Ostomy appliance

Abstract

The present application relates to a kind of stomal apparatus, comprising: puncture component, including puncture guide wire, puncture guide wire includes the predetermined structure of remote end, predetermined structure contains puncture needle, puncture guide wire has constraint state and the expansion state that predetermined structure is unbound around puncture needle and is coiled;And cutting component, including outer sleeve and cutting catheter, cutting catheter is used to be movably inserted into outer sleeve, cutting catheter includes the cutting structure of remote end, cutting structure can cut target tissue on target object after the remote end of outer sleeve is stretched;Puncture guide wire is movably inserted into cutting catheter, predetermined structure can be stretched to the remote end of cutting component, to be punctured to target object by puncture needle, predetermined structure can also be changed from constraint state to expansion state to pull target tissue after puncture.So configured, it can simplify the stoma operation process, reduce the risk of cutting tissue drop, reduce the size of instrument.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a stoma device capable of opening on a target object. BACKGROUND

[0002] Heart failure, simply referred to as heart failure, is a heart circulation disorder caused by the contraction and / or diastolic dysfunction of the heart. Heart failure can be divided into heart failure with reduced ejection fraction (HFrEF), heart failure with mid-range ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF). Among them, HFpEF has not yet had an ideal drug treatment plan, which is a difficult problem that the medical community is focusing on.

[0003] The main symptom of HFpEF is the congestion of the pulmonary vascular bed caused by the increase of PCWP (pulmonary capillary wedge pressure) and LAP (left atrial overload). Therefore, reducing the pressure of the left atrium becomes a potential means of treating or relieving HFpEF. In the prior art, a stoma device can be used to open on the atrial wall to communicate the left and right atria, so as to shunt blood from the left atrium to the right atrium, thereby reducing the pressure of the left atrium. However, the current stoma device has a large intervention size, causing pain to the patient, and the target tissue that can be removed is also very limited, and the removed tissue block is also easy to fall off and cause serious adverse events. In addition, a special instrument needs to be used to perform atrial septal puncture to establish a passage, and then the stoma device is used to cut the atrial wall, so the surgical procedure is relatively complex.

[0004] Therefore, for those skilled in the art, how to design a stoma device capable of simplifying the surgical operation procedure, reducing the risk of cutting tissue falling off, and having a small intervention size is a technical problem that needs to be solved at present.

[0005] It should be noted that the information disclosed in the background section of the present application is only intended to deepen the understanding of the general background of the present application, and should not be regarded as acknowledging or implying in any form that the information constitutes prior art known to those skilled in the art. SUMMARY

[0006] Therefore, the purpose of the present application is to provide a stoma device to solve the problems of complex surgical operation, cutting tissue falling off, and large intervention size in the existing stoma surgery.

[0007] To achieve the above-mentioned purpose, the present application provides a stoma device, comprising:

[0008] a puncture component comprising a puncture guide wire, the puncture guide wire comprising a predetermined shape structure at a distal end, the predetermined shape structure comprising a puncture needle, the puncture guide wire having a constrained state and an expanded state in which the predetermined shape structure is unwound around the puncture needle; and,

[0009] The cutting member comprises an outer sleeve and a cutting catheter, the cutting catheter is movably inserted into the outer sleeve, the cutting catheter comprises a cutting structure at a distal end, the cutting structure is capable of cutting a target tissue on a target object after extending out of a distal end of the outer sleeve;

[0010] The puncture guide wire is movably inserted into the cutting catheter, the predetermined shape structure is capable of extending out of a distal end of the cutting member to puncture the target object by the puncture needle, and the predetermined shape structure is further capable of transforming from a constraint state to an expansion state to pull the target tissue after puncture.

[0011] Optionally, the predetermined shape structure further comprises a development enhancement segment, in the expansion state, the development enhancement segment is coiled around the puncture needle, and the puncture needle is bent towards a central axis of the coiled development enhancement segment.

[0012] Optionally, the predetermined shape structure is composed of linear bodies coiled around the puncture needle in a staggered arrangement, and the puncture needle is capable of avoiding the target object in the process of transforming the predetermined shape structure from the constraint state to the expansion state.

[0013] Optionally, the linear bodies are coiled around the puncture needle in a staggered arrangement to form a multi-layer conical spiral, the puncture needle is bent around a central axis of the multi-layer conical spiral at a conical top of the multi-layer conical spiral, or the linear bodies are coiled around the puncture needle in a staggered arrangement to form a petal structure or a star structure, the puncture needle is bent around a central axis of the structure at a center of the petal structure or the star structure.

[0014] Optionally, a shape size of the predetermined shape structure does not exceed a target stoma size.

[0015] Optionally, a protrusion is arranged on the predetermined shape structure.

[0016] Optionally, the puncture guide wire further comprises a proximal support segment and a distal soft segment, a distal end of the distal soft segment is connected with the predetermined shape structure, a proximal end of the distal soft segment is connected with the proximal support segment, and the distal soft segment is softer than the proximal support segment.

