Lancing Device

Abstract

To efficiently execute a manipulation using a puncture device.SOLUTION: A puncture device comprises an internal part, an outer peripheral part, a protrusion part, and an imaging unit. The internal part is a portion where there is formed a lumen for a puncture needle extending from a tip to a base end. The outer peripheral part is a portion extending along a center axis of the internal part and surrounding the periphery of the internal part. The protrusion part is a hollow portion protruding from a tip of the outer peripheral part to the tip side. The imaging unit has an imaging element arranged on a tip of the internal part. The protrusion part is formed of a plurality of protrusion pieces which are arranged so as to surround a center axis. Each of the plurality of protrusion pieces is shifted between a taper shaped state in which a tip of the protrusion piece is closer to the center axis than a base end of the protrusion piece, and a straight state in which a distance from the tip of the protrusion piece to the center axis is equal to a distance from the base end of the protrusion piece to the center axis.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The technology disclosed herein relates to a puncture device. [Background technology]

[0002] The space between the two pericardial membranes that surround the heart is called the pericardium (or pericardial cavity), and is filled with a fluid called pericardial fluid. Cardiac tamponade is a highly urgent condition in which a large amount of fluid accumulates in the pericardium for some reason, causing the intracardiac pressure to rise, preventing the heart from expanding sufficiently and causing it to fail to function as a pump, leading to a rapid shock state. For cardiac tamponade, a procedure is performed to drain the pericardial fluid by pericardiocentesis.

[0003] A puncture device is used for pericardial puncture (see, for example, Patent Document 1). During pericardial puncture, a puncture device is delivered from the surface of a patient's body to the pericardial sac under an endoscopic field of view, and the puncture device punctures the pericardial sac. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2016-158804 A Summary of the Invention [Problem to be solved by the invention]

[0005] Conventional puncture devices have a flat tip surface, and therefore encounter a large resistance from obstacles such as fat when delivering the puncture device from the body surface of a patient to the pericardium. In addition, with conventional puncture devices, the field of view may be blocked by obstacles ahead in the direction of travel. Therefore, conventional puncture devices have a problem in that procedures using the puncture device cannot be performed efficiently. Note that this problem is not limited to puncture devices for pericardiocentesis, but is a common problem with puncture devices for puncturing target tissues in the body.

[0006] This specification discloses a technique that can solve the above-mentioned problems. [Means for solving the problem]

[0007] The technology disclosed in this specification can be realized, for example, in the following forms.

[0008] (1) The puncture device disclosed in this specification includes an inner part, an outer periphery, a protruding part, and an imaging device. The inner part is a part in which a puncture needle lumen extending from the tip to the base end is formed. The outer periphery is a part extending along the central axis of the inner part and surrounding the periphery of the inner part. The protruding part is a hollow part protruding from the tip of the outer periphery to the tip side. The imaging device has an imaging element arranged at the tip of the inner part. The protruding part is composed of a plurality of protruding pieces arranged to surround the central axis. Each of the plurality of protruding pieces is configured to be able to transition between a tapered state in which the tip of the protruding piece is closer to the central axis than the base end of the protruding piece, and a straight state in which the distance from the tip of the protruding piece to the central axis is equal to the distance from the base end of the protruding piece to the central axis.

[0009] In this puncture device, the hollow protruding portion protruding from the tip of the outer periphery toward the tip side is composed of a plurality of protruding pieces arranged to surround the central axis, and each of the plurality of protruding pieces is configured to be able to transition between a tapered state and a straight state. Therefore, by making each protruding piece into a tapered state when delivering the puncture device, the tip of the puncture device can be shaped to have a reduced diameter toward the tip side, and the resistance from obstacles such as fat can be alleviated. In addition, by making each protruding piece transition from a tapered state to a straight state and then returning it to a tapered state when delivering the puncture device, the movement of each protruding piece can push the obstacle from the front of the puncture device to the side, and the resistance from the obstacle accompanying the advancement of the puncture device can be effectively reduced. In addition, by making each protruding piece transition to a straight state, a good field of view can be obtained by the imaging device. Therefore, according to this puncture device, the procedure using the puncture device can be efficiently performed.

[0010] (2) In the above-mentioned puncture device, the outer peripheral portion is provided with a first wire lumen corresponding to each of the plurality of protruding pieces, and extending from the tip to the base end of the outer peripheral portion, and each of the plurality of protruding pieces is formed with a second wire lumen that communicates with the first wire lumen at the base end of the protruding piece and extends to the tip of the protruding piece, and the puncture device further includes an operation wire housed in each combination of the first wire lumen and the second wire lumen that communicate with each other, the tip of which is fixed to the tip of the corresponding protruding piece, and each of the plurality of protruding pieces is in the tapered state in a natural state, and is configured to transition from the tapered state to the straight state by pulling the operation wire toward the base end. According to this puncture device, the simple operation of pulling each operation wire toward the base end can transition each of the plurality of protruding pieces that constitute the protruding portion from the tapered state to the straight state, so that the procedure using the puncture device can be performed more efficiently.

