JP7492862B2 - Cutting instruments - Google Patents

Description

The present invention relates to an incision instrument.

Endoscopic sphincterotomy (EST) is known as a treatment for common bile duct stones. In endoscopic sphincterotomy, an incision instrument is inserted into the papilla, which corresponds to the outlet of the bile duct and pancreatic duct, and the biological tissue of the papilla is incised. Patent Document 1 discloses a sphincterotomy instrument that can be used in such endoscopic sphincterotomy.

Patent No. 4896351

Here, in endoscopic papillotomy, it is necessary to incise a specified area of biological tissue in the papilla in a specified shape. For this reason, it is preferable that the tip of the incision instrument is rotatable and that the tip can be maintained in a rotated state. In this regard, the sphincterotome described in Patent Document 1 is capable of rotating the distal part of the catheter (the tip of the incision instrument) by rotating the handle at hand, and is equipped with a rotation lock that prevents further rotation of the handle relative to the proximal end of the catheter.

However, the sphincterotome described in Patent Document 1 has a problem in that when rotating the handle at hand, the rotation lock always creates resistance, making it difficult to perform fine rotation operations (in other words, fine adjustment of the rotation angle). Furthermore, with the sphincterotome described in Patent Document 1, repeated rotation of the handle can wear out the rotation lock, which can lead to a loss of function. Note that these problems are not limited to endoscopic papillaotomy, which cuts the papilla, but are common to all cutting instruments that are inserted into various organs in the human body to cut biological tissue, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs.

The present invention has been made to solve at least some of the problems described above, and aims to improve the operability and durability of an incision instrument for incising biological tissue.

The present invention has been made to solve at least some of the above problems, and can be realized in the following forms:

(1) According to one aspect of the present invention, an incision instrument for incising biological tissue is provided. The incision instrument includes a wire for incising biological tissue, a shaft on the inside of which the wire is disposed, the tip of the wire is fixed to the tip side of the shaft, and an opening that exposes a portion of the tip side of the wire to the outside of the shaft, a connector connected to the base end of the shaft, a handle portion connected to the base end of the connector, the base end of the wire is fixed via the connector, and is rotatable relative to the connector, and a locking mechanism provided on the connector and having a sliding member that can slide, the locking mechanism allowing the handle portion to rotate relative to the connector when the sliding member is in a first position, and restricting the handle portion from rotating relative to the connector when the sliding member is in a second position.

According to this configuration, the incision instrument is connected to the base end of the connector, the base end of the wire is fixed via the connector, and the handle portion is rotatable relative to the connector. Therefore, the tip side of the shaft (in other words, the tip side of the incision instrument) can be rotated by rotating the handle portion relative to the connector. In addition, the connector is provided with a locking mechanism that allows the handle portion to rotate relative to the connector when the slide member is in the first position, and restricts the handle portion from rotating relative to the connector when the slide member is in the second position. Therefore, by placing the slide member in the second position, the tip side of the shaft (the tip side of the incision instrument) can be maintained in a rotated state. Furthermore, by placing the slide member in the first position, no resistance is generated in the rotation operation of the handle portion (i.e., the operation of rotating the handle portion relative to the connector), so that fine rotation operation (in other words, fine adjustment of the rotation angle) can be easily performed. Furthermore, by placing the slide member in the first position, no resistance is generated in the rotation operation of the handle portion, so that the locking mechanism does not wear out even when the rotation operation is repeated, and the function of the locking mechanism is not impaired. As a result, the incision instrument of this configuration can improve operability and durability.

(2) In the incision instrument of the above form, the handle portion may have a shaft portion at the tip side that is inserted into the connector, the sliding member may have an opening through which the shaft portion is inserted, and the locking mechanism may regulate the relative rotation of the handle portion by contacting the inner periphery of the opening with the shaft portion when the sliding member is in the second position.
According to this configuration, the slide member of the locking mechanism has an opening through which the shaft is inserted, and when the slide member is in the second position, the inner periphery of the opening comes into contact with the shaft, thereby restricting relative rotation of the handle portion. In other words, the locking mechanism can restrict relative rotation by utilizing friction between the slide member and the shaft portion of the handle portion.

(3) In the cutting instrument of the above form, a protrusion that protrudes inward is formed on the inner peripheral portion of the sliding member, and the locking mechanism may regulate the relative rotation of the handle portion by contacting the protrusion with the shaft portion when the sliding member is in the second position.
According to this configuration, a protrusion that protrudes inward is formed on the inner periphery of the slide member of the locking mechanism, and when the slide member is in the second position, the protrusion comes into contact with the shaft portion to restrict relative rotation of the handle portion. In other words, the locking mechanism can restrict relative rotation by utilizing friction between the protrusion of the slide member and the shaft portion of the handle portion.