[0017] Optionally, the puncture member further comprises an introduction sheath, and the puncture guide wire is used to be inserted into the cutting catheter through the introduction sheath.

[0018] Optionally, the introducing sheath is configured to be movably inserted into the cutting catheter, the puncture guide wire is configured to be movably inserted into the introducing sheath, or the cutting member further comprises a central catheter configured to be movably inserted into the cutting catheter, a proximal end of the central catheter is provided with an introducing port configured to be connected with a distal end of the introducing sheath, and the puncture guide wire is configured to be inserted into the central catheter through the introducing sheath and the introducing port.

[0019] Optionally, an outer diameter of the distal end of the introducing sheath is smaller than an outer diameter of the proximal end, and an inner diameter of the introducing sheath matches an outer diameter of the puncture guide wire.

[0020] Optionally, when the introducing sheath is inserted into the cutting catheter, the distal end of the introducing sheath extends 1mm-10mm beyond the distal end of the outer sleeve to position a stoma site through a portion of the introducing sheath extending beyond the distal end of the outer sleeve; when the central catheter is inserted into the cutting catheter, the distal end of the central catheter extends 1mm-10mm beyond the distal end of the outer sleeve to position a stoma site through a portion of the central catheter extending beyond the distal end of the outer sleeve.

[0021] Optionally, the cutting catheter is integrally formed from a raw tube material, and an outer diameter of the raw tube material is less than or equal to a diameter of the target stoma.

[0022] The cutting catheter further comprises a tube body with a hollow structure, and a distal end of the tube body is connected with the cutting structure.

[0023] The cutting structure has a folded state when being constrained within the outer sleeve and an expanded state after extending beyond the distal end of the outer sleeve; in the folded state, a diameter of the cutting structure is less than a diameter of the target stoma, and all the blades have overlapping portions in the circumferential direction; in the expanded state, the diameter of the cutting structure is equal to the diameter of the target stoma, and all the blades are distributed on the same circumference and jointly form a complete annular cutting edge.

[0024] Optionally, the number of the cutting catheters is one, and an outer diameter of the raw tube material for preparing the one cutting catheter is equal to the diameter of the target stoma.

[0025] Optionally, the number of the cutting catheters is multiple, each of the cutting catheters is integrally formed from a raw tube material, an outer diameter of each of the raw tube materials is less than the diameter of the target stoma, and a total of the outer diameters of all the cutting catheters is equal to the diameter of the target stoma.

[0026] Optionally, the cutting structure of each of the cutting catheters has a folded state when being constrained within the outer sleeve and an expanded state after extending beyond the distal end of the outer sleeve.

[0027] In the folded state, the diameter of the cutting structure of each cutting catheter is smaller than the diameter of the target stoma, and the blades of each cutting structure are distributed on different circumferences, and the blades on each circumference overlap in the circumferential direction;

[0028] In the expanded state, the diameter of the cutting structure of each cutting catheter is equal to the diameter of the target stoma, and the blades of all the cutting structures are distributed on the same circumference and jointly form a complete annular cutting edge.

[0029] Optionally, the outer diameters of all the cutting catheters are the same.

[0030] Optionally, the thickness of at least part of the blades gradually increases from one end to the other end in the circumferential direction of the tube body, or the thickness of at least part of the blades gradually increases from both ends to the middle in the circumferential direction of the tube body.

[0031] Optionally, the inner diameter of the outer sleeve is smaller than or equal to the diameter of the target stoma, the angle of each blade deviating from the circumference of the target stoma is -10° to +10°, and in the expanded state, the total arc length of all the blades is equal to the circumference of the target stoma.

[0032] As described above, the stoma device provided by the application integrates the puncture component and the cutting component, which can puncture the target object (such as the atrial wall) before cutting on one hand, and can cut the target tissue on the target object to form a stoma after puncture without removing the puncture component on the other hand. Therefore, the stoma process is simplified, and the operation time can be shortened.

[0033] The structure of the puncture guide wire is optimized to have a predetermined structure at the distal end, which not only can complete the puncture function through the puncture needle, but also can automatically expand to the coiled structure in the predetermined shape after puncture, and then can pull the target tissue (such as myocardial tissue on the atrial wall) on the target object through the coiled structure in the expanded state. Therefore, the puncture guide wire has both puncture function and pulling function, which can not only reduce the intervention size of the puncture component, but also has a small size when passing through the target tissue, has little damage to the pulled target tissue, and can improve the pulling success rate. Because the predetermined structure is coiled from the wire body of the puncture guide wire, it has good compliance and can be tightly attached to the target tissue to prevent the cut tissue from falling, thereby effectively improving the safety of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0034] Those skilled in the art will understand that the drawings provided herein are for illustrative purposes and are not intended to limit the scope of the application. Among other things,

[0035] Figure 1 is a schematic diagram of an assembled structure of a puncture component in an embodiment of the present application;

[0036] Figure 2 is a schematic diagram of an assembled structure of a cutting component in an embodiment of the present application;

