WO2015010222A1

WO2015010222A1 - Self-sealing anti-thrombotic venous indwelling needle and use method thereof

Info

Publication number: WO2015010222A1
Application number: PCT/CN2013/001236
Authority: WO
Inventors: 谢世庚
Original assignee: Xie Shigeng
Priority date: 2013-07-25
Filing date: 2013-10-14
Publication date: 2015-01-29
Also published as: CN103330970B; CN103330970A

Abstract

Disclosed are a self-sealing anti-thrombotic venous indwelling needle and a use method thereof. The venous indwelling needle comprises a needle base (3), a catheter (2) provided at the front end of the needle base (3) and a puncture needle core (1) axially penetrating the needle base (3) and the catheter (2). The inner cavity (4) of the needle base (3) is divided into two parts, i.e. a positive pressure chamber (42) and an infusion cavity (41), by a partition portion (5). The infusion cavity (41) is in communication with the catheter (2) and the partition portion (5) uses a medical sealing material. The partition portion (5) is provided with a seepage channel (6), wherein when there is a pressure difference between the positive pressure chamber (42) and the infusion cavity (41), the liquid in the positive pressure chamber (42) can automatically and slowly flow into the infusion cavity (41) via the seepage channel (6). When an infusion is paused, the venous indwelling needle may automatically seal the tube, and as the pressure difference between the positive pressure chamber (42) and the infusion cavity (41) decreases, the speed of the seepage will slow down therewith, enabling the positive pressure chamber (42) to maintain a positive pressure for a long time, thus preventing thrombosis.

Description

Description: Self-styled anti-thrombosis intravenous indwelling needle and its use method

The present invention relates to a medical device for inputting a medium into a human body, and more particularly to an indwelling needle for infusion of a patient and a method of using the same. BACKGROUND OF THE INVENTION The invention and application of intravenous indwelling needles alleviate patient suffering and improve medical quality, and also reduce the labor intensity of medical personnel infusion for patients. However, the existing intravenous indwelling needle must be sealed when the infusion is suspended, and the tube is flushed every 6-8 hours. Otherwise, a thrombus is formed to cause blockage and vasculitis; when the infusion is performed again, the tube is required to be intubated. The operation of sealing, flushing and communicating the tube increases the economic burden of the patient and the workload of the medical staff. It is also possible that the formed thrombus enters the blood vessel and causes other diseases, and the heparin sodium used for sealing, flushing and communicating the tube. Anticoagulant drugs such as urokinase may also cause side effects to the human body. In recent years, in order to solve the above-mentioned technical problems at home and abroad, there have been techniques such as positive pressure joints, anti-backflow intravenous indwelling needles, and the reports of the clinical application effects of these techniques are quite different. It has been reported that the above-mentioned positive pressure joint and anti-backflow indwelling needle can extend the time of sealing the indwelling needle, but still need to seal, flush and pass the tube, and the operation is more complicated, which not only greatly increases the use cost, but also It is impossible to reduce the work of medical staff and not alleviate the suffering of patients. Patent No. 201020651442. x The utility model patent for the anti-thrombosis device of the venous indwelling needle discloses a prevention of a venous indwelling needle composed of a cannula, a cannula seat, a piston, a push tube, a sealing plug and a needle core. In the thrombus device, a piston is fixed in the end of the push tube, and the core is inserted from the piston into the sleeve in the push tube. The anti-thrombosis device of the intravenous indwelling needle pushes the piston forward to achieve positive pressure and anti-backflow. The anti-thrombosis device of the intravenous indwelling needle is a device with better anti-thrombosis effect of the intravenous indwelling needle, but the structure and the process of the device are complicated, so that the production cost is high; and the effect of manually pushing the piston sealing tube is unstable, and the plunger is pushed. The speed and the amount of force will affect the effect of the sealing tube, and the piston may vibrate and the like, causing the internal pressure to change, resulting in failure of the anti-thrombosis. SUMMARY OF THE INVENTION The technical problem to be solved by the present invention is to provide a self-sealing antithrombotic venous indwelling needle which is easy to operate and low in cost. The technical solution adopted by the present invention to solve the technical problem thereof is: A self-sealing anti-thrombosis venous indwelling needle, comprising a needle seat, a catheter disposed at the front end of the needle seat, and a puncture needle core axially passing through the needle seat and the catheter, the inner cavity of the needle seat being separated into a positive pressure by the partition portion a chamber and an infusion chamber, the infusion chamber is in communication with the catheter, the partition portion is a medical sealing material; and the partition portion is provided with a percolation passage for when there is a pressure difference between the positive pressure chamber and the infusion chamber The liquid in the positive pressure chamber can automatically flow into the infusion chamber through the percolation channel. The percolation passage is a filter material, a porous medium or a combination of the two embedded in the partition, and the filter material, the porous medium or both end faces of the combination of the two are respectively associated with the positive pressure chamber and the infusion chamber Contact. The percolation channel is a hydrophilic fiber line embedded in the partition portion and offset from a center position thereof, and two ends of the hydrophilic fiber line respectively communicate with the positive pressure chamber and the infusion chamber. Preferably, the volume of the positive pressure chamber is greater than the sum of the volumes of the infusion chamber and the catheter. 01之间。 The volume of the positive pressure chamber is 0. 02ml-0. 3ml, the sum of the volume of the infusion chamber and the catheter is less than 0. 02ml ₀ the rear end of the needle cavity is closed with a medical isolation plug, The medical isolation plug is also used as the partition. The rear end opening of the inner cavity of the needle hub is closed by a sealing cap that is convenient to be disassembled, and the partitioning portion is a medical isolation plug. The sealing cap is a heparin cap. The invention also provides a method for using the self-sealing antithrombotic venous indwelling needle: a method for using a self-sealing antithrombotic venous indwelling needle, and the sealing operation after the end of the infusion comprises the following steps:

