Insert Piece For A Blood Tubing Set to Promote Mixing An Infusion Solution With A Further Fluid

Abstract

The present disclosure relates to an insert piece for a blood tubing set. The insert piece includes at least a first connection site for connecting a first tubing portion of the blood tubing set to the insert piece, and a second connection site for connecting a second tubing portion of the blood tubing set to the insert piece. The insert piece also includes a third connection site for connecting a third tubing portion of the blood tubing set to the insert piece, and a main line for forwarding a first liquid through the insert piece. The main line is in fluid communication with the first connection site and with the second connection site. The insert piece also includes a secondary line for forwarding a second liquid into the main line. The secondary line is in fluid communication with the third connection site.

Claims

1-17. (canceled)

18. An insert piece for a blood tubing set, the insert piece comprising: a first connection site for connecting a first tubing portion of the blood tubing set to the insert piece; a second connection site for connecting a second tubing portion of the blood tubing set to the insert piece; a third connection site for connecting a third tubing portion of the blood tubing set to the insert piece; a main line for conducting a first fluid through the insert piece, wherein the main line is in fluid communication with the first connection site and with the second connection site; and a secondary line for conducting a second fluid into the main line, wherein the secondary line is in fluid communication with the third connection site, and wherein the secondary line is in fluid communication with the main line in an intermediate portion of the insert piece, the intermediate portion being arranged between the first connection site and the second connection site; wherein the first connection site comprises a perfusable lumen having a first cross section area; the second connection site comprises a perfusable lumen having a second cross section area; the intermediate portion comprises a perfusable lumen having a third cross section area; the secondary line comprises a lumen portion which protrudes into an interior of the intermediate portion, and which comprises at least an outlet for the second fluid.

19. The insert piece according to claim 18, wherein the secondary line is connected in fluid communication to or comprises an infusion solution source.

20. The insert piece according to claim 18, wherein the second fluid is an infusion solution and the first fluid is blood.

21. The insert piece according to claim 20, wherein the infusion solution is or comprises a calcium solution.

22. The insert piece according to claim 18, wherein the third cross section area is substantially equal to the first cross section area and the second cross section area.

23. The insert piece according to claim 18, wherein the third cross section area is substantially equal to the first cross section area or the second cross section area.

24. The insert piece according to claim 18, wherein the lumen portion is configured to deliver the second fluid into the main line in an axial direction.

25. The insert piece of claim 18, wherein the lumen portion is configured to deliver the second fluid into the main line parallel to a main flow direction of the main line.

26. The insert piece according to claim 18, wherein the outlet is arranged to pass the second fluid into the main line in an axial direction of the main line or parallel to a main flow direction of the main line.

27. The insert piece according to claim 18, wherein a portion of the lumen portion is arranged such that a longitudinal direction of the portion of the lumen portion extends parallel to a longitudinal axis of the intermediate portion, wherein the portion of the lumen portion is adjacent the outlet and is upstream of the outlet relative to a flow direction.

28. The insert piece according to claim 18, wherein a deflector element is arranged in the interior of the intermediate portion such that a second fluid flowing out of the outlet of the secondary line has limited radial movement.

29. The insert piece according to claim 18, wherein the lumen portion extends through the entire interior of the intermediate portion or of the main line.

30. The insert piece according to claim 18, wherein the lumen portion comprises at least one groove, which extends in a direction parallel to the main line.

31. The insert piece according to claim 18, wherein, in an area of the intermediate portion, a protrusion extends into the interior of the intermediate portion, the protrusion being disposed in an extension of the secondary line in the intermediate portion.

32. A blood tubing set or an extracorporeal blood circuit comprising: at least one insert piece comprising: a first connection site for connecting a first tubing portion of the blood tubing set or extracorporeal circuit to the insert piece; a second connection site for connecting a second tubing portion of the blood tubing set to the insert piece; a third connection site for connecting a third tubing portion of the blood tubing set to the insert piece; a main line for conducting a first fluid through the insert piece, wherein the main line is in fluid communication with the first connection site and with the second connection site; and a secondary line for conducting a second fluid into the main line, wherein the secondary line is in fluid communication with the third connection site, and wherein the secondary line is in fluid communication with the main line in an intermediate portion of the insert piece, the intermediate portion being arranged between the first connection site and the second connection site, wherein the first connection site comprises a perfusable lumen having a first cross section area, wherein the second connection site comprises a perfusable lumen having a second cross section area, wherein the intermediate portion comprises a perfusable lumen having a third cross section area, and wherein the secondary line comprises a lumen portion which protrudes into an interior of the intermediate portion and which comprises at least an outlet for the second fluid.

