Lymphangiogenesis inducing device

Abstract

A lymphangiogenesis inducing device (10) is a single-needle device comprising a puncture needle (12). A rod-shaped body (14) that forms the puncture needle (12) has a wound imparting portion (40) provided on the outer circumferential surface (24) of a shaft portion (22). The wound imparting portion (40) has a protruding portion (42) that protrudes outward from the outer circumferential surface (24) of the shaft portion (22). When the position of the puncture needle (12) relative to skin (SK) shifts, the protruding portion (42) makes contact with the skin (SK). Through this contact, the protruding portion (42) imparts a microscopic wound (H) to the skin (SK). The wound (H) induces lymphangiogenesis.

Description

Lymphangiogenesis induction device

[0001] The present invention relates to a lymphangiogenesis induction device that induces lymphatic vessel neogenesis.

[0002] Lymphatic vessels are one of the pathways that collect tissue fluid in the body. When lymphatic vessels become blocked, tissue fluid stagnates, causing swelling in the body and lymphedema. Lymphedema is often caused by lymph node dissection or radiation therapy, which are performed as part of cancer treatment, such as breast cancer treatment, and is accompanied by functional decline, including sensory paralysis.

[0003] Lymphedema is a disease that is difficult to cure completely once it develops. Chronic lymphedema is not easily improved. If lymphedema is left untreated, it will become more severe.

[0004] Currently, complex physical therapy is available as a treatment for lymphedema ("2018 Lymphedema Treatment Guidelines," edited by the Japanese Lymphedema Society, pages 81-83). Complex physical therapy is a treatment method that appropriately combines multiple therapies for areas of the body where swelling has occurred, depending on the patient's condition. The multiple therapies include compression therapy, which applies pressure to the body using elastic clothing or elastic bandages, skin care, exercise under compression, massage, etc.

[0005] Lymphaticovenular anastomosis (LVA) is a radical treatment for lymphedema. LVA is a procedure that connects blocked lymphatic vessels to veins (Takumi Yamamoto et al., "SCIP Flap Transplantation for Lymphedema," PEPARS, No. 150, pp. 54-64, 2019).

[0006] "2018 Lymphedema Treatment Guidelines," edited by the Japanese Lymphedema Society, pp. 81-83. Takumi Yamamoto et al., "SCIP Flap Transplantation for Lymphedema," PEPARS, No. 150, pp. 54-64, 2019.

[0007] Complex physical therapy is a conservative treatment that primarily aims to slow the progression of lymphedema. For this reason, symptom improvement cannot be expected from complex physical therapy. Furthermore, daily self-care, including compression, is required, which places a heavy burden on patients.

[0008] On the other hand, lymphaticovenous anastomosis requires advanced plastic surgery techniques. Therefore, according to Takumi Yamamoto et al., "SCIP Flap Transplantation for Lymphedema," PEPARS, No. 150, pp. 54-64, 2019, patients have limited opportunities to receive treatment. Furthermore, suitable veins and lymphatic vessels for anastomosis may not be found. Thrombus formation may also occur in the anastomosed vessels. Therefore, even if treatment is performed using lymphaticovenous anastomosis, sufficient results may not be achieved. For this reason, the "2018 Lymphedema Treatment Guidelines," edited by the Japanese Lymphedema Society, pp. 81-83, merely explains that lymphaticovenous anastomosis may be considered in cases where it is difficult to administer compression therapy to the patient.

[0009] In view of the above circumstances, a simple yet effective treatment for lymphedema is desired.

[0010] An object of the present invention is to solve the above-mentioned problems.

[0011] (1) One aspect of the present invention is a single-needle lymphangiogenesis induction device that includes a puncture needle that is used without being combined with a hollow outer needle, wherein the puncture needle has a rod-shaped body that has a tip that is one longitudinal end of the rod-shaped body, a body that extends along the longitudinal direction, and a wound-inflicting portion provided on the outer peripheral surface of the body, and the wound-inflicting portion has a protrusion that protrudes outward from the outer peripheral surface, and when the puncture needle is displaced relative to the skin of a living body, the protrusion comes into contact with the skin to inflict minute wounds in the skin that can induce lymphatic vessel neogenesis.

[0012] According to this aspect, a wound can be created in the skin (mainly in the subcutaneous tissue) by the wounding portion constituting the puncture needle. Lymphatic vessel neogenesis can be induced starting from this wound. As can be seen from this, lymphatic vessel neogenesis can be induced by the simple procedure of creating a minute wound in the skin.

