WO2022202282A1

WO2022202282A1 - Delivery device

Info

Publication number: WO2022202282A1
Application number: PCT/JP2022/009927
Authority: WO
Inventors: 善紀米田; 大貴有馬
Original assignee: テルモ株式会社
Priority date: 2021-03-25
Filing date: 2022-03-08
Publication date: 2022-09-29

Abstract

A delivery device 100, which is for delivering an object to be delivered to an affected part in a living body, is provided with: a first operation part 10; an outer tube 30 that has a lumen 31 and extends along the longitudinal axial direction from the tip of the first operation part 10; a second operation part 20 that is attached to the first operation part 10 in a slidable manner along the longitudinal axial direction; an injection needle 40 that is reciprocatably housed in the lumen 31 of the outer tube 30 and extends along the longitudinal axial direction from the tip of the second operation part 10; and an irradiation part 50 that is attached to the first operation part 10 and/or the second operation part 20 and irradiates line light L, said line light L overlapping a plane passing through the central axis of the injection needle 40, to the surface S of the living body.

Description

delivery device

The present invention relates to a delivery device that delivers a delivery product such as a drug or medical device to an affected area in vivo.

In Patent Document 1, a delivery device (puncture device) that delivers a drug is used to treat an affected area such as a tumor or a site suspected of being an affected area. There is disclosed a technique of performing puncture while observing an affected area using an ultrasonic image (photoacoustic image) based on an ultrasonic signal obtained by transmitting and receiving ultrasonic waves (photoacoustic waves) to and from a needle.

JP 2009-31262 A

When treating tumors that occur in vivo, it is a method of administering directly to the tumor as an administration method that increases the amount of drug accumulation in the tumor while suppressing systemic side effects of drugs with strong side effects or drugs with low selectivity. There is a way. However, in order to permeate and diffuse the drug into the tumor tissue, the amount of the drug is limited even if it is administered from one site. In addition, since it is difficult for drugs to permeate tumors having fibrous septa, expected effects may not be obtained even if the drugs are administered from one site. Therefore, the operator re-punctures the puncture device to approach the tumor from multiple locations and attempt to administer the drug, but there is a problem that the risk of bleeding and dissemination increases.

Therefore, as a countermeasure against the above problem, the tip of the injection needle of the puncture device is curved outward from the axial direction, and the injection needle is rotated to change the puncture point to the tumor while injecting the drug. Treatment methods are conceivable. According to this treatment method, the injection needle can be rotated to direct the puncture end of the injection needle to different positions of the tumor, so that different positions of the tumor can be approached without changing the puncture site of the puncture device. Become.

By the way, when inserting the injection needle into the tumor, in order to avoid the risk of damage to other tissues and blood vessels around the tumor, the operator should check the ultrasound image and check the tip of the injection needle and the tumor. It is necessary to grasp the positional relationship. In order to display the tip portion of the injection needle on the ultrasonic image, the ultrasonic waves transmitted from the ultrasonic probe must be irradiated so as to overlap a plane passing through the central axis of the injection needle. However, when performing the treatment method as the above countermeasure, the tip of the injection needle is curved and faces sideways, so depending on the bending direction of the injection needle, the puncture end may deviate from the ultrasonic irradiation area. . When the tip portion of the injection needle is not displayed on the ultrasound image, the operator tries to position the ultrasound probe in accordance with the bending direction of the injection needle, but the bending direction of the injection needle can be adjusted from outside the body. Correct placement of the ultrasound probe is difficult because there is no way to check.

In addition, in the treatment method that serves as the above countermeasure, a needle guide that holds the puncture device is typically attached to the ultrasound probe, and treatment is performed while simultaneously moving the ultrasound probe and the puncture device. However, depending on the position of the tumor, it may be preferable to move the puncture device and the ultrasonic probe separately without using the needle guide. In such a treatment method, since the puncture device and the ultrasonic probe are moved separately, it is more difficult to position the ultrasonic probe correctly compared to the treatment method using a needle guide.

As described above, in order to perform a treatment method that approaches the tumor while confirming the direction and behavior of the injection needle using an ultrasound probe, it is necessary to grasp the correct placement position of the ultrasound probe on the biological surface. is important. However, the technique of Patent Document 1 cannot easily grasp the correct arrangement position of the ultrasonic probe, and there is room for improvement.

At least one embodiment of the present invention has been made in view of the above circumstances. To provide a delivery device capable of ascertaining the correct arrangement position of an ultrasonic probe with respect to.

A delivery device according to this embodiment is a delivery device that punctures from the surface of a living body to deliver a delivery product to an affected area in the living body, and has a first operation section and a lumen, and a distal end of the first operation section. an outer cylinder extending along the longitudinal direction from the outer cylinder; a second operating part attached to the first operating part so as to be slidable in the longitudinal direction; , an injection needle extending along the longitudinal direction from the tip of the second operating portion; and a plane attached to at least one of the first operating portion and the second operating portion and passing through the central axis of the injection needle. an irradiating unit that irradiates the surface of the living body with overlapping line lights.

According to at least one embodiment of the present invention, it is possible to grasp the correct arrangement position of the ultrasonic probe with respect to the surface of the living body when confirming the behavior of the injection needle inserted into the living body and the position with respect to the affected part with the ultrasonic image. can.

