Methods and devices for inserting a treatment device into a hollow organ

Abstract

The guide wire holding device comprises a sheath comprising a lumen, a holder arranged at a distal end of the sheath and configured to switch between holding the guide wire and releasing the guide wire, a therapeutic tool inserted in the lumen to perform an intended therapy, and a wire connected with the therapeutic tool and configured to move the therapeutic tool between a first configuration and a second configuration. In the first configuration, the therapeutic tool is accommodated within the lumen, and in the second configuration, the therapeutic tool protrudes from the distal end of the sheath.

Description

TECHNICAL FIELD

[0001] The present invention relates to a device and a method for inserting a medical tool into a hollow organ of a subject such as a patient using a guide wire. In particular, the present invention relates to a guide wire holding device and a method of using the guide wire holding device to insert an endoscopic therapeutic tool into a hollow organ such as a bile duct or a pancreatic duct through an opening such as a duodenal papilla. BACKGROUND

[0002] A method and a device for introducing a medical tool into a hollow organ of a human body using a guide wire for the purpose of treatment and examination of the hollow organ of the human body are known. When an obstruction such as a stricture and an occlusion occurs at an opening of a hollow organ, the guide wire itself cannot be inserted into the hollow organ. For example, when a duodenal papilla is tightly closed, it is difficult to insert a guide wire into a desired hollow organ such as a bile duct or a pancreatic duct through the duodenal papilla.

[0003] As a solution to such a situation, an endoscopic ultrasound-guided intervention technique (EUS-RV) has been developed. In a typical EUS-RV, an operator inserts an ultrasound endoscope into a digestive tract through a mouth of a patient. A bile duct or a pancreatic duct is confirmed by an ultrasound image so as to insert a puncture needle into a channel of the ultrasound endoscope, and to penetrate the bile duct or the pancreatic duct. Then, the operator inserts a first guide wire into a lumen of the puncture needle, and inserts a distal end of the first guide wire from the lumen of the puncture needle into the bile duct or the pancreatic duct. Next, the operator pushes the first guide wire so that the distal end of the first guide wire enters a duodenum from the duodenal papilla. Subsequently, the distal end of the first guide wire is left in the duodenum, for example, by pulling out the ultrasound endoscope and the puncture needle from the body of the patient.

[0004] Next, the operator inserts an endoscope to a vicinity of a duodenal papilla of the duodenum through the mouth of the patient. A guide wire holding device is inserted into a channel of the endoscope so as to hold and retain the first guide wire. With the first guide wire retained, the guide wire holding device is pulled with respect to the endoscope, the distal end of the first guide wire is introduced into the channel of the endoscope, and is pulled out from a jaw of the endoscope. Another catheter is inserted into the jaw of the endoscope along the first guide wire pulled out, and a distal end of the catheter is inserted into the bile duct. A second guide wire is inserted into the bile duct through a lumen of the catheter.

[0005] When the second guide wire is left under a view of the endoscope, the engagement of the guide wire holding device with the first guide wire is released. The first guide wire is pulled out from the body of the patient, and the guide wire holding device is pulled out of the duodenum, leaving the second guide wire at the bile duct. When the above operations are completed, a therapeutic device is left in the body through the second guide wire to perform an endoscopic retrograde cholangiopancreatography (ERCP) procedure.

[0006] However, the conventional EUS-RV procedure requires at least two guide wires for the therapeutic device to be left in the body, and also requires the first guide wire to be caught and released before performing the ERCP procedure. In order to perform the treatment as soon as possible to reduce the burden on the patient, the operation before the ERCP procedure has become a problem because it is complicated and time-consuming. SUMMARY

[0007] Accordingly, the present disclosure relates to a guide wire holding device and a method of inserting a therapeutic tool using the guide wire holding device, which substantially eliminates one or more of the problems caused by the limitations and disadvantages of the existing EUS-RV device and method.

[0008] An object of the present disclosure is to provide a guide wire holding device including a sheath including a lumen, a holder disposed at a distal end of the sheath and configured to switch between holding a guide wire and releasing the guide wire, a therapeutic tool inserted in the lumen to perform an intended treatment, and a wire connected with the therapeutic tool and configured to move the therapeutic tool between a first configuration and a second configuration. In the first configuration, the therapeutic tool is accommodated within the lumen, and in the second configuration, the therapeutic tool protrudes from the distal end of the sheath.

[0009] Another object of the present disclosure is to provide a guide wire holding device including a sheath including a first lumen and a second lumen, a holder disposed at a distal end of the sheath and configured to switch between holding a guide wire and releasing the guide wire, an operation wire inserted in the first lumen and connected with the holder, and a therapeutic tool mounted to the sheath, connected with the second lumen, and operable in a manner of switching between a first configuration and a second configuration, wherein the therapeutic tool is a balloon, the second lumen is an air delivery lumen, in the first configuration, the balloon is not inflated by the air delivery lumen, and in the second configuration, the balloon is inserted in a target organ and inflated by the air delivery lumen.

[0010] Still another object of the present disclosure is to provide a method of inserting a therapeutic tool into a patient's body using a guide wire holding device. The method includes placing a guide wire through a duodenal papilla at a bile duct and a duodenum, inserting a therapeutic tool through a sheath of an endoscope into the duodenum, connecting the therapeutic tool with the guide wire in the duodenum using a holder, inserting the therapeutic tool in a first state along the guide wire into the bile duct, switching the therapeutic tool from the first state to a second state, and performing a treatment after the therapeutic tool is switched to the second state. In the first state, the therapeutic tool is accommodated within the sheath, and in the second state, the therapeutic tool protrudes from a distal end of the sheath.