[0037] Figure 3 is a schematic diagram of a structure of an introduction port in an embodiment of the present application;

[0038] Figure 4 is a schematic diagram of a use state of a stoma device in an embodiment of the present application;

[0039] Figure 5 is a schematic diagram of a structure of a puncture guide wire in an embodiment of the present application;

[0040] Figure 6 is a schematic diagram of a structure of a predetermined structure on a puncture guide wire in an embodiment of the present application;

[0041] Figure 7 is a schematic diagram of another structure of a predetermined structure on a puncture guide wire in an embodiment of the present application;

[0042] Figure 8 is a schematic diagram of a structure of a cutting catheter in an embodiment of the present application;

[0043] Figure 9 is a schematic diagram of a cutting structure at a distal end of a plurality of cutting catheters in a folded state after being nested in an embodiment of the present application;

[0044] Figure 10 is a schematic diagram of a cutting structure at a distal end of a plurality of cutting catheters in an intermediate state after being nested in an embodiment of the present application;

[0045] Figure 11 is a schematic diagram of a cutting structure at a distal end of a plurality of cutting catheters in an expanded state after being nested in an embodiment of the present application;

[0046] Figure 12 is a schematic diagram of a cutting structure at a distal end of a single cutting catheter in a folded state in an embodiment of the present application;

[0047] Figure 13 is a schematic diagram of a distal end of a stoma device in an embodiment of the present application;

[0048] Figure 14 is a scene diagram of guiding a stoma device of an embodiment of the present application to a right atrium through a guide wire;

[0049] Figure 15is a scene diagram of the puncture guide wire puncturing the atrial wall to enter the left atrium according to an embodiment of the present application, in which the target tissue at the stoma position is pulled away from the right atrium;

[0050] Figure 16 is a scene diagram of the application of the cutting structure of the cutting catheter and the pulling of the target tissue by the pre-shaped structure of the puncture guide wire according to an embodiment of the present application;

[0051] Figure 17 is a scene diagram of the cutting of the atrial wall by the cutting structure of the cutting catheter according to an embodiment of the present application;

[0052] Figure 18 is a scene diagram of the retraction of the stoma device according to an embodiment of the present application after the completion of the cutting.

[0053] In the drawings:

[0054] 1 - puncture component; 11 - puncture guide wire; 111 - pre-shaped structure; 1111 - puncture needle; 1112 - development enhancement section; 112 - proximal support section; 113 - distal soft section; 12 - introduction sheath; 121 - sharp mouth; 2 - cutting component; 21 - central catheter; 211 - introduction port; 22 - cutting catheter; 221 - cutting structure; 2211 - blade; 222 - tube body; 23 - outer sleeve; 10 - guide guide wire; 20 - stoma. DETAILED DESCRIPTION

[0055] The various illustrative embodiments of the present disclosure will be described below in detail with reference to the accompanying drawings. It should be noted that the relative arrangement, numerical expressions, and values of the components and steps set forth in these embodiments are not limiting to the scope of the present disclosure unless otherwise specifically stated.

[0056] The following description of at least one illustrative embodiment of the present disclosure is merely exemplary in nature and is in no way intended to limit the present disclosure, its application, or uses.

[0057] Techniques, methods, and devices known to those of ordinary skill in the relevant art can not be discussed in detail herein. However, where appropriate, such techniques, methods, and devices can be viewed as part of the specification.

[0058] In all of the examples shown and discussed herein, any specific values should be interpreted as merely illustrative and not as a limitation. Thus, other examples of the illustrative embodiments can have different values.

[0059] It should be noted that like reference numerals and characters refer to like elements throughout the several views of the drawings, and that, unless otherwise indicated, like reference numerals and characters refer to like elements throughout the first few views where they are defined and in subsequent views thereof wherein they can be discussed further. The term "axial" as used in the present document means parallel to the central axis of the device, the term "circumferential" means around the central axis of the device, and the term "radial" means perpendicular to the central axis of the device.

[0060] The core idea of the present application is to provide a stoma device to solve the problems of complicated operation, cutting tissue falling, and large intervention size in the prior art.

[0061] The following is described with reference to the accompanying drawings. The target object described herein can be understood as a patient or an individual or a prosthesis on which cutting is required. The target object includes but is not limited to an atrial wall (or called an atrial septum), and can also be other positions. The target tissue described herein can be understood as a part of the target object that needs to be cut.

[0062] Referring to Figures 1-13 According to one embodiment disclosed in the present application, a stoma device is provided, which includes a puncture component 1 and a cutting component 2. As Figure 1 The puncture component 1 includes a puncture guide wire 11 and further includes a guide sheath 12. Generally, the puncture guide wire 11 is loaded in the guide sheath 12 for storage before use. As Figure 2 The cutting component 2 includes a central catheter 21, a cutting catheter 22, and an outer sleeve 23, and the central catheter 21 is optional. The cutting catheter 22 is one or more, and the more includes at least two, and the more cutting catheters 22 are nested in sequence. As Figure 2 In an exemplary embodiment, the cutting catheter 22 is two, and the two cutting catheters 22 are nested in sequence. The cutting catheter 22 is movably inserted into the outer sleeve 23 when needed.

