Another insert piece for a blood tubing set to promote mixing an infusion solution with a further fluid

Abstract

The present invention relates to an insert piece for a blood tubing set that includes 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 first main line for conducting a first liquid through the insert piece; a second main line for conducting the first liquid through the insert piece; a secondary line for conducting a second liquid into at least one of the first main line, and the second main line; and a connection portion which connects both main lines to each other or to the second connection site.

Claims

1. An insert piece for a blood tubing set, the insert piece comprising: a first connection site configured to couple to a first tubing portion of the blood tubing set; a second connection site configured to couple to a second tubing portion of the blood tubing set; a third connection site configured to couple to a third tubing portion of the blood tubing set; a first main line configured to conduct a first liquid through the insert piece, wherein the first main line is fluidly coupled to the first connection site and the second connection site; a second main line configured for conducting the first liquid through the insert piece, wherein the second main line is fluidly coupled to the first connection site and the second connection site; and a secondary line configured to conduct a second liquid into at least one of the first main line, the second main line, or a connection portion connecting the first main line and the second main line to each other or to the second connection site, wherein: the secondary line is fluidly coupled to the third connection site; the first connection site comprises a perfusable lumen having a first cross sectional area; the second connection site comprises a perfusable lumen having a second cross sectional area; at least one of the first main line and/or the second main line comprises a perfusable lumen having a third cross sectional area; and at least one of the first main line, the second main line, a portion of the first main line, or a portion of the second main line is a tube inserted into a tube intake in fluid communication with the first connection site or with the second connection site.

2. The insert piece of claim 1, wherein a sum of a first cross sectional area of the first main line and a second cross sectional area of the second main line is smaller than at least one of a cross sectional area of the first connection site, a cross sectional area of the second connection site, or a cross sectional area of a tube section of the blood tubing set.

3. The insert piece of claim 1, wherein the secondary line is in fluid communication with a source of infusion solution.

4. The insert piece of claim 1, wherein the third cross sectional area is substantially half as large as at least one of the first cross sectional area or the second cross sectional area.

5. The insert piece of claim 1, wherein the third cross sectional area is less than half as large as at least one of the first cross sectional area or the second cross sectional area.

6. The insert piece of claim 1, wherein the connection portion is arranged along a flow direction of the first liquid between at least one of the first main line or the second main line on a first side and at least one of the second connection site or the third connection site on a second side.

7. The insert piece of claim 1, wherein the connection portion comprises a cross section in a flow direction towards the second connection site that widens or enlarges along the flow direction.

8. The insert piece of claim 1, wherein a longitudinal axis of the connection portion is perpendicular to a longitudinal axis of the secondary line.

9. The insert piece of claim 1, further comprising a through-opening arranged between the first main line and the second main line.

10. The insert piece of claim 1, wherein the insert piece comprises two or more components welded or glued to each other.

11. The insert piece of claim 1, wherein at least one of the first main line or the second main line is an integral part of the insert piece.

12. The insert piece of claim 1, wherein the first liquid comprises blood.

13. The insert piece of claim 1, wherein the second liquid comprises an infusion solution.

14. A blood tubing set comprising: at least one insert piece comprising: a first connection site configured to couple to a first tubing portion of the blood tubing set; a second connection site configured to couple to a second tubing portion of the blood tubing set; a third connection site configured to couple to a third tubing portion of the blood tubing set; a first main line configured to conduct a first liquid through the insert piece, wherein the first main line is fluidly coupled to the first connection site and the second connection site; a second main line configured for conducting the first liquid through the insert piece, wherein the second main line is fluidly coupled to the first connection site and the second connection site; and a secondary line configured to conduct a second liquid into at least one of the first main line, the second main line, or a connection portion connecting the first main line and the second main line to each other or to the second connection site; an addition line; a blood withdrawal line; and a blood return line; wherein: the at least one insert piece is fluidly coupled to at least one of the addition line, the blood withdrawal line, or the blood return line; the secondary line is fluidly coupled to the third connection site; the first connection site comprises a perfusable lumen having a first cross sectional area; the second connection site comprises a perfusable lumen having a second cross sectional area; at least one of the first main line and/or the second main line comprises a perfusable lumen having a third cross sectional area; and at least one of the first main line, the second main line, a portion of the first main line, or a portion of the second main line is a tube inserted into a tube intake in fluid communication with the first connection site or with the second connection site.