(4) In the incision instrument of the above aspect, in the locking mechanism, the sliding member may slide in a direction perpendicular to an extending direction of the shaft portion inserted into the connector.
According to this configuration, the slide member of the locking mechanism can be switched between the first position and the second position by sliding in a direction perpendicular to the extension direction of the shaft portion inserted into the connector. Therefore, the surgeon can easily intuitively understand the unlocking operation of the handle portion (i.e., the operation of moving the slide member to the first position to enable the rotational operation of the handle portion) and the locking operation of the handle portion (i.e., the operation of moving the slide member to the second position to restrict the rotational operation of the handle portion). As a result, the operability of the incision instrument can be further improved.

(5) In the cutting instrument of the above form, the slide member may have a flat outer shape and both ends may have a shape that follows the shape of the outer peripheral surface of the connector, and in the first position, one end may protrude from the connector and an end face of the other end may be aligned with the outer peripheral surface of the connector, and in the second position, the other end may protrude from the connector and an end face of the one end may be aligned with the outer peripheral surface of the connector.
According to this configuration, when the slide member of the locking mechanism is in the first position, one end protrudes from the connector and the end face of the other end is aligned with the outer circumferential surface of the connector, and when the slide member is in the second position, the other end protrudes from the connector and the end face of the one end is aligned with the outer circumferential surface of the connector. Therefore, the surgeon can switch between the first position and the second position by pushing the slide member of the locking mechanism until the end face of the slide member is aligned with the outer circumferential surface of the connector. Therefore, the surgeon can easily intuitively grasp the unlocking operation and the locking operation of the handle part. As a result, the operability of the incision instrument can be further improved.

(6) In the incision instrument of the above aspect, the shaft may have a first lumen in which the wire is disposed, and a second lumen different from the first lumen.
According to this configuration, the shaft has a first lumen in which the wire is disposed and a second lumen different from the first lumen, so that a combined device such as a guidewire can be inserted into the second lumen, improving the usability of the incision instrument.

The present invention can be realized in various forms, such as an incision instrument, a connector used in combination with a handle portion, a gripping tool having a connector and a handle portion, a system including these devices, and a method for manufacturing these devices and systems.

1 is an explanatory diagram illustrating a configuration of an incision instrument according to a first embodiment. FIG. 2 is an explanatory diagram illustrating a cross-sectional configuration of a portion A (FIG. 1) on the tip side of the incision instrument. FIG. 3 is a cross-sectional view of the incision instrument taken along line CC (FIG. 2). FIG. 2 is an explanatory diagram illustrating a configuration of a connector. 1 is an explanatory diagram illustrating the configuration of a portion B (FIG. 1) on the base end side of the incision instrument. FIG. 11 is an explanatory diagram illustrating the configuration of the slide member in a second position. FIG. 10A and 10B are explanatory diagrams illustrating the configuration of a slide member in a first position. FIG. 13 is a diagram showing the incision instrument with the wire housed therein. FIG. 13 is an explanatory diagram showing a state in which the nipple is incised using an incision tool. FIG. 13 is a diagram showing an incision instrument with its tip side rotated. FIG. 13 is a diagram showing a cutting instrument with the wire exposed. 13A and 13B are explanatory diagrams illustrating the configuration of a lock mechanism according to a second embodiment. 13A to 13C are explanatory diagrams illustrating the configuration of a lock mechanism according to a third embodiment. 13A to 13C are explanatory diagrams illustrating the configuration of a shaft according to a fourth embodiment.

First Embodiment
FIG. 1 is an explanatory diagram illustrating the configuration of an incision instrument 1 of the first embodiment. The incision instrument 1 is an instrument for incising biological tissue, and is used, for example, in endoscopic sphincterotomy (EST) as a treatment method for choledocholithiasis. The incision instrument 1 may be inserted into various organs in the human body, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs, and used to incise biological tissue. As shown in FIG. 1, the incision instrument 1 includes a shaft 10, a wire 20, a connector 30, a handle portion 40, and a locking mechanism 50.

