Stoma instrument

Abstract

The invention relates to the technical field of medical instruments, in particular to a stoma instrument. The stoma instrument comprises a connecting rod; the cutting pieces surround the outer portion of the connecting rod, and one ends of the cutting pieces are gathered and fixed to the connecting rod to form a containing cavity with an opening in one end; and the control device is connected with the connecting rod, and the control device can control the connecting rod to move in the axial direction so that the opening side of the cutting piece can abut against the to-be-cut tissue and cut the to-be-cut tissue. By arranging the connecting rod, the cutting piece and the control device, the containing cavity with the opening in one end is formed in the cutting piece, and when the opening side of the cutting piece makes contact with the tissue to be cut, the cutting piece can cover the tissue to be cut so as to stably abut against the tissue to be cut; ostomy can be achieved only by using the control device to drive the connecting rod to axially move so as to drive the opening side of the cutting piece to abut against the to-be-cut tissue and cut the to-be-cut tissue, other negative pressure or grabbing equipment does not need to be matched, and operation is easy and convenient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a stoma device. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Heart failure is a complex clinical syndrome characterized by impaired ventricular filling or ejection function due to abnormal cardiac structure or function. Its main clinical manifestations are dyspnea and fatigue (limited activity tolerance), as well as fluid retention (pulmonary congestion and peripheral edema). Heart failure is a serious and terminal stage of various heart diseases with a very high incidence rate, so it has become a widely concerned cardiovascular disease.

[0004] Heart failure can be divided into diastolic heart failure and systolic heart failure. Among them, diastolic heart failure refers to the condition in which the ventricular relaxation and compliance are reduced under the condition of normal ventricular contractile function, resulting in reduced ventricular filling volume and increased filling pressure, thereby producing pulmonary circulation and systemic circulation congestion syndrome. Diastolic heart failure can cause increased pressure in the left atrium and pulmonary veins, hindering the normal flow of oxygenated blood. At present, the treatment of diastolic heart failure is mainly based on drug therapy, but clinical data show that the use of interventional devices to open a small hole in the atrial septum of patients with diastolic heart failure to form a shunt from left to right is beneficial to reduce the pressure in the left atrium of patients with diastolic heart failure and improve the symptoms of heart failure patients.

[0005] At present, there are two main ways to use interventional devices to open a small hole in the atrial septum: one is to first puncture the atrial septum tissue, then use a balloon to expand the puncture site to a larger size to form an opening of a certain size, and then withdraw the balloon to form an interatrial shunt. In this way, tissue rebound often occurs after the balloon is withdrawn, causing the opening to shrink or even close. Another treatment method is to first puncture the atrial septum tissue, and then implant a stent at the puncture site. There is an opening of a set size in the middle of the stent. The stent props the puncture site to form an opening on the atrial septum, and the stent is used to maintain the existence of the opening. In this method, the stent is an implant, which will undergo endothelialization, making the opening of the atrial septum easily covered and blocked by the endothelial membrane. That is, both of the above-mentioned opening methods have the risk of opening closure, resulting in poor patient prognosis.

[0006] Currently, some researchers treat diastolic heart failure by cutting tissue to form a hole directly in the atrial septum. Some cutting instruments use coils as cutting pieces. During the cutting process, negative pressure equipment or grasping pieces are required to stabilize the tissue to be cut in a state surrounded by the coil before cutting. The operation steps are cumbersome. Summary of the invention

[0007] Based on this, it is necessary to provide a stoma instrument with simple operation.

[0008] A stoma instrument includes: a connecting rod; a cutting member surrounding the outside of the connecting rod, one end of the cutting member converging and fixed on the connecting rod to form a receiving cavity with one end open; and a control device connected to the connecting rod, the control device being capable of controlling the axial movement of the connecting rod so that the open side of the cutting member abuts against the tissue to be cut and cuts the tissue to be cut.

[0009] In one embodiment, the cutting member includes a sleeve and an annular body, the sleeve being sleeved and fixed on the connecting rod, one end of the annular body converging on the sleeve and connected to the sleeve, and the other end forming an opening.

[0010] In one embodiment, the cutting member further includes an anchoring member connected to the open side of the annular body, the anchoring member being used for anchoring on the tissue to be cut when the cutting member abuts against the tissue to be cut.

[0011] In one embodiment, the control device includes: a housing, and a first operating member slidably connected to the housing and connected to the connecting rod, the first operating member being capable of sliding axially along the housing to drive the axial movement of the connecting rod.

[0012] In one embodiment, the stoma instrument further includes a holding member sleeved outside the connecting rod and axially movable relative to the connecting rod, the holding member being used for holding the tissue to be cut on the side opposite to the cutting member during cutting.

[0013] In one embodiment, the holding member includes an assembled portion and a holding portion connected to each other, the radial dimension of the holding portion gradually decreasing axially from the side close to the cutting member to the side away from the cutting member to be connected to the assembled portion.

[0014] In one embodiment, the control device further includes a second operating member slidably connected to the housing and connected to the holding member, the second operating member being capable of sliding axially along the housing to drive the axial movement of the holding member relative to the connecting rod.

[0015] In one embodiment, the stoma instrument further includes a restraining member sleeved outside the connecting rod and axially movable relative to the connecting rod, the restraining member being used for movably restraining the cutting member so that the cutting member forms a constricted state or releases the constriction.

[0016] In one embodiment, the control device further includes a third operating member, which is slidably assembled with the first operating member and connected to the restraint member. The third operating member can axially slide along the first operating member to drive the restraint member to axially slide relative to the connecting rod.

[0017] In one embodiment, the restraint member is a hollow tube body, and the stoma instrument further includes a pulling wire connected to the opening side of the cutting member. The pulling wire can axially slide along the connecting rod to cause the opening side of the cutting member to converge and be received in the restraint member or to be released from the restraint.