[0063] The puncture guide wire 11 is preferably inserted into the cutting catheter 22 directly or indirectly through the guide sheath 12. However, it should be understood that both the central catheter 21 and the guide sheath 12 can be used at the same time, or only the guide sheath 12 is used, but the central catheter 21 can be provided or not provided, at this time, the guide sheath 12 can play the role of the central catheter 21.

[0064] In some embodiments, as Figure 4 The central catheter 21 is movably inserted into the cutting catheter 22 when needed. Correspondingly, as Figure 3As shown, the proximal end of the central catheter 21 is provided with a lead-in port 211, which is used to connect with the distal end of the lead-in sheath 12, at this time, the puncture guide wire 11 can be inserted into the central catheter 21 through the lead-in sheath 12 and the lead-in port 211. In this way, the puncture guide wire 11 can be smoothly loaded into the central catheter 21 through the lead-in sheath 12 and the lead-in port 211, and the shape and material of the lead-in port 211 are not limited in the application as long as the purpose can be achieved. The lead-in port 211 is mainly used in cooperation with the lead-in sheath 12 to facilitate the lead-in of the puncture guide wire 11 in the lead-in sheath 12 into the central catheter 21 in a storage state, and in this way, the puncture guide wire 11 with the predetermined structure 111 at the distal end can be conveniently sent to the cutting member 2. The cooperation of the lead-in sheath 12 and the lead-in port 211 means that the two can be detachably connected, and the connection mode is not limited.

[0065] In another embodiment, the lead-in sheath 12 is movably inserted into the cutting catheter 22 directly, and the puncture guide wire 11 is movably inserted into the lead-in sheath 12 when needed. In this scheme, the lead-in port 211 can be cancelled. In this way, the puncture guide wire 11 can also be smoothly loaded into the cutting catheter 22 through the lead-in sheath 12. In a non-limiting operation, the entire central catheter 21 can be pulled out from the cutting catheter 22, and the entire puncture member 1 is inserted into the cutting member 2 from which the central catheter 21 is pulled out, to achieve similar functions.

[0066] It should be recognized that the cutting member 2 can be provided with or without the central catheter 21, and if the central catheter 21 is provided, the operator can decide whether to use the central catheter 21 according to actual needs. It should also be understood that when the cutting catheter 22 is multiple, the central catheter 21 or the lead-in sheath 12 is inserted into the innermost cutting catheter 22.

[0067] When the lead-in sheath 12 is inserted into the cutting catheter 22, the part of the lead-in sheath 12 extending out of the distal end of the outer sleeve 23 can accurately position the stoma position on the target object. Similarly, when the central catheter 21 is inserted into the cutting catheter 22, the part of the central catheter 21 extending out of the distal end of the outer sleeve 23 can accurately position the stoma position on the target object. Taking the atrial wall as an example, the stoma position is usually selected at the position of the foramen ovale, but it can not be limited to this.

[0068] The length of the part of the lead-in sheath 12 or the central catheter 21 extending out of the distal end of the outer sleeve 23 should not be too long or too short, and the extension is too long, which can easily affect the cutting of the target tissue by the cutting catheter 22, and the extension is too short, which cannot achieve the effect of accurate positioning. Therefore, preferably, the length L of the part of the lead-in sheath 12 or the central catheter 21 extending out of the distal end of the outer sleeve 23 is 1mm-10mm, and the specific length can be seen in Figure 2 .

[0069] Referring again to Figure 8 andFigure 13 The cutting catheter 22 comprises a cutting structure 221 at the distal end, which corresponds to a cutting head. When cutting is required, the cutting structure 221 can be extended out of the distal end of the outer sleeve 23 to cut the target tissue on the target object, and at the same time, the puncture guide wire 11 can be retained in the cutting member 2 to pull the target tissue to be cut by the predetermined shape structure 111 described below.

[0070] Further referring to Figures 5-7 , and in combination with Figure 13 The puncture guide wire 11 comprises a predetermined shape structure 111 at the distal end, which comprises a puncture needle 1111. In this way, the predetermined shape structure 111 can complete puncture by the puncture needle 1111, and can also automatically expand to the coiled shape in the predetermined shape after puncture, and then can pull the target tissue on the target object by the expansion and coiling of the predetermined shape structure 11. Therefore, the predetermined shape structure 111 can be used as a pulling member. The predetermined shape structure 11 can pull the target tissue before and during the cutting of the target tissue by the cutting catheter 22. The cut target tissue can be clamped between the coiled predetermined shape structure 11 and the cutting head before and after cutting.

