JP2020054601A - Two-way suture equipment for medical use - Google Patents

Abstract

To provide two-way suture equipment for medical use with which biological membranes and the like can be safely sutured.SOLUTION: Two-way suture equipment 1 for medical use has a first needle member, a second needle member, and a regulation member on a distal side and a handle part 21 on a proximal side. The first needle member has an end facing the distal side. The second needle member is arranged nearer on the distal side than the first needle member and has an end facing the proximal side. The regulation member is located nearer on the distal side than the first needle member and located nearer on the proximal side than the second needle member. The handle part 21 has a first operation part 23 moving the first needle member, a second operation part 24 moving the second needle member, and a third operation part 25 moving the regulation member. The first needle member moves to the distal side in a loaded condition of the first operation part 23, the second needle member moves to the proximal side in a loaded condition of the second operation part 24, and the regulation member moves from a position which hinders the movements of the first needle member and/or the second needle member to a position which does not in a loaded condition of the third operation part 25.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a medical bidirectional suturing device capable of suturing an object with a thread in both directions from a proximal side to a distal side and a distal side to a proximal side.

  In order to remove a tumor formed in the pituitary gland, trans-sphenoidal pituitary tumor removal (TSS; Trans-Sphenoidal Surgery) is often performed. TSS is generally performed in the following procedure. First, the surgeon advances while peeling the nasal mucosa along the patient's nasal septum, and reaches the pituitary gland by fenestrating the sphenoid bone and opening the dura. The pituitary tumor is then removed, and the dura is finally sutured to reconstruct the sphenoid bone and nasal mucosa. As a device for suturing a dura, a device for passing a suture in both directions from a distal side to a proximal side and a proximal side to a distal side of the dura has been proposed (for example, Patent Documents 1 to 3). 7).

JP 2011-509121 A International Publication No. 2009/089110 JP 2014-528768 A International Publication No. WO 2013/024466 JP 2011-72790 A JP 2012-515636 A International Publication No. 2010/085793

  In a medical suturing device that allows a thread to pass in both directions from one side to the other side and from the other side of the object to be sutured, the needle is moved in both directions during suturing to pass the thread. There is a tendency that the mechanism and operation for realizing it are complicated. For example, in the suture holder described in Patent Literatures 1 and 2, in order to reciprocate the needle in both directions, it is necessary to re-grip the needle and change the gripping position each time. In the devices described in Patent Literatures 3 to 5, it is necessary to produce a knot on the suture or tie the knot to a ferrule, so that these operations require time. The threading devices described in Patent Documents 6 and 7 have a problem that it is physically difficult to move the suture from the cutout of the needle into the groove of the distal boom arm housing.

  In a medical bidirectional suturing device, the movement of the needle is more complicated than in a suturing device in which the needle is sent out in only one direction, but safety is ensured so that the needle does not inadvertently damage the suturing object etc. Is desired. The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a medical two-way suturing apparatus capable of safely performing a suturing operation of a biological membrane or the like.

  The medical bidirectional suturing device of the present invention that can solve the above problem has a first needle member, a second needle member, and a regulating member on the distal side, and has a handle portion on the proximal side. A medical bidirectional suturing device, wherein the first needle member is distally movable and distally movable; the second needle member is disposed distally of the first needle member. The tip is directed proximally and is movable in the near-far direction; the regulating member is located more distally than the first needle member and more proximally than the second needle member; Alternatively, the handle can move between a position where the movement of the second needle member is not hindered and a position where the movement of the second needle member is not hindered; the handle portion moves the first operation member that moves the first needle member and the second needle member. A second operating portion; and a third operating portion for moving the regulating member; the first operating portion is in a no-load state and the first needle member is positioned proximally. Then, the first needle member moves to the distal side in the loaded state; the second needle member is located to the distal side in the unloaded state of the second operating portion, and the second needle member moves to the proximal side in the loaded state. Moving; when the third operating portion is in a no-load state, the regulating member is at a position where movement of the first needle member and / or the second needle member is obstructed, and in a loaded state, the first needle member and / or the second needle member It is characterized in that it moves to a position that does not hinder the movement of the user.

  In the medical bidirectional suturing device of the present invention, the first needle member is sent forward by setting the first operation portion to the load state, and the second needle member is moved forward by setting the second operation portion to the load state. The third operating portion is sent out, and in a no-load state, the regulating member is at a position where the movement of the first needle member and / or the second needle member is hindered. It is configured to move to a position that does not hinder the movement of the two-needle member. Therefore, in order to send out the first needle member forward, it is necessary to put both the first operating portion and the third operating portion in the load state, and to send out the second needle member forward, the second operating portion is required. It is necessary to put both the and the third operation unit in the load state. Therefore, according to the medical two-way suturing device of the present invention, when a load is erroneously applied to only one of the first to third operation units, the first needle member or the second needle member is moved. It is possible to prevent the object to be sutured from being erroneously damaged by being sent forward, and the suturing operation can be performed safely.

  The first to third operation units are preferably push buttons or levers. Further, the third operation unit is provided on the distal side of the first operation unit and the second operation unit, and the first operation unit and the second operation unit are push buttons that are in a load state by being pushed to the distal side. In this case, it is preferable that the third operation unit is a lever that is brought into a load state by being pulled proximally.

  As a regulating member, a first regulating member and a second regulating member located on a distal side of the first regulating member are provided, and the first regulating member prevents the movement and movement of the first needle member. The second regulating member may be movable between a position where it does not hinder the movement of the second needle member and a position where it does not hinder the movement of the second needle member. By providing the first regulating member and the second regulating member in this manner, it becomes difficult for both the first needle member and the second needle member to be accidentally sent forward. In this case, when the third operating portion is in a no-load state, the first regulating member is located at a position where the movement of the first needle member is obstructed, and the second regulating member is located at a position obstructing the movement of the second needle member. With the third operating portion being loaded, the first regulating member moves to a position where it does not hinder movement of the first needle member, and the second regulating member moves to a position where it does not hinder movement of the second needle member. Is preferred. Thereby, the first regulating member and the second regulating member can be easily operated.

  It is preferable that the suturing device further includes a fixing member for fixing a biological membrane to be sutured on the distal side, and the handle unit includes a fourth operation unit that moves the fixing member. In this case, the fixing member has a distal end that is more distal and more distal than the first needle member in a state where the first needle member is located at the most proximal side and the second needle member is located at the most distal side. The fixing member is located closer to the proximal side than the two-needle member and can move in the near-far direction. Are preferred. Alternatively, the fixation member may be configured such that the proximal end is distal and second from the first needle member in a state where the first needle member is located most proximally and the second needle member is located most distally. The fixing member is located on the distal side with respect to the needle member, is movable in the near and far directions, and the fixing member is located on the distal side when the fourth operation unit is in a no-load state, and the fixing member moves proximally in the loaded state. It may be something.

  The fourth operation unit is preferably a push button or a lever. Further, it is preferable that the fourth operation unit is provided on the distal side with respect to the first operation unit and the second operation unit, and the fourth operation unit is a lever that is brought into a load state by being pulled proximally.

