JP6392162B2 - Injection needle device and injection instrument set - Google Patents

Description

  The present invention relates to an injection needle device and an injection instrument set.

  In recent years, regenerative medicine in which cells obtained by inducing differentiation of stem cells such as iPS cells or aggregates thereof are transplanted into affected tissues has attracted attention. In addition, regeneration of tissues or organs by gene therapy, which is performed by injecting various drugs and / or virus vectors into the affected tissue of a patient, has attracted attention. In such regenerative medicine, conventionally, a syringe having a single injection needle having a single opening at the tip is used. In such a conventional syringe, for example, when cells are transplanted, since the cells are delivered from a single opening of a single injection needle, the number of cells to be transplanted by one insertion is small, and The range of tissue that can be implanted is also limited to the vicinity of the tip of the needle. This is less efficient in regenerative medicine where a sufficient number of cells need to be transplanted extensively. On the other hand, although there exists an injection device which has a plurality of needles (patent documents 1 to 3), these needles have a sharp edge for insertion, and the sharp edge of the needle is Since it damages tissue, it is insufficient from the viewpoint of minimally invasiveness. Further, the sharp edge of the needle may damage a blood vessel passing through the tissue, and the needle may penetrate the tissue depending on the insertion length of the needle. In addition, although it is desired that the cells are transplanted uniformly within a certain range, it may be difficult to appropriately position the needle at regular intervals only by the manual operation of the surgeon.

Special table 2013-514114 Special table 2013-544600 JP 2014-036846 A

  Development of an injection needle device which is excellent in minimal invasiveness and excellent in efficiency is desired.

  According to one embodiment of the present invention, at least one implantable needle comprising a closed tip and a body including a lumen and a side opening communicating with the lumen, and supporting at least one implantable needle A support block, wherein the support block includes an inclined surface that is inclined with respect to a side surface of the main body portion of the at least one implant needle, and the at least one implant needle extends from the inclined surface. An implantable needle device is provided that protrudes and extends. According to this configuration, the transplant needle includes a closed tip portion and a main body portion including a lumen and a side opening communicating with the lumen. Therefore, a needle having a single opening at a conventional tip portion is provided. In comparison, the shape of the opening can be set relatively freely according to the size of the transplanted substance such as cells. Further, by forming a plurality of side openings of the needle, a transplant substance such as a cell can be delivered over a wide range in the tissue. The support block that supports the at least one transplantation needle includes an inclined surface that is inclined with respect to the side surface of the main body portion of the at least one transplantation needle, and the at least one implantation needle protrudes from the inclined surface and extends. Therefore, by inserting the transplantation needle until the inclined surface comes into contact with the tissue to be transplanted, the transplantation needle can be placed in a desired manner so as to obtain a sufficient insertion length without fear of penetrating the tissue. Easy to insert at an angle. Further, since the insertion is stopped when the inclined surface comes into contact with the tissue, the doctor can easily confirm by touch that the desired insertion length has been obtained. Further, by bringing the inclined surface into close contact with the tissue to be transplanted, the position of the transplant needle device can be stabilized while the transplant substance is delivered.

  According to an embodiment of the present invention, the at least one implantation needle is composed of six linear implantation needles arranged at a position forming a substantially pentagonal apex on the inclined surface and at the center of the regular pentagon. Has been. According to this configuration, the transplant needle device can be transplanted efficiently within a desired range simply by moving straight at a predetermined pitch.

  According to one embodiment of the present invention, at least one implantable needle comprising a closed tip and a body including a lumen and a side opening communicating with the lumen, and supporting at least one implantable needle And a support block, wherein the at least one implantation needle is an arcuate needle device. According to this configuration, the transplant needle includes a closed tip portion and a main body portion including a lumen and a side opening communicating with the lumen. Therefore, a needle having a single opening at a conventional tip portion is provided. In comparison, the shape of the opening can be set relatively freely according to the size of the transplanted substance such as cells. Further, by forming a plurality of side openings of the needle, a transplant substance such as a cell can be delivered over a wide range in the tissue. In addition, since the transplant needle is an arc-shaped needle, it is possible to insert the transplant needle in an arc shape so that there is no possibility of penetrating the tissue and the transplant needle has a desired length so as to obtain a sufficient insertion length. Easy to insert at an angle.

  According to an embodiment of the present invention, the at least one implantation needle is arranged in a line on the distal end surface of the support block. With this configuration, the arc-shaped needle can be inserted into a range that avoids a portion that is not desired to be inserted, such as a blood vessel in a tissue.

  According to an embodiment of the present invention, the support block of the transplant needle device includes an inclined surface that is inclined with respect to the distal end surface. According to this configuration, the transplantation needle is inserted without inserting the transplantation needle until the inclined surface comes into contact with the tissue to be transplanted so as to penetrate the tissue and obtain a sufficient insertion length. Can be easily inserted at a desired angle. Further, since the insertion is stopped when the inclined surface comes into contact with the tissue, the doctor can easily confirm by touch that the desired insertion length has been obtained. Further, by bringing the inclined surface into close contact with the tissue to be transplanted, the transplant needle device can be stabilized while the transplant material is delivered.

  According to one embodiment of the present invention, the closed tip of the implantation needle forms a blunt tip. With this configuration, it is possible to minimize the possibility of damaging tissue or blood vessels by the tip of the needle, and it is possible to provide a transplant needle device that is excellent in minimally invasiveness. Moreover, the possibility that the needle penetrates the tissue can be minimized.

  According to one embodiment of the invention, the side openings are arranged to form a helical pattern along the length of at least one implantation needle. According to this configuration, an appropriate number of cells can be easily distributed three-dimensionally and uniformly over a wide range.

  According to an embodiment of the present invention, the at least one implantation needle is composed of a plurality of implantation needles that protrude from the support block at the same length. Thereby, a plurality of transplant needles can be inserted with the same insertion length.

  According to one embodiment of the present invention, a guide member for guiding a transplant needle device to a tissue to be transplanted, the guide member having a substantially tubular form, The distal end surface of the member includes an inclined surface that is inclined with respect to the side surface of the main body portion of at least one implantation needle, and the side surface of the guide member is open over a part of the circumferential direction of the guide member. Is provided. According to this configuration, the transplant needle device can be easily guided according to a desired insertion angle. Further, the guide member can be easily removed without changing the posture of the transplantation needle device after insertion. Therefore, the surgeon's procedure after insertion is not hindered by the guide member. Further, the guide member closed in the circumferential direction is clouded with water vapor that evaporates from the living tissue, and there is no possibility of hindering the visual recognition of the insertion site.

