WO2022168862A1

WO2022168862A1 - Medical instrument

Info

Publication number: WO2022168862A1
Application number: PCT/JP2022/004029
Authority: WO
Inventors: 大貴有馬
Original assignee: テルモ株式会社
Priority date: 2021-02-08
Filing date: 2022-02-02
Publication date: 2022-08-11
Also published as: JP2024040532A

Abstract

A medical instrument 100 has: an injection needle 140 which is provided with an internal space 144 through which a drug can flow and an outflow section 143 out through which the drug flowing through the internal space can flow; and an outer tube 150 which is provided with an internal space 152 which can contain a tip of the injection needle, wherein at least either the injection needle or the outer tube is provided with a separating section which separates the tip side of the internal space in the lengthwise direction from the outside with the outflow section disposed in the internal space of the outer tube.

Description

medical instruments

The present invention relates to medical instruments.

When treating a tumor formed in the liver, percutaneous ethanol injection therapy (see, for example, Patent Document 1) may be performed to locally treat and necrotic cancer cells. The operator makes an incision in the abdomen or chest, pierces the liver with a needle cannula, and makes the tip of the needle reach the affected part of the liver cancer. By injecting ethanol from the tip of the needle, cancer cells can be necrotized.

Japanese Patent No. 4588977

In the above-described treatment using a needle cannula, etc., drugs that are relatively likely to have side effects on the human body, such as anticancer drugs, can be used as drugs to be administered. If such a drug spills from the needle tip of a medical device during surgery or the like and is exposed, there is a possibility that it may affect a medical worker, a patient, or the like. Among the spillage of the drug from the needle tip, the present inventors have found that the drug does not enter the injection needle after so-called priming, which is when the drug is filled into the inner space of the injection needle for injecting the drug into the patient, other than when the drug is administered. We are intensively studying matters to prevent spillage from the tip side.

The present invention has been made in view of the above problems, and an object of the present invention is to prevent a drug such as an anticancer drug from spilling from the tip side of an injection needle after priming and other than when the drug is administered. .

A medical device according to one aspect of the present invention that achieves the above object has an injection needle and an outer cylinder. The injection needle is configured to have a first internal space through which the drug can flow, and an outflow portion through which the drug flowing through the first internal space can flow out. The outer cylinder is configured to provide a second internal space capable of accommodating the tip of the injection needle. The injection needle and the outer cylinder are elongated. At least one of the injection needle and the outer cylinder is provided with an isolation part that isolates the tip side of the outflow part in the longitudinal direction from the outside when the outflow part is arranged in the second internal space.

According to the above medical device, it is possible to prevent drugs such as anticancer drugs from spilling from the tip side of the injection needle after priming and other than when the drug is administered.

1 is a schematic perspective view showing a medical instrument according to a first embodiment of the invention; FIG. 2 is a side view of the medical device of FIG. 1; FIG. 2 is a plan view of the medical device of FIG. 1; FIG. FIG. 2 is a cross-sectional view taken along the central axis of the outer cylinder that constitutes the medical device of FIG. 1, showing a state in which the tip of the injection needle is arranged in the inner space of the outer cylinder. It is a figure which shows the front-end|tip part of an injection needle in sectional drawing of FIG. It is a figure which shows the state which has arrange|positioned the front-end|tip part of the injection needle to the exterior of the front end side from the internal space of an outer cylinder in sectional drawing of FIG. It is a figure which shows the state which made the front-end|tip part of the injection needle contact the cap member of the outer cylinder in sectional drawing of FIG. FIG. 7 is a diagram showing a tip portion of an injection needle corresponding to FIG. 6, which is Modification 1 of the first embodiment. FIG. 7 is a view showing a tip portion of an injection needle corresponding to FIG. 6, which is Modification 2 of the first embodiment. FIG. 11 is a side view showing a medical device according to Modification 3 of the first embodiment, in which the injection needle has a second connecting portion; FIG. 10 is a view of a medical device according to a second embodiment, showing a cross-section of a barrel showing a different adjustment mechanism than the first embodiment for adjusting the position of the injection needle with respect to the barrel. FIG. 6 is a cross-sectional view showing a modification of FIG. 5 and showing a state in which the distal end portion of the injection needle is arranged in the internal space of the outer cylinder that constitutes the medical device.

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiment shown here is an example for embodying the technical idea of the present invention, and does not limit the present invention. In addition, other practicable modes, embodiments, operation techniques, etc. that can be conceived by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are described in the scope of claims. Included within the scope of the invention and its equivalents.

Furthermore, the drawings attached to this specification may be represented schematically by appropriately changing the scale, length-to-width ratio, shape, etc. from the actual thing for the convenience of illustration and ease of understanding. and does not limit the interpretation of the present invention.

Also, in the following description, ordinal numbers such as "first" and "second" will be used, but unless otherwise specified, they are used for convenience and do not prescribe any order.

(First embodiment)
A medical device 100 according to a first embodiment will be described below with reference to FIGS. 1 to 7. FIG. 1 to 3 are a schematic perspective view, side view, and plan view showing a medical instrument 100 according to a first embodiment. FIG. 4 is a cross-sectional view taken along the central axis of the outer cylinder 150 that constitutes the medical device 100 of FIG. .

FIG. 5 is a diagram showing the tip of the injection needle 140 in the cross-sectional view of FIG. FIG. 6 is a diagram showing a state in which the distal end portion of the injection needle 140 is arranged outside the inner space 152 of the outer cylinder 150 on the distal end side in the cross-sectional view of FIG. FIG. 7 is a diagram showing a state in which the distal end portion of the injection needle 140 is brought into contact with the cap member 156 that constitutes the outer cylinder 150 in the cross-sectional view of FIG.

