JP2009045124A - Blood vessel fixing kit - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a shunt blood vessel fixing kit to be effectively used to fix a target blood vessel for the hemodialysis such as a shunt blood vessel, capable of significantly improving the success rate of the button hole puncture. <P>SOLUTION: The kit 10 for fixing a blood vessel to the peripheral tissue comprises a puncture needle 12 to puncture the blood vessel; an outer barrel body 14 to be inserted into the puncture needle 12 from outside; an injection needle 16 to be inserted into the barrel of the outer barrel body 14, having the obtuse-angled distal end not to puncture the blood vessel; a syringe 18 connected to the injection needle 16; and a liquid bioadhesive 20 to be injected into the body of a patient via the syringe 18. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a novel technique for fixing a patient's blood vessel, particularly the vicinity of a blood vessel site forming a puncture port into which a needle is repeatedly inserted in buttonhole puncture, to the surrounding tissue.

  Conventionally, blood dialysis using a so-called artificial kidney (artificial dialysis), purifying blood taken from the patient's body and returning it to the body again to treat patients with renal failure and maintain life Has been done. And when purifying blood with such an artificial kidney, it is necessary to take out blood from a part of the living body in order to secure the amount of blood necessary for extracorporeal circulation. Since the vein on the surface side has a small blood flow volume and it is difficult to extract a sufficient amount of blood from the vein to the outside of the body, an arterial / venous anastomosis operation called a shunt operation is usually performed. In this, a vein located on the body surface side is connected (anastomized) to one of the arteries located deep in the body, thereby bypassing the blood. A blood vessel having a high flow rate, a so-called shunt blood vessel is formed. During the treatment with the artificial kidney, the blood is taken out from the shunt blood vessel by inserting a needle into the shunt blood vessel thus formed.

  In general, hemodialysis is performed on a renal failure patient at a frequency of 2 to 3 times per week, and 16 to 17 gauge (outer diameter 1.49 to 1. A very thick needle (about 65 mm) is punctured, which causes great pain to dialysis patients. This puncture technique requires skill, and sometimes the sharp needle tip inserted into the shunt blood vessel during puncture or dialysis may damage the blood vessel wall opposite to the puncture opening. It has become.

  In order to solve such problems caused by puncture, a fixed puncture route (hole like a buttonhole in clothes) that forms a passage for inserting a needle from the skin to the shunt blood vessel is formed like a hole for passing a piercing. At the time of hemodialysis, a method of inserting a dull needle with a blunt tip through the fixed puncture route into a blood vessel from a puncture port previously formed on the shunt blood vessel wall, so-called “button hole puncture method” is performed. (See Patent Document 1). According to this buttonhole puncture method, the puncture is facilitated and the needle is inserted from the same puncture port each time, unlike the case where the shunt blood vessel is punctured from the skin surface with a sharp needle each time the puncture site is changed. Therefore, the benefits that the shunt blood vessel lasts long and pain during puncture is alleviated can be enjoyed. In addition, since a needle with a blunt tip is used for puncture, it is possible to advantageously prevent damage to the inner wall of the shunt blood vessel opposite to the puncture opening during puncture or dialysis. ing.

  However, since the blood vessels are not fixed to the surrounding tissues in the first place, the blood vessels move under the skin depending on the degree of skin pulling and the degree of blood transfer, and the puncture opening formed in the blood vessels accordingly. The position of also moves. Moreover, the puncture opening formed in the blood vessel cannot be confirmed from above the skin. For this reason, in such buttonhole puncture, although the tip of the dull needle can easily reach the blood vessel wall of the shunt blood vessel through the fixed puncture route, the puncture opening formed in the shunt blood vessel cannot be easily found. The problem that it is difficult to insert the tip of the dull needle into the blood vessel cavity is inherent, and the success rate of buttonhole puncture was not so high.

International Publication No. 2004/011063 Pamphlet

  Here, the present invention has been made in the background of such circumstances, and the problem to be solved is a shunt blood vessel that can dramatically improve the success rate of buttonhole puncture. It is an object of the present invention to provide a blood vessel fixing kit that is advantageously used for fixing blood vessels to be hemodialyzed.

  In order to solve such a problem, the gist of the present invention is that a sharp puncture needle for puncturing a patient's blood vessel and a puncture needle so that a tip portion does not protrude from the puncture needle. An outer cylinder of a predetermined length to be extrapolated, and in the state of being extrapolated to the puncture needle, by puncturing the patient's blood vessel with the puncture needle, the distal end portion of the patient's skin and blood vessel wall In this state, the puncture needle is removed from the patient, so that a part of the length direction remains in the body of the patient, and the needle is placed inside the cylinder. An outer cylinder that serves as a guide passage for guiding the vicinity of the blood vessel wall, and a distal end blunted so as not to puncture the blood vessel that is inserted into the outer cylindrical body and guided to the vicinity of the blood vessel wall of the patient. Injection needle and syringe connected to the injection needle And a liquid bioadhesive that is injected in the vicinity of the blood vessel wall of the patient with the syringe, and adheres to and fixes the blood vessel to the surrounding tissue at the puncture site of the puncture needle, In the vascular fixation kit.