[0071] Specifically, the puncture guide wire 11 has a constrained state and an expanded state in which the predetermined shape structure 111 is coiled around the puncture needle 1111 when the predetermined shape structure 111 is released from the constraint. The constrained state of the puncture guide wire 11 refers to a state in which the puncture guide wire 11 is entirely accommodated in the introduction sheath 12 or the cutting member 2, and the puncture guide wire 11 is elongated along the central axis direction of itself and is generally linear, so that the intervention size is small during delivery. The expanded state of the predetermined shape structure 111 refers to a state when the puncture guide wire 11 has been inserted into the cutting catheter 22 for puncture, at which time the puncture guide wire 11 is pushed to make the predetermined shape structure 111 extend out of the distal end of the cutting member 2. After extending out, the predetermined shape structure 111 does not immediately recover to the expanded state, but first passes through the target tissue by the puncture needle 1111. After the puncture needle 1111 punctures, the puncture guide wire 111 is continuously pushed forward to make the predetermined shape structure 111 gradually separate from the cutting member 2, and then gradually recover to the coiled shape in the predetermined shape on the opposite side of the target tissue. During the coiling process, the predetermined shape structure 111 can tightly adhere to and embrace the target tissue, so as to change from the constrained state to the expanded state and pull the target tissue during and before cutting by the cutting catheter 22.

[0072] Therefore, the stoma device described above can puncture the target object by the puncture member 1 before cutting, and can also cut the target tissue on the target object by the cutting member 2 after puncture without removing the puncture member 1. More specifically, please refer to Figures 14-18In the operation, the cutting member 2 is first sent into the right atrium (RA) along the guide wire 10, then the puncture guide wire 11 is inserted into the cutting member 2, and then the puncture of the interatrial septum is performed by the puncture guide wire 11 to establish the passage. After the passage is established, the target tissue on the atrial wall is cut by the cutting catheter 22, and after the cutting is completed, the entire stoma device is withdrawn. In this way, the dedicated device for puncturing the interatrial septum is not needed, the operation process is simplified, the operation time is shortened, and the operation efficiency is improved.

[0073] Moreover, the puncture guide wire 11 has both puncture and traction functions, which can not only reduce the intervention size of the puncture member 1, but also reduce the damage to the target tissue when the puncture guide wire 11 passes through the target tissue, and can improve the success rate of traction. Because the predetermined structure 111 is formed by the puncture guide wire 11 itself, the compliance of the coiled structure is good, which can tightly adhere to the target tissue and prevent the cut tissue from falling, thereby effectively improving the safety of the operation. Moreover, the predetermined structure 111 can elastically deform and provide some elastic force, so that the target tissue can be tightly held by the coiled structure and tearing of the target tissue can be avoided, and the problem of tissue debris falling due to tearing can also be avoided.

[0074] Continuing to refer to Figures 5-7 As shown, the predetermined structure 111 preferably further includes a development enhancement segment 1112, which can be developed under X-ray irradiation. The development enhancement segment 1112 can enhance the perspective visibility of the puncture guide wire 11. In this way, when the predetermined structure 111 tightly adheres to the target tissue, the shape and position of the cut tissue can also be indirectly understood through the developed shape and position of the predetermined structure 111, thereby enhancing the monitoring ability of the tissue block during the operation and further improving the safety of the operation.

[0075] For the puncture guide wire 11, it should be understood that the part of the puncture guide wire 11 other than the predetermined structure 111 is mainly linear in structure. As shown in Figure 5 As shown, after the entire puncture guide wire 11 is elongated along the central axis direction, the puncture guide wire 11 basically presents a linear shape, and therefore, the intervention size of the puncture guide wire 11 is small when it is delivered, which is beneficial to reduce the pain of the patient. The puncture guide wire 11 is usually made of an inner core and a wire material wound on the inner core, and has good pushability and flexibility. The inner core can be made of a common medical metal wire material such as a nickel-titanium wire.

[0076] Further, the puncture guide wire 11 further includes a proximal support segment 112 and a distal soft segment 113. The distal end of the distal soft segment 113 is connected with the predetermined structure 111, and the proximal end of the distal soft segment 113 is connected with the proximal support segment 112.

[0077] The proximal support section 112 provides good pushability. The proximal support section 112 is made by spirally winding common medical metal wire (such as stainless steel wire) or polymer wire into an inner core. Optionally, the pitch of the proximal support section 112 is 1 to 10 times the diameter of the wound wire.

[0078] The distal flexible segment 113 is more flexible than the proximal supporting segment 112, facilitating the passage of the guidewire 11 through tortuous blood vessels or bends. The distal flexible segment 113 is made of common medical metal wire or polymer wire spirally wound into an inner core. Optionally, the pitch of the distal flexible segment 113 is 1.25 to 10 times the diameter of the wound wire. In practice, the distal flexible segment 113 can be formed by winding with a gradually varying pitch or a constant pitch.