  ADVANTAGE OF THE INVENTION According to the medical bidirectional suturing apparatus of this invention, it is possible to suture bidirectionally by using the first needle member and the second needle member. When performing the suturing operation, the first needle member can be sent forward by setting both the first operation unit and the third operation unit in the load state, and both the second operation unit and the third operation unit are moved. By setting the load state, the second needle member can be sent forward. Therefore, when a load is erroneously applied to only one of the first operation unit to the third operation unit, the first needle member or the second needle member is sent forward and erroneously damages the suture target. Can be prevented, and the suturing operation can be performed safely.

FIG. 2 illustrates an example of a side view of a medical two-way suturing device. FIG. 3 shows an example of a cross-sectional view of a treatment section on the distal side of a medical bidirectional suturing device, showing a configuration example of a treatment section in a state where a regulating member is at a position that does not hinder movement of a first needle member and a second needle member. Represent. FIG. 4 shows an example of a cross-sectional view of a treatment section on the distal side of the medical bidirectional suturing device, showing a configuration example of the treatment section in a state where a regulating member is at a position that obstructs movement of a first needle member and a second needle member. Represent. FIG. 13 shows another example of a cross-sectional view of the treatment section on the distal side of the medical bidirectional suturing device, showing the configuration of the treatment section in a state where the regulating member is at a position that does not hinder movement of the first needle member and the second needle member. Here is an example. FIG. 13 shows another example of a cross-sectional view of the treatment section on the distal side of the medical bidirectional suturing device, showing the configuration of the treatment section in a state where the restricting member is at a position that prevents movement of the first needle member and the second needle member. Here is an example. FIG. 2 shows an example of a cross-sectional view of a treatment section on the distal side of the medical bidirectional suturing device, and shows a configuration example of a treatment section in which a spacer member is provided below a regulating member. FIG. 3 illustrates an example of a side view of a proximal handle portion of a medical bidirectional suturing device. 1 illustrates an example of a cross-sectional view of a distal portion of a medical bidirectional suturing device, illustrating a configuration example of a treatment unit provided with a biological membrane fixing member. 1 illustrates an example of a cross-sectional view of a distal portion of a medical bidirectional suturing device, illustrating a configuration example of a treatment unit provided with a biological membrane fixing member. FIG. 13 shows another example of a cross-sectional view of a distal portion of the medical bidirectional suturing device, showing a configuration example of a treatment unit provided with a biological membrane fixing member. FIG. 13 shows another example of a cross-sectional view of a distal portion of the medical bidirectional suturing device, showing a configuration example of a treatment unit provided with a biological membrane fixing member. FIG. 13 shows another example of a cross-sectional view of a distal portion of the medical bidirectional suturing device, showing a configuration example of a treatment section in which a biological membrane fixing member is provided and a spacer member is provided below a regulating member. FIG. 9 illustrates another example of a side view of the proximal handle portion of the medical bidirectional suturing device.

  The present invention relates to a medical bidirectional suturing apparatus capable of passing a thread through an object to be sutured such as a biological membrane from one side to the other side and from the other side to one side. The medical bidirectional suturing device of the present invention includes a first needle member for sending a thread from a proximal side to a distal side, a second needle member for sending a thread from a distal side to a proximal side, and a regulating member. Then, the first needle member, the second needle member, and the regulating member are operated by a handle provided on the proximal side. ADVANTAGE OF THE INVENTION According to the medical bidirectional suturing apparatus of this invention, it is possible to reliably sew bidirectionally by using the first needle member and the second needle member. Alternatively, it is possible to prevent the second needle member from being sent forward and damaging a biological membrane or the like.

  Hereinafter, the medical bidirectional suturing apparatus of the present invention will be specifically described based on the following embodiments. However, the present invention is not limited to the following embodiments, and may be adapted to the purpose described above. It is of course possible to implement the present invention with appropriate changes within the scope, and all of them are included in the technical scope of the present invention. In each drawing, for convenience, hatching, reference numerals, and the like may be omitted, but in such a case, the specification and other drawings are referred to. In addition, dimensions of various members in the drawings are different from actual dimensions because priority is given to contributing to understanding of features of the present invention.

  FIG. 1 shows an example of a side view of the entire medical bidirectional suturing apparatus, and FIGS. 2 and 3 show examples of cross-sectional views of a treatment section on the distal side of the medical bidirectional suturing apparatus. 4 and 5 show another example of a cross-sectional view of the treatment section on the distal side of the bidirectional medical suturing device. In this specification, the “medical two-way suturing device” may be simply referred to as a “suturing device”.

  The suturing device 1 has a treatment section 2 on the distal side for suturing a suture target such as a biological membrane, and a handle section 21 on the proximal side for operating the treatment section 2. The treatment section 2 includes a first needle member 5, a second needle member 6, and a regulating member 7. By operating these members, an object to be sutured can be sewn. The handle section 21 is provided with an operation section for operating each member of the treatment section 2.

  In the present invention, the proximal side of the suturing device refers to the direction close to the user or the operator, and the distal side refers to the direction opposite to the proximal side, that is, the direction toward the treatment object. 1 to 5, the left side of the drawing is the distal side, and the right side of the drawing is the proximal side. In addition, the direction from one of the proximal side and the distal side of the suturing device to the other side is referred to as a perspective direction.

  The size of the suturing device 1 in the perspective direction may be set based on the distance from the operator's hand to the suture target, and may be, for example, 5 cm or more and 80 cm or less. In TSS (transsphenoidal pituitary tumor extirpation), the distance may be set with reference to the distance from the pituitary gland to the nostril, for example, preferably 20 cm or more and 50 cm or less.

  Each part of the suturing device 1 is preferably made of a biocompatible material. Examples of such a material include a metal material such as stainless steel and a resin material. In particular, the portion to be inserted into the body is preferably made of a biocompatible material or provided with a biocompatible coating layer.

  As shown in FIGS. 2 to 5, the first needle member 5 has a distal end facing the distal side and is movable in a near-far direction. The second needle member 6 is disposed more distally than the first needle member 5, and the tip is directed to the proximal side, and is movable in the near and far directions. The object to be sutured is disposed between the distal end of the first needle member 5 and the distal end of the second needle member 6, and the thread is applied to the first needle member 5 and moved to the distal side, so that the suture object is proximal to the suture object. The thread can be passed from the side to the distal side, and the thread can be passed from the distal side to the proximal side through the suture target by placing the thread on the second needle member 6 and moving it to the proximal side. . At this time, the thread sent from the proximal side to the distal side by passing through the suture target from the proximal side by the first needle member 5 moves to the second needle member 6 side, and is moved by the second needle member 6 from the distal side. The thread sent to the proximal side after passing the suture target moves to the first needle member 5 side. Accordingly, the thread can be moved in the near and far directions, and the object to be sewn can be sewn. In the suture, for example, a thread is passed from the proximal side to the distal side by the first needle member 5 on one side of the incision line such as a biological membrane, and the second needle member 6 is passed on the other side by the second needle member 6. This can be done by passing the thread from the side to the proximal side.

  The suturing device 1 has a main body on the distal side of the handle 21. It is preferable that the main body has the tubular body 3 extending in the near-far direction, and the first needle member 5 and the second needle member 6 be disposed in the tubular body 3. It is preferable that the cylindrical body 3 be provided with a notch 4 in which the object to be sutured is arranged. The notch 4 may be provided in at least a part of the cylindrical body 3 between the tip of the first needle member 5 and the tip of the second needle member 6. In detail, the notch 4 is provided in the first needle member 5 of the tubular body 3 in a state where the first needle member 5 is located at the most proximal side and the second needle member 6 is located at the most distal side. The second needle member 6 may be provided on at least a part of a portion on the distal side of the tip of the second needle member 6 and on the proximal side of the tip of the second needle member 6. The notch 4 may be formed to extend proximally of the distal end of the first needle member 5 and / or distally of the distal end of the second needle member 6.