33. The blood tubing set according to claim 32, wherein the insert piece is connected in fluid communication with an addition line and with a blood withdrawal line and with a blood return line.

34. The blood tubing set according to claim 32, wherein the insert piece is connected in fluid communication with an addition line and with a blood withdrawal line or with a blood return line.

35. The blood tubing set according to claim 32 is configured to execute a regional anticoagulation.

36. The blood tubing set according to claim 32 is configured to execute a hemodialysis, a hemofiltration, a hemodiafiltration, a plasmapheresis treatment or a whole blood adsorption treatment.

37. The blood tubing set according to claim 32, wherein the first connection site and the second connection site are connected to a blood-conducting line of the blood tubing set, and wherein the third connection site is connected to a line for an electrolyte solution.

38. the blood tubing set of claim 37, wherein the line for an electrolyte solution is a calcium line.

39. A blood treatment apparatus, connected to at least a blood tubing set comprising: an insert piece comprising: a first connection site for connecting a first tubing portion of the blood tubing set to the insert piece; a second connection site for connecting a second tubing portion of the blood tubing set to the insert piece; a third connection site for connecting a third tubing portion of the blood tubing set to the insert piece; a main line for conducting a first fluid through the insert piece, wherein the main line is in fluid communication with the first connection site and with the second connection site; and a secondary line for conducting a second fluid into the main line, wherein the secondary line is in fluid communication with the third connection site, and wherein the secondary line is in fluid communication with the main line in an intermediate portion of the insert piece, the intermediate portion being arranged between the first connection site and the second connection site; wherein the first connection site comprises a perfusable lumen having a first cross section area, wherein the second connection site comprises a perfusable lumen having a second cross section area, wherein the intermediate portion comprises a perfusable lumen having a third cross section area, and wherein the secondary line comprises a lumen portion which protrudes into an interior of the intermediate portion and which comprises at least an outlet for the second fluid.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0068] The present disclosure is exemplarily explained in the following, regarding the accompanying drawings in which identical reference numerals denote the same or similar elements. The following applies in the partially highly simplified figures:

[0069] FIG. 1 shows a longitudinal cut of an insert piece for a blood tubing set, not shown in FIG. 1, in a first exemplary embodiment;

[0070] FIG. 1a shows the insert piece of FIG. 1 with a slight modification;

[0071] FIG. 2 shows the insert piece of FIG. 1;

[0072] FIG. 3 shows a longitudinal cut of an insert piece in a second exemplary embodiment;

[0073] FIG. 3a shows the insert piece of FIG. 3 in a cross section;

[0074] FIG. 4 shows a longitudinal cut of an insert piece in a third exemplary embodiment;

[0075] FIG. 5 shows a longitudinal cut of an insert piece in a fourth exemplary embodiment; and

[0076] FIG. 6 shows a blood tubing set having an insert piece according to the present disclosure.

DETAILED DESCRIPTION OF THE FIGURES

[0077] FIG. 1 shows a longitudinal cut of the insert piece 100 in a first exemplary embodiment for a blood tubing set 200, not shown in FIG. 1 (see however FIG. 6).

[0078] The insert piece 100 comprises a first connection site 101 by means of which a first tubing portion 205a (see FIG. 6) of the blood tubing set 200 may be connected to the insert piece 100.

[0079] The insert piece 100 comprises a second connection site 103 by means of which a second tubing portion 205b of the blood tubing set 200 may be connected to the insert piece 100.

[0080] The insert piece 100 comprises a third connection site 105 by means of which a third tubing portion, here it is a line for calcium solution 209 of the blood tubing set 200, may be connected to the insert piece 100.