  According to one of the preferred embodiments of the blood vessel fixing kit according to the present invention, the connecting portion connecting the injection needle and the syringe can be releasably locked in the axial direction so as not to be separated from each other. A locking mechanism will be provided.

  According to another preferred embodiment of the blood vessel fixing kit according to the present invention, the thickness of the puncture needle is 23 gauge or more and 27 gauge or less.

  Further, according to one of the desirable embodiments of the blood vessel fixing kit according to the present invention, the injection needle has a thickness of 23 gauge or more and 27 gauge or less and the same thickness as the puncture needle, or the same. It is said that the thickness is thinner.

  Still further, according to one of the other desirable embodiments of the present invention, the distal end surface of the injection needle is constituted by a cut surface in a direction perpendicular to the axial direction.

  According to another desirable mode of the blood vessel fixing kit according to the present invention, the tip of the puncture needle is sharply configured with a cut surface inclined with respect to the axial direction.

  Furthermore, according to another preferred embodiment of the blood vessel fixing kit according to the present invention, the shortest distance from the tip of the puncture needle to the tip of the outer cylinder is 1 mm or more.

  In addition, according to another preferred embodiment of the blood vessel fixing kit according to the present invention, the outer cylindrical body is a tube base having a predetermined length and a cylindrical base fixedly connected to one end of the tube portion. The cylindrical base portion is externally inserted into a holder portion that supports the puncture needle, and the puncture needle is inserted into the tube portion.

  In the present invention, the blood vessel fixing method using the kit as described above is also an object, and specifically, (a) the tip portion of the sharp puncture needle does not protrude beyond the puncture needle. After extrapolating the outer cylinder of a predetermined length to the patient, the puncture needle is punctured into the patient's blood vessel, and the distal end of the outer cylinder inserted into the puncture needle is attached to the patient's skin and blood vessel wall. And (b) with the outer cylinder inserted, the puncture needle is removed from the patient, and a part of the outer cylinder in the length direction is inserted. Is left in the patient's body, and an injection needle whose tip is blunted so as not to puncture a blood vessel is inserted into the cylinder of the outer cylinder, and the tip of the injection needle is inserted into the patient's body. Guiding to the vicinity of the blood vessel wall of the patient, and (c) a syringe connected to the injection needle, A method of fixing a blood vessel, which includes the step of injecting a liquid bioadhesive and fixing the blood vessel by partially adhering to the surrounding tissue. Become.

  As described above, the blood vessel fixing kit according to the present invention is used to form a blood vessel to be taken out and returned during blood dialysis of a patient, particularly a puncture port into which a needle is repeatedly inserted in buttonhole puncture. If the skin is partially adhered to the surrounding tissue and fixed, the puncture port of the blood vessel such as the shunt blood vessel continues from the skin to the blood vessel even if the skin is pulled or blood is fed. Successful buttonhole puncture because the tip of the dull needle can be introduced very easily into the puncture port formed in the blood vessel through the fixed puncture route without significantly deviating from the fixed puncture route (buttonhole). The rate is drastically improved.

  As a result, the situation in which a new puncture opening must be formed on a blood vessel such as a shunt blood vessel due to frequent failure of the buttonhole puncture can be advantageously reduced.

  In addition, since the patient's blood vessel is partially fixed with the liquid bioadhesive, the fixed portion becomes harder than the other portions. For this reason, it is possible to confirm the fixation site of the blood vessel by touching it with the fingers or the like from above the skin. As a result, the puncture port of the blood vessel formed in the vicinity of the fixation site is also confirmed from above the skin. It can be done. That is, such a fixed part acts like a marker indicating the position of the puncture opening formed on the blood vessel, and this also improves the success rate of buttonhole puncture.

  Moreover, since the entire blood vessel is not fixed to the surrounding tissue but partially fixed, it is prevented that the extension of the blood vessel accompanying arteriosclerosis that progresses over a long time is inhibited. In addition, there is no inconvenience when performing repair surgery for vascular stenosis.

  Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention will be described in detail with reference to the drawings.

  First, in order to clarify the configuration of the blood vessel fixing kit according to the present invention, FIG. 1 schematically shows a typical example. In this case, the blood vessel fixing kit 10 includes a puncture needle 12, an outer cylinder 14, an injection needle 16, a syringe 18, and a liquid bioadhesive 20.

  More specifically, the puncture needle 12 is used for puncturing a blood vessel such as a shunt blood vessel into which an indwelling needle is punctured in hemodialysis or the like, and like a known injection needle, A small-diameter cylindrical puncture needle main body 22 made of a material having rigidity is fixed to a hollow holder portion 23 made of a transparent resin material or the like that holds the puncture needle main body 22. Further, a cap 24 made of a stepped cylindrical transparent resin material or the like is provided at the opening end of the holder portion 23 on the side where the puncture needle body 22 is not fixed. Removably attached. Further, a filter 25 that allows air to permeate but does not allow liquid to permeate is attached to the large-diameter opening end of the cap 24 so that blood can flow into the cap 24 from the puncture needle body 22 side. The blood is not leaked to the outside.

  2 (a) and 2 (b), the distal end portion of the puncture needle 12 (puncture needle main body 22) is shown enlarged in the front form and the side form, respectively. As is clear from FIG. 2, the tip of the puncture needle 12 (puncture needle main body 22) has a plurality of (in this case, three cut surfaces) inclined relative to the axial direction of the puncture needle 12 (vertical direction in FIG. 2). This makes it possible to pierce the patient's skin, tissue and the like easily without puncturing at the time of puncturing.