[0013] Furthermore, an outer needle that covers the puncture needle from the outside is not required, which allows the lymphangiogenesis induction device to be configured as a single-needle device, thereby simplifying the configuration of the lymphangiogenesis induction device.

[0014] The single-needle lymphangiogenesis induction device allows the outer dimensions of the puncture needle to be freely set, which allows for a larger area of ​​skin injury than when an outer needle is used.

[0015] (2) In the lymphangiogenesis inducing device according to the above item (1), the protrusion may have a corner at the tip in the protruding direction.

[0016] With this configuration, the corners come into contact with the skin, making it easy to inflict wounds on the skin.

[0017] (3) In the lymphangiogenesis induction device according to the above item (1) or (2), the rod-shaped body may be a hollow body having a lumen.

[0018] For example, a medicinal solution can be administered to subcutaneous tissue etc. via the lumen. Alternatively, an implant can be supplied to subcutaneous tissue etc. via the lumen. Here, the implant is made of a material in which cells that induce lymphatic vessel neogenesis can settle.

[0019] (4) In the lymphangiogenesis inducing device according to any one of the above items (1) to (3), the body portion may be in the shape of a round rod.

[0020] The round rod-shaped body allows the puncture needle to be easily rotated within the skin, making it easy to create a wound in the skin.

[0021] (5) In the lymphangiogenesis inducing device according to the above item (4), the wounding portion may be a spiral-shaped protrusion.

[0022] The outer peripheral surface of the round bar-shaped body is curved in an arc shape. By subjecting the body having such a curved outer peripheral surface to cutting, for example, it is possible to easily form the spiral-shaped protrusion.

[0023] (6) In the lymphangiogenesis inducing device according to the above item (1) or (2), the rod-shaped body may have a flat portion on the body, and the wound-inflicting portion may be provided on the surface of the flat portion.

[0024] It is easier to perform cutting or other processes on the surface of the flat portion (flat surface) than on a curved surface, so in this case, it is easy to provide the protrusion as the wound-inflicting portion on the surface of the trunk portion (flat portion).

[0025] (7) In the lymphangiogenesis inducing device according to the above item (1) or (2), the rod-shaped body may be a solid body.

[0026] The rigidity of a puncture needle with a solid rod-shaped body is greater than that of a puncture needle with a hollow rod-shaped body. Therefore, the former is less likely to bend within the skin than the latter. Therefore, the former can easily inflict a wound on the skin. This promotes lymphatic neogenesis. In addition, the operability of the puncture needle is improved.

[0027] (8) In the lymphangiogenesis inducing device described in any one of items (1) to (4), (6), or (7) above, the wounding portion may have a plurality of the protrusions, and the plurality of protrusions may be arranged at a distance from each other.

[0028] By providing a plurality of protrusions on the rod-shaped body so that they are spaced apart from one another, it is possible to increase the area of ​​the skin that can be injured.

[0029] (9) In the lymphangiogenesis induction device according to any one of the above items (1) to (8), the tip may have a sharp edge that is inserted through the epidermis of the living body.

[0030] The sharp corner allows the puncture needle to be easily inserted into the skin.

[0031] (10) In the lymphangiogenesis induction device described in the above item (9), the rod-shaped body may be a hollow body having a lumen, and the opening of the lumen may be provided at a position offset from the apex of the acute-angled portion.

[0032] This prevents the tip from becoming missing. Moreover, it is possible to administer a medicinal solution to the subcutaneous tissue, etc., through the lumen. Alternatively, it is possible to supply an implant to the subcutaneous tissue, etc., through the lumen. In this way, by locating the opening of the lumen at a position offset from the tip of the acute angle, it is possible to administer a medicinal solution to the subcutaneous tissue, etc., through the lumen, even if the body of the puncture needle is flat-rod shaped.

[0033] According to the present invention, the configuration of the lymphangiogenesis induction device is simplified, the area of ​​the skin that is injured can be increased, and lymphangiogenesis can be induced by the simple operation of inflicting minute wounds on the skin.

[0034] FIG. 1 is a schematic perspective view of a main portion of a lymphangiogenesis induction device according to a first embodiment. FIG. 2 is a schematic side view of a lymphangiogenesis induction device. FIGS. 3A and 3B are schematic perspective views of a main portion of a puncture needle having a protruding portion with a shape different from that shown in FIG. 1 as a wound inflicting portion. FIGS. 4A to 4C are enlarged views of a main portion of a protruding portion with a shape different from that shown in FIGS. 1, 3A, and 3B. FIG. 5 is a schematic cross-sectional view of the skin when the puncture needle has reached the subcutaneous tissue. FIG. 6 is a schematic perspective view of a main portion of a puncture needle having a solid rod-shaped body. FIG. 7 is a schematic perspective view of a main portion of a lymphangiogenesis induction device according to a second embodiment. FIG. 8 is a schematic perspective view of a main portion of a puncture needle having a protruding portion with a shape different from that shown in FIG. 7 as a wound inflicting portion. FIG. 9 is a schematic perspective view of a main portion of a puncture needle having a solid rod-shaped body.