1 is a schematic side view of a delivery device according to this embodiment; FIG. FIG. 4 is a partial cross-sectional view showing a state before the injection needle is advanced in the delivery device according to the present embodiment; FIG. 4 is a partial cross-sectional view showing a state after the injection needle has advanced in the delivery device according to the present embodiment; FIG. 4 is a conceptual diagram of the delivery device according to the present embodiment, viewed from the side, in which line light is emitted from the irradiation unit. FIG. 4 is a conceptual diagram of the delivery device according to the present embodiment, viewed from above, in which line light is emitted from the irradiation unit. FIG. 10 is a partial cross-sectional view showing the configuration of the delivery device of Modification 1; FIG. 11 is a partial cross-sectional view showing another form of the delivery device of Modification 1; FIG. 11 is a partial cross-sectional view showing the configuration of the delivery device of Modification 2; FIG. 11 is a schematic configuration diagram showing a usage example of the delivery device of Modification 2; FIG. 11 is a schematic configuration diagram showing a usage example of the delivery device of Modification 2; FIG. 11 is a schematic side view showing the configuration of the delivery device of Modification 3; FIG. 11 is a partial cross-sectional view showing another form of the delivery device of Modification 3; FIG. 20 is a schematic side view showing a state before rotation of the second operating portion in the delivery device of Modified Example 4; FIG. 20 is a schematic side view showing a state after rotation of the second operating portion in the delivery device of Modification 4; FIG. 12 is a conceptual diagram when the ultrasonic probe is arranged in the correct posture in the delivery device of Modification 5; FIG. 12 is a conceptual diagram when the ultrasonic probe is arranged in a wrong posture in the delivery device of Modification 5; FIG. 20 is a schematic side view showing a state before one injection needle is advanced in the delivery device of Modification 6; FIG. 20 is a schematic side view showing a state after advancing one injection needle in the delivery device of Modification 6; FIG. 11 is a schematic cross-sectional view of a delivery device of Modification 7;

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.

In addition, the side where the delivery device 100 is inserted into the living body is defined as the "distal side", and the side opposite to the distal side (the side gripped by the operator) is defined as the "base end side". In addition, a portion including a certain range along the longitudinal direction (extending direction of the central axis Z of the delivery device 100) from the distal end (most proximal end) is referred to as a “distal portion”, and from the proximal end (most proximal end) in the longitudinal direction. Let the part including the fixed range in be a "base end part."

It should be noted that, in the following description, when describing with ordinal numbers such as "first" and "second", unless otherwise specified, it is used for convenience and does not prescribe any order.

<Configuration>
As shown in FIGS. 1, 2A, and 2B, the delivery device 100 generally includes a first operating section 10, a second operating section 20, an outer cylinder 30, an injection needle 40, an irradiation section 50, Prepare. The delivery device 100 is for delivering a predetermined delivery product (medicine or medical device) to an affected area in the living body through the injection needle 40 while being inserted into the living body.

The central axis A of the first operating section 10, the second operating section 20, the outer cylinder 30, and the central axis B of the injection needle 40 all coincide with the central axis Z of the delivery device 100 (see FIG. 2A). The central axis Z coincides with the direction in which the delivery device 100 advances and retreats with respect to the biological surface S and the direction in which the second operation section 20 is pushed and pulled. In addition, since the injection needle 40 is deformed into a curved shape by a bending portion 44 described later when it advances from the outer cylinder 30, the central axis Z is also curved along the bending direction of the injection needle 40 (see FIG. 2B).

As shown in FIG. 2A, the first operating section 10 is composed of a hollow cylindrical member having a lumen 11, and an outer cylinder 30 is attached to the tip. A lumen 11 of the first operating portion 10 communicates with a lumen 31 of the outer cylinder 30 . A second operating portion 20 is housed inside the first operating portion 10 so as to be slidable along the longitudinal direction. An irradiation unit 50 is arranged on the outer peripheral surface of the first operation unit 10 .

As shown in FIG. 2A, the second operation part 20 is composed of a hollow cylindrical member having a lumen 21, and an injection needle 40 is attached to the tip. A lumen 21 of the second operating portion 20 communicates with a lumen 41 of the injection needle 40 . The second operating portion 20 is housed in the lumen 11 of the first operating portion 10 so as to be slidable along the longitudinal direction. Therefore, the injection needle 40 can be advanced and retracted from the outer cylinder 30 along the long axis direction by pushing and pulling the second operation portion 20 .

The distance between the tip position of the second operation part 20 and the tip-side inner wall of the lumen 11 of the first operation part 10 is set according to the advance amount of the injection needle 40 . That is, as shown in FIG. 2A, in the state before the second operation part 20 slides, the distal end position of the second operation part 20 and the distal end side inner wall of the lumen 11 of the first operation part 10 are at least the advancing position. separated by an amount. Further, as shown in FIG. 2B , the second operating portion 20 slides toward the distal end side by the amount of advance after sliding, and the tip of the second operating portion 20 slides inside the first operating portion 10 . It will be in close proximity to the distal inner wall of the cavity 11 . In this state, the injection needle 40 advances from the outer cylinder 30 .

In addition, as shown in FIG. 2A, the second operating section 20 includes a push-pull section 22 and a hub section 23 on the proximal end side.

The push/pull part 22 is operated when performing a push/pull operation for advancing and retracting the injection needle 40 from the outer cylinder 30 . The operator can advance the injection needle 40 from the outer tube 30 by pushing (sliding toward the distal end side) the push/pull portion 22 . In addition, the operator can retract the injection needle 40 advanced from the outer tube 30 into the outer tube 30 by pulling the push/pull portion 22 (sliding toward the proximal side).

The hub portion 23 has a lumen that communicates with an opening formed on the proximal side. The lumen of hub portion 23 communicates with lumen 41 of injection needle 40 via lumen 21 of second operation portion 20 . Therefore, lumen 41 of injection needle 40 can communicate with the outside via hub portion 23 . Hub portion 23 functions as an introduction port for introducing a delivery product into injection needle 40 . For this reason, the hub portion 23 is used to attach, for example, a tip of a syringe or a tube for drug administration, or to insert a medical device. In this embodiment, the hub portion 23 is provided on the push/pull portion 22 on the base end side of the second operation portion 20 , but may be provided on the side surface side of the second operation portion 20 .

Note that the outer peripheral surface of the second operation portion 20 may be provided with a marker portion that allows the bending direction of the injection needle 40 to be visually or tactilely confirmed. This allows the operator to insert the delivery device 100 into the living body while grasping the bending direction of the injection needle 40 in advance. In addition to the marker portion, the second operation portion 20 has, on its outer peripheral surface, the extension length (puncture length) of the injection needle 40 from the outer cylinder 30 and the degree of curvature in the bending direction (the central axis of the needle body portion 42). It is preferable to provide a scale portion that allows the distance from B1 to the puncture end 43b to be visually or tactilely confirmed. This allows the operator to grasp the puncture length of the injection needle 40 with respect to the affected area and the degree of bending in the bending direction while the delivery device 100 is inserted into the living body.