[0011] (3) In the above puncture device, the inner part may be constituted by a shaft member in which the puncture needle lumen is formed, the outer circumferential part may be constituted by a sheath base part that is a part on the base end side of a tubular sheath that houses the shaft member, and the protruding part may be constituted by a sheath protruding part that protrudes from the tip of the sheath base part to the tip side of the sheath. According to this puncture device, the inner part in which the puncture needle lumen is formed and the outer circumferential part surrounding the inner part are constituted as separate members, which improves the degree of freedom in design, including the selection of materials for each part of the puncture device.

[0012] (4) In the above puncture device, the inner part may be constituted by a shaft inner part that is a part close to the central axis of the shaft member in which the puncture needle lumen is formed, the outer periphery part may be constituted by a shaft outer periphery part that surrounds the periphery of the shaft inner part of the shaft member, and the protruding part may be constituted by a shaft protruding part that protrudes from the tip of the shaft outer periphery part of the shaft member toward the tip side. According to this puncture device, the inner part in which the puncture needle lumen is formed and the outer periphery part that surrounds the inner part are constituted as an integral member, so that the operation of the puncture device can be made easier and the procedure using the puncture device can be performed more efficiently.

[0013] (5) The puncture device may further include a puncture needle slidably disposed within the puncture needle lumen. With this puncture device, a procedure using a puncture device including a puncture needle can be efficiently performed.

[0014] The techniques disclosed in this specification can be realized in various forms, for example, in the form of a puncture device, a medical device including a puncture device, a manufacturing method thereof, etc. [Brief description of the drawings]

[0015] [Figure 1]FIG. 1 is an explanatory diagram illustrating a schematic configuration of a pricking device 100 according to a first embodiment. [Diagram 2] FIG. 1 is an explanatory diagram illustrating a schematic configuration of a pricking device 100 according to a first embodiment. [Diagram 3] FIG. 1 is an explanatory diagram illustrating a schematic configuration of a pricking device 100 according to a first embodiment. [Figure 4] FIG. 1 is an explanatory diagram illustrating a schematic configuration of a pricking device 100 according to a first embodiment. [Diagram 5] FIG. 1 is an explanatory diagram illustrating a schematic configuration of a pricking device 100 according to a first embodiment. [Figure 6] FIG. 1 is an explanatory diagram illustrating a schematic configuration of a pricking device 100 according to a first embodiment. [Figure 7] FIG. 1 is an explanatory diagram illustrating a schematic configuration of a pricking device 100 according to a first embodiment. [Figure 8] FIG. 13 is an explanatory diagram illustrating a schematic configuration of a pricking device 100a according to a second embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] A. First embodiment: A-1. Configuration of the pricking device 100: 1 to 7 are explanatory diagrams that show the schematic configuration of the pricking device 100 in the first embodiment. FIG. 1 shows the configuration of the side of the pricking device 100 in which each protruding piece 42 described later is in the maximum tapered state, FIG. 2 shows the configuration of the longitudinal section of the pricking device 100 in which each protruding piece 42 described later is in the maximum tapered state (sectional configuration at the position of II-II in FIG. 3), FIG. 3 shows the configuration of the transverse section of the pricking device 100 in the same state (sectional configuration at the position of III-III in FIG. 2), and FIG. 4 shows the configuration of the front of the pricking device 100 in the same state (configuration when viewed from the Z-axis positive direction side to the Z-axis negative direction side). FIG. 5 shows the configuration of the longitudinal section of the pricking device 100 in which each protruding piece 42 described later is in a straight state, and FIG. 6 shows the configuration of the front of the pricking device 100 in the same state. FIG. 7 shows the configuration of the longitudinal section of the pricking device 100 in which each protruding piece 42 described later is in the maximum reverse tapered state. In each figure, a part of the puncture device 100 (and its constituent members) may be omitted. In each figure, the positive Z-axis direction is the tip side (distal side) inserted into the body, and the negative Z-axis direction is the base side (proximal side) operated by an operator such as a doctor. In the following, for the puncture device 100 and its constituent members, the tip side end is referred to as the "tip", the tip and its vicinity are referred to as the "tip portion", the base side end is referred to as the "base end", and the base end and its vicinity are referred to as the "base portion".