  In this embodiment, as the puncture needle 12, a needle having a thickness of 23 gauge (G) or more and 27 gauge or less, which generally does not require a hemostasis operation, is advantageously used. This is because if the puncture needle 12 to be punctured in the blood vessel is too thick, a situation in which a hemostasis operation must be performed after the withdrawal of the needle is likely to occur, and when performing such a hemostasis operation, the puncture needle 12 is used. At the same time, the outer cylindrical body 14 inserted and placed under the skin of the patient becomes an obstacle, and the skin on the puncture site cannot be compressed. On the other hand, if the puncture needle 12 is too thin, the outer cylinder 14 to be externally inserted into the puncture needle 12 must be made thinner accordingly, and thus inserted into the cylinder of the outer cylinder 14. This is because the injection needle 16 for injecting the liquid bioadhesive 20 is also inconvenient because it must be made thin in accordance with the puncture needle 12. Here, the above-mentioned “G (gauge)” is a unit of thickness of the injection needle, and as shown in Table 1 below, it is understood that the smaller the number, the thinner. Should.

  On the other hand, the outer cylinder 14 is a cylindrical outer cylinder main body (tube portion 26) made of a transparent material having flexibility, such as plastic, having a shorter length than the puncture needle main body 22 of the puncture needle 12. And a stepped cylindrical base portion 28 made of a material such as resin, which is fixedly connected to one end of the tube portion 26, and the inner diameter of the tube portion 26 is the puncture needle 12. The outer diameter of the main body 22 is the same as or slightly larger. Therefore, the main body 22 of the puncture needle 12 can be inserted into the tube portion 26 of the puncture needle 12.

  Then, by inserting the outer cylinder 14 with respect to the puncture needle 12 from the base portion 28 side, in other words, the main body 22 of the puncture needle 12 is inserted from the base portion 28 side of the outer cylinder 14. Further, by inserting the holder portion 23 of the puncture needle 12 further, the puncture needle 12 and the outer cylindrical body 14 are integrated as shown in FIG. It can be attached detachably. At this time, the needle support portion 30 having a substantially cross-shaped cross section provided on the holder portion 23 of the puncture needle 12 projects outward in the radial direction with respect to the inner peripheral wall of the base portion 28 of the outer cylindrical body 14. In addition, the outer cylindrical body 14 and the puncture needle 12 are arranged coaxially by being slidably contacted by four rib-shaped protrusions 32 provided at intervals of 90 ° in the circumferential direction. The end 34 on the base portion 28 side of the outer cylindrical body 14 abuts on the stepped portion 36 of the holder portion 23 of the puncture needle 12, whereby the outer cylindrical body 14 is further moved from there to the holder portion 23 side of the puncture needle 12. It is possible to prevent extrapolation to (lower in FIG. 3).

  Further, in the present embodiment, in a state where the outer cylinder body 14 is attached to the puncture needle 12, the distal end portion of the outer cylinder body 14 (tube portion 26) is prevented from protruding beyond the distal end portion of the puncture needle body 22. 4 and, advantageously, as shown in FIG. 4, the shortest distance from the tip of the outer cylinder 14 to the tip of the puncture needle 12 is D, in other words, the tip of the outer cylinder 14 and the shaft. The axial distance from the edge of the puncture needle 12 or the cut surface of the puncture needle 12 cut obliquely with respect to the direction (the vertical direction in FIG. 4) is 1 mm or more, preferably 2 to 3 mm.

  Thus, when the puncture needle 12 to which the outer cylinder body 14 is attached is punctured into the patient's blood vessel, the distal end portion of the puncture needle 12 is inserted into the patient's blood vessel, while the distal end portion of the outer cylinder body 14 is inserted. Can be advantageously positioned at a site between the patient's skin and the blood vessel wall, effectively preventing the distal end of the outer cylinder 14 from entering the blood vessel together with the puncture needle 12. It has come to gain. In other words, if the distance D is too short, even the distal end portion of the outer cylindrical body 14 may be inserted into the patient's blood vessel together with the puncture needle 12.

  The tube portion 26 of the outer cylinder 14 as described above has an inner diameter that is the same as or slightly larger than the outer diameter of the puncture needle 12 as described above, while its thickness is When the puncture needle 12 to which the outer cylinder body 14 is attached is punctured, the tube portion 26 of the outer cylinder body 14 can be smoothly inserted together with the puncture needle 12 into the patient's skin, and the patient is strongly punctured. It is desirable that the thickness is about 0.08 to 0.12 mm so as not to cause stinging.

  On the other hand, the injection needle 16 shown in FIG. 1 is inserted under the skin of the patient, introduced into the cylinder of the indwelling outer cylinder 14, and the distal end thereof is guided to the vicinity of the patient's blood vessel wall. A cylindrical injection needle body 38 made of a rigid material such as metal, and a step made of a material such as a resin fixedly connected to one end side of the injection needle body 38 A cylindrical base portion 40 is included.