Also, the second operation unit 20 may be provided with a puncture length limiting mechanism (stopper) for limiting the puncture length of the injection needle 40 to a predetermined length. As a result, the operator can puncture the affected area with an appropriate puncture length without excessively puncturing the affected area with the injection needle 40 .

As shown in FIG. 2A, the outer cylinder 30 is composed of a hollow tubular member having a lumen 31 that communicates from the distal end to the proximal end, and extends along the longitudinal direction from the distal end of the first operation section 10. . A lumen 31 of the outer cylinder 30 communicates with a distal opening 32 on the distal side and communicates with a proximal opening 33 on the proximal side. The proximal end opening 33 communicates with the lumen 11 of the first operating section 10 . An injection needle 40 is housed in the lumen 31 of the outer cylinder 30 .

As the constituent material of the outer cylinder 30, a non-invasive or minimally invasive material (resin material, metal material, etc.) that can be used in the medical field can be applied. It is preferable to adopt a material with relatively high rigidity (stainless steel, titanium alloy, CoCr alloy, etc.).

The outer cylinder 30 is inserted along an introduction device such as a cannula that has been previously introduced into the living body. In addition, when the outer cylinder 30 has a sharp needle-like tip, it can be inserted into the affected part by puncturing from the living body surface S without using an introduction device.

Note that the outer cylinder 30 may be provided with a fixing member on its outer peripheral surface for position fixing on the living body surface S during the procedure. As a result, the operator can fix the position of the outer tube 30 during the procedure and accurately puncture the injection needle 40 into the target site of the affected area.

As shown in FIG. 2A, the injection needle 40 is composed of a hollow cylindrical member having a lumen 41, and extends from the tip of the second operating portion 20 along the longitudinal direction. The injection needle 40 includes a needle body portion 42 , a needle tip portion 43 and a curved portion 44 . The needle body portion 42 and the needle tip portion 43 communicate with each other through the lumen 41 .

The needle main body portion 42 is composed of a hollow tubular member, and the proximal end thereof is connected to the distal end of the second operating portion 20 . Therefore, lumen 41 of injection needle 40 communicates with lumen 21 of second operation section 20 . The distal end of the needle main body 42 is connected to the proximal end of the needle distal end portion 43 .

The needle tip 43 has a sharp puncture end 43b with an opening 43a at the tip. At least part of the needle tip portion 43 advances from the outer cylinder 30 into the living body as the second operation portion 20 slides. Further, the needle tip portion 43 has a curved portion 44 and is configured to be deformable into a shape in which at least a portion thereof is curved sideways.

The curved portion 44 constitutes at least a portion or substantially the entirety of the needle tip portion 43, and gradually extends from the tip of the needle body portion 42 toward the opening 43a of the needle tip portion 43 toward the central axis A ( It has a shape bent in a direction (radial direction with respect to the central axis A of the outer cylinder 30) away from the central axis B1) of the needle main body 42). As an example, the curved portion 44 may be set in the same region as the needle tip portion 43, as shown in FIG. 2A.

The curved portion 44 maintains its curved shape when the needle tip portion 43 advances from the outer cylinder 30, as shown in FIG. 2B. In addition, since the bending portion 44 has a lower rigidity than the outer cylinder 30, when the needle tip portion 43 is accommodated in the outer cylinder 30, as shown in FIG. Thereby, the curved shape is corrected to a substantially straight state.

The curved portion 44 is configured to have a curved shape in advance, and is also a guide member that guides the needle distal end portion 43 extending from the distal end opening portion 32 of the outer cylinder 30 in an oblique direction (a direction away from the central axis B1 of the needle main body portion 42). Any configuration that bends the needle tip portion 43 when it advances from the outer tube 30 , such as a configuration that curves by a needle (not shown), may be used.

Although the injection needle 40 has the opening 43a at the puncture end 43b, the injection needle 40 may have a configuration in which the opening 43a of the puncture end 43b is sealed and a plurality of holes are provided on the side surface of the needle tip portion 43. .

The material of the injection needle 40 is not particularly limited as long as it is a material that is applied to a puncture needle that is attached to a known syringe used in the medical field. Applicable.

The irradiation section 50 is attached to the outer peripheral surface of the first operation section 10 . The irradiating unit 50 irradiates a linear beam of light having a predetermined wavelength (hereinafter referred to as “line light L”). The irradiation unit 50 is not particularly limited as long as it is a light source that can irradiate the line light L. However, in order to be able to linearly irradiate the line light L onto the living body surface S having a three-dimensional gradient, it is possible to It is preferred to use a high laser light source. Further, since the line light L irradiates the living body surface S, it is preferable that the line light L has a greenish color tone as a complementary color.

The irradiation unit 50 passes through the central axis B of the injection needle 40 (more specifically, the central axis of the lumen 41 coincides with the central axis B1 of the needle main body 42 and the central axis B2 of the needle tip portion 43 of the injection needle 40). Line light L is applied so as to overlap the plane. The living body surface S is irradiated with the line light L emitted from the irradiation unit 50 . As shown in FIGS. 3A and 3B, the line light L is irradiated so as to overlap the plane passing through the central axis B of the injection needle 40, so that the needle tip portion 43 of the injection needle 40 inserted into the living body is curved. Illuminated from the direction side. Therefore, if the operator arranges the wave transmission surface 210 of the ultrasonic probe 200 along the line light L, the operator can enter the irradiation area of the ultrasonic waves U emitted from the wave transmission surface 210 at least from the outer cylinder 30. Needle tip 43 of infusion needle 40 will be present. Therefore, the operator can deliver the delivery product to the target position of the affected area by viewing the ultrasonic image showing the entirety of the needle tip 43 advanced from the outer cylinder 30 .

The irradiation unit 50 may include a light guide member such as a diffusion plate or a reflection plate at the irradiation port so as to irradiate the line light L at a predetermined irradiation angle (preferably 30 degrees or more, more preferably 45 degrees or more). good. As a result, the irradiating unit 50 can irradiate the surface of the living body S with the line light L having a length sufficient for alignment when the ultrasound probe 200 is arranged on the surface of the living body S.

<Treatment method>
Next, a treatment method using the delivery device 100 according to this embodiment will be described. The following description shows an example of a treatment in which a drug (liquid drug) for treating a tumor in an affected area is administered to the tumor at three sites as a delivered product.

