Catheter device

Abstract

[Problem] To provide a catheter device with which a medical liquid can be transvascularly administered locally to a target site located outside a blood vessel, with which positioning of a medical device in a puncture direction can be facilitated, with which positional deviation can be prevented from occurring when the medical device punctures the target site, and with which the medical liquid and cells of the target site can be prevented from leaking into the blood vessel from a puncture hole formed in a biological tissue by the medical device. [Solution] A catheter device (100) comprises: a longitudinal axis (110a); an anchoring part (120) which anchors the catheter device at a predetermined position in a blood vessel (v); a first lumen (115) which establishes communication from a base end side to a side hole (114) provided in a side surface at a distal end side, and into which a medical device (200) for puncturing a biological tissue (b) in the vicinity of the blood vessel can be inserted; a sealing part (130) for sealing a puncture hole (h) formed in the biological tissue by the medical device; and a second lumen (116) into which an imaging device (300) can be inserted. The catheter device has at least one field-of-view limiting part (140) that limits an imaging range of the imaging device to a prescribed range. The sealing part and the field-of-view limiting part at least partially overlap each other in a longitudinal axis direction, and at least a portion of the field-of-view limiting part is further toward the distal end side in the longitudinal axis direction than the side hole.

Description

Catheter device

[0001] The present invention relates to a catheter device.

[0002] Conventionally, the development of medical devices for realizing the administration of a local drug solution to a target site of a patient's biological tissue has been underway. For example, Patent Document 1 discloses a catheter device (catheter assembly) having a lumen (first lumen) into which a needle that enables puncturing of biological tissue located near a blood vessel and administration of a drug solution to a target site is inserted, and an imaging device capable of acquiring an image of the blood vessel.

[0003] In a procedure using the catheter device of Patent Document 1, when an operator punctures a biological tissue with a needle, the puncture position of the needle and the like can be confirmed by referring to the image acquired by the imaging device. Therefore, an operator can smoothly proceed with the puncture of the biological tissue using the needle and the administration of the drug solution to the target site.

[0004] WO2020 / 002177

[0005] As described above, smooth procedures can be achieved by using the catheter device of Patent Document 1. However, it can be said that the catheter device of Patent Document 1 has room for further improvement in the following points.

[0006] Patent Document 1 proposes the use of an IVUS system or an OCT system as an imaging device for the catheter device. When these imaging devices are used, the acquired images are tomographic images that include the blood vessel and the surrounding biological tissue. Furthermore, tomographic images are generally 360° cross-sectional images of the area around the blood vessel. The operator can use the tomographic images acquired by the imaging device to confirm a relatively wide area including the blood vessel, the surrounding biological tissue, and the target site. On the other hand, when a wide area of ​​biological tissue, including parts other than the target site, is displayed on the tomographic image, it becomes difficult for the operator to grasp the relative positional relationship between the puncture direction of the needle protruding from the catheter device and the target site located outside the blood vessel when performing the puncture procedure toward the target site. Therefore, it takes time to align the direction of needle puncture with the target site.

[0007] Furthermore, for example, if the target site for needle puncture is a relatively hard tumor (e.g., a tumor such as pancreatic cancer), it is desirable to support the catheter device with sufficient force against the blood vessel (the inner wall of the blood vessel) when inserting the needle protruding from the catheter device into the target site. If the catheter device is not supported with sufficient force against the blood vessel, displacement of the catheter device may occur when inserting the needle into the target site. This can make accurate needle insertion into the target site difficult and hinder the smooth progress of the procedure.

[0008] Furthermore, when a needle is inserted into living tissue and a target site from within a blood vessel and a drug solution is administered to the target site via the needle, there is a possibility that the drug solution or cells from the target site (e.g., tumor cells) may leak into the blood vessel through the puncture hole created in the living tissue by the needle.

[0009] The present invention aims to solve the above problems and provides a catheter device that enables transvascular local administration of a drug solution to a target site located outside a blood vessel, which allows for easy alignment of the puncture direction of the medical device, prevents misalignment when the medical device is inserted into the target site, and prevents leakage of the drug solution or cells from the target site into the blood vessel through the puncture hole formed in the biological tissue by the medical device.

[0010] The above objective is achieved by any one of the following embodiments (1) to (12) of the present invention.

[0011] (1) A catheter device that can be used in combination with an imaging device for acquiring images of blood vessels, comprising: a longitudinal axis; an anchoring portion for anchoring the catheter device to a predetermined position in a blood vessel; a first lumen that communicates from the proximal end toward a side hole provided on the tip side surface and through which a medical device for puncturing biological tissue near the blood vessel can be inserted; a sealing portion for sealing a puncture hole formed in the biological tissue by the medical device; and a second lumen through which the imaging device can be inserted, wherein the catheter device has at least one field-of-view limiting portion for limiting the imaging range of the imaging device to a predetermined range, the sealing portion and the field-of-view limiting portion overlap by at least a portion in the longitudinal axis direction, and the field-of-view limiting portion is at least a portion located on the tip side in the longitudinal axis direction relative to the side hole.

[0012] (2) The catheter device according to (1), wherein the portion of the field-view limiting portion that does not overlap with the sealing portion is located on the tip side in the longitudinal direction.

[0013] (3) The catheter device according to (1) or (2), wherein the catheter device has a proximal portion, the second lumen has a proximal opening, and the proximal opening is located on the tip side of the catheter device relative to the proximal portion.

[0014] (4) The catheter device according to any one of (1) to (3), wherein the first lumen is bent toward the side hole at a predetermined angle with respect to the longitudinal axis.

[0015] (5) The catheter device according to any one of (1) to (4), wherein the medical device through which the first lumen is inserted is a needle tube having a lumen communicating in the longitudinal direction.

[0016] (6) The catheter device according to any one of (1) to (5), wherein the field of view limiting portion is capable of limiting the transmission of ultrasound.

[0017] (7) A catheter device according to any one of (1) to (6), comprising a third lumen that communicates from the proximal end in the longitudinal direction to the sealing portion.

[0018] (8) The catheter device according to (7), wherein the sealing portion comprises a first expansion portion that expands by manual operation.

[0019] (9) The catheter device according to (3), wherein the anchoring portion is positioned on the proximal end side in the longitudinal direction of the side hole and on the distal end side in the longitudinal direction of the proximal opening.

[0020] (10) A catheter device according to any one of (1) to (9), comprising a fourth lumen that communicates from the proximal end in the longitudinal direction to the anchoring portion.

[0021] (11) The catheter device according to (10), wherein the anchoring portion comprises a second expansion portion that expands by manual operation.

[0022] (12) The catheter device according to any one of (1) to (11), wherein the anchoring portion, the medical device, and the sealing portion are independently operable.