In FIG. 1 and the following figures, the components constituting the locking mechanism 50 are indicated by dot hatching. In FIG. 1, the axis passing through the center of the incision instrument 1 is indicated by the axis O (dash line). In the example of FIG. 1, the axes passing through the centers of the shaft 10, the connector 30, and the handle portion 40 all coincide with the axis O. However, the axes passing through these centers may differ from the axis O. In addition, FIG. 1 illustrates XYZ axes that are mutually perpendicular. The X axis corresponds to the longitudinal direction (length direction) of the incision instrument 1, the Y axis corresponds to the height direction of the incision instrument 1, and the Z axis corresponds to the width direction of the incision instrument 1. The left side (-X axis direction) of FIG. 1 is called the "tip side" of the incision instrument 1 and each component, and the right side (+X axis direction) of FIG. 1 is called the "base side" of the incision instrument 1 and each component. For the incision instrument 1 and each component, the end portion located on the tip side is called the "tip", and the tip and its vicinity are called the "tip portion". Additionally, the end portion located on the proximal side is called the "proximal end," and the proximal end and its vicinity are called the "proximal end portion." The distal end is inserted into the living body, and the proximal end is operated by an operator such as a doctor. These points are the same in Figure 1 and subsequent figures.

Figure 2 is an explanatory diagram illustrating the cross-sectional configuration of a portion A (Figure 1) on the tip side of the incision instrument 1. Figure 3 is a cross-sectional view of the incision instrument 1 taken along line C-C (Figure 2). Figure 4 is an explanatory diagram illustrating the configuration of the connector 30. For ease of explanation, the shaft 10, wire 20, handle portion 40, inner shaft 351, and holding member 62 arranged inside the connector 30 are shown with dashed lines in Figure 4.

The shaft 10 is an elongated member that extends along the longitudinal direction (axis O) of the incision instrument 1. The shaft 10 is hollow and approximately cylindrical with a thick portion 111 on the inside. Specifically, as shown in Figures 2 and 3, the shaft 10 has a device lumen 11L and a wire lumen 12L formed in the thick portion 111 of the shaft 10, giving the shaft 10 an approximately hollow cylindrical shape. The outer diameter and length of the shaft 10 can be determined as desired.

The device lumen 11L is open at the tip 10d and the base end of the shaft 10. The tip opening of the device lumen 11L (hereinafter also referred to as the "tip opening 11o") is connected to the outside (Figure 2). The base opening of the device lumen 11L is connected to the inner cavity (inside) of the connector 30 (Figure 4). The wire lumen 12L is open at the tip 10d and the base end of the shaft 10. The tip opening of the wire lumen 12L is sealed by a fixing member 61 (Figure 2). The base opening of the wire lumen 12L is connected to the inner cavity of the connector 30 (Figure 4). The diameter Φ11 of the device lumen 11L is larger than the diameter Φ12 of the wire lumen 12L (Figure 3). However, the diameters Φ11 and Φ12 can be determined arbitrarily and may be approximately the same, or the diameter Φ11 may be smaller than the diameter Φ12. The device lumen 11L corresponds to the "second lumen" and the wire lumen 12L corresponds to the "first lumen."

As shown in FIG. 2, the wire 20 is inserted through the wire lumen 12L of the shaft 10. An opening 12o is formed at the tip of the shaft 10, connecting the wire lumen 12L to the outside. The opening 12o is elongated and extends along the axis O. As shown in FIG. 2, by bending the tip of the shaft 10, a portion of the tip of the wire 20 can be exposed to the outside (outside the shaft 10) through the opening 12o. The length of the opening 12o in the axis O direction can be determined as desired.

The wire 20 is a conductive wire. The wire 20 is connected to a high-frequency heating source (not shown) provided outside the incision instrument 1, and transmits energy applied from the high-frequency heating source. This allows the wire 20 to smoothly incise the biological tissue that comes into contact with the wire 20. The wire 20 is elongated and extends along the longitudinal direction (axis O) of the incision instrument 1, and has a generally cylindrical shape with an outer diameter Φ20 smaller than the wire lumen 12L (FIG. 3). The tip 20d of the wire 20 is fixed to the tip side of the shaft 10 by a fixing member 61 (FIG. 2). The base end of the wire 20 passes through the inner cavity of the connector 30 and the inner cavity 40L of the handle portion 40 (FIG. 4), and is fixed to the handle body portion 42 of the handle portion 40. The fixing can be performed by any bonding agent, such as an epoxy adhesive.

The connector 30 is connected to the base end 10p of the shaft 10 and is a member used by the surgeon to grasp the incision instrument 1 and insert the combination device. The connector 30 is hollow, with a tip opening 31o formed at the tip 30d, a base opening 33o formed at the base end 30p, and an inner cavity formed inside that connects the openings 31o and 33o (Figs. 1 and 4). The connector 30 has a small diameter section 31, a tapered section 32, a large diameter section 33, a branch section 35, and a locking mechanism 50. Details of the locking mechanism 50 will be described later.