[0018] In one embodiment, the control device further includes a fourth operating member, which is slidably assembled with the first operating member and connected to the pulling wire. The fourth operating member can axially slide along the first operating member to drive the pulling wire to axially slide relative to the connecting rod.

[0019] In one embodiment, the stoma instrument further includes a traction tube, which is sleeved on the connecting rod and fixedly connected to the connecting rod. A channel for the pulling wire to pass through is provided on the traction tube.

[0020] In one embodiment, both the cutting member and the connecting rod are conductive members, and the control device further includes a power-off structure for cutting off the circuit of the cutting member after tissue cutting is completed. The power-off structure includes: a first conductive member provided on the housing and connected to the RF power supply connector; a second conductive member, one end of which is connected to the first operating member and electrically connected to the connecting rod, and the other end extends towards the first conductive member to be movably abutted against the first conductive member. The first operating member can axially slide to drive the first conductive member to abut against the second conductive member to connect the circuit of the cutting member, or the first conductive member and the second conductive member are disengaged from abutment to disconnect the circuit of the cutting member.

[0021] The stoma instrument provided by the embodiment of the present invention, by providing a connecting rod, a cutting member and a control device, a receiving cavity with an opening at one end is formed on the cutting member. Therefore, when the opening side of the cutting member contacts the tissue to be cut, it can cover the tissue to be cut and stably abut against the tissue to be cut. Therefore, when cutting tissue, it is only necessary to use the control device to drive the connecting rod to axially move so as to drive the opening side of the cutting member to abut against the tissue to be cut and cut, and a stoma can be realized. There is no need to cooperate with other negative pressure or grasping devices, and the operation is simple and convenient, which reduces the surgical difficulty to a certain extent. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for description in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0023] Wherein:

[0024] Figure 1 is a schematic structural diagram of a stoma instrument according to an embodiment of the present invention;

[0025] Figure 2 is Figure 1 an enlarged view of part A in

[0026] Figure 3 is a schematic structural diagram of a traction tube according to an embodiment of the present invention;

[0027] Figure 4 is a cross-sectional view of a control device according to an embodiment of the present invention;

[0028] Figure 5 is a schematic structural diagram of a part of the stoma instrument in a puncture state according to an embodiment of the present invention;

[0029] Figure 6 is a schematic structural diagram of a part of the stoma instrument in a state where a cutting member is released according to an embodiment of the present invention;

[0030] Figure 7 is a schematic structural diagram of a part of the stoma instrument in a state of preparing to cut tissue according to an embodiment of the present invention;

[0031] Figure 8 is a schematic structural diagram of a part of the stoma instrument in a state after completing cutting according to an embodiment of the present invention;

[0032] Figure 9 is an exploded view of a control device according to an embodiment of the present invention;

[0033] Figure 10 is a schematic structural diagram of a first operating member according to an embodiment of the present invention;

[0034] Figure 11 is a schematic structural diagram of a stoma instrument according to another embodiment of the present invention. Detailed implementation manners

[0035] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0036] In the description of the embodiments of the present invention, it should be noted that terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the embodiments of the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0037] In the description of the embodiments of the present invention, it should be noted that unless otherwise clearly defined and limited, the terms "installation", "connection", and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a replaceable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium. It can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific situations.

[0038] In the field of interventional medical devices, generally, the end of a medical device implanted into the human body or an animal body that is closer to the operator is called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined based on this principle. The "axial direction" generally refers to the length direction of the medical device when it is being delivered, and the "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction", and the "axial direction" and "radial direction" of any component of the medical device are defined based on this principle. The "circumferential direction" refers to the circumferential direction, that is, the direction around the axis of the lumen structure or the column.

[0039] Please refer to Figure 1 , an embodiment of the present invention provides a stoma instrument 100, which is used to form a hole in the atrial septum by a cutting method. It can be understood that in other embodiments, it can also be used to perform tissue cutting at other positions to form a hole, not limited to cutting atrial septum tissue.

[0040] Please refer to Figure 1-2 , in one embodiment, the stoma instrument 100 includes a connecting rod 10, a cutting member 20, and a control device 30.

[0041] Among them, the cutting member 20 surrounds the outside of the connecting rod 10. One end of the cutting member 20 converges on the connecting rod 10 to form a receiving cavity 200 with one end open, and the end of the cutting member 20 converging on the connecting rod 10 is fixedly connected to the connecting rod 10. The control device 30 is connected to the connecting rod 10. The control device 30 can control the connecting rod 10 to move along its own axial direction, so that the open side of the cutting member 20 abuts against the tissue to be cut and cuts the tissue to be cut.

[0042] For the stoma instrument 100 provided in this embodiment, by providing the connecting rod 10, the cutting member 20 and the control device 30, among which, a receiving cavity 200 with one end open is formed on the cutting member 20. Therefore, when the open side of the cutting member 20 abuts against the tissue to be cut, the cutting member 20 can cover the tissue to be cut and thus stably abut against the tissue to be cut. When cutting the tissue, only need to transport the stoma instrument 100 to the target position, and then use the control device 30 to drive the connecting rod 10 to axially move to drive the open side of the cutting member 20 to abut against the tissue to be cut and move relative to the tissue to be cut, then the cutting and stoma formation of the tissue can be realized. The operation is simple and convenient, and to a certain extent, the surgical difficulty is reduced.

[0043] Moreover, when using the stoma instrument 100 to cut the tissue, there is no need to use a grasping member to pull the tissue, nor is it necessary to use a negative pressure device to suck the tissue and then cut it, which is beneficial to avoiding damage to normal tissue due to excessive pulling or excessive absorption.

