CN1852745B

CN1852745B - Blood chamber for extracorporeal blood circuits

Info

Publication number: CN1852745B
Application number: CN2004800254163A
Authority: CN
Inventors: C·詹内拉
Original assignee: Gambro Lundia AB
Current assignee: Gambro Dasco SpA; Gambro Lundia AB
Priority date: 2003-09-05
Filing date: 2004-07-15
Publication date: 2010-06-23
Anticipated expiration: 2024-07-15
Also published as: WO2005023338A1; ITMO20030244A1; EP1663348A1; KR20060095945A; CN1852745A; KR101066947B1

Abstract

A blood chamber for extracorporeal blood circuits comprises a container body (2) made in a single piece by blowing of a plastic material, and has a plurality of connection ports (3, 4) for fluid communication with outside; each connection port (3, 4) comprises a tubular mouth (6) having a truncoconical internal surface (61) which is coupled in a fluid-proof coupling to a tubular first part (101) of an insert (10), made by injection molding of a plastic material. The insert (10) has a truncoconical and smooth internal surface (102) which is coupled by gluing with a solvent to an end zone of a fluid transport tube (7, 8). The coupling between the blood chamber and the fluid transport tubes is very strong and reliable. The blood chamber is part of an extracorporeal blood circuit which is operatively associated to a dialysis machine.

Description

A kind of blood chamber that is used for extracorporeal blood circuit

Technical field

The present invention relates to a kind of blood chamber and manufacture method thereof that is used for extracorporeal circuit.

Particularly, but be not ad hoc, the present invention can be effectively applied in the extracorporeal circuit, and the designated machine that is used for extracorporeal blood treatment that is connected to of this extracorporeal circuit is such as hemodialyzer.

Especially, the present invention relates to a kind of blood chamber that is used for extracorporeal circuit of the preamble manufacturing according to first claim.

Background technology

Prior art for example comprises that at US 5,643,205, US 5,605,540, and US 5,520,640, US5, and 578,070, US 5,330,425, and US 5,328,461, and US 5,061,365, and US 4,681, the blood chamber of the above-mentioned type described in 606.

Defective fluid-tight appears in a shortcoming of the blood chamber of the known type by the blowing manufacturing when being flexible fluid delivery tube to being connected with of chamber inlet.

This main with at least one contact surface, apply the join dependency that solvent produces, this solvent makes the surface bonding mutually by the dissolved material top layer: in order to be effective, the connection that forms needs the structure and the size of connected contact surface very accurate by this way.Yet, for this is unwarrantable by the inlet of the blood chamber made of blowing plastic material, this is that the structure and the size of because the inner surface of any one inlet the joining surface of outer surface of the flexible pipe end regions that is used for FLUID TRANSPORTATION (promptly with) can only pre-determine in bigger numerical range.

Summary of the invention

Under the circumstances, target of the present invention provides a kind of solution that overcomes above-mentioned shortcoming of the prior art.

The present invention further target be obtain a kind of simple in structure, cheap and can be advantageously utilised in as the blood chamber in the extracorporeal blood circuit of blood dialysis circuit.

The present invention further target provides simple, the reliable and economic method that a kind of manufacturing is used for the blood chamber of extracorporeal circuit.

Advantage of the present invention is its blood chamber that provides a kind of (most of at least) to be made by non-PVC plastic material.

Further advantages of the invention are that blood chamber can be connected on one or more fluid delivery tubes, and connection wherein is very firm and reliable, and blood chamber is made simple, feasiblely in addition.

According to the feature in one or more additional claim, the present invention will obtain these and reach in addition more target and advantage.

Feature of the present invention is that blood chamber comprises that at least one has the tubular mouth of tubular insert, and this insert is used to connect the end regions of ground admitting fluid carrier pipe.

In an embodiment of the present invention, container body forms by the blowing plastic material, and insert is formed by the plastic material injection molding.

In further embodiment of the invention, insert has and is used for the medial surface that links to each other with fluid delivery tube, and it is smooth, truncated cone shape and towards the inside convergence of chamber.

In further embodiment of the invention, tubular mouth and insert have corresponding side surface, and it has the convergence diameter and is connected continuously or discontinuously towards chamber interior.

In an embodiment of the present invention, insert has the flange portion of the front end surface that covers tubular mouth.

In further embodiment of the invention, the structure of blood chamber and size are made into and can be inserted in the extracorporeal circuit.

In an embodiment of the present invention, the extracorporeal circuit that is used for hemodialysis comprises the blood chamber that at least one is constructed in accordance.

To other features and advantages of the present invention will be showed better, the embodiment in the accompanying drawing is illustrated in the mode of unrestricted example from subsequently.