In addition, the coordinate system is indicated in the drawing. X indicates the longitudinal direction of the injection needle 140, etc., and is referred to as the longitudinal direction X. As shown in FIG. YZ is a plane intersecting (perpendicular to) the longitudinal direction X, and is called a YZ plane. r extends radially in the YZ plane from the center of the injection needle 140 and is referred to as the radial direction r. θ is along the circumferential direction (angular direction) on the YZ plane that intersects the longitudinal direction X of the injection needle 140 and the outer tube 150, and is referred to as the circumferential direction θ.

The medical device 100 according to this embodiment can be used when administering drugs such as anticancer drugs to patients.

A medical device 100 according to the present embodiment will be outlined with reference to FIGS. 1 to 4 and the like. have. Each configuration will be described in detail below.

(Cylinder)
The tubular portion 110 provides a semi-closed space for containing drugs such as anticancer drugs. The tubular portion 110 is configured in a tubular 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 arranged in one of the openings (also referred to as the proximal opening). An injection needle 140 can be attached to the other opening (also referred to as the distal opening). In addition, a hollow tube member to which the injection needle 140 and the like can be attached may be attached to the distal end side opening of the tubular portion 110 .

(pressing member)
The pressing member 120 is configured such that the distal end side is accommodated in the semi-closed space of the cylindrical portion 110 and the proximal end side is disposed outside the cylindrical portion 110 . The pressing member 120 is configured to move relative to the tubular portion 110 in the axial direction (longitudinal direction X) of the tubular portion 110 to change the size of the semi-closed space in which the drug is stored. As the size of the semi-enclosed space is reduced by the pressing member 120, the medicine contained in the semi-enclosed space flows into the inner space 144 of the injection needle 140 and can be administered to the patient.

(seal member)
The sealing member 130 is configured to be attached to the distal end portion of the pressing member 120 in the axial direction (longitudinal direction X). The seal member 130 is slidably fitted to the inner wall of the tube portion 110 to prevent the drug contained in the semi-closed space of the tube portion 110 from flowing outside the internal space 144 of the injection needle 140 .

(injection needle)
The injection needle 140 is attached to the opening on the distal end side of the tubular portion 110 . The injection needle 140 is hollow and elongated so that the drug can be circulated inside. The injection needle 140 is attached to the distal end portion of the cylindrical portion 110 directly or via a tube member or the like. The tip of the injection needle 140 is straight when no external force is applied.

As shown in FIG. 4 and the like, the injection needle 140 includes a first portion 141, a second portion 142, an outflow portion 143, an internal space 144 (corresponding to the first internal space), an inner engagement portion 145, Prepare.

The injection needle 140 is elongated so that it can be inserted into the patient's biological lumen. The injection needle 140 is hollow so that the drug can flow out while the tip is placed inside the patient's body. The injection needle 140 is configured to have a substantially circular cylindrical shape in cross section intersecting the longitudinal direction X in this embodiment. However, if the drug can be administered to the intended site in the patient's body with the distal end placed inside the patient's body, the shape of the injection needle may be a polygonal column other than a cylinder.

The first part 141 is configured to have an internal space 144 and an outflow part 143 . As shown in FIG. 5, the outflow portion 143 is configured to be provided on the outer surface (side surface) of the first portion 141 on the distal end side, not the distal end in the longitudinal direction X of the second portion 142 . The outflow part 143 is configured so that the medicine flowing in the internal space 144 can flow out along the radial direction r.

In this embodiment, the outflow part 143 is configured such that one or more substantially circular holes are provided in the substantially cylindrical side surface. In this embodiment, a plurality of holes forming the outflow part 143 are arranged at regular intervals in the longitudinal direction X, and are arranged at intervals of a prescribed angle in the circumferential direction θ.

However, the specific shape, number, arrangement, etc. of the outflow part are not limited to the above as long as the medicine can be administered to the patient's intended site from the outflow part with the tip of the injection needle 140 placed inside the patient's body.

The internal space 144 is provided in the first portion 141 so that the medicine flows from the proximal side to the distal side. The internal space 144 communicates with the semi-closed space of the cylindrical portion 110 so that the drug contained in the semi-closed space of the cylindrical portion 110 can flow. The internal space 144 can be formed so that the thickness of the first portion 141 in the radial direction r is constant.

The second portion 142 is configured to be provided closer to the distal end than the first portion 141 in the longitudinal direction X. The second portion 142 has a larger dimension in the radial direction r intersecting the longitudinal direction X than the first portion 141 . In the present embodiment, the second portion 142 has a sharp tip as shown in FIG. 6 and the like. The second portion 142 is configured such that the distance from the inner wall surface 151 in the radial direction r is such that the medicine does not flow when the base end portion is disposed in the inner space 152 .

As shown in FIG. 5 , the base end portion of the second portion 142 is close to the inner wall surface 151 of the outer cylinder 150 with the outflow portion 143 disposed in the inner space 152 of the outer cylinder 150 . The tip side in the direction X is isolated from the outside. As a result, it is possible to prevent the medicine from leaking out of the outer cylinder 150, particularly from the distal end side. The outer peripheral edge of the second portion 142 may be chamfered. The second part 142 constitutes an isolation part in this embodiment.

The dimension of the first portion 141 and the second portion 142 in the radial direction r (the diameter corresponding to the outer diameter) is not limited, but as an example, the first portion 141 is 0.68 mm and the second portion 142 is 0.76 mm. be able to. Also, the total length of the injection needle 140 can be configured to be 100 to 400 mm.

In addition, the diameter of the hole of the outflow part 143 is 0.1 to 0.2 mm, but by increasing the diameter, the resistance during injection can be reduced. Further, the interval between the outflow portions 143 adjacent to each other in the longitudinal direction X can be set to 1 to 4 mm, and it can be expected that the diffusion efficiency of the drug can be improved by widening the interval.

