Device for handling transcutaneous terminals

Abstract

In terminals connecting the inside and outside of the body, the aim is to reduce maintenance of the terminals, suppress external infections, alleviate the burden on patients, and improve their quality of life. [Solution] The device comprises a fixing unit that uniformly presses and fixes the peripheral sides of the terminal portion, which is implanted on the skin surface and inner surface and made of a calcium phosphate compound, toward the center; a coating and curing unit that applies a curable resin to the lid portion on the upper surface of the terminal portion and hardens it to form a sealed state; and a removal unit that removes the coating and curing unit to the extent that at least the lid portion can be detached.

Description

Technical Field

[0001] The present invention relates to an apparatus for handling a percutaneous terminal in which a biocompatible member such as hydroxyapatite is disposed at a site in contact with the skin with respect to a conduit or a conducting wire that communicates between inside and outside of the body.

Background Art

[0002] When connecting a catheter through the skin, during the unused period, a part that has been sterilized remains on the skin, and it is necessary to constantly maintain a sterile state. Training for this has imposed a burden on patients and caregivers. Also, in the case of hemodialysis, during treatment, puncturing with a thick puncture needle is performed more than three times a week, etc., which places a heavy burden on the patient and shortens the lifespan, and has also become a reason for choosing CKM (conservative kidney therapy). Also, puncturing was limited to the patient himself / herself, his / her relatives, and medical staff even in the case of home hemodialysis. Peritoneal dialysis does not require puncturing and is a treatment method suitable for home dialysis during the period until the peritoneum deteriorates.

[0003] A percutaneous terminal has been proposed in which a terminal structure made of a calcium phosphate compound ceramic such as hydroxyapatite shown in Japanese Patent Laid-Open No. 59-174146 is disposed so as to partially protrude from the skin, and a connector structure suitable for connecting the inside and outside of the body for a long period of time by bonding the skin and hydroxyapatite. Ceramic materials of calcium phosphate-based compounds such as hydroxyapatite not only have biocompatibility, but it has been reported that they can be implanted in the skin and maintain a stable state for 5 years or more (Takayuki Tsuji et al., Human 3 Case Implantation Longest 5-Year Experience, Journal of the ES.T. Society, Vol. 3 (1990 - 1991) Supplement No. 1-C-11)

[0004] Mechanisms that connect the inside and outside of the body as needed, such as hemodialysis and peritoneal dialysis, are beneficial in that, in the case of hemodialysis, they eliminate the pain of puncture needles, and in the case of peritoneal dialysis, they prevent infection at the terminal site. Furthermore, when administering large amounts of medication, oral administration places a significant burden on the patient, and children in particular often dislike oral administration of drugs, making it increasingly difficult. Therefore, percutaneous drug administration and nutritional supply are effective.

[0005] The silicone material used to form the catheters for peritoneal dialysis is biotoxic. Although the patient spends time outside of treatment with the catheter connected to the body, it remains a foreign object. Body movements or poor health can lead to infection at the contact surface between the catheter and the body, requiring cumbersome procedures such as repeated disinfection. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] Japanese Patent Application Publication No. 07-313476 [Patent Document 2] Japanese Patent Publication No. 60-055965 [Patent Document 3] Japanese Patent Publication No. 60-058154 [Patent Document 4] Japanese Patent Publication No. 60-092768 [Patent Document 5] Japanese Patent Publication No. 61-179163 [Non-patent literature]

[0007] [Non-Patent Document 1] Hideki Aoki, et al. Histological changes around percutaneously implanted hydroxyapatite sintered bodies, Artificial Organs 13(3), 1131-1134 (1984) [Non-Patent Document 2] Miharu Hata et al., Attempt at long-term continuous measurement of in vivo information through transcutaneous terminals of hydroxyapatite sintered bodies. Artificial Organs 14(2), 879-882 ​​(1985) [Non-Patent Document 3] Takayuki Tsuji et al., Chronic Implantation Experiments of Hydroxyapatite Skin Connectors in Humans, Artificial Organs 15(1), 447-450 (1986) [Non-Patent Document 4] Takayuki Tsuji, et al., Experience with implantation of hydroxyapatite cutaneous terminals in 3 human cases, Artificial Organs 17(2), 747-750 (1988)

[0008] [Non-Patent Document 5] Hata, M. et al., Tissue reaction around percutaneously implanted hydroxyapatite, β-tricalcium phosphate, and glassy carbon, Artificial Organs 18(1), 88-91 (1989) [Non-Patent Document 6] Masanori Taniguchi, et al., Development of an intravenous catheter with a hydroxyapatite skin terminal, Artificial Organs 19(3), 1202-1205 (1990) [Non-Patent Document 7] N. Yoshiyama,et.al.CLINICAL USES OF HYDROXYAPATITE PERCUTANEOUS DEVICES FOR CAPD Second International Symposium on Apatite JuLY3-7 1995,Tokyo,Japan [Non-Patent Document 8] Hideki Aoki, author, Kien Tosho, Savior of Medicine, Hydroxyapatite, 2019, pp. 44-48. [Non-Patent Document 9] Takayuki Tsuji et al., Experience over the longest 5-year period with the implantation of three cases of hydroxia pathide cutaneous tinea, Journal of the LST Society, Vol. 3 (1990-1991) Supplement No. 1-C-11 [Overview of the project] [Problems that the invention aims to solve]

[0009] While calcium phosphate compounds such as hydroxyapatite adhere to soft tissues like skin at the terminal contact surface, preventing bacterial infection between the terminal and skin tissue over the long term and ensuring stability, the risk of bacterial infection is high inside the terminal, particularly in the conduit and connector structure. Currently, this necessitates cumbersome procedures, such as wrapping the terminal in gauze containing disinfectant in a protective bag, especially when not in use.

[0010] Japanese Patent Publication No. 2020-6167 describes a mechanism for sealing and releasing a lid. However, when sealing, releasing, or covering a percutaneous terminal, the sealing and releasing operation is performed mechanically, which can cause vibration and shaking to be applied to the terminal, potentially leading to the terminal detaching from the skin. Therefore, it is difficult to perform the sealing and releasing operation quickly, simply, and without putting stress on the fragile ceramic terminal, and without causing discomfort to the patient. Furthermore, since the terminals are implanted in various parts of the living body, it is always preferable to have an operation that integrates fixing and manipulation. [Means for solving the problem]

[0011] In view of the above, the present invention provides a fixing part that uniformly fixes the peripheral sides of the terminal portion implanted on the skin surface and inner surface in the direction toward the center, which is made of a calcium phosphate compound; a coating and curing unit that applies and cures a curable resin to the lid portion on the upper surface of the terminal portion; and a removal unit that removes the coating and curing part to the extent that the lid portion can be removed. By automatically sealing the lid portion in a sterile state, when not in use, the percutaneous terminal can be left as is, covered with a simple bandage, or lightly disinfected. During use, the hardened resin in the parts necessary for attaching and detaching the lid is melted and cut using a laser beam and mill, allowing the lid to be easily removed. This enables the administration of medication and food, as well as blood withdrawal and return during hemodialysis, thus fully utilizing the percutaneous terminal, further reducing the burden on the patient, and significantly improving the patient's quality of life.

[0012] The calcium phosphate compounds in the present invention include, for example, hydroxyapatite, α-tricalcium phosphate, β-tricalcium phosphate, tetracalcium phosphate, etc. All of them can be used as percutaneous terminals. Among them, hydroxyapatite with a Ca / P molar ratio of around 1.67 having long-term stability is preferable, and a synthetic type using a wet synthesis method is preferable.

