JP2022069094A - Medical liquid injection port and medical liquid injection device - Google Patents

Abstract

To provide a medical liquid injection port which can surely grasp that a puncture needle is positioned in a medical liquid storage space, which can achieve compactification by decreasing the thickness of the medical liquid injection port, and which hardly stands out at the time of subcutaneous implantation, and to provide a medical liquid injection device.SOLUTION: A medical liquid injection port 10 includes: a housing 20 having an opening 25; and a septum 40 mounted on the opening 25. At the housing 20, a conductive part 51 is arranged in which at least part is exposed to the outside of the housing. A surface side peripheral edge 41a of the septum 40 is covered by an insulation part 23. The medical liquid injection port is used by utilizing a detection device which detects that a puncture needle has come into contact with the conductive part 51, by the variation of an electricity conduction parameter at that time, when an AC voltage is applied between an electrode arranged in contact with the body of a patient to be applied and the puncture needle.SELECTED DRAWING: Figure 3

Description

The present invention relates to a drug solution injection port and a drug solution injection device that can be implanted subcutaneously and inject a drug solution by puncturing a puncture needle from the outside.

Conventionally, as a device for efficiently injecting a drug solution such as an anticancer drug, a drug solution injection port has been subcutaneously implanted. In general, this drug solution injection port has a liquid pool inside, and its opening is closed with a septum made of an elastic material, and a tube placed in a blood vessel such as the heart is further provided. It has a connected structure. Then, when a puncture needle such as a non-coring needle is punctured into the septum from outside the body and a drug solution such as an anticancer drug is injected, the drug solution flows through a tube through a liquid pool portion and the drug solution is supplied to a blood vessel or the like. ..

However, since the septum of the drug solution injection port cannot be visually recognized from outside the body, it is difficult to properly puncture the septum of the drug solution injection port with the puncture needle. If the drug solution is injected while the puncture needle has not been punctured into the septum, the drug solution leaking out of the port causes inflammation of the tissue or necrosis of the tissue. Therefore, it is desired to be able to reliably know that the puncture needle has been properly punctured by the septum of the drug solution injection port.

As a device in line with such a problem, for example, Patent Document 1 below describes a subcutaneously embedded device (access port) to be embedded subcutaneously. In the embodiment shown in FIG. 3 of Patent Document 1, the access port has a main body forming a receptor for a liquid drug, and the receptor is sealed with a diaphragm. In addition, a contact plate is provided at the bottom of the receptor. Further, a substrate is arranged on the bottom of the main body, and an electric circuit body provided with an integrated circuit is mounted on the substrate. A contact plate and a voice generator arranged in the main body are electrically connected to the integrated circuit. Furthermore, a battery is built in the main body and is connected to the board.

Then, when the needle is punctured into the diaphragm through the skin, inserted into the receptor, and is electrically connected in contact with the contact plate, the substrate becomes the same potential as the contact plate, and this is integrated circuit. Detects and applies a pulse signal of a predetermined frequency to the voice generator to generate voice. This makes it possible to know that the needle is located inside the receptor.

Japanese Unexamined Patent Publication No. 3-90168

However, in the subcutaneously embedded device of Patent Document 1, since the electric circuit body, the voice generator, the battery, etc. are arranged in the main body of the access port, the access port tends to be bulky in the thickness direction and is large. There was a problem that it became conspicuous at the time of subcutaneous implantation.

Therefore, an object of the present invention is that it is possible to surely grasp that the puncture needle is located in the drug solution storage space, and it is possible to reduce the thickness of the drug solution injection port to make it compact, which is conspicuous at the time of subcutaneous implantation. Difficult, is to provide a drug solution injection port and a drug solution injection device.

In order to achieve the above object, the drug solution injection port according to the present invention is a drug solution injection port that is embedded subcutaneously and can be injected with a drug solution by puncturing a conductive puncture needle from the outside, and is a drug solution injection port inside. A housing provided with a storage space, having an opening for inserting the puncture needle into the drug solution storage space, and having a discharge hole communicating with the drug solution storage space and the outside, and attached to the opening. The housing has a septum capable of puncturing the puncture needle, and a conductive portion that is at least partially exposed to the drug solution storage space and the outside of the housing is arranged on the front peripheral edge of the septum. Is covered with an insulating portion, and an AC voltage is applied between the electrode placed in contact with the body of the applicable patient and the puncture needle, and the puncture needle becomes conductive due to the fluctuation of the energization parameter at that time. It is characterized in that it is used by utilizing a detection device that detects contact with a portion.

Further, the chemical solution injection device according to the present invention includes the chemical solution injection port, an electrode contacted with the body of the applicable patient, a conductive puncture needle that contacts and energizes the conductive portion, the electrode and the puncture. It is characterized by having an AC power source that applies an AC voltage between the needles and a detection device that detects that the puncture needle has come into contact with the conductive portion due to fluctuations in energization parameters.

According to the present invention, when the puncture needle punctured by the septum comes into contact with the conductive portion, an alternating current is exposed to the outside of the housing and from the conductive portion that has come into contact with the living tissue, passes through the living tissue and moves to the electrode side. As the puncture needle flows and energizes the electrode via the conductive portion, the change in the energization parameter at that time is detected by the detector, so that the puncture needle is punctured by the septum and is located in the drug solution storage space. You can surely grasp that. Further, since this chemical injection port has only a conductive portion provided in the housing and exposed to the outside as an energizing structure, the structure of the chemical injection port can be simplified and the thickness of the port can be reduced. It can be made compact.

It is an exploded perspective view which shows the 1st Embodiment of the chemical liquid injection port which concerns on this invention. It is a perspective view of the drug solution injection port. It is sectional drawing of the chemical solution injection port. It is explanatory drawing which shows the use state of the drug solution injection port and the drug solution injection device. It is a schematic block diagram of the drug solution injection port and the drug solution injection device. It is explanatory drawing which shows the detection state of the energization parameter in the chemical solution injection port and the chemical solution injection device. It is sectional drawing which shows the 2nd Embodiment of the chemical liquid injection port which concerns on this invention. It is sectional drawing which shows the 3rd Embodiment of the chemical liquid injection port which concerns on this invention. It is sectional drawing which shows the 4th Embodiment of the chemical liquid injection port which concerns on this invention.