[0011] Additional features and advantages will be set forth in the description which follows, and in part will be apparent from the description, or can be learned by practice of the application. The objectives and other advantages of the disclosed input device will be realized and attained by the structure particularly pointed out in the written description and claims thereof as well as the appended drawings. BRIEF DESCRIPTION OF DRAWINGS

[0012] The following detailed description of the preferred embodiment can be read in connection with the accompanying drawings, where like numerals designate like elements, and in which:

[0013] Figure 1 is an exploded view schematically showing a guide wire holding device of an endoscope according to an exemplary embodiment.

[0014] Figure 2 is a plan view schematically showing a distal end portion of the guide wire holding device of Figure 1

[0015] Figure 3 is a side view schematically showing a distal end portion of the guide wire holding device of Figure 1

[0016] Figure 4 is a front view of a sheath of an exemplary embodiment.

[0017] Figure 5 is a cross-sectional view taken along line V-V in Figure 3

[0018] Figure 6 is a schematic view showing a mode of using the guide wire holding device according to an exemplary embodiment in a partial perspective view.

[0019] FIG. 7(A) is a schematic view showing another mode of using the guide wire holding device according to an exemplary embodiment in a partial perspective view, and FIG. 7(B) is a perspective view showing the same mode using a different guide wire holding device according to another exemplary embodiment.

[0020] Figure 8 is a plan view showing a modification of the guide wire holding device according to an exemplary embodiment.

[0021] Figure 9 is a diagram illustrating a method of introducing the guide wire holding device into a hollow organ according to an exemplary embodiment.

[0022] Figure 10 is a diagram illustrating a method of performing a surgery by a down approach using the guide wire holding device according to an exemplary embodiment.

[0023] Figure 11 ​​​is a flow chart illustrating the general steps of a method of introducing a guidewire retaining device into a hollow organ according to an exemplary embodiment.

[0024] Figure 12 is a front view of a sheath schematically showing a guidewire retaining device comprising a therapeutic device housed within the sheath.

[0025] Figure 13 is Figure 12 is a cross-sectional view of line A-A of

[0026] Figure 14(A) is a perspective side view of a guidewire retaining device according to an exemplary embodiment with a therapeutic device extended from a sheath; Figure 14(B) is a cross-sectional side view of a guidewire retaining device according to an exemplary embodiment with a therapeutic device extended from a sheath; Figure 14(C) is a top view of a guidewire retaining device according to an exemplary embodiment with a therapeutic device extended from a sheath; Figure 14(D) is a front view of a guidewire retaining device according to an exemplary embodiment with a therapeutic device extended from a sheath.

[0027] Figure 15(A) is a front view of a retaining member schematically showing a therapeutic device in a second configuration in which the therapeutic device is extended from a sheath 2, Figure 15(B) is a front view of a sheath schematically showing a therapeutic device in a second configuration.

[0028] Figure 16(A) is a front view of a retaining member schematically showing a therapeutic device extended from a sheath, Figure 16(B) is a front view of a sheath schematically showing a therapeutic device extended from a sheath.

[0029] Figures 17(A)-17(E) Examples of a therapeutic device in a first state / configuration and a second state / configuration according to exemplary embodiments are shown.

[0030] Figure 18(A) is a cross-sectional view of line B-B in Figure 18(B) which is a front view of a sheath schematically showing a side view of a guidewire retaining device according to another exemplary embodiment.

[0031] Figure 19(A) is a cross-sectional view of line B-B in Figure 19(B) which is a front view of a sheath schematically showing a side view of a guidewire retaining device according to another exemplary embodiment.

[0032] Figure 20(A) is a cross-sectional view schematically showing a main view of the sheath, Figure 20(B) shows a cross-sectional view of line AA in Figure 20(A), schematically showing a side view of the guide wire retaining device, Figure 20(C) shows a cross-sectional view of line AA in Figure 20(A), schematically showing another side view of the guide wire retaining device, and Figure 20(D) shows a cross-sectional view of line AA in Figure 20(A), schematically showing yet another side view of the guide wire retaining device according to another exemplary embodiment. DETAILED DESCRIPTION

[0033] Various examples of devices and methods for inserting a medical tool into a hollow organ of a subject, such as a patient, using a guide wire will be described with reference to the drawings.

[0034] Figure 1 1 is an overall view schematically showing a guide wire holding device 1 for an endoscope according to an exemplary embodiment. Figure 2 It is schematically shown Figure 1 A top view of the distal end portion of the guidewire retaining device 1. Figure 3 It is schematically shown Figure 1 Side view of the distal portion of the guidewire retention device.

[0035] like Figure 1 As shown, the endoscope includes a guide wire holding device 1 capable of holding a medical guide wire used by being inserted into a patient's body and capable of placing a treatment device (tool) in a target cavity of a hollow organ during an EUS-RV procedure.

[0036] In the present exemplary embodiment, the guidewire holding device 1 is configured as a combined device that combines a guidewire holder and a treatment tool into one device. The guidewire holding device 1 is arranged at or extends from the distal end of an insertion portion of an endoscope.

[0037] like Figures 1-4 As shown, the guide wire holding device 1 may include: a sheath 2, which is inserted into the insertion part of the endoscope; an operating wire 3, which is located inside the sheath 2; a retaining member 5, which is connected to the operating wire 3; an operating unit 4, which operates the guide wire holding device 1; and a treatment device 24, which is housed in the sheath 2.

[0038] In the guide wire holding device 1, the holder 5 can advance and retreat on the distal end side of the sheath 2 as the operation wire 3 advances and retreats, and as will be described later, the guide wire GW ( Figure 6 ) can be captured and held by the holder 5.