[0044] Please continue to refer to FIGS. 1-2. In one embodiment, the distal end of the cutting member 20 converges on the connecting rod 10, and the proximal end is the open side. The control device 30 realizes the cutting of the tissue by driving the connecting rod 10 to move towards the proximal side. In other embodiments, the proximal end of the cutting member 20 may also converge on the connecting rod 10, and the distal end is the open side. The control device 30 realizes the cutting of the tissue by driving the connecting rod 10 to move towards the distal side. However, it can be understood that the stoma instrument 100 is withdrawn from the human anatomical structure from the proximal end. Therefore, when the distal end of the cutting member 20 converges on the connecting rod 10 and the proximal end is the open side, the opening of the receiving cavity 200 of the cutting member 20 faces the direction in which the stoma instrument 100 is withdrawn from the human anatomical structure. Therefore, it is beneficial to enable the cut tissue to be more stably accommodated in the receiving cavity 200 of the cutting member 20 and withdrawn from the human anatomical structure together with the stoma instrument 100 after the tissue cutting is completed, thereby preventing the cut tissue from falling out of the open side of the cutting member 20 during the process of the cutting member 20 being withdrawn from the human anatomical structure and entering the blood circulation system to cause blood circulation system blockage.

[0045] Please continue to refer to Figure 2, in one embodiment, the cutting member 20 includes a sleeve 210 and an annular body 220.

[0046] Wherein, the sleeve 210 is sleeved on the distal end of the connecting rod 10 and fixedly connected to the connecting rod 10. The annular body 220 surrounds the connecting rod 10. The distal ends of the annular body 220 converge on the sleeve 210 and form a connection with the sleeve 210, and the proximal end of the annular body 220 forms an opening.

[0047] It should be noted that, in other embodiments, when the cutting member 20 converges at the proximal end on the connecting rod 10 and the distal end is the opening side, the sleeve 210 is adaptively connected to the proximal end of the connecting rod 10, and the annular body 220 converges at the proximal end on the sleeve 210 and the distal end forms an opening.

[0048] The fixed connection between the sleeve 210 and the connecting rod 10 can be achieved by means such as welding, threaded connection, or clamping that can be selected by those skilled in the art, and will not be elaborated here.

[0049] Please continue to refer to Figure 2 , in one embodiment, the annular body 220 includes a cylindrical portion 221 and a connecting portion 222.

[0050] Wherein, the cylindrical portion 221 is generally cylindrical. One end of the connecting portion 222 is connected to the cylindrical portion 221, and the other end converges towards the central axis of the cylindrical portion 221. There is a certain distance between the distal end of the projection of the cylindrical portion 221 on the connecting rod 10 and the proximal end of the projection of the sleeve 210 on the connecting rod 10. The connecting portion 222 includes a plurality of connecting rods 2221. The proximal ends of the connecting rods 2221 are connected to the distal end of the cylindrical portion 221, and the distal ends of the connecting rods 2221 incline and extend towards the position of the sleeve 210, so as to realize the connection with the sleeve 210.

[0051] When cutting tissue, the proximal end of the cylindrical portion 221 first abuts against the tissue to be cut, and then moves proximally along the axial direction with the connecting rod 10, so that the proximal end of the cylindrical portion 221 continuously abuts against the tissue to be cut to cut the tissue to be cut. After cutting, the tissue that falls off will enter the accommodating cavity 200 of the cutting member 20 along the connecting rod 10 for accommodation, and finally be taken out of the human anatomical tissue together with the cutting member 20.

[0052] It can be understood that the cutting member 20 can be electrically connected to a radio frequency power supply to perform electrocuting on the tissue to be cut. Alternatively, the proximal end of the cylindrical portion 221 of the cutting member 20 can also be provided with a blade to perform mechanical cutting on the tissue to be cut.

[0053] Please continue to refer to 2. In one embodiment, the cylindrical portion 221 is composed of a plurality of generally rhombic frame units, so as to facilitate radial restraint of the cylindrical portion 221 and reduce its size during delivery.

[0054] Please continue to refer to Figure 2 In one embodiment, an anchor 230 is further provided at the distal end of the cylindrical portion 221. The anchor 230 is a spike connected to the cylindrical portion 221. The anchor 230 is used to anchor on the tissue to be cut when the cutting member 20 abuts against the tissue to be cut, so that the cutting member 20 can grasp the tissue to be cut more stably, and thus the cut hole is more regular and the cutting accuracy is higher.

[0055] It can be understood that the sleeve 210, the connecting rod 2221, the cylindrical portion 221 and the anchor 230 can be an integrally formed structure. For example, the sleeve 210, the connecting rod 2221, the cylindrical portion 221 and the anchor 230 are formed by shaping after cutting a tubular member. Alternatively, the connecting rod 2221, the cylindrical portion 221 and the anchor 230 can be first formed into an integral structure by cutting and shaping a tubular member, and then fixedly connected to the sleeve 210 by means such as welding or bonding. When the cutting member 20 performs electro-cutting on the tissue, the entire cutting member 20 is made of a conductive material. When the cutting member 20 performs mechanical cutting on the tissue, the anchor 230 and the proximal end of the cylindrical portion 221 are both provided with blades. In addition, the size of the proximal end of the cylindrical portion 221 can be adjusted to adjust the specification of the hole to be formed. In other embodiments, the connecting portion 222 may not be located on the central axis of the cylindrical portion 221. No matter which method is used to form the cutting member 20, the cutting member 20 is a self-expanding structure, that is, when the radial restraint on the cutting member 20 disappears, the cutting member 20 automatically returns to its natural state.