Description of drawings

With reference to the accompanying drawings, description of the invention provides the nonrestrictive explanation to the present invention, and wherein:

Fig. 1 is the view of blood chamber on vertical height constructed in accordance;

Fig. 2 is the cutaway view according to II-II line among Fig. 1;

Fig. 3 is the view of observing below Fig. 1;

Fig. 4 is the thin portion enlarged drawing of Fig. 2.

The specific embodiment

1 represents to be used for the blood chamber of extracorporeal circuit on the whole, and this blood chamber comprises the container body 2 that is used for blood, and this container body 2 is made into an integral body by the blowing plastic material.The material of making container body 2 is adapted to pass through blow molding.Especially, container body 2 is made by plastic material, and this plastic material is not PVC or does not contain PVC or other chloride, for example PET.

The structure of blood chamber 1 and size be made in case the function of carrying out arterial chamber in particular cases, that is to say, it is designated be inserted into known type and the arterial line (or blood discharge tube line) that is not illustrated such as the extracorporeal circuit of blood dialysis circuit in.Be used for discharging blood and being transported to the device (for example hemodiafiltration device) that is used for haemodialysis as known arterial line from the patient's blood vessel inlet.

In the embodiment shown, container body 2 is for to have the elongate structure of substantial cylindrical sidewall, and the longitudinal axis with vertical layout in work structuring (Fig. 1 and 2).The structure of container body 2 is a known type.

Blood chamber 1 has a plurality of connectors with fluid and external communications.

In this embodiment, connector comprises: blood inlet 3, blood outlet 4, auxiliary mouthful 5 (for example can be used for the pressure reading in the blood chamber, in this case, the fluid feed line that links to each other with the pressure reading device is inserted in auxiliary mouthful).

At least the first connector is positioned at the lower area of container body 2.In this embodiment, be provided with two bottom connectors, i.e. blood inlet 3 and blood outlet 4.At least the second connector is arranged in the upper area of container body 2: in this embodiment, be provided with the top connector, promptly auxiliary mouthful 5.The term D score and " on " be work structuring with reference to blood chamber 1, this work structuring is in the structure represented (Fig. 1 and 2) of vertical direction in the embodiment shown by the chamber longitudinal axis.In the embodiment shown, lower ports is positioned on the bottom of container body 2, and upper port is positioned at the top of container body 2.

Other embodiment that are not illustrated also are possible, wherein blood chamber has the container body of known type, it has structure and the size that is different from above-mentioned those container bodies, perhaps be provided with access hole, the number of access hole and distribution (also being known type) are different from type described herein.

Each connector 3,4 and 5 all comprises tubular mouth 6, and it has and is used for the pipe 7,8 of FLUID TRANSPORTATION and 9 the joining inner surface 61 of end regions.Pipe 7,8 and 9 is for example for being generally used for the flexible PVC pipe of FLUID TRANSPORTATION (for example blood).

The inner surface 61 that is used to connect tubular mouth 6 has the internal diameter less than the inside dimension of container body 2, and this inside dimension is assumed to horizontal direction with reference to the work structuring (this structure is shown vertical substantially structure among Fig. 1 and 2) of blood chamber.In the embodiment shown, the interior contact surface 61 that is used to connect tubular mouth 6 has non-constant diameter (will explain better below), and container body 2 has the internal diameter greater than the maximum inner diameter of each tubular mouth 6.

During identical forming operation (for example plastic material blowing), each tubular mouth 6 is made into one with container body 2.

Each tubular mouth 6 is protruded from the major part of container body 2, is located immediately at the outside of container body 2.

Each tubular mouth 6 has vertical axis, and here " vertical " is for the work character of blood chamber 1.

The inboard conjunction plane 61 of each tubular mouth 6 has first transverse section of at least one more outer (with respect to container body 2), its with respect at least the second and more inner transverse section have bigger diameter.In other words, the interior contact surface 61 of each tubular mouth 6 presents a kind of variation on the diameter at least, and is discontinuous or successive, and it causes channel cross-section to narrow down towards the inside of container body 2.In illustrated embodiment,, realize towards the interior contact surface 61 of the convergence of container body 2 inside each tubular mouth 6 by being truncated cone shape substantially as what from the zoomed-in view of Fig. 4, see.

Each tubular mouth 6 has the insert of being made by plastic material 10, and it has first barrel portion 101 of the inboard conjunction plane 61 of at least a portion that covers tubular mouth 6.

First barrel portion 101 be inserted into the inboard conjunction plane 61 of tubular mouth 6 and the end regions of the pipe 7,8 that is used for linking to each other and 9 with access hole 3,4 and 5 between.