[0013] The terminal portions implanted and formed on the skin surface and the inner surface shown in the present invention are those called so-called percutaneous terminals and biological terminals. The shape may be simply formed in a conduit shape, but if it adheres to the skin only, it will be easily pulled out. Therefore, in order to obtain an anchor effect, a disk shape with a larger bottom diameter or a disk shape with larger diameters at the top and the bottom are exemplified. In addition, the size of the terminal portion is in a state that is slightly larger than the diameter of the tubular body passing through the center, and an example is one manufactured by shaping with a 3D printer using the ceramic powder. For shaping, a 3D printer that mainly shapes and fires using a mixture of ceramic powder and a photocurable resin is used. For example, an apparatus for performing ceramic shaping, which is formed by a combination of firing apparatuses, is exemplified, but it is not limited to these methods, and shaping may be performed using conventional methods such as casting shaping and injection molding.

[0014] In the present invention, the size of the percutaneous terminal varies depending on the content such as the liquid to be transported, but it is preferable to standardize the size of the lid and the mounting position according to the treatment purpose. The device for attaching and detaching the lid portion is shown as the first embodiment. However, when the implantation location varies due to the patient's symptoms, etc., or when the shape is different, the shape and size may be recognized and formed by using a shape recognition sensor unit, etc.

[0015] The lid portion in this invention is made of the same ceramic material or resin as the percutaneous terminal and only needs to have a shape that allows it to be inserted into or placed on top of the percutaneous terminal. It may be disposable, reusable, or replaceable. The shape is generally cylindrical, but the shape may be appropriately changed depending on the implantation site or purpose.

[0016] The fixing portion in this invention is intended to prevent the terminal portion from being subjected to oscillation by the movement of each processing unit when processing is performed by each processing unit, such as when resin coating and resin removal is carried out, by clamping the side surface of the percutaneous terminal, and it is preferable that it be constructed as an integrated unit. The shape of the fixing part is such that it clamps the sides from both sides, and it can be manual or automatic, and it is sufficient that it fixes the terminal part for at least the duration of either the process of sealing the lid or the process of releasing the seal.

[0017] Methods of fixing include using two semi-circular fasteners shaped to match the curved surface of the terminal's side to press the terminal from opposite sides, or surrounding and fixing almost the entire side of the terminal from one side. The method of fixing is also selected depending on the shape of the percutaneous terminal. By fixing the terminal in place, stable adhesion between the terminal and the skin is maintained during the sealing and release processes without applying excessive load to the terminal and the skin. In the present invention, the coating and curing unit is exemplified by a photocurable resin, and is exemplified by a resin that has curability with moisture, and is preferably a material that does not react with living organisms and has immediate curing properties.

[0018] Examples of photoinitiators include benzoin isopropyl ether, benzophenone, Michlar's ketone, chlorothioxanthone, isopropylthioxanthone, benzyldimethyl ketal, acetophenone diethyl ketal, α-hydroxycyclohexylphenyl ketone, and 2-hydroxy-2-methylphenylpropane. Preferably, those possessing biocompatibility and bioaffinity are preferred. The irradiated light sources each have different wavelengths and are selected according to the type of photoinitiator. In some cases, laser light with a wavelength appropriate to each initiator may also be used. Furthermore, while ultraviolet irradiation is preferable for sterilizing the area around the lid, a combination of visible light curing and ultraviolet irradiation may also be used.

[0019] The removal unit in the present invention removes a coated and sealed cured resin and includes a laser ablation operation, a rotary mill, and a cutting tool. However, to better avoid vibration stimulation to the patient, it is preferable to use ablation removal with laser light such as a fiber laser, CO2 laser, or nanosecond pulse width LD-excited solid-state (DPSS) laser. In the case of a removal unit, residue may be generated during removal using cutting tools, etc., and in some cases, a suction device is also provided to remove this residue by suction.

[0020] The coating and curing unit and the removal unit may be housed as separate units in different enclosures, or they may be housed in a single enclosure and used selectively depending on the purpose. The present invention is suitable as long as it is positioned to cover the percutaneous terminal and has a configuration that fixes the side portion of the terminal to perform sealing and unsealing. However, since the mounting portion of the terminal portion needs to be near the armpit or on the back side, and the housing needs to be maintained in a way that does not put a load on the terminal fixing portion, a configuration in which the housing is supported by a multi-jointed arm with multiple axes is preferred. Furthermore, this arm may be a robotic arm, and the present invention can be easily used when a terminal is implanted in a location where treatment by drug administration, fluid infusion, or dialysis is difficult, such as the throat or armpit.

[0021] If the shape, size, etc. of the terminal section differ from the standard, it may be formed by attaching the removal unit and covering unit to the robot arm and combining them with the fixing unit and image recognition unit. In this case, the operation of the access unit and cover section may also be automated. In the present invention, it is preferable to use recognition means to electrically recognize the shape of the upper part of the terminal of the transcutaneous terminal. Examples of recognition means include a combination of a stereo camera, ultrasonic or infrared irradiation type sensor that detects the upper surface properties and the contour and shape of the cover of the transcutaneous terminal, and a computer processing device that obtains contour shape and object identification information from 2D coordinate data or 3D data obtained from the sensor, recognizes the sealed coating, and performs an operation to remove this part, and applies a curable resin to the part to be sealed and cures it with light or the like.

[0022] The upper surface shape shows the three-dimensional shape before and after the lid is attached, and represents data obtained by recognizing the surface of the opening, the shape of the lid, the top surface, the sides, and the bottom surface, which can be detected by three-dimensional data. The hardware and software are configured to perform steps such as recognizing whether or not it is a lid, and collecting contour coordinate data of the lid. This system, for example, utilizes a Convolutional Neural Network (CNN) to recognize various lid shapes and materials, and collects their contours and 3D coordinates. These 3D coordinates are identical to those used when a robotic arm, multi-axis, or parallel-link robotic arm is operating. An example of an image acquisition device is one that is positioned in the space where the robotic arm operates, where the transcutaneous terminals can be observed, and collects information in real time and outputs the 3D coordinates.

[0023] The recognition means in this invention, for example, in the case of a lid, indicates the contour side of the lid, and in the case of a sealed process, a combination of a recognition program and a computer that executes this program is shown, which identifies the contour of the lid when applying the hardening agent and confirms the gap between the lid and the lid placement area. The processed surface shows the 3D shape of the lid mounting surface if the lid is attached, or the 3D shape data of the lid mounting recess or lid mounting hole if the lid is not attached.

[0024] The resin curing unit in the present invention consists of a combination of a discharge unit for dispensing a curable resin and a light irradiation unit used for curing, and a mill, drill, or laser irradiation unit for removing a sealed lid. It may also include an operating unit for gripping the lid that needs to be released and removed, and moving it to the outside, and an operating unit for connecting an access connector extending from an external treatment device to the opening for connection with an external treatment device. [Effects of the Invention]

[0025] This invention simplifies the use of percutaneous terminals, suppresses the risk of infection, and enables easy adaptation to various treatments via percutaneous terminals. [Brief explanation of the drawing]

[0026] [Figure 1] Figure 1 shows one embodiment of the present invention. [Figure 2] Figure 1 illustrates one embodiment of the present invention. [Figure 3] A figure illustrating another embodiment of the present invention. [Figure 4] This diagram illustrates the operation of the embodiment shown in Figure 3. [Figure 5] A figure illustrating another embodiment of the present invention. [Figure 6] This diagram illustrates the operation of the embodiment shown in Figure 5. [Figure 7] A figure illustrating another embodiment of the present invention. [Figure 8] This figure illustrates the embodiment shown in Figure 7. [Figure 9] This figure illustrates the embodiment shown in Figure 7. [Figure 10] This figure illustrates the embodiment shown in Figure 5. [Figure 11] This figure illustrates the embodiment shown in Figure 7. [Figure 12] A diagram illustrating an embodiment of the present invention. [Modes for carrying out the invention]

[0027] The present invention provides a configuration for a conduit, connector, etc., attached to the portion of a percutaneous terminal that penetrates the inside and outside of a living body, which is partially implanted in a living body and can be used from the moment it becomes fused with the skin, in order to prevent infection by keeping the internal and external penetration portions sealed when not in use. The device includes a means for applying a hardening material to the contour of the lid while the upper part of the terminal is fixed, and then hardening it, as well as a means for removing the hardened material during treatment. In the case of one conduit to one terminal, it can be used in hemodialysis, peritoneal dialysis, drug administration, nutritional supply, etc., and should be small, for example, with a diameter of 10 mm or less, and should be configured to cover the top of the terminal and allow for sealing and releasing the top of the terminal. These operating tools can be housed within a surrounding body that covers the terminal, and can be supported and fixed by hand or a mechanical arm.