[0039] The sheath 2 is a long flexible member. The proximal end portion of the sheath 2 is connected to the operation portion main body 41 of the operation unit 4 which is operated by the operator. The sheath 2 is inserted into the patient's body via the insertion portion of the endoscope, and has a length such that the distal end portion of the sheath 2 can be protruded from the insertion portion of the endoscope. As Figure 1 shown, the sheath 2 can include a plurality of lumens. In the present exemplary embodiment, the sheath 2 includes a lumen 21( Figure 2 ) which extends in the longitudinal axis L direction, and a lumen 22 which extends parallel to the lumen 21. The lumen 21 can be configured for insertion of the operation wire 3, and the lumen 22 can be configured for insertion and storage of the treatment device 24. The sheath 2 can have an additional lumen 23 (refer to FIG. 7(A) and FIG. 7(B)) without increasing the diameter of the sheath 2. The lumens 21-23 can differ from each other in size and shape.

[0040] As will be described later, the guide wire holding device 1 can use the lumen 21 for the treatment device 24. In this case, the treatment device 24 is connected to the holder 5, and functions as the operation wire or is further connected to the operation wire 3.

[0041] The sheath 2 includes a groove 26 formed in a portion of the outer periphery thereof. The portion of the outer periphery of the groove 26 is formed in a concave shape. The groove 26 is formed so as to extend from the distal end to the proximal side of the sheath 2 in the longitudinal axis L direction. From the distal end to the proximal end of the groove 26, the groove 26 has the same shape as that of the distal end edge 261( Figure 4 ). The groove 26 can be formed throughout the entire length of the sheath 2, or can be formed in a region having a predetermined length from the distal end to the proximal side, for example, can be formed only in the portion protruding from the distal end of the insertion portion of the endoscope.

[0042] As Figure 2 shown, the sheath 2 includes a distal end face 27 on which a step portion 273 is formed so as to be recessed toward the proximal end side. The operation wire 3 is inserted in the lumen 21, and advances and retreats through the step portion 273. The step portion 273 has a side surface 274 which is cut in a planar shape along the longitudinal axis L. When the proximal end of the protruding portion 58 comes into contact with the step portion 273, a slight gap is preferably formed between the proximal end face 505 of the holder 5 (excluding the protruding portion 58) and the distal end face 27 of the sheath 2. When the holder 5 and the sheath 2 are in contact with each other as described above, the guide wire GW( Figure 6 ) is held between the guide wire engaging face 53 and the inner wall face 264 of the groove 26.

[0043] As Figure 1 shown, the holder 5 is disposed at the distal end of the sheath 2. In the present exemplary embodiment, the holder 5 is a three-dimensional hook connected to the distal end of the operation wire 3, and has a substantially columnar outer shape. The hook 5 includes a slit 56 formed in the longitudinal axis L direction. As Figure 2As shown, the hook 5 further includes a proximal end portion 503 having a proximal end face 505 abutting against a distal end face 27 of the sheath 2, and a guide wire engagement face 53 Figure 1 which is distal from a distal end of the slot 26. As will be described later, the guide wire GW is held between the guide wire engagement face 53 and an inner wall face 264 of the slot 26, the hook 5 is configured to be switchable between holding the guide wire GW and releasing the guide wire GW.

[0044] Further referring to Figure 1 , the hook 5 further includes a protruding portion 58 formed in a region where the wire fixing portion 54 Figure 3 is provided. The protruding portion 58 includes a contact face 581 which is capable of contacting a side surface of the sheath 2 when the hook 5 is retracted. The contact face 581 is continuously formed from an inner wall face of the slit 56, but the contact face 581 can be provided separately from the slit 56. The protruding portion 58 can be provided at a position different from the wire fixing portion 54.

[0045] As Figure 2 shown, the hook 5 further includes a tip end portion 501 having a curved face 502 formed on an outer peripheral portion of the tip end portion 501. Thus, the hook 5 is capable of smoothly advancing and retracting. In addition, as Figure 8 shown, in addition to the tip end portion 501 of the hook being provided with the curved face 502, the proximal end portion 503 can be provided with a bevel face 504. The proximal end portion 503 of the hook 5 can also be formed as a curved face. Further, the outer peripheral portion of the hook 5 can be formed using any shape suitable for smoothly advancing and retracting the hook 5.

[0046] The slit 56 is a U-shaped groove. As Figure 5 shown, the slit 56 is open on a first diameter line R1 of the outer peripheral face of the hook 5 and is recessed in the radial direction. The slit 56 is formed so as to extend over the entire length in the longitudinal axis L direction of the hook 5. In Figure 1 and Figure 5 the example shown, the bottom face of the slit 56 is the guide wire engagement face 53.

[0047] Referring to Figure 5 and Figure 6 , the slit 56 is open in a direction opposite to the opening of the slot 26 of the sheath 2. When viewed from the longitudinal axis direction (when viewed from the front along the longitudinal axis), the guide wire engagement face 53 of the slit 56 is preferably intersected with the curved shaped tip edge (ridge line) 261 of the slot 26 to form a closed region C3. On the other hand, as Figure 3 shown, in the direction of the longitudinal axis L, the bottom 262 of the slot 26 and the guide wire engagement face 53 do not face each other, and the slit 56 is located on the tip side of the tip edge 261 of the slot 26.

[0048] As Figure 3 and Figure 6As shown, the guide wire engaging surface 53 is inclined from the proximal end toward the distal end of the hook 5 in a manner close to the extension line of the longitudinal axis L of the sheath 2. Figure 5 As shown, the radial position of the guidewire engagement surface 53 at the proximal end 503 of the hook 5 is located radially outward from the position of the bottom 262 of the groove 26. When viewed along the longitudinal axis, the closed region C3 can be formed as a region enclosed by at least the proximal end of the hook 5 and the distal edge 261 of the groove 26. Therefore, the guidewire GW captured in the closed region C3 can move smoothly back and forth within the closed region C3. As a result, when the distal end of the guidewire retaining device 1 is inserted into the duodenum, the sheath 2 can easily advance along the guidewire GW. The groove 26 of the sheath 2 is formed on an inclined extension of the guidewire engagement surface 53.

