medical equipment

Abstract

A medical instrument 100 comprises: an injection part 140 that can be connected to a cylinder part 110 capable of accommodating a drug, and that is provided with internal spaces 152, 162 through which the drug flows; and a first measurement part 170 that measures pressure at a first location P1 on the tip side of the internal spaces and a second location P2 which is nearer the base side of the internal spaces than the first location.

Description

[Technical Field]

[0001] The present invention relates to medical devices. [Background technology]

[0002] When treating tumors formed in the liver, percutaneous ethanol injection therapy (see, for example, Patent Document 1) is sometimes used, which locally treats and kills cancer cells. The surgeon makes an incision in the abdomen or chest, inserts a needle cannula into the liver, and reaches the affected area of ​​the liver cancer. Then, ethanol is injected from the needle tip, causing necrosis of the cancer cells. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 4588977 Summary of the Invention [Problem to be solved by the invention]

[0004] The present inventors have been diligently studying matters for confirming (understanding) in detail that a drug has been administered to an affected area such as inside a tumor.

[0005] The present invention has been made in view of the above-mentioned problems, and aims to provide a medical device that can acquire information on how a drug is administered to an affected area such as inside a tumor. [Means for solving the problem]

[0006] A medical device according to one aspect of the present invention that achieves the above object includes an injection section and a first measurement section. The injection section is connectable to a drug storage section that can store a drug and includes a flow path through which the drug can flow. The first measurement section is configured to determine the pressure difference between a first section at the distal end of the flow path and a second section that is closer to the proximal end of the flow path than the first section. [Effects of the Invention]

[0007] The above medical device makes it possible to obtain information on how a drug is administered to an affected area such as inside a tumor. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a schematic perspective view showing a medical device according to a first embodiment of the present invention. [Figure 2] 2A and 2B are diagrams showing the inside of the injection part of the medical device shown in FIG. 1 and other configurations of the medical device. [Figure 3] 10A and 10B are diagrams showing the inside of a needle member according to a modified example. [Figure 4] 4 is a cross-sectional view of the needle member shown in FIG. 3, taken along a line intersecting the longitudinal direction. [Figure 5] 10 is a diagram showing the inside of a needle member that constitutes an injection section, and is a diagram showing a medical device according to a modified example that includes a second measuring section. FIG. [Figure 6] 6 is a cross-sectional view of the needle member shown in FIG. 5, taken along a line intersecting the longitudinal direction. [Figure 7] 10A and 10B are views showing the inside of the injection portion and other configurations of the medical device according to a modified example of the connecting member. [Figure 8] 10A and 10B are views showing the inside of the injection portion and other configurations of the medical device according to a modified example of the connecting member. DETAILED DESCRIPTION OF THE INVENTION

[0009] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely examples for embodying the technical concept of the present invention and are not intended to limit the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, as well as within the scope of the claims and their equivalents.

[0010] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

[0011] In the following description, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, these are used for convenience and do not stipulate any particular order.

[0012] A medical device 100 according to a first embodiment will be described below with reference to Figures 1 and 2. Figure 1 is a schematic diagram showing the medical device 100 according to the first embodiment. Figure 2 is a diagram showing the inside of an injection section 140 constituting the medical device 100 according to Figure 1, as well as other components of the medical device 100.

[0013] The drawings show a coordinate system. X indicates the longitudinal direction of needle members 150, 150a (hereinafter referred to as needle members 150, etc.) that constitute injection section 140, and is referred to as the longitudinal direction X. YZ is a plane that intersects (is perpendicular to) the longitudinal direction X, and is referred to as the YZ plane. r is a radial direction from the center of needle members 150, etc. on the YZ plane, and is referred to as the radial direction r. θ is a circumferential direction (angular direction) of needle members 150, etc. on the YZ plane that intersects with the longitudinal direction X of needle members 150, etc., and is referred to as the circumferential direction θ.

[0014] The medical device 100 according to this embodiment can be used when administering a drug such as an anticancer drug to a patient.

[0015] 1 and 2, medical device 100 according to this embodiment includes a cylindrical portion 110 (corresponding to a drug containing portion), a pressing member 120, a sealing member 130, an injection portion 140, a first measuring portion 170, a notification portion 180, and a control portion 190. Each component will be described in detail below.