The operator prepares a drug to be administered to the tumor in the affected area, and primes the syringe and injection needle 40 for injecting the drug. The operator operates the ultrasonic probe 200 to confirm the central position of the patient's tumor with the ultrasonic diagnostic apparatus, and determines the puncture route from the biological surface S to the tumor.

After disinfecting the puncture site and applying local anesthesia, the operator inserts (punctures) the outer cylinder 30 of the delivery device 100 toward the tumor under echo guidance. At this time, the operator positions the ultrasonic probe 200 on the body surface so as to visualize the tumor, and extends the distal end of the outer cylinder 30 of the delivery device 100 to a position where it reaches the outer surface of the tumor. Insert barrel 30 . At this time, the living body surface S is irradiated with the line light L emitted from the irradiation unit 50 . By piercing the ultrasound probe 200 so that the line light L is irradiated in parallel with the ultrasound probe 200, the needle tip portion 43 of the injection needle 40 advanced from the outer cylinder 30 can be displayed on the ultrasound image. .

In addition, when the operator punctures the injection needle 40, there are directions in which the tumor cannot be confirmed due to interference with the ultrasonic waves U by air in the bones and lungs and the viewing angle of the ultrasonic probe 200. The direction of puncture into the tumor can also be oriented prior to puncturing 40 into the tumor. While positioning the ultrasonic probe 200 based on the line light L emitted from the irradiation unit 50, the operator determines a plurality of puncture directions that can be confirmed by echo, and marks the biological surface S. If you do, you can proceed with the procedure smoothly.

After confirming that the tip of the outer tube 30 has reached the outer surface of the tumor, the operator pushes the push/pull unit 22 while checking the interface of the tumor, and moves the needle tip 43 of the injection needle 40 to the outer tube 30 . advance from and puncture the tumor. After puncturing the tumor with the injection needle 40, the operator operates the syringe or syringe pump to administer the drug. As a result, the first administration is completed, and the drug, which is the product to be delivered, is delivered to the affected tumor.

The operator pulls the push/pull part 22 to retract the injection needle 40 into the outer cylinder 30 . The operator removes the delivery device 100 from the needle guide, rotates the delivery device 100 in a predetermined direction, and moves the bending direction of the injection needle 40 to the second puncture site. At this time, the line light L emitted from the irradiation unit 50 follows the rotation of the device and is emitted in a direction corresponding to the bending direction of the injection needle 40 . Therefore, the line light L is irradiated with a trajectory different from the orientation of the first puncture. The operator positions the arrangement position of the ultrasonic probe 200 in the second puncture direction based on the line light L irradiated on the living body surface S. FIG. By arranging the ultrasonic probe 200 along the line light L, the operator can roughly grasp the behavior of the injection needle 40 . In addition, in order to obtain a more accurate ultrasound image as necessary, the operator tilts the injection needle 40 forward and backward with the wave transmission surface 210 of the ultrasound probe 200 along the line light L. It is also possible to find a posture in which the behavior can be grasped more precisely.

The operator presses the push-pull part 22 while confirming the interface of the tumor, and advances the needle tip part 43 of the injection needle 40 from the outer cylinder 30 to puncture the tumor. After puncturing the tumor with the injection needle 40, the operator operates the syringe or syringe pump to administer the drug. This completes the second administration. The drug, which is the product to be delivered, is delivered to a site different from the first delivery to the affected tumor.

The operator pulls the push/pull part 22 to retract the injection needle 40 into the outer cylinder 30 . At this time, before withdrawing the injection needle 40, an operation such as opening a three-way stopcock in the administration route may be performed in order to remove the pressure in the administration route increased by the administration. As with the second puncture, the operator rotates delivery device 100 in a predetermined direction to move injection needle 40 in the curved direction to the third puncture site. At this time, the line light L emitted from the irradiation unit 50 follows the rotation of the device and is emitted in a direction corresponding to the bending direction of the injection needle 40 . Therefore, the line light L is irradiated with a trajectory different from the directions of the first and second punctures. The operator positions the arrangement position of the ultrasonic probe 200 with respect to the third puncture direction with reference to the line light L irradiated on the living body surface S.

The operator presses the push-pull part 22 while confirming the interface of the tumor, and advances the needle tip part 43 of the injection needle 40 from the outer cylinder 30 to puncture the tumor. After puncturing the tumor with the injection needle 40, the operator operates the syringe or syringe pump to administer the drug. This completes the third administration. The drug, which is the product to be delivered, is delivered to a site different from the first and second delivery to the affected tumor.

After that, the operator pulls the push/pull part 22 to retract the injection needle 40 into the outer cylinder 30 . After that, the delivery device 100 is removed from the living body to complete the procedure.

[Modification]
It should be noted that the present invention is not limited to the above-described embodiments, and can be implemented with appropriate modifications according to the usage environment and the like, for example, as shown below. Also, the following modifications can be arbitrarily combined within the scope of the present invention. In Modifications 1 to 7 described below, constituent elements having the same functions as those of the above-described embodiment are denoted by the same reference numerals, detailed descriptions are omitted, and configurations, members, and methods of use that are not particularly mentioned are omitted. etc. may be the same as in the above-described embodiment.

<Modification 1>
Modification 1 is a configuration in which the outer cylinder 30 is attached so as to be rotatable about the long axis of the first operating portion 10, as shown in FIGS. 4A and 4B.

In Modification 1, as shown in FIG. 4A, the outer cylinder 30 is provided with a collar portion 34 along the entire circumference of the outer peripheral surface on the proximal end side of the outer cylinder 30 . An annular support portion 12 that rotatably holds the collar portion 34 is provided at the tip of the first operation portion 10 .

In another form of Modification 1, as shown in FIG. 4B, the outer cylinder 30 extends from the base end side of the outer cylinder 30 along the outer peripheral surface of the first operating portion 10, and the distal end thereof is the first operating portion. An extension 35 is provided that slidably engages an annular groove 13 formed in the outer peripheral surface of portion 10 .