[0023] The catheter device described above allows for the transvascular local administration of a drug solution to a target site located in biological tissue outside a blood vessel using the medical device. Furthermore, it facilitates alignment of the puncture direction of the medical device, prevents misalignment when puncturing the target site, and prevents leakage of the drug solution or cells from the target site into the blood vessel through the puncture hole created in the biological tissue by the medical device.

[0024] This figure shows a catheter device according to an embodiment. This is an enlarged cross-sectional view of the area near the tip of the catheter device according to an embodiment. This is an enlarged cross-sectional view of the area near the tip of the catheter device according to an embodiment, showing the state when the first and second expansion parts are expanded. This is a perspective view of the area near the tip of the catheter device according to an embodiment. This is a perspective view of the area near the tip of the catheter device according to an embodiment, showing the state when the first and second expansion parts are expanded. This is a front view of the catheter device as seen from the direction of arrow 6A in Figure 3. This is a cross-sectional view along arrows 7A-7A in Figure 3. This is a cross-sectional view along arrows 8A-8A in Figure 3. This is a perspective view showing the proximal part of the catheter device according to an embodiment. This is a cross-sectional view of the proximal part along arrows 10A-10A in Figure 9. This is a cross-sectional view of the proximal part along arrows 11A-11A in Figure 9. This is a schematic cross-sectional view for illustrating an example of use of the catheter device according to an embodiment This is a schematic cross-sectional view illustrating an example of use of a catheter device according to an embodiment. This is a schematic diagram illustrating the effect of the field-of-view limiting part. This is a schematic diagram illustrating the effect of the anchoring part. This is a diagram showing a part of a catheter device according to Modification 1. This is a cross-sectional view showing a part of a catheter device according to Modification 2. This is a schematic diagram illustrating a catheter device according to Modification 3. This is a diagram illustrating the catheter device anti-dislodgement mechanism according to Modification 4, showing the proximal end of the proximal part. This is a diagram illustrating the catheter device anti-dislodgement mechanism according to Modification 4, showing a cross-sectional view near medical device. This is a cross-sectional view illustrating the catheter device anti-dislodgement mechanism according to Modification 4.This is a diagram illustrating the anchoring portion of the catheter device according to modified example 5. This is a diagram illustrating the anchoring portion of the catheter device according to modified example 6. This is a diagram illustrating the anchoring portion of the catheter device according to modified example 7.

[0025] Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown herein are illustrative examples to embody the technical idea of ​​the present invention and do not limit the present invention. Furthermore, all other implementable forms, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included in the scope and spirit of the present invention, as well as in the claims and their equivalents.

[0026] Furthermore, the drawings attached to this specification may be schematically represented with changes to scale, aspect ratio, shape, etc., from the actual object for the sake of illustration and ease of understanding, but these are merely examples and do not limit the interpretation of the present invention.

[0027] Furthermore, in the following explanations, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, they are used for convenience and do not prescribe any particular order.

[0028] (Embodiment) Figures 1 to 11 are diagrams illustrating the structure of each part of the catheter device 100 according to this embodiment. Figures 12 to 19 are diagrams illustrating an example of use and effect of the catheter device 100 according to this embodiment.

[0029] Figure 1 shows the overall configuration of the catheter device 100. Figure 2 shows a cross-sectional view along the longitudinal axis before the anchoring portion 120 (second expansion portion 121) and sealing portion 130 (first expansion portion 131) are expanded, and Figure 3 shows a cross-sectional view along the longitudinal axis when the anchoring portion 120 (second expansion portion 121) and sealing portion 130 (first expansion portion 131) are expanded. Figure 4 shows a perspective view before the anchoring portion 120 (second expansion portion 121) and sealing portion 130 (first expansion portion 131) are expanded, and Figure 5 shows a perspective view when the anchoring portion 120 (second expansion portion 121) and sealing portion 130 (first expansion portion 131) are expanded. Figure 6 shows a front view of the catheter device 100 as seen from the direction of arrow 6A shown in Figure 3, Figure 7 shows a cross-sectional view along arrow 7A-7A shown in Figure 3, and Figure 8 shows a cross-sectional view along arrow 8A-8A shown in Figure 3.

[0030] In this specification, the side of the catheter device 100 that is inserted into the body is defined as the "proximal side" (indicated by arrow X1), and the end located on the proximal side and its surrounding area are defined as the "proximal portion." Furthermore, the side of the catheter device 100 opposite to the proximal side (the side where the proximal portion 150 is located) is defined as the "proximal side" (indicated by arrow X2), and the end located on the proximal side and its surrounding area are defined as the "proximal portion."

[0031] Furthermore, in this specification, the longitudinal axis direction is defined as the direction parallel to the extending direction of the sheath portion 110 of the catheter device 100 (indicated by arrows X1-X2). In the figures, arrows Y1-Y2 indicate the depth direction perpendicular to the longitudinal axis direction, and arrows Z1-Z2 indicate the height direction perpendicular to both the longitudinal axis direction and the depth direction. Note that the cross section perpendicular to the longitudinal axis direction (Y1-Y2 / Z1-Z2 cross section) is also referred to as the orthoaxial cross section (see Figures 7, 8, etc.).

[0032] <Catheter Device 100> The catheter device 100 according to this embodiment will be described below with reference to Figures 1 to 19.

[0033] As shown in Figures 1, 12 to 17, the catheter device 100 is configured as a catheter device that can be used in combination with an imaging device 300 that acquires images of blood vessels v.

[0034] Referring to Figures 1 to 3, the catheter device 100 comprises a longitudinal axis 110a, an anchoring portion 120 for anchoring the catheter device 100 to a predetermined position within the blood vessel v, a first lumen 115 that communicates from the proximal end toward a side hole 114 provided on the tip side surface and through which a medical device 200 for puncturing biological tissue near the blood vessel v can be inserted, a sealing portion 130 for sealing the puncture hole h formed in the biological tissue b by the medical device 200, and a second lumen 116 through which an imaging device 300 can be inserted.

[0035] Figure 1 shows the catheter device 100 with the imaging device 300 inserted into the second lumen 116.

[0036] As shown in Figure 1, the catheter device 100 has a sheath portion 110 extending along the longitudinal axis 110a and a proximal portion 150 located on the proximal end side of the sheath portion 110.

[0037] The sheath portion 110 can be made of, for example, a flexible tubular member having a plurality of lumens 115, 116, 117, and 118 formed thereon. The sheath portion 110 can be made of, for example, a resin material known in the field of medical devices such as catheters. The outer surface of the sheath portion 110, the inner surface of the first lumen 115, and the inner surface of the second lumen 116 can be coated to improve sliding properties.