  It is preferable that an insertion passage through which the first needle member 5 passes and / or an insertion passage through which the second needle member 6 passes is provided in the tubular body 3. By providing these insertion passages, it is easy to stably move the first needle member 5 and the second needle member 6 in the near and far directions.

  The first needle member 5 is preferably movable to a position closer to the distal end of the second needle member 6 in a state where the second needle member 6 is located at the most distal side, and the second needle member 5 It is preferable not to reach the distal side from the tip of No. 6. The second needle member 6 is preferably movable to a position more distal than the tip of the first needle member 5 in a state where the first needle member 5 is located on the most proximal side, and the first needle member 6 Preferably, it does not reach the proximal side of the tip of the fifth. Thereby, when the yarn is applied to the first needle member 5 or the second needle member 6 and moved in the near-far direction, it is easy to appropriately transfer the yarn between the first needle member 5 and the second needle member 6. Become.

  The first needle member 5 and the second needle member 6 are preferably arranged so as to overlap each other when viewed from the distal side or the proximal side, and the axial center of the first needle member 5 and the second needle member 6 More preferably, the center of the shaft coincides with the center of the shaft. That the first needle member 5 and the second needle member 6 overlap each other when viewed from the distal side or the proximal side means that the first needle member 5 and the second needle member 6 are on the same straight line in the perspective direction. Means that In this case, it is preferable that at least the distal end portion of the first needle member 5 and the distal end portion of the second needle member 6 overlap each other when viewed from the distal side or the proximal side. By arranging the first needle member 5 and the second needle member 6 in this manner, the yarn moved to the distal side by the first needle member 5 is easily arranged near the tip of the second needle member 6, and The yarn moved proximally by the needle member 6 is easily arranged near the tip of the first needle member 5. Therefore, it becomes easy to appropriately transfer the yarn between the first needle member 5 and the second needle member 6. If it is difficult to puncture the suture target with the threaded one of the first needle member 5 and the second needle member 6, a hole is formed in the suture target with the non-threaded needle member. By opening the opening, it becomes possible to easily sew the object to be sewn.

  The thread is not particularly limited as long as it is a suture used for medical use, and may be a single thread or a knitting thread. The diameter of the thread can be appropriately selected as long as it is a diameter generally used for a suture. The thread material may be a degradable material. The length of the thread is desirably long enough not to disturb the operation, and is preferably 20 cm or more and 200 cm or less. For example, in a TSS, a length that allows a suture to reciprocate from the outside of the body to the dura plus a length sufficient for a physician to make a knot on the suture outside the patient's body is preferred. The length of the yarn is 40 cm or more and 150 cm or less.

  The first and second needle members 5, 6 are preferably made of a material having biocompatibility and having a strength capable of puncturing a suture target such as a biological membrane. The first and second needle members 5, 6 are preferably made of, for example, a metal material such as stainless steel or a resin material, and more preferably made of stainless steel from the viewpoint of rust resistance and ease of processing. .

  The first and second needle members 5, 6 may be solid or hollow. In addition, it is preferable that the 1st and 2nd needle members 5 and 6 are solid from a viewpoint of manufacturability and high strength.

  The outer diameter of the first and second needle members 5, 6 is not particularly limited as long as it is a diameter used for a general suturing needle, but is preferably, for example, 0.05 mm or more and 1.5 mm or less. When the first and second needle members 5 and 6 are hollow, the thickness thereof is preferably, for example, 0.01 mm or more and 0.5 mm or less.

  For example, in the case of TSS, the length of the first and second needle members 5 and 6 can be appropriately set in a range from 1.5 mm to 40 cm, which is the distance from the nasal cavity to the pituitary gland.

The first needle member 5 and the second needle member 6 may be directly connected to the handle portion 21 or may be connected to the handle portion 21 via one or a plurality of connection members. When the first needle member 5 and the second needle member 6 are connected directly or indirectly to the handle portion 21, the handle portion 21 is operated to move the first needle member 5 and the second needle member 6 in the perspective direction. be able to.
The distal end portions of the first and second needle members 5, 6 are preferably formed so that the cross-sectional area decreases toward the distal ends, whereby the first and second needle members 5, 6 are sewn to the object. Easier to puncture.

  It is preferable that the first and second needle members 5 and 6 have a distal end divided into at least a first end and a second end. The first and second needle members 5, 6 may have three or more end portions at the tips. Thereby, when the first needle member 5 is moved to the distal side or the second needle member 6 is moved to the proximal side, the bifurcated portion of the first needle member 5 or the second needle member 6 is formed. You can thread it. The bifurcated portion of each needle member is preferably a groove having a predetermined angle with respect to the direction of movement of the needle member, that is, the perspective direction, and is arranged, for example, perpendicular to the perspective direction. When the thread is hooked on such a bifurcated portion, the thread can be moved together with the movement of the first needle member 5 and the second needle member 6 in the perspective direction, and the thread can be passed through the object to be sutured. It will be easier. In addition, the foremost portions of the first and second needle members 5 and 6 may be located on the outer periphery of the portion on the base side of the end of the needle member or on the inner side of the range around the outer periphery. preferable. This makes it easier to pass the needle member through the suture target. Further, it is preferable that each of the distal ends of the branched ends is tapered toward the distal end. The tip positions of the branched ends may be the same or different from each other in the perspective direction. The number of branches at the distal ends of the first and second needle members 5 and 6 is not particularly limited as long as it is 2 or more, but is preferably 8 or less, more preferably 6 or less, and still more preferably 4 or less. In particular, as shown in the drawings, it is preferable that the distal ends of the first and second needle members 5, 6 are bifurcated.

  The overall shape of the first and second needle members 5, 6 may be linear, curved, or a combination thereof. The first and second needle members 5, 6 may have bent portions. In the drawing, a bent portion is provided on the second needle member 6. Since the bent portion is provided in the second needle member 6, the distal end of the second needle member 6 is formed so as to face the proximal side, and the proximal end side of the second needle member 6 is also formed so as to face the proximal side. Thereby, the second needle member 6 can be connected to the handle portion 21. Although not shown in the drawings, the second needle member 6 is not provided with a bent portion, but a distal end portion of the second needle member 6 is provided with a connecting member extending in a near-far direction. The second needle member 6 may be connected to the handle portion 21 via the.

  Although not shown in the drawings, a protective cover that covers the notch 4 may be attached to the cylindrical body 3. Accordingly, when the tubular body 3 is moved in the body before and after the suturing, the distal ends of the first needle member 5 and the second needle member 6 can be prevented from being exposed from the cutout 4. It is preferable that the protective lid is mounted so as to be movable in the near and far directions. Further, it is preferable that opening and closing of the protective lid can be operated by the handle 21 on the hand side. Thus, the notch 4 can be exposed by moving the protective lid at the time of suturing, and the notch 4 can be covered with the protective lid at the time of non-suturing.

