Blood line and hemodialysis apparatus provided with such a blood line

Abstract

The invention relates to a blood line (10) comprising a blood withdrawal line (12) and a blood return line (14), the blood withdrawal line (12) comprising a first inlet line (120) comprising a first inlet (120A) configured to receive blood from a patient and a first outlet (120B) opening into a three-way connector (16), a second inlet line (122) comprising a second inlet (122A) configured to receive physiological saline and a second outlet (122B) opening into the three-way connector (16), the three-way connector (16) being connected to a main line (124) having an outlet (124B) configured to be connected to a dialyzer (1002), the blood withdrawal line (12) being provided with a single puncture / injection housing (126), the puncture / injection housing (126) being arranged on the main line (124).

Description

Description Title: Blood line and hemodialysis machine equipped with such a blood line Technical Field

[0001] This presentation concerns a blood line and a hemodialysis machine equipped with such a blood line.

[0002] As a reminder, the term "blood line," also known as "blood line" in English, refers to all the lines used to carry a patient's blood from the patient to a hemodialysis machine, and to carry blood from the hemodialysis machine back to the patient. The blood line generally does not include the catheters or needles used for drawing and reinfusing blood into the patient.

[0003] As a reminder, there are two main types of dialysis: peritoneal dialysis and hemodialysis. Peritoneal dialysis is a procedure where a patient's blood is purified using the patient's peritoneum. A dialysate is injected into the peritoneal cavity, and the impurity-laden dialysate is drained at the end of the dialysis cycle. Hemodialysis is a procedure where a patient's blood is purified by passing it through a dialyzer. The blood is drawn from the patient and then directly returned to the patient via a closed circuit that includes the dialyzer. This presentation focuses on hemodialysis, not peritoneal dialysis. For the purposes of this presentation, and unless otherwise specified, "dialysis" refers to "hemodialysis."

[0004] Both medical and veterinary applications are conceivable. Previous technique

[0005] Hemodialysis is a very demanding medical procedure for patients, both during the individual hemodialysis session itself and due to the repetition of successive sessions. Specifically, there is always a loss of a certain amount of residual blood from the patient at the end of each session. This residual blood corresponds to blood drawn but lost within the hemodialysis machine and cannot be recovered. However, this amount of lost blood, however small, accumulates to a relatively significant quantity when considering the succession of hemodialysis sessions a patient undergoes over a given period. Compared to hemodialysis in a medical center, daily home hemodialysis sessions are shorter but more frequent, which exacerbates the cumulative loss of residual blood over time. Therefore, there is a need for this type of treatment. Description of the invention

[0006] One embodiment relates to a blood line comprising a blood collection line and a blood return line, the blood collection line comprising a first inlet line including a first inlet configured to receive blood from a patient and a first outlet leading into a three-way fitting, a second inlet line comprising a second inlet configured to receive physiological serum and a second outlet leading into the three-way fitting, the three-way fitting being connected to a main line having an outlet configured to be connected to a dialyzer, the blood collection line being equipped with a single puncture / injection unit, the puncture / injection unit being disposed on the main line.

[0007] For the purposes of this document and unless otherwise specified, the term "line" refers to a fluid line. Similarly, the terms "inlet" and "outlet" refer respectively to a fluid inlet and a fluid outlet, with the fluid flowing within a line from upstream to downstream, from an inlet to an outlet. Hereafter, and unless otherwise specified, "connected," "linked," "linked," etc., means "fluidically connected," "fluidically linked," "fluidically linked," etc.

[0008] The blood collection line may also be referred to by professionals as the "arterial line." The blood return line may also be referred to by professionals as the "venous line."

[0009] The first and second finish lines are distinct. They form two separate lines, each with its own finish line (the first finish line for the first and second finish lines for the second) and its own exit (the first exit for the first and second exits for the second). The first and second finish lines are distinct. The first and second exits are distinct.

