CN115317693A - Hemodialysis harbor, set thereof and hemodialysis system - Google Patents

Abstract

The application discloses hemodialysis harbor includes: body, first hemodialysis pipe, second hemodialysis pipe, wherein, the body is provided with first stock solution chamber, second stock solution chamber, first stock solution chamber with second stock solution chamber mutual isolation sets up. The application also discloses a hemodialysis port kit, which comprises the hemodialysis port, a first lossless puncture needle and a second lossless puncture needle; furthermore, a hemodialysis system is also disclosed. The hemodialysis harbor according to the present application can be completely buried in the body, has no catheter exposed on the exterior, and does not need to be sterilized when not in use, thereby being not easy to be infected, and effectively reducing the risk of generating thrombus and the risk of secondary infection.

Description

Hemodialysis harbor, set thereof and hemodialysis system

Technical Field

The present application relates generally to the field of medical devices, and more particularly to a hemodialysis port and hemodialysis system.

Background

Hemodialysis, also known as artificial kidney or kidney washing in popular parlance, is called hemodialysis for short, and is one of the blood purification techniques. Which uses the principle of membrane equilibrium to pass the patient's blood through a membrane (or tube, medically known as a semi-permeable membrane) having a plurality of small pores that allow the passage of molecules smaller than the pores, while molecules larger in diameter than the pores are prevented from remaining, while the semi-permeable membrane is in contact with a dialysate containing a chemical composition. During dialysis, blood of a patient flows through a small gap formed by the semi-permeable membrane, dialysate flows outside the small gap, and large particles such as red blood cells, white blood cells, proteins and the like cannot pass through the small holes of the semi-permeable membrane; small and medium substances such as water, electrolytes and metabolites in blood, such as urea, creatinine, guanidine and the like can be dispersed into the dialysate through the semipermeable membrane; substances in the dialysate such as bicarbonate radical, acetate and the like can also be dispersed into blood to achieve the purposes of eliminating harmful substances in the body, purifying the blood, supplementing substances required in the body and correcting the balance of water electrolytes and acid and alkali, and is one of the most common renal replacement therapy methods.

The traditional hemodialysis puncture method comprises the following steps: arteriovenous retention intubation, arteriovenous external fistula and subclavian vein catheterization. Before hemodialysis, a patient needs to establish a vascular access in a kidney disease specialty. Vascular access is divided into both temporary and long-term. The temporary vascular access comprises a central great vein hemodialysis double-lumen tube (internal jugular vein, femoral vein and subclavian vein), direct arteriovenous puncture and vein-vein temporary puncture; the long-term vascular access comprises arteriovenous fistula, artificial blood vessel implantation, double-cavity hemodialysis catheter implantation with a polyester sleeve, blood vessel transplantation and the like.

The puncture method, especially the internal fistula and the central great vein cannula, connects the artery and the vein, and part of patients can be narrowed, blocked by thrombus and even calcified in less than half a year. Moreover, as the puncture or the connection of the arteriovenous catheter is frequently carried out, the upper limb with the punctured internal fistula cannot move freely, the neck with the indwelling double-cavity tube for the internal jugular vein puncture or the thigh with the indwelling double-cavity tube, especially the temporary great vein double-cavity tube cannot be twisted freely in the process of hemodialysis every time, if the upper limb moves freely, the posture is improper, the action is overlarge, the bleeding caused by needle running is easy to occur, and even the upper limb falls off, so that the chemotherapy drug leaks, stimulates the blood vessel, brings great inconvenience to the life of a patient, and even causes irreversible injury; the tail end of the catheter is exposed on the body surface, the open ends of the arteriovenous vessels are strictly disinfected before and after each dialysis, the nursing operation is complex, the requirement is high, a certain infection proportion exists, the weight of the operative limb cannot be loaded, the life is inconvenient, the internal fistulation operative limb cannot measure the blood pressure, and all venous treatment and blood drawing are performed. Blood pressure is monitored daily to prevent hypertension and avoid hypotension.

Disclosure of Invention

In one aspect of the application, a hemodialysis harbor is disclosed, comprising: body, first hemodialysis pipe, second hemodialysis pipe, wherein, the body is provided with

-a first reservoir chamber having a first inlet end for sterile connection to the first hemodialysis catheter and a first outlet end for communication with a hemodialysis machine for the entry of human blood into the hemodialysis machine;

-a second reservoir chamber having a second inlet end for communication with a hemodialysis machine and a second outlet end for sterile connection to the second hemodialysis catheter for flow of blood treated by the hemodialysis machine back to the body;

the first liquid storage cavity and the second liquid storage cavity are arranged in an isolated mode.

