Lymphangiogenesis induction device

Abstract

This lymphangiogenesis induction device (10) is a single-needle device comprising a puncture needle (12). A rod-like body (14) constituting the puncture needle (12) has a wound-imparting section (40) provided on the outer peripheral surface (24) of a trunk section (22). The wound-imparting section (40) has a recess (42) and corners (49). When the puncture needle (12) is displaced relative to the skin (SK), the corners (49) contact the skin (SK). The corners (49) impart a fine wound (H) to the skin (SK) as result of the contact. 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. Therefore, even if treatment is performed using lymphaticovenous anastomosis, sufficient results may not be obtained. 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 a 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) An 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, and the rod-shaped body 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 recess that is recessed inward from the outer peripheral surface and has an inner surface that intersects with the outer peripheral surface, and a corner formed between the inner surface and the outer peripheral surface, and when the puncture needle is displaced relative to the skin of a living body, the corner comes into contact with the skin to inflict a minute wound 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 induction device described in the above item (1), the rod-shaped body may be a hollow body having a lumen.

[0016] For example, a medicinal solution can be administered to the subcutaneous tissue through the lumen, or an implant can be supplied to the subcutaneous tissue through the lumen, where the implant is made of a material capable of hosting cells that induce lymphatic vessel neogenesis.

[0017] (3) In the lymphangiogenesis inducing device according to the above item (2), the recess may have a bottom surface, and the bottom surface may block communication between the recess and the lumen.

[0018] The subcutaneous tissue that has been injured by the injury unit is prevented from entering the lumen through the recess, which prevents the lumen from being blocked by the subcutaneous tissue, allowing the medicinal solution, implant, etc. to easily pass through the lumen.

[0019] (4) In the lymphangiogenesis inducing device according to the above item (1), the rod-shaped body may be a solid body.

[0020] The high rigidity of the puncture needle allows for easy wounding of the subcutaneous tissue, which promotes lymphatic neogenesis.

[0021] (5) In the lymphangiogenesis inducing device according to any one of the above items (1) to (4), the body portion may be in the shape of a round rod.

[0022] The round rod-shaped body allows the puncture needle to be easily rotated within the subcutaneous tissue, making it easy to inflict a wound on the subcutaneous tissue.

[0023] (6) In the lymphangiogenesis induction device according to the above item (5), the recess may be a groove having a spiral, annular, or linear shape.

[0024] (7) In the lymphangiogenesis induction device according to item (5), the recess may be a blind hole or a through-hole. Here, the opening of the blind hole or the through-hole may have a polygonal or circular shape. A blind hole or a through-hole having a polygonal opening is called a square hole or a rectangular hole, respectively. A blind hole or a through-hole having a circular opening is called a round hole or a circular hole, respectively.

[0025] In either case, a recess (groove or blind hole) can be easily formed in the outer peripheral surface of the arc-shaped curved body portion by, for example, cutting the body portion.

[0026] (8) In the lymphangiogenesis inducing device described in any one of items (1) to (4) above, 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.

[0027] The flat portion can be easily subjected to cutting or other processes, and therefore it is easy to provide the recess that constitutes the wounding portion on the outer peripheral surface of the body portion (flat portion).

[0028] (9) In the lymphangiogenesis induction device according to the above item (8), the recess may be a linear groove, a blind hole, or a through-hole. As in the above item (7), if the recess is a blind hole, the blind hole may be a square hole or a round hole. If the recess is a through-hole, the through-hole may be a square hole or a round hole.

[0029] In either case, the recesses can be easily formed on the outer peripheral surface of the flat portion that constitutes the body by, for example, cutting or hole-forming the flat portion.

[0030] (10) In the lymphatic vessel angiogenesis induction device described in any one of items (1) to (9) above, the corner portion may have a first corner portion located at the tip end side when the puncture needle is inserted into the skin, and a second corner portion located at the base end side when the puncture needle is inserted into the skin, and the first angle, which is the angle of intersection between the outer surface and the first corner portion, may be 90° or less, and the second angle, which is the angle of intersection between the outer surface and the second corner portion, may be 90° or more.

[0031] When the puncture needle is inserted into the skin (the puncture needle moves forward), the second corner comes into contact with the skin preferentially. If the second angle is 90° or more, the resistance that the puncture needle receives from the skin is small. On the other hand, when the puncture needle is removed from the skin (the puncture needle moves backward), the first corner comes into contact with the skin preferentially. If the first angle is 90° or less, it is easy to inflict a wound on the skin.