According to the delivery device 100 of Modified Example 1, by rotatably attaching the outer cylinder 30 to the first operation section 10, when the injection needle 40 is rotated, the outer cylinder 30 does not rotate with the injection needle 40 and is inserted. The state (insertion posture) is maintained. Therefore, in Modification 1, damage due to friction with the surrounding living tissue that may occur due to rotation of the outer cylinder 30 is prevented.

<Modification 2>
As shown in FIGS. 5, 6A, and 6B, Modification 2 has two irradiating units 50, and is characterized by its arrangement position.

The delivery device 100 of Modification 2 has a first irradiation position where the line light L1 can be irradiated along the central axis B of the injection needle 40 from the bending direction side of the needle tip portion 43, and the outer peripheral surface of the first operation portion 10. Arranged at a second irradiation position where the line light L2 can be irradiated along the central axis B of the injection needle 40 from the side opposite to the bending direction side of the needle tip portion 43, which is a position facing the first irradiation position in the radial direction. It is configured to be Both the first irradiation position and the second irradiation position are positions where the line light L can be irradiated so as to overlap the plane passing through the needle main body 42 and the needle tip 43 of the injection needle 40 .

The delivery device 100 of Modification 2 can irradiate the line light L1 and the line light L2 in two directions, ie, the bending direction of the needle distal end portion 43 of the injection needle 40 and the opposite side of the bending direction. Therefore, when inserting the delivery device 100 into the living body, the operator places the ultrasonic probe 200 on the living body surface S along the line light L1 emitted from the first irradiation position as shown in FIG. 6A. In addition, when the operator cannot confirm the needle tip portion 43 of the injection needle 40 at the position of the line light L1 irradiated from the first irradiation position due to obstacles such as bones in the living body and air in the lungs, as shown in FIG. As shown, the ultrasound probe 200 can be placed on the biological surface S along the line light L2 irradiated from the second irradiation position. Therefore, the operator has a higher degree of freedom in positioning the ultrasound probe 200, which facilitates treatment.

<Modification 3>
In Modification 3, as shown in FIGS. 7A and 7B, the second operation unit 20 is rotatably attached to the first operation unit 10, and the irradiation unit 50 can follow the rotation operation of the second operation unit 20. It is a configuration that The delivery device 100 of Modification 3 is configured to rotate the second operation section 20 to change the puncture direction of the injection needle 40 with respect to the affected area.

The delivery device 100 of Modified Example 3 has a configuration in which the irradiation section 50 is attached to the outer peripheral surface of the second operation section 20 by joining it, as shown in FIG. 7A. In addition, the delivery device 100 of Modification 3 is provided with a notch 14 on the outer peripheral surface of the first operation section 10 so that the irradiation section 50 can be rotated as the position of the irradiation section 50 is changed. As a result, a part of the outer peripheral surfaces of the second operating part 20 and the injection needle 40 and the irradiation part 50 are exposed from the first operating part 10 . In the delivery device 100 of Modification 3, when the second operation section 20 is rotated to change the puncture direction of the injection needle 40 with respect to the affected area, the irradiation section 50 also rotates so as to follow the rotational movement.

Also, the delivery device 100 of Modification 3 can adopt the form shown in FIG. 7B. As shown in FIG. 7B, the delivery device 100 of Modification 3 has a configuration in which the irradiation section 50 is attached to the outer peripheral surface of the second operation section 20 by being joined thereto. The irradiation unit 50 is arranged on the outer peripheral surface of the second operation unit 20 while being accommodated inside the first operation unit 10 . In addition, the delivery device 100 of Modified Example 3 is provided with a window portion 15 through which the line light L emitted from the irradiation section 50 is transmitted as the arrangement position of the irradiation section 50 is changed. The window part 15 is arranged at a position facing the irradiation port of the irradiation part 50 on the distal end side of the first operation part 10 . The window part 15 is made of a colorless or colored transparent material (glass, acrylic, etc.) having translucency that does not obstruct the line light L as much as possible. Further, the refractive index of the window 15 may be adjusted so that the irradiation angle of the line light L is wide.

According to the delivery device 100 of Modified Example 3, when the injection needle 40 is rotated, the outer cylinder 30 is maintained in a state of being inserted into the living body (insertion posture). Therefore, the delivery device 100 of Modification 3 can prevent damage due to friction with the surrounding living tissue that may occur when the outer cylinder 30 rotates. In addition, since the irradiation unit 50 rotates along with the rotation operation of the second operation unit 20 , the line light L can be irradiated following the bending direction of the needle distal end portion 43 of the injection needle 40 .

Note that the delivery device 100 of Modification 3 has a configuration in which the irradiation unit 50 can follow the rotational movement of the second operation unit 20 in a configuration in which the second operation unit 20 is rotated to change the orientation of the injection needle 40 with respect to the affected area. should have Therefore, the delivery device 100 is not limited to the configuration shown in FIGS. 7A and 7B. It is also possible to adopt a configuration in which it is attached so as to follow only rotational movement without following movement in the forward/backward direction (front-rear direction).

<Modification 4>
Modification 4, as shown in FIGS. 8A and 8B, includes two irradiation units 50, one irradiation unit 50 (first irradiation unit 51) is attached to the outer peripheral surface of the first operation unit 10, and the other It is configured such that the irradiation unit 50 (second irradiation unit 52 ) can follow the rotation operation of the second operation unit 20 on the outer peripheral surface of the second operation unit 20 . The delivery device 100 of Modification 4 is configured to rotate the second operation part 20 to change the puncture direction of the injection needle 40 with respect to the affected area, as in the modification 3. FIG.

The first irradiation unit 51 and the second irradiation unit 52 are irradiated from the first irradiation unit 51 in a state before the second operation unit 20 is rotated with respect to the first operation unit 10, as shown in FIG. 8A. The line light L3 emitted from the second irradiation unit 52 and the line light L4 emitted from the second irradiation unit 52 are attached at positions where the line light L4 is superimposed on the living body surface S. Both the line light L3 and the line light L4 are irradiated so as to overlap a plane passing through the central axis B of the injection needle 40 . The second irradiation unit 52 rotates following the rotation of the second operation unit 20, as shown in FIG. 8B. The line light L<b>4 emitted from the second irradiation unit 52 is applied so as to overlap a plane passing through the central axis B of the injection needle 40 .