Hereinafter, an embodiment of the chemical solution injection port and the chemical solution injection device according to the present invention will be described with reference to the drawings. First, the first embodiment of the chemical solution injection port will be described.

As shown in FIG. 4, the drug solution injection port 10 (hereinafter, also simply referred to as “port 10”) in this embodiment is implanted subcutaneously, and the drug solution is punctured by puncturing the conductive puncture needle 120 from the outside. It can be injected. As shown in FIGS. 1 and 3, the port 10 is provided with a drug solution storage space 30 inside, has an opening 25 for inserting the puncture needle 120 into the drug solution storage space 30, and has a drug solution storage space. It has a housing 20 provided with a discharge hole 58a communicating with the 30 and the outside, and a septum 40 attached to the opening 25 and capable of puncturing the puncture needle 120.

Further, as shown in FIG. 1, the housing 20 in this embodiment has a case shape made of an insulating material. Inside the housing 20, at least a part (exposed portion 51) of the chemical liquid storage space 30 and a conductive portion 50 exposed to the outside of the housing 20 are arranged. Further, the port 10 has a conductive member 60 made of a conductive material that sandwiches the septum 40 with the conductive portion 50. Further, an insulating member 70 made of an insulating material is arranged inside the conductive portion 50 (see FIG. 3). As shown in FIG. 3, in this port 10, the peripheral edge of the opening 25 of the housing 20 is covered with the insulating portion 23, and the inner circumference of the chemical liquid storage space 30 of the housing 20 is also an insulating portion (described later). 1 It is covered with an insulating portion 71).

The septum 40 is larger than the inner diameter of the drug solution storage space 30 and has a disk shape formed with a predetermined thickness. Further, the septum 40 is made of a material such as rubber, silicon resin, soft resin, etc., which can puncture the puncture needle 120 and elastically closes the punctured hole when the puncture needle 120 is pulled out. , The surface may be coated with a fluororesin film or the like. The septum 40 is arranged in a septum mounting portion 29 (see FIG. 3) described later, and can be mounted in the opening 25 of the housing 20.

Further, as shown in FIG. 3, the septum 40 is provided with a punctureable region 41 in which the puncture needle 120 can be punctured. The punctureable region 41 is a chemical solution that passes through the septum 40 when the puncture needle 120 is punctured from the surface 43 of the septum 40 exposed from the opening 25 (hereinafter, also simply referred to as “exposed surface 43”). It means that it is a region that can reach the storage space 30, and here it is a region surrounded by broken lines on the left and right on the paper of FIG. 3, when the puncture needle 120 is punctured into the septum 40. The region that cannot reach the chemical liquid storage space 30 by hitting the insulating member 70 or the like is excluded. That is, the punctureable region 41 is arranged at a position consistent with the chemical liquid storage space 30 in the thickness direction of the port 10, and is a region equal to or smaller than the inner diameter of the chemical liquid storage space 30. There is.

Further, as shown in FIG. 3, in this port 10, the exposed portion 51 of the conductive portion 50 is arranged at the bottom of the chemical liquid storage space 30. Further, the front peripheral edge 41a of the punctureable region 41 of the septum 40 is covered with the insulating portion 23.

The housing 20 has a substantially cylindrical peripheral wall 21 having an outer peripheral surface whose diameter gradually decreases from the base end side to the tip end side, and projects from the inner circumference of the tip end portion of the peripheral wall 21 toward the inside of the peripheral wall. It has a substantially trapezoidal case shape with upper and lower openings having the insulating portion 23 having a substantially annular shape.

The bottom surface 21a and the ceiling surface 21b of the peripheral wall 21 are formed so as to be parallel to each other. Further, an annular protrusion 23a is projected from the tip of the insulating portion 23 in the protruding direction toward the bottom surface 21a side of the peripheral wall 21. The inner circumferences of the insulating portion 23 and the annular protrusion 23a are circular openings 25. The bottom surface 21a and the ceiling surface 21b of the peripheral wall 21 may have their peripheral corners rounded or tapered.

Further, on the inner circumference of the peripheral wall 21, a concave groove-shaped septum mounting portion 29 is formed over the entire inner circumference of the peripheral wall 21 at a position closer to the opening 25. Further, at a predetermined position of the peripheral wall 21, a through hole 21c for communicating the internal space and the external space of the peripheral wall 21 with each other is formed. Further, as shown in FIG. 3, a circular opening 27 is formed on the bottom surface 21a side of the peripheral wall 21, and the exposed portion 51, which is a part of the conductive portion 50, is exposed from the opening 27. It is designed to do.

As shown in FIG. 3, the annular protrusion 23a abuts on the front peripheral edge 41a of the punctureable region 41 of the septum 40 in a state where the septum 40 is attached to the septum mounting portion 29, and presses the septum 40. It is designed to be crowded.

Further, as shown in FIGS. 1 and 2, a plurality of insertion holes 21d are formed on the outer periphery of the peripheral wall 21 on the bottom surface 21a side at predetermined intervals. A suture (not shown) is inserted into these insertion holes 21d, and by sewing this suture to a predetermined part in the body, the displacement of the drug solution injection port 10 embedded subcutaneously is suppressed. To.

The housing 20 may be made of, for example, nylon, polyethylene, polypropylene, fluororesin, polyimide, polyether sulphon resin, epoxy resin, polysulphon, polyacetal, liquid crystal polymer, polyurethane, silicone rubber, vinyl chloride resin, polyethylene terephthalate resin, or the like. It is preferably formed of an insulating material having insulating properties such as synthetic resin, and more preferably formed of a material having biocompatibility in addition to insulating properties. Further, the internal shape and the external shape of the housing are not limited to the above aspects.

The conductive portion 50 arranged inside the housing 20 has a disk-shaped exposed portion 51 arranged in the opening 27 and a substantially cylindrical shape erected from the peripheral edge of the exposed portion 51. It has a bottomed substantially cup shape with an open upper part (direction facing the exposed portion 51), which is composed of the peripheral wall 53.

