Potting of tubular bundles in housing

• US 6,113,782 A
• Filed: 07/28/1998
• Issued: 09/05/2000
• Est. Priority Date: 07/28/1998
• Status: Expired due to Term

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Inventors: Leonard, Ronald J.
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US09/123,696
• Time in Patent Office: 770 Days
• Field of Search: 210/232, 210/321.71, 210/321.78, 210/321.79, 210/321.8, 210/321.88, 210/321.89, 210/323.2, 210/493.1, 210/493.2, 210/500.23, 210/645 , 210/321.61, 264/28, 264/263, 264/311, 264/313, 264/258, 422/44-48, 96/8, 96/10
• US Class Current: 210/321.89
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: B01D 63/022 Encapsulating hollow fibres
• CPC Class Codes: B01D 63/0222 using centrifugal forces
• CPC Class Codes: B01D 63/0225 Multiple encapsulation layers
• CPC Class Codes: B01D 63/04 comprising multiple hollow fibre assemblies
• CPC Class Codes: B29C 33/12 with incorporated means for positioning inserts, e.g. labels positioning reinforcements B29C70/541
• CPC Class Codes: B29C 39/10 incorporating preformed parts or layers, e.g. casting around inserts or for coating articles coating a surface by casting in general B05D1/30, B29C39/126 takes precedence
• CPC Class Codes: F28F 21/062 the heat-exchange apparatus employing tubular conduits
• CPC Class Codes: F28F 21/067 Details
• CPC Class Codes: Y02A 20/131 Reverse-osmosis

Abstract

Tubular bundles are potted in a housing, such as in an oxygenator or a pheresis unit. Spacer material is placed into the housing to cover the first ends of the tubular elements. A layer of potting material is placed into the housing covering the spacer material, and then solidified in place to seal between each of the tubular elements and the housing. The spacer material is then removed from the housing to expose the first ends of the tubular elements. In the oxygenator, at least some of the tubes are gas exchange tubes having an interior lumen and a tube wall which is permeable for oxygen and carbon dioxide flow through the tube wall. The potting separates the housing into manifold chambers communicating with the interior of the tubes and a blood flow chamber sealed from the manifold chambers. Blood flows over the exterior surface of the tubes. Other tubes may be heat transfer tubes, such as for carrying a heat transfer fluid to control the temperature of the blood. Multiple pottings may be performed to provide separate sealed manifold chambers for each set of tubes.

Claims

1. A method for potting, a plurality of tubular elements within a housing, the method comprising:

providing a housing;

placing a plurality of tubular elements in an aligned array within the housing, each of the tubular elements having a first end at a first side of the aligned array;

placing spacer material into the housing to cover the first ends of the tubular elements, the spacer material being fluid at the time of placing, the spacer material forming a first surface intersecting each of the tubular elements;

placing a first layer of potting material into the housing and covering the first surface of the spacer material, the first layer of potting material being fluid at the time of placing;

solidifying the first layer of potting material to seal between each of the tubular elements; and

substantially removing the spacer material from the housing to thereby define a first fluid manifold within the housing and to expose the first ends of the tubular elements, the first ends of the tubular elements being in fluid communication with the first fluid manifold.

2. The method of claim 1, wherein the tubular elements have walls defining a lumen for flow therethrough, and wherein the walls are permeable to oxygen and carbon dioxide.

3. The method of potting of claim 1, wherein the tubular elements have a second end at a second side of the aligned array opposite the first side, the second end being in fluid communication with the first end through lumen of each of the tubular elements, the method further comprising:

placing spacer material into the housing to cover the second ends of the tubular elements, the spacer material being fluid at the time of placing, the spacer material forming a second surface intersecting each of the tubular elements and spaced from the first surface;

placing a second layer of potting material into the housing and covering the second surface of the spacer material, the second layer of potting material being fluid at the time of placing;

solidifying the second layer of potting material to seal between each of the tubular elements; and

substantially removing the spacer material to expose the second ends of the tubular elements.

4. The method of claim 3, wherein the solidifying of the first layer of potting material occurs simultaneously with the solidifying of the second layer of potting material.

5. The method of claim 4, further comprising spinning the housing with tubular elements therein in a centrifuge during the solidifying steps, with centrifugal force placing the first surface in a different nominal plane than the second surface.

6. The method of claim 1, wherein the potting material has a lesser density than the spacer material causing the potting material to separate from the spacer material.

7. The method of claim 1, further comprising:

solidifying the spacer material prior to placing of the first layer of potting material.

8. The method of claim 7, wherein the solidifying of the spacer material is by freezing, and further comprising:

melting the spacer material after solidifying of the first layer of potting material.

9. The method of claim 7, wherein the solidifying of the spacer material is by gelling, and further comprising:

dissolving the spacer material in a solvent after solidifying of the first layer of potting material.

10. The method of claim 1, wherein the spacer material is a perflurocarbon.

11. The method of claim 1, further comprising:

collecting the spacer material after removal; and

reusing the spacer material in subsequent potting.

12. The method of claim 1, wherein the spacer material is a powder.

13. The method of claim 1, wherein the plurality of tubular elements in an aligned array are provided in a flexible mat, and further comprising the act of rolling the mat into a radial configuration prior to placing the mat within the housing.