[0035] 5 will be referred to as "advancement." Relative displacement of the puncture needle 12 in the direction of insertion into the subcutaneous tissue TS will be referred to as "retraction." Relative displacement of the puncture needle 12 in the direction of removal from the subcutaneous tissue TS will be referred to as "retraction."

[0036] 1 is a schematic perspective view of a main portion of a lymphatic vessel angiogenesis induction device 10 according to a first embodiment. The lymphatic vessel angiogenesis induction device 10 is a single-needle device equipped with a single puncture needle 12. That is, the lymphatic vessel angiogenesis induction device 10 does not include a hollow outer needle (see, for example, WO 2023 / 100890) that covers the outside of the puncture needle 12. Therefore, the puncture needle 12 is used without being combined with an outer needle.

[0037] 5, the skin SK of a living body includes the epidermis EP, the dermis DM, and the subcutaneous tissue TS. The puncture needle 12 is inserted through the epidermis EP and reaches, for example, the subcutaneous tissue TS.

[0038] As shown in Figure 1, the puncture needle 12 has a rod-shaped body 14. The rod-shaped body 14 has a tip portion 20, a body portion 22, and an incision portion 40. The tip portion 20 is one end portion of the rod-shaped body 14 in the axial direction (longitudinal direction). The body portion 22 extends linearly along the longitudinal direction of the rod-shaped body 14. The tip side of the body portion 22 is continuous with the base end side of the tip portion 20. The incision portion 40 is provided on the outer peripheral surface 24 of the body portion 22.

[0039] In the illustrated example, the rod-shaped body 14 is a hollow body having a lumen 26. The body portion 22 of the rod-shaped body 14 is in the shape of a round bar. Therefore, the outer peripheral surface 24 is the curved outer surface of the body portion 22.

[0040] The tip 20 of the rod-shaped body 14 has a blade surface 28 that is cut out obliquely with respect to the central axis CL of the rod-shaped body 14. The tip 20 is the portion from the cutting edge 30, which is the most distal end of the blade surface 28, to the base end 32 of the blade surface 28. Therefore, the blade surface 28 is not formed on the body 22.

[0041] The cutting edge 30 has an acute angled portion 34 that is sharp enough to penetrate from the epidermis EP (see FIG. 5) to the subcutaneous tissue TS. Specifically, as shown in FIG. 2, a blade surface axis BX along the extending direction of the blade surface 28 intersects with a parallel axis PL that passes through the cutting edge 30 and is parallel to the central axis CL at an intersection angle α. The intersection angle α is an acute angle. The intersection angle α is, for example, within a range of 10° to 50°. The acute angled portion 34 is not essential.

[0042] Here, in treatments for inducing lymphatic vessel de novo generation, the skin SK is often incised with a scalpel. It is easy to insert the puncture needle 12 into the incised skin SK. Therefore, it is not essential to form a blade surface 28 on the rod-shaped body 14. In other words, the tip of the rod-shaped body 14 does not need to be sharp enough to be able to be directly inserted into the epidermis EP.

[0043] The body 22 of the rod-shaped body 14 extends in the axial direction (longitudinal direction) along the central axis CL of the rod-shaped body 14. Since the body 22 has a round bar shape, the outer peripheral surface 24 of the body 22 is a curved surface.

[0044] The wounding portion 40 is composed of a protrusion 42 that protrudes outward (away from the central axis CL) from the outer circumferential surface 24 of the barrel 22. The protrusion 42 protrudes radially outward from the rod-shaped body 14. That is, the protrusion 42 protrudes in a direction perpendicular to the axial direction of the rod-shaped body 14. Hereinafter, the tip of the protrusion 42 in the protruding direction will be referred to as the protruding tip 44. As shown in FIG. 2 , when the distance from the outer circumferential surface 24 of the barrel 22 to the protruding tip 44 of the protrusion 42 is defined as the protruding height T, a preferred range for the protruding height T is 0.1 mm to 3.0 mm. If the protruding height T is less than 0.1 mm, it is difficult to inflict a wound H (see FIG. 5 ) in the subcutaneous tissue TS. Furthermore, if the protruding height T is greater than 3.0 mm, the puncture needle 12 may encounter relatively large resistance when displacing it relative to the subcutaneous tissue TS. A more preferable range for the protrusion height T is 0.1 mm to 2.0 mm.