In a preferred embodiment, the method further comprises the following steps: the first bacterium isolation piece and the second bacterium isolation piece are respectively used for isolating the first liquid storage cavity and the second liquid storage cavity from the external environment; first fungus piece, second fungus piece that separates have and open and/or closed two kinds of states, when external puncture part communicates with first stock solution chamber, second stock solution chamber respectively, first fungus piece, second separate the fungus piece and set up respectively to the open mode to form the passageway that gets into first stock solution chamber, second stock solution chamber respectively, when external puncture part separates with first stock solution chamber, second stock solution chamber respectively, first fungus piece, second separate the fungus piece and set up respectively to the closed state.

In a preferred embodiment, the first bacteria-isolating piece is arranged at the first outlet end of the first liquid storage cavity in a sealing manner; the second separates the sealed second entry end that sets up at second stock solution chamber of fungus piece.

In a preferred embodiment, the first bacterium isolation member is fixedly connected with the first liquid storage cavity in a sealing manner or detachably connected with the second liquid storage cavity in a sealing manner.

In a preferred embodiment, the inner surfaces of the first liquid storage cavity and the second liquid storage cavity are provided with threads, and the first liquid storage cavity is in threaded connection with the first bacterium isolation piece, and the second liquid storage cavity is in interference fit with the second bacterium isolation piece.

In a preferred embodiment, the first bacteria-blocking member and the second bacteria-blocking member are respectively puncture diaphragms. In a preferred embodiment, the body further includes: a first connecting pipe and a second connecting pipe, wherein

The first end of the first connecting pipe is used for being communicated with the first liquid storage cavity, and the second end of the first connecting pipe is used for being communicated with a first hemodialysis catheter;

the first end of the second connecting pipe is used for being communicated with the second liquid storage cavity, and the second end of the second connecting pipe is used for being communicated with a second hemodialysis catheter.

In a preferred embodiment, the first hemodialysis catheter sealing sleeve is arranged at the second end of the first connecting pipe, and the second hemodialysis catheter sealing sleeve is arranged at the second end of the second connecting pipe.

In a preferred embodiment, the body further comprises a first clamp and a second clamp, the first clamp is arranged at the connecting part between the first connecting pipe and the first hemodialysis catheter so as to seal and fix the first hemodialysis catheter and the first connecting pipe; the second clamp is arranged at the connecting part between the second connecting pipe and the second hemodialysis catheter so as to seal and fix the second hemodialysis catheter and the second connecting pipe.

In a preferred embodiment, a first silica gel sleeve is sleeved on the first hemodialysis catheter, the first silica gel sleeve is provided with a first internal thread, a first external thread matched with the first internal thread is arranged on the first connecting pipe, the first hemodialysis catheter is configured to at least partially cover the first external thread, and the silica gel sleeve is screwed on the first connecting pipe through the matching of the first internal thread and the first external thread so as to realize the sealing and fixed connection of the first liquid storage cavity and the first hemodialysis catheter; and/or the presence of a gas in the gas,

the cover is equipped with the second silica gel cover on the second hemodialysis pipe, the second silica gel cover is equipped with the second internal thread, be equipped with on the second connecting pipe with second internal thread matched with second external thread, the second hemodialysis pipe is configured as at least partial cover in on the second external thread, the silica gel cover passes through the second internal thread with the cooperation of second external thread closes soon on the second connecting pipe to realize second stock solution chamber and the sealed fixed connection of second hemodialysis pipe.

In a preferred embodiment, the hemodialysis harbor further comprises a rim portion and a securing member, the rim portion circumferentially surrounding the body, the securing member for securing the rim portion to the body to secure the hemodialysis harbor to the body.

In a preferred embodiment, the first hemodialysis catheter and/or the second hemodialysis catheter have elasticity at least at a portion connected to a blood vessel of a human body, are closed at distal ends, and are provided with a three-way valve structure configured to be able to determine whether to open and close, and an opening and closing direction, according to a difference in internal and external pressures.

In a preferred embodiment, the three-way valve structure is a slit and is positioned 5-10mm from the end.

In another aspect of the application, a hemodialysis port kit is disclosed, comprising a hemodialysis port as described in any of the above, and

-a first atraumatic spike piercing a first septum aseptically connected to the first reservoir forming a passageway for directing blood of the person from the hemodialysis port to the hemodialysis machine;

-a second non-destructive piercing needle piercing a second septum aseptically connected to the second reservoir forming a pathway for the return of dialyzed blood from the hemodialysis machine back to the body.

In yet another aspect of the present application, a hemodialysis system is disclosed, comprising a hemodialysis port kit as described above, and

hemodialysis apparatus, which removes harmful solutes from the blood and replenishes the blood with the necessary solutes, correcting water, electrolytes and acid-base equilibrium, according to the diffusion and/or ultrafiltration and/or adsorption principle of semipermeable membranes.

The hemodialysis port, the hemodialysis port kit and the hemodialysis system according to the present invention have at least one of the following advantages:

1. the hemodialysis harbor is completely buried in the body, no catheter is exposed on the outer surface, and the psychological burden of a user is reduced; when not used, the artificial anus is not required to be disinfected, can be used for swimming or bathing, is not easy to be infected, and solves the problems that the skin of the traditional arteriovenous internal fistula is easy to itch, red and swollen and the like; effectively reducing the risk of generating thrombus and the risk of secondary infection;

2. in the hemodialysis port, the liquid storage cavity realizes the sterile communication between the nondestructive puncture needle and the hemodialysis catheter, and the risk that the nondestructive puncture needle punctures the hemodialysis catheter is reduced.