[0049] In this exemplary embodiment, hook 5 is a member made of resin. Considering the insertability of the duodenal papilla, hook 5 can be made of any material that exhibits sufficient strength when formed into a small shape. Hook 5 can be made of metal. Alternatively, hook 5 can be formed by combining metal and resin. For example, if the inner wall surface of the slit is made of resin, the guidewire GW can slide smoothly.

[0050] like Figure 3 As shown, a wire securing portion 54 for inserting and securing the operating wire 3 is disposed between the slit 56 and the outer peripheral surface of the hook 5. The wire securing portion 54 includes a U-shaped connecting hole at the distal end, connecting two cavities extending parallel to the longitudinal axis L. The operating wire 3 is inserted into the connecting hole and secured, for example, by bonding. The method for securing the operating wire 3 in the wire securing portion 54 is not limited to bonding. The operating wire 3 can also be secured in the wire securing portion 54 by interlocking, crimping, or the like.

[0051] like Figure 1 As shown, the operating wire 3 may include a first portion 31 and a second portion 32 extending in the direction of the longitudinal axis L. The first wire portion 31 may extend linearly in parallel with the longitudinal axis L, and the second wire portion 32 may be bent at multiple locations in a manner that is not flat in the vertical direction in a side view. The proximal end of the first wire portion 31 is fixed to the operating slide 42 of the operating unit 4. The proximal end of the second wire portion 32 is disposed in the cavity 21. That is, the base end of the second wire portion 32 is disposed in the cavity 21 without being connected to the operating portion 4. As shown Figure 2 As shown, the first wire portion 31 and the second wire portion 32 extend in a manner overlapping with the longitudinal axis L in a top view. The first wire portion 31 and the second wire portion 32 are inserted into the cavity 21 of the sheath 2 in a manner capable of moving forward and backward. Figure 4As shown, the cavity 21 is an oblong shape at least in the end opening formed at the step portion 273. The cavity 21 is formed so that the long side 21a of the cavity 21 is parallel to the side surface 274. With this structure, the cavity 21 and the side surface 274 of the step portion 273 serve as limiting portions, and the two operating wires 31 and 32 and the contact surface 581 serve as restricted portions. As a result, the rotation around the axis is more stable than the structure in which the operating wire 3 is constrained only by the cavity 21. In addition, since the second wire portion 32 moves in the vertical direction, the concave and convex shape of the second wire portion 32 is stably maintained, thereby effectively preventing the hook 5 from rotating around the axis. That is, when a force is applied to the hook 5 in a direction pulling the hook 5 proximally, for example when the operating slide 42 is pulled, it is difficult for external force to be applied to the second wire portion 32, thereby preventing deformation of the vertical uneven shape.

[0052] The guide wire engaging surface 53 of the hook 5 and the inner wall surface 264 of the groove 26 of the sheath 2 are configured so that the guide wire GW can be held between the hook 5 and the groove 26 in a manner capable of moving forward and backward.

[0053] like Figure 6 As shown in FIG, since the guidewire engaging surface 53 of the slit 56 is inclined in such a manner that the distal end portion of the slit 56 is located near the central axis of the sheath 2, the guidewire GW is not attached to the sheath at the distal end portion 501 of the hook 5. As a result, when the distal end portion of the guidewire holding device 1 is inserted into the duodenum, the sheath 2 can be easily advanced along the guidewire GW. In addition, as shown in FIG. Figure 6 In the embodiment, the hook 5 is provided with an X-ray marker 59 that can be visually identified in an X-ray image. In this exemplary embodiment, the X-ray marker 59 is configured in the return portion of the distal end portion of the operating wire 3 and is embedded in the hook 5. The return portion of the distal end portion of the operating wire 3 can be configured to extend from the distal end of the hook 5.

[0054] FIG7(A) shows a mode in which the hook 5 is advanced and exits the sheath 2. When the hook is maintained in this position, the guide wire GW can be easily caught in the slit 56 of the hook 5 and can also be positioned corresponding to the groove 26 of the sheath 2. Then, while the guide wire GW is maintained in the slit 56, the hook 5 is retracted toward the sheath 2, thereby retaining the guide wire GW between the slit 56 of the hook 5 and the groove 26 of the sheath 2.

[0055] FIG7(B) shows the same mode as FIG7(A) but shows a guide wire holding device different from that shown in FIG7(A). Figures 1 to 7(A)As shown, the exemplary embodiment shows that the sheath 2 includes a concave portion (formed by the stepped portion 273 and the side surface 274) that can engage with a convex portion (formed by the contact surface 581) of the hook 5. However, the present application is not limited to this configuration. As an example, FIG. 7(B) shows that the sheath 2 can include a flat distal end surface 27 without the concave shape of FIG. 7(A), and the hook 5 can include a flat base end surface 505 without the convex contact surface 581 of FIG. 7(A). In addition, as shown in FIG. 7(B), the X-ray marker 59 is disposed outside the hook 5 to cover at least a portion of the turn-back portion of the distal end portion of the operating wire 3, and the cover tube 33 is disposed to cover at least a portion of the distal end of the operating wire 3 that is exposed between the sheath 2 and the hook 5. With this configuration of FIG. 7(B), when the hook 5 is retracted into the sheath 2, the cover tube 33 and the X-ray marker 59 are housed within the cavity 21 of the sheath 2. The cavity 22 can be used to deliver the treatment tool 24. The cavity 23 can be used as a liquid delivery cavity, or can be used to deliver an additional treatment tool.

[0056] The X-ray marker 59 is made of an X-ray opaque material, and is used to determine the position of the distal end of the hook 5 under X-ray fluoroscopy.