The thin-diameter portion 31 is a portion having a substantially constant outer diameter provided on the tip side of the connector 30. The tapered portion 32 is a portion provided between the thin-diameter portion 31 and the thick-diameter portion 33, and has an outer diameter that increases from the tip side to the base end side. The thick-diameter portion 33 is a portion provided on the base end side of the connector 30, and has a substantially constant outer diameter that is thicker than the thin-diameter portion 31. Two side openings 36 are formed on the outer periphery of the thick-diameter portion 33, which communicate the inner cavity of the thick-diameter portion 33 with the outside. As shown in FIG. 4, one side opening 36 and the other side opening 36 are formed in opposing positions. From each of the two side openings 36, a portion of the locking mechanism 50 provided on the connector 30 is exposed to the outside (FIGS. 1 and 4).

The branch section 35 is a portion extending from the side of the thin-diameter section 31 in a direction intersecting the axis O direction (FIG. 1). As shown in FIG. 4, a hollow inner shaft 351 is inserted into the inner cavity of the branch section 35. The base end of the inner cavity of the inner shaft 351 is connected to the branch opening 35o formed at the base end of the branch section 35. The tip of the inner cavity of the inner shaft 351 is connected to the device lumen 11L of the shaft 10. As a result, a combination device such as a guide wire inserted from the branch opening 35o is guided to the device lumen 11L of the shaft 10 through the inner cavity of the inner shaft 351. The base end 10p of the shaft 10 inserted into the connector 30, the tip of the inner shaft 351, and a part of the wire 20 are integrally held by the holding member 62. Here, the holding member 62 holds a part of the wire 20 in a state in which the wire 20 can slide in the axis O direction relative to the holding member 62.

The handle portion 40 is connected to the base end 30p of the connector 30 and is a member used by the surgeon to operate the incision instrument 1. The handle portion 40 has a shaft portion 41, a handle main body portion 42, a first finger receiving portion 43, and a second finger receiving portion 44 (FIG. 1). The shaft portion 41 is an elongated member extending along the longitudinal direction (axis O) of the incision instrument 1 and is a substantially cylindrical member having a substantially constant outer diameter. The shaft portion 41 is disposed on the tip side of the handle portion 40. As shown in FIG. 4, the wire 20 is inserted into the inner cavity 41L of the shaft portion 41. The handle main body portion 42 is a cylindrical member provided so as to surround the outer periphery of the shaft portion 41. The base end of the wire 20 is fixed to the handle main body portion 42. The first finger receiving portion 43 is a ring-shaped member provided at the base end of the shaft portion 41. The second finger receiving portion 44 is a pair of ring-shaped members attached to the handle main body portion 42.

The operation of the incision instrument 1 using the handle portion 40 will be described with reference to FIG. 1. With the thumb inserted through the first finger receiving portion 43, the surgeon inserts the index finger and middle finger through the second finger receiving portion 44 and pulls the index finger and middle finger (arrow A1 in FIG. 1). This causes the handle body portion 42 to slide along the outer circumferential surface of the shaft portion 41 in the direction of the axis O, pulling the base end of the wire 20 fixed to the handle body portion 42 and applying tension to the wire 20. The surgeon also rotates the handle portion 40 relative to the connector 30 (arrow A2 in FIG. 1). Specifically, with the connector 30 fixed, the handle portion 40 is rotated in the circumferential direction (YZ axis direction). This causes the tip side of the incision instrument 1 (in other words, the tip side of the shaft 10) to rotate.

Figure 5 is an explanatory diagram illustrating the configuration of a portion B (Figure 1) on the base end side of the incision instrument 1. The connector 30 is further provided with a locking mechanism 50. The locking mechanism 50 is a member used to lock the handle portion 40 and to release the handle portion 40 from the locked state. Here, the "locked state" refers to a state in which the relative rotation of the handle portion 40 with respect to the connector 30 (Figure 1, arrow A2) is restricted and the handle portion 40 cannot rotate relative to the connector 30. The "unlocked state" refers to a state in which the handle portion 40 can rotate relative to the connector 30 (Figure 1, arrow A2). The locking mechanism 50 has a slide member 51 and a protrusion 52 (Figure 5).

The slide member 51 is a member that can slide in the Z-axis direction perpendicular to the extension direction of the shaft portion 41 of the handle portion 40 (i.e., the axis O, X-axis direction) (Figure 5, black arrow). The slide member 51 is a flat member having ends 512 curved in the ±Z-axis direction. An opening 51o that penetrates the slide member 51 in the axis O direction is formed in the center of the slide member 51. The shaft portion 41 of the handle portion 40 is inserted into the opening 51o of the slide member 51. The protrusion 52 is a portion that protrudes inward from the inner peripheral portion 511 of the slide member 51. In the illustrated example, the lock mechanism 50 has three protrusions 52 in the shape of a substantially square pillar, but the shape and number of the protrusions 52 may be changed as desired. The protrusions 52 are formed on the inner peripheral portion 511 of the slide member 51 over approximately half of the direction in which the slide member 51 can slide. In the illustrated example, the protrusion 52 is formed over approximately half of the inner periphery 511 of the slide member 51 in the -Z axis direction.