According to the delivery device 100 of Modified Example 4, before the second operation section 20 is rotated, the line light L3 emitted from the first irradiation section 51 and the line light L4 emitted from the second irradiation section 52 are emitted. is superimposed. This allows the operator to arrange the ultrasound probe 200 along the two line lights. Further, when the bending direction of the injection needle 40 is changed by rotating the second operating section 20 , the second irradiation section 52 also rotates following the rotational movement of the second operating section 20 . Accordingly, after rotating the second operation unit 20 , the operator can arrange the ultrasound probe 200 along the line light L4 emitted from the second irradiation unit 52 . Thus, in the delivery device 100 of Modification 4, by providing two irradiation units 50, even when the bending direction of the injection needle 40 is changed by rotating the second operation unit 20, the ultrasonic probe 200 can be accurately grasped. In addition, by checking the difference between the line light L3 of the first irradiation unit 51 and the line light L4 from the second irradiation unit 52, the position where the injection needle was first punctured and then the injection needle It is possible to visually confirm how far apart the positions are.

In addition, in the delivery device 100 of Modified Example 4, the line light L3 emitted from the first irradiation unit 51 and the line light L4 emitted from the second irradiation unit 52 can be easily distinguished. Attributes (hue, lightness, saturation) and illumination width may be changed.

<Modification 5>

Modification 5 is a configuration in which two types of line light L emitted from the irradiation unit 50 are emitted, as shown in FIGS. 9A and 9B. In the delivery device 100 of Modified Example 5, the irradiation unit 50 includes a first line light LA for alignment of the wave transmission surface 210 indicating the arrangement position of the ultrasonic probe 200 with respect to the biological surface S, and the first line light LA arranged on the biological surface S Second line light beams LB (LB1, LB2) for angle adjustment for correcting the inclination of the wave transmission surface 210 with respect to the biological surface S of the ultrasound probe 200 are emitted. The second line beams LB1 and LB2 are emitted substantially parallel to the first line beam LA with a predetermined gap therebetween. The interval of the second line light LB with respect to the first line light LA is set to the extent that the deviation of the tilt of the ultrasonic probe 200 can be confirmed.

According to the delivery device 100 of Modified Example 5, as shown in FIG. 9A, when the operator places the ultrasonic probe 200 at the correct position, the ultrasonic probe 200 and the second line light LB intersect. I don't wear it without doing it. On the other hand, if the placement angle of the ultrasound probe 200 is not correct, the operator will be affected by the second line light LB intersecting with the ultrasound probe 200 as shown in FIG. 9B. Therefore, the operator correctly positions the ultrasonic probe 200 by placing it on the first line light LA of the biological surface S so as not to overlap the second line light LB. be able to. Further, when the ultrasound probe 200 is covered with the second line light LB, the operator adjusts the inclination so that the ultrasound probe 200 is not covered with the second line light LB (LB1 or LB2). By doing so, the ultrasonic probe 200 can be positioned correctly.

Note that in Modification 5, the irradiation unit 50 may be configured to irradiate the second line light LB along both side edges of the first line light LA. That is, the first line light LA may be surrounded by the second line light LB.

<Modification 6>
Modification 6 provides a plurality of injection needles 40, and each of the injection needles 40 is configured to be independently advanceable and retractable. In addition, the delivery device 100 of Modification 6 has an irradiation section 50 on the outer peripheral surface of the outer cylinder 30 corresponding to the bending direction of the plurality of injection needles 40 . As shown in FIGS. 10A and 10B , in the delivery device 100 of Modification 6, as an example, the bending directions of the three injection needles 40 are set at a predetermined angle (when viewed from the axial direction) in the circumferential direction of the second operation section 20. For example, the injection needle 40 is positioned at 0°, 120°, 240° clockwise, and the base end of the injection needle 40 is connected to each of the push-pull portions 22 divided into three. Further, the hub portion 23 is provided in each of the pushing/pulling portions 22 divided into three.

As shown in FIG. 10B , when the operator pushes and pulls one of the divided push-pull sections 22 , the injection needle 40 connected to the operated push-pull section 22 moves toward the outer cylinder 30 . Advance or retreat. Further, when the operator simultaneously pushes and pulls the three divided push-pull portions 22, the three injection needles 40 can be advanced and retracted at the same time.

According to the delivery device 100 of Modified Example 6, the injection needle 40 can be punctured at different positions of the affected area without rotating the second operation section 20 or rotating the delivery device 100 itself. can. Further, the delivery device 100 of Modification 6 includes an irradiation unit 50 that irradiates each injection needle 40 with line light L so as to overlap a plane passing through the central axis B of the injection needle 40 . Therefore, when the operator pushes and pulls the injection needle 40 individually, the operator can arrange the ultrasonic probe 200 along the line light L emitted from the corresponding irradiation unit 50 .

Note that, in Modification 6, a plurality of injection needles 40 may be provided at the distal end of one second operating portion 20, and may be configured to move forward and backward simultaneously when the second operating portion 20 is pushed and pulled. In such a configuration, the operator can confirm the advancing direction of each injection needle 40 by relying on each line light L in advance, and simultaneously puncture while looking at the needle closest to the edge of the tumor. Also, after puncturing, the operator can confirm that the other injection needles 40 are not protruding from the tissue based on each line light L.

<Modification 7>
Modification 7 is provided with reflecting portions 60 for increasing the difference in acoustic impedance with the surroundings on the outer peripheral surfaces of the distal end side of the outer cylinder 30 and the distal end side of the injection needle 40 (mainly in the vicinity of the needle distal end portion 43). Configuration.

As shown in FIG. 11, the reflecting part 60 is provided on the outer peripheral surface of the outer cylinder 30 on the distal end side and the outer peripheral surface of the needle distal end portion 43 of the injection needle 40 . The reflecting part 60 has the effect of improving the reflection efficiency of the ultrasonic waves U and improving the visibility on the ultrasonic image. The reflecting part 60 has a shape that improves the reflection efficiency of the ultrasonic waves U. As shown in FIG. As an example, the reflecting portion 60 is configured with a concave groove (concave shape), a ridge or a plurality of projections (convex shape), or an uneven shape such as a satin finish. The reflecting part 60 is preferably provided on the outer peripheral surface corresponding to the bending direction so that the bending direction of the injection needle 40 can be confirmed on the ultrasonic image.