Further, as shown in FIG. 3, in this port 10, the exposed portion 51, which is a part of the conductive portion 50, passes through the opening 27 at the bottom portion of the housing 20 (the portion where the bottom surface 21a of the peripheral wall 21 is located). Is exposed to the outside of the housing 20.

As shown in FIG. 3, the internal space surrounded by the exposed portion 51 and the peripheral wall 53 forms the chemical liquid storage space 30. The drug solution storage space 30 in this embodiment has a circular concave shape with an opening at the upper side and a diameter smaller than that of the septum mounting portion 29. Further, as shown in FIG. 3, an exposed portion 51 is arranged at the bottom of the chemical liquid storage space 30, so that the outer surface 51a of the exposed portion 51 is exposed to the outside of the housing 20 via the opening 27. It has become. Further, the outer surface 51a of the exposed portion 51 is flush with the bottom surface 21a of the peripheral wall 21 of the housing 20, and the inner surface 51b on the opposite side of the outer surface 51a of the exposed portion 51 is on the chemical liquid storage space 30 side. The exposed portion 51 is arranged in the opening 27 so as to face (see FIG. 3). The exposed portion 51 may have its outer surface 51a protruding or recessed with respect to the bottom surface 21a of the housing 20.

Further, the peripheral wall 53 includes a first wall portion 55 erected from the peripheral edge of the exposed portion 51, a stepped portion 56 extending outward from the upper end of the first wall portion 55 in the erection direction, and the stepped portion 56. It has a second wall portion 57 having a diameter larger than that of the first wall portion 55.

Further, a through hole 58a (see FIG. 3) is formed at one position in the circumferential direction of the peripheral wall 53 of the conductive portion 50, and a tubular connector 58 extends integrally from the front peripheral edge of the through hole 58a. (Note that the connector 58 may be a separate body from the conductive portion 50). The connector 58 is inserted into the through hole 21c of the housing 20 and is inserted through the opening on the outer diameter side of the through hole 21c, and the tube 5 is connected to the outer periphery on the tip end side thereof. Further, the connector 58 communicates with the chemical liquid storage space 30 through the through hole 58a on the proximal end side. Further, the opening on the tip end side of the connector 58 forms a discharge hole 58b for discharging the chemical solution stored in the chemical solution storage space 30 to the tube 5.

Then, as shown in FIG. 3, the first wall portion 55 of the conductive portion 50 is arranged on the inner circumference of the peripheral wall 21 of the housing 20, and the step of the conductive portion 50 is placed on one end portion 29a of the septum mounting portion 29 of the housing 20. The housing 20 is engaged with the portions 56, and the second wall portion 57 of the conductive portion 50 is arranged in the septum mounting portion 29 of the housing 20 with a predetermined gap from the inner circumference of the septum mounting portion 29. The conductive portion 50 is arranged inside the. In this state, as described above, the exposed portion 51 is arranged at the bottom of the chemical liquid storage space 30, and the outer surface 51a of the exposed portion 51 is exposed to the outside of the housing 20 through the opening 27. Therefore, as shown in FIG. 4, the exposed portion 51, which is a part of the conductive portion 50, is embedded in the port 10 under the skin (in the state of being embedded in the biological tissue 3 on the inner surface side of the skin 2). Is in contact with the living tissue 3.

The conductive portion 50 is, for example, a Ti, Ti-based alloy, stainless steel, Ta, Ta-based alloy, Ti—Al—V based alloy, Ti—Al—Nb—Ta based alloy, Ti—Zr—Nb—Ta based alloy Ti. It is made of a conductive material having conductivity, such as a Mo—Zr—Al alloy, a Co—Cr alloy, and a Co—Cr—Mo alloy. Among these, Ti, Ti-based alloys and stainless steel are preferably used, and those having biocompatibility are more preferable.

Further, in the conductive portion 50 in this embodiment, the exposed portion 51, the peripheral wall 53 (first wall portion 55, step portion 56, second wall portion 57), and the connector 58 are all integrally formed. Further, the shape and structure of the conductive portion are not limited to the above-mentioned embodiment, and may be, for example, only a disk shape (this will be described later in the embodiment), and the puncture needle 120 comes into contact with the puncture needle 120. It suffices to have a conductive portion that can be energized. Further, although the exposed portion 51 of this embodiment is exposed to the outside of the housing from the bottom of the housing 20, it may be exposed to the outside of the housing from the peripheral wall of the housing (this will be described later in the embodiment). ..

Further, the insulating member 70 arranged inside the conductive portion 50 has a substantially cylindrical sleeve shape with openings at the upper and lower sides.

Specifically, the insulating member 70 includes a first insulating portion 71, a stepped insulating portion 72 extending from the upper end of the first insulating portion 71 in the vertical direction to the outside of the wall portion, and the stepped insulating portion 72. It is composed of a second insulating portion 73 which is erected through the structure and has a diameter larger than that of the first insulating portion 71.

Then, as shown in FIG. 3, the first insulating portion 71 of the insulating member 70 is arranged on the inner circumference of the first wall portion 55 of the conductive portion 50, and the step portion 56 of the insulating member 50 is stepped with the insulating member 70. The insulating member 70 is arranged inside the conductive portion 50 in a state where the insulating portion 72 is engaged and the second insulating portion 73 of the insulating member 70 is arranged on the inner circumference of the second wall portion 57 of the conductive portion 50. It is supposed to be done. The outer circumference of the septum 40 abuts on the inner circumference of the second insulating portion 73, and the back peripheral peripheral edge 41b of the punctureable region 41 of the septum 40 engages with the stepped insulating portion 72.

Further, as shown in FIG. 3, the insulating member 70 is arranged inside the conductive portion 50, and is located inside the first wall portion 55, the step portion 56, and the second wall portion 57 of the conductive portion 50. Since the 1 insulating portion 71, the stepped insulating portion 72, and the second insulating portion 73 are arranged respectively, the inside of the peripheral wall 53 of the conductive portion 50 is covered. As a result, the inner circumference of the chemical liquid storage space 30 is covered with the first insulating portion 71. Therefore, even if the puncture needle 120 tries to come into contact with the conductive portion 50, it is covered. The first insulating portion 71 is one of the "insulating portions" in the present invention.