Drawings

FIG. 1 is a schematic view of the construction of a hemodialysis harbor kit according to the present invention;

FIG. 2-A is a front view of a hemodialysis harbor kit according to the present invention;

FIG. 2-B isbase:Sub>A cross-sectional view A-A ofbase:Sub>A hemodialysis harbor kit according to the present invention;

FIG. 2-C is a sectional view B-B of the hemodialysis harbor kit according to the present invention;

FIG. 3-A is a schematic view of a hemodialysis catheter having a three-way valve for use in accordance with an embodiment of the present invention;

FIG. 3-B isbase:Sub>A cross-sectional view A-A ofbase:Sub>A hemodialysis catheter havingbase:Sub>A three-way valve for use in accordance with an embodiment of the present invention;

fig. 4 is a schematic view of a hemodialysis system in accordance with the present invention.

Description of reference numerals:

10-body

1001-first connecting pipe

1002-second connecting pipe

101-first reservoir

102-second reservoir

103-edge part

1030-fixing piece

110-first bacteria-isolating piece

120-second bacteria-isolating piece

11-first hemodialysis catheter

12-second hemodialysis catheter

21-first non-destructive puncture needle

22-second non-destructive puncture needle

Detailed Description

The present inventors have made extensive and intensive studies and, as a result, have disclosed a port for hemodialysis for the first time. The hemodialysis harbor can be completely embedded under the skin, is arranged under the skin in a mode of sewing through a sewing hole and the like, is not easy to shift or turn over, and has no part exposed on the body surface; the artery and vein hemodialysis catheters are made of medical grade materials such as silicon rubber and TPU, and the transfusion port is designed in a flat structure, so that the foreign body sensation of a patient is further reduced. The invention also discloses a hemodialysis harbor kit. The invention also discloses a hemodialysis system comprising the hemodialysis harbor, and the hemodialysis system further comprises a hemodialysis monitoring module, wherein the hemodialysis monitoring module is provided with a concentration measuring device and is used for measuring the respective concentrations of a certain specific component before and after the use of dialysate, so that the concentration-time distribution and the removal rate of the specific component in blood are calculated.

Term(s)

As used herein, "hemodialysis port," "dialysis port," are used interchangeably;

"hemodialysis system", "system" are used interchangeably;

"hemodialysis kit", "kit" are used interchangeably;

"first hemodialysis catheter", "arterial hemodialysis catheter" are used interchangeably;

"second hemodialysis catheter", "venous hemodialysis catheter" are used interchangeably;

"catheter", "first hemodialysis catheter", "second hemodialysis catheter" are used interchangeably;

the first lossless puncture needle and the arterial puncture needle can be used interchangeably;

the 'second nondestructive puncture needle' and 'vein puncture needle' can be used interchangeably;

the first reservoir chamber and the arterial reservoir chamber can be used interchangeably;

"second reservoir" and "intravenous reservoir" are used interchangeably.

The terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element. In the present patent application, if it is mentioned that a certain action is executed according to a certain element, it means that the action is executed according to at least the element, and two cases are included: performing the action based only on the element, and performing the action based on the element and other elements. The expression of a plurality of, a plurality of and the like includes 2, 2 and more than 2, more than 2 and more than 2.

In the present patent application, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions.

In the present invention, all directional indications (such as up, down, left, right, front, rear, etc.) are used only to explain the relative positional relationship between the components, the movement, etc. in a certain posture (as shown in the drawings), and if the certain posture is changed, the directional indication is changed accordingly.

Hemodialysis harbor

The invention provides a hemodialysis port comprising a body, a first hemodialysis catheter and a second hemodialysis catheter. Wherein, the body includes first stock solution chamber and the second stock solution chamber of mutual isolation. The first liquid storage cavity is respectively communicated with the first hemodialysis catheter and the hemodialysis equipment in a sterile way so as to enable blood to enter the hemodialysis equipment; and the second liquid storage cavity is respectively communicated with the second hemodialysis catheters and is aseptically communicated with the hemodialysis equipment so that blood treated by the hemodialysis equipment flows into a human body. The method comprises the following specific steps:

in the embodiment shown in fig. 1, 2-a to 2-C, the hemodialysis port includes a body 10, a first hemodialysis catheter 11 (also referred to as an arterial hemodialysis catheter in this embodiment), and a second hemodialysis catheter 12 (also referred to as a venous hemodialysis catheter in this embodiment). Upstream of said first hemodialysis catheter 11 for communication with an artery of the human body; downstream of the second hemodialysis catheter 12 is for communication with a vein of the body. The main body 10 is provided with a first reservoir 101 (also called an arterial reservoir in this embodiment) and a second reservoir 102 (also called a venous reservoir in this embodiment). The first reservoir 101 and the second reservoir 102 are independently and completely separated. The first liquid storage cavity is respectively communicated with the first hemodialysis catheter and an extracorporeal hemodialysis device in a sterile way so as to enable blood to enter the extracorporeal hemodialysis device; the second liquid storage cavity is respectively communicated with the second hemodialysis catheters and is aseptically communicated with extracorporeal hemodialysis equipment so as to enable blood treated by the hemodialysis equipment to flow into a human body. The inventor finds that the diameters of the first hemodialysis catheter and the second hemodialysis catheter are small, the first hemodialysis catheter and the second hemodialysis catheter are difficult to realize if the non-destructive puncture needle is directly and removably connected with the hemodialysis catheter, and the non-destructive puncture needle easily punctures the hemodialysis catheter, so that a first liquid storage cavity and a second liquid storage cavity are required to be formed in a body to realize communication between the non-destructive puncture needle and the hemodialysis catheter. Optionally, the first liquid storage cavity and the second liquid storage cavity are arranged in a left-right or up-down separated mode. Further, in order to prevent arterial blood from flowing into the vein to cause vein stenosis and even embolism, the respective volumes V of the first reservoir 101 and the second reservoir 102 are preferably in a range of 0.5V 2ml.

Further, the reservoir needs to be aseptically connected to the non-invasive puncture needle. Therefore, the first liquid storage cavity 101 comprises a first inlet end and a first outlet end, the first inlet end of the first liquid storage cavity 101 is communicated with the first hemodialysis conduit, and the first outlet end of the first liquid storage cavity 101 is provided with a first bacteria-isolating piece 110. The first bacteria-isolating piece 110 is used for isolating the first liquid storage cavity 101 from an external bacteria-carrying environment. And, the first bacteria-isolating piece 110 includes two states of opening and/or closing, when the non-destructive puncture needle is communicated with the first reservoir 101, the first bacteria-isolating piece 110 is set to be in the opening state and provides a passage into the first reservoir 101, and when the non-destructive puncture needle is isolated from the first reservoir 101, the first bacteria-isolating piece 110 is set to be in the closing state to prevent blood from flowing out. Correspondingly, the second liquid storage cavity 102 comprises a second inlet section and a second outlet end, the second outlet end of the second liquid storage cavity 102 is communicated with the second hemodialysis conduit, and the second inlet end of the second liquid storage cavity 102 is provided with a second bacteria-isolating piece 120. The second bacteria barrier 120 is configured to isolate the second reservoir 102 from the external sterile environment. And, the second bacteria-isolating piece 120 includes two states of opening and/or closing, when the non-destructive puncture needle is communicated with the second reservoir 102, the second bacteria-isolating piece 120 is set to be in the opening state and provides a passage into the second reservoir 102, and when the non-destructive puncture needle is separated from the second reservoir 102, the second bacteria-isolating piece 120 is set to be in the closing state to prevent the blood from flowing out. .

First fungus-isolating piece can be sealed and be fixed in the first exit end of first stock solution chamber 101. Exemplarily, the shape of the first reservoir 101 matches with the shape of the first bacteria-isolating member, so that the first bacteria-isolating member can be accommodated in the first reservoir 101. Optionally, the first septum is a first piercing septum. The first puncture diaphragm is arranged at the first outlet end in a gluing and welding mode. In an alternative embodiment, the first piercing septum is removably and sealingly disposed at the first outlet end of the first reservoir 101. Illustratively, the shape of the first reservoir 101 matches the shape of the first piercing septum, and the size of the first reservoir 101 is smaller than the size of the first piercing septum, such that the first piercing septum forms an interference fit with the first reservoir. Preferably, in order to enhance the sealing effect, the first reservoir 101 is further provided with an internal thread, and the blood is further prevented from infiltrating and overflowing through a structure with uneven thread height. The matching relationship between the second reservoir 102 and the second bacteria barrier is similar and will not be described again. Optionally, the second septum is a second septum. Preferably, the first and second septal elements 110 and 120 are provided with distinguishing features to facilitate distinguishing between the two septal elements with different functions, thereby avoiding confusion between arterial and venous blood. For example, the distinguishing features are bumps, more specifically, the presence or absence of bumps, the number of bumps, the shape of bumps, and the like. The material of the first and second bacteria-blocking materials 110 and 120 is preferably silicone rubber. The silicon rubber material has good chemical stability and higher biocompatibility, is not easy to hydrolyze and wear, and can not generate rejection reaction and inflammation when being implanted into a body. In addition, the silicone rubber is in a high-elastic state at room temperature, and the bacteria-isolating piece is soft and easy to puncture, so that the silicone rubber is suitable for being matched with a nondestructive puncture needle to realize a communication effect; meanwhile, the silicon rubber has good resilience, can wrap the nondestructive puncture needle after the nondestructive puncture needle is punctured, and can be quickly closed after the nondestructive puncture needle is pulled out, so that a bacterium isolation effect can be well realized. In addition, the first bacterium isolation piece 110 and the second bacterium isolation piece 120 can be repeatedly punctured for more than 1000 times, so that the service life of the bacterium isolation pieces can be greatly prolonged, the replacement frequency of the bacterium isolation pieces is reduced, and the operation taking-out frequency is further reduced.

