JP2024040532A - medical equipment - Google Patents

Abstract

The present invention provides a medical device and a medical device set that can prevent a drug such as an anticancer drug from spilling from the tip side of an injection needle after priming and other than when administering the drug. A medical device 100 has an internal space 144 through which a drug can flow, an injection needle 140 having an outflow portion 143 through which a drug flowing into the internal space can flow out, and a distal end portion of the injection needle. an outer cylinder 150 provided with an internal space 152, and at least one of the injection needle and the external cylinder has a distal end in the longitudinal direction of the internal space facing the outside when the outflow portion is disposed in the internal space of the external cylinder. An isolation section is provided for isolation. [Selection diagram] Figure 5

Description

TECHNICAL FIELD The present invention relates to medical devices.

When treating a tumor formed in the liver, percutaneous ethanol injection therapy (for example, see Patent Document 1) may be performed, which locally treats cancer cells to cause necrosis. The surgeon makes an incision in the abdomen or chest, inserts a needle cannula into the liver, and uses the needle tip to reach the area affected by liver cancer. By injecting ethanol through the needle tip, cancer cells can be necrotized.

Patent No. 4588977

In the above-mentioned treatment using a needle cannula or the like, drugs that are relatively likely to cause side effects on the human body, such as anticancer drugs, may be used. If such drugs spill from the needle tip of a medical device during surgery or the like and are exposed to them, they may affect medical personnel, patients, etc. The inventor of the present invention discovered that, among the cases where the drug spills from the needle tip, the drug spills out of the injection needle after so-called priming, in which the internal space of the injection needle for injecting the drug into the patient is filled with the drug, and other than when administering the drug. We are actively studying ways to prevent spills from spilling from the tip.

The present invention has been made in view of the above-mentioned problems, and aims to prevent drugs such as anticancer drugs from spilling from the tip side of an injection needle after priming and other than during drug administration. .

A medical device according to one aspect of the present invention that achieves the above object includes an injection needle and an outer cylinder. The injection needle is configured to have a first internal space through which the medicine can flow, and an outflow portion through which the medicine flowing into the first internal space can flow out. The outer cylinder is configured to provide a second internal space in which the tip of the injection needle can be accommodated. The injection needle and outer cylinder are configured in a long shape. At least one of the injection needle and the outer cylinder is provided with an isolating part that isolates a longitudinally distal end side of the outflow part from the outside when the outflow part is disposed in the second internal space.

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

1 is a schematic perspective view showing a medical device according to a first embodiment of the present invention. FIG. 2 is a side view of the medical device of FIG. 1; 2 is a plan view showing the medical device of FIG. 1. FIG. FIG. 2 is a cross-sectional view taken through the central axis of the outer cylinder constituting the medical device of FIG. 1, showing a state in which the tip of the injection needle is disposed in the internal space of the outer cylinder. FIG. 5 is a view showing the tip of the injection needle in the cross-sectional view of FIG. 4; FIG. 6 is a diagram showing a state in which the distal end of the injection needle is disposed externally on the distal side from the internal space of the outer cylinder in the cross-sectional view of FIG. 5; 6 is a diagram showing a state in which the tip of the injection needle is brought into contact with the cap member of the outer cylinder in the cross-sectional view of FIG. 5. FIG. FIG. 7 is a diagram illustrating a tip of an injection needle corresponding to FIG. 6, which is a first modification of the first embodiment. FIG. 7 is a diagram showing a tip of an injection needle corresponding to FIG. 6, which is a second modification of the first embodiment. It is a side view which shows the medical device based on the modification 3 of 1st Embodiment in which an injection needle is equipped with a 2nd connection part. It is a medical device concerning a 2nd embodiment, and is a figure showing the cross section of the outer cylinder showing an adjustment mechanism which adjusts the position of the injection needle with respect to the outer cylinder, which is different from the first embodiment. FIG. 6 is a cross-sectional view showing a modification of FIG. 5 in which the tip of the injection needle is placed in the internal space of the outer cylinder constituting the medical instrument.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are exemplified to embody the technical idea of the present invention, and are not intended to limit the present invention. In addition, all other possible embodiments, examples, operational techniques, etc. that can be considered by those skilled in the art without departing from the gist of the present invention are included within the scope and gist of the present invention, and are described in the claims. inventions and their equivalents.

Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically by changing the scale, vertical/width dimensional ratio, shape, etc. from the actual thing as appropriate, but these are merely examples. However, this does not limit the interpretation of the present invention.

Further, 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 define any order.

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

FIG. 5 is a view showing the tip of the injection needle 140 in the cross-sectional view of FIG. 4. As shown in FIG. FIG. 6 is a diagram showing a state in which the distal end of the injection needle 140 is disposed outside the internal space 152 of the outer cylinder 150 on the distal side in the cross-sectional view of FIG. FIG. 7 is a diagram showing a state in which the tip 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.

Note that the coordinate system is indicated in the drawings. X indicates the longitudinal direction of the injection needle 140, etc., and is referred to as longitudinal direction X. YZ is a plane that intersects (perpendicularly intersects) the longitudinal direction X, and is referred to as a YZ plane. r extends from the center of the injection needle 140 in the radial direction in the YZ plane, and is referred to as the radial direction r. θ is along the circumferential direction (angular direction) in the YZ plane intersecting 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.

If the medical device 100 according to the present embodiment is briefly described with reference to FIGS. have Each configuration will be explained in detail below.

(cylindrical part)
The cylindrical portion 110 has a semi-closed space that accommodates a drug such as an anticancer drug. The cylindrical portion 110 has a cylindrical shape such as a cylinder, and has openings at both ends in the axial direction of the cylindrical 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). Further, a hollow tube member to which an injection needle 140 or the like can be attached may be attached to the opening on the distal end side of the cylindrical portion 110.

(Press member)
The pressing member 120 is configured such that its distal end side is accommodated in the semi-closed space of the cylindrical portion 110 and its proximal end 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 medicine is accommodated by moving relative to the cylinder part 110 in the axial direction (longitudinal direction X) of the cylinder part 110. As the size of the semi-closed space is reduced by the pressing member 120, the reduced amount of the drug contained in the semi-closed space flows into the internal 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 tip of the pressing member 120 in the axial direction (longitudinal direction X). The sealing member 130 is slidably engaged with the inner wall of the cylindrical portion 110 to prevent the drug contained in the semi-closed space of the cylindrical portion 110 from flowing outside the internal space 144 of the injection needle 140.

(injection needle)
The injection needle 140 is attached to an opening on the distal end side of the cylindrical portion 110. The injection needle 140 is hollow and long so that the medicine can flow therein. The injection needle 140 is attached to the tip of the cylindrical portion 110 directly or via a tube member or the like. The tip of the injection needle 140 is configured in a straight line when no external force is applied.

As shown in FIG. 4 etc., the injection needle 140 includes a first part 141, a second part 142, an outflow part 143, an internal space 144 (corresponding to the first internal space), and an inner engaging part 145. Equipped with.

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

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

In this embodiment, the outflow portion 143 is configured to have one or more substantially circular holes in a substantially cylindrical side surface. In this embodiment, a plurality of holes constituting the outflow portion 143 are arranged at regular intervals in the longitudinal direction X, and are arranged at a predetermined angle and at intervals 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 drug can be administered to the patient's intended site from the outflow part with the distal end 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 drug can flow from the proximal end to the distal end. The internal space 144 is configured to communicate with the semi-closed space of the cylindrical portion 110 so that the medicine contained in the semi-closed space of the cylindrical portion 110 can flow therethrough. 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 this 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 drug does not flow therethrough when the base end portion is disposed in the internal space 152.

As shown in FIG. 5, the proximal end portion of the second portion 142 comes close to the inner wall surface 151 of the outer tube 150 when the outflow portion 143 is disposed in the inner space 152 of the outer tube 150, so that The distal end side in direction X is isolated from the outside. This can prevent the medicine from leaking to the outside, particularly from the tip side of the outer cylinder 150. The outer peripheral edge of the second portion 142 may be chamfered. The second portion 142 constitutes an isolation portion in this embodiment.

The dimensions of the first portion 141 and the second portion 142 in the radial direction r (diameter corresponding to the outer diameter) are 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. Further, the total length of the injection needle 140 can be configured to be 100 to 400 mm.

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

Further, the first portion 141 and the second portion 142 are both made of stainless steel in this embodiment. However, as long as the drug can be administered to a predetermined site within the patient's body, the first site and the second site may be made of different materials.