[0010] The three-way connector can be a Y-connector, a T-connector, or any other configuration known to a person skilled in the art. The first outlet of the first supply line can be connected to the first port of the three-way connector, and the second outlet of the second supply line can be connected to the second port of the three-way connector. The third port of the three-way connector can be connected to an inlet of the main line. The main line outlet is configured to be connected to an inlet of the dialyzer. A blood return line inlet is configured to be connected to an outlet of the dialyzer. The blood line does not include the dialyzer. The dialyzer is a separate component from the blood line.

[0011] The puncture / injection unit can, for example, allow for blood collection upstream of the dialyzer, before blood processing, to perform analyses and obtain information about the patient's health status, or for the injection of a product into the blood after collection and before blood processing, for example, to thin the blood, such as an anticoagulant bolus at the start of treatment. The blood return line may include one or more other puncture / injection units, but not necessarily.

[0012] As an example of blood line implementation, the blood line can be installed within a hemodialysis machine. Specifically, the outlet of the blood collection line can be connected to an inlet of a dialyzer on the hemodialysis machine, and the inlet of the blood return line is connected to an outlet of the dialyzer. Then, once the blood line is installed within the hemodialysis machine, the second inlet can be connected to a source of saline solution, such as a saline bag, and saline solution is circulated through the blood line from the second inlet to the outlet of the blood return line. The saline solution can be collected at the outlet of the blood return line in a dedicated container, such as a collection bag. This operation allows the blood line and the dialyzer to be flushed before the patient's blood is treated.For example, the first supply line, between the first inlet and the three-way connector, can be manually flushed, for instance, by manually flowing the saline solution backward from the three-way connector to the first inlet, and then collecting the corresponding (very small) volume of saline solution using a sterile gauze pad. Once this flushing operation is complete, the saline injection can be stopped via the second inlet, and the first inlet of the first supply line can be connected to a blood collection point, such as a catheter or needle, inserted in the patient, and blood can be drawn from the patient.In one variation, the outlet of the blood return line is connected to a blood injection point, such as a catheter or needle, inserted in the patient. This creates a closed fluid loop with the patient, allowing for the treatment of the patient's blood. The blood drawn from the patient, after being treated, is then directly reinjected. As the blood flows through the blood line, it pushes the saline solution towards the patient, and a volume of fluid corresponding to the volume of saline injected is removed from the patient's blood during the dialysis procedure.According to a second variation, blood is allowed to flow through the blood line until the remaining saline is partially or completely drained through the outlet of the blood return line. The outlet of the blood return line is then connected to a blood injection point, such as a catheter or needle, placed on the patient. This creates a closed blood loop with the patient, allowing the patient's blood to be treated. The blood drawn from the patient, processed, is then directly returned to the patient. Once the blood treatment is complete, blood can be drawn from the patient through the first inlet line, and saline can be injected again through the second inlet line until the saline is drained and replaces the blood in the main line, the dialyzer, and the blood return line, and finally reaches the outlet of the blood return line.For example, to visualize the replacement of blood by saline and vice versa within the blood line, the lines can be made entirely or partially of transparent material. When saline reaches the outlet of the blood return line, the saline supply can be stopped and the blood line disconnected from the patient. The dialysis procedure is complete, and the amount of residual blood that could not be returned to the patient corresponds to the internal volume of the first supply line.

[0013] By positioning the puncture / injection unit on the main line, the diameter and / or length of the initial inlet line can be minimized while utilizing commercially available medical components. This allows for an optimized blood line that reduces residual blood loss at the end of hemodialysis. Furthermore, using commercially available, or even standard, medical components helps control manufacturing costs, making the blood line economically and industrially viable. Since blood lines are single-use and therefore considered consumables, cost reduction is a key consideration from the initial design stage.

[0014] In some embodiments, the inner diameter of the first finish line can be between 3.00 mm (three millimeters) and 4.00 mm (four millimeters), for example equal to about 3.50 mm (three millimeters and fifty hundredths of a millimeter).

[0015] For the purposes of this discussion, the inside diameter of a line is understood to be the inside diameter of the conduit (e.g., the pipe(s)). This inside diameter differs from the inside diameter of the various components other than the conduit that a line might include. For example, the inside diameter of the first supply line may be equal to the inside diameter of a blood supply line from the collection point to the first inlet of the first supply line, but not necessarily.