[0016] (cylindrical part) The tubular portion 110 has a semi-closed space for accommodating a drug such as an anticancer drug. The tubular portion 110 is configured in a cylindrical shape, such as a cylinder, and has openings at both ends in the axial direction of the tubular shape. A pressing member 120 can be movably disposed in one of the openings (also called the base-end opening). A connecting member 160 that constitutes the injection portion 140 can be attached to the other opening (also called the tip-end opening).

[0017] (Pressing member) The pressing member 120 is configured so that its tip side is housed in the semi-closed space of the cylindrical portion 110 and its base side is disposed outside the cylindrical portion 110. The pressing member 120 is configured to change the size of the semi-closed space in which the drug is housed by moving relative to the cylindrical portion 110 in the axial direction of the cylindrical portion 110 (direction Y intersecting the longitudinal direction X). As the size of the semi-closed space is reduced by the pressing member 120, the drug housed in the semi-closed space flows into the internal spaces 152, 162 of the injection portion 140 by the reduced amount, and can be administered to the patient.

[0018] (Sealing material) Sealing member 130 is configured to be attached to the tip end in the axial direction (direction Y intersecting longitudinal direction X) of pressing member 120. Sealing member 130 slidably engages with the inner wall of tubular portion 110, thereby preventing the drug contained in the semi-closed space of tubular portion 110 from circulating outside internal spaces 152, 162 that constitute injection portion 140.

[0019] (Injection part) Injection section 140 is configured to be connectable to an opening at the tip side of tubular section 110 that contains a medicine. Injection section 140 includes needle member 150 and connecting member 160, as shown in FIG.

[0020] Needle member 150 is configured to be able to puncture the patient's body. Needle member 150 includes discharge portion 151 and internal space 152. Needle member 150 is configured in a long, hollow, tubular shape, and discharge portion 151 includes an opening for discharging the drug circulating in internal space 152 to the outside. In this embodiment, discharge portion 151 is configured to open toward the tip in longitudinal direction X. However, as long as the drug can be discharged toward the tumor with injection portion 140 placed in the body lumen, the direction of the opening of the outflow portion is not limited to the tip in longitudinal direction X.

[0021] In this embodiment, the tubular shape of needle member 150 is a cylinder, but it may be a square tube.

[0022] The internal space 152 forms a long flow path through which the drug can flow from the tubular portion 110. The internal space 152 is configured so that the drug can flow from the tubular portion 110 to the discharge portion 151. The internal space 152 is configured to communicate with the semi-closed space of the tubular portion 110. In this embodiment, the needle member 150 is configured so that its wall thickness in the radial direction r intersecting with the longitudinal direction X is constant. However, as long as the drug can flow through the internal space 152, the wall thickness in the radial direction r of the needle member 150 that forms the internal space 152 does not need to be constant.

[0023] The dimensions of needle member 150 are not particularly limited, but for example, the length in the longitudinal direction X can be 300 mm, and the inner diameter can be 0.3 to 0.5 mm.

[0024] As shown in FIG. 2, the connecting member 160 includes a body portion 161, an internal space 162, a first opening 163, a second opening 164, a third opening 165, and a valve body 166.

[0025] The body portion 161 is connected to the tip side of the tubular portion 110 and to the base end side of the needle member 150, and is configured to lead out wiring W from the first sensor 171 and the second sensor 172 that make up the first measuring portion 170 to the outside.

[0026] The internal space 162, together with the internal space 152 of the needle member 150, forms a long flow path through which a drug can flow. The internal space 162 is configured so that the dimensions that define the cross-sectional shape, such as the diameter dimension, of the section connecting the second opening 164 and the third opening 165, intersecting with the longitudinal direction X, are the same as or approximately the same as the dimensions, such as the diameter dimension, of the needle member 150.

[0027] The first opening 163 is a portion that connects to the tip side of the tubular portion 110, and in this embodiment, the opening is configured to face a direction Y that intersects with the longitudinal direction X. The first opening 163 that connects to the tubular portion 110 and the second opening 164 that leads out the wiring W from the first measuring unit 170 are configured to be in different positions.

[0028] The second opening 164 is configured so that the wiring W of the first sensor 171 and the second sensor 172 that configure the first measuring unit 170 can be led out to the outside of the internal space 162. In this embodiment, the second opening 164 is oriented along the longitudinal direction X and is disposed at a position opposite to the third opening 165. A valve 166 is disposed in the second opening 164 to prevent the drug from circulating from the second opening 164 to the outside of the internal space 162.

