WO2006108336A1

WO2006108336A1 - Implantable administrating catheter

Info

Publication number: WO2006108336A1
Application number: PCT/CN2006/000354
Authority: WO
Inventors: Hongfan Sun; Tianjun Liu; Cunxian Song
Original assignee: Chinese Academy Of Medical Sciences Institute Of Biomedical Engineering
Priority date: 2005-03-31
Filing date: 2006-03-09
Publication date: 2006-10-19
Also published as: CN2776423Y

Abstract

A long-term implantable administrating catheter is provided. The catheter consisits of a flexible catheter(1) which the outside diameter is less than 1 mm, an injecting head(2) in which a crimp(5) is provided on its port, an airproof plug(4) and an injecting cap(6). The base end of the injecting head(2) is connected with one to four flexible catheter(s)(1), the airproof plug(4) can be inserted in the other end, a link-body intussusception sheath(8) of the top of the airproof plug(4) turnovers outwards from the injecting head(2), wrapping the injecting head(2) and the crimp(5). The injecting cap(6) is mantled on the outside of the injecting head(2).

Description

Buried drug delivery catheter

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an instrument for inserting a medium into a body, and more particularly to a catheter for administration. BACKGROUND OF THE INVENTION In the medical clinic, a flexible catheter can be inserted into the abdominal cavity through the abdominal wall, and then an anti-tumor drug or an anti-inflammatory drug is injected into the abdominal cavity through a catheter to achieve the purpose of treatment. There are also flexible catheters buried under the skin that meet the requirements for subcutaneous or intravenous administration. The above-mentioned drug delivery device, or drug delivery catheter, or cannula, cannot be retained for a long time, and must be removed after a certain period of use. If it continues to be used, the site needs to be replaced and re-intubated. This causes great pain and inconvenience to patients who need long-term injections of drugs, such as diabetes. Under normal physiological conditions, insulin is secreted from the pancreas, enters the liver through the portal vein, and then enters the peripheral blood circulation. The concentration gradient of insulin between the liver and the peripheral blood, the insulin concentration of the liver is higher than the insulin concentration of the peripheral blood. This physiological process ensures that the sugar absorbed from the digestive tract and entering the liver through the portal vein is first stored in the liver. If insulin is administered intravenously or subcutaneously, the concentration of insulin in the peripheral blood is higher than that in the liver. A large amount of insulin first exerts a physiological effect on the periphery, so that a large amount of sugar remains in the periphery, which leads to sugar metabolism and fat. Abnormal metabolism. Abnormalities in sugar and fat metabolism can cause vascular disease, which in turn leads to complications of diabetes. Therefore, although blood glucose can be precisely controlled by subcutaneous injection of insulin, the problem of diabetic complications cannot be completely solved. Diabetes patients through the intraperitoneal administration of insulin, insulin can be first absorbed by the mesenteric vein, into the hepatic portal vein and liver, more in line with physiological processes, is the development direction of insulin delivery. Since diabetic patients use insulin for long-term or even lifetime use, intraperitoneal administration must address the long-term or even permanent placement of the drug delivery catheter. The long-term placement of the catheter should solve four problems: (1) the catheter can not fall off; (2) the wound formed by the catheter through the skin surface should be well healed and not susceptible to infection. C3) For the aseptic administration operation, the pathogen does not enter the body from the administration port. (4) Little impact on the user's daily life. China Patent No. 2,824,424 discloses a patent for a "buried intra-abdominal drug delivery device" which consists of a needle socket and a base, the needle socket is a cylindrical body, and the upper end has a round table having an outer diameter larger than the cylinder body, and the sealing body Placed therein, a hole is formed in the center of the bottom of the cylinder; one end of the infusion tube is inserted into the hole; the base is a combination of a cylinder and a disc along the outer edge of the cylinder, and the guide tube is inserted into the center of the disc from the side of the base disc and the infusion tube is passed through . This patent solves