[0016] Such an internal diameter of the first finish line can present a passage cross-section sufficient to allow adequate blood flow while minimizing the internal volume of the first finish line.

[0017] For example, the second finish line, the main line, and / or the blood return line may have an inside diameter between 4.00 mm (four millimeters) and 5.00 mm (five millimeters), for example, approximately 4.30 mm (four millimeters and thirty hundredths of a millimeter). Alternatively, the second finish line, the main line, and the blood return line may all have the same inside diameter.

[0018] In some embodiments, the length of the first finish line can be between 35 mm (thirty-five millimeters) and 45 mm (forty-five millimeters).

[0019] Such a length of the first arrival line may be sufficient to give the patient some freedom of movement during the dialysis operation, to ensure some comfort, while minimizing the internal volume of the first arrival line.

[0020] In some embodiments, the ratio between the inner diameter of the main line and the inner diameter of the first finish line can be between 1.1 and 1.4, for example approximately equal to approximately 1.24.

[0021] The ratio R is equal to the internal diameter of the main line D2 divided by the internal diameter of the first arrival line D1 (i.e., R = D2 / D1). Such a ratio can ensure a sufficient cross-sectional area to allow adequate blood flow in both the first arrival line and the main line, while minimizing the internal volume of the first arrival line.

[0022] In some embodiments, the first finish line may be equipped with a first clamp and the second finish line may be equipped with a second clamp, the first clamp and the second clamp having at least one distinct visual characteristic.

[0023] The first and second clamps can be used to block / allow the flow of fluid within the first and second supply lines, respectively. These clamps are, for example, manual clamps. Clamps can facilitate the management of saline and blood flow, particularly during the initial flushing phase and the final phase of retrieving the patient's blood from the blood line.

[0024] A visual characteristic can be a general shape, the size or dimension of all or part of the clamp, a sign or mark, a surface appearance, a color, etc. For example, the first clamp and the second clamp may have the same shape, the first clamp may be smaller than the second clamp, and the first clamp may have a different color than the second clamp, for example, the first clamp may be red and the second clamp may be white.

[0025] By presenting distinct visual characteristics, the differentiation between the first and second clamps can be improved, and handling errors can be avoided. This can minimize accidental blood loss.

[0026] In some embodiments, the blood line can be configured so that the blood circulation flow rate is between 00 ml / min (one hundred milliliters per minute) and 350 ml / min (three hundred and fifty milliliters per minute), for example between 200 ml / min (two hundred milliliters per minute) and 300 ml / min (three hundred milliliters per minute).

[0027] Such a flow rate is generally considered low in the context of hemodialysis. This flow rate generates a low negative pressure within the lines, allowing the use of small-diameter lines without the risk of pinching (as the lines are manufactured from commercially available medical-grade materials). This can help minimize the volume of residual blood within the blood line.

[0028] In some embodiments, the main line may be provided with a linear pump tube for a linear peristaltic pump.

[0029] The peristaltic pump can be configured to ensure the flow rate within the blood line. The tubing is straight, notably in comparison to the circular tubing used for circular peristaltic pumps.

[0030] In some embodiments, the linear pump tube may have a Shore A hardness strictly lower than the Shore A hardness of the rest of the main line.

[0031] For example, Shore A hardness is measured according to the ISO 48-4:2018 standard of August 2018. For example, the term "main line remnant" refers only to the flexible tubing sections, and not to connectors, fittings, or other puncture / injection housings. For example, the Shore A hardness of the pump tubing can range from 55 Shore A to 65 Shore A, for example, approximately 58 Shore A.

[0032] One embodiment relates to a low-flow daily hemodialysis device comprising a blood line according to any of the embodiments described in this presentation.

[0033] In the context of hemodialysis, the term "daily" refers to at least five hemodialysis sessions per week, with at least one session on two consecutive days. In the context of hemodialysis, the term "low flow rate" refers to a dialysate flow rate between 100 ml / min (one hundred milliliters per minute) and 200 ml / min (two hundred milliliters per minute). The dialysate is the product that circulates within the dialyzer to treat the blood. Such a dialysate flow rate is generally associated with a similar blood flow rate. The volume of blood treated during a single daily low-flow hemodialysis session can be around 30 L (thirty liters), which is approximately nine to ten times the total blood volume of an adult patient.