The inner engaging portion 145 is provided to allow the injection needle 140 to move forward and backward relative to the outer cylinder 150 in the longitudinal direction X. The inner engaging portion 145 is configured to have a plurality of concave and convex shapes that can mesh with the teeth of the gear member 153 that constitutes the outer cylinder 150, as shown in FIG. In this embodiment, the inner engaging portion 145 is configured such that the extending direction of the uneven shape is orthogonal to the longitudinal direction X. 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 cylinder 150, the extending direction of the uneven shape is not limited to orthogonal to the longitudinal direction X, but may be orthogonal to the longitudinal direction X, such as diagonally. It may be configured to extend at other angles. In this embodiment, the inner engaging 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.

(outer cylinder)
The outer cylinder 150 has an elongated shape similar to the injection needle 140. As shown in FIG. 4, 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 adjustment mechanism), and a grip part 154. 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).

In this embodiment, the inner wall surface 151 of the outer cylinder 150 is configured like a cylindrical side surface similarly to the first portion 141 of the injection needle 140, thereby forming an internal space 152 that accommodates the tip of the injection needle 140. It is configured as follows.

However, if the tip of the injection needle can be accommodated in the internal space of the outer cylinder, and if it is possible to prevent the drug 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, the structure may include side surfaces of a polygonal prism. Further, the proximal end side of the outer cylinder 150 can be used as a handle portion to be grasped by the user's fingers when operating the medical instrument.

The inner wall surface 151 isolates the distal end side of the inner 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 inner space 152 as described above. The inner wall surface 151 is made larger in size than the second portion 142 to the extent that it contacts the second portion 142 of the injection needle 140, thereby preventing the medicine from leaking out from the distal end side of the outer cylinder 150. The inner wall surface 151 constitutes an isolation section in this embodiment.

Note that in a state where the proximal end of the second portion 142 of the injection needle 140 is disposed in the internal space 152 of the outer tube 150, the drug flowing out from the outflow portion 143 flows through the inner space 152 of the outer tube 150 toward the proximal end. sell.

The dimension of the inner wall surface 151 in the radial direction r can be configured to be about 0.78 mm, just as an example. The difference in dimensions in the radial direction r and the like in 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 have a plurality of concave and convex shapes along the side surface of the cylindrical shape so that it can engage with the concave and convex shapes of the inner engaging portion 145 of the injection needle 140 . As a result, the injection needle 140 is moved toward the distal end or the proximal end in the longitudinal direction X relative to the outer cylinder 150, and is exposed to the distal end from the outer cylinder 150 in accordance with the size of the site such as a tumor to which the drug is to be administered. The length of the injection needle 140 can be adjusted.

Here, by attaching a scale to the cylindrical outer surface (outer surface) of the outer cylinder 150, the length of the injection needle 140 exposed from the distal end side of the outer cylinder 150 can be determined.

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

Therefore, the position of the injection needle 140 in a state where the distal end portion is slightly exposed from the distal end side of the outer tube 150 can be fixed. Thereby, by arranging the proximal end of the second portion 142 in the internal space 152 of the outer tube 150, it is possible to prevent the medicine from leaking during transportation of the medical device 100 or during puncturing. Further, the piercing force of the injection needle 140 can be maintained.

The grip portion 154 is configured to be grippable by the user's fingers. The grip part 154 is configured integrally with the gear member 153, and is configured to transmit rotation of the grip part 154 to the gear member 153 while the grip part 154 is being gripped by the user. In this embodiment, the grip portion 154 has a cylindrical shape and is configured to integrally connect with the gear member 153.

The support portion 155 is configured to be provided in a cylindrical shape of the outer cylinder 150. The support portion 155 is configured to support shaft shapes provided outside both ends of the gear member 153 in the axial direction of the gear member 153 (Y direction intersecting the longitudinal direction X), as shown in FIG. ing.

The cap member 156 is provided at the tip of the cylindrical shape of the outer cylinder 150 in the longitudinal direction X. The cap member 156 includes a member such as silicone, and 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, as shown in FIG. In this embodiment, the cap member 156 is formed into a hollow truncated cone shape, and the dimension of the edge of the truncated cone tip is smaller than the outer 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. This can be prevented.