15. The blood tubing set of claim 14, wherein the blood tubing set is configured to execute a regional anticoagulation.

16. The blood tubing set of claim 14, wherein the blood tubing set is configured to execute at least one of a hemodialysis treatment, a hemofiltration treatment, a hemodiafiltration treatment, a plasmapheresis treatment, or a whole blood adsorption treatment.

17. The blood tubing set of claim 14, wherein: the first connection site and the second connection site are each fluidly coupled to the blood return line; and the third connection site is fluidly coupled to the addition line.

18. The blood tubing set of claim 17, wherein the addition line is a calcium line.

19. A system comprising: a blood treatment apparatus; and a blood tubing set coupled to the blood treatment apparatus, wherein the blood tubing set comprises: at least one insert piece comprising: a first connection site configured to couple to a first tubing portion of the blood tubing set a second connection site configured to couple to a second tubing portion of the blood tubing set; a third connection site configured to couple to a third tubing portion of the blood tubing set; a first main line configured to conduct a first liquid through the insert piece, wherein the first main line is fluidly coupled to the first connection site and the second connection site; a second main line configured for conducting the first liquid through the insert piece, wherein the second main line is fluidly coupled to the first connection site and the second connection site; and a secondary line configured to conduct a second liquid into at least one of the first main line, the second main line, or a connection portion connecting the first main line and the second main line to each other or to the second connection site; an addition line; a blood withdrawal line; and a blood return line, wherein: the at least one insert piece is fluidly coupled to at least one of the addition line, the blood withdrawal line, or the blood return line; the secondary line is fluidly coupled to the third connection site; the first connection site comprises a perfusable lumen having a first cross sectional area; the second connection site comprises a perfusable lumen having a second cross sectional area; at least one of the first main line and/or the second main line comprises a perfusable lumen having a third cross sectional area; and at least one of the first main line, the second main line, a portion of the first main line, or a portion of the second main line is a tube inserted into a tube intake in fluid communication with the first connection site or with the second connection site.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1 shows an insert piece in a first exemplary embodiment.

(2) FIG. 2 shows a cross sectional view of the insert piece of FIG. 1 along a first plane.

(3) FIG. 3 shows a cross sectional view of the insert piece of FIG. 1 along a second plane.

(4) FIG. 4 shows an insert piece in a second exemplary embodiment.

(5) FIG. 5 shows a cross sectional view of an insert piece similar to that of FIG. 4.

(6) FIG. 6 shows a cross sectional view of a lower part of the insert piece of FIG. 4.

(7) FIG. 7 shows a cross sectional view of an upper part of the insert piece of FIG. 4.

(8) FIG. 8 shows a cross sectional view of an insert piece according to a third exemplary embodiment.

(9) FIG. 9 shows a partly cut insert piece according to a fourth exemplary embodiment.

(10) FIG. 10 shows a cross sectional view of the insert piece of FIG. 9.

(11) FIG. 11 shows a blood tubing set according to the present disclosure having an insert piece according to the present disclosure.

(12) FIG. 12 shows a cross sectional view of an insert piece according to a fifth exemplary embodiment.

(13) FIG. 13a shows a rear view of the insert piece of FIG. 12; and

(14) FIG. 13b shows a front view of the insert piece of FIG. 12.

DETAILED DESCRIPTION

(15) FIG. 1 shows an insert piece 100 in a first exemplary embodiment according to the present invention for a blood tubing set, such as the blood tubing set 200 of FIG. 11).

(16) As depicted in FIG. 1, insert piece 100 includes a first connection site 101 configured to couple a first tubing portion 205a (see FIG. 11) of the blood tubing set 200 to the insert piece 100.

(17) The insert piece 100 also includes a second connection site 103 configured to couple a second tubing portion 205b (see FIG. 11) of the blood tubing set 200 to the insert piece 100.