[0081] The insert piece 100 comprises a main line 107 for conducting a first liquid, preferably blood, through the insert piece 100. The main line 107 is in fluid communication with the first connection site 101 and with the second connection site 103. The first liquid may flow in direction of the arrow H into the main line 107.

[0082] The insert piece 100 comprises a longitudinal direction, which extends parallel to the middle line of the main line 107, the latter being denoted with the reference numeral M_H. The insert piece 100 comprises a transverse direction or radial direction, which is denoted with r.

[0083] The insert piece 100 comprises an intermediate portion 109, throughout which the main line 107 extends. The intermediate portion 109 is circled with a dashed line in FIG. 1.

[0084] The insert piece 100 comprises a secondary line 111. It serves conducting a second liquid, preferably an infusion solution, into the main line 107. The second liquid may flow in direction of the arrow N into the secondary line 111.

[0085] The secondary line 111 is in fluid communication with the third connection site 105. It is further in fluid communication with the main line 107 in the intermediate portion 109 of the insert piece 100.

[0086] The first connection site 101 comprises a perfusable lumen having a first cross section area and an inner wall 101. The inner wall 101 encloses an interior of the first connection site 101. The interior in the example of the first connection site 101 is equal to its perfusable lumen.

[0087] The second connection site 103 comprises a perfusable lumen having a second cross section area and an inner wall 103. The inner wall 103 encloses an interior of the second connection site 103. The interior in the example of the second connection site 103 is equal to its perfusable lumen.

[0088] The intermediate portion 109 comprises a perfusable lumen having a third cross section area and an inner wall 109. The inner wall 109 encloses an interior of the intermediate portion 109. The interior in the example of the intermediate portion 109 is not equal to its perfusable lumen. The cross section area of the interior is rather larger than the perfusable cross section area of the lumen by as much as the cross section area of a lumen portion 113, provided the latter extends into the interior. If one imagines that the lumen portion 113 is not shown in FIG. 1, then the interior in FIG. 1 would correspond to the perfusable lumen.

[0089] The middle line of the main line 107 (defined e.g. by the middle points of the first and the second cross section areas, see supra) is denoted with M_H. The middle line M_H is equal to the longitudinal axis of the main line 107 and its axial direction.

[0090] The secondary line 111 comprises the lumen portion 113 which protrudes into the interior of the intermediate portion 109 and which comprises at least one opening or outlet opening 115. The second liquid may be introduced into the lumen of the main line 107 through the outlet opening 115.

[0091] As is seen in FIG. 1, the inner wall 101 encloses or boarders a perfusable lumen or flow-through lumen of the main line 107 in the area of the first connection site 101, while the inner wall 103 encloses a perfusable lumen of the main line 107 in the area of the second connection site 103. The inner wall 109 encloses a perfusable lumen of the main line 107 in the area of the intermediate portion 109.

[0092] As FIG. 1 further shows, the lumen portion 113 protrudes into the interior of the intermediate portion 109. Thereby, the lumen portion 113 is not to be understood as thickening or narrowing of the wall of the insert piece, rather as an opening or break through or continuation of the wall in order to radially place or shift the outlet opening 115 as far as possible into the perfused interior of the main line 107and thus into the flow of the first liquid through the main line 107.

[0093] This may be achieved when, as exemplarily shown in FIG. 1, the diameter of the outlet opening 115 makes up or comprises a major part of the diameter or the cross section area of the lumen portion 113, as this is further explained with reference to FIG. 2.

[0094] The first connection site 101, the second connection site 103 and/or the third connection site 105 may optionally comprise, respectively, a chamfer 119 of the inner wall or of the outer wall.

[0095] As is seen in FIG. 1, the lumen portion 113 is preferably not a portion which contacts, in a stepless or continuous manner, the inner wall 109 of the intermediate portion 109. While the inner wall 109 limits or boarders the interior of the intermediate portion 109, the lumen portion 113 protrudes beyond or above the inner wall 109 into the interior of the intermediate portion 109.

[0096] Optionally, the lumen portion 113 is also not a structure being ring-formed in a cross section of the intermediate portion 109.

