Support element, an integrated module for extracorporeal blood treatment comprising the support element, an apparatus for extracorporeal blood treatment equipped with the integrated module, and an assembly process for an integrated module for extracorporeal blood treatment

• US 20040162513A1
• Filed: 02/05/2004
• Published: 08/19/2004
• Est. Priority Date: 02/07/2003
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Aberkane, Aziz, Duchamp, Jacques, Meyssonnier, Gabriel, Pouchoulin, Dominique, Neri, Roberto, Ribolzi, Roberto
• Granted Patent: US 7,232,418 B2
• Time in Patent Office: Days
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 2205/126 with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2209/08 Supports for equipment
• CPC Class Codes: Y10T 137/877 With flow control means for branched passages

Abstract

An integrated module for extracorporeal blood treatment comprises a flat-shaped support element which exhibits on an internal face thereof a complex of fluid distribution lines and on an external face thereof a high-flow dialyzer. The support element comprises a base body (1) which exhibits fixture seatings (2), each of which houses an axially extended tract (38) of a fluid distribution line. The tract of line, with respect to adjacent tracts, has an increased diameter which is caused by a junction collar (39) made of a rigid material. Each fixture seating exhibits two axial locators (3a, 3b) for positioning the axial tract of line in a fixed position. The locators (3a, 3b) interact with the junction collar (39). The distribution lines are fixed to the base body (1) by a resilient fixture of the junction collars (39) in the seatings, with no necessity of gluing. The module is destined to be mounted on an apparatus for intensive treatment of renal insufficiency.

Claims

1. A support element for an integrated module for extracorporeal blood treatment, comprising:

a base body;

at least one fixture seating located on the base body and axially extended for housing an axially extended tract of a fluid distribution line;

at least one axial locator arranged in said seating fixture for positioning said axial tract of line in a fixed position, said at least one axial locator being destined to interact with a corresponding element predisposed on said axial tract of line.

2. The support element of claim 1, comprising two axial locators axially reciprocally distanced, between which the axial tract of line is positioned in a fixed position.

3. The support element of claim 1, wherein the fixture seating comprises a superiorly-open channel for insertion of the axial tract of line and wherein said at least one axial locator comprises an edge projecting internally of the channel from a wall delimiting the channel.

4. The support element of claim 1, comprising at least one pair of the fixture seatings arranged side-by-side on a periphery of the base body, the at least one pair of fixture seatings receiving two tracts of end of a U-shaped segment of at least one line, the U-shaped segment being destined to cooperate with a peristaltic pump.

5. The support element of claim 4, wherein the U-shaped segment projects externally beyond the periphery of the base body.

6. The support element of claim 4, wherein the base body has a part which is flat plate-shaped with a plurality of perimeter sides which define a polygonal shape of the base body and wherein the base body exhibits a plurality of pairs of fixture seatings, each pair thereof being made up of two fixture seatings arranged side-by-side and reciprocally parallel and arranged on one of the plurality of perimeter sides.

7. The support element of claim 1, wherein the axial locator comprises a surface which is undercut with respect to an axial direction of the axial tract of line.

8. The support element of claim 1, wherein the fixture seating is predisposed and configured for forced insertion and resilient joint-coupling of the axial tract of line, the fixture seating having at least one opening for insertion of the axial tract of line, a passage section of the at least one opening being at least partially smaller in width than a maximum width of the fixture seating.

9. The support element of claim 1, wherein the fixture seating is delimited by a surface for receiving the axial tract of line, which surface exhibits at least two undercut surfaces predisposed and configured for obstructing displacements of the axial tract of line with respect to the fixture seating in two reciprocally transversal displacement directions, namely an axial direction and an upwards extraction direction passing through an upper insertion opening.

10. The support element of claim 1, wherein the fixture seating superiorly exhibits at least one opening for forced insertion of the axial tract of line and inferiorly exhibits at least one through-hole, facing the insertion opening and through which a pressure can be exerted from below on the axial tract of line when engaged in the fixture seating, enabling extraction of the axial tract of line through the superior opening for forced insertion.

11. The support element of claim 1, wherein:

the fixture seating is defined by a channel having a superior opening for insertion of the axial tract of line;

the channel extends axially and at least partially axially projects in an externalwise direction beyond a perimeter border of the base body;

the channel is laterally delimited by two walls arranged side-by-side, each of which two walls exhibits an upper edge;

the insertion opening is delimited by the upper edges of the two lateral walls;

at least one lateral relief projects from at least one of the two lateral walls and projects inwardly of the channel;

the at least one lateral relief defining an undercut surface with respect to an extraction direction of the axial tract of line through the superior opening of the channel;

the undercut surface is predisposed inferiorly of the upper edge of the lateral wall.