[0034] In comparison, dialysis in a medical center is not daily, but rather occurs two to three times per week, with at least two days between consecutive sessions. Hemodialysis machines in medical centers generally have dialysate flow rates exceeding 350 ml / min, and can reach up to 11 ml / min (one liter per minute). The volume of blood treated during a single hemodialysis session in a medical center can reach 60 L (sixty liters) or even more, which is approximately twenty times the total blood volume of an adult patient, or even more.

[0035] The blood line described herein, which reduces residual blood loss at the end of dialysis as much as possible, may be particularly suitable for low-flow daily hemodialysis machines where residual blood loss at each use is particularly impactful for the patient over successive dialysis procedures. Brief description of the drawings

[0036] The purpose and advantages of this presentation will be better understood upon reading the detailed description below of various embodiments given by way of non-limiting examples. This description refers to the attached figure pages, on which:

[0037] [Fig. 1] Figure 1 represents a low-flow daily hemodialysis machine including a blood line. Description of the implementation methods

[0038] Figure 1 represents a low-flow daily hemodialysis machine 1000, including a blood line 10. The hemodialysis machine 1000 is shown schematically, with dashed lines, and partially. The parts of the hemodialysis machine 1000 shown are primarily those that interact with the blood line 10. Once installed within the hemodialysis machine 1000, the blood line 10 can be considered part of the hemodialysis machine 1000.

[0039] The blood line 10 includes a blood collection line 12 and a blood return line 14. The blood collection line 12 includes a first inlet line 120 comprising a first inlet 120A configured to receive blood from a patient and a first outlet 120B leading to a three-way connector 16. The blood collection line 12 includes a second inlet line 122 comprising a second inlet 122A configured to receive physiological saline and a second outlet 122B leading to the three-way connector 16. The three-way connector 16 is connected to a main line 124 having an outlet 124B configured to be connected to a dialyzer 1002. For example, outlet 124B can be connected to a blood inlet 1002A of the dialyzer 1002. The blood collection line 12 is equipped with a single puncture / injection unit. 126, the puncture / injection unit 126 being located on the main line 124.The arrows in Figure 1 represent the direction of flow from upstream to downstream from an inlet to an outlet.

[0040] The three-way connector 16 can have a first track V1, a second track V2 and a third track V3. The first track V1 can be connected fluidly to the first exit 120B of the first arrival line 120, the second track V2 to the second exit 122B of the second arrival line 122 and the third track V3 to an arrival 124A of the main line 124.

[0041] For example, the first 120A inlet, the second 122A inlet, and the 124B outlet can each include a Luer fitting. For example, the first 120A inlet and the second 122A inlet can each include a Luer lock fitting.

[0042] The first finish line 120 may be equipped with a first clamp 121. The first finish line 120 may include no other equipment than the first clamp 121.

[0043] The second finish line 122 may be equipped with a second clamp 123. The second finish line 122 may include no other equipment than the second clamp 123.

[0044] The first clamp 121 and the second clamp 123 may have at least one distinct visual characteristic. For example, the first clamp 121 may be smaller than the second clamp 123. For example, the first clamp 121 may have a first color, for example red, and the second clamp 123 may have a second color, distinct from the first color, for example white. For example, the first clamp 121 and the second clamp 123 may have the same shape.

[0045] The blood line 10 may include a structure 30 configured to hold the blood collection line 122 and the blood return line 14 in position within the device 1000. The structure 30 may be configured to be fixed within the hemodialysis device 1000, for example, by complementary shape, interlocking, clipping, or any other means known to those skilled in the art. For example, the structure 30 may have a support housing shape or any other shape conceivable by those skilled in the art.

[0046] The main line 124 includes the tapping / injection unit 126, which can be located immediately downstream of the inlet 124A. In other words, the main line 124 may not include any equipment between the inlet 124A and the unit 126.

[0047] The main line 124 can be fitted with a linear pump tube 128 for a linear peristaltic pump 1004. In this example, the linear pump tube 128 can be arranged immediately downstream of the housing 126. The linear pump tube 128 can have an inlet 128A and an outlet 128B.