[0028] In cases where the size of the terminal portion differs, a configuration may be provided for using a robotic arm to open and close the lid and attach and detach the access connector before and after treatment, which involves three-dimensional recognition of the portion protruding from the skin, and during treatment, after three-dimensional recognition of the lid portion, the area around the lid portion is recognized as three-dimensional data, and the lid portion is formed by operating means that move a processing unit for cutting or melting along this three-dimensional data of the area around the lid portion.

[0029] Furthermore, when removing the sealed cover on a transcutaneous terminal using a cutting mill, vibration and oscillation are applied to the terminal, which may cause the connection with the skin to be released and the terminal to detach. Therefore, the terminal should be secured by holding it down or other means to disperse the vibration and prevent the terminal from oscillating. The fixing device is preferably paired with an operating part for sealing with resin and removing the resin. For example, it is used for clamping and fixing the upper part of the terminal, or for inserting the upper part of the terminal into a plate-shaped hole and sealing the lid. For example, it is fixed by applying pressure to the opposing sides facing inward up to the terminal embedding part of the upper arm. Since the terminals are made of ceramic, it is preferable to process them while fixing the surrounding sides with pressure that does not cause cracks. [Examples]

[0030] Next, an embodiment of the present invention will be described in detail with reference to Figure 1. 100 is a cover member, formed from plastic, resin, metal, etc., and in the drawing, it has a hemispherical shape with an opening downwards and an end that extends in the direction of the skin, having a contact surface 100a with the skin, and an open space is formed on the lower surface that is sized to surround the upper part of the terminal. A connecting shaft portion 108 is formed on the upper part of the cover member 100 for connecting to one end of a bendable flexible arm 109. The connecting shaft portion 108 is preferably formed to be rotatable, and the flexible arm 109 may be replaced with a robot arm. Examples of robot arms include parallel link type and single-axis type, and the connected microcomputer executes a built-in program to move and attach the cover member 100 to the installed terminal portion. 101 is a fixing press unit, which presses the side PDB of the terminal section to fix the cover member 100 on the terminal section PD.

[0031] In the fixing pressure unit 101, 101a is a cushioning member, and has an arc shape at its tip made of rubber, sponge, or cushioning material. The buffer member 101a is formed, for example, in an arc shape and has an area that makes uniform contact with the terminal side surface with a predetermined width. 101b is a locking portion formed on the pressing tool 101e. One end is a rod-shaped rod projecting upward in a right-angled triangular shape, and the other end is connected to the pressing tool 101e in a position where it can be locked by the protrusion 101d of the pressing tool 101e. It is formed to be elastic so that it can swing up and down in the figure. One end of the locking portion 101b has a surface perpendicular to the long axis of the pressing tool 101e that serves as the locking surface with the protrusion 101d. 101c is an opening operation part, a rod-shaped body that can be flexibly bent up and down, with a protrusion 101d integrally formed in the middle, and one end fixed inside the cover member 100. The portion of the opening operation part 101c that protrudes from the cover member 100 forms the manual operation part. A gap is formed between the opening operation part 101c and the cover member 100 so that the opening operation part 101c can swing up and down, and a protrusion 101d is formed that protrudes perpendicularly downward with respect to the long axis of the pressing tool 101e. The protrusion 101d swings up and down in conjunction with the up and down movement of the opening operation part 101c.

[0032] 101d is a protrusion formed midway along the long axis of the opening operation part 101c, and at least the protruding surface in the direction of the cover member 100 protrudes perpendicular to the long axis. 101e is a pressing tool, with a cushioning member 101a attached to its tip, and a locking portion 101d preferably integrally formed at one end in the middle of its long axis, with vertical elasticity. Between the locking portion 101b and the cushioning member 101a, a fixing projection 101f is formed in a projection shape perpendicular and continuous with respect to the long axis of the pressing tool. 101f is a fixing projection, which is formed in an annular shape on a part of the pressing tool 101e as described above, and contacts one end of the spring member 101g. 101g is a spring member, and examples include a coil-shaped or other elastic member that has a restoring force when it returns to its original state after contraction and deformation. One end of the spring member 101g contacts the fixing projection 101f of the pressing tool 101e, and the other end contacts the spring fixing surface 100b formed on the cover member 100. In the diagram, two fixing pressure units 101 are arranged facing each other on the side of the terminal section, and they are all denoted by the same reference numeral. 102 is a nozzle for dispensing curable resin, and preferably has a size that allows several portions of curable resin to be stored in the storage section 102a. Since nozzle 102 is fixed, in addition to being a nozzle that sprays at a wide angle, in the case of a fluid resin, it may be dispensed only to the center, and the resin may be used to seal and cure the area around the terminal portion of the lid. 102a is a storage section, which is a part for temporarily storing a sufficient amount of curable resin to seal the lid PDC. In some cases, the storage section 102a may not be required, and a configuration that connects to the outside and a supply tube may also be used.

[0033] 103 is a curing light output unit, which is used to irradiate light having a wavelength necessary for curing the curable resin, and is formed in a ring shape around the nozzle 102. The curing light output unit 103 may also be a light source such as an LED equipped with a specific wavelength for sterilization and disinfection, and after attaching the cover member 100 to the top of the terminal, it is possible to sterilize the top of the terminal by irradiating it with germicidal light. 104 is a nozzle drive unit, which is a drive unit for dispensing curable resin from nozzle 102 using electric force.

[0034] 105 is a control drive unit, which, for example, is a part that provides an amplified electrical output based on a control signal, and includes an electrical output unit that provides electrical output to the curing light output unit 103, and an electrical output unit that provides electrical output to the nozzle drive unit 104. Unit 106 is the control unit and consists of a computer including RAM, ROM-type memory, and a CPU. The control unit 106 executes a program and outputs commands to drive the curing light output unit 103 and the nozzle 102. For example, when the terminal side is pressed and fixed with the fixing pressing unit 101, and the coating start button is pressed, the control unit 106 has a built-in program to sequentially perform the resin coating step and the curing light irradiation step at optimal times and executes this program. 107a and 107b are electrical lead wires A and B, respectively, and are used to supply the electrical output of the nozzle drive unit 104 to the curing light output unit 103 and the nozzle drive unit 104.

[0035] 108 is a connecting shaft portion, formed from the same material as the cover member 100, and in some cases, a rotatable configuration is incorporated to allow uniform contact with the skin, thereby making the cover member 100 rotatable. The connecting shaft portion 108 is configured to connect to one end of the flexible arm 109. 109 is a flexible arm, a robotic arm, or a manually operated arm, which moves the cover member 100 to the terminal embedding portion via the connecting shaft portion 108, and also avoids excessive load on the terminal portion when the cover member 100 is fixed onto the percutaneous terminal, thereby maintaining the stable condition of the cover member 100. The flexible arm 109 and connecting shaft portion 108 are for fixing the cover member 100 onto the terminal portion PD. They may be omitted if the terminal portion is sufficiently fixed by the pressing fixing device 101, and a handheld type may also be used. The PDC is a lid that closes the internal and external guide channels PDA of the terminal section from the end of treatment until it is resumed. In the case of Figure 1, since the hardening agent is applied by a fixed nozzle, the upper part of the PDC is angled to ensure that the hardening resin reaches the contact area between the edge of the lid and the internal and external guide channels PDA of the terminal section. This embodiment, in which the discharge nozzle is fixed, is suitable for use when the diameter of the terminal section's internal and external guide passage PDA is small, 10 mm or less, and is similar to the resin discharge area from the discharge nozzle.