  According to one embodiment of the present invention, there is provided a transplantation device set comprising a transplantation needle device and a puncture device for puncturing at least one transplantation needle into a tissue to be transplanted. The insertion device includes a fixing portion that can be fixed to a tissue to be transplanted, a first movable portion that moves the transplant needle device straight along the surface of the tissue to be transplanted, There is provided a transplantation instrument set including a second movable part that rotates the transplantation needle device so as to insert and remove at least one transplantation needle with respect to a target tissue. With this configuration, the transplantation needle device can be moved straight along the surface of the tissue using the puncture device and can be rotated at the desired puncture position, so that uniform implantation within the desired range can be efficiently performed. It can be done well and easily.

  According to one embodiment of the present invention, the fixed portion includes a plate member having an opening that opens on a surface of a tissue to be transplanted, and the first movable portion is disposed on a side portion of the plate member. A rail member that is fixed and includes a gear, a tooth portion that cooperates with the gear, and a rack member that can slide along the rail member, and the second movable portion includes: A base portion fixed to the rack member, a shaft portion rotatably attached to the base portion, an insertion lever fixed to the shaft portion, one end fixed to the shaft portion, and the other end fixed to the transplant needle device, And an arm portion.

  According to an embodiment of the present invention, the arm portion includes a main body fixed to the shaft portion, and a plunger that can be fixed to the transplant needle device, and the plunger is attached to the plunger receiving portion fixed to the main body. The support block of the implantable needle device is slidably received and has a notch that can receive the plunger. According to this configuration, by inserting the tip of the plunger into the notch of the support block, the transplant needle device can be reliably fixed to the arm portion.

  According to one embodiment of the present invention, in the transplantation instrument set, the main body of the arm portion has an engagement surface that can be engaged with the support block, and the support block is held between the engagement surface and the plunger. Is done. According to this structure, a support block can be reliably fixed between the engaging surface of an arm part main body, and the front-end | tip of a plunger.

  According to one embodiment of the present invention, in the transplant device set, the arm portion includes a rod that is disposed in the opening portion of the shaft portion and is movable with respect to the plunger, and the rod and the opening portion are mutually connected. Corresponding screw part is provided. According to this configuration, the plunger can be easily moved with respect to the support block by rotating the rod.

  According to one embodiment of the present invention, in the transplantation instrument set, the rod includes a grip portion. According to this structure, in order to fix a support block, a rod can be easily operated manually.

  According to one embodiment of the present invention, in the transplant device set, the gear includes a shaft portion having a grip portion. According to this structure, in order to move the 2nd movable part to a desired insertion position, a gear can be easily operated manually.

  According to one embodiment of the present invention, at least one injection needle comprising a closed tip and a body including a lumen and a side opening communicating with the lumen, and supports at least one injection needle An injection needle device comprising: a support block that includes an inclined surface that is inclined with respect to a side surface of the main body portion of the at least one injection needle, wherein the at least one injection needle is An infusion needle device is provided that protrudes and extends.

  According to one embodiment of the present invention, the at least one injection needle is composed of six linear injection needles arranged at a position forming a substantially pentagonal apex on the inclined surface and at the center of the regular pentagon. Has been.

  According to one embodiment of the present invention, at least one injection needle comprising a closed tip and a body including a lumen and a side opening communicating with the lumen, and supports at least one injection needle An injection needle device is provided, wherein the injection needle device is an arcuate needle.

  According to one embodiment of the present invention, at least one injection needle is arranged in a line on the distal end surface of the support block.

  According to one embodiment of the present invention, the support block of the injection needle device includes an inclined surface that is inclined with respect to the distal end surface.

  According to one embodiment of the present invention, the closed tip of the injection needle forms a blunt tip.

  According to one embodiment of the invention, the side openings are arranged to form a spiral pattern along the length of at least one injection needle.

  According to an embodiment of the present invention, the at least one injection needle is composed of a plurality of injection needles that protrude from the support block at the same length.

  According to an embodiment of the present invention, a guide member for guiding an injection needle device to a tissue to be injected, the guide member having a substantially tubular form, The front end surface of the member includes an inclined surface that is inclined with respect to the side surface of the main body portion of at least one injection needle, and the side surface of the guide member is open over a part of the circumferential direction of the guide member. Is provided.

  According to one embodiment of the present invention, an injection device set includes an injection needle device and a puncture device for inserting at least one injection needle into a tissue to be injected. The insertion device includes a fixed portion that can be fixed to the tissue to be injected, a first movable portion that moves the injection needle device straight along the surface of the tissue to be injected, An injection device set is provided, comprising: a second movable part that rotates the injection needle device so as to insert and remove at least one injection needle with respect to a target tissue.

  According to an embodiment of the present invention, the fixed portion includes a plate member having an opening that opens on the surface of the tissue to be injected, and the first movable portion is disposed on a side portion of the plate member. A rail member that is fixed and includes a gear, a tooth portion that cooperates with the gear, and a rack member that can slide along the rail member, and the second movable portion includes: A base portion fixed to the rack member, a shaft portion rotatably attached to the base portion, an insertion lever fixed to the shaft portion, one end fixed to the shaft portion, and the other end fixed to the injection needle device, And an arm portion.

  According to an embodiment of the present invention, the arm portion includes a main body fixed to the shaft portion, and a plunger that can be fixed to the injection needle device, and the plunger is attached to the plunger receiving portion fixed to the main body. The support block of the injection needle device is slidably received and has a notch that can receive the plunger.

  According to one embodiment of the present invention, in the injection device set, the main body of the arm portion has an engagement surface that can be engaged with the support block, and the support block is held between the engagement surface and the plunger. Is done.

  According to one embodiment of the present invention, in the injection device set, the arm portion includes a rod that is disposed in the opening portion of the shaft portion and is movable with respect to the plunger, and the rod and the opening portion are mutually connected. Corresponding screw part is provided.

  According to one embodiment of the present invention, in the injection device set, the rod includes a grip portion.

  According to one embodiment of the present invention, in the injection device set, the gear includes a shaft portion having a grip portion.

