The present disclosure relates to an applicator for treating a target tissue in a body, a medical device (more specifically, a ligation apparatus used to ligate tissue), and a loading method of a clip.
Conventionally known endoscopic treatment tools are introduced into a patient's body via an endoscopic channel in order to ligate an opening or a blood vessel formed in a target tissue in a body, as described in Japanese Unexamined Patent Application, First Publication No. 2012-500158 (hereinafter referred to as Patent Document 1).
The endoscopic treatment tool described in Patent Document 1 includes a tubular outer sheath, a tubular inner sheath inserted through the outer sheath, a drive wire inserted through the inner sheath, a connecting hook that is connected to the distal end of the drive wire and makes it possible to grasp the clip, a base part that is connected to the proximal end of the inner sheath, and a slider part that is connected to the proximal end of the drive wire and is slidable with respect to the base part. The base part has a fixed base in which two positioning grooves are formed and a rotating base in which one positioning groove is formed.
The endoscopic treatment tool described in Patent Document 1 has three positions, that is, a clip release position where the connecting hook is opened, a clip-fastening position to fasten to the clip grasped by the connecting hook, and a clip-connecting position where the connection hook is closed to grasp the clip and the clip is not fastened.
Specifically, the clip release position is the position where the slider is most pulled out from the base part, the clip-fastening position is the position where the slider is pushed most with respect to the base part, and the clip-connecting position is a position set between the clip release position and the clip-fastening position. In other words, in the endoscopic treatment tool described in Patent Document 1, when the slider is moved to the position closest to the distal end with respect to the base part, the connecting hook protrudes from the distal end of the inner sheath, so as to be opened by its own elastic force.
Generally, a medical device for treating (ligating) a target tissue in the body is configured by connecting a treatment tool (for example, a clip) inserted in the body with an applicator for adjusting the position and orientation of the treatment part at the operator's hand. When treating a target tissue in the body using such a medical device, for example, additional treatment may be performed on a new target tissue that could not be found by a preoperative examination. As an example, when a clip is used as a treatment tool, for example, it is necessary to replace the plurality of clips in order to ligate each of the plurality of target tissues. In other words, in a medical device for treating a target tissue in the body, it is preferable to be able to reload the so-called treatment tool by loading a new treatment tool to the applicator.
On the other hand, when treating one target tissue in the body, it may be necessary to temporarily release the state of grasping the tissue by the treatment tool and then grasp the target tissue again, that is, a so-called re-grasping operation of the treatment tool, for example, when a clip used as a treatment tool is used to accidentally grasp an unintended tissue, or when it is desired to adjust the state of grasping the target tissue.
Therefore, in order to appropriately treat the target tissue in the body, it is preferable that the medical device can reload the treatment portion and the treatment tool can re-grasp the target tissue.
In the endoscopic treatment tool described in Patent Document 1, as described above, when the slider is moved to the clip release position, which is the position where the slider is most pulled out from the base part, the connecting hook is opened. Therefore, in the endoscopic treatment tool described in Patent Document 1, different clips can be loaded to the connecting hooks at the clip release position, and so-called clips can be reloaded.
In the endoscopic treatment tool described in Patent Document 1, when treating the target tissue in the body, in order to adjust the grasping state of the target tissue by the clip, it is necessary to move the slider from the clip connection position to the distal end side with respect to the base part. However, such movement may move the endoscopic treatment tool to the clip open position and release the connection state between the clip and the connection hook. That is, the endoscopic treatment tool described in Patent Document 1 does not consider a re-grasping operation of the target tissue by the treatment tool, and it is not possible to achieve both the reloadability of the treatment tool and re-grasping of the target tissue by the treatment tool.
The present disclosure provides an applicator and a medical device (more specifically, a ligation apparatus) that realize both reloadability of a treatment tool and a re-grasping operation of a target tissue by the treatment tool. Also, the present disclosure provides a loading method of a clip.
A medical device includes: a clip; a wire configured to be capable of operating the clip; a link that detachably connects the clip and the wire; a sheath with an inner diameter that can accommodate the link; a handle connected to the sheath; a slider provided on the handle and configured to be movable relative to the handle, the slider being connected to the wire; a first sheath constituting the sheath, the first sheath having a length such that the link is arranged at a position protruding from the first sheath when the slider is advanced with respect to the handle to a maximum extent; and a second sheath constituting the sheath and connected to the first sheath, the second sheath having a length such that the link is arranged at a position accommodated in the sheath when the slider is advanced with respect to the handle to a maximum extent.
The clip may include a first link capable of engaging with the link. The link may be engageable with the first link at a protruding position protruding from the sheath, and disengagement with the first link may be restricted by the sheath at an accommodation position accommodated in the sheath. The sheath may be configured to be mutable such that the sheath can change lengths: a first length, which is a length of the sheath when the link is placed in the accommodation position when the slider is maximally advanced with respect to the handle, and a second length, which is a length of the sheath when the link is placed in the protruding position when the slider is maximally advanced with respect to the handle.
In a state where the first link and the second link are engaged and the length of the sheath is the first length, when the slider is maximally advanced, the connecting portion between the first link and the link may be placed in the sheath.
The medical device may further include: a first arm and a second arm provided on the clip; and a holding tube provided in the clip and formed in a tubular shape, the holding tube being configured so that at least one of the first arm and the second arm can be inserted. The first link may be arranged so as to protrude from the holding tube.
In a state where the first link and the link are engaged and the length of the sheath is the first length, when the slider is maximally advanced, the holding tube and the sheath may be in contact.
The medical device may further include: a connecting member provided on the sheath, the connecting member connecting the first sheath and the second sheath and capable of moving the first sheath to a side of the second sheath side with respect to the second sheath; and a restricting part provided on the sheath and restricting the movement of the first sheath with respect to the second sheath in a state where the sheath has the first length.
The restricting part may restrict a movement of the first sheath with respect to the second sheath by a first force, and the medical device may further include an arm provided on the clip, the arm being configured to be closed by pulling the wire with a second force smaller than the first force.