[0036] Next, the operation shown in Figure 1 will be explained using Figure 2. The terminal section shown in Figure 1 is composed of a single internal / external terminal section guideway PDA connecting the inside and outside of the body. For example, it shows the state after an access connector extending from an external device has been removed, with the valve body formed inside closed and the cover section PDC attached. The valve body (not shown) closes the passage connecting the inside and outside of the body within the terminal when the access connector is removed. However, in cases where there is little risk of bodily fluids leaking to the outside, such as when supplying nutrients to the body, it may not be necessary to close the valve. The overall size of the terminal section PD may vary depending on the purpose and the size of the internal and external guide passages PDA of the terminal section. However, it is preferable to select the appropriate size of the cover member 100 based on the overall size. Figure 2(a) shows the cover member 100 being attached so as to cover the upper part PDF of the terminal PD.

[0037] Both pressing tools 101e are pressed in the direction of the cylindrical terminal side PDB below the upper PDF of the terminal, until the cushioning member 101a presses against the terminal side PDB from both sides. This pressing force causes the spring member 101g to contract and deform via the fixing projection 101f. Furthermore, when the locking portion 101b comes into contact with the projection 101d, the projection 101d is pushed upward along the inclined surface of the locking portion 101b, causing the locking portion 101b to pass through. Once the locking portion 101b has passed the projection 101d, the projection 101d returns to its original position from its pushed-up state, causing the vertical surface of the locking portion 101b to come into contact with the projection 101d, preventing the locking portion 101b from moving outward.

[0038] When the external pressing force on the pressing tool 101e is stopped, the contracted spring member 101g exerts a restoring force that pushes the fixing projection 101f outward. However, the movement of the locking portion 101b is prevented by the projection 101d, maintaining the engaged state, and the pressing force of the buffer member 101a on the terminal portion side PDB is maintained, fixing the cover member 100 on the terminal portion PD. Furthermore, since the cover member 100 is supported by the flexible arm 109 via the connecting shaft portion 108, the flexible arm 109 may be moved and adjusted so that it is fixed in this position.

[0039] The flexible arm 109 is suitable for preventing the cover member 100 from putting a load on the terminal due to its own weight when it is fixed on the terminal by the fixing pressing unit 101. However, if the covering is completed in a short time, for example, the flexible arm 109 is not required, and it can be done by hand. Once the fixing is complete, the control unit 106 irradiates the curing light output unit 103 for a predetermined time when the operator presses the start button, thereby creating a sterilized state. After sterilization, the control unit 106 issues an electrical signal to the nozzle 102 via 107b to instruct it to output the photocurable resin from the nozzle 102.

[0040] The storage section 102a supplies a slurry of photocurable resin to the nozzle 102. The fluid photocurable resin fills the top and sides of the lid PDC, forming a resin layer 201 (Figure 2(b)). Since the amount of resin is roughly determined by the size of the lid and the size of the opening of the percutaneous terminal, a predetermined amount is released, forming a resin layer with no excess or deficiency. However, it is also possible to measure the volume of the filling section with a sensor and fill it with the appropriate amount. After reaching the amount to be filled in one batch, or after confirming that the periphery of the lid PDC has been filled, the control unit 106 instructs the control unit 106 to irradiate the curing light output unit 103 with curing light. The control unit 106 instructs the control drive unit 105 to supply electrical output to the curing light output unit 103, switching from germicidal light to curing light.

[0041] The curing light output unit 103 irradiates the area filled with curable resin with curing light for a predetermined time to form a cured layer 202 (Figure 2(c). This irradiation time is determined in advance by calculating the degree of curing progress of the curing agent. After curing is complete, the control unit 106 indicates completion by illuminating an LED or outputting an audio signal.

[0042] After hardening, the treatment is completed either as is or by covering it. Simple covers are adjusted depending on the degree of protrusion of the terminal's upper part. Minimizing the portion protruding from the skin H will relieve the inconvenience of snagging on things in daily life, but in that case, the cover member 100 may have groove-shaped or flat areas for pressing and fixing on the upper part of the terminal. When the opening operation part 101c is lifted upward, the fixing projection 101f also lifts up, releasing the locking state of the locking part 101b. Due to the restoring force of the spring member 101g, the pressing tool 101e moves outward, separating the cushioning member 101a from the side of the terminal part and releasing the lock. Although the fixing pressure unit 101 is shown configured for manual operation, it may also be mechanically driven using a motor.

[0043] Next, an example of removing the surface-coated resin portion and the lid portion PDC in order to perform the treatment will be explained using Figures 3 and 4. Since the configuration of the fixing pressure unit 101 is the same as that of the embodiment shown in Figure 1, the same numbering will be used and the explanation will be omitted. 300 is a cover member, and like the cover member 100, its bottom surface is open, and its peripheral edge is shaped to be parallel to the skin, forming a contact surface 300a so that the cover member 300 can be placed stably on the skin. A portion for housing the upper PDF of the terminal is formed and is made of the same material as the cover member 100. 301 is a laser output section, formed by laser light emitted from a YAG laser, semiconductor light source, optical fiber end, etc., and is exemplified by having an output and wavelength that causes an ablation reaction in the coating material, ranging from heating and melting to vaporization.

[0044] 302 is a light source housing section, and when the laser output section 301 is the end of an optical fiber, it is formed by the optical fiber and the light source. When the light source is located externally, the light source housing section 302 may be the part that houses the optical fiber from the light source to the laser output section 301. 303 is a rotary motor, preferably a combination of a stepping motor, gears, etc., and is at least a motor whose rotational speed can be controlled. Preferably it is a motor that rotates at a low speed controllable by a pulse signal or the like, at a speed that removes the resin, and rotates approximately 360 degrees. However, even if it rotates multiple times, it is sufficient as long as the covering material is removed so that the lid PDC is reliably detached. 304 is a rotating support, which is made of plastic, metal, or the like in a disc shape or radially arranged, and has a configuration that rotates around the rotating shaft portion 304a.

[0045] The rotating support 304 supports the laser output unit 301 and only needs to rotate at least 360 degrees, for example, at a speed that allows for rotational movement while melting and evaporating the coating resin. 304a is the rotating shaft portion, located at the center of the rotating support 304, and connected to the shaft portion of the rotating motor 303. 305 is a connecting shaft portion, which is integrally connected to the cover member 300 and connected to one end of the flexible arm 306, thereby fixing the direction of the terminal housing portion of the cover member 300 on the skin surface. If the connecting shaft portion 305 is rotatable, the direction of the cover member 300 can be varied to cover the terminal portion PD in a way that fits the skin surface.

[0046] 306 is a flexible arm, formed from plastic, lightweight metal, etc., and may take the form of a multi-axis robot arm or a multi-axis arm configuration. The cover member 300 can be moved electrically by the multi-axis robot arm and attached to the upper part of the erected terminal section PD. The connecting shaft section 305 and the flexible arm 306 have the same configuration as in Figure 1. 307a, 307b, and 307c are lead wires A, B, and C, respectively, and are used to supply power to the rotary motor 303 and the laser output unit 301. Lead wire A307a supplies electrical energy to the germicidal lamp 311. Lead wire B307b supplies electrical energy to the rotating motor 303. Lead wire C307c supplies electrical energy to the light source housing 302. In some cases, the lead wire C307c may be an optical fiber if the laser light source is housed in the drive circuit 308. 308 is a drive circuit that supplies electrical output to the laser light source and outputs rotational electrical signals to the rotary motor 303 according to instruction signals from the control unit 309.