(18) The insert piece 100 comprises a third connection site 105 configured to couple a third tubing portion, such as a line 209 for calcium solution of the blood tubing set 200 (see FIG. 11), to the insert piece 100.

(19) The insert piece 100 comprises a first main line 107a for conducting a first liquid, such as blood, through the insert piece 100. The first main line 107a is in fluid communication with the first connection site 101 and the second connection site 103. The first liquid may flow in direction of the arrows H depicted in FIG. 1 into and through the first main line 107a.

(20) The insert piece 100 also includes a second main line 107b for conducting the first liquid through the insert piece 100. The second main line 107b is in fluid communication with the first connection site 101 and the second connection site 103. The first liquid may flow in direction of the arrows B as depicted in FIG. 1 into and through main line 107b. In some embodiments, the insert piece includes three, four, or more main lines for conducting the first liquid through the insert piece 100.

(21) The insert piece 100 includes an optional junction portion 109 (also referred to herein as a connection portion), in which the first main line 107a, the second main line 107b and a secondary line 111 (see FIG. 3) of the insert piece converge. As depicted in FIG. 1, the second connection site 103 and/or the third connection site 105 may form part of the junction portion 109.

(22) As depicted in FIG. 3, insert piece 100 includes a secondary line 111. The secondary line 111 is configured to conduct a second liquid, preferably an infusion solution. The second liquid may flow in direction of the arrow N into the secondary line 111, as depicted in FIG.

(23) The secondary line 111 is in fluid communication with the third connection site 105, and the secondary line 111 can be part of or end with the third connection site 105, as depicted in FIG. 1. The secondary line 111 is further in fluid communication with the first and the second main lines 107a, 107b.

(24) The first connection site 101 defines a perfusable lumen having a first cross sectional area.

(25) The second connection site 103 defines a perfusable lumen having a second cross sectional area.

(26) The first and/or the second main lines 107a, 107b can define a perfusable lumen having a third cross sectional area.

(27) The secondary line 111 defines a lumen which protrudes or opens into the interior of the junction portion 109 and which includes at least one opening or outlet opening 115. The second liquid conducted through the secondary line 111 and through the outlet opening 115 can be introduced into a lumen defined by the junction portion 109 or into the lumen defined by another line.

(28) As FIG. 3 further shows, the lumen defined by the secondary line opens into and is fluidly coupled to the interior of the junction portion 109.

(29) The first connection site 101, the second connection site 103 and/or the third connection site 105 can each optionally include a chamfer 119 in the inner wall or of the outer wall of the respective connection site as depicted in FIGS. 2 and 3.

(30) As depicted in FIG. 1, the first and the second main lines 107a, 107b together can, form an optional through-opening 130 of the insert piece 100.

(31) Hence, blood entering the insert piece 100 through the first connection site 101 is split into two flows (by means of the first and the second main lines 107a, 107b) that are separate from each other and that rejoin near the outlet of the secondary line 111. In some embodiments, dividing and rejoining the flow of fluid into the insert piece 110 using the two separate main line 107a, 107b generated turbulences within the fluid flowing through the insert piece 100.

(32) As can be seen from FIG. 1, the first and the second main lines 107a, 107b can be advantageously arranged such that the two flows collide or meet in a more or less frontal direction.

(33) FIG. 2 shows a section view of the insert piece 100 of FIG. 1 along a first cut plane in the longitudinal direction in a plan view.

(34) FIG. 3 shows a section view the insert piece 100 of FIG. 1 along a second plane perpendicular to the first plane of FIG. 2.

(35) As can be seen from FIG. 3, in any embodiment according to the present invention—such as the one shown in FIG. 3 without being limited to this particular embodiment the secondary line 111 and/or the third connection site 105 may be perpendicular to the plane in which the first and the second main lines 107a, 107b extend, the plane being in a horizontal or left-right direction in FIG. 3. However, as depicted in FIGS. 1 and 3, the plane parallel to the outlet opening 115 of the secondary line 111, through which the second fluid exits in order to mix with the first fluid in the insert piece 100, can be perpendicular to the plane in which the first and the second main lines 107a, 107b extend. Alternatively, the direction along which the second fluid exits from the secondary line 111 in order to mix with the first fluid may be parallel to or part of the plane in which the first and the second main lines 107a, 107b extend.