[0097] Optionally, the lumen portion 113 is not a bezel-like or nozzle-like structure which forms an through-opening for the fluid in a cross section of the intermediate portion 109, while it would, at its outer periphery, circularly contact the inner wall 109, i.e. for example contacting the whole inner periphery of the intermediate portion 109.

[0098] Optionally, the lumen portion 113 is arranged in the interior of the main line 107 such that the liquid, which perfuses the lumen of the main line 107, may, in the area of the lumen portion 113, flow in front of it (i.e. above the drawing plane) as well as behind it (i.e. behind the drawing plane).

[0099] Optionally, the lumen portion 113 protrudes in a pen-like or cylinder-like manner (e.g. with the middle line M_N as a rotation axis) into the interior of the main line 107.

[0100] An optional feature of the insert piece 100 is that the perfusable area of the main line 107, in the area of the intermediate portion 109, is not smaller than the perfusable area of the main line in the area of the first connection site 101 and/or in the area of the second connection site 103. Here, several embodiments are contemplated. One option is shown in FIG. 1; the inner wall of the intermediate portion 109 is embodied thinner than the adjacent portions, which leads to enlarging the perfusable lumen by a step-less outer wall. Alternatively or in addition to that, offsetting the wall of the main line 107 in the area of the intermediate portion 109 may be provided such that the inner wall is radially placed to the outside when compared to adjacent areas and such that also the outer wall is radially placed or shifted to the outside when compared to adjacent areas. The latter is not shown in FIG. 1, however, the former is.

[0101] FIG. 1a shows the insert piece 100 of FIG. 1 with a modification in the left side or arm of the main line 107.

[0102] As it is shown with or through the reference numeral 101a, the inner wall 101 of the main line 107 comprises a stop, against which a tube (not shown in FIG. 1a), which is inserted into the first connection site 101, may be moved to or pushed to.

[0103] The herein exemplarily ring-shaped stop 101a may contact during use the end surface of the likewise ring-shaped tube (not shown). The height of the stop 101a may thereby be advantageously chosen so that the inner wall of the tube step-lessly contacts the inner wall of the section of the inner wall 109 neighboring the stop 101a to the right. In this way, the laminar flow of the fluid in the stagnation area (near the wall) is not undesirably impaired.

[0104] In FIG. 1a, such a stop 101a, which may have the form of a step in the inner wall 101, is only shown on the left side of the insert piece 100. Such a stop may however be provided also in the area of the second connection site 103.

[0105] Such a stop may further be provided in any other embodiment.

[0106] Such a stop may moreover be provided together with a chamfer 119 in any embodiment.

[0107] FIG. 2 shows the insert piece 100 of FIG. 1. For better clarity, a repeated mentioning of many of the reference numerals already known from FIG. 1 has been omitted.

[0108] As is seen, the lumen portion 113 protrudes into the interior of the intermediate portion 109. Thereby, the opening or the outlet opening 115 clearly projects beyond the level of the inner wall 101 or 103 into the interior.

[0109] The inner diameter of the main line 107 takes on the value A in the area of the first connection site 101 or in the area of the second connection site 103. The middle point M_115 (or the geometric center) of an opening plane of the outlet opening 115 is disposed apart from the middle line M_H by as much as step a. Thereby, the ratio a/A takes on preferably a maximum of 0.33.

[0110] The outer diameter of the secondary line 111 takes on the value D in the area of the outlet opening 115. The inner diameter of the secondary line 111 takes on the value d in the area of the outlet opening 115. Thereby, the ratio d/D is preferably at least 0.125.

[0111] Particularly preferred, the ratio a/A has preferably a maximum of 0.17, measured within an area whose points are maximally disposed apart from a middle line M_N of the secondary line 111 by as much as the value 2*d.

[0112] The second liquid may be introduced into the lumen of the main line 107 through the outlet opening 115.

[0113] FIG. 3 shows a longitudinal cut of the insert piece 100 for a blood tubing set 200, not shown in FIG. 3, in a second exemplary embodiment.

[0114] As is seen in FIG. 3, the lumen portion 113 comprises parts, which reach up or extend to, respectively, both inner wall portions of the main line 107 disposed on opposite sides thereof.