At least one of the first sheath and the second sheath may be connected to the connecting member in a state of being in a cavity formed in the connecting member.
At least a part of either the first sheath or the second sheath may be configured by a spring. The sheath may be configured to be mutable with a first length, which is a length of the sheath when the link is accommodated in the sheath due to elastic deformation of the spring, and a second length, which is a length of the sheath when the link protrudes from the sheath.
By transitioning between a form in which the first sheath and the second sheath are attached and a form in which the first sheath and the second sheath are separated, the sheath may be configured to be mutable with a first length, which is a length of the sheath when the link is accommodated in the sheath due to elastic deformation of the spring, and a second length, which is a length of the sheath when the link protrudes from the sheath.
An applicator configured to be connectable to a clip, the applicator including: a link capable of being connected to the clip; a wire connected to the link; a sheath that accommodates the link; a handle connected to the sheath; a slider provided on the handle and configured to be movable relative to the handle, the slider being connected to the wire; a first sheath constituting the sheath, the first sheath having a length such that the link is arranged at a position protruding from the first sheath when the slider is maximally advanced with respect to the handle; and a second sheath, which constitutes the sheath and is connected to the first sheath, the second sheath having a length to be arranged in a position where the link is accommodated in the sheath when the slider is maximally advanced with respect to the handle.
The applicator may further include: a connecting member provided on the sheath, the connecting member connecting the first sheath and the second sheath and capable of moving the first sheath to a side of the second sheath with respect to the second sheath; and a restricting part provided on the sheath and restricting the movement of the first sheath with respect to the second sheath in a state where the sheath has a first length.
The restricting part may restrict a movement of the first sheath with respect to the second sheath by a first force, and the first force may be larger than a second force, which is a traction force of a wire required when an arm provided in the clip closes.
At least a part of either the first sheath or the second sheath may be configured by a spring, the sheath may be configured to be mutable or changeable between a first length, which is a length of the sheath when the link is accommodated in the sheath due to elastic deformation of the spring, and a second length, which is a length of the sheath when the link protrudes from the sheath.
By transitioning between a form in which the first sheath and the second sheath are attached and a form in which the first sheath and the second sheath are separated, the sheath may be configured to be mutable or changeable between a first length, which is a length of the sheath when the link is accommodated in the sheath due to elastic deformation of the spring, and a second length, which is a length of the sheath when the link protrudes from the sheath.
A loading method of a clip, includes: changing a length of the sheath of the applicator from a first length, which is a length of the sheath when the link accommodating in the sheath is accommodated in the sheath, to a second length, which is a length of the sheath when the link protrudes from the sheath; and engaging the link with the clip in a state where the sheath is at the second length.
The loading method may further includes: changing the length of the sheath from the first length to the second length by elastically deforming a spring forming a part of the sheath.
The mounting method may further include: deforming the spring elastically by pressing the sheath against a cartridge containing the clip.
According to each of the above-described aspects of the medical device and the applicator, it is possible to realize both the reloadability of the treatment tool and a re-grasping operation of the target tissue by the treatment tool. Further, according to each of the above aspects of the loading method of the clip, the clip can be suitably loaded to the medical device by engaging the clip with the applicator.
Hereinafter, the configuration of a medical device according to a first embodiment of the present disclosure will be described with reference to
A medical device 1 according to the present embodiment is used by being inserted into the patient's body through a channel formed in an endoscope (not shown). More specifically, the medical device 1 according to the present embodiment is a ligation apparatus for ligating a target tissue in the body.
In the present specification, the side where the endoscope operating part for the operator to operate the endoscope is positioned is defined as the proximal end side, and the side where the distal end portion of the endoscope inserted into the body is positioned is defined as the distal end side.
The medical device 1 according to the present embodiment includes a clip (treatment tool) 10 provided on the distal end side and an applicator 30 configured to be connectable to the clip 10 (see
As shown in
The arm member 11 has a first arm 12, a second arm 13, and an intermediate portion 14. The first arm 12 and the second arm 13 extend from the proximal end side toward the distal end side and are arranged so as to face each other. As shown in
In the present embodiment, as shown in
In the present embodiment, the first arm 12 and the second arm 13 are separated from each other in a natural state and have an elastic restoring force so that the distance between them increases along the direction from the proximal end side to the distal end side. In the present specification, the “natural state” means a state in which an external force does not act on the arm member 11. A claw 12a extending toward the second arm 13 side is formed at the distal end of the first arm 12. A claw 13a extending toward the first arm 12 side is formed at the distal end of the second arm 13. The first arm 12 and the second arm 13 of the arm member 11 have an elastic restoring force that moves in the direction in which the distal ends thereof are separated from each other, that is, in the direction in which the arm member 11 opens.
The arm member 11 having the first arm 12 and the second arm 13 can be formed by forming the first arm 12 and the second arm 13 by bending a metal material such as a leaf spring material such as stainless steel and then crossing the first arm 12 and the second arm 13. With this configuration, the arm member 11 can slide along the inner peripheral surface of the holding tube 31 when it is pulled into the holding tube 31 described later.
A pair of protrusions 16 and 17 are formed in the intermediate portion 14 of the arm member 11. More specifically, the pair of protrusions 16 and 17 protrude at right angles to the longitudinal direction in which the first arm 12 and the second arm 13 of the arm member 11 extend. The pair of protrusions 16 and 17 may be formed at positions line-symmetrical with respect to the longitudinal axis C1. By forming a pair of protrusions 16 and 17 of the clip 10, when the arm member 11 is pulled into the holding tube 31, by contacting the inner wall of the holding tube 31, the movement of the arm member 11 with respect to the holding tube 31 can be restricted. In the present embodiment, an example in which the arm member 11 is configured to include the first arm 12 and the second arm 13 which are a pair of arms will be described, but the present invention is not limited thereto. For example, the arm member may be configured by connecting one rod-shaped member and one elastically deformable arm.