[0056] Please continue to refer to Figure 2 In one embodiment, the stoma instrument 100 further includes a holding member 40. The holding member 40 is sleeved outside the connecting rod 10 and can axially move relative to the connecting rod 10. The holding member 40 is used to abut against the tissue to be cut on the side opposite to the cutting member 20 during cutting. By axially moving the holding member 40, the relative position between the holding member 40 and the cutting member 20 can be adjusted to adapt to tissues to be cut with different thicknesses for cutting.

[0057] The provision of the holding member 40 can, on the one hand, hold the tissue to be cut during the cutting process, thereby preventing the tissue to be cut from undergoing significant deformation due to excessive pulling by the cutting member 20 during the cutting process, so as to avoid the situation where the size of the finally obtained hole differs greatly from the dimensional accuracy of the proximal end of the cutting member 20. On the other hand, the holding member 40 can also completely push the cut tissue into the receiving cavity 200 of the cutting member 20 after cutting is completed, and cooperate with the cutting member 20 to clamp the cut tissue, thereby further ensuring that the cut tissue can be stably withdrawn from the human anatomical structure together with the stoma instrument 100, preventing the cut tissue from falling into the blood circulation system and causing blockage.

[0058] Please continue to refer to Figure 2 , in one embodiment, the holding member 40 includes an assembly portion 410 and a holding portion 420.

[0059] Among them, both the assembly portion 410 and the holding portion 324 are hollow members for the connecting rod 10 to pass through. The holding portion 420 is provided at the distal end of the assembly portion 410, and the radial dimension of the holding portion 420 gradually decreases along the axial direction from the side close to the cutting member 20 to the side away from the cutting member 20 so as to be connected to the assembly portion 410. That is, the holding portion 420 forms a flared shape. By increasing the size of the side of the holding portion 420 close to the cutting member 20, the holding portion 420 can hold more tissue, thereby further enhancing the tissue stability during cutting and the accommodation stability of the tissue after cutting. And, during the cutting process, the holding member 40 and the cutting member 20 are respectively located on both sides of the tissue to be cut and hold the tissue respectively, and the holding member 40 can provide a supporting effect on the tissue, avoiding damage to normal tissue caused by the cutting member 20 pulling the tissue during the cutting process.

[0060] It can be understood that the assembly portion 410 and the holding portion 420 can be integrally formed, for example, by extrusion or injection molding. Or, the assembly portion 410 and the holding portion 420 can also be formed separately and then fixedly connected and formed by means such as welding or bonding. Or, the assembly portion 410 and the holding portion 420 can also be formed separately and then movably connected and formed by means such as threaded connection or snap connection.

[0061] Please continue to refer to Figure 2 , in one embodiment, the stoma instrument 100 further includes a restraint member 50. The restraint member 50 is sleeved outside the connecting rod 10 and is movably accommodated inside the holding member 40. The restraint member 50 can axially move relative to the connecting rod 10 so as to at least movably restrain the opening side of the cutting member 20 to make the opening side of the cutting member 20 form a constricted state or release the constriction.

[0062] The provision of the restraint member 50, on the one hand, can overall restrain the cutting member 20 before cutting, so that the cutting member 20 can be conveyed to the distal side of the tissue to be cut through a puncture hole with a smaller aperture for cutting. The puncture hole with a smaller aperture can enable the tissue to be cut to be more stably clamped by the cooperation of the cutting member 20 and the abutting member 40, thereby ensuring that the size of the cut hole is closer to the size of the opening side of the cutting member 20 and increasing the cutting accuracy. On the other hand, the restraint member 50 can restrain the opening side of the cutting member 20 after cutting is completed, that is, it can close the opening of the accommodation cavity 200 of the cutting member 20, thereby further preventing the cut tissue from falling out of the opening side of the cutting member 20 and falling into the blood circulation system.

[0063] It can be understood that in other embodiments, the restraint member 50 can also be sleeved outside the abutting member 40, and it can also achieve the restraint of the opening side of the cutting member 20. However, setting the restraint member 50 between the connecting rod 10 and the abutting member 40 is beneficial to reducing the size of the restraint member 50, so that the cutting member 20 can be restrained to a smaller size state, and further beneficial to reducing the overall radial size of the stoma instrument 100. When the abutting member 40 is omitted in other embodiments, the restraint member 50 can also be only sleeved outside the connecting rod 10.

[0064] Please continue to refer to Figure 2 , in one embodiment, the restraint member 50 is a hollow tube body. That is, by axially moving the restraint member 50, the restraint member 50 can wrap and accommodate the opening side or all of the cutting member 20 to complete the radial restraint of the opening side or all of the cutting member 20. When the radial restraint on the cutting member 20 needs to be released, only move the restraint member 50 in the reverse direction. The structure is simple, the operation is convenient, and it is easy to implement. In other embodiments, the cutting member 20 can also be restrained by means of wire binding.

[0065] Please continue to refer to Figure 2. In one embodiment, the stoma instrument 100 further includes a pulling wire 60. One end of the pulling wire 60 is connected to the opening side of the cutting member 20, and the other end extends proximally along the axis. The pulling wire 60 can axially slide relative to the connecting rod 10. By pulling the pulling wire 60, the opening side of the cutting member 20 can be constricted, so as to be accommodated in the restraint member 50. Or, when the cutting member 20 is disengaged from the restraint member 50, the cutting member 20 returns to its natural state under the action of self-expansion, and the pulling wire 60 does not affect the shape recovery of the cutting member 20.

[0066] The arrangement of the pulling wire 60 can more stably constrict the open side of the cutting member 20 after tissue cutting is completed so as to be accommodated in the restraining member 50, thereby further preventing the situation that after tissue cutting is completed, the open side of the cutting member 20 cannot be constricted or is constricted unstably, resulting in the opening of the open side of the cutting member 20 and the cut tissue falling off from the cutting member 20. At the same time, the pulling wire 60 constricts the open side of the cutting member 20, which is also beneficial to retracting the cutting member 20 into an external sheath tube 90 (discussed below) after cutting is completed.