6 is an explanatory diagram illustrating the configuration of the slide member 51 in the second position. For convenience of explanation, in FIG. 6, the slide member 51 arranged inside the connector 30 is illustrated, and the connector 30 is illustrated with a dashed line. As illustrated, the opening 51o of the slide member 51 has a substantially elliptical shape that is long in the direction in which the slide member 51 can slide (i.e., the Z-axis direction). The short-side length LΦ51 of the opening 51o can be determined arbitrarily as long as it is greater than the outer diameter of the shaft portion 41 of the handle portion 40. The longitudinal length L52 of the opening 51o can be determined arbitrarily as long as it is greater than the short-side length LΦ51 of the opening 51o. In addition, the ends 512 formed in the ±Z-axis directions of the slide member 51 have a curved shape that follows the shape of the outer circumferential surface of the connector 30 (FIGS. 5 and 6).

When the slide member 51 is in the second position shown in FIG. 6, the locking mechanism 50 restricts the relative rotation of the handle portion 40 with respect to the connector 30 by contacting the protrusion 52 with the shaft portion 41 of the handle portion 40. In other words, the handle portion 40 is in a locked state. Also, as shown in FIG. 6, when the slide member 51 is in the second position, the other end portion 512 (+Z axis direction) protrudes from the connector 30, and the end face of the one end portion 512 (-Z axis direction) is aligned with the outer peripheral surface of the connector 30.

Figure 7 is an explanatory diagram illustrating the configuration of the slide member 51 in the first position. In Figure 7, as in Figure 6, the slide member 51 arranged inside the connector 30 is illustrated, and the connector 30 is illustrated with a dashed line. When the slide member 51 is in the first position shown in Figure 7, the locking mechanism 50 allows the handle part 40 to rotate relative to the connector 30 by not contacting the shaft part 41 of the handle part 40 with either the protrusion part 52 or the inner peripheral part 511 (Figure 7, black arrow). In other words, the handle part 40 is in an unlocked state. Also, as shown in Figure 7, when the slide member 51 is in the first position, one end part 512 (-Z axis direction) protrudes from the connector 30, and the end face of the other end part 512 (+Z axis direction) is aligned with the outer peripheral surface of the connector 30.

The shaft 10 is preferably antithrombotic, flexible, and biocompatible, and can be made of a resin material or a metal material. Examples of resin materials that can be used include polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of metal materials that can be used include stainless steel such as SUS304, NiTi alloy, and cobalt chrome alloy. The wire 20 is preferably conductive and antithrombotic and biocompatible, and can be made of stainless steel such as SUS304, and metal materials such as NiTi alloy. The connector 30, the handle portion 40, and the locking mechanism 50 can be made of a resin material such as polyurethane, polypropylene, and hard polyvinyl chloride. The protrusion 52 of the locking mechanism 50 may be made of an elastic body. The fixing member 61 and the holding member 62 can be made of any bonding agent, such as a metal solder such as silver solder, gold solder, zinc, Sn-Ag alloy, and Au-Sn alloy, or an adhesive such as an epoxy adhesive.

Figure 8 is a diagram showing the incision instrument 1 with the wire 20 in a retracted state. Figure 9 is an explanatory diagram showing the state in which the incision instrument 1 is used to incise the nipple 100. Figure 10 is a diagram showing the incision instrument 1 with the tip side rotated. Figure 11 is a diagram showing the incision instrument 1 with the wire 20 in an exposed state. Hereinafter, a method of using the incision instrument 1 will be explained using Figures 8 to 11.

First, the surgeon inserts the endoscope into the duodenum and delivers the guidewire (combined device) inserted under the endoscope from the opening 101 of the papilla 100 to the common bile duct. Next, the surgeon delivers the incision instrument 1 along the guidewire to the opening 101 of the papilla 100 (FIG. 9). Specifically, after inserting the base end side of the guidewire into the tip opening 11o of the incision instrument 1, the incision instrument 1 is advanced toward the tip side (distal side) until the tip 10d of the incision instrument 1 reaches the opening 101 of the papilla 100. At this time, the surgeon positions the handle portion 40 in a position where the handle main body portion 42 abuts against the base end 30p of the connector 30 (FIG. 8). Then, as shown in FIG. 8, the tip side of the shaft 10 (in other words, the tip side of the incision instrument 1) becomes straight, and the wire 20 can be accommodated in the wire lumen 12L of the shaft 10. This prevents the wire 20 from getting caught when the incision instrument 1 is delivered, improving the safety of the procedure and reducing the risk of the wire 20 being damaged.