In one aspect, the body further comprises a first connecting tube 1001 and a second connecting tube 1002. One end of the first connection tube 1001 is communicated with the first liquid storage cavity, and the other end thereof extends out of the body 10 to be communicated with the first hemodialysis catheter. Similarly, one end of the second connection tube 1002 is connected to the second reservoir, and the other end extends out of the body 10 to connect to a second hemodialysis catheter. On the other hand, the first liquid storage cavity is fixedly connected with the first hemodialysis catheter in a sealing way. Similarly, the second liquid storage cavity is fixedly connected with the second hemodialysis catheter in a sealing way. By "fixedly attached" is meant that, in use, there is no relative movement between the reservoir and the hemodialysis catheter. Furthermore, the first hemodialysis pipe is sleeved at the second end of the first connecting pipe in a sealing manner, and the second hemodialysis pipe is sleeved at the second end of the second connecting pipe in a sealing manner. Illustratively, the body 10 further includes a clip (e.g., a titanium alloy clip) that is snap-fit to a connection portion between the hemodialysis catheter and the connection tube to sealingly secure the hemodialysis catheter and the connection tube. Other means for securing the hemodialysis catheter and the connecting tube may be used. For example, a silicone sleeve is sleeved on the hemodialysis catheter, and the silicone sleeve is provided with internal threads for increasing the friction force between the hemodialysis catheter and the silicone sleeve. And the connecting pipe is provided with an external thread matched with the internal thread. The internal diameter of silica gel cover slightly is greater than hemodialysis pipe's external diameter, and hemodialysis pipe passes the back cover from the silica gel cover and is equipped with the connecting pipe, and at least part covers on the external screw thread. Then the silica gel cover is screwed on the connecting pipe through the matching of the internal thread and the external thread, and the sealing and fixed connection of the liquid storage cavity and the hemodialysis catheter is realized.

The hemodialysis port further comprises an edge part 103, and the edge part 13 is of a flange-like structure and is arranged around the circumference of the body. Further, the hemodialysis harbor further comprises a fixing member for fixing the hemodialysis harbor to the human tissue. For example, the fastener is a suture hole. In this embodiment, a plurality of suture holes 1030 is provided on the rim portion 103, optionally 6-10 suture holes. The diameter of the suture hole 1030 is D, and the diameter of the suture hole 1020 may be determined according to the diameter of the suture thread. Optionally, the value range of D is 4Fr ≦ D ≦ 5Fr. In an alternative embodiment, the anchors are barbs, a biocompatible adhesive. In this case, the fixing member may be provided on the edge portion 103 or the body 10.

The body 10 and the edge 103 are made of a material with high biocompatibility, such as a biocompatible metal such as titanium alloy, or a biocompatible polymer material such as silica gel or polyurethane. Preferably, the hemodialysis harbor made of titanium alloy with good compatibility with human body and prepared by titanium alloy is not easy to degrade and absorb after being implanted into human body, has good corrosion resistance, does not easily cause material deterioration in the internal environment of human body, and still has good mechanical properties under repeated stress conditions. In addition, the body 10 and the edge 103 may be forged, welded, injection molded or woven. Optionally, the body 10 and the edge 103 are machined to form a burr-free, ultra-thin structure on the surface. Further, the body 10 is a flat structure, that is, the height of the body 10 is significantly smaller than the length and width of the body 10. The design reduces the foreign body sensation of the patient and the abrupt sensation of the body surface.

The aperture d of the first hemodialysis catheter 11 and the second hemodialysis catheter 12, optionally, the value range of the aperture d is: d is more than or equal to 7Fr and less than or equal to 8Fr. Further, the first hemodialysis catheter 11 and the second hemodialysis catheter 12 are easily made of soft medical grade materials, such as silicone rubber and TPU (Thermoplastic polyurethane elastomer rubber), so as to further reduce the foreign body sensation of the patient.

As shown in fig. 3-a and 3-B, in order to prevent the reverse flow of blood, the first hemodialysis catheter 11 and the second hemodialysis catheter 12 have elasticity at least at a portion connected to an artery/vein of a human body, are closed at their ends, and have a three-way valve structure configured to be able to determine whether to open or close and a direction of opening or closing according to a difference in internal and external pressures. Specifically, the method comprises the following steps: the catheter has elasticity at the part connected with the human artery/vein, the end part of the catheter is closed, a seam is axially cut on the wall of the catheter at the position 5-10mm away from the end part of one end of the catheter connected with the human artery/vein, and valves are formed at two sides of the seam, so that a three-way valve structure is formed. When in idle, the two valves of the three-way valve structure are closed together by the elasticity of the two valves, so that the possibility of thrombus caused by the backflow of blood into the catheter is prevented; when in use, the two valves of the three-way valve structure can be opened inwards or outwards along with the change of the internal and external pressure of the catheter, so that the two-way circulation of blood is realized.