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

The valve member 157 is provided on the base 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 even if the injection needle 140 moves relative to the outer tube 150, the inner engaging portion 145 and the gear member 153 do not come into contact with the medicine. In this embodiment, the valve member 157 is constructed by attaching an O-ring or the like to the base end of the outer cylinder 150.

The connecting part 158 is configured as a part that can be connected to an instrument 200 that can aspirate the medicine flowing out from the outflow part 143 into the internal space 152. For example, as shown in FIG. 4, the instrument 200 connected to the connecting portion 158 includes a cylindrical portion 210 having a semi-closed space, a sealing member provided at the tip, and the tip portion accommodated in the semi-closed space of the cylindrical portion 110. and a pressing member 220 that is movable in the axial direction of the cylindrical portion 210 in this state.

By moving the pressing member 220 relative to the cylindrical portion 210, the device 200 can make the internal space 152 a negative pressure and collect the drug 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 it can collect the drug that can flow through the internal space 152.

Furthermore, the connecting portion 158 can be disposed closer to the distal end than 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 if the injection needle 140 moves relative to the outer cylinder 150 in the longitudinal direction X.

The specific materials of the cylinder portion 110, pressing member 120, sealing member 130, and 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. For example, the cylinder portion 110, the pressing member 120, and the outer cylinder 150 may be made of plastic such as polypropylene or polyethylene, and the seal member 130 may 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, with the distal end of the injection needle 140 accommodated in the internal space 152 of the outer cylinder 150, the operator grasps the cylindrical proximal outer surface of the outer cylinder 150 and the gripping part 154 with his/her fingers. Rotate. As the gripping part 154 rotates, the gear member 153 integrated with the gripping part 154 rotates, and the tip of the injection needle 140 including the outflow part 143 comes to appear from the tip side of the outer tube 150 to the outside.

Next, the operator moves the pressing member 120 relative to the cylindrical portion 110 so as to reduce the volume of the semi-closed space of the cylindrical portion 110 . By this operation, the medicine contained in the semi-closed space of the cylinder part 110 moves (circulates) from the semi-closed space of the cylinder part 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 it can be visually confirmed that the internal space 144 has been filled with the drug (priming).

In addition, when the drug leaks to the outside due to priming, the pressing member 120 should be carefully moved relative to the cylindrical portion 110 so that the drug does not scatter to an unintended location, and a tray or the like should be installed below the medical device 100 to prevent the drug from scattering to an unintended location. Prevent it from scattering to unintended areas.

Next, the operator grasps the cylindrical proximal outer surface of the outer cylinder 150 and the gripping part 154, rotates the gripping part 154, and accommodates the tip of the injection needle 140 in the internal 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. It can be carried around etc.

Next, the surgeon makes a small incision around the patient's abdomen. Then, the operator percutaneously punctures the injection needle 140 and outer cylinder 150 from the body surface under ultrasound echo, and advances (carries) the tip of the injection needle 140 to the front of or inside the tumor. Then, the operator grasps the cylindrical proximal outer surface of the outer cylinder 150 and the gripping part 154, rotates the gripping part 154, and inserts the distal end of the injection needle 140 including the outflow part 143 into the distal end of the outer cylinder 150. Move (expose) from the side to the outside.

Then, the operator moves the pressing member 120 relative to the cylinder part 110 in the longitudinal direction X so that the semi-closed space of the cylinder part 110 is reduced, and administers the medicine to the patient. As a result, the drug 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.

When the administration of the drug is completed, the operator grasps the cylindrical proximal outer surface of the outer cylinder 150 and the grip part 154, rotates the grip part 154, and inserts 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 medicine from the outflow portion 143 of the injection needle 140 from leaking from the distal end side of the outer cylinder 150 at times other than when administering the medicine.

As explained 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 medicine can flow, and an outflow portion 143 through which the medicine flowing into the internal space 144 can flow out. The outer cylinder 150 is configured to provide an internal space 152 in which the tip of the injection needle 140 can be accommodated.

The injection needle 140 and the outer cylinder 150 are configured in an elongated shape. At least one of the injection needle 140 and the outer cylinder 150 is configured to be provided with an isolation part that isolates the distal end side of the outflow part 143 in the longitudinal direction X from the outside when the outflow part 143 is disposed in the internal space 152. Furthermore, in the method of administering a drug using the medical device 100, the tip of the injection needle 140 is accommodated in the inner space 152 of the outer cylinder 150 after the drug is passed through the inner space 144 of the injection needle 140. The configuration is such that when the distal end of the outer cylinder 150 is advanced into the relevant region of the patient, the distal end of the injection needle 140 is exposed from the distal side of the outer cylinder 150 and the drug is administered into the patient's body. .