Both the first part 141 and the second part 142 are made of stainless steel in this embodiment. However, the first part and the second part may be made of different materials as long as the medicine can be administered to a predetermined part in the patient's body.

The inner engaging portion 145 is provided to allow the injection needle 140 to move forward and backward in the longitudinal direction X relative to the outer cylinder 150 . As shown in FIG. 4, the inner engaging portion 145 is configured to have a plurality of uneven shapes that can mesh with the teeth of the gear member 153 forming the outer cylinder 150 . The inner engaging portion 145 is configured such that the extending direction of the uneven shape is orthogonal to the longitudinal direction X in this embodiment. Thereby, the position of the injection needle 140 with respect to the outer cylinder 150 can be fixed.

However, as long as the injection needle 140 can be moved relative to the outer tube 150, the direction in which the uneven shape extends is not limited to being perpendicular to the longitudinal direction X, and may be perpendicular to the longitudinal direction X such as obliquely. It may be configured to extend at an angle other than that. The inner engagement portion 145 constitutes an adjustment mechanism that adjusts the relative position of the injection needle 140 in the longitudinal direction X with respect to the outer cylinder 150 in this embodiment.

(Outer cylinder)
The outer cylinder 150 is elongated like the injection needle 140 . The outer cylinder 150 includes an inner wall surface 151, an internal space 152 (corresponding to a second internal space), a gear member 153 (corresponding to an adjusting mechanism), and a grip portion 154, as shown in FIG. The outer cylinder 150 includes a support portion 155, a cap member 156 (corresponding to an elastic member), a valve member 157, and a connecting portion 158 (corresponding to a first connecting portion).

An inner wall surface 151 of the outer cylinder 150 forms an inner space 152 for accommodating the tip of the injection needle 140 by forming a cylindrical side surface like the first portion 141 of the injection needle 140 in this embodiment. It is configured as follows.

However, if the tip of the injection needle can be accommodated in the inner space of the outer cylinder and the drug can be prevented from leaking from the tip of the injection needle while the tip of the injection needle is accommodated, the specific shape of the outer cylinder is cylindrical. Not limited to sides. In addition to the above, it may be configured to include the side surface of a polygonal prism. In addition, the base end side of the outer cylinder 150 can be used as a handle portion to be gripped by the user's fingers when operating the medical instrument.

The inner wall surface 151 isolates the distal end side of the internal space 152 in the longitudinal direction X from the outside together with the second portion 142 when the outflow portion 143 is arranged in the internal space 152 as described above. The inner wall surface 151 prevents the medicine from leaking out from the distal end side of the outer cylinder 150 by making the dimension larger than the second part 142 of the injection needle 140 to the extent that it contacts the second part 142 of the injection needle 140 . The inner wall surface 151 constitutes an isolation part in this embodiment.

In a state in which the proximal end of the second portion 142 of the injection needle 140 is arranged in the inner space 152 of the outer cylinder 150, the drug flowing out from the outflow portion 143 flows through the inner space 152 of the outer cylinder 150 toward the proximal end. sell.

The dimension of the inner wall surface 151 in the radial direction r can be configured to be approximately 0.78 mm as an example only. The difference in dimensions such as the radial direction r on the YZ plane between the inner wall surface 151 and the second portion 142 of the injection needle 140 can be configured to be 0.03 mm or less.

The gear member 153 is configured to have a cylindrical shape that rotates in conjunction with the grip portion 154 . The gear member 153 is configured to provide a plurality of uneven shapes along the side surface of the cylindrical shape so that it can be engaged with the uneven shape of the inner engaging portion 145 of the injection needle 140 . As a result, the injection needle 140 is moved to the distal end side or the proximal end side in the longitudinal direction X with respect to the outer cylinder 150, and is exposed from the outer cylinder 150 to the distal end side according to the size of the site such as the tumor to be administered with the drug. The length of the infusion needle 140 used can be adjusted.

Here, the cylindrical outer surface (outer surface) of the outer cylinder 150 can be graduated so that the length of the injection needle 140 exposed from the distal end side of the outer cylinder 150 can be grasped.

In addition, the gear member 153 maintains its current position unless an external force is applied while the tip of the injection needle 140 is placed in the inner space 152 of the outer cylinder 150 or placed outside the inner space 152. be able to.

Therefore, the position of the injection needle 140 can be fixed when the tip is slightly exposed from the tip of the outer cylinder 150 . By arranging the proximal end of the second part 142 in the internal space 152 of the outer cylinder 150, the medicine can be prevented from leaking out during transportation or puncturing of the medical device 100. FIG. Moreover, the piercing force of the injection needle 140 can be maintained.

The grip part 154 is configured to be grippable by the user's fingers. The gripping portion 154 is integrally formed with the gear member 153 and configured to transmit the rotation of the gripping portion 154 to the gear member 153 while the gripping portion 154 is gripped by the user. The grasping portion 154 is configured to integrally connect the cylindrical shape with the gear member 153 in this embodiment.

The support part 155 is configured to be provided in the cylindrical shape of the outer cylinder 150 . As shown in FIG. 1 and the like, the support portion 155 is configured to support the axial shape provided outside of both ends of the gear member 153 in the axial direction of the gear member 153 (the Y direction intersecting with the longitudinal direction X). ing.

The cap member 156 is provided at the tip of the cylindrical outer cylinder 150 in the longitudinal direction X. The cap member 156 contains a member such as silicone, and as shown in FIG. 7, is configured to be able to come into contact with the injection needle 140 exposed to the outside from the internal space 152 and to be elastically deformable. In this embodiment, the cap member 156 is configured in a hollow truncated cone shape, and is configured such that the dimension of the edge of the tip of the truncated cone shape is smaller than the external dimension of the second portion 142 of the injection needle 140 .

As a result, the outer surface of the second portion 142 of the injection needle 140 comes into contact with the cap member 156 as shown in FIG. can be prevented.