[0047] 309 is a control unit, which consists of a computer and contains a program for controlling the rotation of the rotating support 304 and the laser light output of the laser output unit 301. The control unit 309 may also output a signal to the drive circuit 308 instructing it to output laser light. 310 is a cured resin layer, which is applied and cured to seal the upper part of the terminal with the lid, and shows the cured resin layer 202 formed by the embodiment shown in Figures 1 and 2. Note that while the cured resin layer 310 is shown as being applied to the entire upper surface of the lid PDC, if the resin is applied only to the contact edges between the lid and the upper terminal PDF, the cured resin layer may be formed only on the contact edges. 311 is a germicidal lamp, and is formed with a light source that primarily emits germicidal wavelengths such as ultraviolet light and near-ultraviolet light. The germicidal lamp 311 is formed continuously or intermittently in a hollow circular shape, but it may be installed only in part, as long as it is configured to sterilize at least the periphery of the lid PDC.

[0048] Next, the operation of the embodiment shown in Figure 3 will be explained using Figure 4. The lid portion PDC is sealed with a hardened resin layer 310 made of resin, metal, etc., over the terminal upper PDF, which is then manually or automatically placed over the opening of the cover member 300. As shown in the embodiments in Figures 1 and 2, the fixing press unit 101 is used to press and fix both sides of the terminal portion (Figure 4(a)). In this state, the laser output unit 301 is already set to be located near the boundary between the lid and terminal portions on the cured resin layer 310.

[0049] The control unit 309 supplies electrical power to the laser output unit 301 to output laser light and prepares to rotate the rotary motor 303. As shown in Figure 4(b), the laser output unit 301 rotates while emitting laser light, removing the peripheral portion of the lid of the cured resin layer 310. The rotation speed is preferably low enough to achieve ablation, and after approximately one rotation, the seal is removed and the lid PDC becomes removable. Alternatively, the unit may rotate several times instead of once to remove the cured resin layer 310. The laser light demonstrated the process of removing the material by vaporizing the sealed area. However, in cases where residue remains, a suction recovery unit may be installed on the rotating circumference to collect this residue. Furthermore, the present invention is applicable not only to laser light, but to any means that produces minimal residue and can remove the sealed portion.

[0050] Next, Figure 5 shows an embodiment that includes a configuration for sealing the lid and a configuration for removing the function. In Figure 5, parts identical to those shown in Figure 1 are given the same numbers and their descriptions have been omitted. 500 is a cover member, made of the same material as in Figures 1 and 3, with a flexible arm 508 connected to its upper part via a connecting shaft 507. The flexible arm 508 is identical to the one shown in Figure 1, and is formed from a multi-axis robot arm or a multi-axis arm, for automatically or manually moving and fixing the cover member 500 to a predetermined state. 501 is a resin coating nozzle, for example, a nozzle body that dispenses a photocurable resin. Upon receiving a supply of photocurable resin, it dispenses the photocurable resin in response to an electrical signal from the drive unit 510. It is preferable that the dispensing is performed with minimal diffusion, and that the photocurable resin is dispensed evenly and without excess at the boundary between the lid and the upper part of the terminal.

[0051] 502 is a curing light output section, and is formed of an LED, laser light emitter, etc., that emits curing light having a curing wavelength. 503 is a light output unit for resin removal, and is used to output laser light to vaporize and remove the cured resin layer by laser ablation. 504 is a support, formed in a disc shape and radially, connected at predetermined intervals to the resin coating nozzle 501, the curing light output unit 502, and the resin removal light output unit 503, and rotates around its central point 504a. Figure 10 shows the configuration near the support 504 shown in Figure 5, viewed from direction (10a). The resin coating nozzle 501, resin removal light output unit 502, and resin removal light output unit 503 are arranged at equal or predetermined intervals on the disc-shaped support 504. The resin coating process, resin curing process, and resin removal process are performed while rotating the support 504 for each work step.

[0052] 505 is a germicidal light output unit, which is an LED or the like that emits ultraviolet light over a wide area, and is intended to sterilize the upper part of the terminals covered by the cover member 500. Preferably, the irradiation is performed at least before or after the lid PDC is sealed. The resin coating nozzle 501, the curing light output unit 502, and the resin removal light output unit 503 do not necessarily have to be arranged at equal angles. For example, the distance between the resin coating nozzle 501 and the curing light output unit 502 may be increased.

[0053] 506 is a rotating body, preferably a stepping motor, which rotates at a predetermined speed up to 360 degrees while the resin hardens or is removed. 507 is a connecting shaft portion, which connects to the cover member 500 and fixes the cover member 500 so that it can rotate. 508 is a flexible arm, which may also be a multi-axis robotic arm, and it connects to the connecting shaft portion 507, moving the cover member 500 to the percutaneous terminal mounting portion and fixing its position.

[0054] 509a is lead wire A, which electrically connects the germicidal light output unit 505 and the drive unit 510. 509b is lead wire B, which electrically connects the drive unit 510 and the curing light output unit 502. 509c is lead wire C, which electrically connects the drive unit 510 and the rotating body 506. 509d is lead wire D, which electrically connects the resin coating nozzle 501 and the drive unit 510. 509e is lead wire E, which electrically connects the resin removal optical output unit 503 and the drive unit 510. 510 is a drive unit and is composed of a computer equipped with an input / output unit, a memory unit, an arithmetic unit, etc. It is formed by an electrical circuit that converts control signals from the control unit 511 into power signals for driving the rotating body 506, etc., and supplies them. 511 is a control unit, formed by a microcomputer consisting of an arithmetic unit, a memory unit, input / output ports, etc., and outputs control signals based on the program stored in the memory unit. The microcomputer has a large-capacity storage medium such as a hard disk or SSD, and memory such as RAM or ROM, and has the function of controlling the operation of the connected robot by storing and executing programs. The control unit 511 incorporates two programs: a coating mode and a coating removal mode. Depending on the situation, it switches between these modes based on user selection, automatic detection of the state, etc., and operates accordingly.

[0055] Next, the operation of the embodiment shown in Figure 5 will be explained with reference to Figure 6. The embodiment shown in Figure 5 is installed in the same manner as in Figures 2 and 4, and the cover member 500 is fixed by pressing the terminal side portion PDB with the fixing pressing unit 101. Figure 6(a) is a flowchart showing the operation of the embodiment shown in Figure 5 after the completion of treatment. 601 is the step of manually placing the lid PDC on the upper terminal PDF, although depending on the shape of the lid PDC, it may also be inserted. In this case, the lid PDC is cylindrical with a large-radius cylindrical body on top, and the upper part of the conductive hole in the upper terminal PDF also forms a large-radius cylindrical recess, so that the lid PDC does not penetrate too deeply into the conductive hole.

[0056] Step 602 involves attaching the cover member 500 to the terminal portion PD so as to cover it, and then operating the fixing press unit 101 to fix the terminal portion PD and the cover member 500 in place. Step 603 is a step in which it is determined whether to start sealing, and the system waits until the manual operation switch connected to the control unit 511 is operated. Step 604 is a step in which the control unit 511 outputs a command to apply a curable resin for sealing, caused by the pressing of a sealing start switch installed on the control panel or the like. Upon receiving this coating command, the resin coating nozzle 501 begins to apply the resin.

[0057] Step 605 is the step in which the control unit 511 outputs a rotation command signal to the rotating body 506 so that it rotates by a predetermined angle. When it rotates by a predetermined angle, it rotates at a speed that allows the resin to be applied uniformly. Step 606 is the step that determines whether the rotation has completed 360 degrees. In the case of a stepping motor, this is calculated from the pulse width length, the number of pulses generated, etc. Step 607 is the step in which the control unit 511 outputs a signal to the control unit 511 to stop resin dispensing. When this stop signal reaches the rotating body 506, the rotating body 506 stops.