In the present embodiment, the holding tube 31 is formed in a cylindrical shape and has an inner diameter through which at least a part of the arm member 11 can enter. That is, the holding tube 31 is formed with a lumen having an inner diameter that allows at least one of the first arm 12 and the second arm 13 of the arm member 11 to enter. In the present embodiment, the holding tube 31 is formed so that the outer diameter is larger than the inner diameter of the sheath (first sheath) 66A of the insertion portion 60 of the applicator 30, which will be described later. Further, a tapered surface 31a is formed on the inner wall of the distal end of the holding tube 31 over the entire circumference. The diameter of the tapered surface 31a increases toward the distal end side.
As shown in
The connecting rod 3 is configured to connect the arm member 11 and the operation wire 62 described later. In other words, the connecting rod 3 is configured to connect the clip 10 and the applicator 30.
The distal end portion 3a of the connecting rod 3 is configured to support the hook portion 3c for connecting the arm member 11, and the shape thereof is not particularly limited. For example, the distal end portion 3a may be formed in a rod shape having an outer diameter slightly smaller than the inner diameter of the holding tube 31. The distal end portion 3a can move back and forth within the holding tube 31.
The hook portion 3c is formed so as to protrude in a direction intersecting the longitudinal direction in which the connecting rod 3 extends from the distal end portion 3a. The hook portion 3c can connect the arm member 11 to the connecting rod 3 by hooking the hook portion 3c into a loop shape formed in the intermediate portion 14 of the arm member 11. In the present embodiment, the hook portion 3c is removed from the intermediate portion 14 by bending and deforming on the proximal end side protruding from the distal end portion 3a due to the traction force transmitted to the proximal end side transmitted by the operation wire 62 described later (See
The proximal end portion 3b is formed by being connected to the proximal end side of the distal end portion 3a. In the present embodiment, the notch portion 3d and the deformed portion 3f are formed at the proximal end portion 3b. A notch 3d is formed in the proximal end portion 3b by cutting a part of the proximal end portion 3b according to the shape of the hook 62a (see
On the proximal end side of the proximal end portion 3b, the deformed portion 3e is bifurcated to form a pair of tails. As shown in
A protrusion 3f is formed on the outer peripheral surface of the distal end 3a on the proximal end side where the connecting rod 3 protrudes from the proximal end opening of the holding tube 31. The connecting rod 3 can engage with the holding tube 31 at the position where the protrusion 3f is formed. In the present embodiment, by the elastic restoring force of the first arm 12 and the second arm 13 of the arm member 11, the force for moving the connecting rod 3 toward the distal end side acts on the hook portion 3c of the connecting rod 3. By having the protrusion 3f, the connecting rod 3 can restrict the movement of the connecting rod 3 toward the distal end side with respect to the holding tube 31.
In the present embodiment, as shown in
These members constituting the clip 10, including the arm member 11, are formed of a material such as a cobalt-chromium alloy, titanium, or stainless steel. The clip 10 is configured so that it can be observed under MRI (magnetic resonance imaging) fluoroscopy.
The arm member 11 is formed integrally by punching, for example, a plate material made of a cobalt-chromium alloy or the like into a shape in which the first arm 12, the second arm 13, the intermediate portion 14, and the pair of protrusions 16 and 17 are developed in a plane shape.
The holding tube 31 may be integrally formed of, for example, a material such as a 64 titanium alloy (Ti-6AL-4V) or a cobalt-chromium alloy.
The clip 10 according to the present embodiment is easy to transport in the process of being actually used after being manufactured, and in order to prevent contamination by the external environment, for example, as shown in
As shown in
As shown in
In the clip cartridge 40, when the hook 62a, which will be described later, enters the notch 3d through the through hole formed in the proximal end portion 3b of the connecting rod 3, the groove 38 has an inner diameter such that the proximal end portion 3b of the connecting rod 3 can be elastically deformed outward in the radial direction. As shown in
As shown in
As described above, the configuration of the lower case 42 of the clip case 40 according to the present embodiment has been described, but since the upper case 41 has the same configuration as the lower case 42, the description thereof will be omitted.
Next, the configuration of the applicator 30 according to the present embodiment will be described with reference to
The insertion portion 60 includes a sheath 66A and an operation wire 62. The operation wire 62 is inserted into the sheath 66A so as to be able to advance and retreat. The operation wire 62 is configured by connecting the proximal end to the operating portion 100 and connecting the distal end to a hook 62a formed having an arrowhead shape. More specifically, the operation wire 62 may be connected to the concave portion 102 of the slider 102 of the operating portion 100, which will be described later.
The operation wire 62 is provided for the operator to transmit the force for operating the operating portion 100 on the proximal end side (for example, the operation of pushing the slider 102 of the operating portion 100 and the operation of pulling back the slider 102) to the clip 10. In other words, the operation wire 62 is provided for operating the clip 10.
In the present embodiment, the operation wire 62 is formed of, for example, a single metal wire or a stranded wire. As shown in
The hook 62a is formed in a conical shape. Specifically, the hook 62a has an outer peripheral surface having a slope shape in which the outer diameter gradually decreases toward the distal end side. The outer diameter of the proximal end surface of the hook 62a is larger than the inner diameter of the through hole of the proximal end portion 3c when the deformed portion 3e of the connecting rod 3 is not elastically deformed. That is, in a state where the hook 62a is accommodated in the notch 3d of the connecting rod 3, the hook 62a does not fall out of the notch 3d only by the advancing/retreating operation of the operation wire 62. The large diameter portion 62b is a cylindrical member made of a metal material such as stainless steel. The distal end of the operation wire 62 is fixed to the large diameter portion 62b by various known methods such as adhesion and welding.
In the present embodiment, the operation wire 62, the hook 62a, the large diameter portion 62b, and the shaft portion 62c are integrally formed. Therefore, the hook 62a can move forward and backward together with the operation wire 62 by moving the operation wire 62 forward and backward.