[0067] Please continue to refer to Figure 2 , in one embodiment, a fixing hole 2211 is formed at the distal end of the cylindrical portion 221 of the cutting member 20. One end of the pulling wire 60 passes through the fixing hole 2211 and is fixed to the cutting member 20, and the other end is accommodated in the restraining member 50 and extends along the axial direction of the restraining member 50.

[0068] It can be understood that the pulling wire 60 can directly pass through the fixing hole 2211 and be fixed to the cutting member 20 by tying, or can be fixed to the cutting member 20 by welding after passing through the fixing hole 2211. The fixing manner of the pulling wire 60 to the cutting member 20 is not limited. In other embodiments, the pulling wire 60 can also be connected to the proximal end of the cylindrical portion 221, and the connection between the pulling wire 60 and the cutting member 20 only needs to satisfy that when the pulling wire 60 is pulled to slide axially, the open side of the cutting member 20 can be constricted.

[0069] Please continue to refer to Figure 2 and in combination with Figure 3 , in one embodiment, the stoma instrument 100 further includes a traction tube 70. The traction tube 70 is sleeved on the connecting rod 10 and fixedly connected to the connecting rod 10, and a channel 710 for the pulling wire 60 to pass through is formed on the traction tube 70.

[0070] The arrangement of the traction tube 70 can prevent the movement of the pulling wire 60 from affecting the operation of other components of the stoma instrument. It can be understood that in one embodiment, the number of the channels 710 corresponds to the number of the pulling wires 60 one by one, so as to prevent the pulling wires 60 from being wound during movement and having poor movement. In other embodiments, the number of the channels 710 can also be less than the number of the pulling wires 60, or the channel 710 can be omitted, so that the pulling wires 60 extend axially along the inner wall of the traction tube 70.

[0071] Please return to Figure 2 , in one embodiment, the stoma instrument 100 further includes a puncturing member 80. The puncturing member 80 is connected to the distal end of the connecting rod 10. The puncturing member 80 punctures the tissue to be cut to form a puncture hole, so that the cutting member 20 can extend through the puncture hole to the distal side of the tissue to be cut to cut the tissue to be cut.

[0072] Please refer to Figure 4 , in one embodiment, the distal ends of the abutting member 40, the constraining member 50, and the pulling wire 60 are also connected to the control device 30, so as to be controlled by the control device 30 to slide axially.

[0073] Specifically, in one embodiment, the control device 30 includes a housing 310, a first operating member 320, a second operating member 330, a third operating member 340, and a fourth operating member 350.

[0074] Among them, the first operating member 320 is slidably connected to the housing 310, and the first operating member 320 is connected to the proximal end of the connecting rod 10. The first operating member 320 can slide axially along the housing 310 to drive the connecting rod 10 to move axially, so as to drive the puncturing member 80 to puncture the tissue and the cutting member 20 to cut the tissue. The second operating member 330 is also slidably connected to the housing 310, and the second operating member 330 is connected to the proximal end of the abutting member 40. The second operating member 330 can slide axially along the housing 310 to drive the abutting member 40 to slide axially to approach or move away from the cutting member 20. The third operating member 340 is slidably connected to the first operating member 320, and the third operating member 340 is connected to the proximal end of the constraining member 50. The third operating member 340 can slide axially along the first operating member 320 to drive the constraining member 50 to slide axially to constrain or release the proximal end of the cutting member 20. The fourth operating member 350 is slidably connected to the first operating member 320, and the fourth operating member 350 is connected to the proximal end of the pulling wire 60. The fourth operating member 350 can slide axially along the first operating member 320 to drive the pulling wire 60 to move axially to constrict or release the opening side of the cutting member 20.

[0075] Please continue to refer to Figure 4 and in combination with Figures 5-8 , when cutting tissue, the second operating member 330 can be first moved axially towards the distal side to make the abutting member 40 abut against the tissue to be cut, then the first operating member 320 is moved axially towards the distal side to make the puncturing member 80 puncture the tissue to be cut to form a puncture hole, and then the first operating member 320, the third operating member 340, and the fourth operating member 350 are simultaneously moved further towards the distal side, or the third operating member 340 and the fourth operating member 350 are kept stationary relative to the first operating member 320 when the first operating member 320 is moved towards the distal side, so that the distal ends of the cutting member 20, the constraining member 50, and the pulling wire 60 pass through the puncture hole together (as shown in Figure 5 ), and then the third operating member 340 is moved towards the proximal side to retract the constraining member 50 to release the cutting member 20 (as shown in Figure 6 ), and finally the first operating member 320 is moved towards the proximal side to make the cutting member 20 cut the tissue (as shown in Figure 7As shown). After completing the tissue cutting, the fourth operating member 350 can be first moved toward the proximal side to retract the pulling wire 60 so as to constrict the opening side of the cutting member 20 (as Figure 8 shown), and then the third operating member 340 is moved distally to enable the restraining member 50 to re-restrain on the opening side of the constricted cutting member 20. At this point, the cut tissue is stably accommodated in the accommodation cavity 200 of the cutting member 20, and thus can be taken out of the human anatomical structure as the stoma instrument 100 is withdrawn.

[0076] Please refer to Figure 9 , in an embodiment, the housing 310 includes a first outer shell 311 and a second outer shell 312.

[0077] The first outer shell 311 and the second outer shell 312 are detachably assembled by snap connection. The first outer shell 311 and the second outer shell 312 cooperate to form an installation cavity 3101, and the first operating member 320, the second operating member 330, the third operating member 340, and the fourth operating member 350 are all at least partially accommodated in the installation cavity 3101.

