CV port

Abstract

To provide a CV port that can be protected from breakage against high-pressure given to the inside of it and allows a risk of breakage to be easily detected beforehand.SOLUTION: A CV port 1 has: a resin container 2 that is vertically divided into two pieces, a lower-side container part 2b and an upper-side container part 2a; a space 3 formed in the container 2; a metal cup 4 that is disposed in the space 3 and has its top opened; a connection tube 5 that is connected to the cup 4 and extends to the outside of the container 2; and a septum 6 that is fitted into the upper-side container part 2a so as to cover the space 3 and the cup 4 from above.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a subcutaneously implanted port, which is a type of central venous catheter, namely, a CV port. [Background technology]

[0002] CV ports are known that are implanted in the human body to administer medicines or drip in necessary nutrients (see, for example, Patent Document 1). A CV port has a container that is approximately circular in plan view and has a diameter of about 2 cm to 3 cm, and a septum made of silicone rubber that functions as a lid for the container. A Huber needle, which is a special needle, is inserted into the septum, and a specific medicine is poured into the container. The container is further connected to a catheter, and the medicine is supplied into the body via the catheter.

[0003] CV ports are generally used to deliver medicines to the large blood vessels that lead to the heart, so they are often implanted under the skin of the chest, but in some cases they may be implanted under the skin of the arm. Using this CV port allows medicines to be delivered subcutaneously, which reduces the risk of infection and also allows the patient to take a bath, among other benefits. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2012-76250 A Summary of the Invention [Problem to be solved by the invention]

[0005] However, when the drug is supplied into the container, the pressure inside the container can reach a maximum of 2.1 MPa (300 psi), and in some cases even more. The containers, which are small in size to be implanted in the body, are made of resin and may not be able to withstand such pressure. In this case, there is a concern that the container may break and the drug or other substances may leak directly into the body, so it is necessary to be very careful when using it.

[0006] The present invention has been made in consideration of the above-mentioned conventional technology, and has an object to provide a CV port that can prevent damage caused by high pressure being applied inside, and that can easily detect damage in advance even if it is suspected that it may occur. [Means for solving the problem]

[0007] In order to achieve the above-mentioned object, the present invention provides a CV port comprising: a resin container divided into two parts in the vertical direction, consisting of a lower container part and an upper container part; a space formed within the container; a metal cup disposed within the space and open at the top; a connecting tube connected to the cup and extending toward the outside of the container; and a septum fitted into the upper container part, covering the space and the top of the cup.

[0008] Preferably, the cup is formed from a metal foil having a thickness of 150 μm or more and 200 μm or less, and a side gap is formed between the side surface forming the space and the side surface of the cup, and a bottom gap is formed between the bottom surface forming the space and the bottom surface of the cup.

[0009] Preferably, the bottom surface of the cup has a flat shape, and the apparatus further includes a sensor attached in the bottom gap in contact with the bottom surface of the cup for detecting distortion of the bottom surface of the cup.

[0010] Preferably, a cushioning material made of an elastic material is disposed in the side gap.

[0011] Preferably, the connecting pipe is directly attached to the cup by welding, and the connecting pipe and the container are not threadedly engaged at the portion disposed within the container.

[0012] Preferably, the floor surface in the cup and the bottom of the pipe in the connecting pipe are formed on the same straight line. Effect of the Invention

[0013] According to the present invention, since a metal cup is disposed in the space formed in the container, even if a medicine or the like is supplied from the Huber needle into the container and the pressure inside the container becomes high, the pressure is not applied directly to the container, but is first received by the metal cup. In other words, the resin container can be protected from high pressure by the highly pressure-resistant metal cup, and therefore damage to the container can be prevented.

[0014] In addition, by forming the cup from a metal foil with a thickness of 150 μm to 200 μm, the cup easily expands (distorts) when pressure is applied. At this time, by forming side gaps and bottom gaps, the cup can be prevented from contacting the inner surface of the space when it expands, and damage to the cup can be prevented.