  According to the present invention, it is possible to provide an injection needle device that is excellent in low invasiveness and excellent in efficiency. Moreover, according to this invention, the insertion apparatus which can perform injection | pouring efficiently and easily using an injection needle apparatus can be provided. In the present invention, transplantation of cells into a patient's body is also included in the concept of “injection”. The tissue to be injected is not particularly limited. Moreover, the substance to be injected can be, for example, cells, various drugs and / or virus vectors, but is not limited thereto.

It is a perspective view showing the appearance of the transplant needle device by a 1st embodiment of the present invention. (A) is a figure which shows arrangement | positioning of the side part opening in the length direction of the transplant needle shown in FIG. 1, (b) is a figure which shows arrangement | positioning of the side part opening in the circumferential direction of a transplant needle. It is a side view which shows the moving needle apparatus attached to the syringe. It is a partial expanded sectional view of FIG. It is sectional drawing along the AA line of FIG. It is use explanatory drawing of the transplant needle apparatus of FIG. It is a perspective view of the guide member for a transplant needle device. (A) is the side view which shows a part of transplant needle device by 3rd Embodiment of this invention attached to the syringe in a cross section, (b) was along the BB line of (a). It is sectional drawing. It is a figure which shows the insertion direction of the transplant needle of the transplant needle device by 3rd Embodiment. It is an image figure of the transplant process using the transplant needle device by a 3rd embodiment. It is a side view of the insertion apparatus which can be used with an implantation needle device. It is the side view which looked at the penetration apparatus from the opposite side to FIG. It is the front view which looked at the insertion apparatus in the straight direction of the transplant needle. It is a bottom view which shows the fixing | fixed part of a penetration apparatus. It is a top view which shows the 1st movable part and 2nd movable part of a penetration apparatus. It is a figure which shows the mechanism of the arm part of a transplant needle apparatus. It is a figure which shows the mechanism of FIG. 15 before and behind attachment of the transplant needle apparatus. It is a figure explaining the attitude | position before insertion of the transplant needle apparatus. It is a figure explaining the attitude | position after insertion of the transplant needle apparatus.

  Hereinafter, a first embodiment of the present invention will be described with reference to FIGS. 1 to 6A. FIG. 1 is a perspective view showing an external appearance of an implantable needle device 1 according to a first embodiment of the present invention. The transplant needle device 1 includes at least one transplant needle 2 and a support block 3 that supports the at least one transplant needle 2. In the present embodiment, six transplantation needles 2 are provided, but the number of transplantation needles 2 is not particularly limited. As shown in FIG. 1, each transplant needle 2 includes a plurality of side openings 4. FIG. 2 is a partially cutaway side view of the transplant needle 2. The transplant needle 2 includes a distal end portion 5 having a taper portion and a tubular main body portion 6 extending substantially linearly. The main body portion 6 includes a lumen 7 and an inner portion for receiving a transplant substance such as cells together with a solution. It has a side opening 4 that communicates with the cavity 7. In the present embodiment, the main body portion 6 is open at both ends in the length direction, and a small diameter portion 9 formed on the proximal end side of the distal end portion 5 is fitted to one end of the main body portion 6, thereby The part 5 is attached to the main body part 6. However, the tip 5 and the main body 6 may be integrally formed as one component. As shown in FIG. 2, the tip 5 is solid. In other words, the transplant needle 2 has a closed tip portion 5 and does not have an opening formed in the needle tip like a conventional injection needle. Furthermore, in this embodiment, the front-end | tip part 5 forms the blunt (in other words rounded) front-end | tip part. In FIG. 1, reference numeral 8 denotes a groove formed as an anti-slip when the support block 3 is gripped in order to attach the transplant needle device 1 to, for example, a syringe.

As described above, the side opening 4 that communicates with the lumen 7 in the length direction is formed on the side surface of the body portion 6 of the transplant needle 2. By closing the distal end portion 5 of the transplant needle 2 and forming the side opening 4 on the side surface of the main body portion 6, the transplant material can be transplanted instead of a limited range in the vicinity of the distal end portion of the needle as in the prior art. It can be delivered over a wide range along the length of the needle 2. By adjusting the position and number of the side openings 4, delivery in a desired range becomes possible. Further, the side opening 4 can be freely set in a shape suitable for smooth delivery according to the size of the transplanted substance and the like. In the illustrated example, the side opening 4 has a long hole shape. Moreover, the side part opening 4 may be deburred so that the inner diameter side with respect to the main body part 6 forms a smooth surface. This is preferred to minimize cell damage during delivery from the side opening 4, especially when the transplant material is cells.

  In the embodiment of FIG. 2, the side openings 4 are arranged to form a spiral pattern along the length of the transplant needle 2. By arranging a plurality of side openings 4 so as to form a spiral pattern along the length of the implantation needle 2, an appropriate amount of the implantation substance is uniformly distributed over a wide range in three dimensions. Becomes easier. In FIG. 2, nine side openings 4 are shown. However, the positions where the side openings 4 are arranged, the patterns, and the number of the side openings 4 are not limited to those of the present embodiment. In the embodiment of FIG. 2, each of the nine side openings 4 is arranged at a position rotated 120 degrees with respect to the adjacent side openings 4 (see FIG. 2B). However, in other embodiments, for example, six side openings 4 can be formed. At this time, the six side openings 4 are arranged in a line in the longitudinal direction, and each pair of the side openings 4 is arranged at an angular position of 120 degrees with respect to the adjacent pair. The side openings 4 can also be positioned.

  The transplant needle device 1 can be attached to, for example, a syringe as shown in FIG. FIG. 4 shows a longitudinal section of the implantation needle device 1 attached to a syringe. In FIG. 4, the syringe is indicated by a two-dot chain line. The support block 3 includes a substantially circular recess 10 that is recessed from the base end side toward the tip end side, and a plurality of elongated lumens 11 that extend from the bottom surface of the recess 10 toward the tip end side of the support block 3. Have. The main body 6 of the transplant needle 2 is fixed to these elongated lumens 11. The recess 10 includes an outer annular member 13 disposed so as to engage with a step 12 formed on the inner peripheral surface of the support block 3, and an inner central member 14 disposed on the inner side of the outer annular member 13. The inner central member 14 is positioned via the pin 15 on the bottom surface of the recess 10. An O-ring is disposed between the outer annular member 13 and the inner peripheral surface of the support block 3.

