JP2004242957A - Subcutaneous embedding type access port - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a subcutaneous embedding type access port which is safely used for a long period of time without anxiety (1), reduced in its size to the utmost to be made inconspicuous from an appearance aspect and suppresses an after-pain to the utmost at the time of indwelling (2) and has an extremely simple structure and is also easy technically (3). <P>SOLUTION: Two access needles 8 are thrust in the access routes 2 of a port 1 so as to form an angle without becoming parallel and certainly fixed to a fixing appliance 10 such as a firm plate or the like outside the body to be fixed to the port. By this constitution, the access needles 8 can be certainly fixed, and it becomes unnecessary to provide a lock means to a port main body and thereby, the port can be made small. <P>COPYRIGHT: (C)2004,JPO&NCIPI

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a device (port) for accessing a blood vessel of a human (or animal) that can be implanted, and more particularly to an access device (port) for enabling a flow rate required for dialysis or plasma exchange.
[0002]
[Prior art]
The subcutaneously implantable access port is a widely used device, and is generally used for injecting a drug solution. Another use of subcutaneous implantable access ports has been proposed for artificial dialysis. Access ports for dialysis have already been developed in the United States and are now being used in actual medical settings. As a result, artificial dialysis patients can perform artificial dialysis by piercing a needle from a body surface into a vascular access port implanted under the skin without forming an arterial venous shunt. In general, a port for injecting a drug solution secures an access route to a body cavity by puncturing a needle into a silicon membrane (septum). In this case, the silicon film is thin and has a limit in self-healing power and durability. Therefore, unless a fine needle of 21 gauge or more is used, a hole is formed in the silicon film, which causes liquid leakage. On the other hand, in general, artificial dialysis uses a thick needle of 18 gauge or less in order to obtain a flow rate of 150 ml / min or more (especially about 400 ml / min in Europe and America). For this reason, when a conventional silicon membrane is used, an effective flow rate cannot be obtained with a fine needle of 21 gauge or more, and further, there is a high risk of complications such as lysis of blood cells and hemolysis. Has been advocated. However, an access port that does not use a silicon membrane has a pinhole-shaped access route that allows access by inserting a puncture needle from the body surface. A prevention mechanism is required.
[0003]
An access port having a backflow prevention mechanism that does not use a silicon film has been proposed for a long time, and has been put to practical use by Biolink Inc. (Japanese Patent Application No. 10-501557) and Baska Inc. (Japanese Patent Application No. 10-534589). I have. However, the access ports of both companies have problems with the stability and stability of the access needle. Regarding the fixability of the access needle, the blood flow required for dialysis is 150 ml / min or more, and the internal pressure of the port is increased, so that simply inserting the access needle into the access hole of the port may cause the punctured access needle. There is a high risk of falling off. If the access needle stuck in the port comes off, a major bleeding disaster will occur unless the dialysis circuit is stopped. Therefore, it is absolutely necessary to prevent the access needle from falling out of the port. For that purpose, it is necessary to establish a lock / fixing system for the access needle. BioLink and Baska ports have access needle locking and locking systems and backflow prevention mechanisms all inside the port. The locking / fixing system of these access needles prevents the access needle from coming off by tightening the access needle from around the port. Because this system relies on the frictional force between the access needle locking and securing system and the access needle, some security is guaranteed when the device is new. However, since normal dialysis uses 100 or more times a year, the safety guarantee is low for a port that has passed for many years. As another method, there is a method of fixing the access needle pierced in the port to the skin surface with tape, but there is a risk that the fixed tape may come off or the access needle may come off the port due to the subcutaneous movement of the port. Is very high. Furthermore, if the access needle locking / fixing system is incorporated in the port, the access needle locking / fixing system and the backflow prevention mechanism are necessarily created in the port, and the internal structure of the port is not very complicated. Did not get. Furthermore, in that case, since the lock / fixing system of the access needle and the backflow prevention mechanism are created in the port, the size of the port itself becomes very large and it is embedded under the skin, but it is noticeable in appearance, and the port is embedded. Cosmetic problems arose. Further, the large size of the port causes not only cosmetic problems but also a large invasiveness at the time of placement, which may cause a patient's discomfort and pain even after placement.