[0058] Step 608 is the start of curing light irradiation, in which light is irradiated from the curing light output unit 502 along the surface on which the curable resin has been applied. At that time, the rotation angle is initially set to 0 degrees, for example, as a default value. Step 609 is the step in which the control unit 511 issues a command to the rotating body 506 to output a signal to rotate by a predetermined angle or a signal to rotate at a predetermined speed. Step 610 is a step in which the control unit 511 checks whether the rotating body 506 has rotated 360 degrees. This check may be performed by calculating the integrated value of the angle, etc., which is output based on a program built into the control unit 511.

[0059] Step 611 is to stop the curing light irradiation, for example, the control unit 511 outputs a command to the curing light output unit 502 via the drive unit 510 to irradiate. Step 612 is to check the curing state of the coating. If the curing state is poor, the curing light is irradiated again in a 360-degree direction as a curing failure. Furthermore, since the degree of curing can be estimated in advance based on the properties of the resin and the wavelength and intensity of the curing light, it may not always be necessary to perform all 612 steps. 613 is an indicator output that allows the control unit 511 to remove the cover member 500. This may be done by pre-installing an LED display on the control unit 511, or by using a monitor connected to the control unit 511, or by using wireless remote display such as WiFi or infrared. The control unit 511 may be controlled remotely.

[0060] Figure 6(b) is a flowchart showing the steps for removing the lid to begin treatment. Step 614 is to mount the cover member 511 onto the terminal portion which has a sealed lid. Step 615 is the step in which the control unit 511 waits for input, for example, an external switch signal, to determine whether to start releasing the seal. Step 616 is to irradiate laser light from the resin removal light output unit 503, and step 617 is to output a signal to rotate the rotating body 506 by a predetermined angle.

[0061] Step 618 is to determine from the calculation results in the control unit 511 whether the rotating body 506 has rotated 360 degrees. Step 619 is the step of outputting a signal from the drive unit to the resin removal light output unit 503 to stop laser irradiation. Step 620 is a step to detect whether the covering material has been removed and the lid can be removed. If it has not been completely removed, the laser light is shone again, but this routine has been omitted. Step 621 is a step in which the control unit 511 displays an indication that the lid can be removed.

[0062] Next, we will explain the specific operation based on Figure 6. After treatment For example, after hemodialysis or peritoneal dialysis, after administering nutritional supplements, after administering anticancer drugs, etc., when the supply of blood, drug solutions, or nutrients to the body will not be used for a certain period of time, the access connector (not shown) is removed from the upper PDF of the terminal and the cover PDC is inserted into the internal and external guideway PDA of the terminal (601). The cover member 500 is attached so as to cover the upper part PDF of the terminal, and the fixing pressing unit 101 is operated to fix the cover member 500 onto the upper part PDF of the terminal (602). The flexible arm 508 distributes force to the cover member 500 to maintain this state, ensuring that no unnecessary pressure is applied to the upper PDF of the terminal.

[0063] The control unit 511 waits for a seal operation start signal from the user or the like (603), and outputs a drive signal via the drive unit 510 and lead wire 509d to discharge curable resin to the resin coating nozzle 501 (604). The resin coating nozzle 501, upon receiving this drive signal, dispenses the curable resin onto the boundary portion PDD between the lid portion PDC and the upper terminal portion PDF. The rotating body 506 receives a rotation-like signal, which has been converted into an electrical signal for driving by the drive unit 510 from the control unit 511, via an electrical lead wire 509c. Based on the content of the pulsed electrical signal, it rotates in steps at a predetermined angle (5 to 10 degrees) or speed. The system monitors whether this rotation has completed one full rotation (360 degrees) (606), and if it has rotated 360 degrees, it stops the discharge of resin from the resin coating nozzle 501 (609).

[0064] Furthermore, the control unit 511 issues a command to the curing light output unit 502 via the drive unit 510 and lead wire B509b to irradiate curing light, and the curing light output unit 502 outputs curing light (608). The control unit 511 outputs a signal to rotate the rotating body 506 at a predetermined angle, and the rotating body rotates 360 degrees while curing light is irradiated onto the coated resin. Furthermore, the timing of irradiating with curing light may vary; in some cases, the light may be irradiated sequentially after the resin coating nozzle 501 has dispensed the curable resin onto the boundary portion PDD, thereby curing the resin.

[0065] The rotating body 506 rotates at a predetermined angle or speed (609), checks whether it has rotated 360 degrees (610), and stops when the curing light output unit 502 has irradiated 360 degrees with curing light (611). After confirming that the hardened resin formed on the contour of the lid provides sufficient sealing (612), the pressure of the fixing pressing unit 101 is released and the cover member 500 is removed (613). After that, you can either apply a light support or bandage until your next treatment, or you can go about your daily life as usual.

[0066] Before treatment begins (removal of the lid) In Figure 6(b), The cover member 500 is then attached to the terminal section PD again (614), and the cover member 500 is fixed to the side PDB of the terminal section with the fixing pressing unit 101. The user performs an operation on the control unit 511 to initiate treatment (615). The control unit 511 irradiates the drive unit 510 with laser light via the lead wire 509e to remove the resin hardened part 512 (614). Furthermore, the control unit 511 outputs a signal to the drive unit 510 to rotate the support 504 in relation to the rotating body 506 (615).

[0067] The laser light or the like is irradiated onto the resin coating as the support 504 rotates, and the resin is vaporized and removed. The device monitors whether it has completed one rotation (616), and stops irradiating the laser light when it has rotated 360 degrees (619). It visually confirms that the seal on the lid PDC has been released and that the lid PDC is removable (620). During this time, the germicidal light output unit 505 emits germicidal light continuously, or starts irradiating just before or after the lid PDC becomes removable. The control unit 511 indicates that the cover member 500 should be removed (621). This series of actions allows the terminal implanted percutaneously to safely and stably administer drug solutions, return blood to the patient, and withdraw blood.

[0068] The upper PDF of the terminal shown in the example has a portion that extends horizontally toward the skin surface, but it is not limited to this, and may be formed in a mountain-like shape that protrudes slightly from the skin, as shown in Figure 12. Figure 12(a) is shown in a perspective view, and Figure 12(b) shows the cross-section of the y-y' portion of Figure 12(a) in a state where it is embedded in living skin. In this case, a notch 1203 may be formed that allows a pressing body to be inserted into the portion protruding from the skin, thereby creating a fixed state. 1201 is the terminal side portion, which is formed in a cylindrical shape and converges in a mountain-like shape upwards without protruding laterally. A conductive passage 1206 for conducting electricity between the inside and outside of the body is formed at the top, and it is shaped to accommodate a cover portion 1202. 1205 is a conduit, which is made of, for example, an artificial blood vessel material, and is connected to the conductive passage 1206 and extends to the target site.

[0069] 1204 is the terminal base, which is formed in a disc shape and extends more widely and circumferentially than the terminal side portion 1201, forming a stable state after implantation in a living organism. The embodiment shown in Figure 5 allows for both sealing and releasing the lid with a single device, making it highly convenient, economical, and suitable for home use.

[0070] Next, Figure 7 shows an embodiment that is suitable when the size of the terminal section and the size of the cover section are not constant, and which uses a robot arm similar to a commercially available robot arm that has a process for automatically attaching the cover section and access connector, thereby increasing versatility. The 700 is a computer that, based on its memory, internet communication capabilities, infrared and radio wave data transmission capabilities, and built-in programs, drives the robotic arm, outputs laser light, and operates the robotic hand for tasks such as attaching and detaching the robotic arm, operating the access connector and cover, and attaching and detaching it from the upper terminal opening. In cases such as home healthcare, the 700 computer may also be remotely controlled by other external computers.