the pain of skin and blood when the patient is injected every day. However, the base area for fixing is large, so that it is uncomfortable to the patient after being fixed in the abdominal cavity. Moreover, the infusion tube used is a tube of a general specification, and there is still a certain limit in the time of retention in the abdominal cavity. In order to be administered from the outside, the drug delivery catheter implanted in the body must be left in vitro. The various catheters currently used have an outer diameter of more than 1 mm, which has great damage to the body tissue, and the wound formed on the surface of the skin is large. It is difficult to closely combine the skin tissue with the catheter wall. Therefore, the patient is implanted and fixed. After that, the wound must be sterilized frequently and the catheter fixed state should be checked to avoid wound infection or catheter detachment. SUMMARY OF THE INVENTION The present invention is to provide a buried drug delivery catheter suitable for long-term use in order to solve the above-mentioned drawbacks of prior art intraperitoneal, intravenous or subcutaneous catheter administration. The utility model is realized according to the following technical solutions. The embedded drug delivery catheter comprises a flexible catheter 1 and a sealing plug 4 insertable into the drug injection head 2. After the sealing plug 4 is inserted into the injection head, a cavity is left at the bottom. The upper port of the injection head 2 has a flange 5, and the bottom end of the injection head 2 can be connected with 1-5 flexible conduits 1. The upper portion of the sealing plug 4 is a conjoined folding sleeve 8 with an outer diameter of less than 1 mm. . The embedded drug delivery catheter has a bottom end of the drug injection head 2 connected to at least two flexible catheters 1 , wherein the drug delivery head 2 can be circular, circular injection head There are two symmetrical positioning pins 3 in the lower part of the outer wall. The embedded drug delivery catheter has a drug injection head cap 6 disposed on the outer surface of the drug injection head 2, and two symmetrical positioning grooves 7 are formed in the lower part of the drug injection head cap, and the positioning groove 7 and the positioning pin 3 cooperate with each other to lock the position. The embedded drug delivery catheter, the drug injection head 2, may also be elliptical with a flange on its upper port. The embedded drug delivery catheter has a sealing plug 4 made of a resilient rubber-like material, and the folding sleeve 8 can be folded downward from the upper opening of the injection head. The shape of the sealing plug is the same as the shape of the inner cavity of the injection head. The embedded drug delivery catheter has a flexible catheter 1 made of a polymer material. The key to the utility model is to make the catheter with an outer diameter of less than 1 mm. Such a thin catheter greatly reduces the wound on the surface of the skin, and more importantly, the wound of the skin can heal quickly, and the skin tissue is tightly combined with the wall of the catheter. The biological effect of this small-diameter catheter makes the segment of the catheter passing through the surface of the skin not infected by the wound, and the catheter is not easy to fall off. At the same time, because the catheter is very thin, it is soft and less irritating to the human body. , has little impact on the patient's daily life, greatly reducing the suffering of the patient. Therefore, the utility model can be implanted in the body for a long time. The drug delivery catheter can be used in conjunction with a drug delivery pump for programmed on-demand administration. By substantially reducing the cross-sectional area of the catheter, the stimulation of the skin tissue by the catheter is reduced, but the drug resistance is increased and the flow rate of administration is reduced. If you encounter this problem, you can solve it by increasing the number of catheters. For example, four catheters having an outer diameter of 0.5 mm can be connected in parallel at the bottom end of the injection head, and each of them is buried in a different part of the body, so that a sufficient cross-sectional area can be ensured. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic longitudinal sectional front view of the utility model;

2 is a schematic structural view of the injection cap of the present invention; 3 and FIG. 4 are schematic views showing the bottom of the injection head of the other two embodiments of the present invention.

Marked in the figure

Flexible duct 2 .

3. Positioning pin 4 .

5 . Flanging 6 .

