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CN-121985978-A - Blood guiding device for hemodialysis

CN121985978ACN 121985978 ACN121985978 ACN 121985978ACN-121985978-A

Abstract

The invention relates to a blood flow guiding device for hemodialysis, comprising a bypass valve (2), the bypass valve (2) having two vascular connection lines (3, 4) and a dialyzer connection (5). The valve (2) comprises an internal selector (6) for selecting two positions and an antibacterial reservoir (7) arranged at the dialyzer connection (5), as well as a bio-integration device.

Inventors

  • Valeriano Cavallo Balong
  • Pasqual Medina Baso
  • Jose Louis. Garcia Jimenez
  • Jose Angel Bahamund Romano

Assignees

  • 瓦伦西亚社区临床医院研究基金会(INCLIVA)
  • 克卢斯生命系统有限公司
  • 巴伦西亚大学

Dates

Publication Date
20260505
Application Date
20241028
Priority Date
20231027

Claims (12)

  1. 1. A blood guiding device for hemodialysis, characterized in that it comprises a bypass valve (2), said bypass valve (2) having two vascular connection ducts (3, 4) and a dialyzer connection (5), said valve (2) comprising an internal selector (6) for selecting two positions and an antibacterial reservoir (7) provided at said dialyzer connection (5), and a bio-integration device.
  2. 2. The blood flow guiding device for hemodialysis according to claim 1, wherein the reservoir (7) is integrated in the selector (6).
  3. 3. The blood flow guiding device for hemodialysis according to claim 2, wherein the bypass valve (2) comprises a valve body (20) with an inner cavity (21) into which two ducts (3, 4) open at the lower part and into which the dialyzer connection (5) opens at the upper part, the selector (6) being rotatably arranged in the cavity (21), the selector (6) comprising the reservoir (7) in the communication area of the ducts (3, 4) with the inner cavity (21) of the valve body (20) of the bypass valve (2), comprising a lower blocking part (8) in the communication area of the ducts (3, 4), the lower blocking part (8) having a width equal to or larger than the closable lumen of the ducts (3), and comprising a first opening (9) in the lower side of the lumen (7), the non-closable ducts (4) comprising extensions (40) extending into the reservoir of the valve body, the second opening (41) being in offset relation to the second opening (9) and communicating with the second opening (4) at the position of the non-closable opening (9).
  4. 4. The blood flow guiding device for hemodialysis according to any of the preceding claims, comprising a detachable tubular connector (10) insertable into the dialyzer connection (5).
  5. 5. The blood flow guiding device for hemodialysis according to claim 4, wherein the selector (6) comprises a first driving mechanism (60), the connector (10) comprises a tip (10 a), the shape of the tip (10 a) being complementary to the first mechanism (60).
  6. 6. The blood flow guiding device for hemodialysis according to claim 4 or 5, wherein the connector (10) comprises an external extension (10 c) and an operating protrusion (10 d).
  7. 7. A blood flow guiding device for hemodialysis according to any of the preceding claims, wherein the connector (10) comprises a radial flange (10 b) and the dialyzer connection (5) comprises a stop (50) for the flange (10 b) in a bypass position of the selector.
  8. 8. The blood flow guiding device for hemodialysis according to any of the preceding claims, wherein the dialyzer connection (5) comprises a closing cap (51).
  9. 9. The blood flow guiding device for hemodialysis according to claim 8, wherein the cover (51) comprises a screw thread (52) and a second driving means (51 a), the blood flow guiding device comprising an opening means (11), the opening means (11) being provided with an end (11 a) of complementary shape to the second means (51 a).
  10. 10. The blood flow guiding device for hemodialysis according to any one of the preceding claims, wherein the bio-integrated device is selected from the group consisting of: A bulge or leaf (14) for adipocyte adhesion, And a suture hole (15).
  11. 11. The blood flow guiding device for hemodialysis according to claim 10, wherein the suture hole (15) has a curved path adapted to a1 ⁄ 2 circular arc surgical needle.
  12. 12. A blood flow guiding device for hemodialysis according to any of the preceding claims, the exterior of which comprises an indicator (16) for indicating the position of the valve and the direction of the internal flow.