The sheath 66A may be a coil sheath made of stainless steel such as SUS301 having high compression strength, for example. In this case, as the sheath 66A, a coil formed by tightly winding a wire (not shown) in the axial direction C1 can be used. The sheath 66A has flexibility and is strong against compressive force in the axial direction C1. In the present embodiment, when the sheath 66A is located in the sheath 66A in a state where the hook 62a and the notch 3d of the connecting rod 3 are engaged (see
In the present embodiment, when the hook 62a and the notch 3d of the connecting rod 3 are engaged with each other and are located inside the sheath 66A, the deformation spreading to the outside of the deformed portion 3e of the connecting rod 3 is suppressed by the sheath 66A. In other words, in this state, the deformed portion 3e of the connecting rod 3 is deformed, so that the engagement between the hook 62a and the notch portion 3d is maintained by the sheath 66A even if the width of the connecting rod 3 in the deformed portion 3e is increased.
The connecting member 80 is configured to connect the inserting portion 60 and the operating portion 100. The connecting member 80 has a longitudinal axis and is formed in a cylindrical shape. The connecting member 80 has a first lumen 81 having an inner diameter sufficient to insert the sheath 66A on the distal end side, and a second lumen 82 located on the proximal end side of the first lumen 81 and continuously formed on the first lumen 81. The distal end of the operating portion 100, which will be described later, is inserted into the second lumen 82 so that it can be engaged with the second lumen 82.
On the inner peripheral surface of the second lumen 82, the distal end concave portion 83 and the proximal end concave portion 84 are formed by cutting a part from the inner peripheral surface of the second lumen 82 to the outside in the radial direction of the connecting member 80 at two positions separated by a predetermined distance along the direction of the longitudinal axis of the connecting member 80. As shown in
In the present embodiment, as shown in
The present invention is not limited to this. For example, the sheath 66A may be fixed to the connecting member 80 in a state where the proximal end surface is in contact with the distal end surface of the connecting member 80. In this case, the first lumen of the connecting member 80 may have an inner diameter sufficient to allow only the operation wire 62 to be inserted.
As shown in
In the present embodiment, an example in which the sheath 66A is inserted into and fixed to the connecting member 80 has been described, but the present invention is not limited thereto. For example, the sheath 66B may be fixed in a state of being inserted into the connecting member 80. In this case, the sheath 66A and the connecting member 80 are engaged in a nested configuration. Therefore, the length L of the sheath 66 can be adjusted in the same manner by grasping the operating member 80 and moving it toward the distal end side with respect to the operating portion 100.
As shown in
The operating portion main body 101 is formed in a rod shape extending in the direction of the longitudinal axis C1, and a finger hook portion 101a is provided at the proximal end portion. A slit 101b extending in the radial direction is formed in the operating portion main body 101. The slit 101b is formed to have a front end surface 101c and a proximal end surface 101d.
The slider 102 is provided so as to be inserted through the operating portion main body 101. The slider 102 can slide (forward and backward) in the longitudinal axis C1 direction with respect to the operating portion main body 101. In the present embodiment, when the slider 102 moves forward or backward in the longitudinal axis C1 direction, the operation wire 62 and the hook 62a fixed to the distal end of the operation wire 62 move forward or backward together with the slider 102.
Further, in a state where the operation wire 62 and the connecting rod 3 are connected, the arm member 11 of the clip 10 can move forward or backward together with the operation wire 62 by the forward or backward operation of the operation wire 62. As a result, the pair of first arm 12 and second arm 13 of the arm member 11 can be opened or closed.
The slider 102 is formed in a cylindrical shape. A concave portion 102a is formed on the outer peripheral surface of the slider 102 over the entire circumference. The slider 102 is formed with a flange portion 102b, a concave portion 102a, and a flange portion 102c in this order from the distal end side to the proximal end side in the axial direction C1. The pair of collar portions 102b and 102c have an elliptical shape when viewed in the radial direction of the slider 102. As a result, the slider 102 can be easily grasped, and space can be saved when packing the operating portion 100 of the endoscope clip 1.
By engaging the slider 102 with the slit 101b of the operating portion main body 101, the movement range of the slider 102 in the longitudinal axis C1 direction with respect to the operating portion main body 101 is limited. More specifically, the movable region of the slider 102 is limited between the distal end surface 101c and the proximal end surface 101d of the slit 101b.
The slider 102 is provided with a fixing portion (not shown) to which the proximal end of the operation wire 62 is fixed. In the present embodiment, the position where the fixing portion is provided on the slider 102 is not particularly limited. For example, the fixing portion may be provided at the distal end of the flange portion 102b of the slider 102.
The distal end portion 104 is formed on the distal end side of the operating portion main body 101 and has a pair of legs 104A and 104B. The pair of legs 104A and 104B are formed so as to be separated from each other at a predetermined distance in the radial direction of the operating portion 100. Further, each of the pair of legs 104A and 104B is formed with a convex portion 103 protruding outward in the radial direction of the operating portion 100 from the outer peripheral surface.
In the present embodiment, in consideration of the point that the operation wire 62 is inserted, the region from the distal end surface 104C of the distal end portion 104 of the operating portion 100 to the distal end surface 101c of the slit 101b of the operating portion main body 101 is defined as the sheath (second sheath) 66B through which the operation wire 62 is inserted. In other words, in the present embodiment, the operation wire 62 is connected to the operating portion 100 by inserting the sheath 66A, the first lumen 81 of the connecting member 80, a part of the second lumen 82 of the connecting member 80, and the sheath 66B from the distal end side of the medical device 1. In the present embodiment, the above-described region through which the operation wire 62 is inserted is defined as the sheath 66. More specifically, in the present embodiment, the sheath 66 is configured by connecting the sheath 66A and the sheath 66B by the connecting member 80, and is defined as a region from a position where the fixing portion is arranged when the slider 102 is moved forward to the maximum (for example, the distal end surface 101c of the slit 101b of the operating portion main body 101) to the distal end surface of the sheath 66A.
Based on the above definition, in the present embodiment, the distance from the proximal end surface of the sheath 66A to the distal end surface 104C of the operating portion 100, which is the distal end surface of the sheath 66B, along the longitudinal axis C1 direction is defined as the distance ΔL between the sheath 66A and the sheath 66B. The distance from the distal end surface of the sheath 66A to the distal end surface 101c of the slit 101b of the slider 102 is defined as the length L of the sheath 66.