[0017] The puncture device 100 is a medical device that is inserted into a patient's body for pericardiocentesis. The total length of the puncture device 100 is, for example, about 400 mm to 600 mm, and the outer diameter of the puncture device 100 is, for example, about 1 mm to 5 mm. The tip end of the puncture device 100 is the part that is inserted into the patient's body, and the base end of the puncture device 100 is the part that is held by an operator such as a doctor.

[0018] The puncture device 100 includes a shaft member 110 , an imaging device 120 , a puncture needle 130 , a sheath 140 , a manipulation wire 150 , and a connector 160 .

[0019] The shaft member 110 is an elongated member. The outer shape of the cross section of the shaft member 110 is, for example, substantially circular. The shaft member 110 is housed in a hollow portion 143 of a sheath base portion 141 of a sheath 140, which will be described later. The shaft member 110 is formed of, for example, a resin or a metal. The shaft member 110 is an example of an inner portion in the claims.

[0020] The tip 111 of the shaft member 110 is formed with a needle outlet 11, and the base end 112 of the shaft member 110 is formed with a needle insertion port 12. The shaft member 110 is formed with a puncture needle lumen 114 extending in the direction of the central axis AX of the shaft member 110 so as to communicate the needle outlet 11 and the needle insertion port 12. The outer diameter of the cross section of the puncture needle lumen 114 is, for example, substantially circular. The puncture needle 130 is slidably inserted into the puncture needle lumen 114. The puncture needle 130 is an elongated member having a sharp needle portion 132 formed at the tip. The tip of the puncture needle 130 is located near the tip of the puncture needle lumen 114, and the base end of the puncture needle 130 protrudes from the puncture needle lumen 114 toward the base end side and is grasped by the operator.

[0021] The connector 160 is a cylindrical member attached to the base end of the sheath base 141 that houses the shaft member 110. An opening 201 is formed on the base end side of the connector 160. The opening 201 communicates with the puncture needle lumen 114 via the needle insertion port 12 of the shaft member 110, which will be described later. The operator can insert the puncture needle 130, which will be described later, into the puncture needle lumen 114 from the opening 201. In addition, a substantially ring-shaped operation unit 200 is attached to the outside of the connector 160. The operation unit 200 is configured to be slidable on the outside of the connector 160 toward the base end side or the tip end side of the sheath base 141. The operation unit 200 is connected to the operation wire 150, which will be described later. Therefore, when the operator moves the operation section 200 toward the base end side of the sheath base 141, the operation wire 150 is pulled toward the base end side, and each protruding piece 42 described later transitions from the maximum taper state to a straight state or a reverse taper state. On the other hand, when the operator moves the operation section 200 moved toward the base end side toward the tip side of the sheath base 141, the tension applied to the operation wire 150 toward the base end side is gradually released, and each protruding piece 42 transitions from the straight state or the reverse taper state to the maximum taper state. In addition, the connector 160 is connected to the computer 203 via the cable 202. The cable 202 is electrically connected to the cable 124 extending into the imaging device lumen 115 described later via the connector 160. Since the cable 124 is electrically connected to the imaging device 120 described later, the operator can control the imaging device 120 by operating the computer 203. Since the computer 203 is also connected to the monitor 204 , the operator can control the imaging device 120 while checking the images captured by the imaging device 120 on the monitor 204 .

[0022] Further, the shaft member 110 is formed with an imaging device lumen 115 extending in the direction of the central axis AX from the distal end 111 to the proximal end 112. The imaging device 120 is disposed in the imaging device lumen 115. More specifically, the imaging device 120 has an imaging element 122 and a cable 124. The imaging element 122 is an image sensor (e.g., a CMOS image sensor or a CCD image sensor) that generates an image by imaging. The imaging element 122 is disposed at the position of the imaging device lumen 115 at the distal end 111 of the shaft member 110 with the imaging surface facing the distal end side. Further, the cable 124 constitutes a transmission path for transmitting an image signal generated by the imaging element 122, and extends from a connection point with the imaging element 122 through the imaging device lumen 115 to the proximal end side. The base end of the cable 124 protrudes from the imaging device lumen 115 to the base end side, and is connected to a computer 203 that functions as a control device for controlling the imaging device 120 via a connector 160 and a cable 202. The imaging device 120 may have a light source (e.g., an LED and an optical fiber) that irradiates light from the tip of the shaft member 110 toward the tip side.

[0023] In addition to the puncture needle lumen 114 and the imaging device lumen 115, the shaft member 110 may be formed with other lumens such as a lumen for a combination device for inserting a combination device such as forceps, a flush lumen for releasing liquid, and a suction lumen for aspirating some tissue.

[0024] The sheath 140 is an elongated member. The sheath 140 is made of, for example, resin or metal. The sheath 140 has a sheath base 141 and a hollow sheath protruding portion 142 that protrudes from the tip of the sheath base 141 toward the tip side.