[0045] The protruding tip 44 of the protrusion 42 has a corner 46. When the puncture needle 12 advances or retreats within the subcutaneous tissue TS along the central axis CL, or when the puncture needle 12 rotates within the subcutaneous tissue TS around the central axis CL, the corner 46 comes into preferential contact with the subcutaneous tissue TS. As a result of this contact, the corner 46 creates a wound H in a portion of the subcutaneous tissue TS.

[0046] 1 and 2 is a single spiral protrusion 42A that spirals. The spiral protrusion 42A can be easily formed, for example, by cutting the outer peripheral surface 24 of the intermediate molded body that will become the puncture needle 12. That is, when the body 22 has a round bar shape, it is easy to form the spiral protrusion 42A on the outer peripheral surface 24 of the body 22.

[0047] Instead of the helical protrusion 42A shown in FIGS. 1 and 2 , a plurality of conical protrusions 42B may be provided on the outer peripheral surface 24 of the barrel portion 22, as shown in FIG. 3A . Each conical protrusion 42B has a conical shape. The plurality of conical protrusions 42B are arranged spaced apart from one another. Alternatively, as shown in FIG. 3B , a plurality of triangular prism-shaped protrusions 42C may be provided on the outer peripheral surface 24 of the barrel portion 22. Each triangular prism-shaped protrusion 42C has a triangular prism shape that curves along the outer peripheral surface 24. The plurality of triangular prism-shaped protrusions 42C are arranged spaced apart from one another.

[0048] Furthermore, as shown in FIG. 4A , the protrusion 42 may be a convex portion 42D in which the surface facing the distal end 20 is formed by a vertical surface 50 perpendicular to the central axis CL, and the convex portion 42D has an inclined surface 52a that is connected to the top of the vertical surface 50 and inclined toward the outer circumferential surface 24 as it approaches the base end, an inclined surface 52b that is connected to the base end side of the inclined surface 52a and inclined toward the outer circumferential surface 24 as it approaches the base end, and an inclined surface 52c that is connected to the base end side of the inclined surface 52b and inclined toward the outer circumferential surface 24 as it approaches the base end. In this case, the inclination angles increase in the order of the inclined surface 52a, the inclined surface 52b, and the inclined surface 52c, and a corner 46 is formed between the vertical surface 50 facing the distal end 20 and the inclined surface 52a. Alternatively, the protrusion 42 may be a quadrangular prism-shaped protrusion 42E that has a quadrangular prism shape as shown in FIG. 4B . In this case, the corners 46 are formed on the edges of the protruding tip 44 of the quadrangular columnar protrusion 42E. Alternatively, the protrusion 42 may be a substantially circular flange 42F as shown in Fig. 4C. In this case, the corners 46 are formed on the edges of the protruding tip 44 of the flange 42F.

[0049] The conical protrusions 42B, triangular prism-shaped protrusions 42C, convex portions 42D, square prism-shaped protrusions 42E, or flange portions 42F can be formed on the outer peripheral surface 24 of the body portion 22 by, for example, rolling or cutting. However, the shape of the protrusions 42 is not particularly limited to the shapes shown in FIGS. 1 to 4C. For example, the protrusions 42 may have a triangular pyramid shape. When multiple protrusions 42 are provided on the outer peripheral surface 24 of the body portion 22, the multiple protrusions 42 may be arranged regularly or irregularly. The shapes of the multiple protrusions 42 may be different from each other.

[0050] The puncture needle 12 is connected to the tip of a syringe (not shown), for example, which contains, for example, a medicinal liquid.

[0051] Next, a method for inducing lymphatic vessel neoplasia using the lymphatic vessel neoplasia inducing device 10 will be described with reference to Fig. 5. Note that the term "user" hereinafter refers to a practitioner. A typical example of the user is a doctor.

[0052] In the first embodiment, the lymphangiogenesis induction device 10 is used, for example, to induce the formation of a bypass path that bypasses an obstructed lymphatic vessel. In this case, the user first identifies the obstructed lymphatic vessel in the patient's body. The obstructed vessel is identified, for example, by ICG fluorescent lymphography. Alternatively, the obstructed vessel is identified by lymphoscintigraphy, MRI, CT, ultrasound imaging, or the like. Next, the user determines in which part of the subcutaneous tissue TS a bypass path that bypasses the obstructed vessel is to be formed.