[0071] 701 is the drive output section, and is composed of electrical circuits that perform functions such as a driver electrical amplification circuit, an electrical output for driving the parallel link, and an electrical output for driving the resin discharge nozzle. 702 is joint A, which, for example, has a rotatable configuration and is part of a multi-axis robot or part of a manually operated arm assembly. 703 is an arm, for example, with one end connected to joint A702 and the other end rotatably connected to joint B704a. Arm 703 may be a flexible arm, but it only needs to have sufficient strength to support the robot arm 711. Furthermore, if the terminal is located on the same part of a living organism, the arm may be fixed either hardware-wise or software-wise.

[0072] Joint A702, joint B704a, and arm 703 form part of a multi-axis robot arm or an arm assembly that can be moved by hand, and these are omitted in Figure 7. 704 is the main body, made of metal and hard plastic, and is formed in a U-shape. The upper part of the main body 704 has a support frame 705 for the drive unit, and the lower part has a fixing unit 706. The main body 704 further forms a joint B704a and is rotatably connected to one end of the arm 703.

[0073] 705 is a support frame for the drive unit, located at the top of the main body 704, and supports a robot arm with a parallel link mechanism as the drive unit from above. 706 is a fixing unit located at the bottom of the main body 704 and supports the clamping parts A707 and B708 ​​for fixing the upper terminal PDF. It mitigates vibrations to the upper terminal PDF caused by the movement of the robot arm 711 and protects the ceramic terminal. Sections 707 and 708 are clamping sections A and B, respectively. They slide automatically or manually in opposing directions to clamp and secure the side portion PDB of the upper PDF of the terminal or its upper portion. After treatment, to release the terminal, they are slid in the opposite direction to release the clamping. In some cases, it is advisable to install cushioning material on the surfaces that come into contact with the terminal.

[0074] Section 709 is a jig housing, formed from a metal or plastic casing, and is a part that neatly houses interchangeable units such as a resin dispensing unit 709a, a laser output unit 709b, and a transport unit 709c. The jig housing section 709 is arranged so that the locking projections A714a and B714b of the end plate 714 and each unit are easily connected.

[0075] Examples of these unit configurations are shown in Figures 11(b) to 11(d). Figure 11(b) shows an example of a resin dispensing unit, Figure 11(c) shows an example of a laser output unit, and Figure 11(d) shows an example of a transport unit. Figure 11(b) shows 709a, which is a resin dispensing unit for dispensing photocurable resin, and the resin material can be supplied from the outside via a resin supply tube 709ac. Holes A709aa for connecting resin discharge unit, Holes B709ab for connecting resin discharge unit, It is formed at the top. The lower part is equipped with a discharge nozzle, from which a curable resin is dispensed by electric force. The resin supply tube 709ac also has the electrical lead wires bundled together.

[0076] In Figure 11(c), 709b is a laser output unit, for example, one that outputs laser light having a wavelength for curing resin, and one that irradiates laser light for vaporizing cured resin. The top of the laser output unit is provided with two mounting holes for the laser output unit: A709ba and B709bb. 709bc is a laser output fiber, formed from optical fiber. If the end of the optical fiber is formed at the output terminal of the laser output unit 709b, it may be an optical fiber, and if this output terminal is a laser output element, it becomes an electrical lead wire.

[0077] In Figure 11(d), 709c is a transport unit equipped with a suction section, and is exemplified as being transported by a robot arm 711 while, for example, a lid or access connector is suction-coupled to it. Here, transport refers to moving the lid, etc., to the target part. The upper part of the transport unit 709c is provided with transport unit coupling holes A709ca and B709cb, similar to the resin discharge unit 709a and the laser output unit 709b.

[0078] The 709cc is a suction tube, and the negative pressure created by drawing in air is transmitted through it. In addition, some cutting mill drive units may have a rotating part that rotates the cutting mill to remove the resin around the cover that has been inserted into the terminal. 710 is a placement stand, which is used to place the upper arm or other area where the terminal has been implanted, to seal or remove the seal, and to connect and fix the other end of the arm 703. The placement stand 710 takes shape according to the area where the percutaneous terminal has been implanted; for example, if it is implanted in the chest or abdomen, it may not be a placement stand but rather a part that fixes the arm 703.

[0079] 711 is a robotic arm, and while a parallel link type is exemplified, a multi-axis robot may also be used. 712 is a mounting section, which is a component for attaching the base section 14 of the parallel link mechanism to the drive unit support frame 12. 713 is the base, and three joints A1 (70a), A2 (70b), and A3 (70c) are arranged at 120-degree intervals and connected to each joint, with link A1 (71a) connecting to one end of link A of link A2 (71b) and link A3 (71c).

[0080] The configuration of the operating robot arm 711 will be described below. The operating robot arm 711 is configured such that a self-excited rotating joint, which contains a motor or other component, is connected to both ends of a link made of a hard metal or plastic, and the joint acts as an articulation to change the state of the link. Furthermore, it is equipped with an extendable cylinder in the middle, and the rotation of each joint and the sliding of the cylinder are controlled by a computer program, thereby ultimately controlling the position and tilt of the end plate 714.

[0081] The other ends of links A1 (71a), A2 (71b), and A3 (71c) are connected to parts of joints B1 (72a), B2 (72b), and B3 (72c), respectively. Furthermore, the other parts of joints B1 (72a), B2 (72b), and B3 (72c) are connected to one end of links B1 (73a), B2 (73b), and B3 (73c).

[0082] The other ends of links B1 (73a), B2 (73b), and B3 (73c) are connected to one end of cylinder 1 (74a), cylinder 2 (74b), and cylinder 3 (74c), respectively. The other ends of cylinder 1 (74a), cylinder 2 (74b), and cylinder 3 (74c) are connected to one end of links C1 (75A), C2 (75b), and C3 (75c). One end of link C2(75b) and link C3(75c) are connected to joints C1(76a), C2(76b), and C3(76c), respectively, which are provided on the end plate 714.

[0083] 714 is an end plate, and its operating direction (downward) surface has mounting parts formed for connecting to the resin discharge unit 709a, laser output unit 709b, transport unit 709c, etc. Parts of joint C1 (76a), joint C2 (76b), and joint C3 (76c) are connected to the upper surface of the end plate 714. An example of the bottom surface, which is the operating direction, is shown in Figure 11(a).

[0084] In Figure 11(a), 714a is a locking projection A, and 714b is a locking projection B. Drive motors that allow the end plate surface to slide are connected to both, and as they move on the end plate 714, they slide toward the center and are inserted into the resin discharge unit coupling hole A709aa provided on the upper part of the replaceable driver unit. By sliding toward the center, they clamp the cassette-type driver and fix it in place. Moving them toward the opposite direction releases the fixation.

[0085] Each joint is connected to a computer-controlled drive unit formed by a voice coil motor or the like, and also forms a sliding drive unit for sliding cylinder 1 (74a) to cylinder 2 (74b) and cylinder 3 (74c) using a sliding motor, pneumatics, or the like. Each cylinder is equipped with a drive unit, such as a flat motor, to enable it to slide, for example, while containing air.

[0086] 714s and 714S are position sensors used to form 3D or 2D data. They consist of, for example, multiple still image acquisition sensors for measuring the position of the upper part of the terminal. One still image acquisition sensor recognizes the contour processing area, and 3D position information is obtained by determining the distance from the return time of reflected light to the irradiated light using a stereo camera, two still image acquisition sensors, and a single image acquisition device such as a TOF camera. Although position sensors 714s and 714S perform non-contact measurement as shown in the figure, they are not limited to this, and in some cases ultrasonic sensors or contact probe shapes may be used, and it is preferable to use a device that can improve measurement accuracy.

[0087] Next, the operation of the device shown in Figure 7 will be explained using Figures 8 and 9. As shown in Figure 7, the plant is placed on the planting stand 710 with the upper arm portion where the terminal upper PDF is implanted facing upwards. The arm 703 is moved manually or by robot, and the clamping parts A707 and B708 ​​of the fixing unit 706 grip the terminal side PDB from both sides (for example, Figure 8(d)(e)). The clamping operation of clamping parts A707 and B708 ​​may be performed automatically, or manually depending on the strength of the ceramics constituting the terminal.

