Device for channelling blood for haemodialysis

Abstract

The present invention relates to a device for channelling blood for haemodialysis comprising a bypass valve (2), with two vascular connection ducts (3, 4), and a connection (5) to a dialyser. The valve (2) comprises an inner selector (6) for selecting two positions and an antiseptic tank (7) placed in the connection (5) to a dialyser, as well as biointegration means.

Description

[0001] DESCRIPTION

[0002] DEVICE FOR CHANNELING BLOOD FOR HEMODIALYSIS

[0003] OBJECT OF THE INVENTION

[0004] The present invention relates to a device for channeling blood for hemodialysis, including for transfusions or blood extractions.

[0005] BACKGROUND OF THE INVENTION

[0006] Chronic kidney disease (CKD) is one of the so-called silent diseases. Patients with this condition have only two options: a transplant or diaphragm treatment. Since there are not enough organs for everyone (in addition to other factors such as compatibility), it is necessary to find suitable vascular access for dialysis, which is generally performed using a catheter, an arteriovenous graft (AVG), or an arteriovenous fistula (AVF), which is the option preferred by specialists. An AVF consists of the surgical connection of a vein and an artery. After the operation, its function is not guaranteed until a maturation period (2 to 4 weeks) has elapsed and its function is verified. This technique has not changed since 1960 and can cause side effects such as stenosis, aneurysms, blood clots, and even psychological problems, which are avoided with the use of the device of the invention.

[0007] DESCRIPTION OF THE INVENTION

[0008] The device for channeling blood for hemodialysis of the invention comprises, in a generic description, a diverter valve, with two vascular connection ducts to be connected to the vascular where it is to be implanted (vein or artery), and a connection to a diaphragm to divert the blood through it, said valve comprising an internal two-position selector (closed, where there is continuity between ducts with the connection to the diaphragm closed, or open, where there is continuity between a non-closable duct and the connection to the diaphragm, while the other closable duct remains closed), as well as an antiseptic reservoir interposed in the connection to the diaphragm, also comprising biointegration means. It also preferably has holes for suturing the device to the patient, designed for a 1 / 2 circle surgical needle.It also has blades for biointegration of the device and to prevent internal rotation and displacement when handled by the personnel in charge of the connection, following clinical advice.

[0009] In this way, thanks to advances in the field of biomaterials engineering and new manufacturing techniques, it is possible to materialize the device of the invention and solve the problems of current technology, since the device allows for an orderly, homogeneous, and continuous flow both at the inlet and outlet of the dialyzer. This avoids the maturation times of AVFs and the deformations of veins and arteries caused by various causes. Furthermore, it is important to highlight that the patient does not need to be constantly punctured, as is currently the case, since the device can be implanted in different vascular areas, remaining completely aseptic when closed thanks to the antiseptic in the reservoir, thus ensuring antiseptic prophylaxis.It can also be used for other diseases that cause vascular pathologies, such as cancer or diabetes mellitus, and, in addition to the above, it is suitable for performing transfusions or blood draws.

[0010] In general, it solves all the problems posed by current techniques, such as waiting times (it doesn't have any), vascular deformations (non-deformable), implant location problems (any point is valid), or infections, among others.

[0011] BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 shows an exterior view of the valve of the device of the invention, with the closing cap and opener thereof.

[0013] Figure 2A shows a section of the valve body, showing the relative position of the selector (not sectioned) in a position of continuity between the two valves and with the connector in place, before turning it a quarter of a turn; while Figure 2B shows a detail of the selector in the same position, also with the connector in place. In this position, the device is closed, so dialysis cannot be performed, and the flow proceeds naturally.

[0014] Figure 3A shows a section of the valve body showing the relative position of the selector (not sectioned) in the bypass position between the non-closable duct and the dialyzer connection, with the connector in place after turning it a quarter of a turn; while Figure 3B shows a detail of the selector in the same position and with the connector in place. In this position, the device is open, so dialysis can be performed or blood can be returned from the dialyzer to the vein. In this position, blood extractions or transfusions can be performed.

[0015] Figure 4A shows a sectional view of the valve (including the body and the selector) in a position of continuity between the two devices, without the connector, and with the reservoir ready to be filled with antiseptic. In this position, the device is closed, so dialysis is not possible, and the flow proceeds naturally to the vascular system where it was implanted.