(36) Hence, the second fluid provided by the secondary line 111 has to change its travelling direction (indicated in FIG. 3 in a broken line) upon exiting the outlet opening 115 of the secondary line 111 in order to enter into the first fluid in the insert piece 100.

(37) FIG. 4 shows the insert piece 100 in a second exemplary embodiment.

(38) The first main line 107a and the second main line 107b of the second exemplary embodiment depicted in FIG. 4 are integrally formed parts of the insert piece 100. In some embodiments, the first main line 107a and the second main line 107b are made from the same material as, for example, the first connection site 101, which facilitates the production process of the insert piece 100. The insert piece 100 can be formed by injection molding.

(39) FIG. 5 shows a section view of an insert piece 100 similar to that of FIG. 4 along a first plane.

(40) FIG. 5 depicts an entrance 101a into the first main line 107a and/or into the second main line 107b. The entrance 101a can be either part of the first connection site 101 or the first and/or second main lines 107a, 107b.

(41) FIG. 5 also depicts an exit 103a from the first main line 107a and/or from the second main line 107b. The exit 103a can be either part of the second connection site 103 or the first and/or second main lines 107a, 107b.

(42) The presence of an entrance 101a and/or an exit 103a and their designs as discussed above, are not limited to the embodiment shown in FIG. 5.

(43) As is shown in FIG. 5, the insert piece 100 can include an upper part 140 and a lower part 150, The upper part 140 and the lower part 150 of the insert piece 100 can be glued to one another or connected to each other in any other way (such as welding).

(44) As can be seen from FIG. 5, in any embodiment according to the present invention—such as the one shown in FIG. 5 without being limited to this particular embodiment—the secondary line 111 and/or its third connection site 105 can be perpendicular to the plane along which the first and the second main lines 107a, 107b extend, the plane being in a horizontal or left-right direction in FIG. 5. The opening plane (or mouth) of the secondary line 111, through which the second fluid exits in order to mix with the first fluid can be parallel to the plane along which the first and the second main lines 107a, 107b extend. Alternatively, the direction along which the second fluid exits from the secondary line 111 in order to mix with the first fluid can be perpendicular to the plane along which the first and the second main lines 107a, 107b extend. Hence, inside of the mouth piece of the secondary line 111 the second fluid provided by the secondary line does not have to change its direction of travel (indicated in FIG. 5 in a broken line) in order to exit from the secondary line 111 and to enter into the first fluid in the insert piece.

(45) FIG. 6 shows section view of a first portion of the insert piece 100 of FIG. 4 along a second plane perpendicular to the first plane of FIG. 2.

(46) Also, as can be seen from FIG. 6, in any embodiment according to the present invention—such as the one shown in FIG. 6 without being limited to this particular embodiment—the first and the second main lines 107a, 107b can be arranged such that they form a circular through-opening 130 within a plane extending through the first and the second main lines 107a, 107b.

(47) FIG. 7 shows a section view of a second portion of the insert piece 100 along the second plane perpendicular to the first plane of FIG. 2.

(48) In the embodiment shown in FIG. 7, the cross sectional area of the first main line 107a and/or the cross sectional of the second main line 107b is less than half of the cross sectional area of the first connection site 101 and/or of the second connection site 103.

(49) For example, the first connection site 101 may have a cross sectional area of about 14.51 mm.sup.2 (at a diameter of 4.3 mm) whereas the cross sectional area of the first main line 107a and/or the cross section of the second main line 107b may be about 2.83 mm.sup.2 (at a diameter of 1.9 mm). Other values for the cross section area of the first main line 107a and/or the cross section of the second main line 107b, such as 3.14 mm.sup.2 (at a diameter of 2.0 mm) are within the scope of this disclosure.

(50) FIG. 8 shows a section view of the insert piece 100 in a third exemplary embodiment along a first plane.

(51) FIG. 9 shows a partially cut insert piece 100 in a fourth exemplary embodiment.

