
  US 20100274168A1
• Time in Patent Office: 2,755 Days
• Field of Search: 604 504
• 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 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362223 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 2039/1094 at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: B29C 65/16 Laser beams
• CPC Class Codes: B29C 66/53461 joining substantially flat covers and/or substantially flat bottoms to open ends of container bodies
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

An external functional means comprises at least one housing body, at least one chamber integrated into the housing body for receiving medical fluids, at least one passage integrated into the housing body for receiving and/or conducting a medical fluid, and at least one valve means completely or partly integrated into the housing body for controlling or regulating a fluid flowing through the external functional means. The invention further specifies a blood treatment apparatus and methods which may be carried out by means of the external functional means of the invention and by means of the blood treatment apparatus, respectively.

Claims

1. A medical device, comprising:

at least one housing body,

at least one chamber integrated into the housing body for receiving medical fluids;

at least one passage integrated into the housing body for at least one of receiving and conducting a medical fluid;

at least one valve completely or partly integrated into the housing body for controlling or regulating a fluid flowing through the medical device; and

at least one venous blood chamber;

wherein the medical device is a cassette configured for a blood treatment by dialysis having at least one single-needle chamber for a single-needle access to a patient;

wherein the single-needle chamber is disposed on a venous blood side of the medical device and above the venous blood chamber relative to an orientation of the medical device during its use, the single-needle chamber being in fluid communication with the at least one passage integrated into the housing body for at least one of receiving and conducting a medical fluid only via the venous blood chamber.

2. The medical device according to claim 1, further comprising at least one surface on which a cover is provided, the cover being part of the at least one integrated valve.

3. The medical device according to claim 2, wherein the cover is connected by at least one of friction, form closure, and material connection to the housing body in at least one portion thereof.

4. The medical device according to claim 3, wherein the cover is connected to the housing body by at least one peripheral weld.

5. The medical device according to claim 3, wherein the cover is additionally connected to the housing body by non-peripheral or dot-shaped or local welds.

6. The medical device according to claim 3, wherein the cover is connected at two sides or bilaterally with at least one structure of the medical device.

7. The medical device according to claim 6, wherein the at least one structure is the at least one housing body.

8. The medical device according to claim 2, wherein the cover is a film.

9. The medical device according to claim 1, further comprising connections configured to connect the medical device to an extracorporeal circuit in fluid communication.

10. The medical device according to claim 9, further comprising at least one addition site including at least one septum and configured to supply a fluid which is not blood or not exclusively blood, into an interior or into a line section of the medical device.

11. The medical device according to claim 9, wherein the blood treatment cassette comprises, in a portion of an extracorporeal circuit contained in the blood treatment cassette, at least one arterial cassette-integrated chamber and at least one venous cassette-integrated chamber, wherein the cassette comprises at least one film as a cover, and wherein at least one of an arterial and a venous pressure present in the extracorporeal blood circuit is measurable through the intermediary of the film.

12. The medical device according to claim 11, further comprising a sensor configured to measure at least one of the arterial and venous pressure above at least one of the arterial and venous chamber through the intermediary of the film.

13. The medical device according to claim 1, further comprising a supplying line for an anticoagulant, the supplying line being completely or partly arranged in an upper area with respect to an alignment of the medical device during use, or in a border area of the medical device.

14. The medical device according to claim 1, further comprising at least one heparin line arranged at least in an area of the medical device that, during use of the medical device, is arranged in an upper area of the medical device.

15. The medical device according to claim 1, further comprising at least one handle bar or handhold for at least one of connecting and separating the medical device with or from a treatment apparatus.

16. The medical device according to claim 1, further comprising at least one fill post configured to extract a fluid which is not blood, or not exclusively blood, from the medical device while the medical device is connected with a treatment apparatus for the purpose of its use.

17. The medical device according to claim 1, further comprising at least one tube fixation configured to fix at least one section of at least one tube at the medical device while the medical device is coupled to a treatment apparatus.

18. The medical device according to claim 1, wherein the medical device is adapted to be connected in fluid communication to at least one peristaltic pump by two connectors.

19. The medical device according to claim 18, wherein the peristaltic pump is a roller pump.

20. The medical device according to claim 18, further comprising at least one pump tube segment.

21. The medical device according to claim 1, further comprising at least one valve having a) at least one bar formed on the housing body and b) at least one portion of the cover, wherein the at least one bar and the at least one portion of the cover are operable by an actor of a blood treatment apparatus acting on the at least one bar via the cover in order to alter a passage of fluid.

22. The medical device according to claim 1, wherein the fluid includes at least one of a) substituate, b) heparin, c) blood, d) saline solution, and e) air.

23. The medical device according to claim 1, wherein the medical device is adapted to be coupled to a blood treatment apparatus.

24. The medical device according to claim 23, wherein the medical device is configured to be coupled to the blood treatment apparatus via a reception means.