The valve member 157 prevents the drug flowing out of the outflow portion 143 from leaking out from the proximal end side of the internal space 152 . The valve member 157 prevents the drug from leaking outside from the proximal end side of the outer tube 150 while the injection needle 140 is inserted into the internal space 152 of the outer tube 150 .

The valve member 157 is provided on the proximal end side in the longitudinal direction X of the internal space 152 of the outer cylinder 150 . The valve member 157 can be arranged so that the inner engaging portion 145 and the gear member 153 do not come into contact with the drug even when the injection needle 140 moves relative to the outer cylinder 150 . The valve member 157 is configured by attaching an O-ring or the like to the base end portion of the outer cylinder 150 in this embodiment.

The connection part 158 is configured as a part that can be connected to an instrument 200 capable of aspirating the drug flowing out from the outflow part 143 into the internal space 152 . An instrument 200 connected to the connecting portion 158 has, as an example, a cylindrical portion 210 having a semi-closed space and a sealing member provided at the distal end portion, and the distal end portion is accommodated in the semi-closed space of the cylindrical portion 110 as shown in FIG. and a pressing member 220 that is movable in the axial direction of the cylindrical portion 210 in a state.

By moving the pressing member 220 relative to the tubular portion 210 , the instrument 200 can make the internal space 152 have a negative pressure and collect the medicine in the internal space 152 . However, the specific configuration of the device connected to the connecting portion 158 is not limited to the device 200 as long as the drug that can flow through the internal space 152 can be collected.

Also, the connecting portion 158 can be arranged on the tip side of the gear member 153 in the longitudinal direction X. The connecting portion 158 can be arranged at a position where the inner engaging portion 145 does not come into contact with the drug even when the injection needle 140 moves with respect to the outer tube 150 in the longitudinal direction X.

The specific materials of the cylindrical portion 110, the pressing member 120, the sealing member 130, and the outer cylinder 150 of the medical device 100 are not particularly limited as long as the drug can be administered to the patient through the injection needle 140. As an example, the tubular portion 110, the pressing member 120, and the outer cylinder 150 can be made of plastic such as polypropylene or polyethylene, and the sealing member 130 can be made of butyl rubber, silicone rubber, elastomer, or the like.

(Example of use)
Next, a usage example of the medical device 100 according to this embodiment will be described.

First, in a state in which the tip of the injection needle 140 is accommodated in the inner space 152 of the outer cylinder 150, the operator grasps the cylindrical base end side outer surface of the outer cylinder 150 and the grasping portion 154 with fingers, and grasps the grasping portion 154. to rotate. The rotation of the gripping portion 154 causes the gear member 153 integrated with the gripping portion 154 to rotate, and the distal end portion of the injection needle 140 including the outflow portion 143 is exposed from the distal end side of the outer cylinder 150 .

Next, the operator moves the pressing member 120 so as to reduce the volume of the semi-closed space of the tubular portion 110 with respect to the tubular portion 110 . By this operation, the drug contained in the semi-closed space of the cylindrical portion 110 moves (circulates) from the semi-closed space of the cylindrical portion 110 to the internal space 144 of the injection needle 140 . The drug that has moved into the internal space 144 exits from the outflow portion 143, so that the filling of the internal space 144 with the drug can be visually confirmed (priming).

When the drug leaks out due to priming, the pressing member 120 should be carefully moved with respect to the cylindrical portion 110 so that the drug does not scatter to an unintended location. Avoid splashing to unintended areas.

Next, the operator grips the tubular base end side outer surface of the outer cylinder 150 and the grasping portion 154 and rotates the grasping portion 154 to accommodate the distal end portion of the injection needle 140 in the inner space 152 of the outer cylinder 150 . By arranging the proximal end of the second portion 142 of the injection needle 140 in the internal space 152 of the outer cylinder 150, the operator can operate the medical device 100 without causing the drug in the internal space 144 of the injection needle 140 to leak from the distal end side. You can carry it around.

Next, the operator forms a small incision around the patient's abdomen. Then, the operator percutaneously punctures the injection needle 140 and the outer tube 150 from the body surface under ultrasonic echo, and advances (carries) the tip of the injection needle 140 to the front of the tumor or to the inside of the tumor. Then, the operator grips the cylindrical proximal side outer surface of the outer cylinder 150 and the grip portion 154 and rotates the grip portion 154 to move the distal end portion of the injection needle 140 including the outflow portion 143 to the distal end portion of the outer cylinder 150 . Move (expose) from the side to the outside.

Then, the operator administers the medicine to the patient by moving the pressing member 120 relative to the tubular portion 110 in the longitudinal direction X so that the semi-closed space of the tubular portion 110 is reduced. As a result, the medicine in the internal space 144 of the injection needle 140 flows out from the outflow portion 143 in the radial direction r and is administered to the patient.

After the administration of the drug is completed, the operator grasps the cylindrical base end side outer surface of the outer cylinder 150 and the grasping portion 154 and rotates the grasping portion 154 to move the tip of the injection needle 140 into the inner space of the outer cylinder 150 . 152, and the medical device 100 is removed from the body. This can prevent the drug from leaking from the outflow portion 143 of the injection needle 140 from the distal end side of the outer cylinder 150 except when the drug is administered.

As described above, the medical device 100 according to this embodiment includes the injection needle 140 and the outer cylinder 150. The injection needle 140 has an internal space 144 through which the drug can flow, and an outflow portion 143 through which the drug flowing through the internal space 144 can flow out. The outer cylinder 150 is configured to provide an internal space 152 capable of accommodating the distal end portion of the injection needle 140 .