[0053] The user brings the sharp edge 34 (cutting edge 30) of the rod-shaped body 14 constituting the puncture needle 12 into contact with the epidermis EP and pushes the lymphatic vessel angiogenesis induction device 10 toward the skin SK. This causes the tip 20, including the blade surface 28, to pierce the epidermis EP. As the user further pushes the lymphatic vessel angiogenesis induction device 10, the rod-shaped body 14 passes through the dermis DM and reaches the subcutaneous tissue TS, as shown in FIG. 5 .

[0054] If the rod-shaped body 14 does not have a sharp angled portion 34, the epidermis EP is incised with a scalpel or the like. In this case, the user makes a small incision in the skin SK and then inserts the tip of the rod-shaped body 14 into the incision. When the user pushes in the lymphatic vessel angiogenesis inducing device 10, the rod-shaped body 14 advances within the subcutaneous tissue TS, as shown in FIG. 5 .

[0055] Here, a wound inflicting portion 40 (protrusion 42) is provided on the outer peripheral surface 24 of the trunk portion 22 of the rod-shaped body 14. When the puncture needle 12 advances through the subcutaneous tissue TS, the protrusion 42 comes into contact with the subcutaneous tissue TS. Based on this contact, the protrusion 42 inflicts a minute wound H in the subcutaneous tissue TS. When the protrusion 42 has a corner 46, the corner 46 comes into contact with the subcutaneous tissue TS, making it easy to inflict a wound H in the subcutaneous tissue TS. Note that part of the wound area may overlap the dermis DM.

[0056] When the wound inflicting portion 40 (the protrusions 42) is positioned in the subcutaneous tissue TS, the user may rotate the rod-shaped body 14 around the central axis CL (see FIG. 1). As the rotation occurs, the corners 46 of the protrusions 42, in particular, come into contact with the subcutaneous tissue TS. As a result, a wound H can be inflicted over a relatively wide area in the subcutaneous tissue TS. In particular, when the puncture needle 12 in the embodiment shown in FIG. 3B is rotated, it is easy to inflict a wound H in the subcutaneous tissue TS.

[0057] After stopping the advancement or rotation of the puncture needle 12, the medicinal solution in the syringe may be administered to the subcutaneous tissue TS via the lumen 26. Alternatively, a thread-like implant (not shown) may be supplied to the subcutaneous tissue TS via the lumen 26. The implant is made of a biodegradable polymer such as porous collagen fiber, and cells necessary for lymphatic vessel regeneration settle in the implant placed in the subcutaneous tissue TS.

[0058] Next, the user retracts the puncture needle 12 along the axial direction and pulls it out of the skin SK. During this pullout process, the protrusion 42 (particularly the corner 46) comes into contact with the subcutaneous tissue TS. Therefore, a wound H is also created in the subcutaneous tissue TS. When the implant is delivered to the subcutaneous tissue TS, the portion of the implant exposed from the skin SK is cut off. This leaves the implant primarily indwelling in the subcutaneous tissue TS.

[0059] During the healing process of the wound H, immune cells accumulate in the wound H due to an immune response to the wound H. The immune cells that accumulate in the wound H enhance the expression of lymphatic vessel growth factors. Therefore, the lymphangiogenesis inducing device 10 can induce lymphatic vessel neogenesis. Furthermore, when the implant is placed in the subcutaneous tissue TS, cells that induce lymphatic vessel neogenesis settle in the implant. These cells promote lymphatic vessel neogenesis.

[0060] It has been reported that lymphatic vessels are generated by sprouting from pre-existing lymphatic vessels. For example, newly generated lymphatic vessels can branch off from pre-existing lymphatic vessels and form bypass pathways that bypass obstructed sites and join the pre-existing lymphatic vessels.

[0061] In this way, in the first embodiment, lymphatic vessel neogenesis can be induced by the relatively simple operation of creating a minute wound H in the subcutaneous tissue TS.

[0062] As shown in FIG. 6, instead of the hollow rod-shaped body 14, the puncture needle 12 can also be configured using a solid rod-shaped body 15. In this case, the solid rod-shaped body 15 has greater rigidity than the hollow rod-shaped body 14. Therefore, for example, when the puncture needle 12 advances through the subcutaneous tissue TS, bending of the puncture needle 12 is suppressed. This makes it easy to inflict a wound H on the subcutaneous tissue TS using the wound inflicting unit 40. Therefore, in this case as well, lymphatic neogenesis is induced.

[0063] The tip portion 20 may be a tapered portion whose diameter decreases in a tapered manner. In this case, the tip portion 20 has a conical shape. The taper angle is set to an acute angle.

[0064] The first embodiment has the following advantages.

