KR100690391B1 - Needleless external shunt for hemodialysis - Google Patents

Abstract

The present invention relates to a shunt device that connects the artificial kidney and blood vessels of a patient without a needle when the patient with end-stage renal failure periodically undergoes hemodialysis. It relates to a device for controlling the inflow and outflow of.

To this end, blood vessels are connected to the shunt device of the present invention having a control device on an extracorporeal site to control opening and closing of blood flow, and when hemodialysis is performed, the shunt device of the present invention is connected to a circuit of an artificial kidney by using a screw type. Provide means. It also provides a means to configure the bypass circuit so that blood is not rectified in the connection circuit in the human body after dialysis is completed.

By dialysis by screw connection as above, the patient is freed from the pain of puncturing the skin and blood vessels with the coarse needle before dialysis, can take a comfortable position during the procedure, and hemostasis problem and hematology solution are solved after dialysis. Above all, it has the effect of taking a mental sense of stability.

Hemodialysis, shunt (arteriovenous fistula), dual caster, valve, circuit, bypass

Description

Needleless shunt device for hemodialysis {Needleless external shunt for hemodialysis}

1 is a perspective view of a first embodiment

2 and 3 are cross-sectional views of the control device of the first embodiment.

4 is a perspective view of a modification in which the first embodiment is integrally formed;

5 is a partial cutaway view of the stopper site

6 is a perspective view of the fixing band

7 is an exploded view of the second embodiment

8 is a bottom perspective view of a second embodiment

9 and 10 are cross-sectional views (each 90 degree phase) of the second embodiment.

Fig. 11 is a perspective view of the present invention implanted in the lower chest (before fixing the strap)

Explanation of symbols for each part of drawing

1: main body 2: first outlet pipe

3: second outlet pipe 4: outlet pipe

5: jaw 6: cylinder

7: Shim 8: Stopper

9: guide 10: drain pipe

11: first inflow tube 12: second inflow tube

13 inlet bypass pipe 14: Kaaba

15: rubber stopper 21: valve

22: cap screw 23: valve handle

24: protrusion 25: groove

31: official 32: internal

33: fixing band

The present invention relates to a device for screw-connecting the blood vessels of the patient and the circuit of the artificial kidneys without using a needle when the patient with end-stage renal failure periodically hemodialysis, implanting a part of the shunt device of the present invention subcutaneously To control the inflow and outflow of blood to a control device located outside the body

The human kidney has the function of filtering out metabolites in the body and excreted in the urine, acid-base equilibrium, and many other functions, and also produces and secretes hematopoietic hormones. Therefore, when the function of the kidneys is impaired, sewage builds up in the blood as if the sewer is blocked, causing uremia and death. Therefore, patients with end-stage renal failure may have their life sustained by dialysis of blood from an artificial kidney, an external device that can be transplanted to another kidney, peritoneal dialysis, or replaces the function of the kidney. Phosphorus / carium overaccumulation or anemia may be combined with adjuvant therapy. At present, in Korea, where there are very few chances of receiving a kidney, most patients with renal failure are prolonged by hemodialysis, and even in diabetics, when kidney function is deteriorated, they should be treated in the same way as the renal switchers.