[0016] Figure 4B shows a sectional view of the valve (including the body and selector) in the bypass position between the non-closable duct and the dialyzer connection, during extraction, without the connector. In this position, the device is open, allowing dialysis or blood to be returned from the dialyzer to the vein. Blood extraction is possible in this position.

[0017] Figure 4C shows a sectional view of the valve (including the body and selector) in the bypass position between the non-closable duct and the dialyzer connection, during infusion, without the connector. In this position, the device is open, allowing dialysis or returning blood from the dialyzer to the vein. Blood transfusions are possible in this position.

[0018] Figure 5 shows a view of the device being implanted in a forearm, connecting the tubes to a vein.

[0019] DESCRIPTION OF A PRACTICAL EMBODIMENT OF THE INVENTION

[0020] The device for channeling blood for hemodialysis of the invention (see figs. 1 and 5) comprises a diverter valve (2) with two vascular connection ducts (3, 4) and a dialyzer connection (5); the valve (2) comprising an internal selector (6) (see figs. 2A to 4C) with two positions and communicated, via the connection (5) and a connector (10) connected to it, to the dialyzer, or to extraction or transfusion. It also comprises an antiseptic reservoir (7) interposed in the dialyzer connection (5), as well as biointegration means, ideally consisting of four blades (14). The reservoir (7) is integrated into the selector (6), as seen in figs. 4A to 40, since this simplifies the configuration of the device and therefore its manufacture. In this case, it is preferred that the diverting valve (2) comprises a body (20) with an interior hollow (21) into which the two ducts (3) open out inferiorly.4), and above the connection (5) to the dialyzer; the selector (6) being rotatably arranged in said hollow (21), which comprises the tank (7) over the communication area of ​​the ducts (3, 4) with the hollow (21) inside the body (20) of the valve (2), as well as a lower lateral shutter segment (8) in the communication area of ​​the ducts (3, 4), of width equal to or greater than the light of the closable duct (3), and also a first opening (G) in the lower lateral part of the tank (7) (see figs. 48 and 4C); the non-closable duct (4) comprising an extension.

[0021] (40) through the interior of the hollow of the body, which is determining a second opening

[0022] (41) offset with the first opening (9) in a position of continuity of the flow between the two ducts (3, 4) as seen in fig. 4A (and therefore blocking the flow towards the connection (5)), and aligned with the first opening (G) in a position of communication of the non-closable duct (4) with the connection (5) to the dialyzer as seen in figs. 48 and 4C. Taking into account the above, when the selector is in the closed position (figs. 2A and 4A) it allows the circulation of the flow in its natural direction, while when it is open (figs. 3A : 48 and 4G), allows the extraction or infusion of flow. In addition to the above and in the closed position, it allows the addition of an antiseptic in the reservoir (7) to ensure prophylaxis.

[0023] Additionally, the arrangement of the removable tabular connector (10) has been provided, which can be inserted into the dialyzer connection (5) to connect the patient to the dialyzer without punctures (see figs. 2A to 38 and Fig. 5).

[0024] Likewise, it is preferred that the selector (6) comprises a first machining (60) (see figs. 3A and 38) for operation (for turning and placing the valve in one or another operating mode); the connector (10) comprising a tip (10a) complementary to said first machining (60). This allows, when performing dialysis, to insert the connector and with it directly place the valve in the transfusion position. Furthermore, it is preferred that the connector (10) comprises radial fins (10b), and the connection (5) to the dialyzer comprises stops (50) for said fins (10b) in the selector bypass position, to prevent accidental removal of the connector and bleeding during the transfusion.

[0025] Additionally, the connector (10) comprises an external extension (10c) and handling projections (10d) to facilitate handling.

[0026] Also, the connection (5) to the dialyzer comprises (see fig. 1) a closing cap (51) to close the access and to prevent the antiseptic from escaping when it is in the tank with the valve in the closed position. Said cap (51) comprises a closing thread (52) and a second operating mechanism (51a); comprising an opening tool (11) provided at one end (11a) in a complementary manner to said second mechanism (51a) to be able to open and close it.

[0027] For their part, the biointegration media are selected from:

[0028] -some protrusions or blades (14) for adipocyte adhesion, which guarantees the biointegration of the device and prevents internal rotation in the implant area when manipulated by the specialist;

[0029] -suture holes (15), which preferably have a curved path adapted to a ½ circle surgical needle.

[0030] In addition, it externally comprises indicators (16) of the valve position and internal flow direction.