[0038] As shown in Figure 7, each lumen 115, 116, 117, and 118 can be provided in the sheath portion 110 so as to be aligned in a vertical line in the cross-sectional view perpendicular to the axis.

[0039] The proximal section 150 can be made of, for example, a hard resin material. The proximal section 150 is positioned outside the body when performing procedures using the catheter device 100.

[0040] As shown in Figures 1, 10, and 11, the handle portion 150 can be connected to the base end portion 113 of the sheath portion 110. As will be described later, multiple hubs 152, 153, and 154 can be connected to the handle portion 150.

[0041] The first lumen 115, the third lumen 117, and the fourth lumen 118 continuously extend from the handpiece portion 150 to the vicinity of the distal end 111 of the sheath portion 110.

[0042] As shown in FIGS. 1 to 3, the second lumen 116 is formed only in the vicinity of the distal end 111 of the sheath portion 110. The second lumen 116 has a distal end opening 116a that opens to the distal end side of the sheath portion 110 and a proximal end opening 116b that enables insertion of the imaging device 300 into the second lumen 116.

[0043] The imaging device 300 used with the catheter device 100 is, for example, a catheter device for acquiring diagnostic images capable of acquiring an image of the blood vessel v. As the imaging device 300, for example, an IVUS catheter (intravascular ultrasound diagnostic catheter), an OCT catheter (catheter using optical coherence tomography), an OFDI catheter (catheter using optical frequency domain imaging method), etc. can be used. In the present embodiment, an example of using an IVUS catheter as the imaging device 300 will be described. Further, the specific configuration of the IVUS catheter is not particularly limited, but in the present embodiment, an example of using a rapid exchange type IVUS catheter in which a guide wire lumen through which the guide wire 400 can be inserted is formed at the distal end will be described.

[0044] As shown in FIGS. 1 to 3 and FIG. 8, the catheter device 100 has at least one field-of-view limiting portion 140 that limits the imaging range of the imaging device 300 to a predetermined range.

[0045] As shown in FIG. 8, the field-of-view limiting portion 140 is arranged so as to partially surround the second lumen 116 along the circumferential direction of the sheath portion 110 (clockwise or counterclockwise direction with respect to the longitudinal axis 110a).

[0046] The field-of-view limiting section 140 is provided to narrow the imaging range that the imaging device 300 can acquire. For example, as shown in Figure 8, the field-of-view limiting section 140 can be provided in a range of a predetermined angle θ1 along the circumferential direction of the sheath section 110. The unlimiting section (range indicated by angle θ2) 145, where the field-of-view limiting section 140 is not formed, is the range in which imaging by the imaging device 300 is possible. Therefore, when imaging the blood vessel v and the surrounding biological tissue b with the imaging device 300 inserted into the second lumen 116, it becomes possible to acquire an image only in the circumferential range where the unlimiting section 145 is provided (see Figure 18). At this time, by configuring the direction in which the unlimiting section 145 is provided to coincide with the puncture direction of the medical device 200 for puncturing the biological tissue b near the blood vessel v, the imaging direction and the puncture direction become the same, making the puncture operation easier to perform.

[0047] When an IVUS catheter is intended to be used as the imaging device 300, the field-of-view restriction section 140 is configured to restrict the transmission of ultrasound. By restricting the amount of ultrasound transmission in the field-of-view restriction section 140, a sufficient amount of ultrasound for imaging cannot reach the blood vessel wall, so only images of the circumferential area where the non-restrictive section 145 is provided are acquired. Furthermore, the field-of-view restriction section 140 can be constructed in the sheath section 110 as a structure to restrict the transmission of ultrasound to a certain area surrounding the second lumen 116, for example, by using a material with low acoustic impedance (such as a porous material containing a lot of air or rubber). When the field-of-view restriction section 140 is constructed as described above, the parts of the sheath section 110 other than the field-of-view restriction section 140 can be made of a material that has higher ultrasound transmission than the field-of-view restriction section 140.

[0048] In addition, when assuming the use of an OCT catheter, an OFDI catheter, or the like as the imaging device 300, as a structure for preventing light transmission in a certain range surrounding the second lumen 116 in the sheath portion 110, for example, by applying a color that reduces light transmission or providing a masking material that reduces light transmission, the visual field limiting portion 140 can be configured. When configuring the visual field limiting portion 140 as described above, portions of the sheath portion 110 other than the visual field limiting portion 140 can be configured to be transparent so as to enhance light transmissivity.

[0049] The circumferential range (angle θ1) where the visual field limiting portion 140 shown in FIG. 2 is provided is not particularly limited as long as the target site T can be sufficiently imaged in the unrestricted portion 145. For example, it is preferably 30° to 180°. By providing the visual field limiting portion 140 within such a range, when puncturing the medical device 200 with respect to the biological tissue b and the target site T based on the image acquired by the imaging device 300, it becomes possible to more easily confirm the puncture direction.

[0050] As shown in FIG. 2, the sealing portion 130 and the visual field limiting portion 140 can be arranged so that at least a part thereof overlaps in the longitudinal axis direction. This is because the sealing portion 130 is arranged for the purpose of sealing the puncture hole h formed by the medical device 200, so that the range imaged by the unrestricted portion 145 (that is, a predetermined range in the puncture direction of the medical device 200) and the position sealed by the sealing portion 130 at least partially overlap. In the present embodiment, the sealing portion 130 is arranged to overlap within a predetermined range between the tip portion 141 and the base end portion 143 of the visual field limiting portion 140 extending in the longitudinal axis direction.

[0051] As shown in Figure 2, in this embodiment, the side hole 114 formed in the sheath portion 110 is located on the proximal end side in the longitudinal direction of the field of view limiting portion 140. In other words, the side hole 114 is positioned on the proximal end side of the proximal end portion 143 of the field of view limiting portion 140. Furthermore, the field of view limiting portion 140 only needs to have the same puncture direction as the medical device 200 and the imaging direction of the target area T by the non-limiting portion 145. For example, there are no particular restrictions on the length of the positioning range of the field of view limiting portion 140 in the longitudinal direction of the second lumen 116, and the proximal end portion 143 of the field of view limiting portion 140 may be positioned beyond the side hole 114 on the proximal end side in the longitudinal direction.

[0052] As shown in Figure 2, the portion of the field-of-view limiting section 140 that does not overlap with the sealing section 130 can be positioned towards the tip in the longitudinal direction. In other words, a certain range of the field-of-view limiting section 140 on the tip end 141 side can be positioned closer to the tip than the sealing section 130. By positioning the field-of-view limiting section 140 in this way, it becomes possible to limit the imaging range of the imaging device 300 even at a position closer to the tip than the sealing section 130. When the medical device 200 is inserted into the target site T, the needle tip 201 is positioned closer to the tip in the longitudinal direction than the sealing section 130. With this configuration, the positional relationship between the target site T and the needle tip 201 within the biological tissue b can be more easily determined. Therefore, it becomes possible to more easily determine the insertion direction of the medical device 200 based on the image acquired by the imaging device 300.