  In this embodiment, the attachment block 16 for attaching the transplant needle device 1 to the syringe is formed so as to protrude from the proximal end side of the support block 3. The proximal end side of the mounting block 16 has a threaded portion so that it can be fixed to a conventional syringe, for example, in a luer lock type, and the distal end side of the outer annular member 13 and the inner central member 14. It is configured to be insertable between them. The attachment block 16 has a substantially tubular shape so as to be able to receive a flow path forming portion (reference number omitted) of the syringe, and the flow path of the syringe is a central flow path formed in the inner central member 14. 17 is communicated with. In the vicinity of the bottom surface of the recess 10, the central channel 17 communicates with a radial branch channel 18 that radially penetrates the annular wall that defines the central channel 17 of the inner central member 14. In addition, it communicates with an annular channel 19 formed between the outer peripheral surface of the inner central member 14 and the inner peripheral surface of the support block 3 (see FIG. 5). The annular channel 19 communicates with each of the lumens 11 described above. Accordingly, the transplant material 20 such as cells supplied to the syringe is sent into the central flow path 17 according to the movement of the plunger (not shown) of the syringe, and passes through the branch flow path 18 and the annular flow path 19 from the central flow path 17. Through each lumen 11. The transplant substance 20 sent into the lumen 11 is delivered from the main body 6 of the transplant needle 2 through the side opening 4 into the tissue.

The mounting block 16 can be fixed to the support block 3 by an adhesive or welding. The support block 3 has an inclined surface 21 that is inclined with respect to the side surface of the body portion 6 that extends linearly of the transplant needle 2, and the transplant needle 2 extends outwardly in a straight line from the inclined surface 21. Yes. Moreover, it is preferable that the transplant needle 2 protrudes from the support block 3 by the same length.

  FIG. 6A shows a use state of the transplantation needle device 1 attached to the syringe. Since the transplant needle 2 extends from the inclined surface 21 so as to protrude linearly outside, there is no risk of penetrating the tissue by performing insertion until the inclined surface 21 contacts the tissue to be transplanted, and The tactile sensation can easily confirm that the transplant needle 2 has been inserted with a sufficient insertion length. Since the transplant needles 2 protrude from the support block 3 by the same length as each other, a plurality of transplant needles 2 can be inserted with the same insertion length. Moreover, as shown in FIG. 6A, by performing the transplantation with the inclined surface 21 being in close contact with the tissue surface 50, the transplantation can be performed with the position of the transplantation needle 2 being stable.

  Thus, according to the first embodiment, a plurality of transplant needles 2 are inserted into a tissue at a desired angle (for example, 45 degrees obliquely), and the tissue is inserted with a longer insertion length than in the past. Transplantation can be performed without the risk of penetration. Therefore, compared with the conventional case, a sufficient amount of the transplanted substance can be transplanted over a wide range by one insertion. The implantation needle 2 has a closed blunt tip 5 so that the risk of damaging the tissue can be minimized. In addition, since the transplantation needle 2 has the side opening 4, the size of the opening can be set relatively freely according to the size of the transplanted substance, etc. By adjusting the pattern, the amount of implant material delivered can be adjusted. Further, since the inclined surface 21 of the support block 3 can be brought into close contact with the tissue surface 50, the position of the transplant needle device 1 can be stabilized while the transplant material is delivered. This is because, for example, when transplanting cardiomyocytes, the transplant needle device 1 can be synchronized with the pulsation of the heart, so that it is possible to effectively prevent the transplant needle 2 from moving relative to the tissue during transplantation. . In addition, the large insertion length of the transplantation needle 2 is advantageous in that leakage of the transplantation substance (pump-out) that occurs when the transplantation needle 2 is pulled out from the tissue after transplantation can be reduced.

  Further, in this embodiment, as can be understood from the position of the lumen 11 shown in FIG. 5 in particular, the transplant needle 2 is substantially at the position where the apex of the regular pentagon is formed on the inclined surface 21 and at the center of the regular pentagon. It is composed of six linear implantation needles 2 arranged. When the transplantation needle device 1 is moved in a straight direction on the tissue surface in order to perform multiple insertions, the position of forming the apex of the regular pentagon and the arrangement of the transplantation needles 2 arranged at the center of the regular pentagon are predetermined. It is advantageous to perform uniform transplantation efficiently within the range.

  In addition, according to 2nd Embodiment of this invention, the guide member 22 as shown to FIG. 6A and FIG. 6B used suitably in order to guide the transplant needle apparatus 1 is provided. In FIG. 6A, the guide member 22 is shown in cross section. The guide member 22 has a substantially tubular form, and the distal end surface 22a is formed on the side surface of the main body portion 6 of the transplant needle 2 of the transplant needle device 1 to be guided in the same manner as the inclined surface 21 of the support block 3. It is inclined with respect to it. Thereby, the transplant needle device can be easily guided according to a desired insertion angle. Further, the side surface of the guide member 22 is open over a part of the guide member 22 in the circumferential direction. That is, the side surface of the guide member 22 has an open portion 22b as shown in FIG. 6B. Thereby, the guide member 22 can be easily removed from the transplantation needle device 1 through the opening portion 22b after insertion. Therefore, the surgeon's procedure after insertion is not hindered by the guide member 22. In addition, in the conventional guide member having a wall closed in the circumferential direction, the wall is clouded by the heat of the living tissue, and the visual recognition of the insertion site may be hindered, but the guide partially opened along the circumferential direction. Since the member 22 can release the water vapor that evaporates from the living tissue, there is no possibility of clouding.

  Next, with reference to FIG. 7 thru | or FIG. 9, the transplant needle apparatus 30 by 3rd Embodiment of this invention is demonstrated. Fig.7 (a) is a side view of the transplantation needle apparatus 30 attached to the syringe. Similar to the first embodiment, the implantation needle device 30 comprises at least one implantation needle 33 comprising a closed tip 31 and a body portion 32 including a lumen and a side opening 42 communicating with the lumen. And a support block 34 for supporting at least one implantation needle 33. In addition, an attachment block 35 for attaching the transplant needle device 30 to the syringe is attached to the support block 34. In FIG. 7A, only the support block 34 and the attachment block 35 are shown in a sectional view. In the third embodiment, the transplant needle 33 is formed in a curved shape in an arc shape as a whole. A plurality (four in this embodiment) of the arcuate transplant needles 33 of the third embodiment are arranged in a row (in a direction perpendicular to the paper surface of FIG. 7) on the distal end surface 36 of the support block 34. ing. In other words, the arcuate transplant needles 33 are arranged in a row on the distal end surface 36 as if the tip of the fork, so that even if the transplantation needle 33 is arcuate, a blood vessel or the like is inserted. It is easy to select and insert an appropriate position while avoiding a portion that is not desired or a portion that is not desired to be damaged. Moreover, since it protrudes and extends with the same length from the front end surface 36, the plurality of transplant needles 33 can be inserted with the same insertion length without fear of penetrating the tissue. The support block 34 also includes an inclined surface 37 that is inclined with respect to the distal end surface 36 on which the transplantation needle 33 is disposed.