12. The support element of claim 11, comprising two lateral reliefs, one for each lateral wall, which two lateral reliefs face one another and cooperate to obstruct an extraction of the axial tract of line.

13. The support element of claim 11, wherein the channel is destined to constrain a tract of end of a segment of U-shaped line, operatively associable to a peristaltic pump, and wherein each lateral relief is situated in a part of end of the channel which part of end is facing towards the U-shaped segment.

14. The support element of claim 11, wherein each undercut surface is inclined with respect to an extraction direction of the axial tract of line to enable extraction of the axial tract of line by a forcing movement.

15. The support element of claim 1, wherein the base body is flat-plate shaped and the fixture seatings for the complex of distribution lines extend over an internal face thereof, and wherein the support element further comprises a cover removably couplable to the base body and destined to cover at least a part of the internal face which bears the fixture seatings;

when the cover is coupled to the base body, a containment space for at least a part of the complex of distribution lines is defined between the internal face of the base body and an internal face of the cover.

16. The support element of claim 15, wherein the cover exhibits at least one tooth projecting downwards which, when the cover is coupled on the base body, enters at least partially in the fixture seating and limits a raising movement of the axial tract line constrained in the fixture seating.

17. The support element of claim 15, wherein the internal face of the base body exhibits on a perimeter thereof a raised edge for laterally containing at least a part of the complex of distribution lines, and wherein the cover is flat plate-shaped with a perimeter corresponding to the perimeter of the internal face of the base body.

18. The support element of claim 17, wherein the base body comprises at least one hooking tab made in a single piece with the base body and destined to removably couple the cover to the base body.

19. The support element of claim 1, wherein the fixture seating exhibits an axial end tract which extends axially internally of the perimeter side of the base body and an end tract which extends axially externally of the perimeter side of the base body.

26. The support element of claim 1, comprising at least a first and at least a second connector, associated to the base body and distanced one from another, destined to receive and constrain corresponding seatings of a blood treatment device which is mountable on the support element.

27. The support element of claim 26, wherein the first and the second connector are made in a single piece with the base body.

28. The support element of claim 26, comprising at least a third connector, distanced from the first and second connector and made in a single piece with the base body;

the first, second and third connectors defining pairs of connectors between them, each pair thereof having a different interaxes from other pairs thereof, the interaxes corresponding with interaxes of pairs of seatings associated to various blood treatment devices which are mountable on the support element.

29. The support element of claim 26, wherein each of the first, second and third connectors defines a fluid passage having a first terminal portion which is destined to be placed in fluid communication with a corresponding channel present in a respective seating exhibited by the blood treatment device, and a second terminal portion destined to be placed in fluid communication with a fluid distribution line which is associable to the base body.

30. The support element of claim 29, wherein each of the first, second and third connectors comprises:

a tubular channel, defining the first terminal portion;

a sealing collar, located in a radially external position with respect to the tubular channel; and

a connecting wall, which develops continuously between a lateral external surface of the tubular channel and a lateral internal surface of the sealing collar and defines an annular seating for each seating.

31. The support element of claim 30, wherein the tubular channel defining the first portion is coaxially arranged with respect to the sealing collar, the annular seating exhibiting a bottom which is delimited by the connecting wall.

32. The support element of claim 30, wherein the annular seating exhibits a radius which increases in a distal direction from the bottom of the annular seating.

33. The support element of claim 32, wherein the annular seating exhibits a first zone, adjacent to the bottom and having a constant radius, a second zone, having a constant radius which is larger than the radius of the first zone, and a transitional third zone between the first zone and the second zone which has a radius which progressively increases in a distal direction from the bottom.

34. The support element of claim 30, wherein the tubular channel and the sealing collar of each of the first, second and third connectors are parallel to each other and emerge from the base body, defining a single coupling direction with the corresponding seatings of a blood treatment device.

35. The support element of claim 30, wherein the first, second and third connectors and the base body are made of a rigid material giving mechanical support to the blood treatment device.

36. The support element of claim 30, wherein the first, second and third connectors are not aligned one with another.

37. The support element of claim 30, wherein the first, second and third connectors are directly constrained on the base body.

38. The support element of claim 30, wherein the first, second and third connectors are each borne on a face of the base body which face is opposite a face of the base body bearing the fixture seating.