[0029] Third opening 165 is configured as a portion that connects to the base end side of needle member 150 that configures injection portion 140. In this embodiment, third opening 165 is configured so that the opening direction is along the longitudinal direction X.

[0030] The specific materials of the tubular portion 110, pressing member 120, sealing member 130, needle member 150, and body portion 161 and valve body 166 of connecting member 160 of medical device 100 are not particularly limited as long as they can administer a drug to a patient through needle member 150. Examples of the materials of each include tubular portion 110, pressing member 120, and body portion 161 made of plastic such as polypropylene or polyethylene, and sealing member 130 and valve body 166 made of butyl rubber, silicone rubber, elastomer, or the like. Needle member 150 can be made of stainless steel, or the like.

[0031] (1st measurement section) First measuring unit 170 measures the pressure at a first site P1 on the distal side of internal spaces 152, 162 of injection unit 140 and at a second site P2 on the proximal side of first site P1. First measuring unit 170 includes a first sensor 171 and a second sensor 172 as shown in FIG.

[0032] As described above, in this embodiment, the internal space of injection part 140 includes internal space 152 of needle member 150 and internal space 162 of connecting member 160. First sensor 171 can be disposed near discharge part 151 on the tip side of needle member 150, as shown in Figure 2. In this specification, this position is referred to as first position P1.

[0033] The second sensor 172 is disposed closer to the base end than the first sensor 171 in the internal spaces 152, 162. In this embodiment, the second sensor 172 is disposed on the base end side of the internal space 152 of the needle member 150. In this specification, this position is referred to as the second position P2. In this embodiment, the first sensor 171 and the second sensor 172 are configured to be fixed to the internal space 152 of the needle member 150, etc., by adhesive, heat fusion, staples, or the like.

[0034] There are no particular limitations on the sensors that make up first sensor 171 and second sensor 172, as long as they can measure the pressure difference in the internal space of the injection part. As an example, first sensor 171 and second sensor 172 are diaphragm-type sensors that can measure the pressure at first site P1 and second site P2, and can be configured with a cross-sectional shape intersecting the longitudinal direction X that is a rectangle with a side length of 0.1 mm, for example.

[0035] The first sensor 171 and the second sensor 172 constituting the first measuring unit 170 are configured to be able to measure pressure when connected to the wiring W.

[0036] (Notification Department) The notification unit 180 is configured to be able to notify a user such as an operator of information related to the pressure measured by the first measuring unit 170. The notification unit 180 includes a video notification unit 181 and an audio notification unit 182, as shown in FIG.

[0037] Visual notification unit 181 is electrically connected to control unit 190 and is configured to be able to visually display the measurement results of first measuring unit 170. Visual notification unit 181 may include a known display such as a liquid crystal display or an OLED. The pressure measurement results by first measuring unit 170 can be displayed on visual notification unit 181 using numerical values, graphs, etc.

[0038] Audio notification unit 182 is configured to be operable in response to the measurement result of the pressure difference between two locations in internal space 152 of injection unit 140 measured by first measurement unit 170. Audio notification unit 182 is configured to be able to notify the user when the measurement value by first measurement unit 170 satisfies a certain condition. In this embodiment, the certain condition means when the pressure measurement values ​​of first sensor 171 and second sensor 172 exceed a threshold value.

[0039] If the pressure difference between the internal spaces 152 and 162 does not exceed a predetermined threshold, the drug is likely to be discharged into a closed space, such as a patient's tumor. On the other hand, if the pressure difference exceeds a predetermined threshold, the drug may be discharged into an open space, such as when a tumor ruptures or when the drug is delivered to a blood vessel.

[0040] In view of this relationship, the audio notification unit 182 is configured to notify a user such as an operator by audio when the pressure difference between the two locations in the internal spaces 152, 162 exceeds a predetermined threshold. In this embodiment, the predetermined threshold is intended to indicate whether the pressure difference between the first sensor 171 and the second sensor 172 is the same, i.e., whether a deviation occurs. The audio notification unit 182 is configured to include, as an example, a device capable of emitting audio, such as a speaker.

[0041] (Control unit) The control unit 190 is configured to integrally control the first measuring unit 170, the notification unit 180, etc. The control unit is configured to include a processor such as a CPU or GPU, a main memory such as a RAM, and a storage unit such as a ROM, an HDD, or an SSD. The control unit 190 can be housed inside a housing that includes the notification unit 180, etc., shown in FIG. 1.