[0004]
[Problems to be solved by the invention]
A conventional access port that does not use a silicon film cannot replace the lock means because a lock and fixing system (hereinafter, lock means) for the access needle is provided in the port body. Had to be replaced. Further, the conventional locking means has a structure in which the needle is tightened from the surroundings, and since the fixing property of the needle depends on the frictional force between the needle and the one to be tightened, the frictional force for fixing the needle cannot be said to be reliable. In particular, when the port is used for dialysis, since the flow rate is 150 ml / min or more, it cannot be said that the locking means can withstand an increase in the internal pressure, and the situation is extremely dangerous. In addition, those used for many years have a low safety because the device is deteriorated, and the danger is further increased. Therefore, realization of an access port that can be used safely and for a long period of time is a first problem.
[0005]
Next, since all of the locking means and the backflow prevention mechanism are provided in the port, the size of the port itself becomes larger than the port for injecting the drug solution, which is a cosmetic problem, and furthermore, the invasion at the time of indwelling However, pain after placement was a problem. Therefore, the second problem is to realize an access port that is as small as possible in size, is not noticeable in appearance, and minimizes the pain during placement.
[0006]
Next, a backflow prevention mechanism for preventing backflow that occurs when a needle is removed is indispensable for an access port not using a silicon film. When all of the locking means and the backflow prevention mechanism are provided in the port, the backflow prevention mechanism and the needle fixing function need to be linked well to ensure smooth access. For this reason, it had to be a very complicated internal structure, and it took enormous technology to realize it. As a result, the unit price of the port itself has risen, and the device has to be far from solving the problems of high-priced medical care surrounding today. Therefore, the realization of an access port that has a very simple structure and is technically easy is a third problem.
[0007]
[Means for Solving the Problems]
The access port in the present invention performs liquid removal and liquid return (liquid supply) for the purpose of extracorporeal treatment of a liquid such as dialysis or plasma exchange, or extracts a liquid from the body or supplies a liquid to the body. A subcutaneous implantable access port that is directly or indirectly joined to a tissue such as a blood vessel. This device allows intermittent access to a target organ such as a blood vessel or abdominal cavity by piercing an access needle from the body surface into an access route of the device.
[0008]
As a basic structure of the access port in the present invention, the port is an access port that can be repeatedly accessed by an access needle, an access pipe, or the like, an access route for an access needle or the like to enter, and a port inside the port when not accessed. A backflow preventing mechanism for preventing backflow to the outlet, an outlet, and a relay path connecting the access route and the outlet. That is, the port basically includes an access port, an access route, a backflow prevention mechanism, a relay path, and an outlet. In the present invention, it is desirable to use a port having two access routes for liquid removal and liquid return (liquid supply). The two access routes are basically relayed independently to separate outlets.
[0009]
A tube for maintaining communication with a target organ such as a catheter or a cannula is attached to an outlet portion of the port, and the tip of the tube is located in a target organ for liquid treatment such as a blood vessel or abdominal cavity.
[0010]
The port has a continuous lumen from the access port to the access route, the backflow prevention mechanism, the relay path, and the outlet when the backflow prevention mechanism is open, and the liquid can flow. The access port is an opening of the access route in the port to the outer surface of the port, and enables access to the port by an access needle. That is, the access needle is inserted from the access port to the access route. Further, the lumen from the access port to the access route, the backflow prevention mechanism, the relay path, and the outlet is preferably a substantially straight structure, a gentle curved structure, or a bent or curved structure. It is desirable that the access port has little change in the cavity and minimizes the flow resistance.
[0011]
Furthermore, even when the access needle is inserted into the port, the lumen from the access needle to the access route, backflow prevention mechanism, relay path, and outlet is substantially straight, has a gentle curved structure, or has a bent or curved structure. It is desirable that the port has almost no change in the port lumen and that the access port minimizes the flow resistance.