[0048] The main line 124, for example the inlet 128A of the tube 128, may be provided with a first pressure tap 130. The first pressure tap 130 may include a spigot 130A on the inlet 128A and a first pressure tap line 130B connecting the spigot 130A to a first pressure measuring device (not shown) of the apparatus 1000. The structure 30 may have a connection (not shown) linked to the first pressure tap 130, and configured to be removably connected to the first pressure measuring device of the apparatus 1000. The fluid may not flow within the first pressure tap line 130B, and may remain static. For example, generally, flushing a pressure line can be done by applying rapid pressure surges or spikes.

[0049] The main line 124 may be provided with a second pressure tap 132. For example, the second pressure tap 132 may be located downstream of the linear pump tube 128, downstream of the outlet 128B. The second pressure tap 132 may include a tap 132A on the main line 124 and a second pressure tap line 132B connecting the tap 132A to a second pressure measuring device (not shown) of the apparatus 1000. The structure 30 may have a connection (not shown) linked to the second pressure tap 132, and configured to be removably connected to the second pressure measuring device of the apparatus 1000. The fluid may not flow within the second pressure tap line 132B, and may remain static.

[0050] The main line 124 may successively comprise, from upstream to downstream, the inlet 124A, the housing 126, the tube 128 and the first pressure tap 130 at the inlet 128A of the tube 128, the second pressure tap 132, and the outlet 124B. The main line 124 may be maintained within the structure 30 downstream of the tube 128, downstream of the outlet 128B, and upstream of the second pressure tap 132.

[0051] The inner diameter D1 of the first finish line 120 can be between 3.00 mm and 4.00 mm. The inner diameter D1 could, for example, be approximately 3.50 mm. For example, the outer diameter D3 of the first finish line 120 could be approximately 5.5 mm.

[0052] The length L of the first incoming line 120 can be between 35 mm and 45 mm. For example, the length L can be measured from the outlet of the luer fitting of the first incoming line 120A to the first outlet 120B, at the inlet of the three-way fitting 16.

[0053] The inner diameter D2 of the main line 124 can be between 4.00 mm and 5.00 mm. For example, the inner diameter D2 of the main line could be approximately 4.30 mm. For example, the outer diameter D4 of the main line 124 could be approximately 6.8 mm.

[0054] For example, a ratio R between the inner diameter D2 of the main line 124 and the inner diameter D1 of the first finish line 120 (i.e. R=D2 / D1) can be between 1.1 and 1.4. For example, the ratio R can be about 1.24.

[0055] The length of the main line 124 can be between 1240 mm and 1290 mm. For example, the length of the main line 124 can be measured from the outlet of the three-way connector 16 to the inlet of the Luer connector of outlet 124B.

[0056] For example, the inner diameter D5 of the linear pump tube 128 can be between 6 mm and 10 mm, for example, approximately 8 mm. For example, the outer diameter D6 of the linear pump tube 128 can be approximately 12 mm. The linear pump tube 128 may have a Shore A hardness strictly lower than the Shore A hardness of the rest of the main line 124. For example, the Shore A hardness of the pump tube may be between 53 Shore A and 63 Shore A, for example approximately 58 Shore A. For example, the Shore A hardness of the first inlet line 120 (e.g., the flexible tube) may be between 68 Shore A and 78 Shore A, for example approximately 73 Shore A. For example, the Shore A hardness of the second inlet line 122 (e.g., the flexible tube) may be between 64 Shore A and 74 Shore A, for example approximately 69 Shore A. For example, the Shore A hardness of the main line 124 ... second inlet line 122) may be between 64 Shore A and 74 Shore A, for example approximately 69 Shore A.The hardness of the flexible tube (other than the pump tube 128) can be between 64 Shore A and 74 Shore A, for example approximately 69 Shore A. For example, the Shore A hardness of the return line 14 (e.g., the flexible tube) upstream of the bubble trap 144 (described below) can be between 64 Shore A and 74 Shore A, for example approximately 69 Shore A. For example, the Shore A hardness of the return line 14 (e.g., the flexible tube) downstream of the bubble trap 144 can be between 64 Shore A and 74 Shore A, for example approximately 69 Shore A. For example, the pump tube 128 can have a length between 190 mm and 200 mm, for example approximately 195 mm.