During dialysis: firstly, drawing blood through an arterial hemodialysis catheter, wherein the pressure in the catheter is less than the pressure in a blood vessel, a three-way valve clack membrane of the arterial hemodialysis catheter is inwards opened, and the blood enters the arterial hemodialysis catheter; after the extracorporeal dialysis is completed, the blood flows back through the venous hemodialysis catheter, and when the pressure in the venous hemodialysis catheter is increased to be stronger than the pressure in the venous blood vessel, the three-way valve of the venous hemodialysis catheter is opened outwards, and the blood flows into the venous hemodialysis blood vessel.

Hemodialysis harbor kit

The invention also discloses a hemodialysis port kit, which comprises the hemodialysis port, a first lossless puncture needle and a second lossless puncture needle. The first non-damage puncture needle punctures a first bacteria-isolating piece which is aseptically connected with the first liquid storage cavity to form a passage for leading the human blood from the hemodialysis port to the hemodialysis equipment; the second non-destructive piercing needle pierces a second septum aseptically connected to the second reservoir forming a pathway for returning dialyzed blood processed by the hemodialysis apparatus from the hemodialysis port to the body.

Referring to fig. 1-3, in one embodiment, the hemodialysis kit includes a hemodialysis port as described above, and a first non-invasive puncture needle 21, a second non-invasive puncture needle 22. Wherein the first atraumatic puncture needle 21 is aseptically connected to the first barrier 110, and introduces arterial blood to the extracorporeal hemodialysis apparatus through the hemodialysis port; the second non-invasive puncture needle 22 is connected in a sterile manner to a second septum 120 for introducing the dialyzed blood, which has been treated by an extracorporeal hemodialysis apparatus, back into the vein of the human body through the hemodialysis port. In addition, the present embodiment is not particularly limited to the above-described nondestructive puncture needle. The person skilled in the art can select the type and the specification of the non-destructive puncture needle according to the requirement and the industry standard.

Hemodialysis system

The invention also discloses a hemodialysis system. In addition to the hemodialysis port set, the hemodialysis system further includes a hemodialysis apparatus. As shown in fig. 4, the hemodialysis apparatus includes: the arterial pressure monitor is connected to a flow path at the downstream of the first lossless puncture needle 21; a physiological saline source connected to the flow path downstream of the first atraumatic needle 21; the inlet of the blood pump is connected with the downstream of the first lossless puncture needle 21, and the outlet of the blood pump is connected with the dialyzer; the heparin pump is connected to the blood pump-dialyzer flow path; the inlet of the dialyzer is connected with the blood pump, and the outlet of the dialyzer is connected with the upstream of the second nondestructive puncture needle 22; a venous pressure monitor connected to the flow path upstream of the second non-invasive puncture needle 22; a flow pressure detector is also connected to the flow path upstream of the second nondestructive puncture needle 22. Optionally, a flow path control device is provided on the flow path of the blood flowing out of the first non-destructive puncture needle 21 into the dialyzer or the flow path of the blood flowing out of the dialyzer to the second non-destructive puncture needle 22 for controlling the flow path to be opened or closed. The flow path control device may be a pipe clamp, a check valve, a three-way valve.

The hemodialysis system according to the present invention optionally further comprises a hemodialysis monitoring module. The hemodialysis monitoring module is connected in a used dialysis waste liquid container flowing out of a dialyzer, so that a small volume of dialysis waste liquid can be separated for real-time sampling. The module is provided with a concentration measuring device for measuring a specific component (e.g. K) ⁺ 、H ⁺ Phosphate, urea, creatinine, uric acid, inhibitory titanium, β 2 microglobulin, leptin, parathyroid hormone, etc.) before and after dialysis of blood, and calculating concentration-time distribution and removal rate of the components.

During hemodialysis, blood forms the following circuits in the hemodialysis system: blood is taken from the patient's artery, flows into the first reservoir 101 via the first hemodialysis catheter 11, and then flows out of the patient's body via the first atraumatic needle 21; an arterial pressure monitor is arranged on the flow path; the water is pumped to a dialyzer through a blood pump, flows through a hollow fiber bundle in the dialyzer, and is in convection with dialysate outside the fiber bundle to carry out solute mutual transfer, and then flows out of the dialyzer; through the second hemodialysis catheter 12, back into the patient, through the second reservoir 102, and into the patient's vein.

Example 1 Implantation of hemodialysis Port

The hemodialysis harbor according to this embodiment is implanted in a body.