On the other hand, as described above, in the state where the insulating member 70 is arranged inside the conductive portion 50, the inner surface 51b of the exposed portion 51 of the conductive portion 50 is exposed from the lower opening of the first insulating portion 71 of the insulating member 70. The puncture needle 120 is in contact with the puncture needle 120 and can be energized. Further, in the above state, the second insulating portion 73 and the stepped insulating portion 72 of the insulating member 70 are arranged on the outer periphery of the septum 40 and the back peripheral peripheral edge 41b of the punctureable region 41, respectively, so that the outer periphery of the septum 40 and the punctureable region can be punctured. The back side peripheral edge 41b of the region 41 is covered so that even if the puncture needle 120 is punctured obliquely with respect to the septum 40, it does not come into contact with the conductive portion 50.

Similar to the housing 20, the insulating member 70 is, for example, nylon, polyethylene, polypropylene, fluororesin, polyimide, polyether sulphon resin, epoxy resin, polysulphon, polyacetal, liquid crystal polymer, polyurethane, silicone rubber, vinyl chloride resin. , It is preferable that it is formed of an insulating material having insulating properties such as a synthetic resin such as polyethylene terephthalate resin, and it is more preferable that it is formed of a material having biocompatibility in addition to insulating properties. Further, in the insulating member 70 in this embodiment, the first insulating portion 71, the stepped insulating portion 72, and the second insulating portion 73 are all integrally formed. The shape and structure of the insulating member are not limited to the above aspects, and the insulating member may not be provided in the housing (this will be described later in the embodiment).

Further, in this embodiment, both the peripheral edge of the opening 25 of the housing 20 and the inner circumference of the chemical liquid storage space 30 of the housing 20 are covered with the insulating portion 23 and the first insulating portion 71, but at least the chemical liquid storage is performed. A structure in which the inner circumference of the space 30 is covered with the first insulating portion 71 is desirable.

On the other hand, the conductive member 60 is composed of a substantially cylindrical peripheral wall 61 and a presser foot portion 63 having a substantially annular shape protruding from the inner circumference of the tip of the peripheral wall 61 toward the inside of the peripheral wall. It is almost like a cap covered with. The presser foot 63 extends to one end surface of the second wall portion 57 of the conductive portion 50, one end surface of the second insulating portion 73 of the insulating member 70, and the front peripheral edge 41a of the punctureable region 41 of the septum 40. It stands out.

The conductive member 60 is mounted on the conductive portion 50 in a state of being supported by the stepped insulating portion 72 of the insulating member 70 on the back peripheral peripheral edge 41b of the punctureable region 41 of the septum 40. That is, in the above state, by arranging the peripheral wall 61 of the conductive member 60 on the outer periphery of the second wall portion 57 of the conductive portion 50, the holding protrusion 63 of the conductive member 60 becomes the second wall portion 57 of the conductive portion 50. The conductive portion 50 and the conductive member 60 are in contact with one end surface of the insulating member 70 and one end surface of the second insulating portion 73 of the insulating member 70, and are in contact with and pressed against the front peripheral edge 41a of the punctureable region 41 of the septum 40. The septum 40 is indirectly sandwiched between them via the insulating member 70 (see FIG. 3). As a result, the insulating member 70, the septum 40, and the conductive member 60 are assembled (assembled) to the conductive portion 50.

Further, in the port 10 of this embodiment, at least a part of the conductive portion 50 is arranged on the peripheral wall 21 of the housing 20 and abuts on the septum 40 to prevent the septum 40 from coming off the housing 20. The inner circumference of the conductive portion 50 arranged on the peripheral wall 21 of the housing 20 is covered with an insulating portion, and the insulating portion is exposed to the chemical liquid storage space 30. That is, as shown in FIG. 3, the stepped portion 56 and the second wall portion 57, which are a part of the conductive portion 50, indirectly pass through the stepped insulating portion 72 and the second insulating portion 73 of the first insulating member 70. By abutting on the septum 40, the detachment of the septum 40 from the housing 20 is restricted. Further, the first wall portion 55, the step portion 56, and the second wall portion 56, which are the inner circumferences of the conductive portion 50, are formed by the first insulating portion 71, the stepped insulating portion 72, and the second insulating member 73 of the insulating member 70. The first insulating portion 71, the stepped insulating portion 72, and the second insulating member 73 of the insulating member 70 are each covered, and are exposed to the chemical liquid storage space 30.

By the way, when the insulating member 70 is not present, the stepped portion 56 of the conductive portion 50 supports the back side peripheral edge 41b of the punctureable region 41 of the septum 40, and the second peripheral edge of the conductive portion 50 is on the outer periphery of the septum 40. The wall portion 57 is arranged, and the pressing portion 63 of the conductive member 60 abuts on one end surface of the second wall portion 57 of the conductive portion 50 and the front peripheral edge 41a of the punctureable region 41 of the septum 40. The septum 40 is directly sandwiched between the conductive portion 50 and the conductive member 60.

The septum 40 is sandwiched between a substantially cup-shaped conductive portion 50 made of a conductive material and having a relatively high rigidity, and a substantially cap-shaped conductive member 60 made of a conductive material and having a relatively high rigidity. Therefore, even when the port 10 is used under high pressure, the septum 40 can be kept in a predetermined shape by suppressing crushing and deformation of the septum 40.

Then, for example, the assembly member in which the septum 40 is sandwiched and integrated with the conductive portion 50 and the conductive member 60 is set in a mold (not shown), and the housing 20 is injection-molded to form the assembly inside the housing 20. The members are arranged to manufacture the port 10 having a cross-sectional structure as shown in FIG. In this state, the second insulating portion 73 of the insulating member 70, the second wall portion 57 of the conductive portion 50, and the peripheral wall 61 of the conductive member 60 are sequentially arranged on the outer periphery of the puncture member 40 from the inside to the outside of the housing. At the same time, the annular protrusion 23a of the insulating portion 23 of the housing 20 and the holding protrusion 63 of the conductive member 60 are in contact with the front peripheral edge 41a of the punctureable region 41 of the septum 40, respectively, and the punctureable region 41 of the septum 40 is arranged. The stepped insulating portion 72 of the insulating member 70 abuts on the back side peripheral edge 41b of the housing 20, so that the septum 40 can be mounted on the septum mounting portion 29 of the housing 20. As a result, the upper opening of the drug solution storage space 30 is closed by the septum 40, and the drug solution is sealed so as not to leak from the drug solution storage space 30.