[0057] For example, the second incoming line 122 may have the same inner and / or outer diameter as the inner diameter D2 and outer diameter D4 of the main line 124, respectively. The length of the second incoming line 122 may be between 1480 mm and 1520 mm, for example, approximately 1500 mm. For example, the length of the second incoming line 122 may be measured from the outlet of the second incoming line 122A to the second outgoing line 122B, at the inlet of the three-way connector 16.

[0058] For example, the inner diameter and / or outer diameter of the first pressure tap line 130B and / or the second pressure tap line 132B may be identical respectively to the inner diameter D1 and the outer diameter D3 of the first inlet line 120.

[0059] The blood return line 14 may include an inlet 140A configured to be connected to the dialyzer 1002, for example to a blood outlet 1002B of the dialyzer 1002, and an outlet 140B configured to be connected to a patient for the injection of their blood after treatment. For example, the inlet 140A and the outlet 140B may each include a Luer fitting or connector, for example a Luer lock connector.

[0060] The blood return line 14 may include, downstream of the inlet 140A, puncture / injection unit 142.

[0061] The blood return line 14 may include a bubble trap 144. A bubble trap is a safety device, familiar to those skilled in the art, which allows for the evacuation of any bubbles present in the fluid, particularly in the blood, after treatment within the dialyzer 1002, and prevents any risk of air being injected into the patient's venous system. The bubble trap 144 may be positioned downstream of the puncture / injection port 142.

[0062] The blood return line 14 may include an injection line 146. For example, the injection line 146 may be used for continuous or timed injections, while the puncture / injection unit 142 may be used for bolus injections. An inlet 146A of the injection line 146 may include a Luer fitting. The injection line 146 may open into the bubble trap 144, for example into an inlet 144A of the bubble trap 144. An outlet 146B of the injection line 146 may be connected to the bubble trap 144, for example to the inlet 144A of the bubble trap 144. The injection line 146 may be fitted with a clamp, or injection clamp, 147. The clamp 147 may have at least one visual feature distinct from the other clamps of the blood line 10, and in particular from the first clamp 121, the second clamp 123 and the third clamp 150 described below.For example, clamp 147 may be smaller than all other clamps. Clamp 147 may have a similar shape to other clamps. Clamp 147 may be blue.

[0063] The blood return line 14 can be fitted with a third pressure tap 148. The third pressure tap 148 may include a tap 148A on the bubble trap 144, for example on the inlet 144A of the bubble trap 144, and a third pressure tap line 148B connecting the tap 148A to a third pressure measuring device (not shown) of the apparatus 1000. The structure 30 may have a connection (not shown) linked to the third pressure tap 148, and configured to be removably connected to the third pressure measuring device of the apparatus 1000. The fluid may not flow within the third pressure tap line 148B, and may remain static.

[0064] The blood return line 14 may include a third clamp 150. The third clamp 150 may have at least one visual characteristic distinct from the first and second clamps. For example, the third clamp 150 may have a third color, for example, blue. The third clamp 150 may have a size and shape similar to the second clamp 123. This difference in visual characteristic may help prevent handling errors and potential blood loss. For example, the third clamp 150 may be positioned downstream of the bubble trap 144.

[0065] The blood return line 14 may successively comprise, from upstream to downstream, the inlet 140A, the housing 142, the bubble trap 144, and the third pressure tap 148 at the inlet 144A of the bubble trap 144, the clamp 150, and the outlet 140B. The blood return line 14 may be maintained within the structure 30 downstream of the housing 142 and upstream of the bubble trap 144.