[0079] The distal end of the flexible distal segment 113 is connected to the development enhancement segment 1112. The development enhancement segment 1112 is made by spirally winding common opaque wire around an inner core. The opaque wire can be selected from common opaque wires such as platinum wire or platinum-tungsten wire. Optionally, the pitch of the development enhancement segment 1112 is 1 to 10 times the diameter of the wound opaque wire. In practice, the development enhancement segment 1112 can be formed by winding with a gradually varying pitch or a constant pitch.

[0080] like Figure 6 and Figure 7 As shown, in the expanded state, the imaging enhancement segment 1112 coils around the puncture needle 1111, and the puncture needle 1111 bends towards the central axis of the coiled imaging enhancement segment 1112. This allows the puncture needle 1111 to avoid the target object during the transition of the pre-shaped structure 111 from the constrained state to the expanded state. That is, during the coiling process, the puncture needle 1111 will no longer come into contact with non-target tissue (non-target tissue is tissue that does not require an ostomy) and will avoid scratching non-target tissue.

[0081] Furthermore, the puncture needle 1111 can be directly ground, cut, or integrally molded into a spike shape from the inner core, so that it can puncture the target tissue more smoothly under lower force.

[0082] It should also be noted that this application does not limit the winding method of the pre-shaped structure 111. Although conical spiral, petal structure and star structure are mentioned in the following description, it should be understood that the pre-shaped structure 111 can have other suitable winding methods, or more complex winding methods. Preferably, the pre-shaped structure 111 is composed of a linear body winding around the puncture needle 1111 in an alternating arrangement. This can not only prevent the puncture needle 1111 from contacting the target object during the winding of the pre-shaped structure 111, but also enhance the anti-pull-out capability of the pre-shaped structure 111. This is because the alternating arrangement can achieve the effect of mutual compression and locking during retraction, which facilitates the increase of retraction resistance and prevents the puncture guide wire 11 from being pulled back into the outer sheath 23 during retraction, and also enhances the stability of the pre-shaped structure 111. The following is an illustrative description.

[0083] The predetermined structure 111 is, for example, a circular cone of unequal diameter, an elliptical cone, a polygonal cone, a petal structure, a star-shaped structure, or other regular or irregular shapes.

[0084] like Figure 6 As shown, in one example, the linear body constituting the guidewire 11 is coiled around the puncture needle 1111 at its distal end in an alternating pattern to form a multi-layered conical spiral. The puncture needle 1111 then bends around the central axis of the multi-layered conical spiral at the apex of the spiral. In this case, the multi-layered conical spiral consists of at least two spiral layers, with the inner and outer spirals arranged alternately, which provides a locking effect during withdrawal. Further, one or more of the multi-layered conical spirals are unequal-diameter circular, elliptical, or polygonal conical spirals. In this case, the tip of the puncture needle 1111 bends at the apex of the inner or outer spiral, preventing contact with and scratching of non-target tissue after puncture. The pitch of the multi-layered conical spiral can be 1 to 5 times the wire diameter to ensure sufficient strength and stability of the release pattern.

[0085] like Figure 7 As shown, in another example, the linear body constituting the puncture guidewire 11 is coiled around the puncture needle 1111 at its distal end in an alternating pattern to form a petal-shaped or star-shaped structure. The puncture needle 1111 turns around the central axis of the structure at the center of the petal-shaped or star-shaped structure. This coiling structure is equivalent to having several ring structures, the number of which can be 2 to 10. The different ring structures are arranged alternately to achieve a mutual compression and locking effect during retraction. The ring structures can be circular, elliptical, polygonal, or other shapes.

[0086] In actual production, the heat setting process can be used to heat set the radiopaque segment 1112 and the puncture needle 1111, so that they can automatically recover to the heat set coiled shape when pushed out of the cutting member 2 during use to form the pull member for pulling the tissue. In this regard, the pre-shaped structure 111 can automatically recover to the original coiled shape after being pushed out of the cutting member 2. In this regard, the puncture guide wire 11 has good elasticity and shape memory properties, which can be ensured by the material and / or structure. After the pre-shaped structure 111 is completely released, it is not easy to be pulled back into the cutting member 2. In this regard, the pull-back resistance of the pre-shaped structure 111 can be increased. As described above, the coiled structures can be arranged in a staggered manner to increase the resistance when pulled back. The shape consistency of the pre-shaped structure 111 after release is good, so that it is not easy to be greatly deformed by the target tissue, but can be deformed according to the reaction force of the target tissue, and the shape and position of the stoma can be easily understood. Of course, after the cutting is completed, the pre-shaped structure 111 can be retracted into the cutting member 2 due to its good compliance.

[0087] Further, the shaped size of the pre-shaped structure 111 is not greater than the target stoma size. The shaped size mainly refers to the maximum radial size of the pre-shaped structure 111, and the target stoma size refers to the diameter of the target stoma. In this way, the shape and size of the cut tissue can be determined, and in particular, the situation that the shaped size is too small to cause the force to be too concentrated during the pulling process and the tissue to be broken can be avoided, and the situation that the shaped size is too large to interfere with the cutting of the tissue can also be avoided.