[0057] In the present exemplary embodiment, the treatment device 24 is configured to be switchable between a first configuration or state and a second configuration or state during the EUS-RV procedure. Figure 1 It is shown that the treatment device 24 is in the first configuration when the treatment device 24 is housed within the cavity 22 of the sheath 2. After the guide wire holding device 1 is inserted into the bile duct along the guide wire GW, the treatment device 24 is extended from the distal end of the sheath 2, thereby switching to the second configuration. In the second configuration, the treatment device 24 performs the intended ERCP procedure. Figures 17(A) to 17(E)

[0058] The treatment device 24 can be any endoscopic treatment tool that can be stored within the sheath 2 in the first configuration or can be mounted to the sheath 2 and can perform the ERCP procedure in the second configuration. Examples of the treatment device 24 will be described later. Figures 17(A) to 17(E)

[0059] Next, as an example, a method of introducing the guide wire holding device 1 into a cavity- bearing organ (e.g., the bile duct) by a lower interventional method will be described. Figure 9 and Figure 10 are schematic diagrams showing a method of inserting the guide wire holding device 1 and leaving the treatment tool in place to perform the ERCP procedure.

[0060] First, the guide wire GW is placed in the duodenum D. Specifically, as shown in FIG. 8(A), the guide wire GW is inserted into the duodenum D through the mouth M, the esophagus E, and the stomach S, and is advanced to the duodenum D. The guide wire GW is then inserted into the bile duct BD. Figure 9 ​​As shown, the endoscope insertion section 201 of the ultrasonic endoscope 200 is inserted from the patient's mouth into the stomach St or duodenum D. An access needle 202, inserted into the endoscope insertion section 201 and extending from the distal end thereof, is inserted into the bile duct Bd. A guidewire GW is then inserted into the bile duct Bd via the lumen of the access needle 202. When the guidewire GW is inserted into the bile duct Bd, it is pushed forward so that the distal end of the guidewire GW extends from the duodenal papilla Dp and into the duodenum D. By advancing the guidewire GW toward the duodenal papilla Dp, the distal end of the guidewire GW extending from the duodenal papilla Dp extends along the lumen of the duodenum D.

[0061] Then, the ultrasonic endoscope 200 is removed, while the guide wire GW is left in the patient's body, and the distal end of the guide wire GW is left in the duodenum D. At this time, the proximal end side of the guide wire GW is outside the patient's body.

[0062] Then, if Figure 10 As shown, the endoscope insertion portion 201 of a duodenoscope (not shown) is inserted from the patient's mouth into the duodenum D. The guidewire retaining device 1 is then inserted into the endoscope insertion portion 201, causing the distal end of the sheath 2 to extend from the distal end of the endoscope insertion portion 201. The operating slider 42 is then advanced distally, causing the operating wire 3 to advance relative to the sheath 2, thereby advancing the hook 5 relative to the sheath 2 to an advanced position. The sheath 2 is then guided in a direction such that the hook 5 hooks onto the guidewire GW.

[0063] Next, the operator retracts the operating slider 42 proximally, retracting the operating wire 3 relative to the sheath 2, thereby placing the hook 5 in the retracted position. By retracting the hook 5 to the retracted position, the guide wire GW can be brought closer to the distal edge 261 of the groove 26. In the retracted position, as described above, the guide wire GW is captured and held in the closed area C3 formed between the groove 26 of the sheath 2 and the slit 56 of the hook 5. Captured in the closed area C3, the guide wire GW can smoothly move back and forth within the closed area C3.

[0064] Next, with the guide wire GW held in the closed region C3 between the slit 56 and the groove 26, the distal end portion of the sheath 2 is attached to the duodenal papilla Dp along the guide wire GW while the inner wall surface of the groove 26 is pressed against the guide wire GW. Figure 9 As shown, the operator pushes the operating portion 4 to insert the distal end of the sheath 2 into the duodenal papilla Dp. Since the guidewire GW has already passed through the bile duct Bd and extends to the duodenum D via the duodenal papilla Dp, when the guidewire holding device 1 is pushed in, the sheath 2 advances along the guidewire GW and reaches the interior of the bile duct Bd.

[0065] At this time, the treatment device 24 is in its first state in which it is accommodated in the sheath 2 of the guide wire holding device 1. After the insertion of the guide wire GW into the bile duct Bd is completed, the treatment device 24 is switched to its second state in which it protrudes from the distal end of the guide wire holding device 1 that has been inserted into the duodenum along the guide wire GW. Once the treatment device 24 protrudes into the bile duct, the intended ERCP procedure is performed.

[0066] After the intended ERCP procedure is completed, the holding of the guide wire GW is released. The treatment device 24 is switched from the second state back to the first state by retracting the treatment device 24 into the guide wire holding device 1. Subsequently, the guide wire holding device 1 is removed from the endoscope insertion portion 201.

[0067] Figure 11 is a flowchart showing a method for inserting the guide wire holding device 1 into the bile duct to indwell the treatment device 24 to perform the ERCP procedure according to the present exemplary embodiment.

[0068] As shown in Figure 11 , the above-described method of inserting the guide wire holding device to perform the intended treatment can be divided into the following steps.

[0069] In step S1, the bile duct is punctured by the puncture needle. Specifically, the access needle 202 that is inserted into the endoscope insertion portion 201 and protrudes from the tip of the endoscope insertion portion 201 is punctured into the bile duct Bd.

[0070] In step S2, the guide wire GW is inserted into the duodenum D. Specifically, the guide wire GW is inserted into the endoscope insertion portion 201 and then into the bile duct Bd via the access needle 202. When the guide wire GW is inserted into the bile duct Bd, the operator pushes the guide wire GW forward so that the tip of the guide wire GW protrudes from the duodenal papilla Dp and enters the duodenum D. By advancing the guide wire GW toward the duodenal papilla Dp, the tip of the guide wire GW that protrudes from the duodenal papilla Dp extends along the lumen of the duodenum D.

[0071] In step S3, the endoscope switching process is performed. Specifically, the ultrasonic endoscope 200 is removed while leaving the guide wire GW in the patient's body, and the tip of the guide wire GW in the duodenum D. The endoscope insertion portion 201 of the duodenoscope is inserted from the patient's mouth to the duodenum D.