Therefore, although the respective lengths of the sheath 66A and the sheath 66B do not change, the length L of the sheath 66 can be adjusted by adjusting the distance ΔL between the sheath 66A and the sheath 66B.
In the present embodiment, as shown in
On the other hand, as shown in
In the present embodiment, a state in which a pair of convex portions 103 provided on the distal end portion 104 of the operating portion 100 are arranged in the distal end concave portion 83 of the connecting member 80 and the operating portion 100 and the connecting member 80 are engaged with each other is referred to as a second state of the sheath 66. Therefore, in the second state of the sheath 66, the length ΔL between the sheath 66A and the sheath 66B is reduced, so that the length of the sheath 66 changes from the length L1 in the first state to the second length L2, which is smaller than the length L1. Further, in the second state of the sheath 66, the hook 62a protrudes from the distal end opening of the sheath 66A, so that it becomes possible to engage with the notch 3d of the connecting rod 3 protruding from the opening on the proximal end side of the holding tube 31.
Hereinafter, the operation of loading the clip 10 according to the present embodiment to the applicator 30 will be described with reference to
From the state shown in
As shown in
Next, the operator operates the applicator 30 and executes an operation of loading the clip 10 accommodated in the clip cartridge 40 to the applicator 30. As shown in
The operator grasps and compresses the pair of squeezing portions 34A and 34B of the compressing portion 34 of the clip cartridge 40. By this operation, as shown in
In the present embodiment, when the operator moves the slider 102 to the position closest to the distal end side, the hook 62a is engaged with the notch 3d of the connecting rod.
However, the present invention is not limited to this. For example, in the process in which the slider 102 is advanced along the slit 101b to a position where it abuts on the distal end surface 101c of the slit 101b, it is also possible for the hook 62a to enter and engage with the notch 3d of the connecting rod 3 before the slider 102 abuts on the distal end surface 101c. At this time, when the hook 62a enters the cutout portion 3d of the connecting rod 3 and is engaged, the position of the slider 102 in the operating portion 100 in the slit 101b can be regarded as the most advanced position of the slider 102.
In the present embodiment, as shown in
In order to accommodate the connecting portion between the hook 62a and the connecting rod 3 in the sheath 66A, for example, the following operations can be performed. First, as shown in
In this state, as shown in
Further, a cup-shaped cover member can be arranged at the distal end of the sheath 66A to support the holding tube 31. At this time, the clip 10 may not come into direct contact with the sheath 66A, but may come into contact with any part of the cover member. In this case, since the proximal end portion of the clip 10, more specifically, a part of the proximal end side of the holding tube 31, is received by the cup-shaped cover member, the clip 10 is more stably loaded to the applicator 30. In the present specification, the case where the clip 10 is supported by the cover member provided at the distal end portion of the sheath 66A is also included in “the clip 10 comes into contact with the sheath 66A”.
After that, the operator can grasp the operating portion 100 and integrally remove the applicator 30 and the clip 10 connected to the applicator 30 from the clip cartridge 40.
As a result, the operation of loading the clip 10 according to the present embodiment to the applicator 30 and configuring the medical device 1 is completed.
Hereinafter, a procedure for ligating the target tissue T using the medical device 1 according to the present embodiment will be described with reference to
As shown in
In the procedure according to the present embodiment, the operator does not move the connecting member 80 again and shift the sheath 66 from the first state to the second state until the operation of ligating one target tissue T is completed.
As shown in
The operator inserts an endoscope (not shown) into the patient's body. Then, the operator can insert the medical device 1 from the proximal end of the endoscope channel and protrude the medical device 1 from the distal end of the endoscope channel.
In this process, in order to smoothly insert the endoscope channel through the medical device 1, it is necessary to temporarily close the first arm 12 and the second arm 13 of the arm member 11 in the open state. In this case, although not shown, for example, the operator pulls back the slider 102 of the operating portion 100 on the proximal end side, and pulls the portion located on the distal end side of the intersection of the first arm 12 and the second arm 13 into the holding tube 31. Thereby, the first arm 12 and the second arm 13 can be closed. At that time, the pair of protrusions 16 and 17 provided in the intermediate portion 14 of the arm member 11 are engaged with the inner wall of the holding tube 31, and the elastic restoring force of the first arm 12 and the second arm 13 can restrict the movement of the arm member 11 toward the distal end side with respect to the holding tube 31.
When the operator guides the medical device 1 through the channel of the endoscope to the vicinity of the target tissue T and pushes the slider 102 toward the distal end side, the first arm 12 and the second arm 13 of the arm member 11 can be changed to the open state again.
In the present embodiment, for convenience of explanation, an example in which the slider 102 is in the most advanced position where the slider 102 abuts on the distal end surface 101c of the slit 101b will be described as shown in
As shown in
After confirming that the target tissue T is located between the first arm 12 and the second arm 13, the operator grasps the operating portion main body 101 and pulls the slider 102 back to the proximal end side. At this time, the first arm 12 and the second arm 13 move to the proximal end side together with the operation wire 62. In such a state, while the first arm 12 and the second arm 13 are in contact with the tapered surface 31a provided on the distal end side of the holding tube 31, the first arm 12 is elastically deformed toward the second arm 13, and the second arm 13 is elastically deformed toward the first arm 12. As a result, as shown in
In this state, the operator presses the holding tube 31 with the first arm 12 and the second arm 13 in contact with the distal end of the holding tube 31 by the force of pulling the slider 102 back to the proximal end side. The pressing force provided by the first arm 12 and the second arm 13 that acts on the holding tube also acts on the sheath 66A that is in contact with the holding tube 31. Therefore, the above-described pressing force also acts on the connecting member 80 fixed to the sheath 66A, and has an effect of moving the connecting member 80 toward the proximal end side.