I. partially withdrawing the infusion needle to the infusion hole at the front end of the infusion needle has left the partition but is still in the positive pressure chamber;

II. Roller of the regulator of the rolling infusion device squeezes the infusion tube to pressurize the liquid medicine in the infusion tube, and flows into the positive pressure chamber through the infusion hole at the front end of the infusion needle, so that the pressure in the positive pressure chamber is greater than the infusion chamber The infusion needle is pulled out completely, and there is a pressure difference between the positive pressure chamber and the infusion chamber, and the chemical liquid in the positive pressure chamber automatically flows into the infusion chamber through the percolation channel. During infusion, the infusion needle of the infusion set first passes through the rear end portion of the needle holder, and then enters the infusion chamber through the partition portion in the needle holder, and the infusion liquid of the infusion device is injected from the infusion hole at the front end of the infusion needle. Said infusion chamber. Compared with the prior art, the self-sealing anti-thrombosis intravenous indwelling needle of the present invention and the method of using the same have the following beneficial technical effects;

(1) The self-sealing anti-thrombosis venous indwelling needle of the present invention and the method of using the same, in suspending the infusion, the air in the positive pressure chamber is compressed by injecting the liquid medicine into the positive pressure chamber, and the pressure in the positive pressure chamber is greater than that of the infusion chamber Pressure; the liquid in the positive pressure chamber slowly flows into the infusion chamber through the percolation channel, and the blood flowing into the catheter and/or the infusion chamber is discharged to realize automatic sealing; as the pressure difference between the positive pressure chamber and the infusion chamber is reduced, the percolation The speed will also be slowed down, so that the positive pressure chamber can maintain a positive pressure for a long time, and the volume of the catheter and the infusion chamber is small, and the blood pressure cannot flow back into the catheter due to the pressure difference and the percolation effect after the needle is withdrawn. There will be no coagulation obstruction catheter, so there is no need to flush and pass the tube during re-infusion to achieve good anti-thrombosis effect;

(2) Simple operation: automatic sealing, and no need for flushing or pipe-passing, greatly simplifying the operation process of medical personnel;

(3) The anti-thrombosis venous indwelling needle has a simple structure and less consumables;

(4) Reducing the patient's illness: reducing the occurrence of vasculitis, avoiding other diseases caused by thrombus entering the human body during flushing, and avoiding the side effects caused by the use of anticoagulant drugs;