Next, the surgeon uses the wire 20 of the incision tool 1 to incise a predetermined range R of the nipple 100 in a predetermined shape (straight line in the illustrated example) (arrow in FIG. 9). First, the surgeon slides the slide member 51 of the locking mechanism 50 to a first position (FIG. 7) to set the handle part 40 in an unlocked state. Then, the surgeon rotates the tip side of the shaft 10 (in other words, the tip side of the incision tool 1) to orient the opening 12o of the shaft 10 of the incision tool 1, through which the wire 20 is exposed, toward the direction of the predetermined range R of the nipple 100. Specifically, the handle part 40 is rotated relative to the connector 30 (arrow A2 in FIG. 10), thereby rotating the tip side of the shaft 10. Then, the surgeon slides the slide member 51 of the locking mechanism 50 to a second position (FIG. 6) to set the handle part 40 in a locked state. This allows the tip side of the shaft 10 to be maintained in a rotated state at a desired angle, making the subsequent procedures easier.

Then, the surgeon slides the handle main body 42 in the direction of the axis O along the outer circumferential surface of the shaft 41 (arrow A1 in FIG. 11), thereby pulling the base end of the wire 20 and applying tension to the wire 20. As a result, as shown in FIG. 11, the wire 20 becomes exposed from the opening 12o of the shaft 10. In this state, the surgeon can apply energy to the wire 20 from a high-frequency heating source provided outside the incision instrument 1, thereby incising a specified area R of the nipple 100 into a specified shape.

As described above, the incision instrument 1 of the first embodiment is connected to the base end 30p of the connector 30, and includes a handle portion 40 to which the base end of the wire 20 is fixed via the connector 30 and which can rotate relative to the connector 30. Therefore, by rotating the handle portion 40 relative to the connector 30, the tip side of the shaft 10 (in other words, the tip side of the incision instrument 1) can be rotated (FIG. 10). In addition, the connector 30 is provided with a lock mechanism 50 that allows the handle portion 40 to rotate relative to the connector 30 when the slide member 51 is in the first position, and restricts the handle portion 40 from rotating relative to the connector 30 when the slide member 51 is in the second position. Therefore, by placing the slide member 51 in the second position, the tip side of the shaft 10 (the tip side of the incision instrument 1) can be maintained in a rotated state. Furthermore, by placing the slide member 51 in the first position, no resistance is generated in the rotation operation of the handle portion 40 (i.e., the operation of rotating the handle portion 40 relative to the connector 30), so that fine rotation operation (in other words, fine adjustment of the rotation angle) can be easily performed. Furthermore, when the slide member 51 is in the first position, no resistance is generated when rotating the handle portion 40, so even if the rotation is repeated, the locking mechanism 50 (specifically, the protrusion 52) does not wear out, and the function of the locking mechanism 50 is not impaired. As a result, the incision instrument 1 of the first embodiment can improve operability and durability.

In addition, in the incision instrument 1 of the first embodiment, a protrusion 52 that protrudes inward is formed on the inner periphery 511 of the slide member 51 of the locking mechanism 50, and when the slide member 51 is in the second position, the protrusion 52 comes into contact with the shaft portion 41, thereby restricting the relative rotation of the handle portion 40 (FIG. 6). In other words, the locking mechanism 50 can restrict the relative rotation by utilizing the friction between the protrusion 52 of the slide member 51 and the shaft portion 41 of the handle portion 40.

Furthermore, in the incision instrument 1 of the first embodiment, the slide member 51 of the locking mechanism 50 can be switched between the first position and the second position by sliding in a direction (Z-axis direction) perpendicular to the extension direction (axis line O, X-axis direction) of the shaft portion 41 inserted into the connector 30 (Figs. 6 and 7). Therefore, the surgeon can easily intuitively grasp the unlocking operation of the handle portion 40 (i.e., the operation of moving the slide member 51 to the first position to enable the rotational operation of the handle portion 40) and the locking operation of the handle portion 40 (i.e., the operation of moving the slide member 51 to the second position to restrict the rotational operation of the handle portion 40). As a result, the operability of the incision instrument 1 can be further improved.

Furthermore, in the incision instrument 1 of the first embodiment, when the slide member 51 of the locking mechanism 50 is in the first position, one end 512 protrudes from the connector 30 and the end face of the other end 512 is aligned with the outer circumferential surface of the connector 30 (FIG. 7), and when the slide member 51 of the locking mechanism 50 is in the second position, the other end 512 protrudes from the connector 30 and the end face of the one end 512 is aligned with the outer circumferential surface of the connector 30 (FIG. 6). Therefore, the surgeon can switch between the first position and the second position by pushing the slide member 51 of the locking mechanism 50 until the end 512 of the slide member 51 is aligned with the outer circumferential surface of the connector 30. Therefore, the surgeon can easily intuitively grasp the unlocking operation of the handle portion 40 and the locking operation of the handle portion 40. As a result, the operability of the incision instrument 1 can be further improved.