[0078] Please continue to refer to Figure 9 , in an embodiment, a first sliding hole 3102 is formed in the housing 310, and the first sliding hole 3102 communicates with the installation cavity 3101. The first operating member 320 includes a first sliding portion 321 and a first operating portion 322. Among them, the first sliding portion 321 is accommodated in the installation cavity 3101 and is slidably assembled with the housing 310. One end of the first operating portion 322 is connected to the first sliding portion 321, and the other end extends to a side away from the first sliding portion 321 and protrudes out of the housing 310 through the first sliding hole 3102.

[0079] Please return to Figures 3-4 and combine with Figures 9-10 , in an embodiment, the proximal end of the connecting rod 10 is accommodated in the traction tube 70 and is fixedly connected to the traction tube 70. The first sliding portion 321 is connected to the proximal end of the traction tube 70 to realize the connection with the connecting rod 10. A circular boss 711 is provided at the proximal end of the traction tube 70, and a groove 3210 is formed in the first sliding portion 321. The circular boss 711 is accommodated in the groove 3210 to realize the connection with the first sliding portion 321. In other embodiments, the traction tube 70 and the first sliding portion 321 can also be connected by welding or bonding, or the connecting rod 10 can also protrude from the proximal end face of the traction tube 70 and be directly connected to the first sliding portion 321.

[0080] In one embodiment, there are two first sliding holes 3102 and two first operating parts 322, and they are symmetrically arranged with respect to the central axis of the housing 310 and the central axis of the first sliding part 321 respectively, so as to make the sliding of the first sliding part 321 more stable. In other embodiments, the number and installation positions of the first sliding holes 3102 and the first operating parts 322 can also be adaptively modified as needed without limitation.

[0081] Please continue to refer to Figure 9 , in one embodiment, a second sliding hole 3103 is further formed in the housing 310, and the second sliding hole 3103 is also communicated with the installation cavity 3101. The second operating member 330 includes a second sliding part 331 and a second operating part 332. Wherein, the second sliding part 331 is accommodated in the installation cavity 3101 and is slidably assembled with the housing 310, one end of the second operating part 332 is connected to the second sliding part 331, and the other end extends to the side away from the second sliding part 331 and extends out of the housing 310 through the second sliding hole 3103. The proximal end of the abutting member 40 is fixedly connected to the second sliding part 331 by welding or bonding or other means.

[0082] It can be understood that, in one embodiment, the second operating member 330 is located at the distal end of the first operating member 320. Therefore, an avoidance hole for the connecting rod 10, the constraining member 50, the pulling wire 60 and the pulling tube 70 to pass through is formed in the second sliding part 331 of the second operating member 330. In other embodiments, it can also be that the second operating member 330 is located at the proximal end of the first operating member 320. At this time, an avoidance hole is formed in the first operating member 320 for the abutting member 40 to pass through.

[0083] In one embodiment, there are two second sliding holes 3103 and two second operating parts 332, and they are symmetrically arranged with respect to the central axis of the housing 310 and the central axis of the second sliding part 331 respectively, so as to make the sliding of the second sliding part 331 more stable. In other embodiments, the number and installation positions of the second sliding holes 3103 and the second operating parts 332 can also be adaptively modified as needed without limitation.

[0084] It can be understood that, in one embodiment, the first sliding holes 3102 and the second sliding holes 3103 are both arranged at the splicing position of the first housing 311 and the second housing 312, that is, the first sliding holes 3102 and the second sliding holes 3103 are formed by splicing the slideways respectively formed on the first housing 311 and the second housing 312. And the first sliding holes 3102 and the second sliding holes 3103 are on the same axis of the housing 310, so as to make the operability of the stoma instrument 100 better. In other embodiments, the first sliding holes 3102 and the second sliding holes 3103 can also be arranged on different axes of the housing 310, and their installation positions and installation methods are not limited.

[0085] Please continue to refer to Figures 9-10 In one embodiment, a third sliding hole 3104 and a fourth sliding hole 3105 are further formed in the housing 310. A first sliding groove 3211 and a second sliding groove 3212 are formed in the first sliding portion 321 of the first operating member 320.

[0086] Both the third sliding hole 3104 and the fourth sliding hole 3105 are formed in the first outer shell 311. When viewed in the radial direction of the housing 310, both the third sliding hole 3104 and the fourth sliding hole 3105 are located at the 12 o'clock direction of the housing 310, while the two first sliding holes 3102 are respectively located at the 3 o'clock direction and the 9 o'clock direction of the housing 310, and the two second sliding holes 3103 are also respectively located at the 3 o'clock direction and the 9 o'clock direction of the housing 310.

[0087] The third operating member 340 includes a third sliding portion 341, a third operating portion 342, and a first connecting key 343. The third sliding portion 341 is received in the first sliding groove 3211 and is slidably assembled with the first sliding portion 321. The third operating portion 342 is located outside the housing 210 and is slidably assembled with the housing 2410. One end of the first connecting key 343 is connected to the third sliding portion 341, and the other end extends away from the first sliding portion 321 and extends out of the housing 310 through the third sliding hole 3104 to be connected to the third operating portion 342. The proximal end of the restraint member 50 is fixedly connected to the third sliding portion 341 by welding, bonding, or the like.

[0088] The fourth operating member 350 includes a fourth sliding portion 351, a fourth operating portion 352, and a second connecting key 353. The fourth sliding portion 351 is received in the second sliding groove 3212 and is slidably assembled with the first sliding portion 321. The fourth operating portion 352 is located outside the housing 310 and is slidably assembled with the housing 310. One end of the second connecting key 353 is connected to the fourth sliding portion 351, and the other end extends away from the first sliding portion 321 and extends out of the housing 310 through the fourth sliding hole 3105 to be connected to the fourth operating portion 352. The proximal end of the wire drawing 60 is connected to the fourth sliding portion 351 by welding, bonding, or the like.