  The support block 34 has a substantially circular recess 38 that is recessed from the proximal end side toward the distal end side. The mounting block 35 has a threaded portion so that the base end portion of the mounting block 35 can be fixed to a conventional syringe, for example, in a luer lock type, and can receive the flow path forming portion of the syringe. Thus, it has a tubular form. The distal end portion of the attachment block 35 is configured to be insertable into the recess 38 of the support block 34, and a central flow path 39 that can communicate with the flow path of the flow path forming portion of the syringe is formed at the center of the distal end portion. ing. An O-ring is disposed between the outer peripheral surface of the tip portion and the inner peripheral surface of the recess 38. An elongated channel 41 is formed on the bottom surface of the recess 38 of the support block 34. The elongated channel 41 includes a branch opening 40 that communicates with the central channel 39 and communicates with a lumen in the support block 34 that receives each implantation needle 33. Yes. FIG. 7B shows a cross section taken along the line BB in FIG. As shown in FIG. 7B, the elongate channel 41 has a shape of a long hole extending in the arrangement direction of the transplant needles 33 (direction perpendicular to the paper surface of FIG. 7), and the lumen of the transplant needle 33 A branch opening 40 is provided in communication therewith.

  In FIG. 8, the insertion direction of the transplant needle 33 of the transplant needle device 30 is shown. For example, the transplant needle 33 can be inserted into the tissue by rotating the transplant needle device 30 around the center of curvature of the arc-shaped transplant needle 33. In the example of FIG. 8, the transplant needle 33 has an arc shape with a radius of curvature R30, and the transplant needle device 30 is rotated about 45 degrees around the center of curvature of the transplant needle 33 from a posture substantially perpendicular to the tissue surface 50. To insert. As a result, the transplant needle 33 is inserted into the tissue in an arc shape, and as a result, the distal end side of the main body 32 of the transplant needle 33 is arranged in a substantially horizontal direction along the tissue surface 50. Therefore, a large insertion length can be ensured while minimizing the possibility of penetrating the tissue. By changing the value of R, the insertion length can be adjusted to a desired size. Further, by inserting until the inclined surface 37 comes into contact with the surface 50 of the tissue to be transplanted, the transplant needle 33 was inserted with a sufficient insertion length without fear of penetrating the tissue. This can be easily confirmed by tactile sensation. Since the transplant needles 33 protrude from the support block 34 by the same length as each other, a plurality of transplant needles 33 can be inserted with the same insertion length. In addition, when the transplanted substance is delivered in a state where the inclined surface 37 is in close contact with the tissue surface 50, the transplantation can be performed while the position of the transplantation needle 33 is stable.

  In addition, by adjusting the shape of the side openings 42, the number of the side openings 42, the position and pattern of the side openings 42, and the like, an appropriate amount of the transplanted substance can be uniformly transplanted to a desired range. Can do. Further, by making the distal end portion 31 of the transplantation needle 33 a dull distal end portion, it is possible to minimize the risk of damaging the tissue and blood vessels with the transplantation needle 33.

  In FIG. 9, the image figure of the transplant process using this transplant needle device 30 is shown. As shown in FIG. 9 (a), the transplanted substance is delivered into the tissue through a side opening 42 formed on the distal end side of the main body part 32 substantially oriented in the horizontal direction by one insertion. As shown in FIG. 9B, the transplanted substance can be efficiently and uniformly delivered to a desired range by moving the transplant needle device 30 at a predetermined pitch in the straight direction.

  In addition, various coatings can be applied to the transplant needles 2 and 33, for example, MPC coating can be applied.

  In addition, although the said embodiment demonstrated the case where the transplantation needle apparatuses 1 and 30 were attached and used for a syringe, the transplantation needle apparatuses 1 and 30 do not necessarily need to be attached to a syringe. For example, it can be attached to various devices that can be used for implantation, such as an endoscope.

  According to the fourth embodiment of the present invention, it is possible to efficiently and easily perform uniform transplantation within a desired range by repeating such linear movement and rotation of the transplantation needle devices 1 and 30. An insertion device 60 can be provided.

  Hereinafter, an example of the insertion device 60 will be described with reference to FIGS. 10 to 17B. FIG. 10 is a side view of the insertion device 60, and FIG. 11 is a side view seen from the side opposite to FIG. FIG. 12 is a front view of the insertion device 60 as seen from the straight direction of the transplant needle device 30. In other words, FIG. 12 is a view of the insertion device 60 as seen from the left side of FIG. FIG. 13 is a bottom view showing the fixing portion of the insertion device 60, in other words, the illustration of the insertion device 60 viewed from the lower side of FIG. FIG. 14 is a top view showing the first movable part and the second movable part of the insertion device 60. In this embodiment, the case where the puncture device 60 is used together with the transplant needle device 30 will be described. However, the puncture device 60 can also be used together with the transplant needle device 1, and the transplant needle devices 1, 30. At the same time, an implant device set can be configured.

  The penetration device 60 may be used attached to a stabilizer well known to those skilled in the art for fixing a portion of the beating heart. 10 and 13, the stabilizer portion is indicated by a two-dot chain line. In other words, in this embodiment, the insertion device 60 can be used together with the needle transplant devices 1 and 30 to transplant cells into myocardial tissue. However, in the present invention, the tissue to be transplanted is not necessarily limited to the myocardial tissue. The transplantation needle devices 1 and 30 and the insertion device 60 of the present invention can be used for various tissues that require transplantation of transplantation substances such as cells.