[0032] (11) In the lymphangiogenesis inducing device according to any one of the above items (1) to (10), the tip may have a sharp edge that is inserted through the epidermis of the skin.

[0033] The sharp corner allows the puncture needle to easily penetrate the skin.

[0034] (12) In the lymphatic vessel angiogenesis induction device described in item (11) above, the rod-shaped body may be a hollow body having a lumen, and the opening of the lumen may be provided at the tip end at a position offset from the apex of the acute angled portion of the rod-shaped body.

[0035] This prevents the tip from being missing. Furthermore, it is possible to administer a drug solution to the skin (mainly the subcutaneous tissue) through the lumen. Alternatively, it is possible to supply an implant to the skin (mainly the subcutaneous tissue) through the lumen.

[0036] 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.

[0037] 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 the lymphangiogenesis induction device. FIG. 3A is a schematic perspective view of a main portion of a puncture needle having a recessed portion shaped differently from the recessed portion in FIG. 1. FIG. 3B is a schematic side view of the puncture needle shown in FIG. 3A. FIG. 4 is a schematic perspective view of a main portion of a puncture needle having a recessed portion shaped differently from the recessed portion in FIGS. 1, 3A, 3B, and 4. FIG. 5 is a schematic perspective view of a main portion of a puncture needle having a recessed portion shaped differently from the recessed portion in FIGS. 1, 3A, 3B, 4, and 5. FIG. 7 is a schematic cross-sectional view of skin when the puncture needle has reached subcutaneous tissue. FIG. 8 is a schematic perspective view of a puncture needle having a solid rod-shaped body. FIG. 9 is a schematic perspective view of a main portion of a lymphangiogenesis induction device according to a second embodiment. Fig. 10 is a schematic perspective view of a main part of a puncture needle having a recess with a different shape from the recess in Fig. 9. Fig. 11 is a schematic perspective view of a main part of a puncture needle having a recess with a different shape from the recess in Fig. 9 and Fig. 10. Fig. 12 is a schematic perspective view of a main part of a puncture needle having a solid rod-shaped body.

[0038] 7 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."

[0039] 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 one 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.

[0040] 7, 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.

[0041] 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.

[0042] In the illustrated example, the rod-shaped body 14 is a hollow body having a lumen 26. The body 22 of the rod-shaped body 14 is in the shape of a round bar. Therefore, the outer circumferential surface 24 is the outer circumferential surface of the body 22.

[0043] 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.

[0044] The cutting edge 30 has an acute angle 34 that is sharp enough to penetrate from the epidermis EP (see FIG. 7) 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 θ. The intersection angle θ is an acute angle. The intersection angle θ is, for example, within a range of 10° to 50°.

[0045] 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. In other words, the acute angle portion 34 is not essential.

[0046] 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.

[0047] The rod-shaped body 14 has an injury inflicting portion 40 provided on the trunk portion 22. The injury inflicting portion 40 includes a recess 42 recessed from the outer peripheral surface 24 of the trunk portion 22 toward the inside of the trunk portion 22 (toward the central axis CL). The recess 42 recesses inward in the diameter direction of the rod-shaped body 14. As shown in the partially enlarged view of FIG. 2 , the recess 42 has an inner surface 43 and a bottom surface 48. The inner surface 43 has a first inner surface 44 facing the base end of the puncture needle 12 and a second inner surface 46 facing the tip end of the puncture needle 12 and facing the first inner surface 44.

[0048] The bottom surface 48 is located between the lumen 26 and the recessed portion 42. In other words, the bottom surface 48 blocks communication between the lumen 26 and the recessed portion 42. As can be understood from this, the lumen 26 and the recessed portion 42 are separate spaces that are independent of each other.

[0049] When the distance from the bottom surface 48 of the recess 42 to the outer peripheral surface 24 of the body 22 is defined as the depth DP, a preferred range for the depth DP is 0.1 mm to 5.0 mm. If the depth DP is less than 0.1 mm, it is not easy to create a wound H (see FIG. 7) in the subcutaneous tissue TS. Furthermore, when the rod-shaped body 14 has a lumen 26, the difference between the outer diameter and the inner diameter (wall thickness) of the rod-shaped body 14 is not very large, so it is not easy to form a recess 42 with a depth DP greater than 2.0 mm.