39. A fluid distribution line for an integrated module for extracorporeal blood treatment, having at least one tract of line which has a larger external diameter than adjacent tracts thereof, giving rise to two external abutments;

the at least one tract with larger diameter comprised between the two external abutments being destined for insertion in the fixture seating predisposed on the support element of any one of the preceding claims.

40. The distribution line of claim 39, comprising at least two of the at least one tract of line with a larger external diameter than adjacent tracts thereof, which at least two tracts of line are axially distanced one from another;

a segment of line being comprised between the at least two tracts of line, which segment of line is made to form a U-shaped arched segment which is operatively associated to a peristaltic pump.

41. The distribution line of claim 39, wherein each tract having a larger external diameter comprises a junction collar which contains and joins two end zones of two parts of fluid-connected line.

42. The distribution line of claim 41, wherein the junction collar is made of a more rigid material than the two end zones of the parts of line connected by means of the junction collar.

43. A series of two elements destined to be coupled one to another, wherein the first element is the support element of claim 1, and the second element is a complex of distribution lines for fluids comprising at least one line according to claim 39.

44. An assembly process of the series of elements of claim 43, wherein the tract of line having a larger diameter and comprised between the two abutments is inserted in the fixture seating predisposed on the support element, the two abutments coinciding with the axial locator predisposed in the fixture seating, the support element being provided with a cover which is subsequently coupled to the base body in order to cover at least partially the tract of line having a larger diameter.

47. An integrated module for extracorporeal blood treatment, comprising:

a support element made according to claim 1;

at least one blood treatment device mounted on the support element comprising at least a first chamber and at least a second chamber which are separated by at least one semi-permeable membrane;

a complex of fluid distribution lines associated to the support element and cooperating with the blood treatment device.

48. The integrated module of claim 47, wherein the complex of fluid distribution lines comprises at least one line made according to claim 39.

50. The module of claim 47, wherein the blood treatment device is fixed to a base body made according to claim 26, and is fixed by at least one pair of connectors from the first, second and third connectors.

51. The module of claim 50, wherein the at least one pair of connectors is interpositioned between the seatings and a portion of the fluid distribution line.

52. The module of claim 50, wherein the blood treatment device comprises:

a containment body;

at least one semi-permeable membrane operating internally of the containment body and defining a first chamber and a second chamber;

a first and a second counter-connector, associated to the containment body and fixed to first, second or third connectors associated to the base body, the first connector and the second connector being set in fluid connection with the second chamber of the blood treatment device and with respective first terminal portions of the first connector and the second connector;

at least one inlet port to the first chamber; and

at least one outlet port from the first chamber.

53. The module of claim 52, wherein the complex of fluid distribution lines comprises at least one discharge line of waste fluid set in communication with the second terminal portion of one of the first, second and third connectors.

54. The module of claim 53, wherein the complex of fluid distribution lines comprises at least one infeed line of a treatment fluid, set in communication with the second terminal portion of another of the first, second and third connectors.

55. The module of claim 52, wherein the complex of fluid distribution lines comprises at least one blood withdrawal line, set in communication with the inlet port of the first chamber, and at least one blood return line, set in communication with the outlet port of the first chamber.

56. The module of claim 53, wherein at least one of the lines is constrained to the support element, defining at least one U-shaped arched segment on the support element and being destined to cooperate in use with a peristaltic pump.

57. The module of claim 56, wherein the U-shaped segment extends externally with respect to the perimeter wall of the support element.

58. The integrated module of claim 47, for use in treatment of renal insufficiency, wherein the blood treatment device is selected from a group comprising hemofiltration, hemodialysis, high-flow filtration and hemodiafiltration devices.

59. An apparatus for extracorporeal treatment of blood, comprising:

a housing zone for receiving an integrated module for blood treatment made according to claim 47;

one or more pumps for fluid circulation predisposed to cooperate with the complex of fluid distribution lines of the module.

20. A support element for an integrated module for extracorporeal blood treatment, comprising:

a base body having at least one part which is flat sheet-shaped with an internal face and an external face;

a cover coupled to the base body, for covering at least a part of the internal face of the base body and having at least one part which is flat plate-shaped;

when the cover is coupled to the base body a containment space is defined between the internal face of the base body and an internal face of the cover, which containment space is destined to house a complex of fluid distribution lines;

means for connecting located on the internal face of the base body for engaging and constraining the complex of fluid distribution lines.

21. The support element of claim 20, wherein the internal face of the base body exhibits on a perimeter thereof a raised edge for laterally delimiting the containment space for housing the complex of fluid distribution lines, and wherein the cover is flat plate-shaped with a perimeter which corresponds to the perimeter of the internal face of the base body.