The insertion device 60 includes a fixed portion that can be fixed to a tissue to be transplanted (in this embodiment, a myocardial tissue), a first movable portion that advances the transplant needle device 30 straight along the surface of the tissue, And a second movable portion that rotates the transplant needle device 30 so as to insert and remove the transplant needle relative to the tissue. The fixing part may be formed by a substantially plate-like plate member 61, which is on the inner surface of a foot part 62 (see in particular FIG. 13) having a substantially horseshoe shape of the stabilizer. The engaging part 63 (refer FIG. 12 in particular) which has the surface formed so that it may follow can be provided. By engaging the engaging part 63 with the inner surface of the foot part 62, the plate member 61 can be fixed to the foot part 62. The plate member 61 has an opening 64 that opens on the tissue surface 50, and the opening 64 is positioned to align with the opening of the foot 62 having a substantially horseshoe shape. Elongated rail members 65 are fixed on the left and right side portions along the foot portion 62 on the upper surface of the plate member 61, and an elongated slide plate 80 is disposed inside each rail member 65. A groove 65a extending in the length direction of the rail member 65 is formed on the inner side surface of each rail member 65, and the slide plate 80 is slidable along the groove 65a. Inside one rail member 65, a pair of gear members 66 including a plate member 61 and a shaft portion 67 penetrating the rail member 65 are arranged in alignment with the length direction of the rail member 65, and The inner surface of the rail member 65 has an opening (not shown) that opens into the groove 65a. The tooth portion of the gear member 66 is exposed in the groove 65a through the opening. One gear member 66 can act as a drive gear for sliding the slide plate 80 along the groove 65a, and a drive gear is attached to the tip of the shaft portion 67 extending above the rail member 65. A moving knob 68 (gripping part) for manual operation can be attached. The other gear member 66 can act as an idle gear, and its shaft portion 67 is prevented from coming off from the plate member 61 and the rail member 65 by a nut 69. Each rail member 65 can be fixed to the plate member 61 by screwing. The other rail member 65 may be provided with a handle 70 for gripping when the entire insertion device 60 is moved. The handle 70 can include a bar 72 extending in a substantially horizontal direction and a pillar 73 extending downward from both ends of the bar 72 and penetrating the rail member 65 and the plate member 61.

  One side of the slide plate 80 can constitute a rack member having a tooth portion 81 on the side surface for sliding the slide plate 80 along the groove 65 a of the rail member 65 in cooperation with the gear member 66. Therefore, the gear member 66 and the rack member 80 can constitute a first movable part that can advance the transplant needle device 30 straight along the surface 50 of the tissue. The slide plate 80 is preferably slidable along the rail member 65 as long as the second movable part fixed on the slide plate 80 does not interfere with the arm 82 of the stabilizer.

  A base 83 of the second movable part is attached to the upper surface of the slide plate 80. The base 83 is substantially annular in plan so as to have a central opening 84, and is spaced from each other in the left-right direction so as to form a substantially L-shaped side surface (see FIGS. 10 and 11). Two projecting end portions 85 projecting upward are provided. The base 83 is screwed to the slide plate 80. The base 83 and the slide plate 80 may be integrated with each other instead of being separated.

  A rotation part for rotating the transplant needle device 30 is attached to the protruding end part 85 of the base part 83. The rotation part includes an insertion lever 86 and a rotation shaft part to which the insertion lever 86 is fixed. 87 and an arm portion 88 fixed to the rotation shaft portion 87. The rotation shaft portion 87 has two small-diameter shaft portions 89 disposed in the projecting end portion 85 of the base portion 83, and both ends are fixed to the small-diameter shaft portion 89 and disposed between the two projecting end portions 85. A large-diameter shaft portion 90 can be provided. The arm portion 88 can be fixed to the transplantation needle device 30 by a mechanism described later.

An example of a specific configuration of the arm portion 88 is shown in FIG. A plate-shaped arm body 91 that is bent so as to have a substantially U-shaped planar shape (in particular, see FIG. 14) is fixed to the rotation shaft portion 87. It can rotate integrally with the part 87. Specifically, the arm body 91 includes a side surface portion 91a extending in the length direction and having one end fixed to the rotation shaft portion 87, and a front end surface portion 91b extending between the other ends of the side surface portion 91a. . The distal end surface portion 91 b is configured to be able to engage with the support block 34 of the transplant needle device 30. Inside the arm main body 91, a rod 92 penetrating the large-diameter shaft portion 90 extends in the length direction of the arm main body 91, and a presser knob 93 (gripping portion) is attached to the outer periphery of the tip end portion of the rod 92. . In the large-diameter shaft portion 90, threaded portions that cooperate with each other are formed on the inner peripheral portion of the hole through which the rod 92 passes and the proximal end portion outer periphery of the rod 92, and by rotating the presser knob 93, The rod 92 can be moved in the large-diameter shaft portion 90, and the proximal end side of the plunger 95 arranged in the plunger receiving portion 94 can be pressed by the presser knob 93. Thereby, the plunger 95 can be advanced. The plunger receiver 94 is fixed to the arm body 91. A coil spring 96 that biases the plunger 95 in the proximal direction is provided in the plunger receiving portion 94, and an end portion of the coil spring 96 is connected to a spring seat 97 formed in a through hole of the plunger receiving portion 94 and the plunger. It is supported by the step part 98 formed in the outer peripheral surface of 95. A cutout is provided on the distal end side of the arm body 91 so as to form an inclined surface 99 that is inclined with respect to the lower surface of the arm body 91. The inclined surface 99 is configured to be able to contact the surface 50 of the tissue to be transplanted together with the inclined surface 37 of the support block 34 of the transplant needle device 30 when the arm body 91 rotates.

  In order to fix the transplant needle device 30 to the arm portion 88, a conical cutout 102 can be formed on the outer peripheral surface of the support block 34. Accordingly, as shown in FIGS. 16A and 16B, by rotating the presser knob 93, the tip of the plunger 95 is advanced and inserted into the notch 102 of the support block 34, and the support block 34 is moved. The arm body 91 can be reliably fixed between the distal end surface portion 91b and the plunger 95 (FIG. 16B). At this time, the presser knob 93 can act as a detent for the plunger 95 spring-biased in the proximal direction. Thus, since the transplantation needle device 30 can be mechanically fixed to the arm portion 88, the doctor does not need to hold the syringe by hand during insertion. Therefore, for example, insertion can be performed easily even at a site close to the opened chest wall. For convenience of explanation, the transplant needle 33 is not shown in FIGS. 16 (a) and 16 (b).