[0050] The wounding portion 40 further includes a corner portion 49. The corner portion 49 has a first corner portion 50 and a second corner portion 52. Specifically, as shown in FIG. 2 , the first inner surface 44 intersects with the outer peripheral surface 24 at a first angle α. This intersection forms the first corner portion 50 between the outer peripheral surface 24 and the first inner surface 44. In the illustrated example, the first angle α is an acute angle less than 90°, for example, 45° to 89°. However, the first angle α may also be 90°. Furthermore, the first angle α may also be an obtuse angle. Meanwhile, the second inner surface 46 intersects with the outer peripheral surface 24 at a second angle β. This intersection forms the second corner portion 52 between the outer peripheral surface 24 and the second inner surface 46. In the illustrated example, the second angle β is an acute angle greater than 90°, for example, 91° to 135°. However, the second angle β may also be 90°. Furthermore, the second angle β may also be an acute angle.

[0051] 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 first corner 50 and the second corner 52 come into preferential contact with the subcutaneous tissue TS. As a result of this contact, a wound H is created in a portion of the subcutaneous tissue TS.

[0052] In the illustrated example, the recess 42 is a single spiral groove 42A that spirals. The spiral groove 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 groove 42A on the outer peripheral surface 24 of the body 22.

[0053] Instead of the spiral groove 42A shown in Fig. 1, one or more annular grooves 42B may be provided on the outer peripheral surface 24 of the barrel portion 22, as shown in Fig. 3A and 3B. As shown in Fig. 4, one or more linear grooves 42C may be provided on the outer peripheral surface 24 of the barrel portion 22. Here, the linear grooves 42C are grooves that intersect perpendicularly or at an angle with the central axis CL and extend linearly. The annular grooves 42B and the linear grooves 42C can also be easily formed by cutting the outer peripheral surface 24 of the intermediate molded body that will become the puncture needle 12.

[0054] 5, one or more blind holes 42D may be provided in the outer peripheral surface 24 of the body 22. The blind holes 42D can be easily formed by performing a hole forming process on the outer peripheral surface 24 of the intermediate molded body that will become the puncture needle 12. The annular groove 42B, the linear groove 42C, and the blind holes 42D also have a first inner surface 44, a second inner surface 46, and a bottom surface 48.

[0055] In the illustrated example, the opening of the blind hole 42D is rectangular, but the opening of the blind hole 42D may be a polygonal shape other than rectangular. Alternatively, as shown in Fig. 6, a blind hole 42H having a circular opening may be provided. The blind holes 42D and 42H may, for example, become narrower as they move away from the outer peripheral surface 24. It is not essential that the blind hole 42D extend in a direction perpendicular to the central axis CL, and it may extend in a direction inclined with respect to the central axis CL.

[0056] It is also possible to form a through-hole in body portion 22 that communicates with lumen 26, and to use this through-hole as recess 42. The shape of the opening of the through-hole may be polygonal, similar to blind hole 42D, or circular, similar to blind hole 42H.

[0057] The puncture needle 12 is connected to the tip of a syringe (not shown), for example, which contains, for example, a medicinal liquid.

[0058] Next, a method for inducing lymphatic vessel neoplasia using the lymphatic vessel neoplasia inducing device 10 will be described with reference to Fig. 7. Note that the term "user" hereinafter refers to a practitioner. A typical example of the user is a doctor.

[0059] 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.

[0060] 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. 7 .

[0061] 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. 7 .

[0062] Here, a recess 42 is provided on the outer peripheral surface 24 of the trunk portion 22 of the rod-shaped body 14. Because the subcutaneous tissue TS is flexible, as the puncture needle 12 advances through the subcutaneous tissue TS, a portion of the subcutaneous tissue TS flows into the recess 42. As the puncture needle 12 advances further through the subcutaneous tissue TS in this state, the second corner 52 (see FIG. 2 ) comes into preferential contact with the subcutaneous tissue TS. This contact creates a minute wound H in the subcutaneous tissue TS. Note that a portion of the wound area may overlap the dermis DM.

[0063] When the second angle β is 90° or greater (particularly an obtuse angle), as the puncture needle 12 advances, the subcutaneous tissue TS that has flowed into the recess 42 easily flows out of the recess 42 via the second corner 52. This reduces the resistance that the puncture needle 12 receives from the subcutaneous tissue TS.

[0064] When the wound inflicting unit 40 is positioned in the subcutaneous tissue TS, the user may rotate the rod-shaped body 14 about the central axis line CL (see FIG. 1 ). As the puncture needle 12 rotates, it can inflict wounds H over a relatively wide area of ​​the subcutaneous tissue TS.