14. The method of claim 1, wherein the solidifying of the first layer of potting material is by curing.

15. The method of claim 1, further comprising:

placing a second plurality of tubular elements in a second aligned array within the housing, each of the second plurality tubular elements having an end offset from the first ends;

placing spacer material into the housing to cover the ends of the second plurality of tubular elements, the spacer material being fluid at the time of placing, the spacer material forming a second surface intersecting each of the second plurality of tubular elements;

placing a second layer of potting material into the housing and covering the second surface of the spacer material, the second layer of potting material being fluid at the time of placing, the second layer of potting material being spaced from the first layer of potting material;

solidifying the second layer of potting material to seal between each of second plurality of tubular elements; and

substantially removing the spacer material from the housing to expose the ends of the second plurality of tubular elements, and such that the ends of the second plurality of tubular elements are sealed from fluid communication with the first ends.

16. The method of claim 1, wherein the housing is a housing of a final device, and wherein the solidifying act also seals between the tubular elements and the housing.

17. The method of claim 1, wherein the tubular elements each have a wall defining a lumen for flow therethrough, and further comprising:

cutting the plurality of tubular elements at the first ends to expose the lumens.

18. The method of claim 1, wherein each of the plurality of tubular elements have a wall defining a lumen for flow therethrough, and wherein the walls of the tubular elements are permeable to at least one but not all components of blood.

19. A device for use in treating a fluid flow, the device comprising:

a housing having a fluid inlet and a fluid outlet;

a plurality of tubular elements in an array within the housing, each of the tubular elements having a first end and a second end opposite the first end;

a layer of potting material sealing between each of the tubular elements and supporting the tubular elements in a generally fixed position, the layer of potting material having a first surface and a second surface each intersecting the plurality of tubular elements such that each of the first ends protrudes through the first surface and each of the second ends protrudes through the second surface, the layer of potting material defining a sealed boundary of a fluid flow channel from the fluid inlet across the plurality of tubular elements to the fluid outlet.

20. The device of claim 19, wherein the plurality of tubular elements are connected to each other in a flexible sheet material.

21. The device of claim 19, wherein each of the plurality of tubular elements have a wall defining a lumen for flow therethrough.

22. The device of claim 21 as a filter, wherein the walls of the tubular elements are permeable to at least one but not all components of the fluid flow, and wherein the housing comprises a port in fluid communication with the lumens of the tubular elements for flow of a separated component of the fluid flow.

23. The device of claim 21 as a pheresis unit, wherein the fluid flow is blood flow, and wherein the walls of the tubular elements are permeable to at least one but not all components of blood.

24. A medical device for controlled transfer between a first fluid flow and a second fluid flow, the medical device comprising:

a housing having a first fluid inlet, a first fluid outlet, a second fluid inlet and a second fluid outlet;

a plurality of first tubular elements in an aligned array within the housing, each of the first tubular elements having a lumen for flow between the first fluid inlet and the first fluid outlet, each of the first tubular elements having walls which permit controlled transfer therethrough, each of the first tubular elements having a first open end toward the first fluid inlet and a second open end toward the first fluid outlet;

a first layer of potting material sealing between each of the first tubular elements, each of the first open ends protruding through the first layer; and

a second layer of potting material sealing between each of the first tubular elements, the second layer spaced from the first layer, with a second fluid flow channel defined between the first layer and the second layer, the second fluid flow channel extending from the second fluid inlet across the first tubular elements to the second fluid outlet, each of the second open ends protruding through the second layer.

25. The medical device of claim 24 as an oxygenator, wherein the first fluid is gas and the second fluid is blood, and wherein the walls of the first tubular elements are permeable to oxygen and carbon dioxide.

26. The oxygenator of claim 25, wherein the housing has a temperature regulation fluid inlet and a temperature regulation fluid outlet, and further comprising:

a plurality of second tubular elements in an aligned array within the housing, each of the second tubular elements having a lumen for flow between the temperature regulation fluid inlet and the temperature regulation fluid outlet, each of the second tubular elements having a first open end toward the temperature regulation fluid inlet and a second open end toward the temperature regulation fluid outlet;

a third layer of potting material sealing between each of the second tubular elements, the third layer spaced from the first layer and the second layer, each of the first open ends of the second tubular elements protruding through the third layer; and

a fourth layer of potting material sealing between each of the second tubular elements, the second layer spaced from the first layer, the second layer and the third layer, each of the second open ends of the second tubular elements protruding through the second layer,

wherein a temperature regulation fluid channel extends between the third layer and the fourth layer from the temperature regulation fluid inlet across the second tubular elements to the temperature regulation fluid outlet.

27. The oxygenator of claim 26, wherein the plurality of second tubular elements extend through the first layer and the second layer, and such that a gas inlet flow channel is defined from the first fluid inlet between the first layer and the third layer to the first open ends of the first tubular elements, and a gas outlet flow channel is defined from the second open ends of the first tubular elements between the second layer and the fourth layer to the second fluid outlet.

28. The oxygenator of claim 26, wherein the plurality of first tubular elements are provided in a flexible first mat and the plurality of second tubular elements are provided in a flexible second mat, with the tubular elements of each mat extending across a width of each mat, the second mat having a greater width than the first mat, wherein the first mat and the second mat are rolled together within the housing.

29. The medical device of claim 24 as a heat exchanger, wherein the first fluid is a heat transfer fluid, and wherein the walls of the first tubular elements are impermeable to the heat transfer fluid and to the second fluid.

30. The medical device of claim 24 wherein the first tubular elements are supported solely by the first layer and the second layer of potting material.