CN110694136B

CN110694136B - Tunnel type is through peripheral central venous catheter and auxiliary device thereof

Info

Publication number: CN110694136B
Application number: CN201910894591.4A
Authority: CN
Inventors: 张海军; 刘光; 韩真真; 支树迪; 李宜玮; 侯文博; 周超; 尹玉霞; 鲁手涛; 袁坤山
Original assignee: Shandong Branden Medical Devices Co Ltd
Current assignee: Shandong Branden Medical Devices Co Ltd
Priority date: 2019-09-20
Filing date: 2019-09-20
Publication date: 2021-12-07
Anticipated expiration: 2039-09-20
Also published as: CN110694136A

Abstract

The invention relates to a tunnel type peripherally inserted central catheter and an auxiliary device thereof, belonging to the field of medical instruments and medical materials. The product mainly comprises a tunnel needle and a catheter passing through a peripheral central vein; coarsening the tunnel needle, and developing clearly under ultrasound; the catheter is divided into a near end, a far end and a tip, the hardness of materials of the three parts is different, and the near end is larger than the far end and the tip is larger than the tip; the surface of the near end of the catheter is coated with an antibacterial coating, and the surface of the far end of the catheter is coated with an anticoagulant coating; when the catheter is placed, a tunnel type method is adopted, and a subcutaneous tunnel is established, so that a certain distance is reserved between a blood vessel puncture point and a catheter outlet. Through the establishment of the tunnel, the outlet position of the catheter is far away from the puncture position, so that the thrombus incidence rate can be reduced, and the application range of the PICC is increased. The tunnel forms a barrier for preventing pollution, and can effectively prevent infection caused by external factors. The subcutaneous tunnel can also be better fixed pipe, reduces the pipe rate of displacement.

Description

Tunnel type is through peripheral central venous catheter and auxiliary device thereof

Technical Field

The invention belongs to the field of medical instruments and medical care, and particularly relates to a tunnel type peripherally inserted central venous catheter and an auxiliary device thereof.

Background

At present, the situation of tumor prevention and treatment in China is very severe, more than 300 million cases of new malignant tumors occur every year, about 250 million deaths occur, and the tumors cause heavy economic burden and emotional trauma to the country, the society and individuals. While intravenous chemotherapy is one of the main treatment methods, chemotherapy drugs have great irritation to peripheral blood vessels and drug extravasation can cause local tissue necrosis. The use of a peripheral Central venous Catheter (PICC) as a lifeline for patient treatment plays an important role in promoting patient recovery. The PICC catheter provides a safe, long-term vascular access for patients who require chemotherapy, infusion of hypertonic irritant fluids, infusion of strong acid or strong alkaline fluids, and other drugs that disrupt the intima of the blood vessel. At present, the infusion device becomes the first choice for middle and long term infusion in clinic, and the damage of irritant drugs to peripheral blood vessels is greatly reduced.

The selection of the most appropriate venous catheter is critical to the success of the procedure and to reduce the associated risks, an important parameter being the diameter of the vein: it is preferred to select a vein having a diameter at least three times the diameter of the catheter (Fr equal to or greater than the diameter of the catheter). No tourniquets were used for the assessment to reduce the risk of PICC-related peripheral venous thrombosis. Therefore, a 3 Fr catheter requires selection of a vein of 9 Fr (3 mm) or larger; a 4 Fr catheter requires the selection of a vein of 12 Fr (4 mm) or larger. In the conventional PICC catheterization, puncture catheterization is generally performed in the middle-third part of the upper arm, but for some patients, the region is not suitable for puncture, for example, infants, patients with too thin blood vessels or pathological changes, or patients who cannot be punctured again due to repeated catheterization. At the moment, the patient can not be placed into the PICC catheter for transfusion, so that the application range of the PICC catheter is greatly limited.

In addition, the traditional PICC put the pipe mode and can often appear catheter correlation infection, puncture point hemorrhage, catheter shift scheduling complication, the patient needs extra nursing means could, has increased patient's painful sense, has aggravated medical personnel's nursing task.

Disclosure of Invention

In view of the above problems, the present invention provides a tunnel-type peripherally inserted central catheter and an auxiliary device therefor, which will establish a subcutaneous tunnel to keep the vascular puncture site at a distance from the catheter outlet and transfer the catheter outlet to a more suitable location, thus reducing the infection and mechanical risk associated with the "high" position of the catheter and avoiding the discomfort that may occur during the patient's activity. In addition, the method is still applicable to some patients with vascular restriction, and the application range is increased.