[0025] The sheath base 141 is a long tubular portion extending along the central axis AX of the shaft member 110. The cross-sectional shape of the sheath base 141 is, for example, substantially annular. The shaft member 110 is housed in a hollow portion 143 of the sheath base 141. That is, the sheath base 141 surrounds the periphery of the shaft member 110. In the direction of the central axis AX, the position of the tip 111 of the shaft member 110 substantially coincides with the position of the tip of the sheath base 141 (the connection point with the sheath protruding portion 142). The sheath base 141 and the shaft member 110 are connected to each other, so that the shaft member 110 cannot move relative to the sheath base 141 in the Z-axis direction. In this embodiment, the shaft member 110 is connected to the base end portion of the sheath base 141. However, the connection position between the two can be arbitrarily changed. The sheath base 141 is an example of an outer periphery in the claims.

[0026] The sheath protruding portion 142 is composed of a plurality of (four in this embodiment) protruding pieces 42 arranged to surround the central axis AX of the shaft member 110. Each protruding piece 42 is a substantially trapezoidal plate-like piece with a base end 44 (a connection point with the sheath base portion 141) of each protruding piece 42 as a lower base and a tip end 43 of each protruding piece 42 as an upper base. The sheath protruding portion 142 is an example of a protruding portion as defined in the claims.

[0027] The connection portion between each protruding piece 42 and the sheath base 141 has a flexible configuration compared to other portions of the sheath 140. Such a flexible configuration can be realized, for example, by making the material or cross-sectional shape of the connection portion different from that of other portions. Therefore, each protruding piece 42 can change the inclination with respect to the sheath base 141 (and the shaft member 110 housed in the sheath base 141) by swinging about the base end 44 of the protruding piece 42 as a fulcrum. Specifically, each protruding piece 42 is configured to be able to transition between a tapered state in which the tip 43 of the protruding piece 42 is closer to the central axis AX of the shaft member 110 than the base end 44 of the protruding piece 42, as shown in Figs. 1 to 4, and a straight state in which the distance from the tip 43 of the protruding piece 42 to the central axis AX is equal to the distance from the base end 44 of the protruding piece 42 to the central axis AX, as shown in Figs. 5 and 6. Furthermore, in this embodiment, each protruding piece 42 is configured to be able to transition to an inverse tapered state in which the tip 43 of the protruding piece 42 is farther away from the central axis AX than the base end 44 of the protruding piece 42, as shown in FIG.

[0028] In this embodiment, the protruding pieces 42 are not connected to each other, and therefore can swing independently. In this embodiment, even when the tip 43 of each protruding piece 42 is closest to the central axis AX (the state shown in Figs. 1 to 4, hereinafter referred to as the "maximum taper state"), the tip 43 of each protruding piece 42 does not reach the central axis AX, and when the puncture device 100 is viewed from the front, an opening is secured near the center of the sheath protruding part 142 formed by each protruding piece 42 (see Fig. 4). In this embodiment, each protruding piece 42 is configured to be in the maximum taper state in a natural state (a state in which no load other than the weight of the protruding piece 42 acts on the protruding piece 42). Each figure illustrates one state of each protruding piece 42, and each protruding piece 42 can continuously change its inclination from the maximum taper state to the maximum reverse taper state (a state in which the tip 43 of each protruding piece 42 is farthest from the central axis AX as shown in Fig. 7).

[0029] A plurality of (four in this embodiment) first wire lumens 144 are formed in the sheath base 141 of the sheath 140, extending from the tip (connection points with each protruding piece 42) of the sheath base 141 to the base end. Also, a second wire lumen 145 is formed in each protruding piece 42, extending from the base end 44 of the protruding piece 42 to the tip of the protruding piece 42. One first wire lumen 144 formed in the sheath base 141 communicates with the second wire lumen 145 formed in one protruding piece 42, and constitutes one wire lumen 146 extending from the base end of the sheath base 141 to the tip of the sheath protruding piece 142. Similarly, another first wire lumen 144 formed in the sheath base 141 communicates with a second wire lumen 145 formed in the other protruding piece 42, and constitutes another wire lumen 146 extending from the base end of the sheath base 141 to the tip end of the sheath protruding piece 142. In this way, the multiple first wire lumens 144 formed in the sheath base 141 correspond to the multiple protruding pieces 42.