[0031] There is no single material from which the device can be manufactured; therefore, given that the device is an implantable medical device, it must be guaranteed to be safe and effective. There are countless biomaterials on the market that can be manufactured (metals, alloys, polymers, ceramics, etc.) that have currently been tested in vivo.

[0032] However, the material from which the device will be manufactured will meet the following requirements.

[0033] -Biocompatibility: The material must not trigger adverse immune responses or cause toxicity in the human body. It must be tolerated by the immune system and not cause rejection.

[0034] -Chemical and biological stability: it must maintain its integrity and properties in the biological environment of the human body without degrading or releasing toxic substances,

[0035] -Mechanical resistance: it must be strong enough to withstand the loads and stresses to which it will be exposed in its specific location within the body.

[0036] -Suitable surface: It must have a surface that allows for adequate interaction with surrounding cells and tissues. This may include adhesion properties and controlled porosity.

[0037] -Compatibility with manufacturing techniques: The material must be suitable for manufacturing processes that allow the creation of precise and safe medical devices.

[0038] -Quality control and sterilization: It must be possible to produce the material with high quality standards and sterilize it properly to prevent infections.

[0039] -Long-term durability: It must maintain its properties and functionality over time, as some implants can remain in the body for many years.

[0040] In any case, it will preferably be made with polymeric or ceramic materials, as both the material and manufacturing costs are lower.

[0041] Having sufficiently described the nature of the invention, as well as the manner of carrying it out in practice, it should be noted that the provisions indicated above and represented in the attached drawings are susceptible to modifications in detail as long as they do not alter the fundamental principle.

Claims

CLAIMS 1.- Device for channeling blood for hemodialysis characterized in that it comprises a diverting valve (2), with two vascular connection ducts (3, 4), and a connection (5) to the dialyzer; the valve (2) comprising an internal two-position selector (6) and an antiseptic reservoir (7) interposed in the connection (6) to the dialyzer, as well as biointegration means. 2 - Device for channeling blood for hemodialysis according to claim 1, where the tank (7) is integrated into the selector (6). 3.- Device for channeling blood for hemodialysis according to claim 2, wherein the diverter valve (2) comprises a body (20) with an interior hollow (21) into which the two dialyzer tubes (3, 4) open internally, and the connection (5) to the dialyzer at the top; the selector (6) being rotatably arranged in said hollow (21), which comprises the reservoir (7) over the communication area of ​​the ducts (3, 4) with the interior hollow (21) of the body (20) of the valve (2), a lower lateral shutter segment (8) in the communication area of ​​the ducts (3, 4), of width equal to or greater than the lumen of the closable duct (3), and a first opening (9) in the lower lateral part of the reservoir (7);the non-closable duct (4) comprising an extension (40) inside the hollow of the body which is determining a second opening (41) offset with the first opening (9) in a position of continuity of the flow between the two ducts (3, 4) and aligned with the first opening (9) in a position of communication of the non-closable duct (4) with the connection (5) to the dialyzer. 4 - Device for channeling blood for hemodialysis according to any of the preceding claims, comprising a removable tubular connector (10), insertable into the dialyzer connection (5). 5.- Device for channeling blood for hemodialysis according to claim 4, wherein the selector (6) comprises a first drive machining (60); the connector (10) comprising a tip (10a) complementary to said first machining (60). 6.- Device for channeling blood for hemodialysis according to claim 4 or 5, where the connector (10) comprises an external extension (10c) and handling projections (10d). 7 - Device for channeling blood for hemodialysis according to any of the preceding claims, wherein the connector (10) comprises radial fins (10b), and the connection (5) to the dialyzer comprises stops (50) for said fins (10b) in the selector bypass position. 8.- Device for channeling blood for hemodialysis according to any of the preceding claims, wherein the connection (5) to the dialyzer comprises a closing cap (51). 9 - Device for channeling blood for hemodialysis according to claim 8, wherein the cap (51) comprises a thread (52) and a second operating mechanism (51a); comprising an opening tool (11) provided with an end (11a) in a complementary manner to said second mechanism (51a). 10.- Device for channeling blood for hemodialysis according to any of the preceding claims, wherein the biointegration means are selected from: -some protrusions or blades (14) for adipocyte adhesion, -some suture holes (15) 11.- Device for channeling blood for hemodialysis according to claim 10, where the suture holes (15) have a curved path adapted to a surgical needle of 'A circle.

12. - Device for channeling blood for hemodialysis according to any of the preceding claims, which externally comprises indicators (16) of the valve position and internal flow direction.

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