[0042] (Example of use) Next, an example of how the medical device 100 according to this embodiment is used will be described.

[0043] First, the surgeon moves the pressing member 120 relative to the cylindrical portion 110 to move the drug contained in the semi-closed space of the cylindrical portion 110 into the internal spaces 152, 162 of the injection portion 140 in which the first measuring portion 170 is arranged (priming).

[0044] In addition, if the drug leaks to the outside due to priming, the pressing member 120 should be moved carefully relative to the tubular portion 110 so that the drug does not scatter to unintended locations, and a tray or the like should be placed below the medical device 100 to prevent the drug from scattering to unintended locations.

[0045] Next, the surgeon turns on the power supply (not shown) to electrically connect control unit 190 to first measurement unit 170 and notification unit 180. Then, the values ​​of first sensor 171 and second sensor 172 are reset. Next, the surgeon makes a small incision around the patient's abdomen. Then, under ultrasound echography, the surgeon uses needle member 150 of injection unit 140 to percutaneously puncture the area from the body surface, and manipulates the tip of needle member 150 to advance to just before or inside the tumor.

[0046] The surgeon then moves pressing member 120 relative to cylindrical portion 110 so as to reduce the semi-closed space of cylindrical portion 110, thereby administering the drug to the patient. The present inventors have found that when measuring the pressure at two points in internal spaces 152, 162 of injection portion 140 with needle member 150 inserted into a closed or open space, differences in the measured values ​​due to pressure loss can occur depending on the site punctured by needle member 150.

[0047] When the pressure at the two points described above is measured with the tip of the needle member 150 inserted into a closed space, the measured values ​​will be the same. On the other hand, when the tip of the needle member 150 is inserted into an open space, the measured values ​​at the two points described above will be different, with the measured value at the downstream side of the flow path being lower than the measured value at the upstream side.

[0048] The notification unit 180 visually notifies the surgeon of the measurement results of the first measuring unit 170 using a visual notification unit 181, for example, as numerical values. If a pressure loss is detected based on the measurement results of the first measuring unit 170, the audio notification unit 182 notifies the surgeon of the result by audio. In this way, the medical device 100 according to this embodiment can notify the surgeon of information regarding how a drug has been administered to an affected area, such as inside a tumor.

[0049] Once it is confirmed that the drug has been administered to the patient's tumor, the surgeon removes the medical device 100 from the body.

[0050] As described above, medical device 100 according to this embodiment has injection section 140 and first measurement section 170. Injection section 140 is connectable to tubular section 110 capable of containing a drug, and has internal spaces 152, 162 through which the drug can flow. First measurement section 170 measures the pressure at first site P1 on the distal end side of internal spaces 152, 162, and at second site P2 on the proximal end side of internal spaces 152, 162 relative to first site P1.

[0051] By configuring in this way, it is possible to notify a user such as an operator of information about how the medicine is being administered to the affected area of ​​the patient, such as in an open space or a closed space.

[0052] Furthermore, first measuring unit 170 is configured to be able to measure pressure when connected to wiring W. Injecting unit 140 is provided with internal space 152 and includes needle member 150 capable of puncturing the patient's body, and connecting member 160. Connecting member 160 is provided with internal space 162 and is connected to needle member 150 on the proximal end side of needle member 150, and is configured so that first opening 163 connected to tubular portion 110 and second opening 164 through which wiring W from first measuring unit 170 leads out are different.

[0053] This configuration also makes it possible to notify a user such as an operator of information about how the drug is being administered to the affected area of ​​the patient, such as in an open space or a closed space.

[0054] In addition, first measuring unit 170 is configured to include first sensor 171 disposed at first position P1 of internal spaces 152, 162, and second sensor 172 installed at second position P2 of internal space 152. With this configuration, it is possible to measure pressure at two different points in internal spaces 152, 162 of injection part 140.

[0055] Furthermore, the first measuring unit 170 is configured to be fixed relative to the internal space 152. This configuration prevents the positions of the sensors that measure the pressure values ​​at the first site P1 and the second site P2 from changing due to the flow of the drug, thereby reducing fluctuations in the measurement values.

[0056] Furthermore, the medical instrument 100 is configured to include a visual notification unit 181 that visually displays the pressure measurement value measured by the first measuring unit 170. This configuration makes it easier for the user to understand the measurement results by the first measuring unit 170.