Making a longitudinal incision of about 4cm in length between a radial artery pulse obvious position 5cm above an forearm wrist joint and a superficial vein adjacent to and parallel to the radial artery, cutting and separating subcutaneous tissues and fascia, exposing the radial artery and the subcutaneous vein (a section of 2-4cm in length), and respectively drawing by silk threads;

the subcutaneous tissue was incised and separated to allow for the implantation of the hemodialysis harbor of this example. The hemodialysis harbor is sutured to the subcutaneous site with a thread through each suture hole 1030 with the side provided with the septum facing the outside of the skin.

Ligating the distal end of the radial artery, lifting the traction wire at the proximal end to temporarily block blood flow, cutting a small opening on the wall of the radial artery, retracting the two walls by nylon threads, inserting the arterial hemodialysis catheter into the radial artery, ligating the arterial hemodialysis catheter by the threads, and fixing the arterial hemodialysis catheter on the wall of a blood vessel.

The distal end of the separated vein is ligated, and the proximal end is pulled and lifted by silk thread to block blood flow. A small opening is cut in the vein wall and another venous hemodialysis catheter is inserted into the vein.

The skin incision is sutured with silk thread and wrapped with dressing.

EXAMPLE 2 application of hemodialysis System

The hemodialysis system of the embodiment is used for performing low-flux hemodialysis treatment on a uremia patient, and analyzing the real-time change of the urea content in liver cells of the patient through a hemodialysis monitoring module.

The tubing clamp on the blood output pathway is closed. Starting the blood pump, wherein the flow rate is 80-100ml/min. The dialysis tubing and dialyzer blood compartment (membrane) are purged with physiological saline. The flow direction of the physiological saline is arterial end-dialyzer-venous end. The flow rate of the pump is adjusted to 200-300ml/min. Connecting the dialysate joint with the dialyzer bypass, and exhausting the dialysate (outside the membrane) gas in the dialyzer dialysis chamber. The pre-flush of saline is performed strictly according to the dialyzer instructions. Closed circulation or heparin normal saline pre-flushing is carried out after the normal saline pre-flushing amount is 500 ml.

The dialyzate of the dialyzer adopts bicarbonate dialyzate, and the flow rate is 2 times of the blood flow rate. A sampling device is connected to the dialyzer dialysate outlet, i.e., the container of the dialysis waste liquid, and samples a volume (e.g., 2 ml) of the spent dialysis waste liquid at regular intervals (e.g., every 5 minutes). The sampled dialysis waste liquid is sent to a liquid analysis device for reading the concentration of urea. (the liquid analysis device is not limited to the monitoring of a particular component, but may also be used for monitoring of other components including, for example, creatinine, phosphate, calcium, sodium, potassium, glucose, and beta-2-microglobulin). The sampling device and the liquid analysis device form a hemodialysis monitoring module.

After the puncture site was selected, the puncture site was sterilized with iodophor. According to the thickness of the blood vessel and the requirement of blood flow, the proper needle tube aperture is selected for the first non-destructive puncture needle 21 and the second non-destructive puncture needle 22. The needle is punctured at a proper angle by a step-type and button-type method. In this embodiment, the first bacteria-isolating piece and the second bacteria-isolating piece are respectively a first puncturing diaphragm and a second puncturing diaphragm. The first non-invasive puncture needle 21 is first used to puncture the arteriopuncture septum and then the second non-invasive puncture needle 22 is used to puncture the venipuncture septum. The puncture needle is fixed. And opening a pipeline clamp on the blood output flow path.

In the dialysis process, the dynamic and venous pressure detectors and the flow pressure detector are closely observed to ensure that the blood pressure is in a limited range. If the blood pressure exceeds the normal range, the blood resistance of the flow path is possibly too high due to the occurrence of thrombus and blood coagulation; the tubing clamp on the blood infusion body flow path should be closed in time to avoid risk.

When hemodialysis is finished, normal saline is input into the dialyzer, so that all blood in the pipeline quickly flows back to the patient.

And analyzing the concentration change of the urea by using a hemodialysis monitoring module to obtain a time-concentration distribution diagram. Initially, urea will be present in the order of 25mg per 100ml of dialysis fluid. After 4 hours of hemodialysis, urea will be present in the order of 5 to 7mg per 100ml of dialysate due to the volume reduction during hemodialysis treatment. From this the urea removal rate can be calculated.

All documents mentioned in this application are to be considered as being incorporated in their entirety into the disclosure of this application so as to be subject to modification as necessary. Further, it should be understood that various changes or modifications can be made to the present application by those skilled in the art after reading the above disclosure of the present application, and these equivalents also fall within the scope of the present application as claimed.

Claims (15)

1. A hemodialysis port, comprising: body, first hemodialysis pipe, second hemodialysis pipe, wherein, the body is provided with

-a first reservoir chamber having a first inlet end for sterile connection to the first hemodialysis catheter and a first outlet end for communication with a hemodialysis machine for the entry of human blood into the hemodialysis machine;

-a second reservoir chamber having a second inlet end for communicating with a hemodialysis machine and a second outlet end for aseptically connecting to the second hemodialysis catheter for returning blood treated by the hemodialysis machine to the body;

the first liquid storage cavity and the second liquid storage cavity are arranged in an isolated mode.