[0053] In this embodiment, only one field-of-view limiting section 140 is provided in the second lumen 116 so as to extend continuously along the longitudinal axis. However, there are no particular restrictions on the number of field-of-view limiting sections 140 or their specific arrangement, as long as the imaging range in the non-limiting section 145 coincides with the puncture direction by the medical device 200. For example, the field-of-view limiting section 140 may consist of multiple sections arranged at predetermined intervals in the longitudinal axis direction and / or circumferential direction. By configuring it in this way, a wide field of view of the imaging device 300 can be secured while grasping the puncture direction of the medical device 200 and the target site T. Furthermore, the position of the field-of-view limiting section 140 is not limited as long as it can be provided at any location in the second lumen 116 to limit the imaging range of the imaging device 300. For example, the field-of-view limiting section 140 may be placed on the outer surface of the tip 111 of the sheath section 110.

[0054] As mentioned above, the catheter device 100 has a proximal portion 150. The second lumen 116 also has a proximal opening 116b. As shown in Figures 1 and 2, the proximal opening 116b can be positioned on the tip side of the catheter device 100, relative to the proximal portion 150. By positioning the proximal opening 116b of the second lumen 116 in this way, when inserting the catheter device 100 into the blood vessel v, the imaging device 300, which has been inserted into the blood vessel v prior to the catheter device 100, can be inserted into the second lumen 116. Furthermore, this makes it possible to guide the movement of the catheter device 100 within the blood vessel v by the imaging device 300 and the guide wire 400 inserted into the imaging device 300.

[0055] As shown in Figure 2, the first lumen 115 (a portion of the tip of the first lumen 115) is configured to bend at a predetermined angle with respect to the longitudinal axis toward the side hole 114. With the first lumen 115 configured as described above, when the medical device 200 is protruded from the side hole 114, the medical device 200 can be punctured obliquely into the biological tissue b and the target site T. Furthermore, when the medical device 200 is pushed toward the tip by the operator's hand movements to puncture the biological tissue b and the target site T, the needle tip 201 of the medical device 200 can be prevented from escaping (diverting) from the biological tissue b and the target site T. Therefore, the operator can smoothly and appropriately puncture the biological tissue b and the target site T with the medical device 200.

[0056] The inclination angle of the first lumen 115 (the angle of inclination in a direction perpendicular to the longitudinal axis 110a) is preferably, for example, 30° or more and 60° or less.

[0057] As shown in Figures 7 and 10, the medical device 200 that passes through the first lumen 115 can be, for example, a needle tube having a lumen 210 that communicates in the longitudinal direction.

[0058] The tip of the needle tube constituting the medical device 200 is provided with a needle tip 201 that can be inserted into biological tissue b and a target site T. The needle tube is preferably made of a pencil-point needle in order to enhance the ability to puncture the biological tissue b and the target site T, and to suppress the needle tip 201 from getting caught on the inclined portion at the tip of the first lumen 115. Furthermore, the needle tube is preferably made of a relatively rigid material such as metal in order to ensure the ability to puncture the biological tissue b and the target site T.

[0059] The medical device 200 is not particularly limited in its specific configuration as long as it is capable of performing therapeutic actions such as puncturing biological tissue b and target site T, and administering drug solution to target site T. The medical device 200 may be, for example, an ablation device that treats by cauterizing biological tissue b.

[0060] By configuring the medical device 200 with a needle tube equipped with a lumen 210, it becomes possible to locally administer a drug solution to the target site T via the lumen 210 after puncturing the biological tissue b and the target site T with the needle tip 201.

[0061] As shown in Figures 1 and 2, in this embodiment, the sealing portion 130 can be positioned closer to the front end in the longitudinal direction than the side hole 114, and overlapping with at least a portion of the field of view limiting portion 140. Since the puncture hole h created by protruding the medical device 200 from the side hole 114 is formed closer to the front end in the longitudinal direction than the side hole 114, the sealing operation by the sealing portion 130 can be performed without moving the entire catheter device 100 relative to the puncture hole h (while maintaining the position of the catheter device 100) by the above configuration.

[0062] As shown in Figures 1 and 2, the catheter device 100 may be equipped with a third lumen 117 that communicates from the proximal end in the longitudinal direction to the sealing portion 130. By being equipped with the third lumen 117, the catheter device 100 can, for example, control the supply and discharge of an expansion fluid (e.g., physiological saline) to the sealing portion 130 when the sealing portion 130 is composed of an expansion portion such as a balloon that can compress and stop bleeding from the puncture hole h.

[0063] As shown in Figures 3 and 5, the sealing portion 130 can be configured with a first expansion portion 131 that expands through manual operation (for example, by supplying fluid using a syringe connected to the third hub 153).

[0064] The first expansion section 131 can be made up of, for example, a balloon into which a fluid can be injected. The tip of the third lumen 117 opens on the side of the sheath section 110 and communicates with the lumen of the first expansion section 131.

[0065] The first expansion portion 131 can be provided with a guide groove 131a to prevent the medical device 200 protruding from the side hole 114 from interfering with the first expansion portion 131 when the first expansion portion 131 is expanded. The guide groove 131a has a shape that is inclined diagonally toward the direction away from the sheath portion 110 (towards the outer surface side of the first expansion portion 131). Because the first expansion portion 131 has a guide groove 131a, when the first expansion portion 131 is expanded while the medical device 200 is punctured into biological tissue b and target site T, it is possible to prevent the first expansion portion 131 from interfering with the medical device 200 and preventing expansion force from being applied to the medical device 200 (see Figure 15).

[0066] The balloon used in the first expansion section 131 is preferably made of a highly flexible semicon balloon to prevent the needle tube of the medical device 200 from bending or breaking when the first expansion section 131 is expanded. In addition, a hemostatic agent can be applied to the outer surface of the first expansion section 131 to more reliably seal the puncture hole h.

[0067] The sealing portion 130 is not particularly limited in its specific configuration as long as it can seal the puncture hole h. The sealing portion 130 can be made up of, for example, a stent. Furthermore, even when the sealing portion 130 is made up of an expansion portion such as a balloon, there are no particular restrictions on the shape of the sealing portion 130.

[0068] As shown in Figures 2 and 3, the mooring portion 120 can be positioned on the base end side in the longitudinal direction of the side hole 114, and on the tip side in the longitudinal direction of the base end opening 116b of the second lumen 116. By positioning the mooring portion 120 in this way, it is possible to prevent the mooring portion 120 from interfering with the medical device 200 when the medical device 200 is extended out of the side hole 114.