By providing the isolation part in the medical device 100 in this way, it is possible to prevent the drug from unintentionally leaking from the tip side of the injection needle 140 after priming, other than when transporting the medical device or administering the drug by puncturing from the body surface to the affected area. This can be prevented. Therefore, it is possible to prevent the medicine from scattering to the user, exposing the patient, and contaminating the floor and surrounding equipment.

Furthermore, the injection needle 140 includes a first section 141 and a second section 142. The first portion 141 has an outflow portion 143 on its outer surface. The second portion 142 is provided closer to the distal end than the first portion 141 in the longitudinal direction X, and has a larger dimension intersecting the longitudinal direction X than 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 therethrough when at least a portion thereof is disposed in the internal space 152. The isolation portion is configured by arranging the proximal end portion of the second portion 142 in the internal space 152.

Thereby, it is possible to prevent the medicine that has flowed out from the outflow portion 143 from leaking from the internal space 152 to the distal end side of the injection needle 140 after priming and at a timing other than the medicine administration.

In addition, the injection needle 140 and the outer cylinder 150 are equipped with an adjustment mechanism that can adjust the relative position of the injection needle 140 in the longitudinal direction X with respect to the outer cylinder 150, such as the inner engaging part 145 and the gear member 153. It consists of

As a result, the tip of the injection needle 140 can be housed 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 administering the drug after priming. Leakage can be prevented. Furthermore, the exposed length of the injection needle 140 from the outer cylinder 150 can be adjusted according to the size of the tumor.

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

Further, the outer cylinder 150 is configured to include a connecting portion 158 that can be connected to an instrument 200 that can aspirate the medicine flowing out from the outflow portion 143 into the internal space 152. With this configuration, it is possible to recover the medicine that has flowed out from the outflow portion 143 into the internal space 152 of the outer cylinder 150 without leaking to the outside.

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

(Modification 1 of the first embodiment)
FIG. 8 shows a medical instrument 100a according to modification 1 of the first embodiment, and is a diagram corresponding to FIG. 6. In the first embodiment, it has been explained that the second portion 142 and the like of the injection needle 140 have a sharp tip. However, the shape of the tip of the injection needle 140a 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 relevant site. The tip of the injection needle may have a flat shape like the second portion 142a of the injection needle 140a of the medical device 100a shown in FIG. Further, the outer peripheral edge of the second portion 142a may be chamfered.

In addition, the cylinder part 110, the pressing member 120, the sealing member 130, and the outer cylinder 150 which constitute the medical instrument 100a are the same as that of 1st Embodiment. Furthermore, the first portion 141 of the injection needle 140a other than the second portion 142a, the outflow portion 143, the internal space 144, and the inner engagement portion 145 are the same as those in the first embodiment. Therefore, the explanation will be omitted. Further, since the usage example of the medical device 100a is also the same as that in the first embodiment, the explanation will be omitted.

(Modification 2 of the first embodiment)
FIG. 9 is a diagram corresponding to FIG. 6 showing a medical device 100b according to a second modification of the first embodiment. In the first embodiment, it has been explained that the injection needle 140 is configured in a straight line when no external force is applied. However, the distal end side of the injection needle 140b can be configured as follows.

The medical device 100b includes a cylinder portion 110, a pressing member 120, a sealing member 130, an injection needle 140b, and an outer cylinder 150. The cylinder portion 110, the pressing member 120, the seal member 130, and the outer cylinder 150 are the same as those in the first embodiment, and therefore their descriptions will be omitted.

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

The material constituting the tip of the first portion 141 of the injection needle 140b is not particularly limited, but can be configured to include a shape memory alloy such as Ni-Ti. The second portion 142 may be configured to include the same material as the first portion 141, or may be configured to include a material different from that of the first portion 141, such as resin. The injection needle 140b has the first portion 141, the second portion 142, the outflow portion 143, the internal space 144, and the inner engagement portion 145, just like the injection needle 140, so a description of the configuration will be omitted.