[0088] In order to increase the pull-back resistance and the tissue grabbing force, at least one of the puncture needle 1111 and the radiopaque segment 1112 is provided with a protrusion, and the number of the protrusions can be set according to actual needs. The protrusions can have various forms, such as linear, strip-shaped or sheet-shaped. In some embodiments, the protrusions can be provided by embedding metal or high molecular wire or cutting the inner core.

[0089] It should be noted that the introduction sheath 12 is made of materials such as but not limited to stainless steel, nickel-titanium alloy and the like and combinations thereof, or made of materials such as but not limited to polyester, polyamide, polyolefin, polycarbonate, silicone, polyether and the like and combinations thereof.

[0090] Reference Figure 1As shown, the distal end of the introducer sheath 12 has a sharp tip 121 with a thin outer diameter, which cooperates with the introducer port 211 of the central catheter 21 to facilitate the loading of the puncture guide wire 11. The proximal end of the introducer sheath 12 has a thick outer diameter to provide sufficient support to protect the puncture guide wire 11 from damage due to external forces during storage and transportation. The inner diameter of the introducer sheath 12 is matched with the outer diameter of the puncture guide wire 11 to ensure that the puncture guide wire 11 will not be damaged due to insufficient pushing force or excessive pushing force during the loading process, and to ensure that the puncture guide wire 11 will not be damaged due to excessive inner diameter of the introducer sheath 12 during the loading process.

[0091] The central catheter 21 is made of materials such as, but not limited to, stainless steel, nickel-titanium alloy, and combinations thereof, or made of materials such as, but not limited to, polyester, polyamide, polyolefin, polycarbonate, silicone, polyether, and combinations thereof. Preferably, the distal end of the central catheter 21 is equipped with a Tip head for smoothing and softening to avoid damage to the tissue.

[0092] The outer sleeve 23 is made of common medical polymer pipe materials such as polyester, polyamide, polyolefin, polycarbonate, silicone, polyether, and combinations thereof. The outer sleeve 23 is pre-shaped to a suitable angle to facilitate the positioning of the target tissue, and at the same time to protect the internal cutting component 2 and the puncture component 1. Preferably, the distal end of the outer sleeve 23 is equipped with a Tip head for smoothing and softening to avoid damage to the tissue.

[0093] The cutting catheter 22 is further described below.

[0094] The cutting catheter 22 can be made of common medical metal pipe materials such as stainless steel pipe or nickel-titanium pipe, etc. Preferably, the cutting catheter 22 is made of a raw pipe material and the outer diameter (i.e. the pipe diameter) of the raw pipe material is less than or equal to the diameter of the target stoma.

[0095] As shown in FIG. 1, the puncture guide wire 11 is loaded into the introducer sheath 12 through the sharp tip 121 of the introducer sheath 12, and the puncture guide wire 11 is then pushed into the introducer sheath 12 until the puncture guide wire 11 reaches the distal end of the introducer sheath 12. The puncture guide wire 11 is then pushed into the introducer port 211 of the central catheter 21, and the puncture guide wire 11 is then pushed into the central catheter 21 until the puncture guide wire 11 reaches the distal end of the central catheter 21. The puncture guide wire 11 is then pushed into the outer sleeve 23 until the puncture guide wire 11 reaches the distal end of the outer sleeve 23. The puncture guide wire 11 is then pushed into the cutting catheter 22 until the puncture guide wire 11 reaches the distal end of the cutting catheter 22. Figure 8 ​As shown, further, the cutting catheter 22 also comprises a tube body 222, the distal end of which is connected with the cutting structure 221, which comprises a plurality of blades 2211 arranged along the circumference of the tube body 222. In actual use, the cutting structure 221 has a folded state when being constrained within the outer sleeve 23 and an expanded state after extending out of the distal end of the outer sleeve 23. In the folded state, the diameter of the cutting structure 221 is smaller than the diameter of the target stoma, and all the blades 2211 have overlapping portions in the circumference. In the expanded state, the diameter of the cutting structure 221 is equal to the diameter of the target stoma, and all the blades 2211 are distributed on the same circumference and jointly form a complete annular cutting edge.

[0096] In fact, the cutting catheter 22 can be one or at least two. If it is one cutting catheter 22, the outer diameter of the original pipe material for preparing the cutting catheter 22 is equal to the diameter of the target stoma, so as to ensure that the diameter of the cutting structure 221 after expansion is equal to or close to the diameter of the target stoma, and all the blades 2211 can jointly form a nearly circular annular cutting edge. If multiple cutting catheters 22 are used, the number of cutting catheters 22 is preferably 2-5, each cutting catheter 22 is integrally formed by an original pipe material, and the outer diameter of each original pipe material is smaller than the diameter of the target stoma, but the sum of the outer diameters of all cutting catheters 22 is equal to or close to the diameter of the target stoma.