  5 (a) and 5 (b) are enlarged side and top views of the distal end portion of the injection needle body 38, respectively. Is blunt, not sharp, so as not to puncture the blood vessel, so that even if the tip hits the blood vessel wall or surrounding tissue, the blood vessel wall and surrounding tissue are not damaged, Even when the injection needle main body 38 is inserted into the cylinder of the outer cylinder body 14, the tip of the injection needle main body 38 pierces the cylinder wall of the outer cylinder body 14, and is caught in the cylinder. It is possible to advantageously prevent the cylindrical wall portion of the body 14 from being damaged and the fragments from remaining in the body.

  Moreover, as is apparent from FIG. 5, in this embodiment, the tip surface of the injection needle 16 (main body 38) whose tip is blunted is in a direction perpendicular to the axial direction of the injection needle 16. Even if the injection needle 16 is relatively thin, the distal end portion of the injection needle 16 (main body 38) penetrates the blood vessel wall of the patient, and the inside of the blood vessel is formed. Intrusion needle body 38 pierces the cylindrical wall of outer cylindrical body 14 when inserting outer cylindrical body 14 into the cylinder. This can be advantageously prevented and can be inserted smoothly.

  Further, the main body 38 of the injection needle 16 has an outer diameter that is slightly smaller than the inner diameter of the tube portion 26 of the outer cylindrical body 14, and can easily be inserted into the tube portion 26 of the outer cylindrical body 14. The thickness can be interpolated. FIG. 6 is an explanatory view showing a state in which the injection needle 16 is inserted and attached to the outer cylinder 14. In this case as well, the puncture needle 12 is attached to the outer cylinder 14. As in the case of being inserted and attached, the outer cylinder body 14 and the injection needle 16 are provided on the inner peripheral portion of the base portion 28 of the outer cylinder body 14 at the cross-section of the base portion 40 of the injection needle 16. The cross-shaped needle support portion 42 protrudes outward in the radial direction and is slidably contacted by four rib-shaped protrusions 44 provided at intervals of 90 ° in the circumferential direction so as to be arranged coaxially. In addition, the stepped portion 46 of the base portion 40 of the injection needle 16 abuts against the end portion 34 of the outer cylindrical body 14 on the base portion 28 side, so that the injection needle 16 is further moved from its position. The tube part 26 side of the outer cylinder 14 (in FIG. ) To, be interpolated is adapted to be blocked.

  Further, the length of the injection needle 16 is not particularly limited, but advantageously, the stepped portion 46 of the base portion 40 of the injection needle 16 is connected to the base portion 28 side of the outer cylinder 14. The tip of the injection needle main body 38 and the tip of the tube portion 26 substantially coincide with each other in the axial direction, or the tip of the injection needle main body 38 is It is desirable to have a length that slightly protrudes from the distal end of the tube portion 26, and it is even more desirable that the protruding length is preferably about 1 to 3 mm. By adopting such a protruding length, it is possible to advantageously prevent the distal end portion of the injection needle body 38 from protruding and damaging the patient's blood vessel wall. It becomes possible to inject in the vicinity of the blood vessel wall even more advantageously.

  In addition, as the thickness of the injection needle 16 (main body 38), as described above, a needle having the same or smaller outer diameter than that of the outer cylindrical body 14 is used. Of these, those having a thickness of 23 gauge or more and 27 gauge or less and the same thickness as the main body 22 of the puncture needle 12 or a thickness thinner than that are particularly preferably used. This is because if the injection needle 16 is too thick and thicker than the main body 22 of the puncture needle 12, the injection needle 16 cannot be inserted into the cylinder of the outer cylinder 14. If the injection needle 16 is too thin, even if the tip is blunted, the tip may pierce the blood vessel wall and enter the blood vessel. Further, when injecting the liquid bioadhesive 20 This is because the injection pressure for pushing the piston of the syringe 18 is remarkably increased.

  FIG. 7 shows a plan view of the injection needle 16 as described above. An annular portion protruding radially outward is formed at the end of the base portion 40 of the injection needle 16. A stepped portion 48 is provided, and the stepped portion 48 is further formed with projecting portions 50 and 50 having a predetermined width in the circumferential direction at two locations facing each other in the radial direction. And in this embodiment, these two protrusion parts 50 and 50 are engaged in the connector 58 provided in the syringe 18 mentioned later.

  On the other hand, the syringe 18 shown in FIG. 1 is a resin material in which a cylinder 52 made of a transparent material such as glass or resin and a seal portion 53 made of rubber or the like are integrally attached to the tip, similarly to a known syringe. It is configured to have a piston 54 made of, for example.

  8 (a) and 8 (b) show a longitudinal sectional view and a plan view of the cylinder 52 constituting the syringe 18, respectively. A connector 58 made of a transparent resin material or the like for connecting the injection needle 16 as described above is coaxially connected to the distal end small diameter portion 56 in the axial direction and the circumferential direction. It is fixed so that it cannot move.