The injection needle 140 and the outer cylinder 150 are elongated. At least one of the injection needle 140 and the outer cylinder 150 is provided with an isolation portion that isolates the tip side of the outflow portion 143 in the longitudinal direction X from the outside when the outflow portion 143 is arranged in the internal space 152 . In the method of administering a drug using the medical device 100 , the tip of the injection needle 140 is accommodated in the internal space 152 of the outer cylinder 150 after the drug is circulated in the internal space 144 of the injection needle 140 . The tip of the injection needle 140 is exposed from the tip of the outer cylinder 150 in a state in which the tip of the outer cylinder 150 is inserted into the relevant site of the patient, and the medicine is administered into the patient's body. .

By providing the isolation part in the medical device 100 in this way, after priming, the drug is unintentionally leaked from the tip side of the injection needle 140 except when the drug is administered, such as during transportation of the medical device or during puncture from the body surface to the affected area. can be prevented. Therefore, it is possible to prevent the medicine from scattering to the user, exposing the patient, and contaminating the floor and peripheral equipment.

Also, the injection needle 140 includes a first portion 141 and a second portion 142 . The first portion 141 has an outflow portion 143 on its outer surface. The second portion 142 is provided on the distal end side of the first portion 141 in the longitudinal direction X, and has a dimension that intersects the longitudinal direction X larger than that of the first portion 141 . Further, the second portion 142 is configured such that the distance from the inner wall surface 151 of the outer cylinder 150 is such that the medicine does not flow when at least a part of the second portion 142 is arranged in the inner space 152 . The separating portion is configured by arranging the base end portion of the second portion 142 in the internal space 152 .

As a result, it is possible to prevent the drug that has flowed out from the outflow part 143 from leaking from the internal space 152 to the tip side of the injection needle 140 at a timing other than drug administration after priming.

Further, the injection needle 140 and the outer tube 150 are provided with an adjustment mechanism capable of adjusting the relative position of the injection needle 140 with respect to the outer tube 150 in the longitudinal direction X, such as the inner engaging portion 145 and the gear member 153. Configure.

As a result, the tip of the injection needle 140 can be accommodated in the internal space 152 of the outer cylinder 150 depending on the situation, and the drug can be unintentionally released from the tip of the injection needle 140 to the outside at a timing other than when the drug is administered after priming. Leakage can be prevented. Also, the exposed length of the injection needle 140 from the outer tube 150 can be adjusted according to the size of the tumor.

In addition, the outer cylinder 150 is configured to include a valve member 157 that prevents the drug flowing out of the outflow portion 143 from leaking from the proximal end side of the internal space 152 . As a result, it is possible to prevent the drug from leaking outside from the proximal side of the injection needle 140 in addition to the distal side of the injection needle 140 at a timing other than when the drug is administered after priming.

In addition, the outer cylinder 150 is configured to have a connecting portion 158 that can be connected to the instrument 200 capable of aspirating the drug flowing out from the outflow portion 143 into the internal space 152 . By configuring in this way, the medicine that has flowed out from the outflow portion 143 into the internal space 152 of the outer cylinder 150 can be recovered without leaking to the outside.

In addition, the outer cylinder 150 is provided at the distal end in the longitudinal direction X, and is configured to have a cap member 156 that can come into contact with the injection needle 140 that is exposed to the outside from the internal space 152 due to elastic deformation. By configuring in this way, in addition to the combination of the second portion 142 and the inner wall surface 151, the drug is unintentionally injected into the injection needle 140 from the tip side of the injection needle 140 at a timing other than drug administration after priming. Leakage to the tip side can be further prevented.

(Modification 1 of the first embodiment)
FIG. 8 shows a medical device 100a according to Modification 1 of the first embodiment, and is a view corresponding to FIG. In the first embodiment, the second portion 142 and the like of the injection needle 140 are described to have a sharp tip. However, the shape of the tip of the injection needle is not particularly limited as long as the tip of the injection needle 140a can be advanced to the tumor site and the drug can be administered to the site. The shape of the tip of the injection needle may be flat like the second portion 142a of the injection needle 140a of the medical device 100a shown in FIG. Also, the outer peripheral edge of the second portion 142a may be chamfered.

The tubular portion 110, the pressing member 120, the sealing member 130, and the outer cylinder 150 that constitute the medical device 100a are the same as in the first embodiment. Furthermore, the first portion 141 other than the second portion 142a of the injection needle 140a, the outflow portion 143, the internal space 144, and the inner engaging portion 145 are the same as in the first embodiment. Therefore, the description is omitted. Also, the usage example of the medical device 100a is the same as that of the first embodiment, so the description is omitted.

(Modification 2 of the first embodiment)
FIG. 9 is a diagram corresponding to FIG. 6 showing a medical device 100b according to Modification 2 of the first embodiment. In the first embodiment, the injection needle 140 has been described to be straight when no external force is applied. However, the tip side of injection needle 140b can be configured as follows.

The medical device 100b has a tubular portion 110, a pressing member 120, a sealing member 130, an injection needle 140b, and an outer cylinder 150. Since the cylindrical portion 110, the pressing member 120, the sealing member 130, and the outer cylinder 150 are the same as those in the first embodiment, description thereof is omitted.

The injection needle 140b is configured so that the distal end side in the longitudinal direction X is curved as shown in FIG. 9 when no external force is applied. The injection needle 140b is formed in a substantially linear shape following the shape of the internal space 152 of the outer cylinder 150 when the tip side is housed in the internal space 152 . With this configuration, the injection needle 140b curves outward in the radial direction r as shown in FIG. .

The material forming the tip of the first portion 141 of the injection needle 140b is not particularly limited, but it can be configured to include a shape memory alloy such as Ni--Ti. The second portion 142 may be configured to contain the same material as the first portion 141, or may be configured to contain a material different from the first portion 141, such as resin. Since the injection needle 140b includes a first portion 141, a second portion 142, an outflow portion 143, an internal space 144, and an inner engaging portion 145, similarly to the injection needle 140, description of the configuration is omitted.