[0057] The medical instrument 100 also has a notification unit 180 that notifies the user by voice or the like when certain conditions are met, such as when the difference in the measured values ​​between two points by the first measurement unit 170 exceeds a threshold. With this configuration, the medical instrument 100 can more clearly notify the user of situations such as when the drug is not administered as intended by the operator.

[0058] (Variation 1) 3 is a cross-sectional view taken along the longitudinal direction X showing the inside of needle member 150a that constitutes medical device 100a according to Modification 1 and that constitutes injection portion 140a, and FIG. 4 is a cross-sectional view intersecting longitudinal direction X showing discharge portion 151a of needle member 150a. In the first embodiment, it has been described that discharge portion 151 of needle member 150 that constitutes injection portion 140 faces the tip side in longitudinal direction X of needle member 150. However, the orientation of the discharge portion is not limited to the tip side in longitudinal direction X as long as it is possible to discharge a drug into an affected area such as inside a tumor.

[0059] In this modified example, needle member 150a has an internal space 152 as shown in Figures 3 and 4, includes a cylindrical shape such as a cylinder with a closed tip, and ejection portion 151a is configured to be provided on the side of the cylindrical shape. In this modified example, ejection portion 151a is configured to face in a radial direction r that intersects with longitudinal direction X. In this modified example, ejection portions 151a are configured to be provided at four locations equally spaced apart in circumferential direction θ as shown in Figure 4, for example. However, as long as the medicine can be ejected to the affected area, the number of ejection portions is not limited to four, and the arrangement intervals do not have to be equal.

[0060] The use example of the medical device according to this modification differs only in the position and orientation of the discharge portion, and the rest is the same as in the first embodiment, so a description thereof will be omitted.

[0061] As described above, in this modified example, discharge portion 151a of needle member 150a is configured to be provided on the side surface of a cylindrical shape with a closed tip. This configuration allows first sensor 171 and the like, which are arranged on the tip side of internal space 152, to be enclosed and protected. Furthermore, by arranging discharge portion 151a on the side surface of the cylindrical shape, the number and dimensions of discharge portions 151a can be appropriately set without being restricted by the diameter of the cylindrical shape, and the drug discharge efficiency can be improved. Furthermore, by providing discharge portion 151a on the side surface of the cylindrical shape, injection resistance can be reduced.

[0062] (Variation 2) Fig. 5 is a cross-sectional view along the longitudinal direction X showing the interior of needle member 150a constituting injection section 140a and second measurement section 210, etc., which constitute medical device 100b according to Modification 2. Fig. 6 is a cross-sectional view intersecting longitudinal direction X showing discharge section 151a of needle member 150a and second measurement section 210, etc. In the first embodiment, it has been described that first measurement section 170 includes first sensor 171 and second sensor 172 provided in internal space 152 of injection section 140. However, the configuration for detecting pressure loss may include the following sensors in addition to the first sensor and second sensor.

[0063] In this modification, medical device 100b has a tubular portion 110, a pressing member 120, a sealing member 130, an injection portion 140a, a first measuring portion 170, and a second measuring portion 210. Since tubular portion 110, pressing member 120, sealing member 130, and first measuring portion 170 are the same as in the first embodiment, and injection portion 140a is the same as in modification 1, a description thereof will be omitted.

[0064] Second measurement unit 210 is installed outside needle member 150 constituting injection unit 140, and measures the liquid pressure of the liquid present around injection unit 140 when injection unit 140 is in contact with the liquid. Second measurement unit 210 can use sensors similar to first sensor 171 and second sensor 172 of first measurement unit 170. Second measurement unit 210 can be bonded to the outer surface of needle member 150 of injection unit 140 by heat fusion or the like, thereby maintaining the two in an integrated state.

[0065] Next, an example of how to use the medical device according to this modification will be described. Note that the priming operation is the same as in the first embodiment, so a description thereof will be omitted.

[0066] Next, the surgeon turns on the power supply (not shown) to electrically connect the control unit 190 with the first measurement unit 170, the notification unit 180, and the second measurement unit 210. Next, the surgeon makes a small incision around the abdomen. Then, under ultrasound echography, the surgeon uses the needle member 150a of the injection unit 140a to percutaneously puncture the area from the body surface, and manipulates the tip of the needle member 150 to advance just before or into the tumor.