[0012]
It is desirable that the liquid does not flow back into the port or leak out of the port even when the access needle is inserted into or removed from the access port. Specifically, with the access needle inserted into the port, a backflow prevention mechanism and a hermetic seal between the access needle and the port main body including the access route are required. Further, specifically, it is necessary that the port body including the backflow prevention mechanism in a state where the access needle is not inserted into the port, a tube such as a catheter to be connected to the port, and the port connection portions thereof be hermetically sealed. Especially when the access needle is not inserted into the port, that is, when the access needle is not being accessed, the backflow prevention mechanism must establish a seal, block the body cavity and the access route, and prevent the liquid from flowing out of the port. No.
[0013]
In addition, the access port requires a means for locking and fixing the access needle so that the access needle inserted into the port is not accidentally removed. Therefore, the present invention proposes that the access needle locking means be provided outside the port. In order to secure the access needle outside the port, the two access needles are pierced into the access route of the port at an angle, not parallel, respectively. That is, the two access routes of the port are arranged such that the angle formed by the two access needles is within the range of 1 to 359 degrees. The two access needles pierced at an angle are securely fixed to a fixture such as a strong plate outside the body. The angle formed by the two access needles is preferably from 10 degrees to 180 degrees. More preferably, the angle is from 20 degrees to 150 degrees.
[0014]
This forces the two access needles to pull out of each other via the needle, the fixture and the port, so that the access needle will never come off as long as the access needle is fixed to the plate. It must have a strong structure including the port body, the access route, the access needle, and the fixture so that the angle formed by the access needle does not change when two access needles are inserted. Further, the fixing tool may have a structure capable of absorbing an impact applied to the access device as long as the access needle inserted into the port does not come off.
[0015]
Specifically, the access needle and the fixing device of the access needle are securely fixed to each other by a projection structure (or a depression structure) provided on a stem portion of the access needle and a depression structure (or a projection structure) provided on the fixing device. Is done. The method for fixing the access needle to the fixture is not limited to the above-described method as long as it can be fixed securely. The access needle and the fixture are made of a strong material and are not easily damaged by artificial force. After the access needle is inserted into the port from the body surface, the access needle is securely attached to the fixture by the projection and the recessed structure (or the recessed and projected structure). The fixing device and the access needle are securely fixed by the access needle fixing cover in order to further secure the fixing. Further, the fixing tool may be a single one or a plurality of pieces. For those divided into a plurality of pieces, an access needle is fixed to each piece, and the plurality of pieces are connected. It is preferable that a groove is provided on the needle fixing surface of the fixing tool according to the shape of the access needle to be fixed. By fixing along this groove, the angle between the access needle and the plate does not change due to an artificial force.
More preferably, the fixing device is provided with a cover member for the access needle so that the access needle fixed to the fixing device does not easily come off.
[0016]
Since the two access needles inserted into the port have an angle greater than or equal to each other, a force in a direction perpendicular to the axis of the port cancels each other through the fixture. The force in the direction parallel to the port axis is absorbed by the needle and the port body. That is, the force which tries to pull out the needle to the port, the needle, and the fixture is dispersed. Furthermore, as the angle formed by the access needle approaches 180 degrees from 0 degrees, the rate of canceling the force of the needle coming off through the plate increases. The access needle is inserted into the port to a sufficient depth to prevent the access needle inserted in the access route and fixed to the fixture from being shaken by an external force.The inner diameter of the access route is the same as the outer diameter of the access needle. Must be almost equally attached.
[0017]
As described above, the outlet section and the relay path from the access route are continuous with a straight line or a gentle curve in order to reduce the flow resistance. Further, when the port outlet and the liquid route are straight, the route for draining and returning (liquid supply) may be three-dimensionally crossed.
[0018]
Further, the access port in the present invention needs to be equipped with a backflow prevention mechanism in the port. The backflow prevention mechanism is any of a valve structure that opens and closes by inserting and removing an access needle, an access pipe, or the like into an access port, and a conduit clamp body that opens and clamps by inserting and removing an access needle. May be used.
[0019]
The backflow prevention mechanism may be any type of the backflow prevention mechanism that opens and closes by directly touching an access needle, an access pipe, or the like, or the backflow prevention mechanism that has a link mechanism that opens and closes indirectly. A specific example of these is that of a biolink company (Japanese Patent Application No. 10-501557) which proposes a type in which an access needle directly opens a check valve. A good example is that of Baska (Japanese Patent Application No. 10-534589), which proposes a form in which a conduit clamped through a connector is opened. In addition, the backflow prevention mechanism may be of any type as long as the structure allows the flow of liquid by inserting an access needle or the like, and prevents the flow of liquid by removing the access needle. Absent.