[0088] The computer rotates joint A1 (70a), joint B1 (72a), and joint C1 (76a) and retracts cylinder 1 (74a) to move the end plate 714 onto the jig housing 709. The end plate 714 selects the resin discharge unit 709a, laser output unit 709b, and transport unit 709c on the jig housing 709 and inserts and connects them to, for example, the resin discharge unit coupling holes A709aa and B709ab of the resin discharge unit 709a using the locking protrusions A714a and B714b on the back surface of the end plate 714.

[0089] Secure the main unit 704 to the PDF above the terminal. As shown in Figure 7, the main body 704 is moved so that the clamping parts A707 and B708 ​​of the fixing unit 706 can clamp onto the upper part PDF of the terminal. This movement is performed by manually or automatically moving joint A702 and joint B704a. If the upper PDF of the terminal is located, for example, in the area from the chest to the throat, rotate joint A702 and joint B704a to move clamping parts A707 and B708 ​​to the terminal PDF, and then clamp and fix the side PDB of the terminal with clamping parts A707 and B708.

[0090] Removal of the PDC cover The locking projections A714a and B714b on the back surface of the end plate 714 Replace with transport unit 709c. The replacement is performed automatically, but may also be done manually. Figure 8 shows an example of the coupling and uncoupling operation between the end plate 714 and the transport unit coupling hole A709ca. In Figure 8, the lid PDC is shown in a state where a resin seal has not been formed on the upper PDF of the terminals.

[0091] In both cases, a space is formed in the lateral direction inside, and the tip of the locking projection A714a is housed while sliding laterally, forming a fixed state for both. 709cd is a suction section, which has an open configuration facing downwards and is connected to a suction tube 709cc, creating a suction state by negative pressure supplied from the outside. Figure 8 shows a robot arm 711 moving the end plate 714 to the transport unit 709c in the jig housing section 709 shown in Figure 7.

[0092] The robot arm 711 moves the end plate 714 downward, inserting the locking protrusions A714a and B714b into the transport unit coupling holes A709ca and B709cb, as shown in Figure 8(b). Once insertion is complete, the locking protrusions A714a and B714b are moved towards the center and fixed in place, as shown in Figure 8(c). The completion of insertion and movement are performed, for example, based on a computer program executed by the computer 700 shown in Figure 7. The computer 700 completes the insertion and confirms the position by inputting sensor output signals obtained from position sensors 714s and contact sensors (not shown) that detect contact states attached to the end plate 714, GPS sensors, acceleration sensors, etc., into a computer program built into the computer 700 and executing it. In this state, the robot arm 711 moves the transport unit 709c to the position of the terminal cover PDC and brings it into contact with the upper surface of the cover PDC. An external negative pressure generator (not shown) is activated to operate the suction unit 709cd via the suction tube 709cc, connecting the cover PDC with the suction unit 709cd of the transport driver 709c (Figure 8(d)).

[0093] Furthermore, it is preferable that the bottom surface of the suction section 709cd and the lid section PDC are in uniform contact with each other, without any gaps, to prevent airflow leakage. In this state, by operating the robot arm 711 to move the end plate 714 upward, the cover PDC can be removed from the upper PDF of the terminal, as shown in Figure 8(e). Alternatively, the cover portion PDC can be inserted onto the terminal upper PDF and through-hole PDH, and in some cases, it can be fixed in place by incorporating a rotation function.

[0094] Release of the seal on the lid PDC Figure 9(a) shows the state after removing the hardened resin that sealed the lid PDC. Figure 9(a) shows the state in which the clamping parts A707 and B708 ​​have already been moved to clamp and fix the terminal side PDB. Prior to this, as shown in Figure 7, the locking protrusions A714a and B714b on the back surface of the end plate 714 are inserted into the laser output unit coupling holes A709ba and B709bb of the laser output unit 709b, respectively, and slid to form a locked and fixed state. After attaching and fixing the laser output unit 709b to the end plate 714, the robot arm 711 is operated to irradiate the cured resin with laser light from the laser output unit 709b while checking the cured resin with the position sensor 714s, dissolving and vaporizing it to remove the cured resin PDE.

[0095] Installation of the access connector Figure 9(b) shows the state when the access connector 901 is attached to the top of the terminal using the transport unit 709c. 901 is an access connector, a device that connects to the outside when introducing nutrients or medications using terminals, or a device that connects to the outside when removing body fluids via terminals, and in the case of hemodialysis, it refers to the part that connects to the outside in the blood withdrawal unit that removes blood to the outside and the blood return unit that returns purified blood from the outside. 902 is a transport conduit, a tubular body that connects an external device to the access connector 901 when supplying drug solutions or body fluids into the body, or a tubular body used when extracting blood or other body fluids from the body and supplying them to an external device.

[0096] The transport unit 709c is connected to the robot arm as shown in Figure 8. It operates according to the program, and when administering a drug solution using the terminal, after removing the lid, the transport unit 709c is used to suction-connect the access connector 901 to the terminal hole PDH, transport it, and insert it. In some cases, it may be rotated and fixed in place. End of treatment; sealing of the terminal.

[0097] Figure 9(c) shows the end plate 714 of the robot arm 711 shown in Figure 7 with a discharge nozzle for applying a curable resin agent attached, and the curable resin being applied to the boundary between the upper PDF of the terminal section and the PDC of the lid section. Furthermore, the curing light output unit (not shown) is replaced to cure the applied curable resin.

[0098] The end plate 714 allows for treatment to proceed while replacing the driver unit, for example as shown in Figures 11(b) to (d), for each purpose, and while attaching and detaching the cover to the terminal section and attaching and detaching the access connector. This reduces the burden on the patient by minimizing infections during cover attachment and detachment, and by reducing sterilization and disinfection outside of treatment. [Industrial applicability]

[0099] This invention can be used in the medical field to improve patient burden and quality of life by eliminating the need to wrap excessive protective bags around ceramic terminals used for transdermal fluid exchange, drug delivery, and nutrient delivery. [Explanation of Symbols]

[0100] 100 Cover component 101 Fixing Press Unit 102 Nozzles 103 Light output section for curing 104 Nozzle drive unit 105 Control drive unit 106 Control Unit 107a Electrical lead wire A 107b Electrical lead wire B 108 Connecting shaft 109 Flexible Arm

Claims

1. A transdermal terminal handling device comprising: a fixing unit that uniformly presses and fixes the peripheral sides of a terminal portion implanted on the skin surface and inner surface, which is made of a calcium phosphate compound, toward the center; a coating and curing unit that applies and cures a curable resin to the lid portion on the upper surface of the terminal portion; and a removal unit that removes the coating and curing unit to the extent that at least the lid portion can be detached.

2. The transcutaneous terminal handling device according to claim 1, further comprising the steps of: after treatment, pressing and fixing the upper part of the terminal with the fixing part, then with the cover part placed on the upper part of the terminal, applying a curable resin to the contour of the cover part with the coating and curing unit to form a cured coating part; and during treatment, removing the cured coating part with the removal unit and taking out the cover.

3. The transcutaneous terminal handling device according to claim 1, wherein the coating and curing unit comprises a rotating member that applies a curable material while rotating on the upper part of the terminal.

4. The transcutaneous terminal handling device according to claim 1, wherein the removal unit comprises a rotating member that removes the curable material while rotating on the upper part of the terminal.

5. The transcutaneous terminal handling device according to claim 1, wherein the coating and curing unit coats the entire upper part of the lid with a curable resin.

6. The transcutaneous terminal handling device according to claim 1, further comprising: recognition means for recognizing a cover portion or the outline of a cover portion disposed on the upper surface of the terminal; and processing portion identification means for identifying a portion to be processed from the cover portion or the outline of a cover portion obtained by the recognition means.

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