[0067] Next, the surgeon operates pressing member 120 relative to tube portion 110 in the same manner as in the first embodiment to administer the drug to the patient. If the pressure of first sensor 171 increases when the drug is administered but the pressure value of the sensor of second measuring unit 210 does not increase, it can be determined that a blockage has occurred in internal spaces 152, 162 of injection portion 140a.

[0068] The operator can check the result of pressure measurement by the first measuring unit 170 on the notifying unit 180. The rest is the same as in the first embodiment, so a description thereof will be omitted.

[0069] As described above, the medical device 100b according to this modified example has a second measuring section 210 that is installed outside the injection section 140a and measures the liquid pressure of the liquid present around the injection section 140a when the injection section 140a is in contact with the liquid.

[0070] This allows consideration of both the results of the measurement by second measurement unit 210 and the measurement by first measurement unit 170, and makes it possible to notify the user of information regarding the status of drug administration by injection unit 140a, such as whether or not clogging has occurred in internal spaces 152, 162 of injection unit 140a. Furthermore, even if clogging occurs inside needle member 150a, it is possible to measure the internal pressure of the tumor and detect leakage of drug.

[0071] (Variation 3) 7 is a diagram showing the inside of injection section 140c constituting medical device 100c according to Modification 3, as well as other configurations of medical device 100c. In the first embodiment, it was described that the cross section of connecting member 160, which intersects with longitudinal direction X, at the portion connecting second opening 164 and third opening 165, has dimensions such as diameter that are approximately the same as those of needle member 150. However, the injection section can be configured as follows.

[0072] 7, medical device 100c has a tubular portion 110, a pressing member 120, a sealing member 130, an injection portion 140c, a first measuring portion 170c, a notification portion 180, and a control portion 190c. As tubular portion 110, pressing member 120, sealing member 130, and needle member 150 constituting injection portion 140c are the same as those in the first embodiment, a description thereof will be omitted.

[0073] As shown in FIG. 7, the connecting member 160c includes a body portion 161c, an internal space 162c, a first opening 163, a second opening 164, a third opening 165, and a valve body 166.

[0074] The body portion 161c is connected to the tube portion 110 and to the needle member 150, and is configured to lead the wiring W of the first sensor 171 and the second sensor 172 that make up the first measuring portion 170c to the outside of the internal space 162c.

[0075] Internal space 162c is a space formed inside body portion 161c, and is configured to communicate with the semi-closed space in tube portion 110 through which the drug flows, and to communicate with internal space 152 of needle member 150 that constitutes injection portion 140c.

[0076] The internal space 162c is configured to allow the drug to flow through and to accommodate the second sensor 172c of the first measuring unit 170c. The internal space 162c where the second sensor 172c is located is configured so that the dimension of the cross section intersecting the longitudinal direction X of the section connecting the second opening 164 and the third opening 165 is larger than the dimension of the first section P1 where the first sensor 171 is located.

[0077] The first opening 163, the second opening 164, the third opening 165, and the valve body 166 are the same as those in the first embodiment, and therefore their explanations are omitted. The first measuring unit 170c differs only in the position of the second portion P2c where the second sensor 172c is disposed, and therefore their explanations are omitted.

[0078] The control unit 190c can store in its storage a program that corrects pressure measurements that may vary due to differences in the cross sections of the first region P1 and the second region P2c in the longitudinal direction X to measurements that would be obtained if the cross sections of the first region P1 and the second region P2c were the same. The rest of the control unit 190c is the same as in the first embodiment, so a description thereof will be omitted.

[0079] The method of using the medical device 100c according to this modification is the same as that of the first embodiment, except that when measuring the pressure during drug injection, a discrepancy in the measured value that may occur due to the difference in cross section between the first site P1 and the second site P2c is corrected, and then a determination is made as to whether a pressure loss has occurred. Therefore, a description thereof will be omitted.

[0080] As described above, in this modified example, internal spaces 152, 162c of injection section 140c are configured to be elongated, and second region P2c where second sensor 172 is arranged is configured to have a larger cross section intersecting with longitudinal direction X than first region P1 where first sensor 171 is arranged. This configuration makes it possible to reduce the influence of pressure fluctuations within the needle tube of needle member 150, such as reducing the influence of surrounding structures when the needle tube of the injection needle is bent.