An important function of the artificial kidney is a dialysis machine with a bundle of fine hollow fibers, in which blood and dialysate are contacted with a membrane between them to filter wastes in the blood and replenish electrolytes. The waste dialysis ability of the kidneys is remarkably superior to that of living kidneys, but patients cannot carry them, so hemodialysis should be completed within a limited time of 2-3 times a week, 4-6 hours at a time. Patients form an AV fistula subcutaneously to provide an environment for hemodialysis, which is commonly referred to as internal shunt. Arteriovenous fistula is an operation that blocks arterial blood vessels flowing to the tissues and connects them to venous blood vessels. Therefore, blood flowing into the arteriovenous fistula from the heart is pumped directly into the vein instead of the terminal tissue. It is arterial blood and bypasses it as it is in a shunt site. Hemodialysis is performed by inserting an internal jugular dual catheter into the clavicle for a period of three weeks or more during which the shunt site is fused and the size of the blood vessel is mature enough to hemodialysis. Arteriovenous fistula is usually formed in the lower or upper arm for the convenience of hemodialysis procedure. This environment must be created so that hemodialysis by artificial kidneys can be effective and the life of the patient is maintained. In the past, phosphorus hematopoiesis was inserted into the arteries and veins of the patient for the shunt, and the ends thereof were kept outside of the body. During hemodialysis, the centrifugal part of the artificial vessels was connected to the circuit of the artificial kidney. It is rarely used nowadays because of problems such as hypertension and thrombus. In recent years, hemodialysis is usually performed using the permanent shunt as described above, and during hemodialysis, a sufficient amount of blood passes through the dialyzer for a limited time. To do this, a 15-gauge coarse needle is punctured into the shunt site, and dialysis is performed by flowing out blood from the artery and flowing blood into the vein. Therefore, when the needle for outflow and the needle for inflow are inserted, the pain is severe. During the procedure, the needle should be fixed so that the needle does not interfere with the flow of blood. Pain also occurs in the process of preventing blood from leaking out of the perforations of the patient. Local anesthetics are injected at the beginning of the procedure, but the infusion of lidocaine itself, a local anesthetic, also involves pain. In addition, most patients with renal failure have anemia due to hematopoietic holmone. At the end, some blood remains in the circuit, resulting in blood loss, which leads to worsening of anemia. In addition, due to the effect of the anticoagulant (heparin) introduced to prevent blood coagulation on the circuit of the artificial kidney (in vitro), the union of the needle site is delayed even after the end of the procedure, and blood leakage occurs. Excessive pressure on the blood vessels can cause blood clots to temporarily stop blood flow. At this time, if the blood vessels become pulsed (that is, if blood in the blood clots or a blood clot occurs), a procedure to correct them should be performed. Indeed, these side effects occur frequently, and in general, hemodialysis patients are more likely to experience side effects due to thrombus, such as infarction of the brain / heart region, than those who do not. Despite these risks, patients with renal failure cannot stop hemodialysis until the end of life because hemodialysis is a means of life extension.If hemodialysis is prolonged, the blood vessels in the shunt region expand excessively and hemodialysis does not occur. During this time, the amount of blood that bypasses the site also increases, which adds to the burden on the heart. In addition, hemodialysis age groups are mostly mature, so in the formation of shunts, artificial blood vessels are often used depending on the health of blood vessels, and artificial blood vessels have a greater risk of developing blood clots than living blood vessels. If there is no adjacent arteriovenous blood vessel, even if there is no adjacent arteriovenous blood vessel, the vascular shunt should be pulled away from the distant blood vessel. Do. The perforation of blood vessels with coarse needles is a pain in patients, while the invasion is small, which increases the pressure (negative pressure) at which the artificial kidney inhales blood. Adsorption to and then falling off may cause vibrations. In addition, although the blood flow in the shunt region is very active and the blood pressure in other parts is much higher than that in the other region, the high sound pressure is generated when the artificial kidney draws arterial blood. This proves that the invasion is small enough to provide sufficient blood flow, thus increasing the time for hemodialysis.

Currently used in the United States, the device (trade name The Lifesite Hemodialysis Access System, Vasca, Inc., Massachusetts, USA, patent registration number, etc.) incorporates a clamp-type valve in two separate bodies. Since the catheter connected to the main body is inserted from the internal jugular vein area to the relative vein or the right atrium (Central venous system), the entire instrument is implanted subcutaneously (subclavian bone). Is concave like a ball well, and the dialysis is performed by connecting a 14-gauge thick needle to the artificial dialysis machine. The clamp opens only when a 14-gauge thick needle is inserted into the body (the clamp does not open with a thin needle) and the blood flow is automatically cut off when the needle is removed. Therefore, the principle of using a thick needle is not changed from the conventional one, but by using a thick conduit can increase the blood flow to shorten the time for hemodialysis. However, this method also requires the use of a thick needle, and after the end of hemodialysis, the blood flow in the catheter from the main body to the relative venous or right atrium is not flowing, so the risk of thrombus is very high.

The current approach to blood vessels for hemodialysis is to use coarse needles, so that at the beginning of hemodialysis the pain of punctuating a narrow range of shunts (several or decades until end of life) is formed, Hemostasis at the end and pain after termination are inevitable and the most painful procedure and potential psychological fear for hemodialysis patients, as thick needles must remain intact for a long time through the skin and blood vessels.

The present invention has been made to solve the various problems associated with the conventional shunt, and as a method for circulating blood in the artificial kidney, instead of a method of accessing a patient's blood vessel with an injection needle, a built-in control device A part of the shunt device is attached to the patient's subcutaneous to connect with blood vessels, and the control device in the extracorporeal part of the shunt device is opened and closed to open and close the blood flow, and even after the procedure, a small amount of blood can be distributed through the bypass circuit. The present invention provides a shunt device for eliminating the drawbacks of hemodialysis caused by an injection needle.