[0066] For example, the blood return line 14 may have an inner diameter and / or an outer diameter identical to the inner diameter D2 and outer diameter D4 of the main line 124, respectively. The total length of the blood return line 14 may be between 2300 mm and 2800 mm, for example, approximately 2400 mm. For example, the total length of the blood return line 14 may be measured from the outlet of the Luer fitting at inlet 140A to the inlet of the Luer fitting at outlet 140B. For example, the length of the blood return line 14 upstream of the bubble trap 144 may be between 400 mm and 600 mm, for example, approximately 500 mm, and the length of the blood return line 14 downstream of the bubble trap 144 may be between 1800 mm and 2000 mm, for example, approximately 1900 mm.

[0067] For example, the injection line 146 may have an inner diameter of approximately 1 mm. For example, the outer diameter of the injection line 146 may be approximately 2.5 mm. For example, the length of the injection line 146 may be between 480 mm and 500 mm, for example, approximately 490 mm. For example, the length of the injection line 146 may be measured from the outlet of the Luer fitting at inlet 146A to the outlet 146B.

[0068] For example, the third pressure tap line 148B may have an inner diameter of approximately 3.8 mm. For example, the outer diameter of the third pressure tap line 148B may be approximately 6.3 mm.

[0069] The blood line 10 can be configured so that the blood circulation flow rate is between 100 ml / min and 350 ml / min, for example between 200 ml / min and 300 ml / min.

[0070] For example, the various flexible sections, or flexible tubing, of the blood line 10 can be made of phthalate-free polyvinyl chloride (or PVC), also known as DEHP-free PVC. The flexible sections / tubing and / or the bubble trap can be fully or partially transparent to visible light. The other components of the blood line 10 can be either opaque, such as the structure 30, or semi-transparent, such as the puncture / injection ports and the various connectors.

[0071] An example of the implementation of the blood line 10 within the hemodialysis machine 1000 is described below.

[0072] First, the blood line 10 can be flushed with saline solution. The second inlet line 122 can be connected to a saline source (not shown), such as a saline bag. Next, the second clamp 123 can be opened (i.e., configured to allow fluid flow) and the first clamp 121 closed (i.e., configured to block fluid flow). The third clamp 150 can be opened. The injection clamp 147 can be closed. Saline solution can then be circulated through the blood line 10 via the dialyzer 1002, from the second inlet 122A to the outlet 140B of the blood return line 14. This can be done, for example, by activating the pump 1004. The saline solution can be collected at outlet 140B of the blood return line 14 in a dedicated container (not shown), such as a collection bag.Such a recovery bag can be an empty PVC bag, initially connected to the blood line 10 and supplied to the user pre-assembled to the blood line 10. For example, the first supply line 120, between the first inlet 120A and the three-way connector 16, can be manually flushed, for example, by manually circulating saline solution backward from the three-way connector 16 to the first inlet 120A, and recovering the corresponding very small volume of saline solution with a sterile gauze pad. When this flushing operation is complete, for example, when a predetermined volume of saline solution has been circulated through the blood line 10, the saline injection can be stopped via the second inlet 122A, for example, by stopping the pump 1004 and / or closing the second clamp 123. The inlet 122A can remain connected to the saline solution source.The first inlet 120A of the first inlet line 120 can then be connected to a blood collection point, such as a catheter or needle (not shown), inserted in a patient (not shown). Alternatively, clamp 150 can be closed to disconnect the saline recovery bag, and outlet 140B of the blood return line 14 can be connected to a blood injection point, such as a catheter or needle (not shown), inserted in the patient. Upon reopening clamp 150, a closed blood loop is formed with the patient, allowing the patient's blood to be processed. Blood drawn from the patient and then processed within device 1000 is directly injected into the patient. The first clamp 121 can then be opened, and blood collection from the patient can begin, for example, by activating pump 1004.As it flows through the blood line 10, the blood pushes the saline solution towards the patient, and a volume of fluid corresponding to the volume of saline solution injected will be removed from the patient's blood during the dialysis operation. Simultaneously, dialysate is circulated within the dialyzer 1002. For example, dialysate can flow in the opposite direction to the blood flow within the dialyzer 1002. For instance, the dialysate inlet 1002C can be located on the same side of the dialyzer 1002 as the blood outlet 1002B, and the dialysate outlet 1002D can be located on the same side of the dialyzer 1002 as the blood inlet 1002A. When the blood processing is complete, the patient's blood collection can be stopped via the first arrival line 120, for example by stopping the pump 1002 and / or closing the first clamp 121.Physiological saline can be reinjected via the second supply line 122, for example by activating the pump 1004 and / or by opening the second clamp 123 again, until the physiological saline evacuates and replaces the blood within the main line 124, the dialyzer 1002 and the blood return line 14, and arrives at outlet 140B of the blood return line 14. When the physiological saline arrives at outlet 140B of the blood return line 14, the supply of physiological saline can be stopped, for example by closing the second clamp 123 and / or by stopping the pump 1004, and the blood line 10 of the patient can be disconnected. This final phase of physiological saline injection can be carried out at a low flow rate, which means that the pressure within the blood line 10 is very low and the blood within the different pressure outlets flows back and can be returned almost entirely to the patient.The dialysis procedure is then complete, and the amount of residual blood that could not be reinjected into the patient corresponds to the internal volume of the first arrival line 120.