[0069] As shown in Figures 2 and 3, the catheter device 100 may be equipped with a fourth lumen 118 that communicates from the proximal end in the longitudinal direction to the anchoring portion 120. By being equipped with the fourth lumen 118, the catheter device 100 can, for example, control the supply and discharge of an expansion fluid (e.g., physiological saline) to the anchoring portion 120 when the anchoring portion 120 is composed of an expansion portion such as a balloon.

[0070] The anchoring section 120 can be configured with a second expansion section 121 that expands by manual operation (for example, by supplying fluid using a syringe connected to the fourth hub 154). By configuring the anchoring section 120 with a second expansion section 121, it becomes possible to easily switch between supporting (anchoring) and releasing the medical device 200 from the blood vessel v by the anchoring section 120 by operating the expansion and contraction of the second expansion section 121.

[0071] The second expansion section 121 can be, for example, a balloon into which a fluid can be injected. The tip of the fourth lumen 118 opens on the side of the sheath section 110 and communicates with the lumen of the second expansion section 121.

[0072] The balloon used in the second expansion section 121 preferably has physical properties that allow it to flexibly respond to changes in the diameter of the blood vessel v when the second expansion section 121 is expanded. Furthermore, the outer surface of the second expansion section 121 may be provided with a fine uneven structure (a structure that increases friction) to prevent the balloon from slipping and to increase the support force of the medical device 200 against the blood vessel v, or an anti-slip coating material may be applied.

[0073] For example, as shown in Figure 19, the second expansion portion 121 can be configured to expand vertically along the longitudinal direction of the cross-section perpendicular to the axis of the sheath portion 110. When the second expansion portion 121 is configured in this way, the expansion force of the second expansion portion 121 can be applied in the vertical direction of the cross-section perpendicular to the axis of the blood vessel v, making it possible to firmly support the catheter device 100 against the blood vessel v while ensuring a certain amount of blood flow. Furthermore, when the second expansion portion 121 is configured in this shape, it is preferable to configure the second expansion portion 121 with a non-container type balloon so that the expansion force of the balloon can support the catheter device 100 against the blood vessel v with sufficient force.

[0074] The anchoring portion 120 is not particularly limited in its specific configuration, as long as it can support the catheter device 100 with respect to the blood vessel v. The anchoring portion 120 can be made of, for example, a mesh structure such as a stent or a linear structure such as a wire (Figures 28 to 30), as will be described later. Furthermore, even when the anchoring portion 120 is made of an expansion portion such as a balloon, there are no particular restrictions on the shape of the anchoring portion 120.

[0075] The catheter device 100 is configured such that the anchoring portion 120, the medical device 200, and the sealing portion 130 can be operated independently. In other words, the operation of supporting and releasing the catheter device 100 from the blood vessel v by the anchoring portion 120, puncturing the biological tissue b and target site T by the medical device 200, and sealing and releasing the puncture hole h by the sealing portion 130 can be performed by individually operating the anchoring portion 120, the medical device 200, and the sealing portion 130, respectively. Therefore, in procedures using the catheter device 100, the operator can smoothly proceed with the procedure by individually operating the anchoring portion 120, the medical device 200, and the sealing portion 130, respectively, as the procedure progresses.

[0076] As shown in Figure 9, the hubs 151, 152, 153, and 154 are positioned at the base end of the handle portion 150.

[0077] As shown in Figures 9, 10, and 11, the first hub 151 is connected to the proximal end 203 of the medical device 200 (needle tube). The first hub 151 can be fixed to the proximal end 203 of the medical device 200 by adhesive or other means.

[0078] The operator can move the medical device 200 forward and backward along the first lumen 115 by pushing and pulling the first hub 151 with a hand gesture. By moving the first hub 151 forward and backward, the operator can easily switch between the medical device 200 protruding from the side hole 114 and the medical device 200 being housed inside the side hole 114.

[0079] As shown in Figure 11, the second hub 152 is provided to be in fluid communication with the first lumen 115 via a predetermined tube 156a. A fluid supply device such as a syringe used when priming the first lumen 115 can be connected to the second hub 152.

[0080] As shown in Figure 11, a check valve 155 can be placed near the base end of the first lumen 115 to prevent leakage of the priming liquid supplied into the first lumen 115 from a fluid supply device connected to the second hub 152. The check valve 155 can be made of a valve member (for example, a sealing member made of an elastic material) that ensures sealing performance by being in close contact with the outer circumferential surface of the medical device 200.

[0081] As shown in Figure 10, the third hub 153 is provided to be in fluid communication with the third lumen 117 via a predetermined tube 156b. A fluid supply device such as a syringe can be connected to the third hub 153 to operate the supply of expansion fluid to the sealing portion 130 (first expansion portion 131) and the discharge of expansion fluid from the sealing portion 130 via the third lumen 117.

[0082] As shown in Figure 10, the fourth hub 154 is provided to be in fluid communication with the fourth lumen 118 via a predetermined tube 156c. A fluid supply device such as a syringe can be connected to the fourth hub 154 to operate the supply of expansion fluid to the mooring section 120 (second expansion section 121) and the discharge of expansion fluid from the mooring section 120 via the fourth lumen 118.

[0083] <Examples of Catheter Device 100 Use> Next, with reference to Figures 12 to 18, examples of the use of catheter device 100 (examples of procedures using catheter device 100) will be explained. Note that the procedures and purposes of use of catheter device 100 (diseases to be treated, types of target sites T, types of blood vessels v, etc.) are not limited to those described below.

[0084] The following example illustrates a case where a pancreatic cancer tumor formed in the pancreas was used as the target site T for drug administration.

[0085] The surgeon delivers the tip of the medical device 200 (the tip 111 of the sheath portion 110) to near the pancreas via a designated blood vessel v (for example, the superior mesenteric artery, splenic artery, portal vein, etc.), and then performs puncture of the biological tissue b and the target site T with the medical device 200, and administers the drug solution to the target site T using the medical device 200.

[0086] Before commencing the above procedure, the operator or other personnel shall perform the following preparatory steps for the catheter device 100.

[0087] The operator connects a fluid supply device filled with priming fluid (e.g., physiological saline) to each of the third hub 153 and the fourth hub 154. The operator operates each fluid supply device to remove air from the third lumen 117, the sealing section 130 (first expansion section 131), the fourth lumen 118, and the mooring section 120 (second expansion section 121).

[0088] The operator connects a fluid supply device filled with priming fluid to the second hub 152. The operator operates the fluid supply device to prime the first lumen 115.

[0089] The operator connects a fluid supply device filled with a predetermined drug solution to the first hub 151. The operator operates the fluid supply device to prime the lumen 210 of the medical device 200 (needle tube).