By creating a subcutaneous tunnel, distancing the vascular puncture point from the catheter exit and moving the catheter exit to a more desirable location, infection and mechanical risks associated with the "high" position of the catheter are reduced and possible discomfort to the patient during the procedure is avoided. The method comprises two skin wounds, a vascular puncture point and a catheter outlet.

The invention firstly designs a tunnel puncture needle which is specially used for a PICC catheter, and the tunnel puncture needle can be divided into a solid type and a hollow type.

Preferably, the hollow type comprises a needle tube, a needle core and a needle seat, the tunnel needle tube cavity can smoothly guide the catheter, and the catheter is prevented from being excessively pulled, so that the catheter is prevented from being damaged, broken and excessively elongated, and the flow of the catheter and the infusion of liquid medicine are influenced.

One end of the solid type can be connected with a PICC catheter, the other end can penetrate through subcutaneous tissues, and the catheter is pulled to an outlet position together when a subcutaneous tunnel is established.

The tunnel puncture needle can be a straight rod type or a straight rod type with a radian of 10-20 degrees, and the tunnel puncture needle can be made of medical stainless steel, cobalt-chromium alloy, polycarbonate, polypropylene and other hard materials.

Preferably, the length of the tunneling needle is adjustable, and several different lengths can be selectively adjusted according to the characteristics of the patient and the tunnel establishment requirements.

Preferably, the whole tunnel puncture needle is roughened, such as by adding a reflector, so that the tunnel puncture needle can be clearly developed under ultrasound.

The catheter may be a single lumen, dual lumen or multi-lumen catheter.

The catheter can be made of medical silicon rubber, polyurethane, polytetrafluoroethylene and other high polymer materials.

Preferably, the tunnel conduit is embedded in the sub-skin portion and is coated with an antibacterial coating, which is made of a material with high hardness, such as silicone rubber, with a hardness of 60-80, so that the tunnel conduit is prevented from being compressed excessively and collapsed. The hardness of the intravascular part is smaller and is 40-60. The hardness of the catheter tip is smaller than 20-30, and the stimulation damage to the vessel wall is reduced in the catheterization process.

The antibacterial coating can be rifampicin, furacilin, auranofin and other medicines with antibacterial effect.

The anticoagulant coating can be heparin, hexyl-hydroxyethyl-cellulose and other drugs with anticoagulant effect.

The catheter may also be entirely uncoated.

Preferably, the puncture site and the catheter outlet are sealed with a medical adhesive, such as cyanoacrylate adhesive, after cannulation.

The tube placing method can be an in vitro measuring method, an ultrasonic guiding method, an intracavitary electrocardiogram method or a combination of the technologies.

The application range of the tunnel type PICC (peripherally inserted Central catheter) placement technology comprises but is not limited to the situation that the arm puncture point is high,

The axillary cavity is internally provided with an axillary vein puncture catheter, the clavicle puncture (innominate vein) of neonates and children, a femoral vein puncture catheter and the like.

Tunneled PICCs are PICC catheterizations in which the catheter exit is positioned away from the puncture site by creating a subcutaneous tunnel. Compare traditional PICC, tunnel PICC advantage lies in: 1. and (3) reducing the incidence of thrombus: the ratio of vein to catheter is better, the blood flow speed of the blood vessel is high, the indwelling length of the catheter in the blood vessel is shortened, and the mechanical friction is reduced; 2. and (3) increasing the adaptation range: for patients with too thin blood vessels or pathological changes or patients who cannot be punctured again due to repeated tube placement, the method can be adopted to complete tube placement; 3. and (3) the infection rate is reduced: the PICC outlet site is different from the puncture site, so that the difficulty of retrograde infection of microorganisms along the catheter is increased, and the infection rate is reduced due to a better outlet position; 4. and (3) reducing the displacement rate: the subcutaneous tunnel can be better fixed pipe, reduces the rate of displacement.