[0030] An operation wire 150 is housed in each wire lumen 146. The operation wire 150 is an elongated member formed of, for example, metal or resin. A tip portion 151 of the operation wire 150 is fixed to a tip portion of the protruding piece 42, and a base end portion of the operation wire 150 protrudes from the base end of the wire lumen 146 to the base end side. In this embodiment, the tip portion 151 of the operation wire 150 extends further from the tip of the wire lumen 146 to the tip side and is embedded in the tip portion of the protruding piece 42, thereby being fixed to the tip portion of the protruding piece 42. Each protruding piece 42 swings about the base end 44 of the protruding piece 42 as a fulcrum in response to the tension of the operation wire 150 generated by pulling the operation wire 150 to the base end side, thereby changing the inclination with respect to the sheath base portion 141 and the shaft member 110, and takes any state from a maximum taper state to a maximum reverse taper state.

[0031] A-2. How to use the lancing device 100: Next, an example of a method of pericardiocentesis using the puncture device 100 will be described. First, the operator makes an incision, for example, under the patient's sternum, inserts the puncture device 100 into the body through a hole in the chest made by the incision, and delivers the tip of the puncture device 100 to the vicinity of the pericardial cavity. At this time, the tension of each operation wire 150 of the puncture device 100 is set to zero, and each protruding piece 42 is set to a maximum tapered state (see Figs. 1 to 4). Therefore, the tip of the puncture device 100 has a substantially conical shape whose diameter decreases toward the tip side, and resistance from obstacles such as fat can be reduced. Furthermore, if a relatively large resistance is encountered during delivery of the puncture device 100, the operator pulls each operation wire 150 toward the base end, and then stops pulling the operation wire 150. As a result, each protruding piece 42 of the puncture device 100 changes its inclination by swinging with the base end 44 of each protruding piece 42 as a fulcrum, transitioning from the maximum tapered state to a straight state or a reverse tapered state, and then returning to the maximum tapered state. As a result, the obstacle is pushed from the front of the puncture device 100 to the side by the movement of each protruding piece 42, and the resistance accompanying the advancement of the puncture device 100 can be effectively reduced. In addition, when it is desired to obtain a field of view during the delivery of the puncture device 100, the operator shifts each protruding piece 42 to a straight state by pulling each operating wire 150 toward the base end side. As a result, each protruding piece 42 does not block the front of the imaging device 120, and a good field of view by the imaging device 120 can be obtained. The material and shape (thickness, etc.) of each protruding piece 42 are set so that it has sufficient rigidity to be able to push aside obstacles such as fat.

[0032] When the tip of the puncture device 100 reaches the vicinity of the pericardial cavity, the operator inserts the puncture needle 130 into the puncture needle lumen 114 from the base end (needle insertion port 12) of the puncture needle lumen 114 formed in the shaft member 110 of the puncture device 100. Then, the operator grasps the base end of the puncture needle 130 and advances it, so that the tip of the puncture needle 130 reaches the vicinity of the tip (needle ejection port 11) of the puncture needle lumen 114. The puncture needle 130 may be inserted into the puncture needle lumen 114 before delivery. Then, the operator pulls each operation wire 150 toward the base end. This causes each protruding piece 42 of the puncture device 100 to transition from the maximum tapered state to a straight state or a reverse tapered state, and a good field of view can be obtained by the imaging device 120. Next, the operator advances the puncture needle 130 while checking the puncture position by referring to the image captured by the imaging device 120, thereby puncturing the pericardium with the needle portion 132 of the puncture needle 130. Note that, before the puncture, an operation of pulling and holding the pericardium using forceps (not shown) may be performed.

[0033] After puncturing the pericardial sac, the technician removes the puncture needle 130 from the base end side of the puncture needle lumen 114. Thereafter, a syringe (not shown) is attached to the base end side of the puncture needle lumen 114, and the pericardial fluid is aspirated using the syringe, and the pericardial fluid is discharged from the base end of the puncture needle lumen 114 to the outside of the patient's body. Thereafter, the puncture device 100 is removed from the patient's body. This completes the pericardial puncture procedure using the puncture device 100.

[0034] A-3. Advantages of the first embodiment: As described above, the puncture device 100 of this embodiment includes the shaft member 110, the sheath 140, and the imaging device 120. The shaft member 110 is formed with a puncture needle lumen 114 extending from the tip 111 to the base end 112. The sheath 140 has a sheath base 141 and a sheath protruding portion 142. The sheath base 141 is a portion that extends along the central axis AX of the shaft member 110 and surrounds the periphery of the shaft member 110. The sheath protruding portion 142 is a hollow portion that protrudes from the tip of the sheath base 141 to the tip side. The imaging device 120 has an imaging element 122 arranged at the tip 111 of the shaft member 110. In addition, the sheath protruding portion 142 is composed of a plurality of protruding pieces 42 arranged to surround the central axis AX. Each of the multiple protruding pieces 42 is configured to be able to transition between a tapered state in which the tip 43 of the protruding piece 42 is closer to the central axis AX than the base end 44 of the protruding piece 42, and a straight state in which the distance from the tip 43 of the protruding piece 42 to the central axis AX is equal to the distance from the base end 44 of the protruding piece 42 to the central axis AX.