[0081] (Variation 4) 8 is a diagram showing the inside of injection portion 140d constituting medical device 100d according to Modification 4 and other configurations of medical device 100d. Connecting member 160d constituting medical device 100d and constituting injection portion 140d can also be configured as follows. Note that tubular portion 110, pressing member 120, sealing member 130, and needle member 150 constituting injection portion 140d are the same as those in the first embodiment, and therefore description thereof will be omitted.

[0082] 8, the connecting member 160d includes a body 161, an internal space 162d, a first opening 163, a second opening 164, a third opening 165, a valve body 166, and a switching portion 167d. The body 161, the first opening 163, the second opening 164, the third opening 165, and the valve body 166 are the same as those in the first embodiment, and therefore their description will be omitted.

[0083] Switching unit 167d is configured to include a three-way stopcock or the like that can switch between connecting to a syringe S or the like that can create a negative pressure in internal space 152 before administering a drug, and cutting off the connection to syringe S. Note that although internal space 162d has a different shape from internal space 162 due to the provision of switching unit 167d, the cross section of the portion connecting second opening 164 and third opening 165 that intersects with longitudinal direction X is the same as that of needle member 150, and the rest is the same as that of internal space 162.

[0084] The first measuring unit 170d includes a first sensor 171 and a second sensor 172d. The first sensor 171 is configured to be disposed at a first position P1 on the distal end side of the internal space 152, as in the first embodiment. The second sensor 172d is configured to be disposed at a second position P2d, which is the internal space 162d of the connecting member 160d.

[0085] Next, we will explain an example of how to use medical device 100d according to Modification 4. First, the surgeon performs the priming operation in the same manner as in the first embodiment by moving pressing member 120 relative to cylindrical portion 110 while connecting the semi-closed space of cylindrical portion 110 and internal spaces 152, 162d that constitute injection portion 140 using the three-way stopcock associated with switching portion 167d.

[0086] Next, the surgeon turns on the power supply (not shown) to electrically connect control unit 190 to first measurement unit 170 and notification unit 180. Next, the surgeon makes a small incision around the patient's abdomen. Then, under ultrasonic echography, the surgeon uses needle member 150 constituting injection unit 140d to percutaneously puncture the area from the body surface, and manipulates the tip of needle member 150 constituting injection unit 140d to advance to just before or inside the tumor.

[0087] Next, the surgeon administers the medicine to the patient by moving the pressing member 120 relative to the tube portion 110, as in the first embodiment. The surgeon obtains information on the measurement results of the pressures at the first site P1 and the second site P2d by the first measuring unit 170d from the video notification unit 181 of the notification unit 180, etc.

[0088] Next, the surgeon removes medical device 100d from the body while switching portion 167d is used to connect the semi-closed space of tube portion 110 with internal spaces 152, 162d of injection portion 140d.

[0089] As described above, in this modified example, the medical device 100d includes a switching section 167d such as a three-way stopcock that switches between connecting to a syringe S capable of creating negative pressure in the internal space 152 and disconnecting from the syringe S, and the connecting member 160d that constitutes the injection section 140d is provided with the switching section 167d.

[0090] With this configuration, the pressure in internal spaces 152, 162d is released after administration of the drug, preventing leakage of liquid when needle member 150 is removed from the living body. Furthermore, before administration of the drug, switching unit 167d attempts to create a negative pressure in internal spaces 152, 162d using syringe S or cylindrical portion 110 and pressing member 120. If negative pressure is created in internal spaces 152, 162d, it can be determined that the tip of needle member 150 is located in a closed space such as a tumor and has not punctured a blood vessel.

[0091] Conversely, if the internal pressure in internal spaces 152, 162d does not change and become negative, it can be determined that the tip of needle member 150 has punctured a blood vessel. In this way, by using switching unit 167d to check whether internal spaces 152, 162d of the drug become negative pressure with syringe S, it can be determined whether the tip of needle member 150 constituting injection section 140d has punctured a blood vessel.

[0092] It should be noted that the present invention is not limited to the above-described embodiment, and various modifications are possible within the scope of the claims. In the first embodiment, it has been explained that first sensor 171 and second sensor 172 constituting first measuring unit 170 are fixed to internal space 152 of needle member 150 constituting injection unit 140 by adhesive, heat fusion, or the like.

[0093] However, as long as the pressure loss in the long internal space 152 can be measured, the first sensor 171 and the second sensor 172 do not necessarily have to be fixed in the internal space 152 of the needle member 150. The first sensor 171 and the second sensor 172 may be disposed in the internal space of the injection part of the needle member or the like during the procedure.