In order to achieve the above object, the present invention implements hemodialysis by connecting arteries and veins to a shunt device with a means for controlling opening and closing, and after completion of dialysis, means for continuously flowing a small amount of blood to the bypass circuit. to provide.

Preferred embodiments according to the present invention will be described in detail with reference to the drawings.

1 is a view showing a first embodiment of the present invention, the body (1) made of stainless steel, titanium or the two metal alloys are flow-out for dialysis from the vessel to the artificial kidney in the outer lower portion Blood vascular connection tube (in the present invention, called the first outflow tube) (2) and the tube connecting the circuit of the artificial kidney on the upper side of the main body (in the present invention, called the second outflow tube) (3) And a bypass pipe (in the present invention, referred to as an outlet bypass pipe) formed integrally with the first outlet pipe (4) and a jaw (5) fastened to the fixing band (33), and formed inside the main body. A section (in the present invention, referred to as a cylinder) 6 is formed, which is connected to one outlet pipe and controls the opening and closing of the blood flow, and an inner hole is formed in the upper portion of the cylinder 6. (30) has an opening, and a refractive pipe (31) is formed on the upper part of the inner hole (31). ) And the outlet and the second outlet pipe 3 are connected to each other, and a faucet (hereinafter referred to as a blood conduction faucet in the present invention) that controls opening and closing of blood flow, such as a faucet of a water supply. Is installed through the inside of the main body from the inlet to the opposite side of the body, the blood conduction controls the flow of blood in front of the inner cavity. 2 and 3 are enlarged views of a section of the blood-conductive portion of the shunt apparatus of the present invention by about 150%, FIG. 2 is a cross-sectional view when closed, and FIG. 3 is a cross-sectional view when opened (an oblique cross section is shown in FIG. 2 and FIG. Equals). The blood conduction is fixed to a shim (7) with a male screw, a supporting guide (9) for allowing the shim to reciprocate or rotate like a piston, and a terminal end of the shim 1 consists of a stopper (8) for controlling the opening and closing of the inlet pipe and a small conduit-pipe (10) formed at the lower part of the guide, and the female screw which is fastened to the male screw of the shim is a centrifugal part of the guide (9). (違心 部) is spoken at the end. FIG. 5 is a view of a portion of the cylinder 6 when the stopper is closed, in which the inner wall and the stopper come into close contact with each other like a piston and a cylinder of an internal combustion engine, and the rear part of the stopper and the wall of the guide (stopper and When the seam is opened backward, the two parts are in close contact, and the drainage pipe is also blocked by the rear part of the stopper, and the blood flowing from the first outflow pipe flows into the hole. In addition, during hemodialysis, a rubber plug 15 inserted into the inlet of the hemoconductor is provided as an auxiliary product, and the rubber stopper is a disposable consumable to prevent air contamination inside the hemoconductor during hemodialysis to prevent contamination and discard after use. (The rubber stopper is as if it is inserted into the earphone jack of the mobile phone.) After the end of hemodialysis, remove the disposable rubber stopper, and then inject physiological saline into the second outlet tube to drain the remaining blood in the body into the body. While refluxing, the shim 11 of the blood conduction is pushed in, and the seam screw and the female guide screw are fastened and sealed.When closed, the stopper (end) of the stopper seals the hole of the first outlet pipe and the other end (rear). ) Is opened at the rear of the cylinder, and continues to inject physiological saline while discharging the rear portion of the stopper to discharge to the drain pipe (10). After performing the reverse injection as described above, the cover 14 covering the nipple is fastened with screws to prevent contamination and to compensate for instability of blood conduction such as physical shock or damage to be accidentally applied to the seam. The blood in the human body after being completely sealed is continuously distributed in small amounts through the small-diameter bypass tubes 4 and 13 without clogging or rectifying, thereby reducing the burden on the heart due to the expansion of the conventional arteriovenous vasculature. The stopper provides a watertight means by using a biocompatible silicone material, silicone rubber, or elastomer. The shunt device having the above configuration is connected to the arterial side blood vessel. Another body of the same shape and symmetrical is set in a set on the vein side, but the blood flow is reversed to the arterial side, and dialysis is completed in the artificial kidney and blood flows back along the circuit. The body opening of the flow-in portion is the first inflow pipe 11, and the opening through which the artificial blood vessel connected to the vein is coupled is the second inflow pipe 12, and the pipe flowing into the bypass from the artery side is inflow. It becomes the secondary bypass pipe 13. In the bypass circuit between the arterial shunt device and the intravenous shunt device, small blood vessels are connected to the artificial blood vessel during hemodialysis or the blood flows in a small amount in the conduit to the blood vessels of the present invention. Do not The embodiment has the effect of lowering the height of the shunt device because the first outflow pipe and the second inflow pipe are formed on the side.