[0035] Thus, in the puncture device 100 of this embodiment, the hollow sheath protruding portion 142 protruding from the tip of the sheath base portion 141 toward the tip side is composed of a plurality of protruding pieces 42 arranged to surround the central axis AX, and each of the plurality of protruding pieces 42 is configured to be able to transition between a tapered state and a straight state. Therefore, when the puncture device 100 is delivered, by making each of the protruding pieces 42 into a tapered state, the tip of the puncture device 100 can be shaped to have a diameter that decreases toward the tip side, and the resistance from obstacles such as fat can be alleviated. Also, when the puncture device 100 is delivered, by making each of the protruding pieces 42 transition from a tapered state to a straight state and then returning to the tapered state, the movement of each of the protruding pieces 42 can push the obstacle from the front of the puncture device 100 to the side, and the resistance from the obstacle accompanying the advancement of the puncture device 100 can be effectively reduced. Also, by making each of the protruding pieces 42 transition to a straight state, a good field of view can be obtained by the imaging device 120. Therefore, according to the pricking device 100 of the present embodiment, the procedure using the pricking device 100 can be carried out efficiently.

[0036] In the puncture device 100 of this embodiment, the sheath base 141 of the sheath 140 is provided with a first wire lumen 144 that is provided corresponding to each of the multiple protruding pieces 42 constituting the sheath protruding part 142 and extends from the tip to the base end of the sheath base 141. In addition, each of the multiple protruding pieces 42 is formed with a second wire lumen 145 that communicates with the first wire lumen 144 at the base end 44 of the protruding piece 42 and extends to the tip of the protruding piece 42. The puncture device 100 further includes an operation wire 150 housed in a wire lumen 146 that is a combination of the first wire lumen 144 and the second wire lumen 145 that communicate with each other. The tip of the operation wire 150 is fixed to the tip of the corresponding protruding piece 42. Moreover, each of the multiple protruding pieces 42 is tapered in its natural state, and is configured to transition from the tapered state to a straight state by pulling the operation wire 150 toward the base end. According to the puncture device 100 of the present embodiment, each of the multiple protruding pieces 42 constituting the sheath protruding portion 142 can be transitioned from a tapered state to a straight state by the simple operation of pulling each operation wire 150 toward the base end, so that the procedure using the puncture device 100 can be performed more efficiently.

[0037] Furthermore, in the puncture device 100 of this embodiment, the shaft member 110 in which the puncture needle lumen 114 is formed and the sheath 140 (sheath base 141) surrounding the shaft member 110 are constructed as separate members, thereby improving the design freedom, including the selection of materials for each part of the puncture device 100.

[0038] B. Second embodiment: 8 is an explanatory diagram showing a schematic configuration of the puncture device 100a in the second embodiment. In the following, the same components of the puncture device 100a in the second embodiment as those of the puncture device 100 in the first embodiment described above are denoted by the same reference numerals and the description thereof will be omitted as appropriate.

[0039] In the puncture device 100a in the second embodiment, the shaft member 110 and the sheath 140 in the first embodiment are configured as an integrated member (shaft member 110a).

[0040] The shaft member 110a has a shaft base 181 and a shaft protruding portion 182. The shaft base 181 also has a shaft inner portion 21 which is a portion close to the central axis AX, and a shaft outer circumferential portion 22 which surrounds the periphery of the shaft inner portion 21. A puncture needle lumen 114 is formed in the shaft inner portion 21, and an imaging element 122 of an imaging device 120 is disposed at the tip of the shaft inner portion 21.

[0041] The shaft protruding portion 182 protrudes from the tip of the outer shaft portion 22 of the shaft base portion 181 toward the tip side. The shaft protruding portion 182 is composed of a plurality of (four in this embodiment) protruding pieces 82 arranged to surround the central axis AX, similar to the sheath protruding portion 142 in the first embodiment. Each protruding piece 82 can change its inclination with respect to the outer shaft portion 22 and the shaft inner portion 21 by swinging about the base end 84 of the protruding piece 82 as a fulcrum. That is, each protruding piece 82 is configured to be able to transition between a tapered state in which the tip 83 of the protruding piece 82 is closer to the central axis AX than the base end 84 of the protruding piece 82, and a straight state in which the distance from the tip 83 of the protruding piece 82 to the central axis AX is equal to the distance from the base end 84 of the protruding piece 82 to the central axis AX. Furthermore, in this embodiment, each protruding piece 82 is configured to be able to transition to an inverse tapered state in which the tip 83 of the protruding piece 82 is farther from the central axis AX than the base end 84 of the protruding piece 82.