Furthermore, in the incision instrument 1 of the first embodiment, the shaft 10 has a first lumen (wire lumen 12L) in which the wire 20 is disposed, and a second lumen (device lumen 11L) different from the first lumen. Therefore, as explained in the above procedure, a combination device such as a guidewire can be inserted into the second lumen (device lumen 11L), improving the usability of the incision instrument 1.

Second Embodiment
FIG. 12 is an explanatory diagram illustrating the configuration of the lock mechanism 50A of the second embodiment. The incision instrument 1A of the second embodiment has a lock mechanism 50A instead of the lock mechanism 50 in the configuration of the first embodiment. The lock mechanism 50A has a slide member 51A instead of the slide member 51, and does not have a protrusion 52. The slide member 51A has a substantially elliptical opening 51o whose short-side length differs between one side and the other side in the direction in which the slide member 51A can slide. In the illustrated example, the short-side length L51a of the opening 51o in the -Z axis direction is substantially the same as the outer diameter of the shaft portion 41 of the handle portion 40 (or is slightly larger to the extent that the shaft portion 41 of the handle portion 40 contacts the inner periphery portion 511). In addition, the short-side length L51b of the opening 51o in the +Z axis direction is larger than the outer diameter of the shaft portion 41 of the handle portion 40. When the slide member 51A is in the second position shown in Figure 12, the locking mechanism 50A restricts relative rotation of the handle portion 40 with respect to the connector 30 by the inner periphery 511 of the opening 51o contacting the shaft portion 41 of the handle portion 40.

In this way, the configuration of the locking mechanism 50A can be modified in various ways, and the relative rotation of the handle portion 40 with respect to the connector 30 may be restricted using the inner periphery 511 of the slide member 51A without providing the protrusion 52 on the slide member 51A. The inner periphery 511 of the slide member 51A may be provided with a configuration (e.g., an elastic membrane, etc.) for increasing the frictional force between the inner periphery 511 and the shaft portion 41. The incision instrument 1A of the second embodiment as described above can also achieve the same effect as the first embodiment described above. In addition, according to the incision instrument 1A of the second embodiment, the slide member 51A of the locking mechanism 50A has an opening 51o through which the shaft portion 41 is inserted, and when the slide member 51A is in the second position, the inner periphery 511 of the opening 51o comes into contact with the shaft portion 41 to restrict the relative rotation of the handle portion 40. In other words, the locking mechanism 50A can restrict the relative rotation by utilizing the friction between the slide member 51A and the shaft portion 41 of the handle portion 40.

Third Embodiment
FIG. 13 is an explanatory diagram illustrating the configuration of the lock mechanism 50B of the third embodiment. The incision instrument 1B of the third embodiment includes a lock mechanism 50B instead of the lock mechanism 50 in the configuration of the first embodiment. The lock mechanism 50B includes a slide member 51B instead of the slide member 51. When the slide member 51B is in the second position shown in FIG. 13, one end 512B (-Z axis direction) and the other end 512B (+Z axis direction) of the slide member 51B are both in a state of protruding from the connector 30. This is also true when the slide member 51B is in the first position. In this way, the configuration of the lock mechanism 50B can be modified in various ways, and a slide member 51B in which the end 512B is in a state of protruding from the connector 30 in both the first position and the second position may be used. The incision instrument 1B of the third embodiment as described above can also achieve the same effects as the first embodiment described above.

Fourth Embodiment
FIG. 14 is an explanatory diagram illustrating the configuration of a shaft 10C of the fourth embodiment. The incision instrument 1C of the fourth embodiment includes a shaft 10C instead of the shaft 10 in the configuration of the first embodiment. The shaft 10C is formed with only the wire lumen 12L described in the first embodiment, and does not have a device lumen 11L. In this way, the configuration of the shaft 10C can be changed in various ways, and may have no device lumen 11L or may have two or more device lumens 11L. The incision instrument 1C of the fourth embodiment as described above can also achieve the same effects as the first embodiment described above. In addition, the incision instrument 1C shown in FIG. 14 can be made thinner.

<Modifications of this embodiment>
The present invention is not limited to the above-described embodiment, and can be embodied in various forms without departing from the spirit and scope of the invention. For example, the following modifications are also possible.