25. The medical device according to claim 23, wherein the medical device is adapted to be coupled to the blood treatment apparatus at an inclination angle of substantially or precisely 8 degrees relative to a vertical.

26. The medical device according to claim 23, wherein the medical device is adapted to be coupled to the treatment apparatus at a surface of the medical device facing the cover.

27. The medical device according to claim 1, comprising at least one substituate addition site having at least one of a) touch-protection element and b) a drip-protection element.

28. The medical device according to claim 27, wherein the drip-protection element is provided as an integrated closure sleeve.

29. The medical device according to claim 1, wherein the medical device is configured to perform a blood treatment using a double-needle access to a patient.

30. The medical device according to claim 1, wherein the at least one single-needle chamber includes a blood surge redirection element.

31. The medical device according to claim 1, wherein the venous blood chamber is subdivided into at least one upper space and at least one lower space by a cross-sectional restriction of the housing body.

32. The medical device according to claim 31, wherein the upper space and the lower space are in fluid communication or connection with each other, and the upper space is configured to admit or generate a tangential inflow of fluids flowing through the medical device.

33. The medical device according to claim 31, wherein the upper space includes a region for generating a stable rotational flow of the fluids flowing through the medical device.

34. The medical device according to claim 33, wherein the lower space includes a region that is substantially or entirely free from rotational flow of the fluids flowing through the medical device.

35. The medical device according to claim 31, wherein walls of at least one of the upper space and the lower space of the venous blood chamber are adapted to an inclination of the medical device against a vertical of the blood treatment apparatus.

36. The medical device according to claim 1, wherein at least one wall of the venous blood chamber comprises at least one indentation.

37. The medical device according to claim 1, wherein the housing body is configured as a hard part.

38. The medical device according to claim 1, further comprising a tamper protection.

39. The medical device according to claim 38, wherein the tamper protection is provided via a configuration of a substituate addition site.

40. The medical device according to claim 38, wherein the tamper protection is provided via a touch-protection element or a closure sleeve of a substituate addition site, at least one of based on a change of the position of the touch-protection element or closure sleeve within or relative to the cassette and based on a change of the shape of the touch-protection element or closure sleeve.

41. The medical device according to claim 1, further comprising a protection against reuse.

42. The medical device according to claim 41, wherein the protection against reuse is via a configuration of the substituate addition site.

43. The medical device according to claim 41, wherein a closure sleeve is made unusable for reuse.

44. A blood treatment apparatus, comprising:

a dialysis apparatus wherein the blood treatment apparatus is in receipt of at least one medical device according to claim 1.

45. The blood treatment apparatus according to claim 44, further comprising at least one of at least one a) control means b) actor, and c) sensor, configured to at least one of drive and operate the medical device.

46. The blood treatment apparatus according to claim 44, further comprising at least one reception means for receiving the medical device.

47. The blood treatment apparatus according to claim 46, wherein the reception means comprises a coupling surface for coupling the medical device.

48. The blood treatment apparatus according to claim 47, wherein the coupling surface is inclined by an angle against a vertical relative to the orientation of the blood treatment apparatus during its use or to the center of the Earth.

49. The blood treatment apparatus according to claim 48, wherein the angle is between 5 and 11 degrees.

50. The blood treatment apparatus according to claim 48, wherein the angle is substantially or precisely 8 degrees.

51. A method, compising:

treating the blood of a patient using the medical device of claim 1.

52. The method according to claim 51, wherein the blood is treated using a double-needle method.

53. The method according to claim 51, wherein the blood is treated using a single-needle method.

54. The method of claim 51, further comprising:

conducting blood through a dialyzing filter to dialyze the blood; and

storing the blood that has passed through the dialyzing filter in a single-needle chamber of the medical device,

wherein the blood is dialyzed in the dialyzing filter before entering into the single-needle chamber.

55. The method according to claim 51, further comprising:

inserting the medical device in a blood treatment apparatus; and

using sensors of the blood treatment apparatus to examine whether the medical device inserted in the blood treatment apparatus has already been used.

56. A method, comprising:

dialyzing blood using a double-needle procedure, wherein the dialyzing includes a pre-dilution;

during the dialyzing, operating the medical device according to claim 1.

57. A method, comprising:

dialyzing blood using a double-needle procedure, wherein the dialyzing includes a post-dilution; and

during the dialyzing, operating the medical device according to claim 1.

58. A method, comprising:

dialyzing blood using a double-needle procedure, wherein the dialyzing includes at least one pre-dilution step and at least one post-dilution step; and

during the dialyzing, operating the medical device according to claims 1.

59. A method, comprising:

dialyzing blood using a single-needle procedure; and

during the dialyzing, operating the medical device according to claim 1.

60. A dialysis apparatus, comprising:

the medical device according to claim 1, wherein the dialysis apparatus is configured to control the cassette.