Drawings

FIG. 1 is a schematic view of peripheral blood vessels

FIG. 2 is a post-catheter illustration of a PICC catheter

FIG. 3 is a schematic view of a hollow tunnel needle

FIG. 4 is a schematic view of a solid tunnel needle

FIG. 5 is a schematic view of a tunnel needle with a radian

FIG. 6 is a schematic view of catheters of different stiffness

FIG. 7 is a schematic view of a single lumen catheter

FIG. 8 is a schematic view of a double lumen catheter

FIG. 9 is a schematic view of a triple lumen catheter

Detailed Description

Example 1

A tunnel type peripherally inserted central catheter and an auxiliary device thereof are shown in figure 1, wherein an area A represents a traditional puncture area, but blood vessels in the area cannot puncture the catheter normally for some reasons (such as being too thin). While the blood vessel in the B region has a larger diameter and is suitable for placing the catheter, the B region is not suitable for serving as an outlet fixing position of the catheter (for example, the position can often pull the catheter along with the movement of a human body). As shown in fig. 2, which is a post-catheter view of a tunneled PICC, the vascular puncture site is separated from the catheter exit, the puncture is made in region B, and the catheter exit is placed in region a through a subcutaneous tunnel.

Mainly comprising a tunnel needle and a catheter as shown in figures 3 and 7. The tunnel needle is solid, the length of the tunnel needle is 15cm, one end of the tunnel needle can be connected with a catheter, and the tunnel needle is made of medical stainless steel. The catheter is a single cavity and is made of medical silicon rubber. The catheter is divided into a proximal end, a distal end and a head end, and is respectively made of silica gel with different hardness, the proximal end is 60-80, the distal end is 40-60, the head end is 20-30, the hardness of the catheter part under the skin is higher than that of the intravascular part, and the intravascular part is higher than that of the head end part of the catheter. Wherein the proximal surface of the catheter is provided with a rifampicin antibacterial coating, and the rest part of the grafted heparin has an anticoagulation effect, as shown in figure 6.

Example 2

The tunnel needle is a solid type with radian, the length is 10cm, one end of the tunnel needle can be connected with a catheter, and as shown in figure 4, the tunnel needle is made of medical polypropylene. The catheter is a double-lumen catheter made of medical polyurethane, as shown in fig. 8. Wherein the inner surface of the proximal end of the catheter is 20cm and is loaded with a auranofin drug antibacterial coating, and the surface of the rest part of the catheter is grafted with a hexyl-hydroxyethyl-cellulose coating to play an anticoagulant role.

The method comprises the following specific operations: scanning femoral veins on both sides of a patient by using an ultrasonic machine to determine an optimal puncture side; the sterile zone is established according to the requirements of the aseptic technique. Puncture the femoral vein vertically under the guidance of ultrasound; it is generally recommended to make the puncture from near the trigone, just to the right of the junction of the greater saphenous vein and the femoral vein; inserting a guide wire and removing the puncture needle; after the tunnel puncture is finished, the catheter can be pushed along the tunnel, and then a 'double' tunnel is needed: a first tunnel from the planned catheter exit site to the mid-point of the groin; and the second tunnel is from the middle point of the groin to the side of the puncture site. The purpose of the "double" tunnel is to prevent the conduit from bending more than 90 °. The catheter is passed through the subcutaneous tissue using a suitable tunneling needle until it emerges from the puncture site adjacent the guidewire. The catheter is trimmed to the desired length (after leaving the length of the two channels in the vessel, the length of the other end traveling under the skin can be extended). The latter catheterization length can be obtained by measuring the distance between the puncture site and the umbilicus, since the body surface projection in the center of the inferior vena cava is the umbilicus.

Inserting a catheter sheath onto the guide wire, pulling out the dilator and the guide wire, and then inserting the catheter through the peripheral central venous catheter; fixing the catheter, sealing the middle tunnel part of the puncture part with medical glue such as cyanoacrylate glue, and bonding the outlet part to prevent blood leakage.

Example 3

The tunnel needle is hollow and 20cm in length, the catheter can extend the hollow lumen to pass through the subcutaneous tunnel, and as shown in fig. 5, the tunnel needle is made of medical stainless steel. The catheter has a three-cavity structure and is made of medical polyurethane, as shown in fig. 9. The surface of the catheter is not coated and the polyurethane catheter is distinguished by two different hardnesses, the part of the catheter under the skin being harder than the part inside the blood vessel.

Example 4

The tunnel needle is hollow, a tube cavity can pass through the catheter, and the tunnel needle is made of cobalt-chromium alloy. The catheter 2 is a double-cavity made of polytetrafluoroethylene. The surface of the catheter is only provided with the 2-methacryloyloxyethyl phosphatidylcholine coating, so that the anticoagulation effect is better.