Similar to the conductive portion 50, the conductive member 60 is, for example, a Ti, Ti-based alloy, stainless steel, Ta, Ta-based alloy, Ti—Al—V based alloy, Ti—Al—Nb—Ta based alloy, Ti—Zr. -Nb-Ta-based alloy It is formed of a conductive material having conductivity such as Ti—Mo—Zr—Al based alloy, Co—Cr based alloy, Co—Cr—Mo based alloy and the like. Among these, Ti, Ti-based alloys and stainless steel are preferably used, and those having biocompatibility are more preferable. Further, in the conductive member 60 in this embodiment, the peripheral wall 61 and the pressing portion 63 are integrally formed. Further, the shape and structure of the conductive member are not limited to the above aspects. Further, the chemical injection port in the present invention may be configured without a conductive member.

In the port 10 having the above configuration, an AC voltage is applied between the electrode 110 contact-arranged on the body of the applicable patient 1 and the puncture needle 120, and the puncture needle 120 becomes a conductive portion due to the fluctuation of the energization parameter at that time. It is used by utilizing the detection device 150 that detects the contact with the exposed portion 51 which is a part of the 50.

This configuration will be described with reference to FIG. The electrode 110 is fixed to, for example, the back or abdomen of the application patient 1 with a double-sided tape having a conductive wire property, and is arranged in contact with the body. The electrode 110 is connected to the AC power supply 130 via the lead wire L.

Further, as shown in FIG. 2, the puncture needle 120 of this embodiment has a connecting portion 121 to which the tip of a syringe or a drip of a syringe (not shown) is detachably connected, and a conductive portion extending from the connecting portion 121. It has a sex needle portion 123. The needle portion 123 has a cylindrical straight portion 124 extending linearly and a tip portion 125 having a cylindrical shape bent at a predetermined angle with respect to the straight portion 124 and having a sharp tip. ing. The blade surface 125a of the tip portion 125 is parallel to the axial direction of the straight line portion 124. That is, the puncture needle 120 is a well-known non-coring needle that does not puncture the septum 40 so as to scrape off the meat when the septum 40 is punctured. Further, a tip hole (not shown) for allowing fluid to flow out is formed on the inner circumference of the blade surface 125a of the tip portion 125 of the puncture needle 120.

The needle portion 123 of the puncture needle 120 is connected to an AC power supply via a lead wire L (see FIG. 5). At this time, for example, the tip of the lead wire L is connected to a clip adapter having a substantially J-shaped hook-shaped connection portion (not shown), and the connection portion of the clip adapter is pulled to the needle portion 123 of the puncture needle 120. By hooking, the lead wire L can be connected to the base side of the needle portion 123 exposed from the septum 40 in a conductive state.

Further, as shown in FIG. 5, an AC power supply 130 and a detection device 150 are connected between the electrode 110 and the puncture needle 120. Further, the detection device 150 of this embodiment measures the operation unit 151 such as a voice emitting buzzer and a lamp and the energization parameter, and outputs an operation signal to the operation unit 151 based on the measured energization parameter. It has a detection unit 153.

The energization parameter is, for example, a numerical value such as impedance, resistance, and current of an AC circuit. A predetermined threshold value is set for these energization parameters. Then, when the threshold value becomes equal to or more than a predetermined value, becomes equal to or less than a predetermined value, or falls within a certain range, an operation signal is output to the operation unit 151 when measured by the detection unit. ing.

Then, as shown in FIG. 4, in the port 10 embedded under the skin, the exposed portion 51 exposed to the outside of the housing, which is a part of the conductive portion 50, is in contact with the living tissue 3. Therefore, when the puncture needle 120 comes into contact with the exposed portion 51, an alternating current flows through the living body (including the skin 2 and the living tissue 3) of the application patient 1, and the puncture needle 120 and the electrode 110 are energized. At this time, the alternating current flowing in the circuit increases, while the impedance in the circuit decreases according to Ohm's law. Such fluctuations in the energization parameter are detected by the detection device 150, and it is possible to grasp whether or not the puncture needle 120 is in contact with the conductive portion 50.

That is, in this port 10, when the puncture needle 120 contacts the exposed portion 51 and the electrode 110 is energized through the exposed portion 51 in a state where the electrode 110 is in contact with the application patient 1 and arranged. The fluctuation of the energization parameter is configured to be detected by the detection device 150.

In this embodiment, the impedance in the AC circuit is adopted among the energization parameters, and the presence or absence of contact of the puncture needle 120 with the conductive portion 51 can be grasped by the fluctuation of this impedance.

Then, as shown in FIG. 6A, when the puncture needle 120 is not punctured by the skin 2, the exposed portion 51 of the conductive portion 50 is in contact with the living tissue 3, but the puncture needle 120 is in contact with the living body. Since this is not done, almost no AC current flows in the AC circuit, resulting in a high impedance (see "a" in FIG. 6).

On the other hand, as shown in B of FIG. 6, the puncture needle 120 is punctured into the skin 2, but the puncture needle 120 is located in the living tissue 3 of the application patient 1 in a state where the puncture needle 120 is not in contact with the septum 40 of the port 10. Therefore, the puncture needle 120 and the electrode 110 are energized via the living body. As a result, since a higher AC current flows in the AC circuit than in the case of A in FIG. 6, the impedance becomes lower than the impedance “a” in FIG. 6 (see “b” in FIG. 6).