[0015] In addition, by making the bottom surface of the cup flat, it is possible to easily detect the distortion (bulge) caused when pressure is applied to the inside of the cup. By attaching the sensor so that it is in contact with the bottom surface of the cup, the distortion of the cup can be detected accurately.

[0016] Furthermore, by providing a cushioning material in the side gap, it is possible to prevent the side of the cup from coming into direct contact with the inner surface of the space and being damaged when the cup expands.

[0017] In addition, by directly attaching the connecting pipe to the cup, it is not necessary to later connect the connecting pipe from the outside of the container by screwing it in. This eliminates the need to form a screw thread on the container or to thread the connecting pipe accordingly, improving productivity. In addition, since the container is not threaded, there is no loss of strength and the container can be prevented from being damaged.

[0018] In addition, since the floor of the cup and the bottom of the connecting tube are aligned in the same line, the medicine in the cup can be easily delivered to the body through the connecting tube, preventing the medicine from pooling in the cup. [Brief description of the drawings]

[0019] [Figure 1] 1 is a schematic cross-sectional view of a CV port according to the present invention. [Diagram 2] 1 is a schematic external view of a CV port according to the present invention. FIG. [Diagram 3] 1 is a table showing the hardness of the metal material forming the cup. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] As shown in FIG. 1 and FIG. 2, the CV port 1 according to the present invention includes a resin container 2 divided into two parts in the vertical direction. The container 2 is formed by joining an upper container part 2a and a lower container part 2b in the vertical direction. The upper container part 2a is substantially cylindrical in shape and is open in the vertical direction. The lower container part 2b is substantially cylindrical in shape with a closed bottom and is open in the upward direction. When the upper container part 2a and the lower container part 2b are joined together, a space 3 is formed in the container 2. A metal cup 4 is disposed in this space 3. As the metal material, various metals can be used, but titanium-based metals, more preferably pure titanium, can be used. The cup 4 is substantially cylindrical in shape with one end closed, and therefore is open on the upper side. A connection pipe 5 extends from the cup 4 toward the outside of the container 2. Specifically, the connection pipe 5 is welded and connected to the cup 4, and a through hole 4a is formed in the side wall of the cup 4 to communicate with the connection pipe 5. A septum 6 made of silicone rubber is fitted into the upper container portion 2a. The space 3 and the upper portion of the cup 4 are closed by this septum 6.

[0021] In this manner, the CV port 1 according to the present invention has a metal cup 4 disposed in a space 3 formed in a container 2. Therefore, a Huber needle (not shown) inserted into a septum 6 is introduced into the cup 4, and a medicine or the like is supplied into the cup 4. At this time, even if a high pressure is applied by supplying a medicine or the like, this pressure is not directly applied to the container 2, but is first received by the metal cup 4. In other words, the resin container 2 can be protected by the highly pressure-resistant metal cup 4 due to the application of high pressure, and therefore damage to the container 2 can be prevented. In order to ensure that the Huber needle is inserted into the cup 4, a position that fits into the upper opening of the cup 4 may be made prominent as an insertion area 6a on the upper surface of the septum 6. In the figure, a convex portion 6b is provided around the insertion area 6a to make the boundary prominent.

[0022] Here, the cup 4 is formed of a metal foil, for example, pure titanium, having a thickness of 150 μm or more and 200 μm or less. A side gap 3a, which is a gap, is formed between the side surface of the cup 4 and the side surface forming the space 3. A bottom gap 3b, which is a gap, is formed between the bottom surface of the cup 4 and the bottom surface forming the space 3. In this way, by forming the cup 4 with a metal foil having a thickness of 150 μm or more and 200 μm or less, the cup 4 easily expands (distorts) when pressure is applied. At this time, by forming the side gap 3a and the bottom gap 3b, the cup 4 can be prevented from contacting the inner surface of the space 3 when the cup 4 expands, and damage to the cup 4 can be prevented. Therefore, the side gap 3a and the bottom gap 3b are designed to have a width that allows the cup 4 to tolerate the amount of deformation when it expands due to pressure.