(Example of use)
Next, an example of how the medical device 100b is used will be described. After priming, the operator rotates the injection needle 140b in the circumferential direction θ so that the distal end of the injection needle 140b is curved in a desired direction while the distal end of the injection needle 140b is accommodated in the internal space 152 of the outer tube 150. Next, the operator grasps the proximal outer surface of the outer cylinder 150 and the gripping part 154 and rotates the gripping part 154 to curve the distal end of the injection needle 140b and expose it from the distal end side of the outer cylinder 150. . Other operations are the same as those in the first embodiment, so explanations will be omitted.

As explained above, in the present modification 2, the distal end portion of the injection needle 140b is configured to be curved and deformable in a state where it is exposed from the distal end side of the outer cylinder 150. With this configuration, the tip of the injection needle 140b can be rotated about the longitudinal direction X as the rotation axis to change the direction of the tip, thereby making it possible to administer the drug to a wide range of sites such as tumors.

(Variation 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 part 158 that can be connected to the instrument 200 that can aspirate the medicine flowing out from the outflow part 143 into the internal space 152. However, the present invention is not limited thereto, and the injection needle may be provided with the following connection portion.

The medical device 100c includes a cylinder portion 110, a pressing member 120, a sealing member 130, an injection needle 140c, and an outer cylinder 150. The cylinder portion 110, the pressing member 120, the seal member 130, and the outer cylinder 150 are the same as those in the first embodiment, and therefore their descriptions will be 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). . The first portion 141, the second portion 142, the outflow portion 143, the internal space 144, and the inner engagement portion 145 are the same as those in the first embodiment, so their description will be omitted.

The connecting portion 146 is provided on the proximal end side of the first portion 141 of the injection needle 140c and outward from the proximal end 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 the connecting portion 146 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 able to be connected to a device that adjusts the pressure in the internal space 144 of the injection needle 140c as described above. The instrument connected to connection 146 can be configured to include, by way of example, an empty syringe.

(Example of use)
Next, a usage example of the medical device 100c according to the third modification 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 using a three-way stopcock provided at the connecting portion 146. In this state, the operator performs priming by moving the pressing member 120 relative to the cylindrical portion 110 so as to reduce the volume of the semi-closed space of the cylindrical portion 110, as in the first embodiment.

Next, as in the first embodiment, the operator grasps the proximal outer surface of the outer cylinder 150 and the gripping part 154 with fingers, rotates the gripping part 154, and inserts the distal end of the injection needle 140c into the outer cylinder 150. It is accommodated in the internal space 152 of.

Next, the surgeon makes a small incision around the patient's abdomen. Then, the operator percutaneously punctures the injection needle 140c and outer cylinder 150 from the body surface under ultrasound echo, and advances the tip of the injection needle 140c to the front of or inside the tumor. Then, the operator grasps the proximal outer surface of the outer cylinder 150 and the gripping part 154, rotates the gripping part 154, and exposes the distal end of the injection needle 140c to the outside from the distal end side of the outer cylinder 150. Then, the operator moves the pressing member 120 relative to the cylinder part 110 in the longitudinal direction X so that the semi-closed space of the cylinder part 110 is reduced, and administers the medicine to the patient.

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

As described above, in the present modification 3, the injection needle 140c is configured to include a connecting portion 146 that can be connected to a device for adjusting the pressure in the internal space 144 of the injection needle 140c.

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

(Second embodiment)
FIG. 11 is a diagram showing the inside of an outer cylinder 150d that constitutes a medical instrument 100d according to the second embodiment. In the first embodiment, the injection needle 140 includes an inner engaging portion 145 and the outer tube 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 tube 150. He 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 includes a cylinder portion 110, a pressing member 120, a sealing member 130, an injection needle 140d, and an outer cylinder 150d. The cylindrical portion 110, the pressing member 120, and the sealing member 130 are the same as those in the first embodiment, so their description will be 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. The first portion 141, the second portion 142, the outflow portion 143, and the internal space 144 are the same as those in the first embodiment, so their description will be omitted.

The inner engaging portion 145d is configured to be able to engage with an outer engaging portion 153d that constitutes the outer cylinder 150d, as shown in FIG. Thereby, the position of the injection needle 140d in the longitudinal direction X relative to the outer cylinder 150d can be maintained. Further, by changing the position of the inner engaging part 145d that engages with the outer engaging part 153d, the relative position of the injection needle 140d with respect 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 perpendicularly 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 with respect to the outer cylinder can be relatively displaced.