(Example of use)
Next, a usage example of the medical device 100b will be described. After priming, the operator rotates the injection needle 140b in the circumferential direction θ so that the tip portion of the injection needle 140b is curved in a desired direction while the tip portion of the injection needle 140b is accommodated in the internal space 152 of the outer cylinder 150 . Next, the operator grasps the proximal side outer surface of the outer cylinder 150 and the grasping portion 154, rotates the grasping portion 154, and exposes the distal end portion of the injection needle 140b from the distal end side of the outer cylinder 150 so as to be curved. . Since other operations are the same as in the first embodiment, the description is omitted.

As described above, in Modification 2, the injection needle 140b is configured to be curved and deformable in a state where the distal end portion of the injection needle 140b is exposed from the distal end side of the outer cylinder 150. By configuring in this way, the tip of the injection needle 140b can be rotated around the longitudinal direction X as the rotation axis to change the orientation of the tip, thereby administering the medicine to a site such as a tumor over a wide range.

(Modification 3 of the first embodiment)
FIG. 10 is a side view showing a medical device 100c according to Modification 3 of the first embodiment. It has been described above that the outer cylinder 150 includes the connecting portion 158 that can be connected to the device 200 capable of sucking the medicine flowing out from the outflow portion 143 into the internal space 152 . However, the present invention is not limited to this, and the injection needle may be provided with a connecting portion as described below.

The medical device 100c has a tubular portion 110, a pressing member 120, a sealing member 130, an injection needle 140c, and an outer cylinder 150. Since the cylindrical portion 110, the pressing member 120, the sealing member 130, and the outer cylinder 150 are the same as those in the first embodiment, description thereof is omitted.

(injection needle)
The injection needle 140c includes a first portion 141, a second portion 142, an outflow portion 143, an internal space 144, an inner engaging portion 145, and a connecting portion 146 (corresponding to a second connecting portion). . Since the first portion 141, the second portion 142, the outflow portion 143, the internal space 144, and the inner engaging portion 145 are the same as those in the first embodiment, description thereof is omitted.

The connecting portion 146 is provided on the proximal side of the first portion 141 of the injection needle 140c and outside the proximal portion of the outer cylinder 150, as shown in FIG. The connecting portion 146 is provided with a member such as a three-way stopcock, and is configured to be provided with a port that can be connected to a syringe or the like. The connecting portion 146 is configured to be connectable to an instrument for adjusting the pressure in the internal space 144 of the injection needle 140c as described above. Instruments that connect to connection 146 may be configured to include, as an example, an empty syringe.

(Example of use)
Next, a usage example of the medical device 100c according to Modification 3 will be described. The operator communicates the semi-closed space of the cylindrical portion 110 with the internal space 144 of the injection needle 140c at the three-way stopcock provided in the connecting portion 146 . In this state, the operator performs priming by moving the pressing member 120 with respect to the tubular portion 110 so as to reduce the volume of the semi-closed space of the tubular portion 110 in the same manner as in the first embodiment.

Next, as in the first embodiment, the operator grips the proximal side outer surface of the outer tube 150 and the grip portion 154 with fingers, rotates the grip portion 154, and moves the distal end portion of the injection needle 140c to the outer tube 150. is housed in the internal space 152 of the.

Next, the operator forms a small incision around the patient's abdomen. Then, the operator percutaneously punctures the body surface with the injection needle 140c and the outer tube 150 under ultrasonic echo, and advances the tip of the injection needle 140c to the front of the tumor or to the inside of the tumor. Then, the operator grips the proximal side outer surface of the outer cylinder 150 and the grip portion 154 and rotates the grip portion 154 to expose the distal end portion of the injection needle 140c from the distal end side of the outer cylinder 150 to the outside. Then, the operator administers the medicine to the patient by moving the pressing member 120 relative to the tubular portion 110 in the longitudinal direction X so that the semi-closed space of the tubular portion 110 is reduced.

Next, the operator performs an operation to switch the three-way stopcock provided in the connecting portion 146 so that the internal space 144 of the injection needle 140c communicates with the semi-closed space of the cylindrical portion 110 and the internal space on the side of another syringe. The subsequent operation of housing the distal end portion of the injection needle 140c in the internal space 152 of the outer cylinder 150 and removing the medical device 100c is the same as in the first embodiment, so description thereof will be omitted.

As described above, in Modification 3, the injection needle 140c is configured to have a connecting portion 146 that can be connected to a device that adjusts the pressure in the internal space 144 of the injection needle 140c.

In this way, by switching the three-way stopcock of the connection part 146 so that the distal end side of the internal space 144 of the injection needle 140c communicates with the syringe side different from the internal space 144 on the proximal side of the connection part 146, the drug The pressure created in the interior space 144 during administration can be released. Therefore, it is possible to prevent the drug from flowing back from the tumor to the proximal end side of the internal space 144 after the drug is administered.

(Second embodiment)
FIG. 11 is a diagram showing the inside of an outer cylinder 150d that constitutes a medical device 100d according to the second embodiment. In the first embodiment, the injection needle 140 includes an inner engagement portion 145 and the outer cylinder 150 includes a gear member 153 as an adjustment mechanism for adjusting the relative position of the injection needle 140 in the longitudinal direction X with respect to the outer cylinder 150. explained. However, the adjustment mechanism for adjusting the relative position of the injection needle with respect to the outer cylinder can also be configured as follows.

The medical device 100d has a tubular portion 110, a pressing member 120, a sealing member 130, an injection needle 140d, and an outer cylinder 150d. Since the cylindrical portion 110, the pressing member 120, and the sealing member 130 are the same as those in the first embodiment, description thereof is omitted.