  The suturing device 1 is provided with a regulating member 7 at a position distal to the first needle member 5 and at a position proximal to the second needle member 6. The regulating member 7 can prevent the first needle member 5 or the second needle member 6 from being unintentionally sent forward, and can also use the first needle member 5 to send out a thread from the proximal side of the sewing object. Alternatively, when the thread is sent out from the distal side of the sewing object by the second needle member 6, the movement of the thread can be regulated so that the thread does not fall off. In the drawing, a first regulating member 7A and a second regulating member 7B are provided as the regulating member 7, and the second regulating member 7B is provided so that at least a part thereof is located more distally than the first regulating member 7A. Have been. The suturing device 1 may include both the first regulating member 7A and the second regulating member 7B as the regulating member 7, or may include only one of them. In addition, the suturing device 1 has the following features in that it is possible to more reliably prevent the thread from falling off and to prevent both the first needle member 5 and the second needle member 6 from being inadvertently sent forward by the regulating member 7. The one provided with both the first regulating member 7A and the second regulating member 7B is preferable. It is preferable that the regulating member 7 is disposed inside the tubular body 3.

  The regulating member 7 is formed so as to be movable between a position that does not hinder the movement of the first needle member 5 and / or the second needle member 6 and a position that does not hinder the movement. Specifically, the regulating member 7 has a holding portion 8, and the holding portion 8 moves between a position where the movement of the first needle member 5 and / or the second needle member 6 is hindered and a position where the movement is not hindered. Preferably, it is formed so as to move. The position that hinders the movement of the first needle member 5 is on the trajectory of the first needle member 5 when the first needle member 5 is moved in the perspective direction, and the first needle member 5 is the most proximal position. In the state located on the side, it means an arbitrary position on the distal side from the tip of the first needle member 5. The position that hinders the movement of the second needle member 6 is on the trajectory of the second needle member 6 when the second needle member 6 is moved in the perspective direction, and the second needle member 6 is the most distal position. In the state located on the side, it means an arbitrary position on the proximal side from the tip of the second needle member 6. As the regulating member 7, a first regulating member 7A and a second regulating member 7B are preferably provided, and a position between the position where the first regulating member 7A hinders the movement of the first needle member 5 and the position where the first regulating member 7A does not hinder movement is provided. The second needle member 6 is movable so as to be movable between a position where the movement of the second needle member 6 is not hindered and a position where the second needle member 6 is not hindered. More preferably, both the first regulating member 7A and the second regulating member 7B are formed so as to be movable between a position that does not hinder the movement of the first needle member 5 and the second needle member 6 and a position that does not hinder movement. You.

  The holding portion 8 is located on the distal side of the first needle member 5 and the second needle member in a state where the first needle member 5 is located on the most proximal side and the second needle member 6 is located on the most distal side. It is located more proximally than 6. When the first regulating member 7A and the second regulating member 7B are provided as the regulating member 7, the holding portion 8 of the first regulating member 7A is positioned closer to the holding portion 8 of the second regulating member 7B. Provided. In this case, it is preferable that the object to be sewn is disposed between the holding portion 8 of the first regulating member 7A and the holding portion 8 of the second regulating member 7B. Therefore, the holding portion 8 of the first regulating member 7A is It is preferable that the holding portion 8 of the second regulating member 7B is provided on the distal side of the position where the suture target object is arranged in the device 1 than the position where the suture target object is arranged. By providing the holding portion 8 of the first regulating member 7A and the holding portion 8 of the second regulating member 7B in this way, it is difficult for the first needle member 5 and the second needle member 6 to be unintentionally sent forward. Become.

  By moving the holding unit 8 in a direction different from the perspective direction, the holding unit 8 can move between a position that does not hinder the movement of the first needle member 5 and / or the second needle member 6 and a position that does not hinder movement. preferable. The direction different from the perspective direction may be a parallel movement in a direction different from the perspective direction or a rotational movement. FIGS. 2 and 3 show a configuration example of the regulating member 7 in which the holding unit 8 moves in a direction perpendicular to the perspective direction, as a mode in which the holding unit 8 moves in parallel in a direction different from the perspective direction. 4 and 5 show a configuration example of the regulating member 7 in which the holding unit 8 rotates. 2 and 4, the holding portion 8 is located at a position where the movement of the first needle member 5 and the second needle member 6 is not hindered. In FIGS. 3 and 5, the holding portion 8 is connected to the first needle member 5 and the second needle member 5. It is located at a position that hinders movement of the two-needle member 6. Hereinafter, a regulating member having a holding portion formed so as to be capable of parallel translation in a direction different from the perspective direction is referred to as a regulating member according to a first embodiment, and a regulating member having a holding portion formed so as to be rotatable is referred to as a regulating member. It is referred to as a regulating member according to two aspects.

  In the suturing device 1, the holding portion 8 is moved out to a position where the movement of the first needle member 5 and / or the second needle member 6 is hindered, and is thus sent out by the first needle member 5 or the second needle member 6. Can be prevented from easily falling off. On the other hand, when the holding portion 8 is at a position where the movement of the first needle member 5 and / or the second needle member 6 is not hindered, the first needle member 5 or the second needle member 6 is moved in the perspective direction. The thread can be sent out. The holding portion 8 may be one that prevents the yarn from falling off by directly contacting the yarn, or may be one that prevents the yarn from falling off by moving to a position where it becomes an obstacle when the yarn comes off.

  In the restricting member according to the first aspect, the direction of movement of the holding portion 8 is preferably 45 ° or more and 90 ° or less with respect to the perspective direction, more preferably 60 ° or more and 90 ° or less, and more preferably 75 ° or more and 90 ° or less. ° or less is more preferable. The holding portion 8 is preferably movable in a direction perpendicular to the perspective direction in particular, so that even when the holding portion 8 comes into contact with the yarn when the holding portion 8 is moved, the yarn is not easily shifted in the perspective direction. Become. 2 and 3, the regulating member 7 is formed in an L-shape in a cross section along the perspective direction, and the distal end portion of the regulating member 7 that extends perpendicularly to the perspective direction is the holding portion 8. Has become. The holding unit 8 is movable in a direction perpendicular to the perspective direction.

  In the regulation member according to the first aspect, it is preferable that an insertion passage through which the holding portion 8 passes is provided in the tubular body 3. The insertion passage through which the holding unit 8 passes preferably extends in the moving direction of the holding unit 8. By providing these insertion passages, it becomes easy to move the holding portion 8 in parallel in a desired direction, and to accurately move the holding portion 8 to a position where the movement of the first needle member 5 and / or the second needle member 6 is hindered. It is preferable that the insertion passage through which the holding portion 8 passes is connected in the middle of the insertion passage through which the first needle member 5 or the second needle member 6 passes. Further, the notch 4 of the tubular body 3 is located on the distal side of the insertion passage through which the holding portion 8 of the first regulating member 7A passes and on the proximal side of the insertion passage through which the holding portion 8 of the second regulating member 7B passes. Preferably, it is provided.

  In the regulating member according to the second aspect, the holding portion 8 is preferably rotatable about a rotation axis extending in a direction different from the perspective direction, and as shown in FIG. 4, a direction perpendicular to the perspective direction. It is more preferable to be rotatable about a rotation shaft 12 extending to the center. It is preferable that the rotating shaft 12 is not on the trajectory when the first needle member 5 and the second needle member 6 are moved in the perspective direction. The rotational movement range of the holding unit 8 is preferably 45 ° or more, more preferably 60 ° or more, still more preferably 75 ° or more, preferably 180 ° or less, more preferably 150 ° or less, and even more preferably 120 ° or less. Note that the rotational movement range described here means a range in which an arbitrary point of the holding unit 8 can be rotationally moved around a rotation axis when viewed.