[0042] Further, a plurality of (four in this embodiment) first wire lumens 184 are formed in the shaft outer circumferential portion 22 of the shaft base 181, a second wire lumen 185 is formed in each protruding piece 82, and each first wire lumen 184 communicates with each second wire lumen 185 to form a plurality of wire lumens 186. Each wire lumen 186 accommodates the operation wire 150. Each protruding piece 82 swings about the base end 84 of the protruding piece 82 as a fulcrum to change the inclination according to the tension of the operation wire 150 generated by the operation wire 150 being pulled toward the base end side, and takes any state from a maximum taper state to a maximum reverse taper state.

[0043] In the second embodiment of the puncture device 100a, the shaft inner portion 21 of the shaft base 181 is an example of the inner portion as defined in the claims, the shaft outer periphery 22 of the shaft base 181 is an example of the outer periphery as defined in the claims, and the shaft protrusion 182 is an example of the protrusion as defined in the claims.

[0044] As described above, the puncture device 100a of the second embodiment includes the shaft inner part 21 in which the puncture needle lumen 114 extending from the tip to the base end is formed, the shaft outer periphery part 22 extending along the central axis AX of the shaft inner part 21 and surrounding the periphery of the shaft inner part 21, the hollow shaft protruding part 182 protruding from the tip of the shaft outer periphery part 22 toward the tip side, and the imaging device 120 having the imaging element 122 arranged at the tip of the shaft inner part 21. The shaft protruding part 182 is composed of a plurality of protruding pieces 82 arranged to surround the central axis AX. Each of the plurality of protruding pieces 82 is configured to be able to transition between a tapered state in which the tip 83 of the protruding piece 82 is closer to the central axis AX than the base end 84 of the protruding piece 82, and a straight state in which the distance from the tip 83 of the protruding piece 82 to the central axis AX is equal to the distance from the base end 84 of the protruding piece 82 to the central axis AX. Therefore, according to the pricking device 100a of the second embodiment, similarly to the pricking device 100 of the first embodiment, the procedure using the pricking device 100a can be efficiently performed.

[0045] In the puncture device 100a of the second embodiment, the shaft outer periphery 22 of the shaft base 181 is provided with first wire lumens 184 that correspond to the plurality of protruding pieces 82 and extend from the tip to the base end of the shaft outer periphery 22, and each of the plurality of protruding pieces 82 is formed with a second wire lumen 185 that communicates with the first wire lumen 184 at the base end 84 of the protruding piece 82 and extends to the tip of the protruding piece 82. The puncture device 100a further includes an operation wire 150 housed in a wire lumen 186 that is a combination of the first wire lumen 184 and the second wire lumen 185 that communicate with each other. The tip of the operation wire 150 is fixed to the tip of the corresponding protruding piece 82. Moreover, each of the multiple protruding pieces 82 is tapered in its natural state, and is configured to transition from the tapered state to a straight state when the operation wire 150 is pulled toward the base end. Therefore, according to the puncture device 100a of the second embodiment, similarly to the puncture device 100 of the first embodiment, the procedure using the puncture device 100a can be performed more efficiently.

[0046] Furthermore, in the second embodiment of the puncture device 100a, the shaft inner portion 21 in which the puncture needle lumen 114 is formed, the shaft outer periphery 22 surrounding the shaft inner portion 21, and the shaft protrusion 182 extending from the tip of the shaft outer periphery 22 toward the tip side are constructed as an integral member, making it possible to operate the puncture device 100a more easily and to perform procedures using the puncture device 100a more efficiently.

[0047] C. Variations: The technology disclosed in this specification is not limited to the above-described embodiments, and can be modified in various forms without departing from the spirit of the invention. For example, the following modifications are also possible.

[0048] The configuration of the puncture device 100 in the above embodiment is merely an example and can be modified in various ways. For example, in the above embodiment, the sheath protruding portion 142 (or the shaft protruding portion 182, the same applies below) is composed of four protruding pieces 42 (or the protruding pieces 82, the same applies below), but the sheath protruding portion 142 may be composed of two or more, three or less protruding pieces 42, or five or more protruding pieces 42.

[0049] In the above embodiment, each protruding piece 42 is configured to be able to transition between a tapered state, a straight state, and a reverse tapered state, but each protruding piece 42 may be configured to be able to transition between a tapered state and a straight state, but not be able to transition to a reverse tapered state.

[0050] In the above embodiment, even when each protrusion piece 42 is in its maximum tapered state, when the puncture device 100 is viewed from the front, an opening is secured near the center of the sheath protrusion 142 formed from each protrusion piece 42; however, the configuration may be such that when each protrusion piece 42 is in its maximum tapered state, the center of the sheath protrusion 142 is substantially blocked.