[0023] In addition, the bottom of the cup 4 may be thickened because it is the part where the Huber needle hits many times. This thickness was verified. As shown in FIG. 3, both H material, which is a hard material that has been subjected to work hardening treatment, and O material, which is an annealed material that has been annealed, were prepared as metal materials forming the cup 4. The thicknesses of these materials were changed, and metal sheet materials were prepared as follows: (A) H material with a thickness of 50 μm, (B) O material with a thickness of 50 μm, (C) H material with a thickness of 100 μm, (D) O material with a thickness of 100 μm, (E) H material with a thickness of 150 μm, (F) H material with a thickness of 200 μm, and (G) O material with a thickness of 300 μm.

[0024] The Vickers hardness (Hv) of these (A) to (G) was measured using the average of a 5-point evaluation. As a result, (A) had the highest hardness of 234Hv, followed by (C) at 225Hv. This is because the thinner part of the H material was rolled, making it harder. On the other hand, the Vickers hardness of the O material was lower than that of the H material at both thicknesses of 50μm and 100μm.

[0025] Furthermore, since Huber needles are often made of SUS material (SUS304), a blade made of this SUS material was used to press against the metal sheet materials (A) and (C). In this case, holes were sometimes made in (A), but holes were made in (C) when the blade was pressed with a considerable force. This means that regardless of the Vickers hardness, if the metal foil is thin, holes will simply be made. In other words, this means that even if the metal material is rolled to improve its hardness, it is not preferable to apply it to situations where the Huber needle is pierced multiple times, as in the present invention.

[0026] On the other hand, when an aluminum stapler was used to stab the paper, holes were made in both (A) and (C). However, no holes were made in (E), (F), and (G).

[0027] From the above, if the bottom of the cup 4 has a thickness of at least 150 μm, it can be expected to have sufficient strength against repeated punctures with a Huber needle. On the other hand, a thickness of 300 μm results in a large weight. Since it is preferable for the CV port 1 to be lightweight, taking this weight into consideration, it is preferable to have a thickness of 200 μm or less.

[0028] The bottom surface of the cup 4 is formed in a flat shape. The sensor 7 is attached in contact with the bottom surface of the cup 4. That is, the sensor 7 is housed in the bottom gap 3b. The sensor 7 is a strain sensor and is used to detect the strain of the bottom surface of the cup 4. By making the bottom surface of the cup 4 flat in this way, the strain (bulge) when pressure is applied to the inside of the cup 4 can be easily detected. By attaching the sensor 7 in contact with the bottom surface of the cup 4, the strain of the cup 4 can be accurately detected. Here again, as described above, the significance of forming the cup 4 from a metal foil of 150 μm to 200 μm is important. This is because a fairly thin metal foil is more suitable for accurately and easily measuring the amount of strain of the cup 4 by the sensor 7. Note that this value is set not only in consideration of the ease of measuring the amount of strain, but also in consideration of the prevention of damage due to contact with a Huber needle, and further in consideration of the ability to withstand pressure due to the supply of medicines, etc. Furthermore, forming the cup 4 from such a thin metal foil can also contribute to reducing the weight of the CV port 1 that is placed inside the body.

[0029] The distortion of the cup 4 can be detected by the sensor 7 in various ways. For example, two types of lamp units (not shown) may be prepared to indicate when an allowable pressure is applied to the cup 4 and when the pressure is applied to a level that breaks the cup 4. The practitioner adjusts the supply speed and supply amount of the medicine while watching the lamp unit. The lamp unit may be attached to a syringe with a Huber needle so that the practitioner can easily check. For communication between the lamp unit and the sensor 7, a communication device may be provided in the sensor 7, or may be separately accommodated in the side gap 3a or the bottom gap 3b. The power source of the sensor 7 may be a battery disposed in the side gap 3a or the bottom gap 3b, or power may be supplied from the outside by radio waves.

[0030] In addition, a cushioning material 8 made of an elastic material may be disposed in the side gap 3a. This cushioning material 8 may be made of the same material as the septum, for example. This does not increase the number of materials used in manufacturing the CV port 1. By disposing the cushioning material 8 in the side gap 3a in this manner, it is possible to prevent the side surface of the cup 4 from coming into direct contact with the inner surface of the space 3 and being damaged when the cup 4 expands.