[0089] It can be understood that in other embodiments, the third sliding hole 3104 and the fourth sliding hole 3105 may not be on the same axis, the third sliding hole 3104 and the fourth sliding hole 3105 may not be located at the 12 o'clock direction in the radial direction of the housing 310, the first sliding hole 3102 and the second sliding hole 3103 may not be located at the 3 o'clock direction or the 9 o'clock direction in the radial direction of the housing 310, and the positions of the first sliding hole 3102, the second sliding hole 3103, the third sliding hole 3104, and the fourth sliding hole 3105 only need to satisfy that there is no mutual interference.

[0090] Please continue to refer toFigure 10 In one embodiment, both the first sliding groove 3211 and the second sliding groove 3212 are in the shape of a dovetail groove. That is, in the radial cross-sectional view of the first sliding part 321, both the first sliding groove 3211 and the second sliding groove 3212 are in the shape of a trapezoid with a narrow upper base and a wide lower base. Herein, the upper base refers to the side of the first sliding groove 3211 or the second sliding groove 3212 close to the third sliding hole 3104, and the lower base refers to the side of the first sliding groove 3211 or the second sliding groove 3212 far from the third sliding hole 3104. The shape of the third sliding part 341 accommodated in the first sliding groove 3211 is adapted to the first sliding groove 3211, and the shape of the fourth sliding part 351 accommodated in the second sliding groove 3212 is adapted to the second sliding groove 3212. Such a setting can prevent the third sliding part 341 from falling out of the first sliding groove 3211 or the fourth sliding part 351 from falling out of the second sliding groove 3212, thereby enhancing the connection stability between the third operating member 340 and the fourth operating member 350 and the first operating member 320.

[0091] It should be noted that in this embodiment, the maximum static friction force between the first operating member 320 and the third operating member 340 and the fourth operating member 350 is greater than the maximum static friction force between the third operating member 340 and the housing 310, and is also greater than the maximum static friction force between the fourth operating member 350 and the housing 310. Thus, when no external force is applied to the third operating member 340 and the fourth operating member 350 or the applied external force is not sufficient to overcome the maximum static friction force between the third operating member 340 and the fourth operating member 350 and the first operating member 320, the third operating member 340 and the fourth operating member 350 will remain relatively stationary with respect to the first operating member 320, that is, the third operating member 340 and the fourth operating member 350 can move synchronously with the first operating member 320. Only when the external force applied to the third operating member 340 and the fourth operating member 350 is greater than the maximum static friction force between the third operating member 340 and the fourth operating member 350 and the first operating member 320 will the third operating member 340 and the fourth operating member 350 move relative to the first operating member 320.

[0092] In other embodiments, the relative rest or relative sliding between the third operating member 340 and the first operating member 320 can also be realized by additionally providing a releasable locking member to lock or unlock the third operating member 340 and the first operating member 320. The same applies to the assembly between the fourth operating member 350 and the first operating member 320.

[0093] Please continue to refer to Figure 4 and Figure 9 In one embodiment, both the cutting member 20 and the connecting rod 10 are conductive members (a conductive member means that it is made of a conductive material), so that electrocutting of the tissue to be cut can be achieved by electrically connecting to a radio frequency power supply connector (not shown in the figure).

[0094] In one embodiment, the control device 30 further includes a power-off structure 360 for disconnecting the circuit of the cutting member 20 after tissue cutting is completed.

[0095] The power-off structure 360 includes a first conductive member 361 and a second conductive member 362. Among them, the first conductive member 361 is installed on the housing 310 and connected to the RF power supply connector. One end of the second conductive member 362 is fixed on the first operating member 320 and electrically connected to the connecting rod 10, and the other end extends toward the first conductive member 361 to be movably abutted against the first conductive member 361. The first operating member 320 slides axially along the housing 310, which can drive the second conductive member 362 to abut against the first conductive member 361 to connect the circuit of the cutting member 20, or drive the second conductive member 362 to disengage from the first conductive member 361 to disconnect the circuit of the cutting member 20.

[0096] In one embodiment, the traction tube 70 is also a conductive member, and the second conductive member 362 is a conductive elastic piece. The second conductive member 362 is fixed on the first operating member 320 and abuts against the traction tube 70 to achieve electrical connection with the connecting rod 10. The first conductive member 361 is a conductive sheet extending axially along the housing 310, and the first conductive member 361 is connected to the connector of the RF power supply through a power cord. By setting the length of the first conductive member 361, during the process of cutting tissue, the second conductive member 362 slides on the first conductive member 361 as the first operating member 320 slides axially to continuously abut against the first conductive member 361. When the tissue cutting is completed, the second conductive member 362 moves to a position without the first conductive member 361 and separates from the first conductive member 361, so that the circuit of the cutting member 20 is automatically disconnected. Or, in other embodiments, the first conductive member 361 can also be set to be spliced by a conductive part and an insulating part. When the second conductive member 362 abuts against the conductive part of the first conductive member 361, the circuit of the cutting member 20 is connected. When the second conductive member 362 abuts against the insulating part of the first conductive member 361, the circuit of the cutting member 20 is disconnected. Or, by opening a through hole in the first conductive member 361, during the process of cutting tissue, the second conductive member 362 continuously abuts against the non-through hole opening position of the first conductive member 361. When the tissue cutting is completed, the second conductive member 362 moves to the through hole position and separates from the first conductive member 361, so that the circuit of the cutting member 20 is disconnected. That is, the movable abutment between the first conductive member 361 and the second conductive member 362 can mean that the first conductive member 361 and the second conductive member 362 can switch between abutment and separation, or it can mean that the second conductive member 362 can switch between different abutment parts of the first conductive member 361.