That is, in the present embodiment, by the above-described pressing force acting on the connecting member 80, the connecting member 80 has an effect of pressing the pair of convex portions 103 and elastically deforming the pair of legs 104A and 104B of the distal end portion 104 of the operating portion 100.
However, in the present embodiment, the force required to elastically deform the pair of legs 104A and 104B of the distal end portion 104 of the operating portion 100 is set to be larger than the above-described pressing force. Therefore, the above-described pressing force elastically deforms the pair of legs 104A and 104B, and the connecting member 80 cannot be moved to the proximal end side with respect to the operating portion 100.
In other words, in the present embodiment, the pair of legs 104A and 104B (including the pair of convex portions 103) of the distal end portion 104 of the operating portion 100 can generate a regulatory force that restricts the connecting member 80 from moving toward the proximal end side with respect to the operating portion 100. This restricting force is generated by the elastic restoring force of the pair of legs 104A and 104B. That is, in the present embodiment, the pair of legs 104A and 104B (including the pair of convex portions 103) of the distal end portion 104 of the operating portion 100 are a restricting portion that regulates the movement of the connecting member 80 toward the proximal end side with respect to the operating portion 100.
In the present embodiment, this restricting force is set to be larger than the maximum value of the traction force for pulling the slider 102 back to the proximal end side by the operator, in order to grasp the target tissue T, in the process of transitioning the first arm 12 and the second arm 13 of the arm member 11 from the open state to the closed state. Therefore, in the process in which the operator pulls back the slider 102 to the proximal end side and grasps the target tissue T, the connecting member 80 does not move to the proximal end side with respect to the operating portion 100. In other words, in this process, the sheath 66A does not move at the proximal end side with respect to the sheath 66B.
That is, the arm member 11 changes from the open state to the closed state in a state where the target tissue T is located between the first arm 12 and the second arm 13. As a result, as shown in
Therefore, in the present embodiment, in the process of pulling the slider 102 back to the above-described state, by operating the slider 102 until the first arm 12 and the second arm 13 of the arm member 11 are completely closed (a state in which the pair of protrusions 16 and 17 are located on the proximal end side of the opening on the proximal end side of the holding tube 31), the operator can adjust the open/closed state and orientation of the clip 10 again and re-grasp the target tissue T.
If the operator can confirm that the target tissue T is grasped by the arm member 11 of the clip 10 in a desired state, the operator proceeds to the operation of locking the grasped state of the clip 10 of the endoscope clip 1.
At this time, by pulling the slider 102 further toward the proximal end side, the operator pulls back the pair of protrusions 16 and 17 provided in the intermediate portion 14 of the arm member 11 to a position protruding from the opening on the proximal end side of the holding tube 31. When the pair of protrusions 16 and 17 are located closer to the proximal end side than the opening on the proximal end side of the holding tube 31, the pair of protrusions 16 and 17 can abut and engage with the proximal end surface of the holding tube 31. As a result, the arm member 11 is restricted from moving toward the distal end side with respect to the holding tube 31. That is, even if the force for pulling the slider 102 back to the proximal end side by the operator is released, the pair of protrusions 16 and 17 are locked to the distal end side with respect to the proximal end surface of the holding tube 31.
Therefore, the state in which the target tissue T is bound and grasped by the clip 10 is locked. In the present embodiment, the closed state of the arm member 11 includes a state in which the target tissue T is tied up at the root by the first arm 12 and the second arm 13, and the distance between the first arm 12 and the second arm 13 is approximately 0.
After this, the operator separates the clip 10 to which the target tissue T is ligated from the applicator 30. More specifically, as shown in
Thereby, the arm member 11 to which the target tissue T is ligated is placed in the body together with the holding tube 31. On the other hand, the connecting rod 3 is removed from the body while being engaged with the hook 62a.
After the clip 10 ligated with the target tissue T is placed in the body, the operator can operate the endoscope and take out the medical device 1 from the channel of the endoscope. After that, the operator takes necessary measures and completes a series of procedures. For example, the operator can take the medical device 1 out of the body and then remove the connecting rod 3 from the distal end of the hook 62a and dispose of it according to the method shown in
According to the medical device 1 of the present embodiment, in the applicator 30, the sheath 66A and the sheath 66B are connected by a connecting member 80. By the operator moving the connecting member 80 toward the proximal end side toward the sheath 66B, the sheath 66A fixed to the connecting member 80 moves toward the sheath 66B, and the distance between the sheath 66A and the sheath 66B decreases. Thereby, the sheath 66 of the applicator 30 is reduced in length from the first length L1 to the second length L2. As a result, the hook 62a provided at the distal end of the operation wire 62 can move relative to the sheath 66A from the accommodation position in the sheath 66A to the protruding position protruding from the distal end opening of the sheath 66A. As a result, the operator can operate the slider 102 of the operating portion 100 and engage the hook 62a with the notch 3d of the connecting rod 3 to connect the clip 10 and the applicator 30.
On the other hand, when the clip 10 and the applicator 30 are connected, the operator operates the connecting member 80 again and moves the connecting member 80 to the distal end side away from the sheath 66B, thereby separating the sheath 66A from the sheath 66B. By this operation, the connecting portion between the hook 62a and the connecting rod 3 moves from the protruding position protruding from the sheath 66A to the accommodation position in the sheath 66A. As a result, the operator moves the slider of the operating portion 100 to the most advanced position in the procedure of ligating the target tissue T by using the medical device 1 configured by loading the clip 10 to the applicator 30. However, it is possible to prevent the connecting portion between the hook 62a and the connecting rod 3 from protruding from the distal end opening of the sheath 66A and the clip 10 from being unintentionally dropped from the applicator 30. That is, according to the medical device 1 of the present embodiment, in the procedure for ligating the target tissue T, the state and orientation of the clip 10 can be adjusted and the target tissue T can be re-grasped by moving the slider 102 forward and backward.
Further, when the procedure for ligating the target tissue T is completed, the operator can load the new clip 10 by removing the connecting rod 3 connected to the hook 62a from the body and then discarding it. That is, according to the medical device 1 of the present embodiment, the clip 10 can be reloadable.