Especially, first barrel portion 101 has the medial surface 102 of admitting the end regions of pipe 7,8 and 9 with the contact connecting mode of fluid-tight.The medial surface 102 of first barrel portion 101 is the smooth surface (towards the convergence of the inside of chamber) of roughly truncated cone shape and coaxial with tubular mouth 6, and has accurate preliminary dimension and make the pipe of realizing by the known method that for example uses solvent welding be connected to fixing, reliable and competent.

First barrel portion 101 also has lateral surface 103, and its internal direction towards container body 2 restrains, and is on truncated cone shape and the respective inside conjunction plane 61 that is connected to tubular mouth 6.

Therefore, each insert 10 has inboard conjunction plane 102 (with a pipe in the pipe 7,8 and 9) and outside conjunction plane 103 (being used to be connected corresponding tubular mouth 6), inboard conjunction plane 102 be truncated cone shape or under any circumstance towards the inside convergence of blood chamber at least in part, and outside conjunction plane 103 is truncated cone shape at least in part or restrains towards the inside of blood chamber.

The medial surface 102 of insert 10 has the initial part 105 that is used for first's insertion tube of insert, and it is for truncated cone shape and have the bigger degree of convergence with respect to the more inner part on the surface that is used to connect.

Each insert 10 is by making such as the plastic material of soft (plastic) or hard PVC, and this plastic material can pass through casting.This solution has suitable reliability, thus make accurately (promptly for realize with manage 7,8 and 9 connects necessary accurately) internal diameter of the contact surface 102 made, can keep firmly with durable very firmly the time for a long time in sealing.

Each insert 10 is made into a single piece.

The plastic material of making insert 10 can be different from the plastic material of making container body 2.Especially, insert 10 can be made by hard or soft PVC, and the connector 3,4 on container body 2 and the container 2 and 5 can be made by the non-PVC (as PET) of chloride not.

Each insert 10 has second flange portion 104, and its annular end from first barrel portion 101 radially protrudes.Second flange portion 104 covers the front end face 62 of corresponding tubular mouth 6.Second flange portion 104 is overlapping with the front end face 62 of tubular mouth 6 and contact on certain location.

At first insert 10 and container body 2 are separated and carry out molding, subsequently in second step, make blood chamber 1 thereby insert 10 is applied on the corresponding tubular mouth 6 that is positioned on the container body 2.

Thereby insert 10 is inserted in the tubular mouth 6 to contact with the surface of tubular mouth 6 up at least one surface of insert 10 finishes applying of insert 10.

Insert 10 can for example be its second flange portion 104 with oral area 6 contacted surfaces, it is resisted against on supporting (striking) surface of tubular mouth 6, and this surface is in the present embodiment for being disposed in the front end face 62 of tubular mouth 6 of the outside of tubular mouth 6 with respect to container.

According to the structure and/or the size of various elements related in connecting, the lateral surface 101 that this insert area supported can also be a truncated cone shape is positioned at this surface on the insert against the truncated cone shape medial surface of tubular mouth 6.

The special construction of insert 10 and tubular mouth 6 and layout have been guaranteed owing to the insertion effect of insert 10 in tubular mouth 6, under any circumstance, (this belongs to insert 10 to a surface in the surface paired connection surface, another surface belongs to tubular mouth 6), wherein on bigger surface area, exist to be in contact with one another.Even surface itself is not made into the existence that (for example tubular mouth 6 is blow molded into an integral body with container body 2 by plastic material) also can guarantee the paired contact surface that is in contact with one another according to structure and size with high accuracy.In other words, even utilize blown technique that tubular mouth 6 and container 2 is integrally formed with relatively poor degree of accuracy, being connected between insert 10 and the tubular mouth 6 also all is reliable, firm and competent in any case.Because the existence of larger area contact surface, the connection that obtains between insert 10 and tubular mouth 6 are particularly effectively with reliably.This connection can be passed through for example bonding acquisition.In more detail, connection can be by on the outer surface that solvent (appropriate solvent that for example is used for PVC) is coated in insert 10 and bonded.

Being connected between the contact surface that requires high structure precision between pipe and the insert realizes.With regard to insert 10, for container body 2, insert carried out separately or do not make side by side that to guarantee that precision, insert have the shape and size and the container main body 2 of particularly accurate tolerance and precision much smaller by adopting special and being suitable for producing the technology of tubular insert 10 and proprietary technology.

Especially, be to make insert by the plastic material injection molding better than the plastic material blowing of producing container body 2.