(injection needle)
The injection needle 140d includes a first portion 141, a second portion 142, an outflow portion 143, an internal space 144, an inner engagement portion 145d, and a grip portion 147. Since the first part 141, the second part 142, the outflow part 143, and the internal space 144 are the same as those in the first embodiment, description thereof is omitted.

As shown in FIG. 11, the inner engaging portion 145d is configured to be engageable with an outer engaging portion 153d that constitutes the outer cylinder 150d. Thereby, the position in the longitudinal direction X of the injection needle 140d with respect to the outer cylinder 150d can be maintained. Further, by changing the position of the inner engagement portion 145d that engages with the outer engagement portion 153d, the relative position of the injection needle 140d to the outer cylinder 150d can be adjusted.

In this embodiment, the inner engaging portion 145d is configured to have a plurality of uneven shapes (notches) extending orthogonally to the longitudinal direction X of the plurality of injection needles 140d as shown in FIG. . However, the specific configuration of the inner engaging portion is not limited to this, as long as the position of the injection needle can be relatively displaced with respect to the outer cylinder.

The grip part 147 can be provided on the outer surface of the injection needle 140d on the base end side of the cylindrical shape. A user such as an operator grasps the cylindrical base end side outer surface of the outer cylinder 150d together with the grasping portion 147, and pushes the injection needle 140d into the outer cylinder 150d or pulls it, thereby moving the outer cylinder 150d. The injection needle 140d can be advanced and retracted in the longitudinal direction X with respect to.

(Outer cylinder)
The outer cylinder 150d includes an inner wall surface 151, an internal space 152, an outer engaging portion 153d, a cap member 156, a valve member 157, and a connecting portion 158. Since the inner wall surface 151, the internal space 152, the cap member 156, the valve member 157, and the connecting portion 158 are the same as those in the first embodiment, description thereof is omitted.

The outer engaging portion 153d is configured to be provided on the cylindrical inner wall surface 151 of the outer cylinder 150d. As shown in FIG. 11, the outer engaging portion 153d in this embodiment is configured to have an elastically deformable convex shape (protruding shape) protruding inward in the radial direction r from the inner wall surface 151 of the outer cylinder 150d. is doing. The outer engaging portion 153d is configured to be engageable with the inner engaging portion 145d of the injection needle 140d.

By engaging the outer engaging portion 153d and the inner engaging portion 145d, the relative position of the injection needle 140d to the outer cylinder 150d can be fixed (maintained, held). Further, by deforming the outer engaging portion 153d to change the position of the inner engaging portion 145d with which the outer engaging portion 153d engages, the relative position of the injection needle 140d to the outer cylinder 150d can be changed (adjusted). can do. The inner engagement portion 145d and the outer engagement portion 153d constitute an adjustment mechanism in this embodiment.

(Example of use)
Next, a usage example of the medical instrument 100d according to this embodiment will be described.

First, in a state in which the distal end of the injection needle 140d is housed in the internal space 152 of the outer cylinder 150d, the operator grasps the proximal outer surface of the outer cylinder 150d and the grip portion 147 with fingers, and moves the injection needle 140d toward the distal end. push into. By this operation, the engagement points of the inner engaging portion 145d and the outer engaging portion 153d are changed, and the injection needle 140d is inserted into the outer cylinder 150d in a state where the distal end of the injection needle 140d is exposed to the outside from the distal end side of the outer cylinder 150d. The position of 140d is fixed.

The subsequent priming operation is the same as in the first embodiment.

Next, the operator grips the base end side outer surface of the outer cylinder 150d and the grip portion 147, and pulls the injection needle 140d to the proximal side. As a result, the engagement points of the inner engagement portion 145d and the outer engagement portion 153d are changed, and the distal end portion of the injection needle 140d is housed in the internal space 152 of the outer cylinder 150d.

Next, the operator forms a small incision around the patient's abdomen. Then, the operator percutaneously punctures the body surface with the injection needle 140d and the outer tube 150d under ultrasonic echo, and advances (carries) the tip of the injection needle 140d to the front of the tumor or to the inside of the tumor.

Then, the operator pushes the injection needle 140d toward the distal side while grasping the outer surface of the outer cylinder 150d on the proximal side and the grip portion 147, and exposes the distal end of the injection needle 140d to the outside from the distal end side of the outer cylinder 150d. Let Then, the operator administers the medicine to the patient by moving the pressing member 120 relative to the tubular portion 110 in the longitudinal direction X so that the semi-closed space of the tubular portion 110 is reduced.

When the administration of the drug is completed, the proximal outer surface of the outer cylinder 150d and the grip portion 147 are gripped, the distal end of the injection needle 140d is accommodated in the inner space 152 of the outer cylinder 150d, and the medical device 100d is removed from the body. do.

As described above, the medical device 100d according to this embodiment includes the inner engaging portion 145d and the outer engaging portion 153d as a mechanism for adjusting the relative position of the injection needle 140d with respect to the outer cylinder 150d. Prepare. The inner engaging portion 145d is configured so that a plurality of irregularities are arranged in the longitudinal direction X of the injection needle 140d. The outer engaging portion 153d protrudes inward in the radial direction r from the inner wall surface 151 of the outer cylinder 150d and is configured to include an elastically deformable shape.

With this configuration as well, the tip of the injection needle 140d can be housed in the internal space 152 of the outer cylinder 150d depending on the situation, so that the injection needle 140d is unintentionally injected after priming at a timing other than when the drug is administered. Leakage to the outside from the tip side can be prevented. Also, the exposed length of the injection needle 140d from the outer tube 150d can be adjusted according to the size of the tumor to which the drug is administered.

It should be noted that the present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. FIG. 12 is a cross section along the central axis passing through the center of the outer cylinder 150e that constitutes the medical device 100e according to the modification, and is a view corresponding to FIG.