Further, as shown in C of FIG. 6, the puncture needle 120 is punctured into the skin 2, the puncture needle 120 punctures the septum 40 of the port 10, and the tip portion 125 thereof is the inner surface of the exposed portion 51 of the conductive portion 50. Upon contact with 51b, the puncture needle 120 and the electrode 110 are energized via the exposed portion 51 and the living body. That is, when the puncture needle 120 comes into contact with the inner surface 51b of the exposed portion 51, the alternating current applied from the AC power supply 130 is exposed to the outside of the housing 20, and the living tissue 3 is exposed from the exposed portion 51 in contact with the living tissue 3. It passes through and flows to the electrode 110 side, and the puncture needle 120 energizes the electrode 110 through the exposed portion 51. As a result, since a higher AC current flows in the AC circuit than in the case of B in FIG. 6, the impedance becomes lower than the impedance “b” in B in FIG. 6 (see “c” in FIG. 6).

In this embodiment, the impedance "c" is set as a threshold value of the energization parameter. Therefore, when the impedance becomes "c" or less, assuming that the puncture needle 120 comes into contact with the exposed portion 51, an operation signal is output from the detection unit 153 of the detection device 150 to the operation unit 151, and the operation unit 151 A buzzer sound is emitted from the sound generation buzzer, and the lamp of the operating unit 151 lights up or blinks. As a result, the practitioner can grasp that the tip portion 125 of the puncture needle 120 has come into contact with the conductive portion 50 of the port 10. The impedance "c" set as the threshold value may vary depending on the individual patient and the contact position of the exposed portion 51 of the conductive portion 50 with the living tissue 3. , Is set as a detectable value.

The energization parameter may be an alternating current or the like instead of impedance, and the method for detecting fluctuations in the energization parameter is not limited to the above embodiment. Further, the threshold value of the energization parameter may be set within the range of the symbol “D” between the impedance “b” and the impedance “c” in FIG. 6 (the impedance is set within the range of “D”). When the value becomes less than the above value, a buzzer sounds from the detection device 150, and the lamp lights up / blinks). Further, the operating unit of the detection device 150 may be, for example, in such a manner that vibration occurs or is displayed on a display.

On the other hand, the chemical solution injection device 100 according to the present invention is in contact with the chemical solution injection port 10 having the above configuration, the electrode 110 contact-arranged on the body of the applicable patient 1, and the exposed portion 51 of the conductive portion 50 of the port 10. Detection to detect that the puncture needle 120 has come into contact with the conductive portion 50 due to the conductive puncture needle 120 that is energized, the AC power supply 130 that applies an AC voltage between the electrode 110 and the puncture needle 120, and the fluctuation of the energization parameter. It has a device 150.

Next, the operation and effect of the chemical solution injection port 10 and the chemical solution injection device 100 having the above configuration will be described.

FIG. 4 shows a state in which the port 10 is implanted under the skin of the application patient 1 and the drug solution injection device 100 is used. That is, this port 10 is embedded so as to be embedded in the biological tissue 3 on the inner surface side of the skin 2, and a drug solution such as an anticancer agent or a nutritional agent is applied through the tube 5 connected to the connector 58 of the port 10. , It is possible to supply to a tubular organ 4 such as a blood vessel.

When implanting the port 10 subcutaneously, the tip of the tube 5 is placed at a predetermined position of the tubular organ 4 by a well-known Seldinger method or the like, and then the base end of the tube 5 is placed outside the body of the port 10. Connect to the connector 58. After that, the skin 2 is incised and placed at a predetermined position of the biological tissue 3, and the suture thread inserted into the plurality of insertion holes 21d on the outer periphery of the port is sewn to the predetermined site and embedded in the biological tissue 3. By closing the incised skin 2 after implanting in, the port 10 can be placed subcutaneously (below the skin 2) as shown in FIG. In this state, the outer surface 51a of the exposed portion 51 of the conductive portion 50 is exposed to the outside of the housing 20 through the opening 27 of the housing 20.

Further, the electrode 110 is placed in contact with the back or the like of the applicable patient 1 via double-sided tape or the like. In this state, as shown in A of FIG. 6, the puncture needle 120 is not punctured by the skin 2, and the impedance detected by the detection device 150 is “a”.

Then, after grasping the indwelling position of the port 10 by touching the body of the application patient 1 or the like, the tip portion 125 of the puncture needle 120 is substantially aligned with the punctureable region 41 of the septum 40 of the port 10, and the skin is formed. I will puncture 2. Then, as shown in B of FIG. 6, since the puncture needle 120 is located in the living tissue 3 of the application patient 1, the puncture needle 120 and the electrode 110 are energized through the living body, and the impedance by the detection device 150 is “b. It drops to.

When the puncture needle 120 is pushed in from the above state, the tip portion 125 penetrates through the exposed surface 43 of the septum 40 and is extracted from the surface opposite to the exposed surface 43 of the septum 40. The tip hole that does not reach into the drug solution storage space 30. When the puncture needle 120 punctures and is pushed into the punctureable region 41 of the septum 40, puncture resistance is generated, but the puncture resistance can be sensed.

When the puncture needle 120 is further pushed in, the tip portion 125 thereof comes into contact with the inner surface 51b of the exposed portion 51 of the conductive portion 50. Then, the puncture needle 120 and the electrode 110 are energized through the exposed portion 51 of the conductive portion 50 and the living body, and as shown in C of FIG. 6, the impedance detected by the detection device 150 further decreases and "c. , Which is less than or equal to the threshold value of the energization parameter. Then, an operation signal is output from the detection unit 153 of the detection device 150 to the operation unit 151, a buzzer sound is emitted from the voice generation buzzer of the operation unit 151, and the lamp of the operation unit 151 lights up or blinks. Therefore, the practitioner can surely grasp that the tip portion 125 of the puncture needle 120 has come into contact with the conductive portion 50 of the port 10.

On the other hand, even if the puncture needle 120 is punctured into the skin 2 and pushed deeply, the impedance, which is the energization parameter detected by the detection device 150, does not become "b" or less, and does not become less than the threshold value of the energization parameter. Therefore, the voice generation buzzer of the operating unit 151 does not emit a buzzer sound, and the lamp does not light or blink, so that the practitioner is in contact with the conductive portion 50 of the port 10 with the tip portion 125 of the puncture needle 120. You can see that there is no such thing.