Description

Blood guiding device for hemodialysis Technical Field The invention relates to a blood-guiding device for hemodialysis, which is also used for blood transfusion or blood collection. Background Chronic Kidney Disease (CKD) is one of the so-called occult diseases. When the patient is ill, there are only two options, either to receive a transplant or to perform dialysis. Since there is not enough organ available for all patients (among other determinants such as compatibility), it is necessary to find a suitable vascular access for dialysis, typically by means of a catheter, an arteriovenous graft (AVG) or an arteriovenous fistula (AVF), which is the preferred way for a specialist. Arteriovenous fistulae involve the surgical connection of veins and arteries, and require a period of maturity (2 to 4 weeks) after surgery and verification of their function to ensure their function. This technique has not been altered since 1960 and may cause side effects such as stenosis, aneurysms, thrombosis and even psychological problems that can be avoided using the device of the present invention. Disclosure of Invention In a general description, the blood-guiding device for hemodialysis of the present invention comprises a bypass valve having two vascular-connection conduits for connecting the bypass valve to a blood vessel (vein or artery) to be implanted, and a dialyzer connection to shunt blood through the dialyzer. The valve comprises an internal selector for selecting two positions (a closed position in which the two conduits remain in communication and the dialyzer connection is closed, or an open position in which the non-closable conduit remains in communication with the dialyzer connection while the other closable conduit remains closed), and an antibacterial reservoir provided at the dialyzer connection, the blood-guiding device further comprising a bio-integration device. The bio-integrated device preferably also has a hole for suturing the device to the patient, the hole being designed for a1 ⁄ 2 circular arc surgical needle. Similarly, the bio-integrated device has blades for bio-integration of the device in order to prevent internal displacement and rotation from occurring when the person responsible for connection according to clinical advice operates. Thus, thanks to the breakthroughs in the field of biological material engineering and in new manufacturing techniques, it is possible to manufacture the device of the invention and to solve the problems of the prior art, since the device allows to obtain an orderly, uniform and continuous blood flow both at the inlet and at the outlet of the dialyzer. In this sense, maturation times of AVF and deformations of veins and arteries in AVF due to different causes can be avoided. Furthermore, it must be noted that there is no need to puncture the patient as happens nowadays, since the device can be implanted in different vascular areas, since the antibacterial agent is provided in the reservoir for this purpose, the device is completely sterile when closed, thus ensuring the preventive nature of the blood-guiding device. The blood-guiding device may also be used for other diseases causing vascular lesions, such as cancer or diabetes, and may be used for blood transfusion or blood collection in addition to the aforementioned uses. In summary, the blood flow guiding device solves all the problems associated with the prior art, such as latency (no latency), vessel deformation (non-deformability), implantation site problems (anywhere), or infection. Drawings Fig. 1 shows an external view of a valve of the device of the invention, the valve having a closure cap and an opening tool. Fig. 2A shows a cross-sectional view of the valve body, in which it can be seen that the selector (not cut away) maintains a communication position between the two conduits and the relative position of the connector has been placed but has not rotated the connector a quarter turn, while fig. 2B shows a detail of the selector in the same position and the connector has been placed. In this position the device is closed and thus no dialysis can be performed, and the blood flow flows in a natural way. Fig. 3A shows a cross-sectional view of the valve body, wherein the relative position of the selector (not cut away) after the bypass position between the non-closable catheter and the dialyzer connection has been placed and the connector rotated a quarter turn, is seen, while fig. 3B shows a detail of the selector in the same position and the connector placed. In this position the device is open so that dialysis can be performed or blood can be returned from the dialyzer to the vein. In this position, blood collection or transfusion may be performed. Fig. 4A shows a cross-sectional view of the valve (including the valve body and the selector) in a position to maintain communication between the two conduits, with the connector disconnected and the reservoir ready for filling with antimicrobial agent.