According to the delivery device 100 of Modified Example 7, the visibility of the outer cylinder 30 and the injection needle 40 is improved for the operator on the ultrasonic image, so that it is easy for the operator to position the insertion position and the puncture site with respect to the affected area during insertion into the living body. becomes.

[Effect]
As described above, the delivery device 100 according to the present embodiment is a device that punctures the biological surface S to deliver a delivery product to an affected area in the living body, and has the first operation section 10 and the lumen 31. , an outer cylinder 30 extending along the longitudinal direction from the tip of the first operating part 10, a second operating part 20 attached to the first operating part 10 so as to be slidable in the longitudinal direction, and an outer cylinder Injection needle 40 which is housed in lumen 31 of 30 so as to be advanceable and retractable and extends along the longitudinal direction from the distal end of

second

operating section

20 , and at least one of first operating section 10 and second operating section 20 and an irradiating unit 50 that irradiates the living body surface S with line light L that is attached and overlaps a plane passing through the central axis B of the injection needle 40 . The injection needle 40 also has a needle distal end portion 43 having an opening 43a at the distal end, and a hollow needle main body portion 42 extending from the proximal end of the needle distal end portion 43 along the longitudinal direction. The needle distal end portion 43 has a bending portion 44 that bends at least a portion of the needle distal end portion 43 so as to gradually move away from the central axis A of the outer cylinder 30 as it goes from the distal end of the needle main body portion 42 toward the opening 43a. have

According to the delivery device 100 configured in this manner, the line light L emitted from the irradiation unit 50 is applied to the surface of the living body S so as to overlap the plane passing through the central axis B of the injection needle 40. is irradiated from the bending direction side of the needle distal end portion 43 of the injection needle 40 inserted into. This allows the operator to grasp the correct placement position of the ultrasound probe 200 with respect to the biological surface S. Therefore, if the operator arranges the wave transmission surface 210 of the ultrasonic probe 200 along the line light L, the operator can enter the irradiation area of the ultrasonic waves U emitted from the wave transmission surface 210 at least from the outer cylinder 30. A needle tip 43 of the infusion needle 40 may be present. Therefore, the operator can easily confirm the bending direction and behavior of the injection needle 40 on the ultrasonic image, and can deliver the delivery product to the target site of the affected area.

In addition, in the delivery device 100 according to the present embodiment, the irradiating unit 50 includes a laser light source that irradiates a laser beam having a color complementary to that of the living body surface S as the line light L, and the line light L is emitted at an angle of 30 degrees or more. may be configured to be able to irradiate at an irradiation angle of .

According to the delivery device 100 configured in this way, by irradiating a laser beam having a complementary color to the biological surface S, such as green, as the line light L, the biological surface S having a three-dimensional gradient is irradiated. It becomes possible to irradiate the surface S with the line light L linearly. In addition, by irradiating the line light L at an irradiation angle of 30 degrees or more, when the ultrasonic probe 200 is arranged on the surface S of the living body, the line light L having a sufficient length for alignment is applied to the living body. The surface S can be irradiated.

In addition, in the delivery device 100 according to this embodiment, the outer cylinder 30 may be configured to be rotatably held about the long axis of the first operation section 10 .

According to the delivery device 100 configured in this way, by rotatably attaching the outer cylinder 30 to the first operation part 10, when the injection needle 40 is rotated, the outer cylinder 30 does not rotate together. The inserted state (insertion posture) is maintained. Therefore, the delivery device 100 can prevent damage due to friction with the surrounding living tissue that may occur due to the rotation of the outer cylinder 30 .

In addition, in the delivery device 100 according to the present embodiment, the irradiation unit 50 is a first irradiation capable of irradiating the line light L1 so as to overlap the plane passing through the central axis B of the injection needle 40 from the bending direction side of the needle tip portion 43. and a plane that passes through the central axis B of the injection needle 40 from the side opposite to the bending direction side of the needle tip portion 43 and which is a position radially facing the first irradiation position on the outer peripheral surface of the first operation portion 10 . may be configured to be arranged at the second irradiation positions where they can be irradiated with the line light L2.

According to the delivery device 100 configured in this way, when the operator inserts the delivery device 100 into the living body, the line light L1 emitted from the first irradiation position and the line light L2 emitted from the second irradiation position The ultrasound probe 200 can be placed on the biological surface S along the . Both the line light L1 irradiated from the first irradiation position and the line light L2 irradiated from the second irradiation position are irradiated so as to overlap the plane passing through the central axis B of the injection needle 40 . Therefore, the operator has a higher degree of freedom in positioning the ultrasound probe 200, which facilitates treatment.

In addition, in the delivery device 100 according to the present embodiment, the second operation section 20 is attached so as to be rotatable in the circumferential direction with respect to the first operation section 10, and the irradiating section 50 rotates relative to the second operation section 20. It is good also as a structure provided so that it can follow.

According to the delivery device 100 configured in this way, when the injection needle 40 is rotated, the outer cylinder 30 is maintained in a state of being inserted into the living body (insertion posture), so that the rotation of the outer cylinder 30 causes It is possible to prevent damage due to friction with the surrounding living tissue. In addition, since the irradiation unit 50 rotates along with the rotation operation of the second operation unit 20 , the line light L can be irradiated following the bending direction of the needle distal end portion 43 of the injection needle 40 .

Further, in the delivery device 100 according to this embodiment, the irradiation section 50 has a first irradiation section 51 attached to the first operation section 10 and a second irradiation section 52 attached to the second operation section 20. , the first irradiation unit 51 and the second irradiation unit 52, in a state before the second operation unit 20 is rotated with respect to the first operation unit 10, the line light L3 irradiated from the first irradiation unit 51, It may be configured such that the line lights L4 emitted from the second irradiation unit 52 are attached to positions where they overlap on the living body surface S, respectively.

According to the delivery device 100 configured in this way, before rotating the second operation unit 20, the operator places the ultrasonic probe 200 along the two line lights L3 and L4, When the bending direction of the injection needle 40 is changed by rotating the second operation unit 20 , the ultrasound probe 200 can be arranged along the line light L<b>4 emitted from the second irradiation unit 52 . Therefore, even when the operator rotates the second operation unit 20 to change the bending direction of the injection needle 40 , the operator can accurately grasp the arrangement position of the ultrasonic probe 200 .