[0065] As shown in Figure 5, the puncture needle 12 has a rod-shaped body 14. The rod-shaped body 14 has a tip portion 20 which is one longitudinal end of the rod-shaped body 14, a body portion 22 extending along the longitudinal direction, and a wounding portion 40 provided on the outer peripheral surface 24 of the body portion 22. The wounding portion 40 has a protrusion 42 which protrudes outward from the outer peripheral surface 24 of the body portion 22. When the puncture needle 12 is displaced relative to the subcutaneous tissue TS, the protrusion 42 comes into contact with the subcutaneous tissue TS and causes a minute wound H in the subcutaneous tissue TS which can induce lymphatic neogenesis.

[0066] According to this configuration, after the puncture needle 12 is inserted into the subcutaneous tissue TS, a wound H can be created in the subcutaneous tissue TS by the wounding section 40 constituting the puncture needle 12. Therefore, there is no need for an outer needle that covers the puncture needle 12 from the outside. For this reason, the lymphatic vessel angiogenesis inducing device 10 can be configured as a single-needle device that includes the puncture needle 12 that is used without being combined with a hollow outer needle.

[0067] In a single-needle device, the number of parts of the puncture needle 12 is reduced compared to a double-needle device, and the structure of the puncture needle 12 is simpler, so that it is possible to easily mass-produce at low cost the lymphangiogenesis inducing device 10. Here, a double-needle device refers to a device having a double needle consisting of the puncture needle 12 and an outer needle that surrounds the outside of the puncture needle 12.

[0068] Furthermore, for example, when a round tubular puncture needle 12 and a round tubular outer needle are used, the diameter of the puncture needle 12 must be smaller than the inner diameter of the outer needle. As can be understood from this, when an outer needle is used, there are restrictions on the outer dimensions of the puncture needle 12. As a result, the area of ​​the wound H in the subcutaneous tissue TS becomes smaller.

[0069] In contrast, the single-needle lymphangiogenesis inducing device 10 allows for the free setting of the outer dimensions of the puncture needle 12. In other words, the area of ​​the wound H in the subcutaneous tissue TS can be made larger than when an outer needle is used.

[0070] The protrusion 42 has a corner 46 at the tip in the protruding direction.

[0071] Since the corner portion 46 easily comes into contact with the subcutaneous tissue TS, it is easy to create a wound H in the subcutaneous tissue TS.

[0072] The tip portion 20 has a sharp edge 34 that is inserted from the epidermis EP to the subcutaneous tissue TS of the living body.

[0073] The sharp angled portion 34 allows the puncture needle 12 to be easily inserted into the subcutaneous tissue TS.

[0074] In one embodiment, the rod 14 is hollow having a lumen 26 .

[0075] Therefore, for example, it is possible to administer a medicinal solution to the subcutaneous tissue TS via the lumen 26. Alternatively, it is possible to supply an implant mainly to the subcutaneous tissue TS via the lumen 26. Furthermore, with the puncture needle 12 penetrating the skin SK, it is also possible to supply an implant to the subcutaneous tissue TS via the lumen 26.

[0076] The body portion 22 has a round bar shape.

[0077] When the body 22 has a round rod shape, it is easy to rotate the puncture needle 12 within the subcutaneous tissue TS. This rotation makes it easy to create a wound H in the subcutaneous tissue TS.

[0078] In one embodiment where the body portion 22 is rod-shaped, the wounding portion 40 is a spiral-shaped protrusion 42 (spiral protrusion 42A).

[0079] In this case, the spiral protrusion 42A that serves as the wounding portion 40 can be easily provided on the curved outer peripheral surface 24 of the body 22 by, for example, cutting the outer peripheral surface 24.

[0080] In another embodiment, as shown in FIG. 6, the rod 15 is solid.

[0081] The rigidity of the puncture needle 12 having a solid rod-shaped body 15 is greater than the rigidity of the puncture needle 12 having a hollow rod-shaped body 14. Therefore, in this case, a wound H can be easily created in the subcutaneous tissue TS. This induces new lymphatic vessel formation. Furthermore, the solid rod-shaped body 15 is less likely to bend than the hollow rod-shaped body 14. This makes it easier to operate the puncture needle 12. In other words, in this case, a puncture needle 12 with excellent operability is obtained.

[0082] 3A and 3B, in another embodiment, the wounding portion 40 has a plurality of protrusions 42. The plurality of protrusions 42 are spaced apart from one another.

[0083] In this case, it is possible to increase the area of ​​the wound H applied to the subcutaneous tissue TS.