  The shape of the holding portion 8 is not particularly limited. The holding portion 8 is preferably formed in, for example, a rod shape or a plate shape, thereby reducing a space in which the holding portion 8 moves in the cylindrical body 3 and preventing the yarn from falling off due to the movement of the holding portion 8. It will be easier. In the regulating member according to the first aspect, it is preferable that the holding portion 8 is formed in a rod shape or a plate shape extending in a direction different from the perspective direction, and is movable in the direction. In the regulating member according to the second aspect, it is preferable that the holding portion 8 is formed in a rod shape or a plate shape extending in the radial direction about the rotation shaft 12.

  The regulating member 7 is preferably made of a material having biocompatibility. The regulating member 7 is preferably made of, for example, a metal material such as stainless steel or a resin material, and more preferably made of stainless steel from the viewpoint of rust resistance and ease of processing.

  By operating the handle 21 on the hand side, the restricting member 7 moves between a position where the movement of the first needle member 5 and / or the second needle member 6 is hindered and a position where the movement is not hindered. Is formed. From this point, it is preferable that the regulating member 7 has the support portion 9 extending in the near-far direction on the proximal side of the holding portion 8. In this case, by operating the handle portion 21 to directly or indirectly control the movement of the support portion 9, the holding portion 8 is prevented from moving the first needle member 5 and / or the second needle member 6. It can be moved between a certain position and a position that does not interfere.

  The holding portion 8 and the support portion 9 of the regulating member 7 may be integrally formed of one member, or may be formed by combining a plurality of members. In FIGS. 2 and 3, the restricting member 7 is formed by bending the wire into an L shape, and the distal end portion bent in the L shape is used as the holding portion 8, and the portion on the proximal side is supported. Section 9. 4 and 5, the holding portion 8 and the support portion 9 are connected via a hinge shaft, and the portion extending in the near and far directions from the hinge shaft is the support portion 9.

  In the regulation member according to the first aspect, it is preferable that the holding portion 8 and the support portion 9 are formed so as to be movable in a direction perpendicular to the perspective direction. If the holding unit 8 and the support unit 9 can be integrally moved in the direction perpendicular to the perspective direction, the holding unit 8 can be stably moved in the direction perpendicular to the perspective direction. In this case, it is preferable that the regulating member 7 is formed so as to be movable in a direction perpendicular to the perspective direction as follows. That is, the direction perpendicular to the perspective direction in which the holding unit 8 can move is defined as the up-down direction, and the holding unit 8 does not hinder the position where the movement of the first needle member 5 and / or the second needle member 6 is hindered. When the direction of movement to the position is the downward direction and the opposite direction is the upward direction, a spacer member movable in the perspective direction is provided below the support portion 9 of the regulating member 7, and the spacer member is moved to the distal side. It is preferable that the holding portion 8 and the supporting portion 9 move upward when the spacer member is moved, and the holding portion 8 and the supporting portion 9 move downward when the spacer member is moved to the proximal side.

  FIG. 6 shows a configuration example in which a spacer member 11 that can move in the near and far directions is provided below the support portion 9 of the regulating member 7. As shown in FIG. 6, when the spacer member 11 is moved to the distal side, the holding portion 8 and the support portion 9 of the first regulating member 7A move upward, and the holding portion of the second regulating member 7B is moved. 8 and the support 9 move upward. On the other hand, the state shown in FIG. 2 can be regarded as a state in which the spacer member 11 is moved to the proximal side. However, when the spacer member 11 is moved to the proximal side, the holding portion 8 of the first regulating member 7A is moved. And the supporting portion 9 move downward, and the holding portion 8 and the supporting portion 9 of the second regulating member 7B move downward.

  It is preferable that the spacer member 11 is directly or indirectly connected to the handle portion 21. By operating the handle portion 21 to move the spacer member 11 in the near and far directions, the regulating member 7 is moved to a position where the movement of the first needle member 5 and / or the second needle member 6 is hindered and a position where the movement is not hindered. Can be moved between. As the spacer member 11, it is preferable to use a rod-shaped or plate-shaped member extending in the near-far direction. By using such a spacer member 11, it is possible to dispose the spacer member 11 even in a narrow space in the tubular body 3 and move it in the near-far direction.

  When the spacer member 11 is provided below the support portion 9 of the regulating member 7, it is preferable that a downward force acts on the regulating member 7 when the spacer member 11 is moved to the proximal side. This makes it easier for the regulating member 7 to move downward when the spacer member 11 is moved to the proximal side. Therefore, it is preferable that the support portion 9 is in contact with an elastic member such as a spring or rubber. For example, a compression coil spring or a torsion spring is installed on the upper side of the support section 9, a tension coil spring or a leaf spring is installed on the lower side of the support section 9, or the support section 9 is combined with the tubular body 3 on the lower side. A downward force can be applied to the support portion 9 by connecting with a rubber, an elastic string, or an elastic thread. As yet another example, rubber, an elastic string, or an elastic thread encloses the support portion 9 and orbits a cross section of the portion of the cylindrical body 3 including the cutout portion 4 as viewed from the perspective direction. With such a configuration, a downward force can be applied to the support portion 9. This makes it easier for the regulating member 7 to move downward when the spacer member 11 is moved to the proximal side.

  Although not shown in the drawings, a projection may be provided on the inner surface of the tubular body 3 located below the support portion 9. In this case, it is desirable that a part of the support part 9 and the tip part of the spacer member 11 be fixed. When the spacer member 11 is moved to the distal side, the regulation member 7 can be moved upward by the tip of the spacer member 11 hitting the projection and riding on the protrusion. Further, when the spacer member 11 is moved to the proximal side, the tip of the spacer member 11 descends from the projection, so that the regulating member 7 can be moved downward. Alternatively, instead of providing the spacer member 11, a space is provided below the holding portion 8 of the regulating member 7, a wire is connected to the distal portion of the regulating member 7, and the wire is pulled proximally. The holding unit 8 may be formed so as to be movable in the up-down direction.

  In the regulation member according to the second aspect, it is preferable that the support portion 9 of the regulation member 7 be directly or indirectly connected to the handle portion 21. By operating the handle portion 21 to move the support portion 9 in the near and far directions, the holding portion 8 connected via the hinge shaft can be rotated around the rotation shaft 12. Taking the restriction member 7 shown in FIGS. 4 and 5 as an example, by moving the support portion 9 to the proximal side as shown in FIG. 4, the holding portion 8 is rotated and the first needle member 5 and And / or by moving to a position that does not hinder the movement of the second needle member 6 and moving the support portion 9 to the distal side as shown in FIG. And / or moves to a position that hinders movement of the second needle member 6.