[Modification 1]
In the above first to fourth embodiments, one example of the configuration of the incision instruments 1, 1A to 1C has been shown. However, the configuration of the incision instrument 1 can be modified in various ways. For example, the device lumen 11L of the incision instrument 1 may be used as a contrast medium lumen for supplying a contrast medium into a biological lumen in addition to the purpose of inserting a guide wire. For example, the cross-sectional shape of the shaft 10, the device lumen 11L, the wire lumen 12L, and the wire 20 may be a flattened elliptical shape. For example, the tip 10d of the shaft 10 may be provided with a marker for confirming the position of the tip 10d of the shaft 10 under an X-ray image. For example, the incision instrument 1 may be provided with a balloon member on the distal side of the opening 12o and/or on the proximal side of the opening 12o for blocking the flow of bodily fluids flowing in the biological lumen and for positioning the tip 10d of the incision instrument 1.

[Modification 2]
In the above first to fourth embodiments, one example of the configuration of the locking mechanism 50, 50A, 50B has been shown. However, the configuration of the locking mechanism 50 can be modified in various ways. For example, the slide member 51 of the locking mechanism 50 may be switched between the first position and the second position by sliding in the extension direction (axis line O, X-axis direction) of the shaft portion 41 inserted into the connector 30. For example, the slide member 51 of the locking mechanism 50 may be electrically slid by a built-in electric motor instead of being pushed in by the operator's hand. In this case, the end 512 may not protrude from the connector 30 regardless of whether the slide member 51 is in the first position or the second position.

[Modification 3]
The configurations of the incision instruments 1, 1A to 1C of the first to fourth embodiments and the first and second modifications may be appropriately combined. For example, the incision instrument 1 may be configured by combining the locking mechanism 50A described in the second embodiment with the shaft 10C described in the fourth embodiment. Also, the incision instrument 1 may be configured by combining the locking mechanism 50B described in the third embodiment with the shaft 10C described in the fourth embodiment.

Although this aspect has been described above based on the embodiment and modified examples, the embodiment of the above-mentioned aspect is intended to facilitate understanding of this aspect and does not limit this aspect. This aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents are included in this aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate.

Reference Signs List 1, 1A to 1C...Incision instrument 10, 10C...Shaft 11L...Device lumen 12L...Wire lumen 20...Wire 30...Connector 31...Thin diameter section 32...Tapered section 33...Large diameter section 35...Branched section 36...Side opening 40...Handle section 41...Shaft section 42...Handle body section 43...First finger receiving section 44...Second finger receiving section 50, 50A, 50B...Lock mechanism 51, 51A, 51B...Slide member 51o...Opening 52...Protrusion 61...Fixed member 62...Retaining member 100...Nipple section 101...Opening 111...Thick section 351...Inner shaft 511...Inner circumference 512, 512B...End section

Claims (5)

An incision instrument for incising biological tissue,
A wire for cutting biological tissue;
a shaft in which the wire is disposed, the tip of the wire being fixed to a tip side of the shaft, and the shaft having an opening exposing a part of the tip side of the wire to the outside of the shaft;
a connector connected to a proximal end of the shaft;
a handle portion connected to a proximal end of the connector, the proximal end of the wire being fixed via the connector, and the handle portion being rotatable relative to the connector;
a locking mechanism provided on the connector and having a slidable slide member, the locking mechanism allowing relative rotation of the handle portion with respect to the connector when the slide member is in a first position, and restricting relative rotation of the handle portion with respect to the connector when the slide member is in a second position ,
the handle portion has a shaft portion at a tip side thereof that is inserted into the connector,
The slide member has an opening through which the shaft portion is inserted,
The locking mechanism, when the sliding member is in the second position, restricts the relative rotation of the handle portion by contacting the shaft portion with an inner periphery of the opening . 2. The incision instrument of claim 1 ,
A protrusion protruding inward is formed on the inner periphery of the slide member,
When the slide member is in the second position, the locking mechanism restricts the relative rotation of the handle portion by contacting the protrusion with the shaft portion.
Cutting instruments. The incision instrument according to claim 1 or 2 ,
In the locking mechanism, the sliding member slides in a direction perpendicular to an extending direction of the shaft portion inserted into the connector.
Cutting instruments. The incision instrument according to any one of claims 1 to 3 ,
The slide member is
The connector has a flat outer shape and both ends are shaped to conform to the outer circumferential surface of the connector.
In the first position, one end protrudes from the connector, and an end face of the other end is flush with an outer circumferential surface of the connector;
When in the second position, the other end protrudes from the connector, and an end face of the one end is flush with an outer circumferential surface of the connector.
Cutting instruments. The incision instrument according to any one of claims 1 to 4 ,
The shaft has a first lumen in which the wire is disposed;
and a second lumen different from the first lumen.
Cutting instruments.

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