  Also, as shown in FIGS. 16A and 16B, a groove 103 is provided on the peripheral surface of the support block 34 opposite to the notch 102, and the distal end surface portion 91 b of the arm body 91 is received in the groove 103. You can also. Accordingly, the support block 34 can be easily fixed to the distal end surface 91b, and the transplanted needle device is configured such that the curved transplanted needle 33 faces the correct direction with respect to the insertion device 60 by the groove 103. 30 can also be easily positioned. The notch 102 can also be used as an indicator for positioning the implantation needle device 30.

  The insertion device 60 may include a rod-like stopper 100 that prevents the unintended downward movement of the transplant needle device 30 fixed to the arm portion 88. As an example, both ends of the stopper 100 are rotatably attached to the side surfaces of the base portion 83, and an intermediate portion crossing the central opening 84 of the base portion 83 is on the distal end surface 36 of the support block 34 of the implantation needle device 30. You may bend so that the convex part which can contact | abut will be formed. By rotating the stopper 100 and engaging the convex portion with the distal end surface 36, the implantation needle device 30 can be held in a substantially vertical posture. The stopper 100 can be manually operated. Further, in order to prevent the entire insertion device 60 from falling with respect to the foot portion 62 of the stabilizer when the arm portion 88 rotates, a hook component that can be engaged with the foot portion 62 is attached to the plate member 61. May be provided.

  Hereinafter, an example of how to use the insertion device 60 will be described. An injection solution in which a transplant substance such as cells and a solution are mixed is put into a syringe, and is screwed and fixed to the attachment block 35. With the slide plate 80 removed from the rail member 65 and the second movable part separated from the fixed part, the distal end surface part 91 b of the arm body 91 is inserted into the groove 103 of the support block 34. At this time, the convex portion of the stopper 100 may be engaged with the notch on the distal end side of the arm main body 91. The presser knob 93 is rotated to advance the rod 92 and the plunger 95 is pressed to insert the tip of the plunger 95 into the notch 102 of the support block 34. The support block 34 can be fixed between the distal end surface portion 91 b of the arm body 91 and the plunger 95 by tightening the presser knob 93 against the plunger receiving portion 94. The convex portion of the stopper 100 is engaged with the tip surface 36 of the support block 34 so that the syringe maintains a posture perpendicular to the whole.

Next, the slide plate 80 is inserted into the groove 65a of the rail member 85, the handle 70 is grasped, and the entire insertion device 60 is placed on the surface 50 of the tissue to be transplanted. Move up. The engaging part 63 of the plate member 61 is engaged with the inner surface of the foot part 62 of the stabilizer. The state at this time is shown in FIG. 17A. Since the foot portion 62 is adsorbed and fixed to the tissue surface 50 via a stabilizer suction tube (not shown), the plate member 61 of the insertion device 60 is fixed to the tissue surface 50. Further, the distal end portion 31 of the transplantation needle 33 can be positioned at a position close to the tissue surface 50. As a result, the insertion position before insertion can be easily confirmed, and it is easy to avoid a portion that does not want to be inserted, such as a blood vessel, or a tissue that does not want to be damaged. When the hook part is provided, the hook part is engaged with the foot part 62, and when the arm part 88 rotates, the entire insertion device 60 falls down with respect to the foot part 62. Can be prevented.

  The moving knob 68 is manually rotated to rotate the drive gear 66 in the rail member 65, and the slide plate 80 is moved along the groove 65a. The movement of the slide plate 80 also moves the second movable part that is substantially integrated with the slide plate 80, so that the syringe can be moved to a desired insertion position. After moving the syringe to a desired insertion position, the stopper 100 is rotated to remove the convex portion of the stopper 100 from the distal end surface 36 of the support block 34, and the insertion lever 86 is rotated to move the transplant needle 33. Insert into the desired position. The state at this time is shown in FIG. 17B. At this time, when the inclined surface 37 of the support block 34 and / or the inclined surface 99 of the arm body 91 is in contact with the tissue surface 50, the doctor easily confirms that a sufficient penetration depth is obtained by tactile sense. can do. Further, when the inclined surface 37 and / or the inclined surface 99 comes into contact with the tissue surface 50, the insertion of the transplantation needle 33 is stopped at a preset insertion depth. Therefore, it is possible to reliably prevent the transplantation needle 33 from being inserted to an unintended depth and penetrating the tissue.

  After the insertion, the transplant material is delivered from the side openings 42 of the transplant needle 33. After the delivery, the insertion lever 86 is rotated again, and the transplantation needle 33 is pulled out from the tissue. When the syringe is in a vertical posture as a whole, the convex portion of the stopper 100 can be engaged with the distal end surface 36 of the support block 34 to maintain the vertical posture of the syringe. In this state, the moving knob 68 is rotated again to move the slide plate 80 to the next insertion position, and the above rotation operation is repeated. When it is necessary to move the stabilizer and perform transplantation to another site, the handle 70 can be grasped and the entire insertion device 60 can be moved together with the stabilizer. The relationship between the rotation amount of the moving knob 68 and the moving distance of the slide plate 80 can be set as appropriate. For example, among the plurality of side openings 42 arranged along the length direction of the transplantation needle 33, the position of the rearmost side opening 42 and the side opening 42 that becomes the foremost end at the time of the next insertion The relationship between the rotation amount of the movement knob 68 and the movement distance of the slide plate 80 can be set so that the distance between the two can be matched with the pitch between the side openings 42 of the implantation needle 33 (FIG. 9 ( see b)).

  The transplant needle device 1 according to the first embodiment and the transplant needle device 30 according to the third embodiment can be used for injection of various drugs and / or virus vectors for gene therapy in addition to cell transplantation. It may be used as a needle device. In that case, the insertion device 60 can be used for injection of various drugs and / or virus vectors for gene therapy in addition to cell transplantation together with the injection needle device.

  The present invention can be widely used in the injection process of cells, various drugs and / or virus vectors for tissue or organ regeneration.