As already mentioned, blood chamber described herein is the arterial chamber that is used for the extracorporeal blood circuit of hemodialysis.The loop comprises the flexible pipe loop, and at least a portion in loop is by fluid ground, be connected on the connector of blood chamber securely.

Each pipe is connected on the corresponding connector of the end regions with coupled and fluid-tight, and is fixedly connected (for example by using solvent welding) together with the inner surface of first barrel portion of corresponding insert.

Utilization comprises the method manufacturing blood chamber of step that obtains to have the container body 2 of a plurality of connectors that are communicated with the main body external fluid by the blowing plastic material.Each connector comprises the tubular mouth of making one with container body; Each tubular mouth has interior lateral dimension, and it is less than the interior lateral dimension of container body 2.

This method also comprises the step that applies subsequently, and on each tubular mouth, the insert of being made by plastic material has barrel portion, and it is by applying a part of inner surface that effect covers tubular mouth.

Each insert is inserted in the corresponding tubular mouth in the mode that fluid-tight connects.

As mentioned above, in first embodiment of this method, insert is at first formed by plastic material injection moulding, and insert is applied in (for example using solvent welding) subsequently.In second embodiment of this method, applying of insert comprises that directly carrying out plastic material injection moulding on tube-shaped main body forms.In such cases, the connection between insert and the tubular mouth realizes by friction grip.

Be inserted into the inner extracorporeal circuit of making of barrel portion of each insert by end regions with flexible fluid delivery tube.

In this is described, mentioned the concrete application relevant with the arterial chamber that is used for hemodialysis; Yet it also is possible applying the present invention to other purposes, for example makes structure and size be made into to carry out the chamber of venous chamber function, its designated intravenous line that is used for being inserted into extracorporeal circuit.

Claims

1. blood chamber (1) that is used for extracorporeal blood circuit, comprise the container body (2) that is used for blood, it has and is used for a plurality of connectors (3 of being communicated with the external fluid of described container body (2), 4,5), described a plurality of connector (3,4,5) each in all comprises specifying and is used for and pipe (7,8,9) tubular mouth (6) that end regions connects, wherein at least one described tubular mouth (6) has insert (10), and insert (10) has specifies the mode that is used for so that fluid-tight connects to admit described pipe (7,8, the surface of end regions 9) (102)

Wherein said tubular mouth (6) has inner surface (61), described inner surface (61) has at least one first transverse section and at least one second transverse section, described first transverse section is more outer than described second transverse section with respect to described container body (2), the diameter of more outer described first transverse section is greater than the diameter of described second transverse section of inside, wherein, the described inner surface (61) of described tubular mouth (6) is a truncated cone shape.

2. chamber according to claim 1, wherein said insert (10) has first barrel portion (101) at least, and it covers a part of inner surface (61) of tubular mouth (6) at least.

3. chamber according to claim 2 specifies wherein that to be used for admitting the surface of described insert of the end regions of described pipe (7,8,9) in the mode that fluid-tight connects contact be the inner surface of described first barrel portion (101).

4. according to claim 2 or 3 described chambers, wherein said first barrel portion (101) meets and is set to be inserted between the end regions of the inner surface (61) of described tubular mouth (6) and described pipe (7,8,9).

5. chamber according to claim 2, the internal diameter of the described inner surface (61) of wherein said tubular mouth (6) is less than the internal diameter of described container body (2), and the internal diameter of described container body (2) is in horizontal direction with respect to the vertical work structuring of blood chamber (1).

6. chamber according to claim 1, wherein said container body (2) is made into a single piece.

7. chamber according to claim 1, wherein said container body (2) is made by plastic material that can blow molding.

8. chamber according to claim 1, wherein each tubular mouth (6) is made into a single piece with container body (2).

9. chamber according to claim 1, wherein each tubular mouth (6) is protruded along outside direction from described container body (2).

10. chamber according to claim 1, wherein said a plurality of connector (3,4,5) comprise at least one first connector (3 of the lower area that is positioned at described container body (2), 4), with at least one second connector (5) of the upper area that is positioned at container body (2), its middle and lower part and top are that each first connector and second connector comprise the tubular mouth (6) with described insert (10) with reference to the term of the vertical work structuring proposition of described blood chamber (1).

11. chamber according to claim 1, the tubular mouth (6) that wherein is provided with described insert (10) has vertical axis, and the wherein vertical meaning is the vertical work structuring with reference to described blood chamber (1).

12. chamber according to claim 1, wherein said insert (10) is made by plastic material.

13. chamber according to claim 12, wherein the plastic material of insert (10) be can casting material.