  The first needle member 5, the second needle member 6, and the regulating member 7 can be moved in a predetermined direction by operating the handle portion 21. As shown in FIG. 7, the handle portion 21 includes a first operation portion 23 for moving the first needle member 5, a second operation portion 24 for moving the second needle member 6, and a third operation portion for moving the regulating member 7. And an operation unit 25. By operating the first operation unit 23, the first needle member 5 can be moved in the perspective direction, and by operating the second operation unit 24, the second needle member 6 can be moved in the perspective direction, By operating the third operation unit 25, the regulating member 7 can be moved between a position where the movement of the first needle member 5 and / or the second needle member 6 is hindered and a position where the movement is not hindered.

  It is preferable that the first operation unit 23 is directly or indirectly connected to the first needle member 5. It is preferable that the second operation unit 24 is directly or indirectly connected to the second needle member 6. It is preferable that the third operation unit 25 is directly or indirectly connected to the regulating member 7 or is directly or indirectly connected to a member that controls the movement of the regulating member 7. The spacer for controlling the movement of the regulating member 7 corresponds to the spacer member 11 in the regulating member according to the first embodiment. In the case where the first regulating member 7A and the second regulating member 7B are provided as the regulating member 7, even if both the first regulating member 7A and the second regulating member 7B can be operated by one third operation portion 25. Although not shown in the drawings, a third operating section for operating the first regulating member 7A and a third operating section for operating the second regulating member 7B may be provided. The former mode is preferable in terms of facilitating the operation of the handle portion 21.

  The first needle member 5 is located on the proximal side when the first operation unit 23 is in a no-load state, moves distally when the first operation unit 23 is in a loaded state, and the second needle member 6 is The unit 24 is located on the distal side with no load, and the second operating unit 24 moves proximally with the load. The regulating member 7 is located at a position where the movement of the first needle member 5 and / or the second needle member 6 is hindered when the third operation unit 25 is in a no-load state, and It moves to a position that does not hinder the movement of the member 5 and / or the second needle member 6. In the suturing apparatus 1 shown in the drawing, a first regulating member 7A and a second regulating member 7B are provided as regulating members 7, but in this case, the third operating portion 25 is in a no-load state and the first regulating member 7A Are in a position where the movement of the first needle member 5 is hindered, the second regulating member 7B is in a position where the movement of the second needle member 6 is hindered, and the first operation member 25 is in the load state and the first operation member 25 is in the load state. It is preferable that the regulating member 7A moves to a position where it does not hinder the movement of the first needle member 5, and the second regulating member 7B moves to a position where it does not hinder the movement of the second needle member 6.

  As described above, the suturing device 1 is capable of performing the suturing operation safely because the movements of the operation portions 23, 24, 25 and the first needle member 5, the second needle member 6, and the regulating member 7 are associated with each other. it can. That is, in the suturing apparatus 1, the first needle member 5 having the distal end directed to the distal side can be moved to the distal side by setting both the first operation section 23 and the third operation section 25 to the load state. By setting both the second operation unit 24 and the third operation unit 25 in the load state, the second needle member 6 whose distal end faces the proximal side can be moved to the proximal side. Therefore, when a load is erroneously applied to only one of the first operation unit 23 to the third operation unit 25, the first needle member 5 or the second needle member 6 is sent forward, and the biological membrane or the like is discharged. Can be prevented from being accidentally damaged.

  The no-load state of each operation unit means a state where each operation unit is not operated or a state where each operation unit is not moved without applying a load. The load state of each operation unit means a state in which each operation unit is moved by applying a load. Each operation unit is held at a predetermined position by a spring or the like in a no-load state.

  The operation unit includes a push button, a pull button, a slide button, a lever, a rotating body, and the like. The rotator may function, for example, as a pinion of a rack-and-pinion, or may be a spheroid in which a peripheral surface abuts a proximal end surface of a rod extending in a perspective direction, The body may be a screw, the thread of which may abut the proximal end surface of the bar extending in the near-far direction. Among these, the first to third operation units 23 to 25 are preferably push buttons or levers, which makes it easy to operate the first to third operation units 23 to 25 with one hand, Operability of the handle portion 21 is improved.

  Although the shape of the handle portion 21 is not particularly limited, the handle portion 21 has a grip portion 22 that extends in a direction substantially perpendicular to the perspective direction as a portion to be gripped when the operator operates the handle portion 21. Is preferred. By forming the handle portion 21 in this manner, the operability of the handle portion 21 at the time of treatment can be enhanced. It is preferable that the grip portion 22 is provided so as to extend below the cylindrical body 3 with respect to the cylindrical body 3 extending in the perspective direction, and the notch 4 described above is provided above the cylindrical body 3. It is preferably formed in a part.

  As shown in FIG. 7, the position where the first operation unit 23 to the third operation unit 25 are provided on the handle unit 21 is such that the third operation unit 25 is located on the distal side of the first operation unit 23 and the second operation unit 24. Although not shown in the drawings, it is preferable to provide the third operation unit 25 on the proximal side of the first operation unit 23 and the second operation unit 24. As shown in FIG. 7, a third operation unit 25 is provided on the grip portion 22 on the distal side of the grip portion 22 or on the surface on the distal side of the grip portion 22, and on the proximal side of the grip portion 22. Alternatively, a first operation portion 23 and a second operation portion 24 are provided on a surface on the proximal side of the grip portion 22 or, although not shown in the drawing, a distal side of the grip portion 22 or a distal end of the grip portion 22. It is preferable that the first operation unit 23 and the second operation unit 24 are provided on the side surface, and the third operation unit 25 is provided on the surface closer to the grip part 22 or on the proximal side of the grip part 22. The provision of the first to third operation units 23 to 25 makes it difficult for the surgeon to confuse the operation of the first and second needle members 5 and 6 with the operation of the regulating member 7.

  It is preferable that the third operation unit 25 is provided on a more distal side than the first operation unit 23 and the second operation unit 24. That is, it is preferable that the first operation unit 23 and the second operation unit 24 are closer to the hand than the third operation unit 25 is. Providing the first operation unit 23 to the third operation unit 25 in this manner facilitates the operation of sending the first needle member 5 or the second needle member 6 forward. That is, after the operator holds the handle portion 21 and operates the third operation portion 25 with the index finger or the like to make the load state, the operator operates the first operation portion 23 or the second operation portion 24 with the thumb to make the load state. To perform a series of operations. By operating each operation unit in this way, the first needle member 5 or the second needle member 6 can be sent forward without hitting the regulating member 7.

  When the third operation unit 25 is provided on the distal side with respect to the first operation unit 23 and the second operation unit 24, the first operation unit 23 and the second operation unit 24 are pushed to the distal side to change the load state. Preferably, the button is a push button. Thereby, when the surgeon holds the handle portion 21, the first operation portion 23 and the second operation portion 24 are operated with the thumb, and the first needle member 5 or the second needle member 6 is easily sent forward. . In particular, since the first needle member 5 and the second needle member 6 act to puncture a biological membrane or the like, the first needle member 5 that sends out the first needle member 5 forward so that sufficient force can be applied at that time. It is preferable that the first operation unit 23 and the second operation unit 24 that sends the second needle member 6 forward are configured to be operated by the thumb. Further, since the first operation unit 23 and the second operation unit 24 are configured to be operated with the thumb, an erroneous operation due to another finger touching the first operation unit 23 or the second operation unit 24 is less likely to occur. . On the other hand, it is preferable that the third operation unit 25 is a lever that is in a loaded state when pulled to the proximal side or a push button that is in a loaded state when pressed to the proximal side. Thus, the third operation unit 25 can be easily operated with the index finger or the like. In order to enable the operation of the third operation unit 25 with a weaker force and to enhance the operability of the third operation unit 25, the third operation unit 25 should be a lever that is placed in a load state by being pulled proximally. Is preferred.