[0020]
The backflow prevention mechanism in the present invention does not need to have a lock means for the access needle, and may have only the function of opening the access needle in a very simple manner and closing it when the access needle is removed.
[0021]
Further, in order to realize more secure access, a port backflow prevention mechanism is used when an access needle is inserted into both access routes or when an access needle is inserted into two access routes simultaneously. It is desirable that the ports are both opened by the backflow prevention mechanisms belonging to one access route. In this case, it is desirable that the backflow prevention mechanism is closed when the access needle is inserted into only one of the routes.
[0022]
More specifically, by integrating, connecting, or interlocking the backflow prevention mechanisms belonging to the two access routes, when the access needle is inserted in both the access routes, or when the two access routes are simultaneously accessed. It is desirable that the backflow prevention mechanisms belonging to the two access routes be both open ports when the needle is inserted. Preferably, a port having a function of closing both of the backflow prevention mechanisms even if one of the access needles is removed from the access route among the access needles inserted into the two access routes may be used.
[0023]
A specific example of these is Baska, which proposes a form in which a backflow prevention mechanism belonging to the other access route is closed via a link mechanism when one of the access needles is withdrawn in a dual port (see Table 1). 2001-525701) is a good example.
[0024]
Preferably, the check valve has a structure that matches the shape of the distal end of the access needle in order to facilitate insertion of the access needle. The check valve can be opened and closed efficiently.
[0025]
Also preferably, the port desirably has a structure for preventing the access needle from entering beyond a certain amount in the port, and the structure includes an access route, a backflow prevention mechanism, and a relay path connecting the access route and the outlet. The access needle is inserted into the port only to a certain depth by the structure. The structure for preventing the access needle from entering is configured to match the outer surface of the access needle, for example, the port lumen is tapered in a tapered shape even if the port lumen is narrowed by the thickness of the access needle. It may be of a type that prevents the access needle from entering. As a specific example of these, a biolink company (Japanese Patent Application No. 10-501557), which proposes a form for preventing the access needle from entering with a structure that matches the tip of the access needle, is a good example. .
[0026]
Further, as a preferable structure of the port, an access needle guide is arranged around the access port so that the access needle can be securely inserted into the access route from the access port without penetrating the subcutaneous tissue on the body in contact with the access route. It is desirable to be installed. It is desirable that the access needle guide is provided with a groove for facilitating the access needle to be guided from the access port to the access route. Further, it is desirable that the groove is continuous with the access route and that the groove smoothly transitions to the access route without any step. If the access needle pierced from the body surface advances along the groove provided in the access needle guide, the access needle is securely inserted into the access route. That is, the presence of the access needle guide and the groove facilitates access to a port which is embedded under the skin and cannot be confirmed from the body surface.
[0027]
As a specific example, the access needle guide has a disk-shaped access needle guide protruding from the port body bottom side around the access port, and the access needle guides the access guide from the access port to the access route. Since the groove for facilitating the access is provided, the access needle can easily enter the access route.
[0028]
Also, in order to insert the access needle from the body surface to the access route, it is necessary to aim at the pinpoint. For this purpose, it is desirable that the port body be processed such as a protrusion or a recess as a marker for knowing the position of the access route from the body surface. The position of the needle insertion part can be grasped by indirectly touching this marker from the body surface. As a result, the access needle can more reliably access the access route. The access route of the port is desirably arranged slightly obliquely upward with respect to the skin surface so as to facilitate puncturing and insertion from the skin surface.
[0029]
In addition, it is desirable that the access port of the port, the access route, and the backflow prevention mechanism are arranged so that the access needle passes smoothly. In the access port of the present invention, since the lock and fixation mechanism of the access needle is provided outside the port, it is not necessary to lock and fix the access needle inside the port. Therefore, it is desirable for the access needle to pass smoothly through the port, and this allows for smoother access to the port. As a means for arranging the access needle to pass smoothly, the access port of the port, the access route, and the surface of the backflow prevention mechanism may be coated so as to reduce frictional resistance with the access needle.