[0072] At step S4, a guide wire catching step is performed. Specifically, the guide wire holding device 1 is inserted into the endoscope insertion portion 201, and the distal end portion of the sheath 2 is caused to protrude from the distal end of the endoscope insertion portion 201. At this time, the guide wire holding device 1 is guided in a direction in which the hook 5 of the guide wire holding device 1 can easily hook the guide wire GW and also can easily push the guide wire GW into the groove 26, is positioned at the distal end portion of the sheath 2. As a result, the guide wire GW is captured and held in the closed region C formed by the slit 56 of the hook 5 and the groove 26. The guide wire GW can be smoothly moved back and forth in the closed region C. Alternatively, at step S4, the guide wire GW can be inserted into the patient's body from the additional lumen of the sheath 2. In this case, the guide wire holding device 1 can catch the guide wire GW without pushing the guide wire GW into the groove 26 of the sheath 2.

[0073] At step S5, a cannulation process is performed. Specifically, with the guide wire GW held between the slit 56 of the hook 5 and the groove 26, the distal end portion of the sheath 2 is attached to the duodenal papilla Dp along the guide wire GW while the inner wall surface 264 of the groove 26 is pressed against the guide wire GW. As shown in FIG. 6, the operator pushes the operation portion 4 to insert the distal end portion of the sheath 2 into the duodenal papilla Dp. Since the guide wire GW has passed through the bile duct Bd and extended to the duodenum D via the duodenal papilla Dp, the sheath 2 advances along the guide wire GW and reaches the inside of the bile duct Bd when the guide wire holding device 1 is pushed in. At this time, the treatment device 24 is in the first state in which it is housed in the sheath 2 or attached to the sheath 2. Figure 10

[0074] At step S6, an ERCP procedure is performed. Specifically, after the guide wire GW is inserted into the bile duct Bd, the treatment device 24 is switched to the second state in which it protrudes from the guide wire holding device 1. As described above, before the ERCP is performed, the treatment device 24 is in the first state in which the treatment device 24 is housed in the sheath 2. Once the treatment device 24 is switched to the second state in which the treatment device 24 protrudes from the guide wire holding device 1 disposed at the distal end of the sheath 2, the intended ERCP procedure is performed in the target organ.

[0075] At step S7, after the intended ERCP procedure is completed, the holding of the guide wire GW is released. The treatment device 24 is caused to retreat into the sheath 2 of the guide wire holding device 1. Thus, the treatment device 24 is switched from the second state to the first state. Then, the guide wire holding device 1 having the treatment device 24 inside is removed from the duodenum, and the guide wire GW is removed from the patient's body.

[0076] The following will be based on the assumption that the guide wire GW is inserted into the patient's body from the additional lumen of the sheath 2. Figures 12-20(D) ​Examples of the treatment device 24 of the guide wire holding apparatus 1 are described. Some of these drawings show exemplary embodiments in which the sheath does not include a slot. However, even in these exemplary embodiments, the sheath can include a slot as described above.

[0077] Figure 12 is a front view of the sheath 2, schematically showing the guide wire holding apparatus 1 in which the treatment device 24 is housed within the sheath 2. Figure 13 is Figure 12 is a cross-sectional view of line A-A of

[0078] As Figure 12 and Figure 13 shown, in the present exemplary embodiment, the treatment device 24 is a basket wire for collecting a stone within a bile duct. In the first configuration, the basket wire is held within the lumen (lumen 22 in the sheath 2) of the sheath, and thus the basket disposed at the distal end of the basket wire is not open. Figure 1

[0079] Fig. 14(A) is a perspective side view of the guide wire holding apparatus 1 in which the treatment device 24 is extended from the sheath 2, Fig. 14(B) is a cross-sectional side view of the guide wire holding apparatus 1 in which the treatment device 24 is extended from the sheath 2, Fig. 14(C) is a top view of the guide wire holding apparatus 1 in which the treatment device 24 is extended from the sheath 2, and Fig. 14(D) is a front view of the guide wire holding apparatus 1 in which the treatment device 24 is extended from the sheath 2. As shown in Fig. 14(A), the treatment device 24 is a basket wire 241. The basket wire 241 located within the lumen 21 advances in parallel with the sheath 2 along the longitudinal axis L direction. When the basket of the basket wire is extended from the sheath 2, the basket is open and switched to the second configuration. In addition, when the basket wire 241 comes into contact with the guide wire GW, the advancing direction of the basket wire 241 is slightly changed. The basket of the basket wire 241 moves to the target organ along with the guide wire GW. Figures 14(A) to 14(D)

[0080] Fig. 15(A) is a front view of the hook, schematically showing the second configuration of the basket wire in which the basket wire is extended from the sheath. Fig. 15(B) is a front view of the sheath, schematically showing the same situation. As shown in Fig. 15(A), the basket wire is located above the guide wire GW and passes through the slit of the hook.

[0081] ​​Figure 16(A) is a front view of the hook, schematically showing the mesh basket wire protruding from the sheath including an additional lumen for a second guide wire. Figure 16(B) is a front view of the sheath, schematically showing the second lumen. The additional lumen is in communication with the slit of the hook. However, since the slit is positioned overlapping the additional lumen in the front view of the hook, the additional lumen is not shown in Figure 16(A). As shown in Figure 16(A), the second guide wire inserted into the additional lumen after the first guide wire is released from the hook will also pass through the slit. With this configuration, the second guide wire is able to move back and forth to the hook. The slit is configured to have a width equal to or greater than the diameter of the lumen. The slit is configured to have a depth equal to or greater than the sum of the diameter of the guide wire and the diameter of the wire. The central axis of the slit substantially coincides with the central axis of the lumen.

[0082] The retaining member includes a slit configured to pass both the guide wire and the therapeutic tool in a state where the therapeutic tool moves along and over the guide wire, and the slit is configured to have a width equal to or greater than the diameter of the second additional lumen.