[0090] The operator inserts the imaging device 300 into the second lumen 116 through the proximal opening 116b of the second lumen 116 and assembles the catheter device 100 with the imaging device 300.

[0091] Next, the operator delivers the catheter device 100 to the puncture target site and aligns the catheter device 100 with respect to the puncture target site using the following procedure.

[0092] The operator uses a known puncture device (such as an indwelling needle) to create a puncture hole at a predetermined location on the patient's biological surface. The operator inserts a guidewire 400 into the body through the puncture hole. The operator manipulates the guidewire 400 to deliver it via the blood vessel v to the vicinity of the target site T.

[0093] The operator inserts the catheter device 100, with the imaging device 300 attached, along the proximal end of the guidewire 400 positioned outside the body. At this time, the operator inserts the guidewire 400 into the guidewire lumen of the imaging device 300, thereby inserting the guidewire 400 into the second lumen 116 of the catheter device 100 via the imaging device 300.

[0094] The operator moves the imaging device 300 independently along the guidewire 400 to deliver the imaging device 300 to the vicinity of the target site T. After delivering the imaging device 300 to the vicinity of the target site T, the operator uses the imaging device 300 to image the biological tissue b around the target site T and identify the target site T. The operator then identifies the puncture site based on the images acquired by the imaging device 300.

[0095] Next, the operator delivers the catheter device 100 to the puncture site. With the imaging device 300 fixed near the puncture site, the operator moves only the catheter device 100 along the guidewire 400 and the imaging device 300. As shown in Figure 12, the operator advances the catheter device 100 until the field-of-view limiting portion 140 of the catheter device 100 is confirmed by the image acquired by the imaging device 300 (until the field-of-view limiting portion 140 is delivered near the puncture site).

[0096] After confirming that the field-of-view restriction section 140 has moved to near the puncture site, the operator adjusts the positions of the catheter device 100 and the imaging device 300 so that the target site T is clearly visible in the image acquired by the imaging device 300. Specifically, as shown in Figure 18, the catheter device 100 and the imaging device 300 are rotated within the blood vessel v so that the non-restricting section 145 is positioned on the target site T side (so that at least a portion of the non-restricting section 145 is positioned on the side facing the target site T from the perspective of the imaging device 300). Once the positioning is completed as described above and the target site T is visible in the image acquired by the imaging device 300, the operator maintains the rotational position of the catheter device 100 and the imaging device 300 to maintain that state.

[0097] Next, the operator expands the anchoring portion 120 (second expansion portion 121) as shown in Figure 13. By expanding the anchoring portion 120, the operator can support the catheter device 100 against the blood vessel v (the inner wall of the blood vessel v) (see Figure 19).

[0098] Next, as shown in Figure 14, the operator extends the tip of the medical device 200 (the needle tip 201 of the needle tube) through the side hole 114 and punctures the biological tissue b located near the target site T with the medical device 200. At this time, the operator can easily and accurately determine the puncture direction of the medical device 200 by referring to the image acquired by the imaging device 300 (a portion of the tomographic image of the blood vessel v and biological tissue b is not displayed by the field of view limiting unit 140, and only a portion of the overall tomographic image of the blood vessel v and biological tissue b captured by the non-limiting unit 145).

[0099] The operator inserts the medical device 200 into the target site T and administers the drug solution into the target site T through the lumen 210 of the medical device 200 (needle tube). There are no particular restrictions on the drug solution used in the medical device 200, but in the case of a pancreatic cancer tumor as in this embodiment, for example, cell therapies (such as CAR-T cells), nucleic acid therapies (such as mRNA therapeutics), antibody therapies (such as monoclonal antibodies), viral therapies (such as oncolytic viruses), PRR agonists, cytokines, anticancer drugs, and immune checkpoint inhibitors can be used.

[0100] After administering the drug solution to the target site T, the operator expands the sealing portion 130 (first expansion portion 131) with the medical device 200 inserted into the target site T, as shown in Figure 15. By expanding the sealing portion 130, the operator can apply a compressive force to the biological tissue b to seal the puncture hole h formed in the biological tissue b.

[0101] As shown in Figure 16, the operator places the medical device 200 into the first lumen 115 while maintaining the expanded state of the sealing portion 130. By moving the tip of the medical device 200 (the needle tip 201 of the needle tube) into the first lumen 115 while the puncture hole h is sealed, the time during which the puncture hole h is directly exposed to the vascular lumen can be minimized. This effectively prevents the leakage of the drug solution and the tissue of the target site T into the blood vessel v through the puncture hole h when the medical device 200 is removed from the biological tissue b.

[0102] As shown in Figure 17, the operator removes the medical device 200 from the biological tissue b, and then contracts the anchoring portion 120 and the sealing portion 130. After contracting the anchoring portion 120 and the sealing portion 130, the operator removes the catheter device 100 and the imaging device 300 from the body.

[0103] As described above, the catheter device 100 according to this embodiment comprises a longitudinal axis 110a, an anchoring portion 120 for anchoring the catheter device 100 to a predetermined position in a blood vessel v, a first lumen 115 that communicates from the proximal end toward a side hole 114 provided on the tip side surface and through which a medical device 200 for puncturing biological tissue near the blood vessel v can be inserted, a sealing portion 130 for sealing the puncture hole h formed in the biological tissue b by the medical device 200, and a second lumen 116 through which an imaging device 300 can be inserted. The catheter device 100 has at least one field-of-view limiting portion 140 that restricts the imaging range of the imaging device 300 to a predetermined range, the sealing portion 130 and the field-of-view limiting portion 140 overlap in the longitudinal direction at least in part, and the field-of-view limiting portion 140 is located at least partly on the tip side in the longitudinal direction relative to the side hole 114.

[0104] The catheter device 100 according to this embodiment includes a sealing portion 130 for sealing the puncture hole h formed in the biological tissue b by the imaging device 300, thereby preventing the drug solution administered to the target site T or the tissue of the target site T from leaking into the blood vessel v through the puncture hole h. Furthermore, the catheter device 100 includes an anchoring portion 120 for securing the catheter device 100 to a predetermined position within the blood vessel v, thereby preventing displacement of the catheter device 100 when the medical device 200 is inserted into the biological tissue b and the target site T, allowing the medical device 200 to be inserted into the target site T smoothly and accurately. The catheter device 100 also has a field-of-view limiting portion 140 that restricts the imaging range of the imaging device 300 to a predetermined range. By referring to the image acquired within the range restricted by the field-of-view limiting portion 140, the operator can easily grasp the puncture direction for inserting the medical device 200 from the catheter device 100 towards the target site T. Furthermore, since the sealing portion 130 and the field-of-view limiting portion 140 are positioned such that at least a portion of them overlap in the longitudinal direction, the sealing portion 130 can appropriately seal the puncture hole h formed by the medical device 200, whose puncture direction is determined based on the field-of-view limiting portion 140, and the biological tissue b located in its vicinity. In addition, the side hole 114 for protruding the medical device 200 from the catheter device 100 is located on the proximal end side in the longitudinal direction of both the field-of-view limiting portion 140 and the sealing portion 130. Therefore, by moving the medical device 200 from the proximal end side to the tip side in the longitudinal direction and protruding the medical device 200 from the side hole 114, it becomes possible to smoothly puncture the biological tissue b located in the vicinity of the position where the field-of-view limiting portion 140 is located.