(5) Reduce patient expenses: Eliminate the need for auxiliary sealing accessories, anticoagulant drugs, reduce the number of medical staff's care, and save patients' expenses. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic structural view of a self-sealing antithrombotic venous indwelling needle according to the present invention; FIG. 2 is a schematic structural view showing another embodiment of a self-sealing antithrombotic venous indwelling needle according to the present invention; FIG. Figure 4 is a schematic view of the infusion of the self-sealing anti-thrombosis intravenous indwelling needle; Figure 5 is a schematic diagram of the self-sealing anti-thrombosis intravenous indwelling needle sealing operation of the present invention; Figure 6 is a schematic view of the self-sealing anti-thrombosis intravenous indwelling needle sealing step II; Figure 7 is a schematic view of the self-sealing anti-thrombosis intravenous indwelling needle sealing step III. detailed description The invention will be further described with reference to the drawings and specific embodiments. The self-sealing antithrombotic venous indwelling needle 10 of the present invention, as shown in FIG. 1, includes a puncture needle core 1, a needle hub 3 and a catheter 2 disposed at the front end of the needle hub 3, the needle hub 3 being provided with a lumen 4, The opening of the inner chamber 4 is closed using a medical isolation plug 7, and the inner chamber 4 is internally filled with a medical isolation plug 5 that partitions the inner chamber 4 into an infusion chamber 41 in which the catheter 2 communicates and adjacent A positive pressure chamber 42 of the infusion chamber 41 through which the puncture needle 1 can be inserted through the medical isolation plug 5. The medical isolation plug 5 is provided with a permeate passage 6 that can communicate with the infusion chamber 41 and the positive pressure chamber 42. The medical sealing material has a clear definition, and refers to an elastic material having a certain shape and size, and is used for sealing of a medicinal container such as glass or plastic, and is required to contain no harmful substances such as lead, mercury, arsenic or antimony, and The medicinal agent does not work, and the material itself cannot have the squirt; the syringe needle can pierce the medical sealing material into the container, and the syringe sealing needle can be self-sealed after being pulled out; the medical sealing material can be rubberized. , elastic materials such as silicone. The medical isolation plug refers to an elastic plug made of a medical sealing material for isolation and sealing of the indwelling needle. The opening of the inner chamber 4 is not only closed by the medical isolation plug 7, but also other embodiments: Referring to Fig. 2, the opening of the inner chamber 4 can be closed by installing a sealing cap 8, which preferably adopts the existing Heparin caps widely used in technology. It can be understood that the medical isolation plug 5 can also be made of other medical sealing materials, and only needs to realize the function of blocking the infusion chamber 41 from the positive pressure chamber 42. Preferably, the volume of the positive pressure chamber 42 is greater than the sum of the volumes of the infusion chamber 41 and the catheter 2. The percolation channel 6 is a hydrophilic fiber line implanted in the medical isolation plug 5, and both ends of the hydrophilic fiber line extend into the positive pressure chamber 42 and the infusion chamber 41, respectively. The permeate passage 6 may also be a filter material, a porous medium, or a combination of both, embedded in the medical isolation plug 5 and having both end faces exposed to the positive pressure chamber 42 and the infusion chamber 41, respectively. The filter material includes, but is not limited to, one or more of the following materials: a semipermeable membrane, a nanofiltration material, and an ultrafiltration material. The porous medium includes, but is not limited to, one or more of the following materials: a polymeric porous material, a ceramic porous material, a carbon foam, a metal foam, and a natural porous medium. Referring to FIG. 3, the self-sealing anti-thrombosis venous indwelling needle 10 of the present invention cooperates with the existing infusion set 9 to complete the infusion and sealing work. The infusion set 9 includes an infusion needle 91, a regulator 92, an infusion tube 93 and a dropper. 94. When the infusion is as shown in FIG. 4, the infusion needle 91 of the infusion set 9 is inserted into the infusion chamber 41 through the medical isolation plug 5 to inject the medicine into the infusion chamber 41. Preferably, the percolation channel 6 is offset from the center of the medical isolation plug 5 to prevent the percolation channel 6 from being damaged when the puncture needle 1 or the infusion needle 91 passes. After the end of the infusion, the self-sealing antithrombotic indwelling needle 10 of the present invention needs to be sealed. See Figure 5 to Figure 7 for the sealing operation, including the following steps:

I. partially withdrawing the infusion needle 91 to the infusion port at the front end of the infusion needle 91 has left the medical isolation plug 5 but is still in the positive pressure chamber 42, as shown in FIG. 5;

II. The roller of the regulator 92 of the rolling infusion device 9 presses the infusion tube 93 to pressurize the liquid medicine in the infusion tube 93, and flows into the positive pressure chamber 42 through the infusion hole at the front end of the infusion needle 91, thereby making the positive The pressure in the pressure chamber 42 is greater than the infusion chamber 41, as shown in FIG. 6;

III. All the infusion needles 91 are pulled out, and there is a pressure difference between the positive pressure chamber 42 and the infusion chamber 41, and the liquid medicine in the positive pressure chamber 42 automatically flows into the infusion chamber through the percolation passage 6 41, as shown in Figure 7. Since the liquid medicine is injected into the positive pressure chamber 42 so that the air inside the positive pressure chamber 42 is compressed, the pressure of the positive pressure chamber 42 is greater than the pressure of the infusion chamber 41; the liquid in the positive pressure chamber 42 is slowly passed through the permeate passage 6 Flowing into the infusion chamber 41, the blood flowing into the catheter 2 and/or the infusion chamber 41 is discharged to achieve sealing; as the pressure difference between the positive pressure chamber 42 and the infusion chamber 41 is reduced, the percolation velocity is also slowed down. Therefore, the positive pressure chamber 42 can maintain a positive pressure for a long time, and can be infused again even if the tube is not flushed or piped. After the test, when the volume of the positive pressure chamber 42 is 0. 02ml-0. 3ml, a suitable positive pressure can be generated by injecting the chemical solution into the positive pressure chamber 42 using the infusion set 9. When the sum of the volumes of the infusion chamber 41 and the catheter 2 is less than 0.02 ml, the pressure change in the infusion chamber caused by the vibration can be effectively reduced to achieve a good anti-backflow effect. It can be understood that only the chemical solution is injected into the positive pressure chamber 42 so that the pressure of the positive pressure chamber 42 is greater than that of the infusion chamber 41, and the above-mentioned sealing work can be completed, and other syringes can be used to inject the liquid medicine. The drug solution injected into the positive pressure chamber 42 may be a drug for treatment, an anticoagulant drug such as heparin sodium or urokinase, or even physiological saline. The above embodiments are preferred embodiments of the present invention, and the principles and basic structures thereof are the same as or similar to those of the present embodiment, and are all within the scope of the present invention.