[0051] In the above embodiment, the operation wire 150 is housed in the wire lumen 146, but the operation wire 150 may be housed in another location (for example, the hollow portion 143 of the shaft member 110). Also, in the above embodiment, the swinging motion about the base end of each protruding piece 42 as a fulcrum is realized by the operation wire 150, but it may be realized by other means (for example, a balloon installed near the base end of each protruding piece 42).

[0052] In the above embodiment, each protruding piece 42 is configured to be in a maximum tapered state in a natural state (a state in which no load other than the weight of the protruding piece 42 acts on the protruding piece 42), but such a configuration is not necessarily required. For example, each protruding piece 42 may be configured to be in a straight state in a natural state.

[0053] In the above embodiment, each protruding piece 42 may be made of a material that transmits at least light of a specific wavelength used for imaging, so that imaging by the imaging device 120 is possible even when in a tapered state.

[0054] In the above embodiment, other methods may be used to fix the tip 151 of the operating wire 150 to the tip of each protruding piece 42 (for example, a method in which the tip 151 of the operating wire 150 protrudes toward the tip side from the tip of the protruding piece 42, and the tip 151 is folded back toward the inner circumference and fixed to the inner surface of the protruding piece 42).

[0055] The method of using the lancing device 100 in the above embodiment is merely an example, and the lancing device 100 may be used in other ways.

[0056] In the above embodiment, a puncture device 100 was described, but the technology disclosed in this specification is not limited to puncture devices for pericardiocentesis, and is similarly applicable to other puncture devices for puncturing target tissue within the body. [Explanation of symbols]

[0057] 11: needle ejection port 12: needle insertion port 21: shaft inner portion 22: shaft outer periphery 42: protruding piece 43: tip 44: base end 82: protruding piece 83: tip 84: base end 100: puncture device 110: shaft member 111: tip 112: base end 114: puncture needle lumen 115: imaging device lumen 120: imaging device 122: imaging element 124: cable 130: puncture needle 132: needle portion 140: sheath 141: sheath base 142: sheath protruding portion 143: hollow portion 144: first wire lumen 145: second wire lumen 146: wire lumen 150: operation wire 151: tip portion 160: connector 181: shaft base 182: Shaft protrusion 184: First wire lumen 185: Second wire lumen 186: Wire lumen 200: Operation unit 201: Opening 202: Cable 203: Computer 204: Monitor AX: Central axis

Claims

1. 1. A puncture device comprising: An inner portion having a puncture needle lumen extending from the tip to the base end; An outer circumferential portion extending along a central axis of the inner portion and surrounding the inner portion; a hollow protruding portion protruding from a tip of the outer circumferential portion toward a tip side; an imaging device having an imaging element disposed at a tip of the inner portion; Equipped with The protruding portion is composed of a plurality of protruding pieces arranged so as to surround the central axis, each of the plurality of protruding pieces is configured to be capable of transitioning between a tapered state in which a tip end of the protruding piece is closer to the central axis than a base end of the protruding piece and a straight state in which a distance from the tip end of the protruding piece to the central axis is equal to a distance from the base end of the protruding piece to the central axis; The outer circumferential portion has a first wire lumen formed therein, the first wire lumen extending from the distal end to the proximal end of the outer circumferential portion and corresponding to each of the plurality of protruding pieces. Each of the plurality of protruding pieces has a second wire lumen formed therein, the second wire lumen communicating with the first wire lumen at the base end of the protruding piece and extending to a tip end of the protruding piece, The puncture device further includes an operating wire housed in each combination of the first wire lumen and the second wire lumen that are in communication with each other, the operating wire having a tip fixed to the tip portion of the corresponding protruding piece, Each of the plurality of protruding pieces is in the tapered state in a natural state, and is configured to transition from the tapered state to the straight state when the operation wire is pulled toward the base end. Puncture device.

2. The pricking device according to claim 1 , The inner portion is constituted by a shaft member in which the puncture needle lumen is formed, the outer circumferential portion is constituted by a sheath base portion which is a part of a base end side of a tubular sheath which accommodates the shaft member, The protrusion is constituted by a sheath protrusion protruding from a tip of the sheath base portion of the sheath toward the tip side. Puncture device.

3. The pricking device according to claim 1 , the inner portion is constituted by a shaft inner portion which is a portion close to the central axis of the shaft member in which the puncture needle lumen is formed, the outer circumferential portion is configured by a shaft outer circumferential portion that surrounds the periphery of the shaft inner portion of the shaft member, The protrusion is configured by a shaft protrusion protruding from a tip of the shaft outer circumferential portion of the shaft member toward the tip side. Puncture device.

4. The pricking device according to any one of claims 1 to 3, further comprising: A puncture needle is provided slidably within the puncture needle lumen. Puncture device.

Images