[0094] In the first embodiment, injection section 140 is described as including needle member 150 and connecting member 160. However, as long as pressure loss in elongated internal space 152 can be detected, injection section 140 including either needle member 150 or needle member 150a, but not including connecting member 160, etc., is also included in one embodiment of the present invention.

[0095] It has also been explained that audio notification unit 182 notifies the user when the difference between the measurement values ​​of first sensor 171 and second sensor 172 exceeds a predetermined threshold. However, the cases in which notification is given are not limited to the above. In addition to this, audio notification unit 182 may be configured to notify when the measurement value of first sensor 171 disposed on the tip side of internal spaces 152, 162 reaches a certain level or above, or when the measurement value drops suddenly.

[0096] Furthermore, when the above-mentioned conditions are met, the notification to the user, such as the surgeon, is not limited to audio, but may also be text. Furthermore, the method of notifying the user, such as the surgeon, is not limited to video or audio. In a syringe pump or the like, where the pressing member 120 moves relative to the tubular portion 110 by the operation of a motor or the like to deliver a drug, and a control unit controls each unit, such as the motor, the notification to the user may be made by stopping delivery or adjusting the delivery speed under the control of the control unit 190. Furthermore, although the first embodiment has been described as including the tubular portion 110, the medical device may be configured so that a component other than the tubular portion 110 is connected to the injection unit as long as it is capable of containing a drug.

[0097] This application is based on Japanese Patent Application No. 2021-048594, filed on March 23, 2021, the disclosure of which is incorporated by reference in its entirety. [Explanation of symbols]

[0098] 110 cylindrical portion (medicine storage portion), 120 pressing member, 140, 140a, 140c, 140d injection part, 150, 150a needle member, 151, 151a discharge part, 160, 160c, 160d connecting members; 163 first opening (portion connected to the cylindrical portion), 164 second opening (portion through which wiring from the first measuring unit is led out), 170 1st measurement section, 171 First Sensor, 172 Second Sensor, 180 Information Department, 181 Video Notification Department, 182 Voice notification unit, 210 2nd measurement section, W wiring.

Claims

1. an injection unit that is connectable to a medicine storage unit that can store a medicine and that has a flow path through which the medicine can flow; a first measurement unit configured to measure a pressure in a first region on the distal end side of the flow path and a second region on the proximal end side of the flow path relative to the first region; The medical device further comprises a second measuring unit that is installed outside the injection unit and measures the liquid pressure of the liquid present around the injection unit when the injection unit is in contact with the liquid.

2. an injection unit that is connectable to a medicine storage unit that can store a medicine and that has a flow path through which the medicine can flow; a first measurement unit configured to measure a pressure in a first region on the distal end side of the flow path and a second region on the proximal end side of the flow path relative to the first region; The medical device wherein the injection unit further comprises a switching unit that switches between connection with an instrument capable of creating a negative pressure in the flow path and disconnection from the instrument.

3. the first measurement unit is capable of measuring the pressure in a state where it is connected to a wiring, The injection section a needle member provided with the flow path and capable of being inserted into the body of a patient; 3. The medical device according to claim 1, further comprising: a connecting member that is provided with the flow path, is connected to the needle member at the base end side of the needle member, and has a portion that is connected to the medicine container and a portion that leads out the wiring from the first measuring unit that are different from each other.

4. The medical device according to any one of claims 1 to 3, wherein the injection section includes a cylindrical shape in which the flow path is provided and which is closed at its tip, and an ejection section for ejecting the drug from the drug storage section is provided on a side surface of the cylindrical shape.

5. The medical device according to any one of claims 1 to 4, wherein the first measurement unit comprises a first sensor installed at the first portion of the flow path and a second sensor installed at the second portion of the flow path.

6. The medical device according to any one of claims 1 to 5, wherein the first measuring unit is fixed to the flow path.

7. The flow channel is formed in an elongated shape, The medical device according to claim 5 , wherein the second portion in which the second sensor is disposed has a cross section intersecting the longitudinal direction that is larger than that of the first portion in which the first sensor is disposed.

8. The medical device according to any one of claims 1 to 7, further comprising a visual notification unit that visually displays a measurement value relating to the pressure measured by the first measurement unit.

9. The medical device according to any one of claims 1 to 8, further comprising a notification unit that notifies a user when a value measured by the first measurement unit satisfies a certain condition.

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