Further, in the delivery device 100 according to the present embodiment, the irradiation unit 50 includes the first line light LA for aligning the wave transmission surface 210 of the ultrasound probe 200 with respect to the biological surface S, and the first line light LA second line light beams LB (LB1, LB2) for adjusting the angle of the wave transmission surface 210 with respect to the living body surface S and positioned outside the first line light beam LA along both side edges of the good too.

According to the delivery device 100 configured in this way, the operator can place the ultrasound probe 200 on the first line light LA of the biological surface S so as not to overlap the second line light LB. , the ultrasound probe 200 can be positioned correctly. Further, when the ultrasound probe 200 is covered with the second line light LB (LB1 or LB2), the operator adjusts the inclination so that the ultrasound probe 200 is not covered with the second line light LB. By doing so, the ultrasonic probe 200 can be positioned correctly.

In addition, in the delivery device 100 according to the present embodiment, a plurality of injection needles 40 are provided for the second operation section 20 , and the irradiation section 50 is provided in the second operation section 20 corresponding to each of the plurality of injection needles 40 . It is good also as a structure which attached multiple to the outer peripheral surface of.

According to the delivery device 100 configured in this way, the injection needle 40 is punctured at different positions of the affected area without rotating the second operation part 20 or rotating the delivery device 100 itself. be able to. In addition, since the irradiation unit 50 is provided for irradiating each of the injection needles 40 with the line light L so as to overlap the plane passing through the central axis B of the injection needle 40, the operator presses the injection needle 40 individually. When performing the pulling operation, the ultrasonic probe 200 can be arranged along the line light L emitted from the corresponding irradiation unit 50 .

In addition, in the delivery device 100 according to the present embodiment, the outer surface of the distal end portion of the outer cylinder 30 and the outer surface of the needle distal end portion 43 of the injection needle 40 have a reflecting portion 60 for increasing the acoustic impedance difference with the surroundings. It is good also as a structure which has.

According to the delivery device 100 configured in this way, the visibility of the outer tube 30 and the injection needle 40 is improved on the ultrasound image, so that the operator can position the insertion position and the puncture site with respect to the affected part during insertion into the living body. becomes easier.

This application is based on Japanese Patent Application No. 2021-051369 filed on March 25, 2021, the disclosure of which is incorporated by reference in its entirety.

10 first operation unit,
20 second operation unit,
30 outer cylinder,
31 lumen of the barrel,
40 injection needle,
42 needle body,
43 needle tip,
44 bend,
50 irradiation unit,
51 first irradiation unit,
52 second irradiation unit,
60 Reflector,
100 delivery device;
200 ultrasonic probe,
210 transmission surface,
L (L1 to L4) line light,
LA first line light,
LB second line light,
A central axis of the outer cylinder,
B central axis of injection needle (B1 central axis of needle main body, B2 central axis of needle tip),
S biological surface,
U Ultrasonic,
Z central axis of the delivery device;

Claims

A delivery device that punctures from the surface of a living body to deliver a delivery product to an affected area in the living body,
a first operation unit;
an outer cylinder having a lumen and extending along the longitudinal direction from the tip of the first operation portion;
a second operating portion attached slidably in the longitudinal direction with respect to the first operating portion;
an injection needle housed in the lumen of the outer cylinder so as to be advanceable and retractable and extending along the longitudinal direction from the tip of the second operation portion;
an irradiation unit that is attached to at least one of the first operation unit and the second operation unit and that irradiates the surface of the living body with line light that overlaps a plane passing through the central axis of the injection needle;
A delivery device, comprising:
The injection needle has a needle distal end portion having an opening at the distal end thereof, and a hollow needle main body portion extending along the longitudinal direction from the base end of the needle distal end portion,
The needle tip portion has a curved portion that curves at least a part of the needle tip portion so as to gradually move away from the central axis of the outer cylinder as it goes from the tip of the needle body toward the opening. The delivery device of paragraph 1.
The irradiating unit includes a laser light source that irradiates the line light with a laser beam exhibiting a color complementary to that of the surface of the living body, and is configured to be capable of irradiating the line light at an irradiation angle of 30 degrees or more. 3. The delivery device of paragraph 2.
The delivery device according to claim 3, wherein the outer cylinder is rotatably held about the longitudinal axis of the first operating portion.
The irradiation unit has a first irradiation position capable of irradiating the line light so as to overlap a plane passing through the central axis of the injection needle from the bending direction side of the needle tip portion, and the outer peripheral surface of the first operation unit. A second irradiation position that is radially opposite to the first irradiation position and that can irradiate the line light so as to overlap a plane passing through the central axis of the injection needle from the side opposite to the bending direction side of the needle tip portion. 5. A delivery device according to claim 3 or 4, arranged in each of the .
The second operating portion is attached to the first operating portion so as to be rotatable in a circumferential direction,
The delivery device according to claim 3 or 4, wherein the irradiation section is provided so as to be able to follow the rotational movement of the second operation section.
The irradiation unit has a first irradiation unit attached to the first operation unit and a second irradiation unit attached to the second operation unit,
The first irradiation section and the second irradiation section, in a state before the second operation section is rotationally moved with respect to the first operation section, emit line light from the first irradiation section and the second irradiation section. 5. The delivery device according to claim 3 or 4, wherein the line lights emitted from the two irradiation units are attached at positions where they overlap each other on the surface of the living body.
The irradiating unit includes a first line of light for aligning the transmission surface of the ultrasonic probe with respect to the biological surface, and is positioned outside the first line of light along both side edges of the first line of light. and a second line of light for adjusting the angle of the transmitting surface with respect to the biological surface.
A plurality of the injection needles are provided with respect to the second operation section,
5. The delivery device according to claim 3, wherein a plurality of said irradiating sections are attached to the outer peripheral surface of said second operating section corresponding to each of said plurality of injection needles.
The outer surface of the outer cylinder on the distal side and the outer surface of the injection needle on the distal side according to any one of claims 1 to 9, having a reflecting portion for increasing an acoustic impedance difference with the surroundings. delivery device.