[0030]
As another arrangement means for allowing the access needle of another type to pass smoothly, a rotating body such as a ball or a wheel is provided in an access port of a port or an access route, and the access needle is rotated by rotation of the rotating body. A system in which the traffic passes smoothly may be used.
[0031]
The body of the port is made of a material that does not easily penetrate the needle, and is made of a material that is not easily deformed by an artificial external force.
[0032]
Further, the access route, the backflow prevention mechanism, and other structures in the port are made of a material that can withstand frequent access by the access needle.
[0033]
When removing the access needle, the inside of the port and the catheter is supplemented with an anticoagulant to remove the access needle.
[0034]
The access port is preferably implanted under the skin, but a part of the port may be exposed outside the body.
[0035]
The access needle used in the present access system may be a single lumen hollow needle structure or an inner-outer type needle structure. In the case of the inner-outer type, the inner type may have a hollow structure or a solid structure.
[0036]
Here, an example of the present invention having two access routes suitable for dialysis has been described. However, as another application, two or more access needles are inserted into a port having two or more access routes, and The two or more access needles make an angle of 1 degree or more and 359 degrees or less, and all of those that simultaneously fix two or more access needles selected from any one of them to the fixture are included in the present invention. When fixing to a fixture, two non-parallel access needles may be fixed simultaneously with a parallel access needle.
[0037]
Further, by directly or indirectly connecting two or more ports having one or more access routes, two or more access routes selected from them form an angle of 1 degree or more and 359 degrees or less. Such a format is acceptable.
[0038]
Further, in the present apparatus, an arbitrary route can be used as a liquid removal route and a liquid return (supply) route. For example, all routes can be used as a drainage route or a return (liquid supply) route. In addition, a liquid removal route and a liquid return (liquid supply) route can be used as required.
[0039]
In addition, it goes without saying that the present invention can be used not only in liquid treatment such as hemodialysis, peritoneal dialysis, plasma exchange, extracorporeal treatment, extracorporeal circulation, but also for drug solution injection, drainage, and the like. That is, the present invention can be used for all systems that extract liquid from the body or supply liquid to the body.
[0040]
The flow rate when using the device of the present invention is not particularly limited, but is preferably from 50 ml / min to 500 ml / min, more preferably from 100 ml / min to 250 ml / min.
[0041]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, an embodiment of the present invention will be described with reference to FIGS. 1 to 7.
[0042]
1 to 4 show a preferred embodiment of the port 1 in the present invention.
The access route 2 is continuous from the access port 3 of the port 1 to the inside of the port 1, and the two access routes 2 of the port 1 are arranged so as to form about 120 degrees. The port 1 includes two access ports 3 that can be accessed by an access needle 8 from the body surface, and outlets 6 corresponding to the respective access ports 3. An access needle guide 4 protrudes from the port 1 bottom surface side of the port 1 as a means for easily inserting the access needle 8 into the access port 3. The access needle guide groove is a groove of the access needle guide 4. The access needle guide groove 5 allows the access needle 8 to smoothly access the access port 3. The access needle guide groove, access port, and access route are smoothly continuous without any steps.
[0043]
5 and 6 show a preferred embodiment of the access needle 8 and the access needle fixing member 10 according to the present invention.
An access needle fixing member mounting portion 9 is provided near the base of the access needle 8. The access needle fixing member mounting portion 9 has a structure that matches the access needle fixing portion 11 of the access needle fixing member 10. The access needle fixing member 10 has an access needle fixing portion 11 for fixing the access needle 8. Further, the access needle fixing member mounting portion 9 and the access needle fixing portion 11 may be securely fixed to each other by an uneven structure, a notch structure, a cover member, or the like.
[0044]
FIG. 7 shows a preferred embodiment of the present invention.
The access needle 8 inserted into the two access routes 2 forming about 120 degrees is fixed by an access needle fixing member 10. As a result, the force with which the access needle 8 tends to come off is canceled by the port 1, the access needle fixing member 10, and the access needle 8. The catheter 7 connected to the port 1 has two lumens and corresponds to each access route 2. The other end of the catheter 7 is located in a body lumen.