DESCRIPTION OF SYMBOLS 1 transplantation needle apparatus 2 transplantation needle 3 support block 4 side part opening 5 front-end | tip part 6 main body part 7 lumen | bore 8 non-slip groove 9 small diameter part 10 recessed part 11 lumen | bore 12 step part 13 outer annular member 14 inner center member 15 pin 16 attachment Block 17 Central flow path 18 Branch flow path 19 Annular flow path 20 Graft material 21 Inclined surface 22 Guide member 22a Front end surface 22b Opening portion 50 Tissue surface 30 Transplant needle device 31 Tip portion 32 Body portion 33 Transplant needle 34 Support block 35 Mounting block 36 Front end surface 37 Inclined surface 38 Recess 39 Central flow path 40 Branch opening 41 Flow path 42 Side opening 60 Inserting device 61 Plate member 62 Foot part 63 Engagement part 64 Opening part 65 Rail member 65a Groove 66 Gear member 67 Shaft part 68 Moving knob 69 Nut 70 Handle 72 Bar 73 Pillar 80 Slide plate 81 Tooth part 82 Arm 83 Base 4 Center opening 85 Projection end portion 86 Insertion lever 87 Rotating shaft portion 88 Arm portion 89 Small diameter shaft portion 90 Large diameter shaft portion 91 Arm main body 91a Side surface portion 91b Tip surface portion 92 Rod 93 Presser knob 94 Plunger receiving portion 95 Plunger 96 Coil Spring 97 Spring seat 98 Step 99 Inclined surface 100 Stopper 102 Notch 103 Groove

Claims (11)

A plurality of injection needles each comprising a closed tip and a linear body including a lumen and a plurality of side openings communicating with the lumen;
An injection needle device comprising: a support block that supports the plurality of injection needles;
The plurality of injection needles are fixed to the support block;
The support block includes an inclined surface that is inclined with respect to a side surface of the main body portion of the plurality of injection needles, and is configured to contact a tissue into which the plurality of injection needles are inserted. The plurality of injection needles protrude from the inclined surface at the same angle that is not perpendicular to the inclined surface, and the plurality of injection needles form a substantially polygonal apex on the inclined surface The plurality of injection needles extend from the inclined surface so as to protrude from each other with the same length so that the tip portion defines a surface parallel to the inclined surface ;
The support block is
A recess formed on the base end side of the support block;
A plurality of lumens extending from the bottom surface of the recess toward the distal end side of the support block and configured to fix the plurality of injection needles;
An outer annular member attached to the inner circumferential surface of the recess;
An inner central member having an annular wall disposed inside the outer annular member,
The inner central member includes a central flow path defined by an inner peripheral surface of the annular wall, and branch flow paths that extend radially from the central flow path through the annular wall,
The branch needle channel device is formed between the outer peripheral surface of the inner central member and the inner peripheral surface of the support block, and communicates with an annular channel communicating with the plurality of lumens . A plurality of injection needles each comprising a closed tip and a linear body including a lumen and a plurality of side openings communicating with the lumen;
An injection needle device comprising: a support block that supports the plurality of injection needles;
The plurality of injection needles are fixed to the support block;
The support block includes an inclined surface that is inclined with respect to a side surface of the main body portion of the plurality of injection needles, and is configured to contact a tissue into which the plurality of injection needles are inserted. The plurality of injection needles protrude from the inclined surface at the same angle and the same length that are not perpendicular to the inclined surface;
The injection needle device has a longitudinal section in which the inclined surface is inclined with respect to a side surface of the main body portion of the plurality of injection needles, and the distal end portions of the plurality of injection needles in the longitudinal section. Are arranged on a straight line parallel to the inclined surface ,
The support block is
A recess formed on the base end side of the support block;
A plurality of lumens extending from the bottom surface of the recess toward the distal end side of the support block and configured to fix the plurality of injection needles;
An outer annular member attached to the inner circumferential surface of the recess;
An inner central member having an annular wall disposed inside the outer annular member,
The inner central member includes a central flow path defined by an inner peripheral surface of the annular wall, and branch flow paths that extend radially from the central flow path through the annular wall,
The branch needle channel device is formed between the outer peripheral surface of the inner central member and the inner peripheral surface of the support block, and communicates with an annular channel communicating with the plurality of lumens .   The said several injection needle is comprised from the position which forms the vertex of a regular pentagon substantially in the said inclined surface, and the six injection needles arrange | positioned in the center of the said regular pentagon. Injection needle device. It said injection needle device further wherein the support block a mounting block for attachment to a syringe, and a mounting block of the flow path forming portion capable of receiving a tubular of the syringe, of the claims 1 to 3 The injection needle device according to any one of the above. A combination of the injection needle device according to any one of claims 1 to 4 and a tubular guide member that guides the injection needle device relative to the tissue, wherein the guide member contacts the tissue. The distal end surface is configured at the same angle as the inclined surface of the support block with respect to the side surface of the main body portion of the injection needle guided by the guide member. Inclined, combination. A plurality of injection needles each comprising a closed tip and a body including a lumen and a side opening communicating with the lumen;
An injection needle device comprising: a support block that supports the plurality of injection needles;
The support block includes a distal end surface from which the plurality of injection needles protrude and an inclined surface that is inclined with respect to the distal end surface and configured to contact a tissue into which the plurality of injection needles are inserted. ,
The plurality of injection needles protrude from the distal end surface in the same length in a fork shape and extend from the support block so that at least portions extending from the support block are curved in the same direction and with the same radius of curvature. The portion is curved in an arc shape having the constant radius of curvature throughout,
The injecting needle device, wherein the portions extending from the support block have the same insertion length when the inclined surface contacts the tissue. The injection needle device according to claim 6 , wherein the plurality of injection needles are arranged in a line on a distal end surface of the support block. The injection needle device according to any one of claims 1 to 7 , wherein the closed tip portion forms a blunt tip portion. The injection needle device according to any one of claims 1 to 8 , wherein the side openings are arranged so as to form a spiral pattern along a length direction of the plurality of injection needles. An infusion device set,
An injection needle device according to any one of claims 1 to 9 ,
An insertion device for inserting the plurality of injection needles into a tissue to be injected; and
The insertion device is
A fixing part that can be fixed to the tissue to be injected;
A first movable part for moving the injection needle device straight along the surface of the tissue to be injected;
An injection instrument set comprising: a second movable part that rotates the injection needle device so as to insert and remove the plurality of injection needles with respect to the tissue to be injected. The fixing portion includes a plate member having an opening that opens on the surface of the tissue to be injected,
The first movable part is
A rail member fixed to the side of the plate member and provided with a gear;
A tooth portion cooperating with the gear, and a rack member slidable along the rail member,
The second movable part is
A base fixed to the rack member;
A shaft portion rotatably attached to the base portion;
An insertion lever fixed to the shaft portion;
The injection device set according to claim 10 , further comprising: an arm portion having one end fixed to the shaft portion and the other end fixed to the injection needle device.

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