7. Positioning groove 8. Best mode for carrying out the invention The following is a detailed description of the utility model with reference to the accompanying drawings and the implementation of the injection-injection counter-example sealing agent - the plug head

The catheter for intraperitoneal administration of insulin includes a flexible catheter 1 having a diameter of 0.5 mm, a circular injection head 2, and a sealing plug 4 which can be inserted into the injection head and a cap 6 for injection. The injection head has a flange 5, and the lower part of the outer wall of the injection head has two symmetrical positioning pins 3, the bottom of the injection head 2 is connected with a flexible conduit 1, and the upper mouth is inserted into the sealing plug 4, and the upper part of the sealing plug 4 is The conical folding sleeve 8 and the folding sleeve 8 fold down to wrap the injection head 2 and the flange 5 so that the sealing plug is not easily moved off. The sealing plug can be replaced regularly. A cavity is left between the bottom of the injection head and the sealing plug, and the drug injection needle can be inserted into the sealing plug to inject the drug. The injection cap 6 with the positioning groove 7 is placed outside the injection head 2 to prevent contamination of the injection head. The positioning groove 7 cooperates with the positioning pin 3 to lock the position. The catheter is made of a biocompatible polyethylene material and the sealing plug is made of silicone rubber. This rationalized drug delivery catheter can be used in conjunction with an insulin injection pump for the purpose of programmed on-demand administration. Compared with subcutaneous and intravenous insulin administration, insulin intraperitoneal catheter injection of insulin will bring many advantages: (1) fast insulin absorption, high bioavailability, and significantly reduced insulin dosage; (2) easier to control insulin injection according to physiological requirements The amount of blood sugar control is more accurate, and it is not easy to cause hypoglycemia; (3) It does not cause disorder of sugar and fat metabolism, and avoids the occurrence of diabetic complications; (4) Avoid repeated acupuncture of the skin and reduce pain. (5) It is easy to use with insulin pump, which is beneficial for long-term programmed administration. Compared with the embedded insulin pump or the subcutaneous injection of the insulin pump, the design of the insulin pump combined with the intraperitoneal injection can be greatly simplified, and the manufacturing cost can be reduced. The drug delivery catheter can also conveniently inject the drug into other parts of the body such as the abdominal cavity or vein as needed. As shown in Fig. 3, the present invention may also have an embodiment in which the bottom of the injection head is connected to three or four flexible conduits. As shown in Fig. 4, the present invention may also have an embodiment in which the injection head is elliptical.

Claims

Rights request

1 . A buried drug delivery catheter comprising a flexible catheter (1) and a sealing plug (4) insertable into the injection head, wherein a cavity is left in the injection head after the sealing plug (4) is inserted therein The upper port of the injection head is provided with a flange (5), characterized in that the bottom end of the injection head (2) can be connected with 1-5 flexible conduits (1), and the upper portion of the sealing plug (4) is a reflexed portion of the joint The sleeve (8) has a flexible conduit with an outer diameter of less than 1 mm.

The implantable drug delivery catheter according to claim 1, characterized in that the bottom end of the drug injection head (2) is connected to at least two flexible catheters (1).

A buried drug delivery catheter according to claim 2, wherein the injection head (2) is circular, and the outer portion of the circular injection head has two symmetrical positioning pins (3).

4. The implantable drug delivery catheter according to claim 3, characterized in that the injection head (2) is provided with a drug injection cap (6) on the outside, and the injection cap (6) has two lower portions. A symmetrical positioning groove (7), the positioning groove (7) and the positioning pin (3) cooperate with each other to lock the position.

5. The implantable drug delivery catheter of claim 2, wherein the drug injection head (2) is also elliptical with a flange on the upper port.

The embedded drug delivery catheter according to claim 1, characterized in that the sealing plug (4) is made of a resilient rubber-like material, and the folding sleeve (8) can be lowered from the upper end of the injection head. Folded, the shape of the sealing plug (4) is the same as the shape of the inner cavity of the injection head (2).

7. The implantable drug delivery catheter of claim 1, wherein the flexible catheter (1) is made of a bismuth molecular material.