[0115] In the example of FIG. 3, a baffle or deflector plate 113 is disposed opposite to the outlet opening 115. The deflector plate 113 is, or may be, part of the lumen portion 113. The deflector plate 113 may serve such that the second liquid when flowing out of the outlet opening 115 is not brought into the radial, outer flow areas (stagnation areas) of the main line 107, rather it flows or enters, closer to the middle line M_H, i.e. in an area with particularly high flow velocity, into the flow of the first liquid.

[0116] The embodiment of FIG. 3 represents a more symmetrical embodiment of the insert piece 100 in the area of the intermediate portion 109 than the embodiment of FIG. 1. The embodiment of FIG. 3 may contribute in that the flow through the main line 107 remains untouched as much as possible. In this way the flow profile of the flow through the main line 107 may remain unchanged or undisturbed as much as possible. That way, it is easier to bring the second liquid into the main line 107 in an area having highest flow velocitywith regard to the first liquid of the main line 107namely into a radially central area of the main line 107.

[0117] FIG. 3a shows the insert piece 100 of FIG. 3 in a cross section. The flow through the main line 107 takes place in FIG. 3a mainly into the drawing plane or out of it, i.e. perpendicular to the drawing plane.

[0118] The baffle or deflector plate 113, lying opposite to the outlet opening 115, comprises a groove 113a, not seen or recognizable in the view of the FIG. 3. The groove 113a is, or may be, part of the lumen portion 113. It extends preferably in the direction of the flow through the main line 107 and is thus perpendicular to the drawing plane at least in section.

[0119] The groove 113a may serve like the deflector plate 113 that the second liquid when flowing out of the outlet opening 115 is not brought until the radial outer flow areas (stagnation areas) of the main line 107. Rather, it flows or enters, closer to the middle line M_H, i.e. in an area with particularly high flow velocity, into the flow of the first liquid and is led into said area, depending on the shape of the groove 113a, along a pre-determined path.

[0120] The cross section of the groove 113a may be triangular, as exemplarily shown in FIG. 3a. Other cross section forms are contemplated by the present invention as well.

[0121] FIG. 4 shows a longitudinal cut of the insert piece 100 for a blood tubing set 200, not shown in FIG. 4, in a third exemplary embodiment.

[0122] As is seen in FIG. 4, the lumen portion 113 further comprises, in addition to the parts known from FIG. 3, a pipe portion 113 arranged in longitudinal direction of the main line 107. The pipe portion 113, may have a round, cross section form. Other arbitrary cross section forms may also be considered and are encompassed by the present invention as well.

[0123] In FIG. 4, the longitudinal axis of the pipe portion 113 aligns with the longitudinal direction or, presently, with the middle line M_H of the main line 107. In other embodiments, the longitudinal axis of the pipe portion 113 or its longitudinal direction is parallel to the longitudinal direction or, presently, to the middle line M_H of the main line 107.

[0124] Deflecting elements, other than those shown in FIG. 4, for deflecting the liquid flowing out of the secondary line 111 such that it flows out of or exits the outlet opening 115 in or with a, as much as possible, parallel flow direction and flows into the flow of the liquid perfusing the main line 107, are encompassed by the present invention as well.

[0125] The deflecting element 113, may advantageously stabilize the flow, depending on the embodiment. It may advantageously contribute to ensuring that the second liquid is indeed brought in or to a middle of the flow profile along or across the cross section or to where the flow velocity within the main line 107 is at least sufficiently high or even at its highest.

[0126] The pipe portion 113 may, like the baffle or deflecting plate 113 of FIG. 3, contribute to allowing the outflow of the second liquid out of the outlet opening 115 to take place in an area in which the flow into the main line 107 is not stagnated.

[0127] FIG. 5 shows a longitudinal cut of the insert piece 100 for a blood tubing set 200, not shown in FIG. 3, in a fourth exemplary embodiment.

[0128] As is seen in FIG. 5, the lumen portion 113 comprises the pipe portion 113 of FIG. 4. Unlike in FIG. 4, the lumen portion 113 does not reach or extend through the entire interior of the intermediate portion 109. The lumen portion 113 reduces therefore the perfusable lumen of the intermediate portion 109 less than in FIG. 4.