[0097] The setting of the power-off structure 360 can prevent the continuously powered cutting member 20 from contacting other tissues and burning the tissues during the process of completing tissue cutting but not returning to the external sheath 90 (to be discussed below), thus avoiding the occurrence of harm to the human body.

[0098] Please refer to Figure 11 , it can be understood that in one embodiment, the stoma instrument 100 further includes an external sheath 90. The external sheath 90 is a hollow tube, and one end thereof abuts against the distal end of the housing 310, and the other end extends toward the side where the cutting member 20 is located, so that the non-control device 30 part of the stoma instrument 100 is completely accommodated in the external sheath 90. The external sheath 90 cooperates with the stoma instrument 100 for delivering, cutting, and retracting.

[0099] Before the puncturing member 80 and the cutting member 20 reach the target position, both of them are accommodated in the external sheath 90 to avoid contacting other tissues. When the puncturing member 80 and the cutting member 20 reach the target position, by retracting the external sheath 90, the two can be exposed to puncture and cut the tissue to be cut at the target position. After cutting is completed, the puncturing member 80 and the cutting member 20 are retracted into the external sheath 90, and then the entire stoma instrument 100 is withdrawn outside the human anatomical structure.

[0100] It can be understood that the non-control device 30 part of the stoma instrument 100 can be guided by the guiding sheath 91 to be accommodated in the external sheath 90.

[0101] In addition, in other embodiments, an outer sheath that can slide relative to the housing 310 and a control component for controlling the movement of the outer sheath can also be directly added to the housing 310 of the control device 30. By controlling the sliding of the outer sheath through the control component, the loading and release of the puncturing member 80 and the cutting member 20 can be completed, so that the integrity of the stoma instrument 100 is stronger.

[0102] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered to be within the scope described in this specification.

[0103] The above-disclosed are only the preferred embodiments of the present invention. Of course, the scope of the rights of the present invention cannot be limited thereby. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope covered by the present invention.

Claims

1. A stoma instrument, characterized in that, Comprising: Connecting rod; Cutting member, surrounding the outside of the connecting rod, one end of the cutting member converges and is fixed on the connecting rod to form a receiving cavity with one end open; and, Control device, connected to the connecting rod, the control device can control the axial movement of the connecting rod so that the open side of the cutting member abuts against the tissue to be cut and cuts the tissue to be cut.

2. The stoma device according to claim 1, wherein, The cutting member includes a sleeve and an annular body, the sleeve is sleeved and fixed on the connecting rod, one end of the annular body converges on the sleeve and is connected to the sleeve, and the other end forms an opening.

3. The stoma device according to claim 2, characterized in that, The cutting member further includes an anchoring member, the anchoring member is connected to the open side of the annular body, and the anchoring member is used for anchoring on the tissue to be cut when the cutting member abuts against the tissue to be cut.

4. The stoma device according to claim 1, characterized in that The control device includes: Housing, and, First operating member, slidably connected to the housing and connected to the connecting rod, the first operating member can slide axially along the housing to drive the connecting rod to move axially.

5. The stoma device according to claim 4, characterized in that, The stoma instrument further includes a holding member, the holding member is sleeved outside the connecting rod and can move axially relative to the connecting rod, and the holding member is used for holding the tissue to be cut on the side opposite to the cutting member during cutting.

6. The stoma device according to claim 5, wherein, The holding member includes an assembled portion and a holding portion connected to each other, and the radial dimension of the holding portion gradually decreases axially from the side close to the cutting member to the side away from the cutting member to be connected to the assembled portion.

7. The stoma device according to claim 5, wherein, The control device further includes a second operating member, the second operating member is slidably connected to the housing and connected to the holding member, and the second operating member can slide axially along the housing to drive the holding member to move axially relative to the connecting rod.

8. The stoma device according to claim 4, characterized in that, The stoma instrument further includes a constraining member, the constraining member is sleeved outside the connecting rod and can move axially relative to the connecting rod, and the constraining member is used for movably constraining the cutting member so that the cutting member forms a constricted state or releases the constriction.

9. The stoma device according to claim 8, characterized in that, The control device further includes a third operating member, the third operating member is slidably assembled with the first operating member and connected to the constraining member, and the third operating member can slide axially along the first operating member to drive the constraining member to slide axially relative to the connecting rod.

10. The stoma device according to claim 8, characterized in that, The constraining member is a hollow tube body, and the stoma instrument further includes a pulling wire connected to the open side of the cutting member, and the pulling wire can slide axially along the connecting rod so that the open side of the cutting member is constricted and received in the constraining member or the constriction is released.

11. The stoma device according to claim 10, characterized in that, The control device further includes a fourth operating member, the fourth operating member is slidably assembled with the first operating member and connected to the pulling wire, and the fourth operating member can slide axially along the first operating member to drive the pulling wire to slide axially relative to the connecting rod.

12. The stoma device according to claim 10, characterized in that, The stoma instrument further includes a traction tube, the traction tube is sleeved on the connecting rod and fixedly connected to the connecting rod, and a channel for the pulling wire to pass through is formed on the traction tube.

13. The stoma device according to claim 4, wherein, Both the cutting member and the connecting rod are conductive members. The control device further includes a power-off structure for cutting off the circuit of the cutting member after tissue cutting is completed. The power-off structure includes: A first conductive member disposed on the housing and connected to the RF power supply connector; A second conductive member, one end of which is connected to the first operating member and electrically connected to the connecting rod, and the other end extends in the direction of the first conductive member to be movably abutted against the first conductive member. The first operating member can slide axially to drive the first conductive member to abut against the second conductive member to connect the circuit of the cutting member, or the first conductive member and the second conductive member are disengaged from abutment to disconnect the circuit of the cutting member.

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