4 is a variation of the first embodiment in which the arterial shunt device and the vein shunt device in the same manner as the first embodiment are integrally formed in one body. This variant provides a direct connection between the arterial outflow bypass and the venous inflow bypass without an intermediate connection.

7 is a second embodiment of the present invention. In the main body 1, a rotatable valve 21 is built in close contact with the bottom and inner surfaces of the main body, and a cap screw 22 for preventing blood leakage by pressing the valve at an appropriate pressure is screwed on the upper part of the main body. The cap screw is open at the top, where the valve handle 23 rotates. The valve is formed inside the "a" -shaped tube 31, the inlet position of the tube is formed eccentrically to 1/3 of the diameter of the valve, the bottom of the main body 32 for the flow of blood flow It is formed eccentrically in the third part of the inner diameter, the first outflow pipe 2 is addressed to the inner hole 32, at a position coinciding with the second outflow pipe 3 on the side of the main body. The hole is opened so that the valve rotates once every 360 degrees; The bottom face is inner hole and the side is coincided with the second outlet pipe, and the bottom of the valve is in close contact with the bottom of the main body to provide a primary sealing effect, and the protrusion 24 formed along the periphery of the bottom of the valve has a bottom inside the main body. Perfectly bonded to the groove 25 formed along the periphery of the secondary sealing action to completely block the flow and contamination (혈액) of the blood. Outflow bypass pipe (4) is formed integrally with the first outflow pipe, and all the pipes are screwed to the length (less than 1cm) enough to connect the artificial blood vessels. The inner side / bottom side of the main body and the side / bottom of the valve are manufactured to satisfy the contrary requirements of maximum sealing and smooth rotation, and the closing position of the cap pressing the valve is also provided by marking the reference point where it meets the above requirements, On the upper surface of the valve, the side with the hole is provided in color. FIG. 8 is a bottom perspective view of the second embodiment showing a first outlet pipe and an outlet bypass pipe, and FIGS. 9 and 10 are front cross-sections and side portions in the assembled state of the second embodiment; ) Shows a cross section.

As the modification of the second embodiment, the arterial shunt device and the intravenous shunt device, which are identical to the configuration of the second embodiment, are integrally formed in one main body, can be easily inferred from the deformation in the first embodiment (not shown). ).

The position of mounting the shunt device of the first embodiment and the second embodiment and its modifications to the patient may vary depending on the condition of the blood vessel, but it is preferable to mount the lower shunt. The lower half of the body is mounted under the skin and the upper half including the jaw protrudes out of the body. The jaw 5 is fixed by pressing the jaw 5 as the fixing band 33 having an opening formed in accordance with the position and size of the main body. Both ends of the fastening straps are attached with a surface fastner (or Velcro) to provide a means for easily fixing them regardless of the thickness of the area around the fastening straps. The connecting circuit between the main body and the blood vessels in the body is made of artificial blood vessels, and the connecting circuit can be used simply by inserting the connecting circuit into the arteriovenous veins, thus eliminating the need for vascular conjugation as before. Surgery to connect the blood vessels can be greatly simplified. In the existing hemodialysis patients, the connection circuit and the blood vessel may be connected according to the situation of the AV fistula formed already. In the case of the deformable band 33 is composed of the arteriovenous integral type (2), since only one main body is formed, only one engaging opening is formed, and in the case of implanting each shunt device for the arteriovenous vein, surgery for mounting to the patient is performed. After the measurement, the distance between the two shunt devices is measured and manufactured to match the position and size of the opening of the fixing band. In addition, an elastic band may be provided for the cover of the outer side of the fixing band as an auxiliary method for the usual shunt device retention of hemodialysis patients.