Therefore, according to the medical device 1 of the present embodiment, both the reloadability of the clip 10 and the re-grasping operation of the target tissue T can be achieved for the applicator 30.
According to the medical device 1 of the present embodiment, the connecting member 80 is configured by only one component and can be easily manufactured, so that the medical device 1 can be configured at low cost. Further, since the length of the sheath 66 can be adjusted only by moving the connecting member 80 forward and backward by the operation of the operator's hand, the influence of the meandering state of the endoscope in the body is small, and the operation of the operator becomes simple.
Hereinafter, the configuration of a modified example of the applicator 30 according to the present embodiment will be described with reference to
As shown in
The proximal end side of the distal end concave portion 83A in the connecting portion 80 according to this modification is chamfered. Therefore, in the distal end concave portion 83 according to the first embodiment described above, the proximal end surface is formed orthogonal to the longitudinal axis C1, whereas as shown in
Since the applicator 30 according to the present modification has the above-described configuration, as shown in
In the applicator 30 according to this modification, the operator can push the pair of pins 105A inserted into the pair of through holes formed in the proximal end concave portion 84 inward in the radial direction of the connecting member 80. By this operation, as shown in
When the pair of legs 104A and 104B at the distal end portion 104 of the operating portion 100 according to this modification bend inward in the radial direction of the connecting member 80, the pair of convex portions 103A move inward in the radial direction of the connecting member 80 together with the pair of legs 104A and 104B. As a result, as shown in
In this state, as in the first embodiment described above, when the connecting member 80 is grasped and moved toward the proximal end side with respect to the operating portion 100, the pair of convex portions 103A can move toward the distal end side with respect to the connecting member 80. That is, according to the applicator 30 of the present modification, in a state where the operator pushes in the pair of pins 105A and 105B provided on the connecting member 80, by moving the connecting member 80 toward the proximal end, a pair of convex portions 103A provided on the distal end portion 104 of the operating portion 100 overcome the proximal end concave portion 84 of the connecting member 80, move toward the distal end side with respect to the connecting member 80, and enter the distal end concave portion 83A. As a result, as shown in
After that, the operator can load the clip 10 to the applicator 30 and treat the target tissue T in the same manner as the applicator 30 according to the first embodiment described above.
Further, although not shown, according to the applicator 30 of the present modification, in a state where the pair of convex portions 103A are in contact with the distal end concave portion 83A, the operator can grasp the connecting member 80 and move the connecting member 80 to the distal end side with respect to the operating portion 100. When the operator moves the connecting member 80 toward the distal end side with respect to the operating portion 100, while the pair of convex portions 103A abut on the proximal end surface of the distal end concave portion 83A inclined with respect to the longitudinal axis C1, it can be moved to the proximal end side with respect to the operating portion 100. As a result, the pair of convex portions 103A can pass over the distal end concave portion 83A of the connecting member 80, move toward the proximal end side with respect to the connecting member 80, and engage with the proximal concave portion 84.
According to the applicator 30 of the present modification, similarly to the applicator 30 of the first embodiment described above, the operator can adjust the length L of the sheath 66 by adjusting the distance ΔL between the sheath 66A and the sheath 66B. As a result, the sheath 66 can be transitioned to the first state and the second state in the same manner as the applicator 30 according to the first embodiment described above.
According to the applicator 30 of the present modification, when the pair of convex portions 103A are engaged with the proximal concave portion 84 at the distal end portion 104 of the operating portion 100, even if the force of the operator moving the slider 102 forward and backward acts on the connecting member 80, it is possible to regulate that the pair of convex portions 103A and the proximal end concave portion 84 are disengaged from each other. Further, when the pair of convex portions 103A are engaged with the distal end concave portion 83A of the operating portion 100, the engagement between the pair of convex portions 103A and the distal end concave portion 83A can be easily disengaged by the force of the operator to move the connecting member 80 toward the distal end side with respect to the operating portion 100.
That is, according to the applicator 30 of the present modification, the state in which the hook 62a provided on the distal end side of the operation wire 62 is accommodated in the sheath 66A can be more reliably maintained as compared with the applicator 30 according to the first embodiment described above. In other words, according to the applicator 30 of the present modification, the operator can more reliably restrict the hook 62a from unintentionally protruding from the distal end opening of the sheath 66A by operating the slider 102.
Hereinafter, the medical device according to the second embodiment of the present invention will be described with reference to
Compared to the medical device 2 according to the first embodiment described above, the difference is that the operator attaches a protective member 80A externally instead of the connecting member 80 as shown in
As shown in
In the present embodiment, the protective member 80A formed by engaging the upper member 91 and the lower member 92 is formed in a tube shape. The protective member 80A may have an inner diameter that does not allow disengagement with each other when the connecting portion between the hook 62a and the connecting rod 3 is arranged in the protective member 80A, and the numerical value is not specifically limited. Further, the protective member 80A may have an outer diameter sufficient to come into contact with the clip 10.
In the present embodiment, the upper member 91 and the lower member 92 have the same length in the longitudinal axis direction. Further, the lengths of the upper member 91 and the lower member 92 in the longitudinal axis direction need only be able to completely cover the connecting portion between the operation wire 62 and the clip 10, which will be described later, and for example, they may be larger than the sum of the length of the connecting rod 3 of the clip 10 and the lengths of the hook 62a, the fixing portion 62b, and the shaft portion 62c.
As shown in
In the present embodiment, as shown in
On the other hand, when the target tissue T is treated using the medical device 2 configured by connecting the clip 10 to the applicator 30A, depending on the position of the slider 102, the connecting portion between the clip 10 and the applicator 30A may be moved to a protruding position protruding from the distal end opening of the sheath 76. Therefore, in the present embodiment, it is necessary to prevent the clip 10 from being unintentionally dropped from the applicator 30A.
At this time, the operator arranges the upper member 91 and the lower member 92 on the support portion 76a formed at the distal end of the sheath 76 in a state of facing each other with respect to the connecting portion between the operation wire 62 and the clip 10 arranged at the protruding position, and each of the plurality of engaging claws 91A is engaged with the corresponding engaging hole 92A.