As described above, in the port 10 and the chemical injection device 100, when the puncture needle 120 punctured in the punctureable region 41 of the septum 40 comes into contact with the exposed portion 51 of the conductive portion 50, an alternating current is generated in the housing 20. From the exposed portion 51 exposed to the outside and in contact with the living tissue 3, the puncture needle 120 flows to the electrode 110 side via the living tissue 3, and the puncture needle 120 energizes the electrode 110 through the exposed portion 51. Since the fluctuation of the energization parameter such as the impedance is detected by the detection device 150, it is surely grasped that the puncture needle 120 is punctured in the punctureable region 41 of the septum 40 and is located in the drug solution storage space 30. Can be done. That is, it can be surely grasped that the tip portion 125 of the puncture needle 120 penetrates the septum 40 and the tip hole (not shown) of the tip portion 125 is located in the drug solution storage space 30.

Therefore, the puncture needle 120 can be appropriately punctured with the septum 40 so as to be located in the drug solution storage space 30. Further, it is possible to prevent the puncture needle 120 from being accidentally punctured at a portion other than the septum 40 (prevention of erroneous puncture), and to suppress inflammation and necrosis of the living tissue 3.

If the septum 40 is not arranged near the skin 2 but is inverted and arranged, the puncture needle 120 punctured by the skin 2 immediately contacts the exposed portion 51 of the conductive portion 50. Also in this case, the impedance becomes “c”, the sound generation buzzer of the operating unit 151 emits a buzzer sound, and the lamp also lights up or blinks. However, in this case, since the practitioner does not detect the puncture resistance when the puncture needle 120 punctures the punctureable area 41 of the septum 40 and is pushed in, the puncture needle 120 is punctured and the drug solution is stored. It is possible to determine that it is not located in space 30.

That is, in this port 10, the puncture needle 120 can puncture the septum 40 before the detection device 150 detects that the puncture needle 120 has come into contact with the exposed portion 51 of the conductive portion 50 due to the fluctuation of the energization parameter. The puncture resistance when the region 41 is punctured and pushed in is sensed.

Further, unlike the subcutaneously embedded device of Patent Document 1, this port 10 does not have a built-in substrate or electric circuit body, and is provided in the housing 20 as an energizing structure and is partially exposed to the outside of the housing. Since it has only the portion 50, the structure of the port 10 can be simplified, and the thickness of the port 10 can be reduced to make it compact.

Further, as shown in FIG. 3, in this embodiment, at least a part of the conductive portion 50 is exposed to the outside of the housing 20 at the bottom of the housing 20. Here, the exposed portion 51, which is a part of the conductive portion 50, is exposed through the opening 27 provided at the bottom of the housing 20. Therefore, a large contact area of the conductive portion 51 with respect to the biological tissue 3 can be secured, and when the puncture needle 120 comes into contact with the exposed portion 51 of the conductive portion 50, the energization performance of the conductive portion 50 with respect to the biological tissue 3 is enhanced. be able to. In addition, the height of the chemical liquid storage space 30 can be largely secured.

Further, as shown in FIG. 3, in this embodiment, in the port 10, the peripheral edge of the opening 25 of the housing 20 is covered with the insulating portion 23, and the inner circumference of the chemical liquid storage space 30 of the housing 20 is also first insulated. Since it is covered with the portion 71, it is possible to prevent the puncture needle 120 from energizing the electrode 110 even when the puncture needle 120 is punctured obliquely with respect to the punctureable region 41 of the septum 40. In addition, at least a part of the conductive portion 50 is arranged on the peripheral wall 21 of the housing 20 and abuts on the septum 40 to prevent the septum 40 from coming off from the housing 20, thereby increasing the rigidity of the housing 20. At the same time, the septum 40 can be stably attached to the housing 20.

When the insulating member 70 is not arranged inside the conductive portion 50, the needle portion 123 of the puncture needle 120 is punctured diagonally with respect to the septum 40, and the tip portion 125 thereof is the first conductive portion 50. When the puncture needle 120 comes into contact with the wall portion 55 or the second wall portion 57, the puncture needle 120 is energized with the electrode 110, while a part of the tip portion 125 of the puncture needle 120 is located in the septum. In fact, the entire tip hole of the tip portion 125 of the puncture needle 120 is not located in the drug solution storage space 30, but the entire tip hole of the tip portion 125 is located in the drug solution storage space 30. Since there is a possibility of misidentification, the insulating member 70 is arranged inside the conductive portion 50 for the purpose of preventing this.

FIG. 7 shows a second embodiment of the chemical solution injection port according to the present invention. The same parts as those in the embodiment are designated by the same reference numerals, and the description thereof will be omitted.

The chemical injection port 10A (hereinafter, also simply referred to as “port 10A”) in this embodiment is a cup-shaped conductive portion 50, a cap-shaped conductive member 60, and a cylindrical sleeve-shaped insulating member as in the above-described embodiment. Does not have 70. The housing 20A is made of an insulating material, and a concave septum mounting portion 29 is formed at a position closer to the opening 25. The outer circumference of the septum 40 is fitted and mounted on the septum mounting portion 29.

On the other hand, on the bottom side of the housing 20A, a circular opening 27 having a diameter larger than that of the chemical storage space 30 is formed, and the conductive portion 50A is exposed in this opening 27. The opening 27 may have the same or smaller diameter as the inner diameter of the chemical storage space 30. Further, a disk-shaped conductive portion 50A is fitted and arranged in the opening 27, and the outer surface 51a of the conductive portion 50A is exposed to the outside of the housing through the opening 27. Further, the connector 58 is inserted into the through hole 21c of the housing 20A to communicate with the chemical liquid storage space 30.

In the port 10A having the above structure, when the puncture needle 120 punctured in the punctureable region 41 of the septum 40 comes into contact with the conductive portion 50A, the puncture needle 120 energizes the electrode 110 via the conductive portion 50A, and energization at that time. Since the fluctuation of the parameter is detected by the detection device 150, it can be surely grasped that the puncture needle 120 is punctured in the punctureable region 41 of the septum 40 and is located in the drug solution storage space 30.

FIG. 8 shows a third embodiment of the chemical solution injection port according to the present invention. The same parts as those in the embodiment are designated by the same reference numerals, and the description thereof will be omitted.