  When the third operation unit 25 is provided on the proximal side with respect to the first operation unit 23 and the second operation unit 24, the first operation unit 23 and the second operation unit 24 are pulled toward the proximal side. It is preferable that the lever be in a loaded state or a push button that is placed in a loaded state when pressed to the proximal side, and the third operation unit 25 be a push button that is placed in a loaded state when pushed to the distal side. .

  The treatment section 2 preferably further includes a fixing member 15 for fixing a biological membrane or the like to be sutured. 8 and 9 show a configuration example in which a fixing member 15 is provided for the treatment section 2 shown in FIGS. 2 and 3. The fixing member 15 is formed so as to be movable in the perspective direction. By moving the fixing member 15 in the perspective direction, it is possible to sandwich and fix the biological membrane 18 which is a suture target. Thereby, the puncture by the first needle member 5 and the second needle member 6 becomes easy.

  It is preferable that the fixing member 15 is disposed in the tubular body 3 and is disposed in the cutout 4 of the tubular body 3. FIG. 8 shows the suturing device before the biological membrane is sandwiched, and FIG. 9 shows a configuration example of the suturing device with the biological membrane 18 sandwiched therebetween. 8 and 9 show a configuration example of a suturing device that can sandwich a biological membrane when the fixing member 15 is moved to the distal side. In this case, the fixing member 15 includes a first needle. In a state where the member 5 is located on the most proximal side and the second needle member 6 is located on the most distal side, the distal end is located on the distal side of the tip of the first needle member 5 and on the second needle member 6. Preferably, it is located more proximally than the tip. Although not shown in the drawings, the fixing member 15 may be capable of sandwiching the biological membrane when moved to the proximal side, and in this case, the fixing member 15 is most preferably the first needle member 5. The proximal end is located closer to the distal end than the distal end of the first needle member 5 and closer to the distal end of the second needle member 6 in a state where the distal end is located on the proximal side and the second needle member 6 is located most distally. It is preferable to be located on the position side.

  It is preferable that the fixing member 15 has a first insertion passage 16 extending in the near-far direction, and the first needle member 5 and / or the second needle member 6 be inserted through the first insertion passage 16. The first insertion passage 16 is provided to penetrate the fixing member 15 in the near and far directions. By providing the first insertion passage 16 in the fixing member 15 in this manner, the periphery of the point where the biological membrane is punctured by the first needle member 5 or the second needle member 6 can be fixed by the fixing member 15. Puncture with the needle member 5 and the second needle member 6 becomes easy. Further, the trajectories of the first needle member 5 and the second needle member 6 moving in the near and far directions are stabilized.

  It is preferable that the fixing member 15 has a second insertion passage 17 extending in a direction different from the perspective direction, and at least a part of the holding portion 8 of the regulating member 7 is preferably inserted through the second insertion passage 17. The second insertion passage 17 is preferably connected in the middle of the first insertion passage 16. In the suturing device shown in FIGS. 8 and 9, the holding portion 8 of the first regulating member 7 </ b> A is inserted into the second insertion passage 17. The holding portion 8 of the second regulating member 7B may be inserted into the second insertion passage 17, and in this case, the suturing device sandwiches the biological membrane when the fixing member 15 is moved to the proximal side. It can be. By providing the second insertion passage 17 in the fixing member 15, the holding portion 8 of the regulating member 7 can be accurately moved in a direction different from the perspective direction. The second insertion passage 17 is preferably formed to extend in a direction perpendicular to the perspective direction.

  When at least a part of the holding portion 8 of the regulating member 7 is inserted through the second insertion passage 17 of the fixing member 15, for example, as described in FIG. When a spacer member that can move in the direction is provided, and when the spacer member is moved to the distal side, when the holding portion 8 and the support portion 9 move upward, and when the spacer member is moved to the proximal side, The holding unit 8 and the support unit 9 can be configured to move downward. Alternatively, instead of providing a spacer member, a space is provided below the holding portion 8 of the regulating member 7, a wire is connected to a distal portion of the regulating member 7, and the wire is pulled proximally, whereby the holding portion 8 may be formed so as to be movable in the vertical direction.

  When the second insertion passage 17 is provided in the fixing member 15, by moving the fixing member 15 in the perspective direction, at least a part of the regulating member 7 can also be moved in the perspective direction. For example, in the suturing device shown in FIGS. 8 and 9, as shown in FIGS. 10 and 11, a tubular portion 10 in which at least a part in a near-far direction is formed in a tubular shape is provided on a support portion 9 of a second regulating member 7 </ b> B. Preferably, the support portion 9 of the first regulating member 7A is slidably disposed in the tubular portion 10. The support portion 9 of the second regulating member 7B is provided with a tubular portion 10 arranged in the proximal portion of the L-shaped wire in a direction perpendicular to the perspective direction, and the tubular portion 10 is formed into an L-shaped wire. Are joined. The tubular part 10 is provided as a part of the support part 9 of the second regulating member 7B. If the first regulating member 7A and the second regulating member 7B are thus formed, the supporting portion 9 of the first regulating member 7A slides in the tubular portion 10 of the supporting portion 9 of the second regulating member 7B. Further, the space required for the movement of the first regulating member 7A and the second regulating member 7B in the near and far directions in the tubular body 3 can be reduced. In addition, the movement of the first regulating member 7A or the second regulating member 7B in the near-far direction can be stabilized. Although not shown in the drawings, the support portion 9 of the first regulating member 7A is provided with a tubular portion at least part of which is formed in a tubular shape in the perspective direction, and the supporting portion 9 of the second regulating member 7B is It may be slidably disposed in the part.

  FIG. 12 illustrates a configuration example of the suturing device including the spacer member 11 described above in the suturing device illustrated in FIGS. 10 and 11. In FIG. 12, since the support portion 9 of the first control member 7A is inserted into the tubular portion 10 of the support portion 9 of the second control member 7B, the spacer member 11 is moved to the lower side of the tubular portion 10. Thus, both the first regulating member 7A and the second regulating member 7B can be simultaneously moved upward. In addition, by moving the spacer member 11 to the proximal side from the state of FIG. 12, both the first regulating member 7A and the second regulating member 7B can be simultaneously moved downward.

  In a case where the fixing member 15 is provided in the suturing device 1, it is preferable to provide the handle 21 with a fourth operation unit 26 for moving the fixing member 15, as shown in FIG. By operating the fourth operation unit 26, the fixing member 15 can be moved in the near and far directions, and can be fixed with the biological membrane or the like to be sutured therebetween. It is preferable that the fourth operation section 26 be directly or indirectly connected to the fixing member 15.

  As shown in FIGS. 8 to 12, when the fixing member 15 is capable of sandwiching a biological membrane or the like by moving the fixing member 15 to the distal side, the fixing member 15 is in a state where the fourth operation unit 26 is in a no-load state. It is preferable that the fixing member 15 move to the distal side when the fourth operation portion 26 is in a load state. On the other hand, although not shown in the drawings, when the fixing member 15 is capable of sandwiching a biological membrane or the like by moving the fixing member 15 to the proximal side, the fixing member 15 is in a state in which the fourth operation unit 26 is in a no-load state. It is preferable that the fourth operation portion 26 is moved to the proximal side under a load state. If the movement of the fourth operation unit 26 and the fixing member 15 is associated with each other, the operation of sandwiching the biological membrane with the fixing member 15 can be easily performed.