[0084] Next, a lymphatic vessel angiogenesis induction device 60 according to a second embodiment will be described with reference to Fig. 7. Note that components that are the same as or correspond to those of the lymphatic vessel angiogenesis induction device 10 according to the first embodiment are denoted by the same reference numerals, and detailed description thereof may be omitted.

[0085] 7 is a schematic perspective view of a main part of the lymphatic vessel newborn induction device 60. The lymphatic vessel newborn induction device 60 includes one puncture needle 62.

[0086] The puncture needle 62 has a rod-shaped body 64. The rod-shaped body 64 has a tip portion 70, a body portion 72, and a wounding portion 40. In the rod-shaped body 64, the tip portion 70 has two inclined surfaces that approach each other from the tip side of the body portion 72 toward the cutting edge 30. The two inclined surfaces are a first inclined surface 74 and a second inclined surface 76. The tip portion 70 has a thin-walled triangular prism shape having the first inclined surface 74, the second inclined surface 76, and two approximately triangular bottom surfaces. The two bottom surfaces of the triangular prism-shaped tip portion 70 are connected to two large flat surfaces 84a, respectively, of the four surfaces (outer peripheral surface 84) of the body portion 72. One of the two large flat surfaces 84a faces downward in FIG. 7 . The other of the two large flat surfaces 84a is the large flat surface 84a that faces upward in FIG.

[0087] The first inclined surface 74 and the second inclined surface 76 intersect at the center of the width direction perpendicular to the central axis CL (longitudinal direction). This intersection forms an acute angled portion 34 that is sharp enough to penetrate the subcutaneous tissue TS (see FIG. 5 ). The intersection of the first inclined surface 74 and the second inclined surface 76 forms an apex 78 of the acute angled portion 34. In this case, the apex 78 of the acute angled portion 34 is the cutting edge 30. The first inclined surface 74 and the second inclined surface 76 form the blade surface 28. However, as in the first embodiment, the tip of the rod-shaped body 64 does not need to be sharp enough to penetrate directly into the epidermis EP.

[0088] In the illustrated example, the apex 78 of the acute angle portion 34 is located at the center of the tip portion 70 in the width direction perpendicular to the longitudinal direction. However, the position of the apex 78 is not limited to the center of the width direction. For example, the apex 78 may be located closer to one end of the width direction than the center of the width direction.

[0089] The tip portion 70 may be a tapered portion that tapers toward the tip end. In this case, the tip portion 70 has a polygonal pyramid shape (for example, a quadrangular pyramid shape). The taper angle is set to an acute angle.

[0090] In the illustrated example, the rod-shaped body 64 is a hollow body having a lumen 26. An opening 80 of the lumen 26 is formed, for example, in the first inclined surface 74. That is, in the distal end portion 70, the opening 80 of the lumen 26 is provided at a position offset from the apex 78 (cutting edge 30) of the acute angle portion 34. The opening 80 of the lumen 26 may also be formed in the second inclined surface 76. By providing the opening 80 of the lumen 26 at a position offset from the cutting edge 30 in this manner, it is possible to prevent the cutting edge 30 from becoming chipped.

[0091] The body 72 has a flat portion 82. The flat portion 82 has four surfaces that constitute the outer peripheral surface 84. Two of the four surfaces are large flat surfaces 84a with large areas, and two of the four surfaces are small flat surfaces 84b with small areas. The wounding portion 40 is provided on the two large flat surfaces 84a. The wounding portion 40 may be provided on one of the two large flat surfaces 84a. If the body 72 has a sufficiently large thickness in the vertical direction, the wounding portion 40 may be provided on all four surfaces that constitute the outer peripheral surface 84 (the two large flat surfaces 84a and the two small flat surfaces 84b). In the illustrated example, the flat portion 82 has four flat surfaces, but it is sufficient that the flat portion 82 has at least one flat surface. The same applies to other embodiments, such as the embodiments shown in Figures 8 and 9.

[0092] The wounding portion 40 is a protrusion 42 that protrudes outward from the large flat surface 84a of the flat portion 82. The preferred range of the protrusion height T of the protrusion 42 is 0.1 mm to 3.0 mm, as described above, and a more preferred range is 0.1 mm to 2.0 mm.

[0093] The puncture needle 62 having such a shape can be produced, for example, by crushing a square tube by press molding.

[0094] In the illustrated example, a conical protrusion 42B having a conical shape is provided. Alternatively, as shown in FIG. 8, a plurality of triangular prism-shaped protrusions 42C may be provided on the outer peripheral surface 84 of the flat portion 82. Alternatively, a plurality of triangular pyramidal protrusions may be provided on the outer peripheral surface 84 of the flat portion 82. Furthermore, the protrusion 42 may be a convex portion 42D shown in FIG. 4A. Alternatively, the protrusion 42 may be a quadrangular prism-shaped protrusion 42E shown in FIG. 4B.