  More specifically, the connector 58 has an inner diameter that is the same as or slightly larger than the distance between the apexes of the two protrusions 50 and 50 provided at the end of the base portion 40 of the injection needle 16 as described above. In the inner wall 59, two spiral ridges 60a and 60b are formed in a double spiral shape in a form shifted by 180 ° in the circumferential direction. Then, the base portion 40 of the injection needle 16 is inserted into the connector 58 so that the tip portion of the small diameter portion 56 of the syringe 18 is covered with the opening of the base portion 40 of the injection needle 16, and By rotating the injection needle 16 about the axis while sliding the two protrusions 50, 50 of the injection needle 16 on the two protrusions 60a, 60b formed on the inner wall 59, respectively, The injection needle 16 is screwed along the protrusions 60a, 60b of the connector 58, and the injection needle 16 and the syringe 18 are locked in an axially inseparable manner, In addition, the protrusions 60a and 60b of the connector 58 and the injection are rotated by rotating the injection needle 16 to the opposite side. And engagement of the two protrusions 50, 50 of the needle 16 is eliminated, connecting the injection needle 16 and the syringe 18 is adapted to be released. That is, in this embodiment, since the connector 58 having a so-called luer lock type releasable locking mechanism is fixedly provided at the distal end portion of the syringe 18, an injection needle generally used conventionally has been used. Unlike the luer slip type connection, in which the injection needle 16 is detached from the syringe 18 during use, it is advantageously prevented. It has come to gain.

  On the other hand, the liquid bioadhesive 20 shown in FIG. 1 is a liquid bioadhesive used in a patient's body to partially adhere to and fix blood vessels to surrounding tissues, and has a predetermined structure. In an amount sufficient to partially fix the blood vessel.

  The liquid bioadhesive 20 is a liquid bioadhesive having a viscosity that can be injected by a syringe 18 equipped with an injection needle 16 and can adhere a blood vessel and a soft tissue. For example, any conventionally known one can be employed. For example, a cyanoacrylate adhesive containing 2-cyanoacrylate such as ethyl-2-cyanoacrylate or octyl-2-cyanoacrylate or a derivative thereof as an active ingredient. Examples of such products that are commercially available as Aron Alpha A (distributor: Sankyo Co., Ltd.), Dermabond (distributor: Johnson & Johnson Co., Ltd.), and the like.

  Thus, using the blood vessel fixing kit 10 comprising the puncture needle 12, the outer cylinder 14, the injection needle 16, the syringe 18 and the liquid bioadhesive 20 as described above, the patient's blood vessel is fixed to the surrounding tissue. Is performed according to the following method, for example.

  First, the outer cylinder 14 is extrapolated and attached to the puncture needle 12 having a sharp tip. At this time, preferably, the shortest distance from the distal end portion of the puncture needle 12 to the distal end portion of the outer cylindrical body 14 is D so that the distal end portion of the outer cylindrical body 14 does not protrude from the distal end portion of the puncture needle 12. Is 1 mm or more, preferably 2 to 3 mm.

  Next, as shown in FIG. 10, the puncture needle 12 with the outer cylindrical body 14 attached is aimed at a site where the indwelling needle for hemodialysis is to be punctured (site where the blood vessel 62 is to be punctured). When puncturing from above the skin 64 at a predetermined inclination angle, the outer cylindrical body 14 is also inserted subcutaneously together with the puncture needle 12. At this time, the puncture is performed in the direction opposite to the puncture direction of the indwelling needle for hemodialysis, that is, when the indwelling needle for hemodialysis is punctured from the palm side toward the elbow side, It is desirable to puncture the puncture needle 12 from the elbow side toward the palm side.

  When the distal end portion of the puncture needle 12 penetrates the patient's skin 64, the soft tissue 65, and the blood vessel wall 66 of the blood vessel 62 and is introduced into the blood vessel 62, the blood 68 in the blood vessel 62 is transferred to the puncture needle 12. The main body 22 is caused to flow backward to flow into the transparent holder portion 23 and the hollow portion of the cap 24. Thereby, a nurse, a doctor or the like who is puncturing the puncture needle 12 can immediately confirm that the distal end portion of the puncture needle 12 has been introduced into the blood vessel 62. At this time, the distal end portion of the puncture needle 12 is inserted into the blood vessel 62, while the outer cylindrical body 14 extrapolated to the puncture needle 12 has a distal end portion between the skin 64 and the blood vessel wall 66. It is located in the vicinity (in the figure, soft tissue 65), particularly near the blood vessel wall 66.

  In this way, after confirming that the distal end portion of the puncture needle 12 has been introduced into the blood vessel 62, as shown in FIG. 11, the puncture needle 12 remains inserted with the outer cylinder 14 subcutaneously. Is moved in the axial direction (in the direction of the arrow in FIG. 11) and removed. As a result, the outer cylinder 14 is left in the patient's body in a part of the length direction, and the cylinder of the outer cylinder 14 serves as a guide passage for guiding the injection needle 16 to the vicinity of the blood vessel wall 66. It becomes.

  Next, as shown in FIG. 12, the injection needle 16 connected with the syringe 18 containing a predetermined amount of the liquid bioadhesive 20 is moved from the base portion 28 side to the distal end portion side of the puncture needle 12 (FIG. 12). 12, in the direction of the arrow), until the stepped portion 46 of the injection needle 16 contacts the end 34 of the base portion 28 of the puncture needle 12, it is coaxially inserted into the cylinder of the outer cylindrical body 14. By this operation, the distal end portion of the injection needle 16 is guided to the vicinity of the blood vessel wall 66 through the inside of the outer cylindrical body 14 (see FIG. 13). At this time, since the tip of the injection needle 16 is blunted, even if it hits the blood vessel wall 66, it can be advantageously prevented from sticking into the blood vessel wall 66.