[0105] As described above, the catheter device 100 allows for the transvascular local administration of a drug solution to a target site T located outside the blood vessel v. Furthermore, the puncture direction of the medical device 200 can be easily aligned, misalignment of the medical device 200 when puncturing the target site T can be prevented, and leakage of the drug solution or cells from the target site T into the blood vessel v through the puncture hole h formed in the biological tissue b by the medical device 200 can be prevented.

[0106] The following describes modified versions of the catheter device according to the present invention. In describing the modified versions, redundant explanations of points that can be configured in common with the catheter device 100 described in the above-described embodiment will be omitted as appropriate.

[0107] <Modification 1> For example, as shown in Figure 20, the second lumen 116 can also be positioned laterally offset from the first lumen 115 on the cross-sectional view perpendicular to the axis of the sheath portion 110 (a position that is not aligned vertically with the first lumen 115). Even when the second lumen 116 is positioned in this way, the imaging device 300 positioned in the second lumen 116 can display the target area T imaged through the non-restrictive portion 145 in the image. Furthermore, by adjusting the position and angle of the field-of-view restricting portion 140, it is possible to adjust the puncture direction of the medical device 200 toward the target area T displayed by the imaging device 300 when the medical device 200 is protruding from the side hole 114.

[0108] <Modification 2> For example, as shown in Figure 21, the lumens 115, 117, and 118 can be arranged so that they are not aligned in a vertical line on the cross-sectional view perpendicular to the axis of the sheath portion 110. As an example, the third lumen 117 and the fourth lumen 118 can be arranged side by side in the left-right direction on the cross-sectional view perpendicular to the axis. By arranging the lumens 117 and 118 in this way, it is possible to prevent an excessive decrease in the vertical strength of the sheath portion 110, thereby effectively preventing kinks, breaks, etc. from occurring in the sheath portion 110. In addition, compared to the above embodiment, it is possible to reduce the cross-sectional area of ​​the sheath portion 110 in the direction perpendicular to the axis, which enables delivery to smaller diameter blood vessels and reduces the load caused by the sheath portion 110 contacting the blood vessel wall. The positional relationship of the lumens 117 and 118 can also be reversed, with the left and right positions on the drawing shown in Figure 21 being swapped.

[0109] <Modification 3> For example, as shown in Figure 22, the anchoring portion 120 (second expansion portion 121) can be configured to expand on one side of the sheath portion 110 (the lower side of the sheath portion 110 in the illustrated example) to support the sheath portion 110 against the blood vessel v. In this case, the side hole 114 from which the medical device 200 protrudes is close to the blood vessel wall near the target site T, making the puncture operation easier to perform. Furthermore, when the anchoring portion 120 is configured in this way, it is preferable that the second expansion portion 121 be made of a semicon type balloon in order to prevent excessive load from being placed on the blood vessel v when the anchoring portion 120 expands.

[0110] <Modification 4> For example, the catheter device can be provided with a mechanism to prevent the medical device 200 (needle tube) from coming out of the proximal part 150.

[0111] As shown in Figures 23 to 27, the anti-detachment mechanism can be configured, for example, by a protrusion 150a located at the base end 158 of the hand portion 150 and a protrusion 203a located at the base end 203 of the medical device 200.

[0112] As shown in Figures 23, 24, and 25, the proximal end portion 158 of the proximal portion 150 can be provided with a proximal opening 150b that allows insertion of a medical device 200 into the first lumen 115. The inner periphery of the proximal opening 150b can be provided with a protrusion 150a that closes a portion of the proximal opening 150b (a portion other than the vertically upper and lower parts) in the front view from the proximal end shown in Figure 23.

[0113] As shown in Figure 26, the proximal end portion 203 of the medical device 200 can be provided with a protrusion 203a whose shape corresponds to the shape of the proximal end opening 150b narrowed by the proximal end portion 150a formed on the proximal end portion 150.

[0114] As shown in Figure 27, when the surgeon inserts the medical device 200 into the first lumen 115 through the base end opening 150b of the proximal section 150, they adjust the rotational orientation of the medical device 200 so that the protrusion 203a of the medical device 200 does not interfere with the protrusion 150a formed on the inner periphery of the base end opening 150b. After inserting the medical device 200 into the first lumen 115, the surgeon rotates the medical device 200 so that the protrusion 203a of the medical device 200 overlaps with the protrusion 150a of the proximal section 150. By positioning the medical device 200 in this way, when the medical device 200 is moved towards the base end, the protrusion 203a of the medical device 200 will interfere with the protrusion 150a of the proximal section 150. Therefore, it is possible to prevent the medical device 200 from unintentionally coming out of the first lumen 115. Furthermore, the shape of the protrusion 150a on the hand portion 150 and the protrusion 203a on the medical device 200 is not particularly limited, as long as it allows the medical device 200 to be inserted into the first lumen 115 and prevents it from accidentally coming out of the first lumen 115.

[0115] <Modifications 5-7> Modifications 5-7 are modifications relating to the structure of the mooring section. In the following description, the modifications to the mooring section will be described mainly, and descriptions of other structural parts will be omitted. Points that are not specifically described can be the same as those of the embodiments described above.

[0116] In the catheter device 100A according to the modified example 5 shown in Figure 28, the anchoring portion 120A is made of a mesh-like structure (a stent-like structure) that can be expanded and contracted.

[0117] The mooring section 120A can be made of, for example, a self-expanding material (e.g., a nickel-titanium alloy). The mooring section 120 can be fixed near the tip 111 of the sheath section 110.

[0118] The catheter device 100A may be provided with a slide cover 180 for operating the expansion and contraction of the anchoring portion 120A.

[0119] The slide cover 180 has a portion of its proximal end positioned near the proximal end 150. When using the catheter device 100A, a portion of the slide cover 180 is positioned outside the body along with the proximal end 150. The slide cover 180 is configured to move forward and backward along the longitudinal axis of the sheath portion 110. The operator can move the slide cover 180 towards the proximal end by manipulating it with their hand, thereby exposing the anchoring portion 120A from the slide cover 180. When the anchoring portion 120A is exposed from the slide cover 180, it deforms into a pre-shaped expanded form, supporting the catheter device 100 against the blood vessel v. When the operator moves the slide cover 180 towards the distal end and covers the anchoring portion 120A with the slide cover 180, the anchoring portion 120A is retracted and housed inside the slide cover 180.