In the above description, the injection needle 140 is provided with a second portion 142, which is provided on the distal end side of the first portion 141 in the longitudinal direction X and has a dimension in the radial direction r larger than the first portion 141, as the isolation portion. It has been described that the inner wall surface 151 is sized to contact the portion 142 .

However, the specific configuration of the isolation section is not limited to the above, as long as the medicine can be prevented from leaking out from the tip side of the injection needle. In addition to the above, the isolation part changes the dimension of the inner wall surface of the outer cylinder according to the site instead of changing the dimension in the radial direction r of the injection needle according to the site on the tip side of the injection needle as shown in FIG. It may be configured as

That is, the dimension in the radial direction r of the second portion 142e of the injection needle 140e is the same as that of the first portion 141. The inner wall surface of the outer cylinder 150e is provided on the distal end side of the first inner wall surface 151e, which is spaced from the injection needle 140e in the radial direction r, and the first inner wall surface 151e to the extent that it is in contact with the second portion 142e. and a second inner wall surface 151f having a smaller dimension in the radial direction r than the wall surface 151e. In this case, it is preferable to chamfer the proximal end of the second inner wall surface 151f from the viewpoint of ease of insertion of the injection needle 140e.

By configuring in this way, it is possible to prevent the drug from leaking, particularly from the distal end side of the injection needle 140e, after priming and at a timing other than when the drug is administered.

In addition, as shown in FIG. 5, the injection needle has a larger dimension in the radial direction r at the second portion than at the first portion, and the inner wall surface of the outer cylinder is larger than the first inner wall surface and the first inner wall surface as shown in FIG. A medical device having a second inner wall surface having a smaller dimension in the radial direction r is also included in an embodiment of the present invention.

In addition, although it was explained that the valve member 157 is provided on the proximal end side of the outer cylinder 150 in the longitudinal direction X, the valve member 157 can be installed on the proximal end side of the outer cylinder 150 if it is possible to prevent the medicine from leaking from the proximal end side of the outer cylinder 150. The member to be used is not limited to the valve member 157 such as an O-ring. In addition to the above, water-absorbent fibers, water-absorbent resin, etc. are provided on the proximal end of the outer cylinder, and members such as PTFE (Polytetrafluoroethylene) porous membranes that block the flow of liquid and allow the flow of gas. may be provided.

In addition, the outer cylinder such as the outer cylinder 150 may be configured to have a shape that is sharp like a needle on the distal end side in the longitudinal direction X so that the living body can be punctured.

In addition, as long as the medical device has a structure corresponding to the isolating section, the combination of the adjustment mechanism, cap member 156, valve member 157, and connecting section 158 may be modified to differ from the above. Included in the embodiment.

This application is based on Japanese Patent Application No. 2021-018253 filed on February 8, 2021, the disclosure of which is incorporated by reference in its entirety.

100, 100a, 100b, 100c, 100d, 100e medical instruments,
140, 140a, 140b, 140c, 140d, 140e injection needles,
141 first part,
142, 142a, 142e second part (separating part),
143 outlet,
144 internal space (first internal space),
145, 145d inner engagement portion (adjustment mechanism),
146 connection part (second connection part),
150, 150d, 150e outer cylinder,
151 inner wall surface (isolation part),
152 internal space (second internal space),
153 gear member (adjustment mechanism),
153d outer engagement portion (adjustment mechanism),
156 cap member (elastic member),
157 valve member (seal portion),
158 connection (first connection);

Claims

an injection needle provided with a first internal space through which a drug can flow, and having an outflow portion through which the drug flowing in the first internal space can flow out;
an outer cylinder provided with a second internal space capable of accommodating the tip of the injection needle;
The injection needle and the outer cylinder are elongated,
A medical device in which at least one of the injection needle and the outer cylinder is provided with an isolation portion that isolates a distal end side in the longitudinal direction of the second internal space from the outside when the outflow portion is disposed in the second internal space. .
The injection needle has a first portion having the outflow portion provided on the outer surface thereof, and a dimension that is provided on the distal end side of the first portion in the longitudinal direction and intersects the longitudinal direction is larger than the first portion, and at least a second portion configured such that the distance from the inner wall surface of the outer cylinder is such that the drug does not flow when a portion of the portion is disposed in the second inner space;
2. The medical device according to claim 1, wherein the isolation part is configured by disposing the proximal end of the second part in the second internal space.
The medical device according to claim 1 or 2, wherein the injection needle and the outer cylinder are provided with an adjustment mechanism capable of adjusting the relative position of the injection needle with respect to the outer cylinder in the longitudinal direction.
The medical device according to any one of claims 1 to 3, wherein the outer cylinder comprises a seal portion that prevents the drug flowing out from the outflow portion from leaking out from the base end side of the second internal space.
The medical treatment according to any one of claims 1 to 4, wherein the outer cylinder includes a first connection part that can be connected to a device capable of aspirating the drug flowing out of the outflow part into the second internal space. instrument.
6. Any one of claims 1 to 5, wherein the outer cylinder includes an elastic member provided at a distal end portion in the longitudinal direction and capable of coming into contact with the injection needle exposed to the outside from the second internal space and being elastically deformable. A medical device as described above.
The medical device according to any one of claims 1 to 6, wherein the injection needle has a second connection part that can be connected to a device that adjusts the pressure in the first internal space of the injection needle.
The medical device according to any one of claims 1 to 7, wherein the injection needle is bendable in a state where the tip is exposed from the tip side of the outer cylinder.
A method for administering the drug using the medical device according to any one of claims 1 to 8,
housing the tip of the injection needle in the second internal space of the outer cylinder after the drug is circulated in the first internal space of the injection needle;
An administration method in which the tip of the injection needle is exposed from the tip side of the outer cylinder while the tip of the outer cylinder is inserted into a predetermined site of the patient to administer the drug into the patient's body.