[0073] During these operations, the pressures measured via the first pressure port 130, the second pressure port 132, and the third pressure port 148 can be monitored, for example, to detect any anomalies. For instance, the pressure measured via the first pressure port 130 can indicate whether blood has been drawn from the patient and / or if this blood draw has been disconnected. For example, the pressure measured via the second pressure port 132 can indicate the blood circulation conditions within the dialyzer 1002, and in particular, whether blood clotting has occurred within the dialyzer 1002. For example, the pressure measured via the third pressure port 148 can indicate whether blood has been reinfused into the patient, a potential risk of clotting, and / or if the reinfusion has been disconnected.

[0074] Although the present invention has been described with reference to specific embodiments, it is evident that modifications and changes can be made to these examples without departing from the general scope of the invention as defined by the claims. In particular, individual features of the various embodiments illustrated / mentioned can be combined in additional embodiments. Therefore, the description and drawings should be considered in an illustrative rather than restrictive sense.

[0075] It is also evident that all the characteristics described with reference to a process are transposable, alone or in combination, to a device, and conversely, all the characteristics described with reference to a device are transposable, alone or in combination, to a process.

Claims

Demands

1. A blood line (10) comprising a blood collection line (12) and a blood return line (14), the blood collection line (12) comprising a first inlet (120) including a first inlet (120A) configured to receive blood from a patient and a first outlet (120B) leading to a three-way connector (16), a second inlet (122) comprising a second inlet (122A) configured to receive physiological saline and a second outlet (122B) leading to the three-way connector (16), the three-way connector (16) being connected to a main line (124) having an outlet (124B) configured to be connected to a dialyzer (1002), the blood collection line (12) being provided with a single puncture / injection unit (126), the puncture / injection unit (126) being disposed on the main line (124).

2. Bloodline (10) according to claim 1, wherein the inner diameter (D1) of the first finish line (120) is between 3.00 mm and 4.00 mm, for example equal to about 3.50 mm.

3. Bloodline (10) according to claim 1 or 2, wherein the length (L) of the first finish line (120) is between 35 mm and 45 mm.

4. Bloodline (10) according to any one of claims 1 to 3, wherein a ratio between the inner diameter (D2) of the main line (124) and the inner diameter (D1) of the first finish line (120) is between 1.1 and 1.4, for example equal to about 1.

24.

5. Bloodline (10) according to any one of claims 1 to 4, wherein the first finish line (120) is equipped with a first clamp (121) and the second finish line (122) is equipped with a second clamp (123), the first clamp (121) and the second clamp (123) having at least one distinct visual feature.

6. Blood line (10) according to any one of claims 1 to 5, configured so that the blood circulation flow rate is between 100 ml / min and 350 ml / min, for example between 200 ml / min and 300 ml / min.

7. Blood line (10) according to any one of claims 1 to 6, wherein the main line (124) is provided with a linear pump tube (128) for a linear peristaltic pump (1004).

8. Blood line (10) according to claim 7, wherein the linear pump tube (128) has a Shore A hardness strictly lower than the Shore A hardness of the remainder of the main line (124).

9. Low-flow daily hemodialysis apparatus (1000) comprising a blood line (10) according to any one of claims 1 to 8.

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