[0083] As shown in Figure 16(B), the sheath can be provided with an additional lumen for a second guide wire. The second guide wire can be used to insert and leave an additional therapeutic device without increasing the diameter of the sheath. Optionally, as described in page 12, lines 4-11, the first guide wire GW can be inserted into the patient's body through the additional lumen, and the second guide wire can be inserted into the patient's body through another different lumen without increasing the diameter of the sheath.

[0084] The therapeutic device 24 can be any therapeutic tool configured to be stored within the sheath 2 or mounted to the sheath 2 and in the first configuration before the intended treatment, and configured to switch to its second configuration protruding from the guide wire retaining device when the intended treatment is started. The mesh basket wire described above is one example. Other examples of such therapeutic tools include, but are not limited to, an electrode knife wire, an electrotherapy dilator, an ablation probe, a balloon catheter, a cytology brush, biopsy forceps, grasping forceps, a fine endoscope, a puncture needle, etc. Examples of these will be described below. Figures 17(A) to 17(E)

[0085] Figures 17(A) to 17(E) Examples of therapeutic devices applied in exemplary embodiments are shown. Figure 17(A) is a cross-sectional view of line B-B in Figure 17(B), schematically showing a front view of the sheath. Figure 17(B) shows two cross-sectional views of line A-A in Figure 17(A), schematically illustrating a side view of the guide wire retaining device when one example of the therapeutic device is stored within the sheath and in the first configuration, and then switches to the second configuration where the one example of the therapeutic device protrudes from the sheath. ​

[0086] In this example, the treatment device can be an electrode knife wire. The left side view of Figure 17(B) shows the electrode knife wire being de-energized when stored within the sheath. The right side view of Figure 17(B) shows the electrode knife wire being energized when extended from the sheath so that the electrode knife wire can perform the intended ERCP procedure. In this example, as shown in Figure 17(B), instead of the electrode knife wire, an electrotherapy dilator or an ablation probe can also be used as the treatment device. That is, the electrotherapy dilator and the ablation probe are de-energized when housed within the sheath and in their first configuration, and are energized when extended from the sheath and in their second configuration.

[0087] Figure 17(C) shows two cross-sectional views of line A-A in Figure 17(A), schematically illustrating side views of the guide wire retention device when another example of the treatment device is stored within the sheath and in a first configuration, and then switched to the second configuration in which the other example of the treatment device is extended from the sheath.

[0088] In this example, the treatment device can be a balloon catheter. The left side view of Figure 17(C) shows the balloon catheter being stored within the sheath and in a first configuration in which the balloon is not inflated. The right side view of Figure 17(C) shows the balloon catheter being inflated when extended from the sheath 2 so that the balloon catheter can perform the intended ERCP procedure.

[0089] Figure 17(D) shows two cross-sectional views of line A-A in Figure 17(A), schematically illustrating side views of the guide wire retention device when yet another example of the treatment device is stored within the sheath 2 and in a first configuration, and then switched to the second configuration in which the other example of the treatment device is extended from the sheath.

[0090] In this example, the treatment device can be a cytology brush. The left side view of Figure 17(D) shows the cytology brush being stored within the sheath by retracting its brush and in a first configuration thereof. The right side view of Figure 17(D) shows the cytology brush being extended from the sheath and in a second configuration thereof so that the cytology brush can stand up its brush to perform the intended ERCP procedure. Additionally, in this example, as shown in Figure 17(D), instead of the cytology brush, a biopsy forceps or a grasping forceps can also be used as the treatment device. That is, the jaws of the biopsy forceps and the grasping forceps can be retracted when housed within the sheath and in their first configuration, and then opened when extended from the sheath and in their second configuration to perform the intended ERCP procedure.

[0091] Figure 17(E) shows two cross-sectional views of line A-A in Figure 17(A), schematically illustrating side views of the guide wire retention device when yet another example of the treatment device is stored within the sheath 2 and in a first configuration, and then switched to the second configuration in which the other example of the treatment device is extended from the sheath.

[0092] In the present example, the treatment device 24 can be a fine endoscope. The left side view of Fig. 17(E) shows that the fine endoscope is stored within the sheath and is in its first configuration. The right side view of Fig. 17(E) shows that the fine endoscope is extended from the sheath and is in its second configuration, so that the fine endoscope can perform the intended ERCP procedure. Also, in the present example, as shown in Fig. 17(E), instead of the fine endoscope, a puncture needle can also be used as the treatment device. That is, the puncture needle is accommodated within the sheath and is in its first configuration, and then is extended from the sheath and is in its second configuration to perform the desired ERCP procedure.

[0093] The guide wire holding device according to the present application is not limited to the examples of the above-described embodiments. In the following description, the same components as those already described will be referred to with the same reference numerals, and repetitive description will be omitted.

[0094] First modification of the first embodiment

[0095] Fig. 18(A) is a cross-sectional view of line B-B in Fig. 18(B) and schematically shows a front view of the sheath. Fig. 18(B) shows a cross-sectional view of line A-A in Fig. 18(A) and schematically shows a side view of the guide wire holding device, in which the guide wire holding device includes a treatment device that surrounds the sheath. In the present modified embodiment, the treatment device can be a balloon that is fixed to and surrounds a portion of the distal end of the sheath. The second lumen of the sheath is an air delivery lumen that includes an opening within the balloon. Before the guide wire holding device is inserted into the bile duct, the balloon is fixed to the distal end of the sheath in a first configuration in which the balloon is not inflated by the air delivery lumen. Once the guide wire holding device is inserted into the bile duct along with the guide wire GW, the balloon is switched to a second configuration in order to perform the desired treatment, in which the balloon is inflated by the air delivery lumen of the sheath via the opening.