[0031] As described above, the connection tube 5 is directly attached to the cup 4 by welding. The connection tube 5 extends inside the container 2 and its tip is exposed to the outside. Here, the portion where the connection tube 5 is disposed inside the container 2 is not threaded. That is, the connection tube 5 and the container 2 are not screwed together. In other words, the outer surface of the connection tube 5 inside the container 2 is a smooth surface without unevenness, and the inner surface of the container 2 corresponding to this is also a smooth surface without unevenness. Specifically, a linear groove is formed in the lower container part 2b, and the connection tube 5 is disposed in this groove. Then, in this state, the upper container part 2a is placed over the connection tube 5 and the connection tube 5 is disposed in the container 2. In order to restrict the movement of the connection tube 5 in the axial direction, a wide locking part 5a is formed at the tip of the connection tube 5. Further toward the tip side from the locking part 5a, a connection part 5b for connecting to a catheter (not shown) is formed. The connecting pipe 5 is merely sandwiched between the upper container portion 2a and the lower container portion 2b, and is only held in place by this action.

[0032] In this way, by directly attaching the connecting pipe 5 to the cup 4, it is not necessary to later connect the connecting pipe 5 from the outside of the container 2 by screwing or the like. This eliminates the need to form a screw thread on the container 2 or to thread the connecting pipe 5 accordingly, improving productivity. Furthermore, since the container 2 is not threaded, there is no decrease in strength, and damage to the container 2 can be prevented. This effect, combined with the provision of the cup 4, contributes to further improving the effect of preventing damage to the container 2.

[0033] In addition, the floor surface 4b in the cup 4 and the bottom 5c of the conduit in the connecting tube 5 are formed on the same straight line. That is, the floor surface 4b and the bottom surface of the connecting tube 5 are formed on the same plane. In this way, since the floor surface 4b in the cup 4 and the bottom 5c of the conduit in the connecting tube 5 are on the same straight line, the medicine in the cup 4 is easily supplied to the body through the connecting tube 5. Therefore, it is possible to prevent the medicine from puddling in the cup 4. Furthermore, in order to prevent the liquid from puddling in the cup 4, the inner surface of the part where the side of the cup rises from the floor surface 4b of the cup 4 is rounded. Therefore, the liquid can flow smoothly around the periphery of the floor surface 4b of the cup 4, and the liquid can be prevented from puddling in this part as much as possible. [Explanation of symbols]

[0034] 1: CV port, 2: container, 2a: upper container part, 2b: lower container part, 3: space, 3a: side gap, 3b: bottom gap, 4: cup, 4a: through hole, 4b: floor surface, 5: connection tube, 5a: locking part, 5b: connection part, 5c: bottom of pipe, 6: septum, 6a: insertion area, 6b: convex part, 7: sensor, 8: cushioning material,

Claims

1. A resin container that is divided into two parts in the vertical direction and includes a lower container portion and an upper container portion; A space formed within the container; a metal cup disposed in the space and having an open top; a connecting pipe connected to the cup and extending toward the outside of the container; a septum that closes the space and an upper portion of the cup and is fitted into the upper container portion, The cup is formed of a metal foil having a thickness of 150 μm or more and 200 μm or less, A side gap is formed between the side surface forming the space and the side surface of the cup, A bottom gap is formed between a bottom surface forming the space and a bottom surface of the cup, The bottom surface of the cup is flat, a sensor attached to the bottom gap in contact with a bottom surface of the cup for detecting distortion of the bottom surface of the cup.

2. 2. The CV port according to claim 1, wherein a cushioning material made of an elastic material is disposed in the side gap.

3. the connecting pipe is directly attached to the cup by welding; 2. The CV port according to claim 1, wherein the connecting tube and the container are not threadedly engaged with each other at a portion disposed within the container.

4. 2. The CV port according to claim 1, wherein a floor surface in the cup and a bottom portion of the pipe in the connecting pipe are formed on the same straight line.

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