[0120] As described above, the operator can easily switch between expanding and contracting the mooring section 120A by operating the slide cover 180 forward and backward with a hand gesture.

[0121] In the catheter device 100B according to the modified example 6 shown in Figure 29, the anchoring portion 120B is made of a wire (a linear structure such as a guide wire). The anchoring portion 120B can be made of, for example, a metal wire having predetermined elasticity and rigidity.

[0122] The catheter device 100B includes a hub 190 for the anchoring portion 120B to enable insertion of the anchoring portion 120B into the fourth lumen 118. A side hole 119 is provided near the tip 111 of the sheath portion 110, allowing the anchoring portion 120B to protrude from the fourth lumen 118.

[0123] The operator can grasp the proximal end of the anchoring portion 120B, which is led out to the proximal end of the anchoring portion hub 190, with their fingers or the like, and move it along the fourth lumen 118, thereby controlling the protrusion of the anchoring portion 120B from the side hole 119 and the retraction of the anchoring portion 120 into the fourth lumen 118. As shown in Figure 29, by protruding the anchoring portion 120B from the side hole 119, the operator can support the catheter device 100 against the blood vessel v by pressing the anchoring portion 120B against the blood vessel v.

[0124] Furthermore, the tip of the mooring portion 120B can be pre-shaped so that, when it protrudes from the side hole 119, it curves convexly toward the blood vessel v, as shown in Figure 29. By configuring the mooring portion 120B in this way, the burden on the blood vessel v can be reduced when the mooring portion 120B comes into contact with the blood vessel v. In addition, to further increase the support force on the blood vessel v, the mooring portion 120B may be constructed using multiple linear structures.

[0125] In the catheter device 100C according to the modified example 7 shown in Figure 30, the anchoring portion 120C is made of a wire structure (a linear structure such as a guide wire). The anchoring portion 120C can be made of, for example, a metal wire having predetermined elasticity and rigidity.

[0126] The mooring section 120C is inserted into the fourth lumen 118. The base end 128 of the mooring section 120C is connected to the slider 195. The slider 195 is configured to move along the outer surface of the sheath section 110. The base end 128 of the mooring section 120C is configured to move along the longitudinal axis in conjunction with the movement of the slider 195. A certain range of the mooring section 120C on the tip end 129 side protrudes from the side hole 119. The tip end 129 of the mooring section 120C is fixed to the outer surface of the sheath section 110.

[0127] When the operator or other person grasps the slider 195 with their fingers or the like and moves the slider 195 forward, a certain range of the tip 129 side of the anchoring portion 120C connected to the slider 195 curves convexly toward the blood vessel v, as shown in Figure 30. By curving the anchoring portion 120C convexly, the operator or other person can press the anchoring portion 120C against the blood vessel v. As a result, the operator or other person can support the catheter device 100 against the blood vessel v.

[0128] As described above in Modifications 5 to 7, there are no particular restrictions on the specific configuration of the anchoring portion, as long as it is capable of supporting (anchoring) the catheter device 100 to the blood vessel v.

[0129] Although the catheter device according to the present invention has been described through embodiments, the present invention is not limited to the configuration described in the embodiments and can be modified as appropriate based on the claims.

[0130] This application is based on Japanese Patent Application No. 2024-170090, filed on 30 September 2024, the disclosures of which are incorporated herein by reference.

[0131] 100 Catheter device 100A Catheter device 100B Catheter device 100C Catheter device 110 Sheath portion 110a Longitudinal axis 111 Tip portion of sheath portion 113 Base portion of sheath portion 114 Side hole 115 First lumen 116 Second lumen 116a Tip opening of second lumen 116b Base opening of second lumen 117 Third lumen 118 Fourth lumen 120 Anchorage portion 120A Anchorage portion 120B Anchorage portion 120C Anchorage portion 121 Second expansion portion 130 Sealing portion 131 First expansion portion 131a Guide groove 140 Field of view restriction portion 145 Unrestricted portion 150 Proximal portion 151 First hub 152 Second hub 153 Third hub 154 Fourth hub 200 Medical device 201 Needle tip 210 Lumen 300 Imaging device 400 Guidewire T Target site b Biological tissue h Puncture hole v Blood vessel

Claims

1. A catheter device that can be used in conjunction with an imaging device for acquiring images of blood vessels, comprising: a longitudinal axis; an anchoring portion for anchoring the catheter device at a predetermined position within a blood vessel; a first lumen communicating from the proximal end toward a side hole provided on the distal side surface, through which a medical device for puncturing biological tissue near the blood vessel can be inserted; a sealing portion for sealing a puncture hole formed in the biological tissue by the medical device; and a second lumen through which the imaging device can be inserted, wherein the catheter device has at least one field-of-view limiting portion for limiting the imaging range of the imaging device to a predetermined range, the sealing portion and the field-of-view limiting portion overlap at least in part in the longitudinal axis direction, and at least part of the field-of-view limiting portion is located toward the distal end in the longitudinal axis direction than the side hole.

2. The catheter device according to claim 1, wherein the portion of the field-view limiting portion that does not overlap with the sealing portion is arranged on the tip side in the longitudinal direction.

3. The catheter device according to claim 1, wherein the catheter device has a proximal portion, the second lumen has a proximal opening, and the proximal opening is located on the tip side of the catheter device relative to the proximal portion.

4. The catheter device according to claim 1, wherein the first lumen is bent toward the side hole at a predetermined angle with respect to the longitudinal axis.

5. The catheter device according to claim 1, wherein the medical device through which the first lumen is inserted is a needle tube having a lumen communicating in the longitudinal direction.

6. The catheter device according to claim 1, wherein the field of view limiting portion is capable of limiting the transmission of ultrasound.

7. The catheter device according to claim 1, further comprising a third lumen communicating from the proximal end in the longitudinal direction to the sealing portion.

8. The catheter device according to claim 7, wherein the sealing portion comprises a first expansion portion that expands by manual operation.

9. The catheter device according to claim 3, wherein the anchoring portion is positioned on the proximal end side in the longitudinal direction of the side hole and on the distal end side in the longitudinal direction of the proximal opening.

10. The catheter device according to claim 1, further comprising a fourth lumen communicating from the proximal end in the longitudinal direction to the anchoring portion.

11. The catheter device according to claim 10, wherein the anchoring portion comprises a second expansion portion that expands by manual operation.

12. The catheter device according to claim 1, wherein the anchoring portion, the medical device, and the sealing portion are independently operable.

Images