14. chamber according to claim 1 specifies wherein that to be used for admitting the surface (102) of described insert of the end regions of described pipe (7,8,9) in the mode that fluid-tight connects be smooth surface.

15. chamber according to claim 1, wherein said insert (10) is made into a single piece.

16. chamber according to claim 1, wherein said insert (10) has outside conjunction plane (103), described outside conjunction plane (103) is used for connecting with corresponding described tubular mouth (6), and described outside conjunction plane (103) is at least in part towards the convergence of the inside of described blood chamber and have truncated cone shape.

17. chamber according to claim 1, wherein tubular mouth (6) has towards the inside convergence of container body (2) and the inner surface (61) that links to each other with the outside conjunction plane (103) of described insert (10).

18. chamber according to claim 1, wherein said insert (10) has first barrel portion (101) and flange portion (104), and described flange portion (104) radially protrudes and cover the front end face (62) of corresponding tubular mouth (6) from described first barrel portion (101).

19. chamber according to claim 18, wherein said flange portion (104) are stacked in the described front end face (62) of described tubular mouth (6) and go up and be in contact with it.

20. chamber according to claim 1, wherein said container body (2) is made by plastic material, and this plastic material is not PVC or chloride not.

21. chamber according to claim 20, wherein said plastic material is made by PET.

22. chamber according to claim 1, wherein said chamber are arterial chamber, its structure and size are made for the arterial line that is used for being inserted into extracorporeal circuit.

23. chamber according to claim 1, wherein said chamber are venous chamber, its structure and size are made for the intravenous line that is used for being inserted into extracorporeal circuit.

24. chamber according to claim 1, wherein said insert (10) is made by first plastic material, and described container body (2) is made by second plastic material that is different from described first plastic material.

25. an extracorporeal circuit comprises that the loop of pipe (7,8,9) and at least one have a plurality of connectors (3,4,5) blood chamber (1) is with each connector (3,4,5) at least one pipe of Xiang Lianing (7,8,9), wherein said blood chamber (1) is made according to claim 1.

26. loop according to claim 25 is wherein with described connector (3,4,5) pipe (7 that combines, 8,9) pipe in has end regions, this end regions be fluid-tight and be fixedly connected with the surface (102) of the described insert of associated interface.

27. a manufacturing is used for the method for the blood chamber of extracorporeal circuit, may further comprise the steps:

Obtain container body (2) by the blowing plastic material, it has and is used for a plurality of connectors (3 of being communicated with the external fluid of described container body (2), 4,5), a plurality of connectors (3,4,5) each in all comprises with described container body (2) makes a unitarily formed tubular mouth (6), and each tubular mouth (6) has the inner transversal dimension less than the inner transversal dimension of described container body (2); Each tubular mouth (6) has inner surface (61), described inner surface (61) has at least one first transverse section and at least one second transverse section, described first transverse section is more outer than described second transverse section with respect to described container body (2), the diameter of more outer described first transverse section is greater than the diameter of described second transverse section of inside, wherein, the described inner surface (61) of described tubular mouth (6) is a truncated cone shape;

On at least one tubular mouth (6), apply the insert (10) that plastic material with at least one barrel portion (101) is made, by applying effect, make described barrel portion (101) cover at least a portion inner surface (61) of described tubular mouth (6), the surface (102) of described barrel portion (101) is designated to be used for and fluid delivery tube (7,8,9) end regions connects regularly.

28. method according to claim 27, wherein said insert (10) is made by plastic material.

29. method according to claim 27, the described surface (102) of the barrel portion of wherein said insert (101) is an inner surface.

30. method according to claim 27, wherein the mode that connects by fluid-tight is applied to described insert (10) in the described tubular mouth (6).

31. method according to claim 27 wherein applies step and goes up execution in a plurality of described tubular mouth (6).

32. method according to claim 27, at least two connectors in wherein said a plurality of connectors are positioned on the opposite side portion of described container body (2).

33. method according to claim 27, wherein described at least tubular mouth (6) protrude and point to the outside of described container body (2) from described container body (2).

34. method according to claim 27, wherein said insert (10) was made by the plastic material injection molding before being applied on the described tubular mouth (6).

35. method according to claim 27, wherein said insert (10) is upward being made by the plastic material injection molding before by using solvent welding to be applied to described tubular mouth (6).

36. method according to claim 27 wherein applies described insert (10) and comprises that using plastic material directly to go up in described tubular mouth (6) injects Overmolded step to described insert (10).

37. the manufacture method of an extracorporeal circuit, comprise the step of making blood chamber (1) according to any described method in the claim 27 to 36, and the end regions of fluid delivery tube (7,8,9) is applied to the step in the described barrel portion (101) of described insert (10).