[0096] Second modification of the first embodiment

[0097] Fig. 19(A) is a cross-sectional view of line B-B in Fig. 19(B) and schematically shows a front view of the sheath 2. Fig. 19(B) shows a cross-sectional view of line A-A in Fig. 19(A) and schematically shows a side view of the guide wire holding device 1, in which a hook and an operating wire are used as the treatment device. In the present modified embodiment, the operating wire and the hook are also used as an electrode knife or an electrotherapy dilator wire, so that the operating wire is de-energized and is in a first configuration when the hook is retracted back into the sheath 2, and is energized and is in a second configuration when the operating wire pushes the hook to advance away from the sheath. In the case of using the electrode knife, the hook is made of an insulating material. In the case of using the electrotherapy dilator wire, the hook is made of an electrically conductive material. Also, the distal end of the operating wire can be covered by an X-ray transparent material for determining the position of the distal end of the treatment tool or the hook, and the like.

[0098] FIG. 20(A) is a cross-sectional view schematically showing a front view of the sheath. FIG. 20(B) shows a cross-sectional view of line A-A in FIG. 20(A), schematically illustrating a side view of the guide wire holding device with the basket wire connected to the operation wire. FIG. 20(C) shows a cross-sectional view of line A-A in FIG. 20(A), schematically illustrating another side view of the guide wire holding device with the basket wire connected to the operation wire. FIG. 20(D) shows a cross-sectional view of line A-A in FIG. 20(A), schematically illustrating another side view of the guide wire holding device with the basket wire connected to the operation wire.

[0099] In the present exemplary embodiment, inside the operation wire lumen, one end of the basket wire (treatment tool) is connected to the operation wire and the other end is connected to the hook. Thus, as shown in FIG. 20(B), the basket wire is disposed between the hook and the operation wire. The basket wire pushes the hook so that the hook advances to the advanced position to hook the guide wire GW. Once the guide wire is hooked by the hook, as shown in FIG. 20(C), the basket wire and the operation wire are pulled back so that the guide wire GW is captured and held between the hook and the sheath. The guide wire holding device is pushed into the bile duct with the guide wire GW as described above. As shown in FIG. 20(D), once the basket wire is extended from the sheath, the basket wire is opened to perform the desired ERCP procedure.

[0100] While the application has been described in connection with the above exemplary embodiments, it will be appreciated that those skilled in the art will be able to devise modifications, additions and substitutions without departing from the principles and scope of the application as defined in the appended claims.

Claims

1. A guide wire holding device comprising: a sheath comprising a lumen; a retainer disposed at a distal end of the sheath and configured to switch between retaining the guidewire and releasing the guidewire; a treatment tool inserted into the cavity to perform the desired treatment; as well as a wire connected to the treatment tool and configured to move the treatment tool between a first configuration and a second configuration, wherein, in the first configuration, the treatment tool is housed within the cavity, and In the second configuration, the treatment tool extends from the distal end of the sheath, The guide wire holding device further includes a first additional lumen and an operating wire inserted in the first additional lumen, the holding member is connected to the operating wire, and the holding member is advanced and retracted from the sheath to the sheath by operating the operating wire.

2. The guide wire holding device according to claim 1, characterized in that The holding member is arranged in front of the treatment tool and is connected to the treatment tool.

3. The guide wire holding device according to claim 1, wherein: The retaining member includes a slit, and The slit is configured to allow both the guide wire and the treatment tool to pass therethrough in a state in which the treatment tool moves along and over the guide wire.

4. The guide wire holding device according to claim 3, characterized in that: The slot is configured to have a width equal to or greater than a diameter of the cavity.

5. The guide wire holding device according to claim 3, characterized in that: The slot is configured to have a depth equal to or greater than the sum of a diameter of the guide wire and a diameter of the wire.

6. The guide wire holding device according to claim 3, characterized in that: The central axis of the slot is substantially coincident with the center of the cavity.

7. The guide wire holding device according to claim 1, characterized in that: The treatment tool is connected to the holder, and The wire connected to the treatment tool is energized when the treatment tool is extended from the sheath.

8. The guide wire holding device according to claim 1, wherein: The treatment tool is a basket connected between the holder and the wire, The basket is closed when located within the sheath and is open when extended from the sheath, The retaining member is arranged in front of the basket and connected to the basket, the retaining member includes a slot, and The slit is configured to allow both the guide wire and the basket to pass therethrough while the basket moves along and over the guide wire.

9. The guide wire holding device according to claim 1, wherein: The sheath includes a second additional lumen configured to allow insertion of another guidewire, and The second additional cavity is in communication with the slit of the retainer.

10. The guide wire holding device according to claim 9, characterized in that: The retaining member includes a slit, The slit is configured to allow both the guide wire and the treatment tool to pass through while the treatment tool moves along and over the guide wire, and The slit is configured to have a width equal to or greater than a diameter of the second additional cavity.

11. The guide wire holding device according to claim 1, wherein: The treatment tool is configured to be inserted into a target organ along the guide wire in a first state.

12. A guide wire holding device comprising: a sheath comprising a first lumen and a second lumen; a retainer disposed at a distal end of the sheath and configured to switch between retaining the guidewire and releasing the guidewire; an operating wire inserted into the first cavity and connected to the retaining member, wherein the retaining member is advanced and retracted from the sheath to the sheath by operating the operating wire; as well as a treatment tool mounted on the sheath, connected to the second lumen, and operable to switch between a first configuration and a second configuration, Wherein, the treatment tool is a balloon, and the second cavity is an air delivery cavity, In the first configuration, the balloon is not inflated by the air delivery lumen, and In the second configuration, the balloon is inserted into the target organ and inflated by the air delivery lumen.

13. The guide wire holding device according to claim 12, wherein: The treatment tool is configured to be inserted into a target organ along the guide wire in a first state.

14. An endoscope comprising: operating unit; an insertion portion extending from the operation unit; as well as The guide wire retaining device according to any one of claims 1 to 13, which extends from the distal end of the insertion portion.

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