The drug solution injection port 10B (hereinafter, also simply referred to as “port 10B”) in this embodiment has the same basic configuration as that of the second embodiment.

Further, an insulating portion 26 is arranged at the bottom of the housing 20B made of an insulating material, and the insulating portion 26 is exposed to the outside of the housing 20B. A disk-shaped conductive portion 50B is arranged on the inner surface side of the insulating portion 26. The outer diameter of the conductive portion 50B is the same as the outer diameter of the peripheral wall 21 of the housing 20B.

At least a part of the conductive portion 50B is exposed to the outside of the housing 20B at the peripheral wall 21 of the housing 20B. That is, an opening 27B is formed at a position adjacent to the insulating portion 26 on the peripheral wall 21 of the housing 20B so as to communicate the internal space and the external space of the housing 20B. Therefore, the outer peripheral surface 52 of the conductive portion 50B is exposed to the outside of the housing 20 through the opening 27B of the peripheral wall 21 of the housing 20B.

In the port 10B having the above structure, when the puncture needle 120 punctured in the punctureable region 41 of the septum 40 comes into contact with the conductive portion 51B, the puncture needle 120 energizes the electrode 110 via the conductive portion 50B, and at that time. Since the fluctuation of the energization parameter is detected by the detection device 150, it can be surely grasped that the puncture needle 120 is punctured in the punctureable region 41 of the septum 40 and is located in the drug solution storage space 30.

Further, in the port 10B of the third embodiment, an opening 27B is formed in the peripheral wall 21 of the housing 20B, and the outer peripheral surface 52 which is a part of the conductive portion 50B is exposed from the opening 27B, so that the housing 20B is exposed. In the bottom portion of the housing 20B, an insulating portion 26 is arranged so as to be exposed to the outside of the housing 20B. Therefore, when the port 10B is placed under the skin with the port 10B turned inside out (when the bottom of the housing 20B is placed close to the skin 2 and the opening 25 is placed so as to be located on the inner side of the body), the puncture needle is passed through the skin 2. Even if the 120 is punctured, it can be prevented from contacting the insulating portion 26 on the bottom side of the port 10B and energizing the electrode 110.

FIG. 9 shows a fourth embodiment of the chemical solution injection port according to the present invention. The same parts as those in the embodiment are designated by the same reference numerals, and the description thereof will be omitted.

The chemical solution injection port 10C (hereinafter, also simply referred to as “port 10C”) in this embodiment has the same basic configuration as the second embodiment and the third embodiment.

The conductive portion 50C in this embodiment has a substantially disk shape, and an annular protrusion 54 having an annular shape on the back side thereof is projected from the outer peripheral edge portion. On the other hand, an annular opening 27C is formed at the bottom of the housing 20C made of an insulating material. The bottom surface side of the opening 27C communicates with the outside of the housing 20C, and the inner peripheral side communicates with the chemical liquid storage space 30. The conductive portion 50C is arranged so as to be fitted to the opening 27C of the housing 20C, and the outer surface 54a of the annular protrusion 54 is exposed to the outside of the housing 20C via the opening 27C. ing. Further, inside the annular protrusion 54 of the conductive portion 50C, a disk-shaped insulating portion 26 is arranged so as to be located at the bottom of the housing 20C.

In the port 10C having the above structure, when the puncture needle 120 punctured in the punctureable region 41 of the septum 40 comes into contact with the conductive portion 50C, the puncture needle 120 energizes the electrode 110 via the conductive portion 51C, and at that time. Since the fluctuation of the energization parameter is detected by the detection device 150, it can be surely grasped that the puncture needle 120 is punctured in the punctureable region 41 of the septum 40 and is located in the drug solution storage space 30.

The present invention is not limited to the above-described embodiment, and various modified embodiments are possible within the scope of the gist of the present invention, and such embodiments are also included in the scope of the present invention. ..

10,10A, 10B, 10C Chemical injection port (port)
20, 20A, 20B, 20C Housing 21 Peripheral wall 23 Insulation part 25 Opening 27, 27B, 27C Exposed part 29 Septam mounting part 30 Chemical storage space 40 Septum 41 Punctureable area 50, 50A, 50B, 50C Conductive part 51 Exposed part 60 No. 2 Conductive member 70 Insulation member 100 Chemical injection device 110 Electrode 120 Puncture needle 130 AC power supply 150 Detection device

Claims (5)

It is a drug solution injection port that is implanted under the skin and can be injected with a drug solution by puncturing a conductive puncture needle from the outside.
A housing provided with a drug solution storage space inside, an opening for inserting the puncture needle into the drug solution storage space, and a discharge hole communicating with the drug solution storage space and the outside.
It has a septum that is attached to the opening and is capable of puncturing the puncture needle.
The housing is provided with a conductive portion that is at least partially exposed to the chemical storage space and the outside of the housing.
The front peripheral edge of the septum is covered with an insulating portion.
A detection device that applies an AC voltage between the electrodes placed in contact with the body of the applicable patient and the puncture needle, and detects that the puncture needle has come into contact with the conductive portion due to fluctuations in the energization parameters at that time. A drug solution injection port characterized by being used by utilizing. The chemical injection port according to claim 1, wherein at least a part of the conductive portion is exposed to the outside of the housing at the bottom of the housing. At least a part of the conductive portion is exposed to the outside of the housing on the peripheral wall of the housing.
The chemical injection port according to claim 1, wherein the bottom portion of the housing is an insulating portion, and the insulating portion is exposed to the outside of the housing. At least a part of the conductive portion is arranged on the peripheral wall of the housing and abuts on the septum to prevent the septum from coming off the housing.
The chemical injection according to any one of claims 1 to 3, wherein the inner circumference of the conductive portion arranged on the peripheral wall of the housing is covered with an insulating portion, and the insulating portion is exposed to the chemical liquid storage space. port. The drug solution injection port according to any one of claims 1 to 4,
With electrodes placed in contact with the patient's body,
A conductive puncture needle that comes into contact with the conductive part and energizes.
An AC power supply that applies an AC voltage between the electrode and the puncture needle,
A chemical injection device comprising a detection device for detecting that the puncture needle has come into contact with the conductive portion due to a change in the energization parameter.

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