[0095] The outer peripheral surface 84 of the flat portion 82 is a flat surface. When the protrusions 42 are provided on a flat surface, the work of providing the protrusions 42 by rolling or cutting is easier than when the protrusions 42 are provided on the outer peripheral surface (curved outer peripheral surface 24) of the rod-shaped body 14 having a round bar shape.

[0096] The puncture needle 62 is connected to the tip of a syringe (not shown), for example, which contains, for example, a medicinal liquid.

[0097] When inducing lymphatic vessel neogenesis using lymphatic vessel neogenesis induction device 60 equipped with puncture needles 62, the user operates the device in the same manner as lymphatic vessel neogenesis induction device 10. When protrusions 42 create wounds H (see FIG. 5 ) in the subcutaneous tissue TS, for example, neogenesis of a bypass path that bypasses an obstructed lymphatic vessel is induced.

[0098] In the second embodiment, the puncture needle 62 can also be configured using a solid rod-shaped body 65, as shown in Fig. 9, instead of the hollow rod-shaped body 64. Since the rigidity of the solid rod-shaped body 65 is greater than the rigidity of the hollow rod-shaped body 64, bending of the puncture needle 62 is suppressed, making it easier for the wound inflicting section 40 to inflict a wound H on the subcutaneous tissue TS, and promoting the generation of new lymphatic vessels.

[0099] The second embodiment has the same effects as the first embodiment, as well as the following effects.

[0100] As shown in FIGS. 7 to 9, the rod-shaped body 64 has a flat portion 82 on the body portion 72, and the wounding portion 40 is provided on the surface (outer peripheral surface 84) of the flat portion 82.

[0101] It is easier to perform rolling or cutting on the flat portion 82 (flat surface) than to perform rolling or cutting on the arc-shaped curved outer peripheral surface 24. Therefore, in the second embodiment, it is easy to provide the protrusions 42 as the wounding portions 40 on the outer peripheral surface 84 of the body portion 72 (flat portion 82).

[0102] In one embodiment, the rod 64 is hollow and has a lumen 26. An opening 80 of the lumen 26 is located at a position offset from the apex 78 of the sharp angle 34.

[0103] By providing the opening 80 of the lumen 26 at such a position, it is possible to administer a medicinal solution to the subcutaneous tissue TS via the lumen 26 while preventing the apex 78 from becoming defective. Alternatively, it is possible to supply an implant to the subcutaneous tissue TS via the lumen 26.

[0104] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention.

Claims

1. A single-needle lymphatic vessel neogenesis induction device comprising a puncture needle that is used without being combined with a hollow outer needle, wherein the puncture needle has a rod-shaped body, the rod-shaped body having a tip portion which is one longitudinal end of the rod-shaped body, a body portion extending along the longitudinal direction, and a wound-inflicting portion provided on the outer peripheral surface of the body portion, the wound-inflicting portion having a protrusion protruding outward from the outer peripheral surface, and when the puncture needle is displaced relative to the skin of a living body, the protrusion comes into contact with the skin to inflict minute wounds in the skin that can induce lymphatic vessel neogenesis.

2. A lymphangiogenesis induction device according to claim 1, wherein the protrusion has a corner at the tip in the protruding direction.

3. A lymphangiogenesis induction device according to claim 1, wherein the rod-shaped body is a hollow body having a lumen.

4. The lymphangiogenesis induction device according to claim 1, wherein the body portion is rod-shaped.

5. The lymphangiogenesis induction device according to claim 4, wherein the wounding portion is a spiral-shaped protrusion.

6. A lymphangiogenesis induction device according to claim 1, wherein the rod-shaped body has a flat portion on the trunk, and the wound-inflicting portion is provided on the surface of the flat portion.

7. The lymphangiogenesis induction device according to claim 1, wherein the rod-shaped body is a solid body.

8. A lymphangiogenesis induction device according to claim 1, wherein the wounding section has a plurality of the protrusions, the plurality of protrusions being spaced apart from one another.

9. A lymphangiogenesis induction device according to any one of claims 1 to 8, wherein the tip has a sharp edge that is inserted through the epidermis of the living body.

10. A lymphangiogenesis induction device according to claim 9, wherein the rod-shaped body is a hollow body having a lumen, and the opening of the lumen is provided at a position offset from the apex of the acute angle portion.

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