  Then, by pressing the piston 54 of the syringe 18 with the distal end portion of the injection needle 16 positioned in the vicinity of the blood vessel wall 66, that is, in the vicinity of the blood vessel wall 66, as shown in FIG. The liquid bioadhesive 20 accommodated in the cylinder 52 is injected into the vicinity of the blood vessel wall 66.

  In this way, the liquid bioadhesive 20 injected in the vicinity of the blood vessel wall 66 spreads in the tissue around the tip of the injection needle 16 and is rapidly cured. For this reason, while injecting a predetermined amount of the liquid bioadhesive 20, the injection pressure for pushing the piston 54 of the syringe 18 is significantly higher than that at the beginning of the injection, but in this embodiment, the injection needle 16 and the syringe 18. Are connected by a connector 58 having a releasable locking mechanism as described above, and during the injection of the liquid bioadhesive 20, the connection state between the injection needle 16 and the syringe 18 is canceled, It is possible to prevent the injection needle 16 from coming off the syringe 18 very effectively.

  At this time, the injection amount of the liquid bioadhesive 20 injected in the vicinity of the blood vessel wall 66 is not particularly limited, but is generally about 0.05 to 0.30 ml, preferably 0. The liquid bioadhesive 20 in an amount of about 1 to 0.2 ml, more preferably about 0.1 ml is injected.

  Then, after injecting a predetermined amount of the liquid bioadhesive 20, the syringe 18 and the outer cylinder 14 to which the injection needle 16 is connected are both removed from the patient's body, and the blood vessel 62 after removal is injected into the injected liquid. In a few minutes, the bioadhesive 20 firmly adheres to and fixes the surrounding tissue at the puncture site of the puncture needle 12 (see FIG. 14).

  Further, the portion 70 fixed by the liquid bioadhesive 20 becomes hard like a stone due to the hardening of the liquid bioadhesive 20, and the position 70 can be recognized immediately by touching with the fingers from the skin 64. Can be done.

  In the above, an example of a method for fixing a patient's blood vessel to the surrounding tissue using the blood vessel fixing kit 10 according to the present embodiment has been specifically described. For the blood vessel 62 thus fixed, To perform buttonhole puncture, a fixed puncture route (buttonhole) is first prepared as shown in FIGS.

  Specifically, as shown in FIG. 15, an ordinary thick and sharp indwelling needle 72 for hemodialysis is taken from a direction opposite to the puncture direction of the puncture needle 12 as described above (left side in FIG. 15). Then, puncture is performed aiming at the fixed portion 70, and normal hemodialysis is performed one by one. As a result, a needle hole 74 is formed by the thick indwelling needle 72 from the patient's skin 64 to the blood vessel wall 66, and a puncture port 76 into which the hemodialysis needle is repeatedly inserted is formed in the blood vessel 62.

  Then, after the hemodialysis is completed, the indwelling needle 72 is removed and the hemostasis is performed as usual. Thereafter, as shown in FIG. 16, a thumbtack-shaped stick 78 having a length that does not reach the blood vessel wall 66 is inserted from the surface of the skin 64 along the needle hole 74 formed by the indwelling needle 72. To do. Then, the thumbtack-shaped stick 78 is replaced with a new thumbtack-shaped stick 78 every time hemodialysis, and the thumbtack-shaped stick 78 is left in the needle hole 74 for several days to several weeks, so that the fixed puncture route 80 ( 17) is formed.

  Thus, in order to perform buttonhole puncture using the fixed puncture route 80 formed as described above, after peeling the crust (not shown) formed at the entrance of the fixed puncture route 80, As shown in FIGS. 17 (a) and 17 (b), the indwelling dull needle 82 with a blunt tip may be gently inserted along the fixed puncture route 80. In this way, as shown in FIG. 17, even if the blood vessel 62 is fixed to the surrounding tissue at the site on the blood vessel wall 66 side of the fixed puncture route 80, The puncture port 76 formed in 62 is not significantly displaced from the fixed puncture route 80, so that the tip of the indwelling dull needle 82 can be introduced into the puncture port 76 very easily. It has become. As a result, it is no longer necessary to locate the puncture port 76 by moving the indwelling dull needle 82 within the fixed puncture route 80, or reinserting it, thereby advantageously preventing the patient from suffering from puncture pain. As a result, the success rate of buttonhole puncture can be dramatically increased.

  Further, by touching from above the skin 64, it is possible to confirm the position of the fixed portion 70 cured by the liquid bioadhesive 20, and thus the position of the puncture port 76 formed in the vicinity of the fixed portion 70. Therefore, even if the tip of the indwelling dull needle 82 is not inserted into the puncture port 76 in a single shot, if the advancing tip of the indwelling dull needle 82 is aimed at the fixed portion 70, The distal end portion of the indwelling dull needle 82 can be easily inserted into the puncture port 76 formed in the blood vessel 62. In short, the fixing portion 70 of the blood vessel 62 plays a role like a marker indicating the position of the puncture port 76, and this can also significantly improve the success rate of buttonhole puncture.