The grip portion 147 can be provided on the outer surface of the cylindrical proximal end of the injection needle 140d. A user such as a surgeon grasps the cylindrical proximal outer surface of the outer cylinder 150d together with the grip part 147, and pushes or pulls the injection needle 140d into the outer cylinder 150d. The injection needle 140d can be moved forward and backward in the longitudinal direction X relative to the injection needle 140d.

(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. The inner wall surface 151, the inner space 152, the cap member 156, the valve member 157, and the connecting portion 158 are the same as those in the first embodiment, and therefore their description will be omitted.

The outer engaging portion 153d is configured to be provided on the cylindrical inner wall surface 151 of the outer tube 150d. In this embodiment, the outer engaging portion 153d is configured to have an elastically deformable convex shape (projection shape) that protrudes inward in the radial direction r from the inner wall surface 151 of the outer cylinder 150d, as shown in FIG. are doing. The outer engaging portion 153d is configured to be able to engage with the inner engaging portion 145d of the injection needle 140d.

The engagement between the outer engaging portion 153d and the inner engaging portion 145d allows the relative position of the injection needle 140d to the outer cylinder 150d to be fixed (maintained, held). Furthermore, by deforming the outer engaging part 153d and changing the position of the inner engaging part 145d that the outer engaging part 153d engages with, the relative position of the injection needle 140d with respect to the outer cylinder 150d can be changed (adjustment). can do. The inner engaging portion 145d and the outer engaging portion 153d constitute an adjustment mechanism in this embodiment.

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

First, with the distal end of the injection needle 140d accommodated in the internal space 152 of the outer cylinder 150d, the operator grasps the outer surface on the proximal side of the outer cylinder 150d and the grip part 147 with his/her fingers, and moves the injection needle 140d toward the distal end. Push it into. By this operation, the engagement point between the inner engagement part 145d and the outer engagement part 153d changes, and the injection needle is attached to the outer barrel 150d with the tip of the injection needle 140d exposed to the outside from the tip side of the outer barrel 150d. The position of 140d is fixed.

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

Next, the operator grasps the proximal outer surface of the outer cylinder 150d and the grip portion 147, and pulls the injection needle 140d toward the proximal side. As a result, the engagement location between the inner engagement portion 145d and the outer engagement portion 153d changes, and the tip of the injection needle 140d is housed in the internal space 152 of the outer cylinder 150d.

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

Then, the operator pushes the injection needle 140d toward the distal end while grasping the proximal outer surface of the outer cylinder 150d and the gripping part 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 moves the pressing member 120 relative to the cylinder part 110 in the longitudinal direction X so that the semi-closed space of the cylinder part 110 is reduced, and administers the drug to the patient.

When the administration of the drug is completed, the proximal outer surface of the outer cylinder 150d and the gripping part 147 are grasped, the tip of the injection needle 140d is accommodated in the internal 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 the present 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. Be prepared. The inner engaging portion 145d is configured to have a plurality of projections and depressions lined up 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, the tip of the injection needle 140d can be accommodated in the internal space 152 of the outer cylinder 150d depending on the situation, and the drug can be unintentionally inserted into the injection needle 140d after priming at a timing other than when administering the drug. It can prevent leakage to the outside from the tip side. Furthermore, 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 to be administered.

Note that the present invention is not limited only to the embodiments described above, and various changes can be made within the scope of the claims. FIG. 12 is a cross section along the central axis passing through the center of an outer cylinder 150e constituting a medical device 100e according to a modified example, and is a view corresponding to FIG. 5.

In the above, as the isolation part, the injection needle 140 includes a second part 142 which is provided closer to the distal end than the first part 141 in the longitudinal direction X and whose dimension in the radial direction r is larger than the first part 141, It has been explained that the inner wall surface 151 has a size that is in contact with the portion 142.

However, the specific configuration of the isolation section is not limited to the above, as long as it is possible to prevent the medicine from leaking out from the tip side of the injection needle. In addition to the above, instead of changing the dimension in the radial direction r of the injection needle on the distal end side of the injection needle depending on the location, the isolation part changes the dimension of the inner wall surface of the outer cylinder depending on the location, as shown in FIG. 12. It may be configured as follows.