  As the fourth operation unit 26, a button, a lever, or the like that can be used in the first operation unit 23 to the third operation unit 25 can be used. Among them, the fourth operation unit 26 is preferably a push button or a lever, which makes it easy to operate the fourth operation unit 26 with the first operation unit 23 to the third operation unit 25 with one hand, and the handle unit. The operability of 21 is improved.

  As shown in FIG. 13, the fourth operation unit 26 is provided more distally than the first operation unit 23 and the second operation unit 24, or is not shown in the drawing. It is preferable to provide it on the proximal side of the second operation unit 24. As shown in FIG. 13, a fourth operation unit 26 is provided on the grip portion 22 on a surface farther than the grip portion 22 or on a surface on the distal side of the grip portion 22. Although the operation unit 24 is provided on the surface closer to the gripping unit 22 or on the surface on the proximal side of the gripping unit 22, although not shown in the drawing, the fourth operation unit 26 is provided on the proximal side of the gripping unit 22 or It is preferable that the first operating portion 23 and the second operating portion 24 are provided on the surface on the proximal side of the grip portion 22 and the first operating portion 23 and the second operating portion 24 are provided on the surface on the distal side of the grip portion 22 or on the distal side of the grip portion 22. By providing the fourth operation unit 26 in this manner, it becomes difficult for the operator to confuse the operation of the first and second needle members 5 and 6 with the operation of the fixing member 15. For this reason, it is unlikely that the operator erroneously sends the first and second needle members 5 and 6 forward.

  The fourth operation unit 26 is preferably provided on a more distal side than the first operation unit 23 and the second operation unit 24. If each operation unit is provided in this manner, the surgeon holds the handle unit 21, operates the fourth operation unit 26 with the middle finger, the third finger, or the like to load the first operation unit 23 or the second operation unit. It becomes easy to perform a series of operations for putting the load on the unit 24 by operating the unit 24 with the thumb.

  In the above case, it is preferable that the fourth operation unit 26 be a lever that is in a loaded state when pulled to the proximal side or a push button that is in a loaded state when pressed to the proximal side. Thus, the fourth operation unit 26 can be easily operated with the middle finger, the ring finger, and the like. It is preferable that the lever or the push button as the fourth operation unit 26 formed in this way is provided on a surface on the distal side of the grip unit 22. Basically, the fourth operation unit 26 is provided before the first operation unit 23 to the third operation unit 25 in order to fix the biological membrane with the fixing member 15 when performing an actual suturing operation using the suturing device. After the operation of passing the thread through the biological membrane is performed in the load state, the first operation unit 23 to the third operation unit 25 are set to the no-load state and then set to the no-load state. Therefore, it is preferable that the fourth operation unit 26 be formed so as to be easily handled integrally with the grip unit 22. Therefore, the fourth operating portion 26 is preferably a lever that is placed in a load state by being pulled proximally from the viewpoint of facilitating such an operation, and such a lever is provided on the grip portion 22. Is preferred.

1: bidirectional suturing device for medical use 2: treatment section 3: tubular body 4: notch section 5: first needle member 6: second needle member 7: regulating member, 7A: first regulating member, 7B: second Control member 8: Holding part 9: Support part 10: Tubular part 11: Spacer member 12: Rotating shaft 15: Fixing member 16: First insertion path 17: Second insertion path 18: Biological membrane 21: Handle part 22: Grip part 23: First operation unit 24: Second operation unit 25: Third operation unit 26: Fourth operation unit

Claims (8)

A medical bidirectional suturing device having a first needle member, a second needle member, and a regulating member on a distal side, and a handle portion on a proximal side,
The first needle member has a distal end facing the distal side and is movable in a near-far direction,
The second needle member is disposed more distally than the first needle member, the tip is directed to the proximal side, and is movable in the near and far directions,
The regulating member is located on a distal side of the first needle member and on a proximal side of the second needle member, and is a position obstructing movement of the first needle member and / or the second needle member. And can be moved between unobstructed positions,
The handle unit has a first operation unit that moves the first needle member, a second operation unit that moves the second needle member, and a third operation unit that moves the regulation member,
The first needle member is located on the proximal side in a state where the first operation unit is not loaded, and the first needle member is moved distally in a loaded state,
The second needle member is located on the distal side in a state where the second operating portion is not loaded, and the second needle member is moved proximally in a loaded state,
The regulating member is located at a position where the movement of the first needle member and / or the second needle member is hindered when the third operating portion is in a no-load state, and the first needle member and / or the A two-way medical suturing device that moves to a position that does not hinder movement of a two-needle member.   The medical bidirectional suturing device according to claim 1, wherein the first to third operation units are push buttons or levers. The third operation unit is provided more distally than the first operation unit and the second operation unit,
The first operation unit and the second operation unit are push buttons that enter a load state by being pushed to the distal side,
The medical bidirectional suturing device according to claim 1 or 2, wherein the third operation unit is a lever that is placed in a loaded state when pulled in a proximal direction. As the restricting member, a first restricting member and a second restricting member located on a more distal side than the first restricting member are provided,
The first regulating member is movable between a position that does not hinder the movement of the first needle member and a position that does not hinder the movement of the first needle member,
The second regulating member is movable between a position that does not hinder the movement of the second needle member and a position that does not hinder the movement of the second needle member,
While the third operating portion is in a no-load state, the first restricting member is at a position where the movement of the first needle member is obstructed, and the second restricting member obstructs the movement of the second needle member. And the first regulating member moves to a position where the movement of the first needle member is not hindered while the third operating portion is in a load state, and the second regulating member moves the second needle member. The medical bidirectional suturing device according to any one of claims 1 to 3, which moves to a position that does not hinder the operation. The suturing device further has a fixing member for fixing a biological membrane to be sutured on the distal side,
In a state where the first needle member is located at the most proximal side and the second needle member is located at the most distal side, the fixing member has a distal end distal to the first needle member and It is located closer to the second needle member and is movable in the near and far directions,
The handle unit has a fourth operation unit that moves the fixing member,
The medical twin according to any one of claims 1 to 4, wherein the fixing member is located on the proximal side when the fourth operation unit is unloaded, and the fixing member moves distally when the fourth operating unit is loaded. Directional suturing device. The suturing device further has a fixing member for fixing a biological membrane to be sutured on the distal side,
In a state where the first needle member is located at the most proximal side and the second needle member is located at the most distal side, the fixing member has a proximal end distal to the first needle member and It is located closer to the second needle member and is movable in the near and far directions,
The handle unit has a fourth operation unit that moves the fixing member,
The medical twin according to any one of claims 1 to 4, wherein the fixing member is located on a distal side when the fourth operation unit is unloaded, and the fixing member moves proximally when a load is applied. Directional suturing device.   7. The medical two-way suturing device according to claim 5, wherein the fourth operation unit is a push button or a lever. The fourth operation unit is provided more distally than the first operation unit and the second operation unit,
The medical bidirectional suturing device according to any one of claims 5 to 7, wherein the fourth operation unit is a lever that is brought into a loaded state by being pulled proximally.

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