Claims

Claim

A self-sealing antithrombotic venous indwelling needle comprising a needle hub (3), a catheter (2) disposed at the forward end of the hub (3), and a puncture axially passing through the hub (3) and the catheter (2) a needle core (1), characterized in that: the inner cavity (4) of the needle seat (3) is divided into a positive pressure chamber (42) and an infusion chamber (41) by a partition portion (5), the infusion chamber (41) communicating with the conduit (2), the partition (5) is made of a medical sealing material; the partition (5) is provided with a seepage channel (6) for the positive pressure chamber (42) When there is a pressure difference from the infusion chamber (41), the liquid in the positive pressure chamber (42) can automatically and slowly flow into the infusion chamber (41) via the percolation passage (6).

2. The self-sealing antithrombotic venous indwelling needle according to claim 1, wherein: the percolation channel (6) is a filter material, a porous medium or a combination of the two embedded in the partition (5) The filter material, the porous medium, or both ends of the combination of the two are in contact with the positive pressure chamber (42) and the infusion chamber (41), respectively.

The self-sealing anti-thrombosis venous indwelling needle according to claim 2, wherein the percolation channel (6) is a hydrophilic fiber line embedded in the partition portion (5) and offset from a center position thereof, the pro Both ends of the water fiber line are respectively connected to the positive pressure chamber (42) and the infusion chamber (41).

The self-sealing anti-thrombosis venous indwelling needle according to claim 1, wherein the positive pressure chamber (42) has a volume larger than a sum of volumes of the infusion chamber (41) and the catheter (2).

The self-sealing anti-thrombosis venous indwelling needle according to any one of claims 1 to 4, wherein: the volume of the positive pressure chamber (42) is 0.02 ml - 0.3 ml, and the infusion chamber (41) The sum of the volumes of the conduit (2) is less than 0.02 ml.

The self-sealing anti-thrombosis venous indwelling needle according to claim 5, wherein: the rear end opening of the inner cavity (4) of the needle seat (3) is closed by a medical isolation plug (7), and the partitioning portion ( 5) Medical isolation plugs are also used.

The self-sealing anti-thrombosis venous indwelling needle according to claim 5, wherein: the rear end opening of the inner cavity (4) of the needle seat (3) is closed by a sealing cap (8) which is convenient to be disassembled, The medical isolation plug is used for the partition (5).

The self-sealing antithrombotic venous indwelling needle according to claim 7, wherein the sealing cap (8) is a heparin cap.

9. A method of using a self-sealing antithrombotic venous indwelling needle according to claim 1, wherein: the sealing operation after the end of the infusion comprises the following steps: I. partially withdraw the infusion needle (91) until the infusion hole at the front end of the infusion needle (91) has left the partition (5) but is still in the positive pressure chamber (42);

II. The roller of the regulator (92) of the rolling infusion set (9) squeezes the infusion tube (93), so that the liquid medicine in the infusion tube (93) is pressurized, and flows through the infusion hole at the front end of the infusion needle (91). a positive pressure chamber (42) such that the pressure in the positive pressure chamber (42) is greater than the infusion chamber (41);

III. Pulling out the infusion needle (91) completely, because of the pressure difference between the positive pressure chamber (42) and the infusion chamber (41), the liquid medicine in the positive pressure chamber (42) passes through the percolation channel ( 6) Automatically and slowly flow into the infusion chamber (41).

10. The method of using a self-sealing anti-thrombosis venous indwelling needle according to claim 9, wherein: during infusion, the infusion needle (91) of the infusion set (9) first passes through the rear end of the needle holder (3) And then enters the infusion chamber (41) through the partition (5) in the needle seat (3), and the liquid medicine of the infusion device (9) is injected into the infusion chamber from the infusion hole at the front end of the infusion needle (91). (41).