  Therefore, by using the blood vessel fixing kit 10 according to the present embodiment, the patient's blood vessel 62, in particular, the blood vessel site in the vicinity of the site where the puncture port 76 is formed is partially adhered to the surrounding tissue and fixed. Then, puncture pain can be effectively prevented, and repeated formation of a new puncture opening on the blood vessel 62 can be suppressed. As a result, damage to the blood vessel 62 such as the shunt blood vessel due to the puncture is prevented, so that the shunt blood vessel can be used semipermanently.

  In addition, since the entire blood vessel 62 is not fixed to the surrounding tissue but partially fixed, the extension of the blood vessel accompanying arteriosclerosis that progresses over a long time is inhibited. This can be prevented, and there is no inconvenience when performing repair surgery for vascular stenosis.

  The specific configuration of the present invention has been described in detail above. However, this is merely an example, and the present invention is not limited by the above description.

  For example, in the above example, as a connecting structure between the injection needle 16 and the syringe 18, two protrusions 60a, 60b provided on the inner wall 59 of the connector 58 are provided with two protrusions of the injection needle 16. A structure in which 50 and 50 are brought into sliding contact with each other and screwed is employed. However, it may have a releasable lock mechanism that locks the injection needle 16 and the syringe 18 in the axial direction so as not to be separated from each other. For example, the structure of the above example is not limited at all. For example, a structure in which a female screw part and a male screw part are provided at the connecting part of the injection needle 16 and the syringe 18 and they are screwed together is used. In addition to this, a structure having a conventionally known lock mechanism can be appropriately selected.

  Moreover, in the said embodiment, although the holder part 23 fixed to the one end side of the main body 22 of the puncture needle 12 had the length which can be easily picked with a finger, the magnitude | size and shape of the holder part 23 are the above examples. It is not limited in any way, and may have any shape and size as long as it can support the main body 22 of the puncture needle 12 and can be attached to the outer cylindrical body 14. For example, the outer cylindrical body 14 and the base portions 28 and 40 of the injection needle 16 may have shapes and sizes.

  Further, the cap 24 with the filter 25 is attached to the puncture needle 12 at the opening end portion of the holder portion 23 in a liquid-tight manner. However, the holder portion 23 and the holder portion 24 are not limited even if they are integrated. There is no problem. In short, when the puncture needle 12 is punctured into the blood vessel 62, a blood receptor for receiving blood 68 flowing from the blood vessel through the main body 22 of the puncture needle 12 is provided as a separate member from the holder portion 23. Alternatively, it may be provided integrally with the holder portion 24.

  Moreover, in the said embodiment, although the front end surface of the injection needle 16 (main body 38) was comprised by the cut surface of the direction perpendicular | vertical with respect to the axial direction of the injection needle 16, the injection needle 16 ( As long as the distal end portion of the main body 38) does not pierce the patient's blood vessel wall 66, not only the vertical surface but also the distal end surface of the injection needle 16 '(main body 38') is large as shown in FIG. Of course, it is also possible to form a cut surface having an inclination angle (θ in FIG. 18).

  In addition, according to the present invention, not only a shunt blood vessel in which a needle for hemodialysis is generally punctured and an anastomosis of a vein and an artery, but also a deep artery or vein can be fixed to the surrounding tissue. Therefore, it can also be expected to perform a buttonhole puncture directly into an artery or vein.

  In addition, although not enumerated one by one, the present invention can be carried out in a mode to which various changes, modifications, improvements, etc. are added based on the knowledge of those skilled in the art. It goes without saying that all are included in the scope of the present invention without departing from the spirit of the present invention.

  Blood vessel fixing kit as described above (puncture needle: 26 gauge, outer cylinder: 24 gauge, injection needle: 27 gauge, syringe: luer lock type syringe, liquid bioadhesive: Aron Alpha A manufactured by Toagosei Co., Ltd., injection amount : 0.1ml), when the buttonhole puncture is performed with the shunt blood vessel of the dialysis patient fixed to the surrounding tissue, and when the buttonhole puncture is performed without fixing the shunt blood vessel as in the past. The success rate was examined, and the results are also shown in Table 2 below. Here, “successful buttonhole puncture” means that the tip of a dull needle for hemodialysis can be inserted very easily into a puncture opening formed in a shunt blood vessel through a fixed puncture route. In contrast, puncture that does not cause pain due to puncture.

  As is clear from Table 2, when the buttonhole puncture is performed with the shunt blood vessel fixed to the surrounding tissue using the blood vessel fixing kit according to the present invention, the success rate of the buttonhole puncture is drastically improved. , It can be seen that all nurses succeeded in puncturing at a rate of 95% or more.