(52) In contrast to the insert piece 100 of depicted in FIGS. 1 to 3, the through-opening 130 of the insert piece 100 depicted in FIG. 9 is oval in shape.

(53) FIG. 10 shows a section view of the insert piece 100 of FIG. 9 along a plane.

(54) FIG. 11 shows an exemplary embodiment of an arrangement of an insert piece 100 as described herein in an extracorporeal blood tubing set 200 according to the present invention.

(55) As depicted in FIG. 11, the blood tubing set 200 includes or is connected to a hemofilter 201. 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.

(56) The blood withdrawal line 203 is operatively connected to, or includes, a blood pump 301.

(57) In some embodiments, an addition line 207 for citrate solution opens upstream of the blood pump 301 into the blood withdrawal line 203.

(58) The line 207 is operatively connected to, or includes, a citrate pump 307.

(59) Downstream of the hemofilter 201, the line 209 for calcium solution opens into the blood return line 205.

(60) The insert piece 100 is operatively connected to a calcium pump 309. The calcium pump is supplied by a source for infusion solution which is not shown in FIG. 11, such as a calcium source. The source may be a bag or a bottle. The infusion solution may optionally be generated on-line, and the respective device generating the solution on-line is considered as a source.

(61) The operative connection to the calcium pump 309 is to be understood herein as an example. In some implementations, the insert piece 100 is arranged behind another pump other than a calcium pump, for example downstream of a citrate pump like the citrate pump 307 of FIG. 11.

(62) 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 includes, a dialysis liquid pump 313. The line 315 is connected to, or includes, a filtrate pump 317.

(63) The arrow in FIG. 11 indicates the flow direction through the blood tubing set 200.

(64) The blood tubing set 200 shown in FIG. 11 may correspond to a standard extracorporeal blood tubing set and may in particular be suitable for the CVVHD (continuous veno-venous hemodialysis).

(65) The pumps 301, 307, 309, 313 and 317 and the lines 311 and 315 may be part of a blood treatment apparatus 300.

(66) FIG. 12 shows a longitudinal cross section of an insert piece 100 according to a fifth exemplary embodiment. The arrows indicate the flow directions into or out of the insert piece 100, either of the blood or calcium solution or a mixture thereof during use of the insert piece 100.

(67) In some embodiments, and in particular in the embodiment shown in FIG. 12, the diameter or cross sectional area of the first connection site 101 (that can be suitable for a 3.5×5.5 mm tube) of the insert piece 100 is less than, or equal to, the diameter or cross sectional area of the second connection site 103 (that can be suitable for a 4.3×6.8 mm tube). An enlarged lumen closely downstream the connection of the secondary line 111 can be used to decelerate the speed of the flow and, therefore, advantageously allow a more thorough mixing.

(68) FIG. 13a shows a rear view of the insert piece 100 of FIG. 12.

(69) It can be seen that the circular exit 103a has a larger diameter than the circular entrance 101a shown in FIG. 13b.

(70) FIG. 13b shows a front view of the insert piece 100 of FIG. 12.

(71) As can be seen in FIGS. 13a and 13b, the circular exit 103a has a larger diameter than the circular entrance 101a shown in FIG. 13b.

LIST OF REFERENCE NUMERALS

(72) 100 insert piece 101 first connection site 101a entrance 103 second connection site 103a exit 105 third connection site 107a first main line 107b second main line 109 junction portion or connection portion 111 secondary line 115 outlet opening or outlet 119 chamfer 130 through-opening 140 upper part of insert piece 150 lower part of insert piece 200 blood tubing set, blood tubing system 201 hemofilter or blood filter or dialyzer 203 blood withdrawal line 205 blood return line 205a first tubing portion 205b second tubing portion 207 line for citrate solution 209 line for calcium solution; addition line; third tubing portion 300 blood treatment apparatus 301 blood pump 307 citrate pump 309 calcium pump 311 line for fresh dialysis liquid 313 pump for fresh dialysis liquid 315 line for spent dialysate, or filtrate 317 pump for spent dialysate, or filtrate H flow direction of the first fluid into and through the first main line B flow direction of the first fluid into and through the second main line N inflow direction of the second fluid into the secondary line