[0045]
In addition, two catheters 7 each having one lumen may be independently connected to each outlet 6. Further, when the other ends of the two catheters 7 are arranged in the same blood vessel, a blood removal route is used for blood flow in order to perform blood removal efficiently without mixing blood return with blood removal as much as possible. Is desirably located upstream of the catheter tip in the blood return route.
[0046]
The port backflow prevention mechanism is that of Biolink (Japanese Patent Application No. 10-501557), which proposes a type in which the access needle directly opens the check valve, or through the link mechanism by inserting the access needle. It is desirable to follow that of Baska (Japanese Patent Application No. 10-534589) which proposes a form in which the conduit is opened by being clamped.
[0047]
In addition, the backflow prevention mechanism is not limited to a structure in which the flow of the fluid is enabled by inserting the access needle and the flow of the fluid is prevented by removing the access needle.
[0048]
Further, in order to realize more secure access, when one access needle is pulled out of the dual port as proposed by Baska (Tokuhyo 2001-525701), the other access route 2 is connected via the link mechanism. A method may be adopted in which the backflow prevention mechanism to which the device belongs is closed.
[Brief description of the drawings]
FIG. 1 is a plan view showing a preferred embodiment of a port 1 main body of the present invention.
FIG. 2 is a dotted line showing an access route 2 extending from the access port 3 to the inside of the port 1;
FIG. 3 is a side view showing a preferred embodiment of the port 1 main body of the present invention.
FIG. 4 is a sectional view taken along line AA ′ in FIG. 2; Further, an access needle 8 inserted from the access port 3 to the access route 2 is shown.
FIG. 5 is a plan view showing a preferred embodiment of the access needle 8 of the present invention.
FIG. 6 is a plan view showing an embodiment of a preferred access needle fixing member 10 of the present invention.
FIG. 7 is a plan view showing a preferred embodiment of the present invention.
[Explanation of symbols]
1 port
2 access route
3 access port
4 Access needle guide
5 Access needle guide groove
6 outlets
7 catheter
8 Access needle
9 Access needle fixing member mounting part
10 Access needle fixing member
11 Access needle fixing part

Claims (14)

An access port for percutaneously accessing a body lumen, comprising two access routes, wherein an angle formed by two access needles inserted into each access route is from 1 degree to 359 degrees. Subcutaneously implantable access port, characterized in that an access route is provided in the access port. The subcutaneous implantable access port according to claim 1, wherein the angle formed by the two access needles is 10 to 180 degrees. 3. The subcutaneously implantable access port according to claim 1, wherein the two access needles inserted into the two access routes are fixed to a fixing member so as to maintain a fixed angle. An access needle fixing member comprising an access needle fixing member and one or a plurality of members processed so as to fit the access needle in order to simultaneously fix two access needles. . The two access routes include a backflow prevention mechanism that can be opened and closed. The subcutaneous implantable access port according to any one of claims 1 to 4, further comprising a backflow prevention mechanism. The subcutaneous implantable access port according to claim 5, wherein the backflow prevention mechanism has a valve structure. 6. The access port according to claim 5, wherein the backflow prevention mechanism has a structure in which a flexible conduit is clamped. The subcutaneous implantable access port according to any one of claims 5 to 7, wherein the access port is a backflow prevention mechanism that is opened by direct contact with the access needle. The subcutaneous implantable access port according to any one of claims 5 to 7, further comprising a backflow prevention mechanism that is indirectly opened via a link mechanism by insertion of an access needle. The subcutaneous implantable access port according to any one of claims 5 to 9, further comprising a backflow prevention mechanism that opens when two access needles are present in respective access routes at the same time. The subcutaneous implantable access port according to any one of claims 5 to 9, further comprising a backflow prevention mechanism that is opened by simultaneously inserting two access needles into respective access routes. The subcutaneous implantable access according to any one of claims 5 to 11, further comprising a backflow prevention mechanism that closes two access routes when one of the two access needles is not present in the access route. port. The subcutaneous implantable access port according to any one of claims 1 to 12, further comprising an entry preventing function for preventing an access needle from entering the subcutaneous implantable access port more than a certain amount. 14. The subcutaneous implantable access port according to claim 1, further comprising a cover member that covers the access needle fixed by the access needle fixing member.

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