That is, the dimension in the radial direction r of the second portion 142e of the injection needle 140e is configured similarly to the first portion 141. The inner wall surface of the outer cylinder 150e is provided with a first inner wall surface 151e with a gap between the injection needle 140e and the injection needle 140e in the radial direction r, and a first inner wall surface 151e provided on the distal end side of the first inner wall surface 151e. 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 provide a chamfer at the proximal end of the second inner wall surface 151f from the viewpoint of ease of insertion of the injection needle 140e.

With this configuration, it is also possible to prevent the medicine from leaking from the injection needle 140e, particularly from the distal end side, at a timing other than when administering the medicine after priming.

In addition, as shown in FIG. 5, the injection needle has a second portion having a larger dimension in the radial direction r than 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. An embodiment of the present invention also includes a medical device including a second inner wall surface having a smaller dimension in the radial direction r.

In addition, although it has been explained that the valve member 157 is provided on the proximal end side of the outer cylinder 150 in the longitudinal direction The member that does this is not limited to the valve member 157 such as an O-ring. In addition to the above, water-absorbing fibers, water-absorbing resin, etc. may be provided on the proximal end of the outer cylinder, or members such as PTFE (Polytetrafluoroethylene) porous membranes that block liquid flow but allow gas flow. may also be provided.

Further, an outer cylinder such as the outer cylinder 150 may be configured to have a shape that is sharp like a needle and capable of puncturing a living body at the distal end side in the longitudinal direction X.

Further, as long as the medical device has a structure corresponding to the isolation section, it is also within the scope of the present invention that the combination of the adjustment mechanism, the cap member 156, the valve member 157, and the connecting section 158 is changed from the above. Included in the embodiment.

100, 100a, 100b, 100c, 100d, 100e medical equipment,
140, 140a, 140b, 140c, 140d, 140e injection needle,
141 1st part,
142, 142a, 142e second part (isolation part),
143 Outflow part,
144 internal space (first internal space),
145, 145d inner engagement part (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 part (adjustment mechanism),
156 cap member (elastic member),
157 Valve member (seal part),
158 Connection part (first connection part).

Claims (9)

an injection needle provided with a first internal space through which a medicine can flow, and an outflow portion through which the medicine flowing into 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 configured in an elongated shape,
A medical device in which at least one of the injection needle and the outer barrel is provided with an isolation part that isolates a distal end side in the longitudinal direction of the second internal space from the outside when the outflow part is disposed in the second internal space. . The injection needle has a first portion provided with the outflow portion on the outer surface, and a dimension that is provided on the distal side of the first portion in the longitudinal direction and intersects with 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 thereof is disposed in the second internal space;
The medical device according to claim 1, wherein the isolation portion is configured by arranging a proximal end portion of the second portion in the second internal space. The medical device according to claim 1 or 2, wherein the injection needle and the outer barrel include an adjustment mechanism that can adjust the relative position of the injection needle in the longitudinal direction with respect to the outer barrel. The medical device according to any one of claims 1 to 3, wherein the outer cylinder includes a seal portion that prevents the drug flowing out from the outflow portion from leaking from the proximal end side of the second internal space. The medical device according to any one of claims 1 to 4, wherein the outer cylinder includes a first connection part that can be connected to an instrument capable of aspirating the medicine flowing out from the outflow part into the second internal space. utensils. Any one of claims 1 to 5, wherein the outer cylinder includes an elastic member that is provided at a distal end in the longitudinal direction, that is capable of contacting the injection needle exposed to the outside from the second internal space, and that is elastically deformable. Medical devices listed in section. The medical device according to any one of claims 1 to 6, wherein the injection needle includes a second connection part that can be connected to a device for adjusting 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 curved and deformable in a state where a distal end thereof is exposed from the distal end side of the outer cylinder. A method for administering the drug using the medical device according to any one of claims 1 to 8, comprising:
After distributing the drug into the first internal space of the injection needle, storing the tip of the injection needle in the second internal space of the outer cylinder,
An administration method in which the tip of the injection needle is exposed from the tip side of the outer tube while the tip of the outer tube is advanced into a predetermined region of the patient, and the drug is administered into the patient's body.