2. The hemodialysis harbor of claim 1, further comprising: the first bacterium isolation piece and the second bacterium isolation piece are respectively used for isolating the first liquid storage cavity and the second liquid storage cavity from the external environment; first bacteria isolation piece, second bacteria isolation piece have and open and/or closed two kinds of states, when external puncture part communicates with first stock solution chamber, second stock solution chamber respectively, first bacteria isolation piece, second bacteria isolation piece set up respectively to the open mode to form the passageway that gets into first stock solution chamber, second stock solution chamber respectively, when external puncture part separates with first stock solution chamber, second stock solution chamber respectively, first bacteria isolation piece, second bacteria isolation piece set up respectively to the closed state.

3. The hemodialysis port of claim 2, wherein the first septum is sealingly disposed at the first outlet end of the first reservoir chamber; the second separates the sealed second entry end that sets up at second stock solution chamber of fungus piece.

4. The hemodialysis port of claim 2, wherein the first septum is fixedly sealed to the first reservoir and the second septum is removably sealed to the second reservoir.

5. The hemodialysis port of claim 4, wherein the first reservoir and the second reservoir are threaded on their inner surfaces, and wherein the first reservoir is threadably engaged with the first septum and the second reservoir is interference fit with the second septum.

6. The hemodialysis port of any one of claims 2-5, wherein the first and second septal elements are each a puncture septum.

7. The hemodialysis port of claim 1, wherein the body further comprises: a first connecting pipe, a second connecting pipe, wherein

The first end of the first connecting pipe is used for being communicated with the first liquid storage cavity, and the second end of the first connecting pipe is used for being communicated with a first hemodialysis catheter;

the first end of the second connecting pipe is used for being communicated with the second liquid storage cavity, and the second end of the second connecting pipe is used for being communicated with a second hemodialysis catheter.

8. The hemodialysis port of claim 7, wherein the first hemodialysis catheter gland is disposed on the second end of the first connection tube and the second hemodialysis catheter gland is disposed on the second end of the second connection tube.

9. The hemodialysis port of claim 8, wherein the body further comprises a first clip and a second clip, the first clip being disposed on a connection portion between the first connection tube and the first hemodialysis catheter to sealingly secure the first hemodialysis catheter and the first connection tube; the second clamp is arranged at the connecting part between the second connecting pipe and the second hemodialysis catheter so as to seal and fix the second hemodialysis catheter and the second connecting pipe.

10. The hemodialysis port of claim 8, wherein a first silicone sleeve is sleeved on the first hemodialysis catheter, the first silicone sleeve is provided with a first internal thread, the first connection tube is provided with a first external thread matching with the first internal thread, the first hemodialysis catheter is configured to at least partially cover the first external thread, and the silicone sleeve is screwed on the first connection tube through the first internal thread and the first external thread to realize a sealed and fixed connection between the first reservoir and the first hemodialysis catheter; and/or the presence of a gas in the gas,

the cover is equipped with the second silica gel cover on the second hemodialysis pipe, the second silica gel cover is equipped with the second internal thread, be equipped with on the second connecting pipe with second internal thread matched with second external thread, the second hemodialysis pipe is configured as at least partial cover in on the second external thread, the silica gel cover passes through the second internal thread with the cooperation of second external thread closes soon on the second connecting pipe to realize second stock solution chamber and the sealed fixed connection of second hemodialysis pipe.

11. The hemodialysis harbor of claim 1, further comprising a rim portion and a securing member, the rim portion circumferentially disposed about the body for securing the rim portion to a body to secure the hemodialysis harbor to the body.

12. The hemodialysis port of claim 1, wherein the first hemodialysis catheter and/or the second hemodialysis catheter is flexible at least at a portion connected to a blood vessel of a human body, closed at a distal end, and provided with a three-way valve structure configured to be opened and closed and a direction of opening and closing according to a difference between internal and external pressures.

13. The hemodialysis harbor of claim 11 wherein the three-way valve structure is a slit and is positioned 5-10mm from the end.

14. A hemodialysis port kit comprising the hemodialysis port of any one of claims 1-13, and

-a first atraumatic spike piercing a first septum aseptically connected to the first reservoir forming a passageway for directing blood of the person from the hemodialysis port to the hemodialysis machine;

-a second non-invasive puncture needle piercing a second septum aseptically connected to the second reservoir forming a pathway for introducing dialyzed blood processed by a hemodialysis machine from the hemodialysis port back to the body.

15. A hemodialysis system, comprising: the hemodialysis harbor kit of claim 14, and

hemodialysis apparatus, which removes harmful solutes from the blood and replenishes the blood with the necessary solutes, correcting water, electrolytes and acid-base equilibrium, according to the diffusion and/or ultrafiltration and/or adsorption principle of semipermeable membranes.

Images