Example 5

The tunnel needle is hollow, the catheter can extend the hollow tube cavity to pass through the subcutaneous tunnel, and the tunnel needle is made of medical stainless steel. The catheter is of a double-cavity structure and made of medical silicon rubber, as shown in figure 8. The surface of the catheter is only provided with the rifampicin antibacterial coating and is only made of silica gel with one hardness.

The method comprises the following specific operations: scanning and evaluating the upper limb by using an electrocardio-lead Doppler color ultrasound all-in-one machine; marking the puncture point position and the exit position; carrying out axillary vein puncture under ultrasonic guidance, inserting a guide wire after puncture is finished, and pulling out a puncture needle; inserting the extension wire into the catheter sheath; a tunnel needle is used for establishing a subcutaneous tunnel, the tunnel needle is hollow, and the catheter can pass through subcutaneous tissues along the inner cavity of the tunnel needle until the catheter appears from a puncture part close to a guide wire; trimming the catheter to a desired length; inserting a catheter sheath onto the guide wire, pulling out the expansion tube and the guide wire, and then inserting the catheter through the peripheral central venous catheter; in the process of placing the catheter, the electrocardio-lead Doppler color ultrasonic all-in-one machine is adjusted to an electrocardio mode, and the catheter head end is placed at a proper position by using an intracavitary electrocardiogram technology; the catheter is fixed and the puncture site and the catheter exit site are closed with medical glue.

While particular embodiments of the present invention have been described above, it will be understood by those skilled in the art that this is by way of illustration only, and that the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the spirit and scope of the invention, and these changes and modifications are within the scope of the invention.

Claims

1. A tunnel type peripherally-passed central venous catheter device is characterized in that the product mainly comprises a tunnel needle and a peripherally-passed central venous catheter; coarsening the tunnel needle, and developing clearly under ultrasound; the peripheral central venous catheter is divided into a near end, a far end and a tip end, the three parts are different in hardness, and the near end is larger than the far end and the tip end is larger than the tip end; the surface of the near end of the peripheral central venous catheter is coated with an antibacterial coating, and the surface of the far end of the peripheral central venous catheter is coated with an anticoagulant coating; when the catheter is placed, a tunnel type method is adopted, and a subcutaneous tunnel is established, so that a certain distance is reserved between a blood vessel puncture point and an outlet of a peripheral central venous catheter;

coarsening the tunnel needle to add a reflector;

the tunnel needle is straight or has a radian of 10-20 degrees, and is made of medical stainless steel, cobalt-chromium alloy, polycarbonate or polypropylene;

the tunnel needle is divided into a solid type and a hollow type, and the hollow type comprises a needle tube, a needle core and a needle seat.

2. The tunneled peripherally inserted central catheter device as in claim 1, wherein the hollow type tunneling needle is constructed to tunnel subcutaneously through the hollow lumen leading through the peripherally inserted central catheter to an exit location; the solid tunnel needle is directly connected with the peripherally inserted central venous catheter, and the peripherally inserted central venous catheter is pulled to the outlet position together when the subcutaneous tunnel is established.

3. The tunneled peripherally inserted central catheter device as in claim 1, wherein the tunnelled needle is adjustable in length, selectively adjustable in several different lengths, ranging from 5 to 25cm, depending on the patient's characteristics and the tunneling requirements.

4. The tunneled peripherally inserted central catheter device as in claim 1, wherein the peripherally inserted central catheter is a single lumen or multi-lumen catheter and the catheter is made of silicone rubber, polyurethane or polytetrafluoroethylene for medical use.

5. The tunneled peripherally inserted central catheter device as claimed in claim 1, wherein the peripherally inserted central catheter is embedded in the lower skin portion and coated with an antibacterial coating of a material having a high hardness of 60-80A, a small hardness of 40-60A in the intravascular portion, and an anticoagulant coating on the surface of the catheter; the hardness of the catheter tip is smaller than 20-30A, and the stimulation damage to the vessel wall is reduced in the catheterization process.

6. The tunneled peripherally inserted central catheter device as in claim 1, wherein the antimicrobial coating is rifampin, nitrofurazone or auranofin and the anticoagulant coating is heparin or hexyl-hydroxyethyl-cellulose.

7. The tunneled peripherally inserted central catheter device according to claim 1, for use in the field of tunneled PICC catheterization, including axillary cavity axillary venipuncture catheterization, supraclavicular puncture catheterization of neonates and children, femoral venipuncture catheterization.