The method of performing hemodialysis using the shunt device of the present invention is the same as the method of hemodialysis using an inner jugular dual catheter, and a method of injecting saline into the shunt device when the hemodialysis is terminated. Is as described above. Such reverse injection has a disinfecting effect in the first embodiment, and in the second embodiment, physiological saline, not blood, remains in the valve hole 31 to eliminate the risk of blood clots. There is no need for excessive pressure for hemostasis, so the risk of thrombus formation from dialysis is completely eliminated. In the first embodiment, closing the blood conduction while injecting a small amount of physiological saline at the end of dialysis and then irrigating the air to dry the blood conduction also helps clean management. The shunt device is screwed to connect all the circuitry, eliminating the need to use a needle. In addition, a circuit having a length of 3 to 5 cm is always maintained in the second outflow pipe and the first inflow pipe, and a screw cap is closed at the distal end of the circuit to obtain an effect of preventing vascular contamination. When a patient with this shunt device is bathed, a waterproof adhesive plaster can be placed on the shunt device to prevent contamination from water. The present invention can reduce the pain of perforating blood vessels with a thick needle for hemodialysis patients, but efforts to prevent contamination are desired.

In the implantation of the shunt device of all embodiments of the present invention to the human body is provided with a biocompatible material coated on the lower half of the shunt device so that the shunt device and the skin is well adhered. Artificial blood vessels that are inserted into the blood vessels of the human body are also completely fused like a living blood vessel over time, and the junction between the shunt device and the skin is also completely fused over time. This phenomenon can be easily seen in the case of implanting prosthesis in a person with a disability, dental implant, or artificial joint.

Although the figure is shown in black and white, in practice, if the artery shunt device is divided into red color and the vein shunt device is painted blue, no case of confusion occurs even when hemodialysis is performed anywhere in the world. All instruments and consumable parts should be provided after complete sterilization.

As apparent from the above description, the greatest effect of the present invention is to completely relieve the pain of hemodialysis procedure to the patient, to free the position during hemodialysis, to eliminate the risk of thrombosis and the risk of contamination. , Arteriovenous fistula (shunt) formation surgery is simplified because only implant the shunt device of the present invention, and also has the effect of minimizing the heart burden due to excessive expansion of arteriovenous fistula. Currently, hemodialysis patients are nurse license holders, but if the above connection devices become more common in the future, patients with end-stage renal failure may have self-treatment using an artificial kidney or a functional person. Therefore, it is expected to reduce treatment cost. All the above embodiments are a method for flowing a blood flow by connecting a circuit without a needle, it is possible to flow a significantly larger amount of blood per unit time than a needle. The blood volume of the human body is approximately 5 liters and circulates an average of 50 liters to 60 liters in the artificial kidney by one hemodialysis. In other words, the average patient retained blood is circulated approximately 10 to 12 times in one hemodialysis. If the flow rate per unit time of blood is increased, the hemodialysis time can be significantly shortened than the present time.

Claims (6)

The main body has an outflow bypass pipe formed integrally with the first outflow pipe and a second outflow pipe and the first outflow pipe at the outer bottom and a fixing jaw at the outer middle part, and on the opposite side of the first outflow pipe, Inside the penetrating body, the distal end has a blood conduction consisting of a shim with a stopper attached to the stopper and a support formed with a female thread while supporting the shim, and an artery providing a means for controlling blood flow by screwing by rotating the shim. The shunt device, the venous shunt device which is symmetrical in the same configuration as above, and the circuit between the two devices is connected to the bypass tube, and the position and size of the two installed shunt devices are the same. Shunt apparatus for hemodialysis, characterized in that it comprises a fixing band for fixing the body by forming an opening An inner hole is formed at the bottom of the main body at an eccentric position, a bypass pipe is integrally formed at the first outlet pipe addressed to the inner hole, a groove is formed at the periphery of the bottom of the main body to be close to the protrusion of the valve, and an eccentric inside the valve. A cap screw is formed at the position of the tube, and a protrusion is formed at the periphery of the bottom surface, and a second outlet tube of the body is formed at a position coinciding with the outlet of the tube, and the cap screw presses the bottom surface of the valve to rotate in close contact with the inner bottom of the body. The arterial shunt device fastened to the upper part of the main body, the shunt device for symmetry in the same configuration as above, and the small diameter circuit between the two devices are connected to the bypass pipe, Shunt apparatus for hemodialysis, characterized in that it comprises a fixing band for fixing the body by forming an opening having the same size The method of claim 1 A hemodialysis shunt device comprising an arterial shunt device and an intravenous shunt device in one shunt device and directly connecting a bypass tube The method of claim 2 A hemodialysis shunt device comprising an arterial shunt device and an intravenous shunt device in one shunt device and directly connecting a bypass tube delete The method according to any one of claims 1 to 4, Shunt device for hemodialysis, characterized in that the lower half of the shunt device is coated with a biocompatible material

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