By this operation, as shown in
As shown in
Therefore, in the present embodiment, by attaching the protective member 80A to the support portion 76a on the distal end side of the sheath 76 of the applicator 30A, the length L of the sheath 77 can be adjusted from the second length L2 to the first length L1 which is larger than the second length L2. Further, for example, when the treatment of the target tissue is completed using the medical device 2 according to the present embodiment, when the protective member 80A is removed, the length L of the sheath 77 can be adjusted from the first length L1 to a smaller second length L2.
The operator can ligate the target tissue by using the medical device 2 according to the present embodiment in the same manner as in the first embodiment described above. Since the protective member 80A is not removed in the procedure for ligating the target tissue, the connecting portion between the hook 62a of the operation wire 62 and the connecting rod 3 does not move to a position protruding from the protective member 80A. In other words, according to the medical device 2 of the present embodiment, in the procedure for ligating the target tissue, the state in which the length L of the sheath 77 is the first length L1 is maintained, and the connecting portion between the hook 62a and the connecting rod 3 is always in an accommodation position of being accommodated in the protective member (first sheath) 80A.
According to the medical device 2 of the present embodiment, as in the first embodiment described above, both the reloadable clip 10 and the re-grasping operation of the target tissue T can be compatible with respect to the applicator 30A.
Next, the medical device according to the third embodiment of the present invention will be described with reference to
Hereinafter, the same configuration as the medical device 1 according to the first embodiment will be described with the same reference numerals, the description thereof will be omitted, and the points different from those of the above-described embodiment will be mainly described.
As shown in
In the present embodiment, the spring 86 can be attached to the distal end of the sheath 66 by various known methods such as welding and adhesion. In the present embodiment, the region from the proximal end of the fixing member 86b to the distal end surface 101c of the slit 101b of the operating portion 100 is defined as the sheath 66.
In the present embodiment, by appropriately setting the natural length of the spring 86, as shown in
In the present embodiment, the region where the spring 86 (including the fixing member 86b) is arranged is defined as a first sheath, the sheath 66 is defined as a second sheath, and the region including the first sheath and the second sheath is defined as a sheath 87. That is, as shown in
When loading the clip 10 according to the present embodiment to the applicator 30B, as shown in
After that, the operator does not operate the slider 102, but grasps the main body 101 and pushes the entire operating portion 100 toward the distal end side. At this time, as shown in
In this process, the spring 86 is pressed and the length in the longitudinal axis direction becomes shorter than the natural length. Therefore, the length L of the sheath 87 according to the present embodiment is adjusted from the first length L1 to a smaller second length L2. As a result, the hook 62a provided on the distal end side of the operation wire 62 is moved from the accommodation position accommodated in the spring 86 to the protruding position protruding from the distal end 86a of the spring 86.
As a result, as shown in
After confirming that the hook 62a is engaged with the notch portion 3d of the connecting rod 3 through the clip cartridge 40, the operator releases the pressing force acting on the operating portion 100. At this time, the elastic restoring force of the spring 86 acts on the sheath 66 and the operating portion 100 to move the spring 86 toward the proximal end side. As a result, the hook 62a and the clip 10 connected to the hook 62a move to the proximal end side. As described above, when the spring 86 has a natural length, the hook 62a is located closer to the proximal end side than the distal end 86a of the spring 86. Therefore, when the pressing force on the operating portion 100 by the operator is released and the spring 86 is restored to its natural length, as shown in
After that, the operator removes the clip 10 loaded to the applicator 30B from the clip cartridge 40 together with the applicator 30B, and the operation of loading the clip 10 to the applicator 30 is completed.
The operator can ligate the target tissue by using the medical device 3 according to the present embodiment in the same manner as in the first embodiment described above.
As shown in
As shown in
When the operator pushes the slider 102 (pushes the operation wire 62) while the spring 86 is compressed, the compression of the spring 86 is released and the spring 86 returns to the original length, so that even when the slider 102 advances to the maximum, the connecting portion between the hook 62a and the connecting rod 3 is always in the accommodation position accommodated in the spring 86.
According to the medical device 3 of the present embodiment, as in each of the above-described embodiments, both the reloadability of the clip 10 and the re-grasping operation of the target tissue T can be achieved for the applicator 30B. Further, since the operation of loading the clip 10 to the applicator 30B is only the operation of pushing the operating portion 100 toward the distal end side, the operation of the operator can be made easier than in each of the above-described embodiments.
In the present embodiment, the configuration in which the spring 86 is provided on the distal end side of the sheath 66 has been described as an example, but the present invention is not limited thereto. For example, a configuration in which the spring 86 is provided at the intermediate portion or the proximal end portion of the sheath 66 has the same effect. In other words, in the present embodiment, when the region of the spring 86 is defined as the first sheath and the sheath 66 is defined as the second sheath, if at least one part of the first sheath provided on the distal end side and the second sheath located on the proximal end side of the first sheath is configured by the spring 86, it can be said that it has the same effect as the medical device 3 according to the present embodiment.
While preferred embodiments of the invention have been described and illustrated above, it should be understood that these are exemplary of the invention and are not to be considered as limiting. Additions, omissions, substitutions, and other modifications can be made without departing from the spirit or scope of the present invention. Accordingly, the invention is not to be considered as being limited by the foregoing description, and is only limited by the scope of the appended claims.
According to each of the above-described embodiments of the present disclosure, it is possible to provide a medical device and an applicator capable of achieving both reloadability of the treatment tool and re-grasping operation of the target tissue by the treatment tool. Further, in this medical device, it is also possible to provide a method of suitably loading the treatment tool to the medical device by engaging the treatment tool with the applicator.
The present application is a continuation application based on a PCT Patent Application No. PCT/JP2018/046136, filed on Dec. 14, 2018, the entire content of which is hereby incorporated by reference.
Number | Date | Country | |
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Parent | PCT/JP2018/046136 | Dec 2018 | US |
Child | 17344089 | US |