[0065] 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 filamentous 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. Here, the recess 42 and the lumen 26 are formed as separate spaces by the bottom surface 48. This prevents the lumen 26 from being blocked by a portion of the subcutaneous tissue TS that has flowed into the recess 42. This allows the medicinal solution or the implant to easily pass through the lumen 26.

[0066] Next, the user retracts the puncture needle 12 along the axial direction and pulls the puncture needle 12 out of the skin SK. During this pulling (removal), the first corner 50 comes into preferential contact with the subcutaneous tissue TS. Based on this contact, the first corner 50 creates a minute wound H in the subcutaneous tissue TS. When the first angle α is 90° or less (particularly an acute angle), the first corner 50 can easily create the wound H 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 indwelled in the subcutaneous tissue TS.

[0067] 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.

[0068] It has been reported that lymphatic vessels are generated by sprouting from pre-existing lymphatic vessels. Therefore, the newly generated lymphatic vessels can branch off from pre-existing lymphatic vessels, bypassing the obstructed area and forming a bypass pathway that joins the pre-existing lymphatic vessel.

[0069] 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.

[0070] As shown in FIG. 8, 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 vessel neogenesis is induced.

[0071] In this case, even if the depth DP of the recess 42 is increased, the recess 42 does not communicate with the lumen 26. The recess 42 may be a through-hole.

[0072] 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.

[0073] The first embodiment has the following advantages.

[0074] As shown in FIG. 7 , 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 recessed portion 42 and a corner portion 49. The recessed portion 42 is a space recessed inward from the outer peripheral surface 24 and has an inner surface 43 that intersects with the outer peripheral surface 24. The corner portion 49 is formed between the outer peripheral surface 24 and the inner surface 43. When the puncture needle 12 is displaced relative to the skin SK (e.g., subcutaneous tissue TS), the corner portion 49 comes into contact with the skin SK, causing a minute wound H in the skin SK (mainly the subcutaneous tissue TS) that can induce lymphatic neogenesis.

[0075] According to this configuration, after the puncture needle 12 is inserted into the skin SK, a wound H can be created in the skin SK (mainly 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.

[0076] 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.

[0077] 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.

[0078] In contrast, the single-needle lymphangiogenesis inducing device 10 allows for 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.

[0079] In one embodiment, the rod 14 is hollow having a lumen 26 .

[0080] 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.

[0081] In this embodiment, the recess 42 has a bottom surface 48. The bottom surface 48 blocks communication between the recess 42 and the lumen 26.

[0082] Therefore, the subcutaneous tissue TS, to which the wound H has been caused by the wound causing unit 40, is prevented from entering the lumen 26 through the recess 42. This prevents the lumen 26 from being blocked by the subcutaneous tissue TS. This allows the medicinal solution, implant, etc. to easily pass through the lumen 26.

[0083] As shown in FIG. 8, in one embodiment, the rod 15 is solid.

[0084] 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 vessels. 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.

[0085] As shown in Figures 1 to 8, in one embodiment, the body 22 is in the shape of a round bar.

[0086] 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.

[0087] As shown in FIGS. 1 to 4, in one embodiment, the recess 42 is a spiral groove (spiral groove 42A), an annular groove (annular groove 42B), or a linear groove (linear groove 42C).

[0088] 5 and 6, in one aspect, the recess 42 is a blind hole 42D or a blind hole 42H. The recess 42 may be a through hole.

[0089] In either case, the recesses 42 (grooves) can be easily formed in the outer peripheral surface 24 of the body portion 22, whose outer peripheral surface 24 is curved in an arc shape, by, for example, performing cutting work.

[0090] 2 , the corner 49 has a first corner 50 that is located on the distal side when the puncture needle 12 is inserted into the subcutaneous tissue TS, and a second corner 52 that is located on the proximal side when the puncture needle 12 is inserted into the subcutaneous tissue TS. A first angle α, which is the intersection angle between the outer peripheral surface 24 and the first corner 50, is 90° or less. Furthermore, a second angle β, which is the intersection angle between the outer peripheral surface 24 and the second corner 52, is 90° or more.

[0091] When the puncture needle 12 is inserted into the subcutaneous tissue TS (the puncture needle 12 moves forward), the second corner 52 comes into preferential contact with the subcutaneous tissue TS. When the second angle β is 90° or greater, preferably an obtuse angle, the resistance that the puncture needle 12 receives from the subcutaneous tissue TS is small. Therefore, the puncture needle 12 moves forward easily. On the other hand, when the puncture needle 12 is removed from the subcutaneous tissue TS (the puncture needle 12 moves backward), the first corner 50 comes into preferential contact with the subcutaneous tissue TS. When the first angle α is 90° or less, preferably an acute angle, the wound H can be easily created in the subcutaneous tissue TS.