[0129] The aforementioned figures show embodiments in which the second liquid flows out of the outlet opening 115. The present invention encompasses however also solutions with a plurality of outlet openings 115. Thus, several axially spaced outlet openings may be provided.

[0130] FIG. 6 shows an exemplary embodiment of an optional basic arrangement of an insert piece 100 in an extracorporeal blood tubing set 200, the latter being illustrated in a schematically highly simplified manner.

[0131] The blood tubing set 200 comprises a hemofilter 201 or is connected thereto. A blood withdrawal line 203 (or arterial line) and a blood return line 205 (or venous line) are connected to the hemofilter 201 or dialyzer or blood filter.

[0132] The blood withdrawal line 203 is operatively connected to, or comprises, a blood pump 301.

[0133] A further addition line, here a line 207 for citrate solution, opens upstream of the blood pump 301 into the blood withdrawal line 203.

[0134] The line 207 is operatively connected to, or comprises, a citrate pump 307.

[0135] Downstream of the hemofilter 201, the line 209 for calcium solution opens into the blood return line 205.

[0136] The insert piece 100 is operatively connected to a calcium pump 309 or comprises the latter. It is supplied by a source for infusion solution, which is not shown in FIG. 1, herein exemplarily a calcium source. The source may be a bag or a bottle. The infusion solution may optionally be generated on-line; in such case the respective device, in which the infusion solution is generated, is considered as a source.

[0137] The operative connection to the calcium pump 309 is to be understood herein as an example. Arranging the insert piece 100 behind another pump than a calcium pump, i.e. for example downstream of a citrate pump like the citrate pump 307 of FIG. 6, is encompassed by the present invention.

[0138] The hemofilter 201 is connected to a line 311 for fresh dialysis liquid and to a line 315 for spent dialysate or filtrate. The line 311 is connected to, or comprises, a dialysis liquid pump 313. The line 315 is connected to, or comprises, a filtrate pump 317.

[0139] The arrowhead indicates the flow direction when using the blood tubing set 200 as intended.

[0140] The blood tubing set 200 shown in FIG. 6 may correspond to a standard extracorporeal blood tubing set and may in particular be suitable for the CVVHD (continuous veno-venous hemodialysis).

[0141] The pumps 301, 307, 309, 313, and 317 may be part of a blood treatment apparatus 300, which is only schematically indicated. The same applies for the lines 311 and 315.

LIST OF REFERENCE NUMERALS

[0142] 100 insert piece [0143] 101 first connection site [0144] 101 inner wall [0145] 103 second connection site [0146] 103 inner wall [0147] 105 third connection site [0148] 107 main line [0149] 109 intermediate portion [0150] 109 inner wall [0151] 111 secondary line [0152] 113 lumen portion [0153] 113 baffle or deflector plate [0154] 113 pipe portion [0155] 113a groove [0156] 115 outlet opening or outlet [0157] 119 chamfer [0158] 200 blood tubing set, blood tubing system [0159] 201 hemofilter or blood filter or dialyzer [0160] 203 blood withdrawal line [0161] 205 blood return line [0162] 205a first tubing portion [0163] 205b second tubing portion [0164] 207 line for citrate solution [0165] 209 line for calcium solution; addition line; third tubing portion [0166] 300 blood treatment apparatus [0167] 301 blood pump [0168] 307 citrate pump [0169] 309 calcium pump [0170] 311 line for fresh dialysis liquid [0171] 313 pump for fresh dialysis liquid [0172] 315 line for spent dialysate, or filtrate [0173] 317 pump for spent dialysate, or filtrate [0174] A value [0175] a step [0176] D outer diameter of the secondary line [0177] d inner diameter of the secondary line [0178] H inflow direction of the first fluid into the main line [0179] N inflow direction of the second fluid into the secondary line [0180] M_H middle line of the main line [0181] M_N middle line of the secondary line [0182] M_115 middle point of an opening plane of the outlet opening [0183] r radial direction or extension of the main line