It is a schematic explanatory drawing which shows one Embodiment of the blood vessel fixation kit according to this invention. It is a figure which shows the front-end | tip part of the puncture needle shown by FIG. 1, Comprising: (a) is front explanatory drawing, (b) is side explanatory drawing. It is explanatory drawing which shows the state which attached the outer cylinder body to the puncture needle shown by FIG. FIG. 4 is a partially enlarged explanatory view in FIG. 3. It is a figure which shows the front-end | tip part of the needle for injection shown by FIG. 1, Comprising: (a) is front explanatory drawing, (b) is a plane explanatory drawing. It is explanatory drawing which shows the state which attached the injection needle to the outer cylinder body shown by FIG. FIG. 2 is an explanatory plan view of the injection needle shown in FIG. 1. It is a figure for demonstrating schematically the cylinder which comprises the syringe shown by FIG. 1, Comprising: (a) is longitudinal cross-sectional explanatory drawing, (b) is plane explanatory drawing. It is explanatory drawing which shows the state which connected the injection needle to the syringe shown by FIG. It is explanatory drawing which shows the process of puncturing the blood vessel of a patient with the puncture needle with which the outer cylinder body was attached according to this invention. It is explanatory drawing which shows the process which moves a puncture needle to an axial direction, and removes in the state which inserted the outer cylinder body under the patient's subcutaneous according to this invention. It is a fragmentary sectional explanatory view showing the process of inserting the injection needle connected with the syringe into the cylinder of the outer cylinder according to the present invention. It is explanatory drawing which shows the process of inject | pouring a liquid bioadhesive to the vicinity of the blood vessel wall of a patient's blood vessel according to this invention. It is explanatory drawing which shows the blood vessel which was adhere | attached and fixed to the surrounding tissue according to this invention. It is explanatory drawing which shows one of the processes of forming a fixed puncture route (buttonhole) with respect to the blood vessel fixed according to this invention, Comprising: The state which punctured the shunt blood vessel with the normal indwelling needle is shown. It is explanatory drawing which shows another one of the processes which form a fixed puncture route (button hole) with respect to the blood vessel fixed according to this invention, Comprising: A thumbtack shape was formed in the puncture hole formed with the normal indwelling needle. The state where the stick is placed is shown. It is explanatory drawing which shows the process of inserting the dull needle with a blunt tip with respect to the fixed puncture route (button hole) formed with respect to the blood vessel fixed according to this invention, Comprising: (a) is the state before dull needle insertion (B) has shown the state which inserted the dull needle. It is side surface explanatory drawing which shows the front-end | tip part of the needle for injection in embodiment different from the needle for injection shown by FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Blood vessel fixation kit 12 Puncture needle 14 Outer cylinder 16 Injection needle 18 Syringe 20 Liquid bioadhesive 22 Puncture needle main body 23 Holder part 24 Cap 26 Tube part 28, 40 Base part 30 Support part 32, 44 Projection part 34 End portion 36, 46 Stepped portion 38 Injection needle body 42 Needle support portion 48 Step portion 50 Projection portion 52 Cylinder 53 Seal portion 54 Piston 56 Tip small diameter portion 58 Connector 60a, 60b Projection strip 62 Shunt blood vessel 64 Skin 66 Blood vessel wall 68 Blood 70 Fixed site 72 Indwelling needle 74 Needle hole 76 Puncture port 78 Thumbtack shaped stick 80 Fixed puncture route 82 Dal needle for indwelling

Claims (8)

A sharp puncture needle to puncture a patient's blood vessel;
An outer cylinder body of a predetermined length that is externally inserted into the puncture needle so that the distal end portion does not protrude beyond the puncture needle, and in the state of being externally inserted into the puncture needle, the puncture needle is inserted into the blood vessel of the patient Is inserted so that the distal end portion is located at a site between the patient's skin and the blood vessel wall, and in that state, the puncture needle is removed from the patient in the longitudinal direction. An outer cylinder that is used as a guide passage for guiding a needle to the vicinity of the blood vessel wall.
An injection needle inserted into the outer cylinder and guided to the vicinity of the blood vessel wall of the patient, the tip of which is blunted so as not to puncture the blood vessel;
A syringe coupled to the infusion needle;
A liquid bioadhesive that is injected in the vicinity of the blood vessel wall of the patient with the syringe and the blood vessel is adhered and fixed to the surrounding tissue at the puncture site of the puncture needle;
A vascular fixation kit comprising:   The blood vessel fixing kit according to claim 1, wherein a releasable locking mechanism that locks the injection needle and the syringe in an axial direction so as to be non-separable from each other is provided at a connecting portion that connects the injection needle and the syringe.   The blood vessel fixing kit according to claim 1 or 2, wherein a thickness of the puncture needle is 23 gauge or more and 27 gauge or less.   4. The injection needle according to claim 1, wherein the injection needle has a thickness of 23 gauge or more and 27 gauge or less, and has the same thickness as the puncture needle or a thickness thinner than that. The blood vessel fixing kit according to Item.   The blood vessel fixing kit according to any one of claims 1 to 4, wherein a distal end surface of the injection needle is configured by a cut surface in a direction perpendicular to an axial direction.   The blood vessel fixing kit according to any one of claims 1 to 5, wherein a distal end portion of the puncture needle is sharply configured with a cut surface inclined with respect to an axial direction.   The blood vessel fixing kit according to any one of claims 1 to 6, wherein a shortest distance from a distal end portion of the puncture needle to a distal end portion of the outer cylinder is 1 mm or more. The outer cylindrical body has a tube portion having a predetermined length and a cylindrical base portion fixedly connected to one end of the tube portion, and the cylindrical base portion serves as a holder portion that supports the puncture needle. The blood vessel fixing kit according to any one of claims 1 to 7, wherein the blood vessel fixing kit is configured so that the puncture needle is inserted through the tube portion by being externally inserted.

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