[0092] The tip portion 20 has a sharp angled portion 34 that penetrates the epidermis EP.

[0093] The sharp angled portion 34 allows the puncture needle 12 to be easily inserted into the skin SK.

[0094] Next, a lymphatic vessel angiogenesis induction device 60 according to a second embodiment will be described with reference to Fig. 9. 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.

[0095] 9 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.

[0096] 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. 9 . The other of the two large flat surfaces 84a is the large flat surface 84a that faces upward in FIG.

[0097] 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. 7 ). 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 a cutting edge. 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.

[0098] 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.

[0099] 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.

[0100] 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. A wounding portion 40 is provided on one of the two large flat surfaces 84a. The wounding portion 40 may be provided on both 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 10 to 12.

[0101] The wounding portion 40 includes a recess 42 and a corner portion 49. The recess 42 is a space recessed inward from the large flat surface 84a of the flat portion 82, and has a first inner surface 44, a second inner surface 46, and a bottom surface 48. The preferred range of the depth DP of the recess 42 is 0.1 mm to 5.0 mm, as described above.

[0102] The corner 49 has a first corner 50 and a second corner 52. The first angle α, which is the angle of intersection between the large flat surface 84a and the first inner surface 44, is preferably 90° or less, as described above, and is more preferably an acute angle, but may be an obtuse angle. The second angle β, which is the angle of intersection between the large flat surface 84a and the second inner surface 46, is preferably 90° or more, as described above, and is more preferably an obtuse angle, but may be an acute angle.

[0103] The puncture needle 62 having such a shape can be produced, for example, by crushing a square tube by press molding.

[0104] In the illustrated example, the recess 42 is a linear groove 42E that opens on the large flat surface 84a and has open ends at both ends in the width direction of the flat portion 82. The linear groove 42E extends along the width direction perpendicular to the central axis CL, but may extend in a direction inclined relative to the central axis CL. The linear groove 42E may be formed on both sides of the flat portion 82. It is not necessary for the depth direction of the linear groove 42E to coincide with the thickness direction of the flat portion 82 (the direction perpendicular to the central axis CL and the width direction). That is, the depth direction of the linear groove 42E may be inclined relative to the thickness direction of the flat portion 82. In this case, it is preferable that the bottom surface 48 of the linear groove 42E be located closer to the tip than the opening of the linear groove 42E in the large flat surface 84a. This is because the first angle α is an acute angle and the second angle β is an obtuse angle.

[0105] As shown in FIG. 10 , instead of the linear grooves 42E, linear grooves 42F may be formed as recesses 42. The linear grooves 42F open on the large flat surface 84a and have closed ends at both ends in the width direction of the flat portion 82. The linear grooves 42F extend along the width direction perpendicular to the central axis CL, but may also extend in a direction inclined with respect to the central axis CL. The linear grooves 42F may be formed on both sides of the flat portion 82. Instead of the linear grooves 42F, slits may be formed in the flat portion 82. As described above, the depth direction of the linear grooves 42F or the slits may be inclined with respect to the thickness direction of the flat portion 82.

[0106] Furthermore, as shown in FIG. 11 , a blind hole 42G may be used as a recess 42. In the illustrated example, the opening of the blind hole 42G is rectangular, but the opening of the blind hole 42G may be a polygonal shape other than a rectangle. Alternatively, as in FIG. 6 , the opening of the blind hole 42G may be circular. The blind hole 42G may be formed on both sides of the flat portion 82. A through hole may be formed instead of the blind hole 42G. As described above, the depth direction of the blind hole 42G or the slit may be inclined with respect to the thickness direction of the flat portion 82.

[0107] The recesses 42 may be a plurality of linear grooves 42E, a plurality of linear grooves 42F, or a plurality of bottomed holes 42G.

[0108] The outer peripheral surface 84 of the flat portion 82 is a flat surface. The linear grooves 42E, 42F, or blind holes 42G can be easily formed by rolling or cutting the flat surface. That is, when the recesses 42 have such shapes, the recesses 42 can be easily formed in the flat portion 82 of the rod-shaped body 64.

[0109] The puncture needle 62 is connected to the tip of a syringe (not shown), for example, which contains, for example, a medicinal liquid.