22. The support element of claim 21, wherein the base body comprises at least one hooking tab made in a single piece with the base body and predisposed to removably couple the cover to the base body.

23. The support element for an integrated module for extracorporeal blood treatment, comprising a base body and at least a fixture seating borne on the base body for receiving and constraining an axial tract of a fluid distribution line, the fixture seating being a channel superiorly affording an opening for forced insertion of the axial tract of line, the channel being axially extended and at least partially axially projecting externalwards beyond a perimeter edge of the base body, at least the part of channel projecting externalwards being laterally delimited by two side-by-side walls each of which exhibits an upper edge delimiting the insertion opening, at least one lateral relief projecting from at least one of the two lateral walls internally of the channel, the at least one lateral relief defining an undercut surface with respect to an extraction direction of the axial tract of line through the superior opening of the channel, the undercut surface being inferiorly arranged with respect to the superior edge of the lateral wall.

24. The support element for an integrated module for extracorporeal blood treatment, comprising:

a base body having at least one flat plate-shaped part with an internal face and an external face;

a cover coupled to the base body, for covering at least a part of the internal face of the base body and having at least one part which is flat plate-shaped;

when the cover is coupled to the base body a containment space is defined between the internal face of the base body and an internal face of the cover, which containment space is destined to house a complex of fluid distribution lines;

at least one guide channel located on the internal face of the base body for receiving at least one axial tract of a fluid distribution line and for defining a guided pathway for the axial tract of line;

a height of the guide channel being at least double a width thereof, in order to be able to house and laterally contain at least two axial tracts of line, one of the two axial tracts of line being superposed on another thereof.

25. The support element of claim 24, wherein the guide channel is delimited by two lateral walls which rise from the internal face of the base body.

45. An assembly process of an integrated module for extracorporeal treatment of blood, comprising stages of:

predisposing a support element comprising;

a base body made of a rigid material;

at least a first and at least a second connector made in a single piece with the base body and distanced one from another and destined to receive and constrain seatings of a blood treatment device which is mountable on the support element;

each of the first and second connectors defining a fluid passage having a first terminal portion, conformed as a tubular channel and destined to be placed in fluid communication with a corresponding channel present in a respective seating of the seatings of the blood treatment device, the fluid passage having a second terminal portion, destined to be set in fluid communication with a complex of fluid distribution lines associable to the base body;

a sealing collar, located in a radially external position to the tubular channel; and

a connecting wall developing continuously between an external lateral surface of the tubular channel and an internal lateral surface of the sealing collar and defining an annular seating for engaging with the seating of the seatings;

fixing a blood treatment device to the support element;

associating a complex of fluid distribution lines to the support element and the blood treatment device.

46. The assembly process of claim 45, wherein the support element comprises a third connector and wherein a stage of fixture comprises sub-stages of:

selecting a pair of connectors from the first, second and third connectors to which two seatings borne by the blood treatment device are to be fixed;

depositing a predetermined quantity of glue in the annular seatings of each of the selected pair of seatings;

at least partially inserting each seating in a respective annular seating in order to achieve a mechanical constraint and a sealed coupling resistant to passage of liquid.

49. An integrated module for extracorporeal blood treatment, comprising:

a support element comprising;

a base body having at least a part thereof shaped as a flat plate with an internal face and an external face;

a cover couplable to the base body, for covering at least a part of the internal face of the base body and having at least a part thereof shaped as a flat plate;

when the cover is coupled to the base body a containment space being defined between the internal face of the base body and an internal face of the cover, which containment space can house at least a part of a complex of fluid distribution lines;

at least a fixture seating exhibited by the internal face of the base body and axially extending for receiving an axially extended tract of a fluid distribution line;

at least one axial locator being predisposed for positioning the tract of line in a fixed position, the at least one axial locator being destined to interact contactingly with a corresponding locator element predisposed on the axial tract of line, the fixture seating being at least partially covered by the cover;

at least one blood treatment device mounted on the external face of the support element and comprising at least a first chamber and at least a second chamber separated by at least one semi-permeable membrane;

a complex of fluid distribution lines associated to the support element and cooperating with the blood treatment device, at least a part of the complex of fluid distribution lines being housed in the containment space, which complex of lines comprises at least one line having at least one axially extended tract inserted in the fixture seating and provided with at least one axial locator which interacts contacting with the at least one axial locator in the fixture seating for positioning the tract of line in a fixed position.