[0110] When inducing lymphatic vessel neogenesis using the lymphatic vessel neogenesis induction device 60 including the puncture needle 62, the user operates the device in the same manner as the lymphatic vessel neogenesis induction device 10. When the puncture needle 62 is relatively displaced within the subcutaneous tissue TS, a part of the subcutaneous tissue TS comes into contact with the second corner portion 52 or the first corner portion 50. This creates a wound H (see FIG. 7 ) in the subcutaneous tissue TS, which, for example, induces the creation of a bypass path that bypasses the obstructed lymphatic vessel site.

[0111] In the second embodiment, the puncture needle 62 may also be configured using a solid rod-shaped body 65 instead of the hollow rod-shaped body 64, as shown in FIG. 12 . Because the rigidity of the solid rod-shaped body 65 is greater than that of the hollow rod-shaped body 64, bending of the puncture needle 62 is suppressed, making it easier for the wounding unit 40 to inflict a wound H on the subcutaneous tissue TS and promoting lymphatic neogenesis. While FIG. 12 illustrates a linear groove 42E with open ends at both ends in the width direction as the recess 42, the recess 42 may be a linear groove 42F shown in FIG. 10 or a blind hole 42G shown in FIG. 11 . Furthermore, when a rod-shaped body 65 is used, the linear groove 42F or blind hole 42G may be replaced with a slit or a through-hole as the recess 42.

[0112] The second embodiment has the same effects as the first embodiment, as well as the following effects.

[0113] As shown in FIGS. 9 to 12, the rod-shaped body 64 has a flat portion 82 on the body portion 72 , and the wound-inflicting portion 40 is provided on the surface of the flat portion 82 .

[0114] 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 wounding portion 40 on the outer peripheral surface 84 of the body portion 72 (flat portion 82).

[0115] In one aspect, the recess 42 is a linear groove (linear groove 42E and linear groove 42F) or a blind hole 42G. The recess 42 may be a through hole.

[0116] In either case, the recess 42 can be easily provided on the outer peripheral surface 84 of the flat portion 82 that constitutes the body portion 72 by, for example, cutting or hole forming.

[0117] In one aspect, the apex 78 of the acute angled portion 34 of the rod-shaped body 64 is located at the center of the outer circumferential surface 84 in the width direction perpendicular to the longitudinal direction. The rod-shaped body 64 is a hollow body having a lumen 26, and an opening 80 of the lumen 26 is provided in the distal end portion 20 at a position offset from the apex 78.

[0118] 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.

[0119] The communication between the recess 42 and the lumen 26 is blocked by a bottom surface 48 of the recess 42 .

[0120] The subcutaneous tissue TS, which has been wound H by the wounding unit 40, is prevented from entering the lumen 26 through the recess 42. This prevents the lumen 26 from being blocked by the subcutaneous tissue TS. This allows the medicinal solution, implant, or the like to easily pass through the lumen 26.

[0121] 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 recess that is recessed inward from the outer peripheral surface and has an inner surface that intersects with the outer peripheral surface, and a corner formed between the inner surface and the outer peripheral surface, wherein when the puncture needle is displaced relative to the skin of a living body, the corner comes into contact with the skin to inflict fine wounds in the skin that can induce lymphatic vessel neogenesis.

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

3. A lymphangiogenesis induction device according to claim 2, wherein the recess has a bottom surface, and the bottom surface blocks communication between the recess and the lumen.

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

5. The lymphangiogenesis induction device according to claim 1, wherein the body portion is in the shape of a round bar.

6. The lymphangiogenesis induction device according to claim 5, wherein the recess is a groove having a spiral shape, an annular shape or a linear shape.

7. The lymphangiogenesis induction device according to claim 5, wherein the recess is a bottomed hole or a through hole.

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

9. The lymphangiogenesis induction device according to claim 8, wherein the recess is a linear groove, a blind hole or a through hole.

10. A lymphatic vessel angiogenesis induction device according to any one of claims 1 to 9, wherein the corners have a first corner located at the tip end when the puncture needle is inserted into the skin, and a second corner located at the base end when the puncture needle is inserted into the skin, and a first angle which is the intersection angle between the outer circumferential surface and the first corner is 90° or less, and a second angle which is the intersection angle between the outer circumferential surface and the second corner is 90° or more.

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

12. A lymphangiogenesis induction device as described in claim 11, wherein the rod-shaped body is a hollow body having a lumen, and the opening of the lumen is provided at the tip end at a position offset from the apex of the acute angle portion of the rod-shaped body.

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