[0097] Taking two cutting catheters 22 as an example, the cutting structure 221 on each cutting catheter 22 can be configured with 2-8 blades 2211, and each cutting catheter 22 can form an expandable and foldable cutting structure 221 at the distal end under a suitable mold and shaping process. In the cutting structure 221, the curvature and angle of the blades 2211 are set according to needs, but the curvature and angle of the blades 2211 can make all the blades 2211 distributed on the same circumference and jointly form a complete annular cutting edge in the expanded state, so as to make the stoma 20 on the target object circular or quasi-circular.

[0098] When there are multiple cutting catheters 22, each cutting catheter 22 has a folded state when constrained within the outer sleeve 23 and an expanded state when extended beyond the distal end of the outer sleeve 23. In the folded state, the diameter of each cutting catheter 22 is smaller than the diameter of the target stoma, and the blades 2211 of each cutting catheter 22 are distributed on different circumferences, and the blades 2211 on each circumference are overlapped in the circumferential direction, which is small in the intervention size. In the expanded state, the diameter of each cutting catheter 22 is equal to the diameter of the target stoma, and the blades 2211 of all cutting catheters 22 are distributed on the same circumference and form a complete annular cutting edge. Here, it should be understood that the cutting structure 221 of the outermost cutting catheter 22 is in a folded state due to the constraint of the outer sleeve 23, and the cutting structures 221 of the other cutting catheters 22 are in a folded state due to the constraint of the outer cutting structure 221. However, in any case, the cutting structures 221 are nested one inside the other without being extended beyond the outer sleeve 23, and the blades 2211 on each cutting structure 221 are stacked in the circumferential direction without being opened, maintaining the smallest intervention size.

[0099] Although the sum of the diameters of all cutting catheters 22 is equal to the diameter of the stoma to achieve the above functions, in practice, the outer diameters of all cutting catheters 22 are preferably equal, which is most advantageous for the compression of the intervention size and facilitates a smaller intervention size. It should be understood that the outer diameter of the cutting catheter 22 described herein refers to the diameter of the cutting catheter 22 in the original state, which is the initial state when not inserted into the outer sleeve 23 or another cutting catheter 22.

[0100] In this embodiment, the blades 2211 are generally arc-shaped blades, and the curvature of the blades 2211 is determined according to the number of cutting catheters 22 and the total number of blades. In the embodiment where multiple cutting catheters 22 are arranged, the curvature of the blades 2211 can be 9°-90°, and the angle of each blade 2211 deviating from the circumference of the target stoma can be -10° to +10°. In the expanded state, the sum of the arc lengths of all blades 2211 is equal to the circumference of the target stoma, so as to effectively cut the target tissue. Preferably, the structure of the blades 2211 is cut and polished to have a sharp cutting edge.

[0101] The tube body 222 of the cutting catheter 22 can be expanded and compressed, and the diameter of the tube body 222 can be sized under suitable mold and sizing process to minimize the intervention size. Further, the tube body 222 is defined with a hollow structure, which can be formed by cutting or one-piece forming. The hollow structure can enhance the compression performance of the tube body 222, facilitate the compression of the tube body 222 into the outer sleeve 23, and facilitate the nesting of the multiple layers of tube bodies 222. The inner diameter of the outer sleeve 23 is generally less than or equal to the diameter of the target stoma.

[0102] It is worth mentioning that although two concentrically nested cutting catheters 22 are shown in the figure, in fact, the number of cutting catheters 22 can be more than two, and all cutting catheters 22 are concentrically nested. When the cutting catheters 22 are multiple, the tubes 222 of the multiple cutting catheters 22 can be concentrically nested, that is, the diameters of the tubes 222 of the multiple cutting catheters 22 decrease from outside to inside, and the diameters of all cutting structures 221 after expansion are the same and are the diameter of the target stoma, and the total arc length of all blades 2211 after setting is equal to the circumference of the target stoma.

[0103] The nested mode of the multiple cutting catheters 22 is as follows: before the cutting catheters 22 are pushed out of the outer sleeve 23, the cutting structures 221 of the cutting catheters 22 are in a folded state, and the blades 2211 are orderly stacked a (see Figure 9 ); after being pushed out of the outer sleeve 23, the cutting structures 221 of the cutting catheters 22 self-expand to an expanded state; it should be noted that due to the thickness of the stacked blades, at this time, except for the outermost cutting catheter 22, the inner cutting catheters 22 do not reach the expanded size b (see Figure 10 ); thereafter, each cutting catheter 22 is rotated so that the blades of each cutting structure 221 are staggered to obtain a fully expanded state; at this time, since the curvature and angle of the blades 2211 are limited during the setting process, and the total arc length of all blades 2211 is equal to the circumference of the target stoma, all blades 2211 at this time are combined to form a complete annular knife edge c (see Figure 11 ). Then, after the cutting of the stoma is completed, the above operations are performed in reverse, that is, each cutting catheter 22 can be orderly recovered into the outer sleeve 23.

[0104] Similar to the above embodiment, if the cutting catheter 22 is one, the cutting catheter 22 is obtained by cutting or integrally forming the tube 222 of the original pipe material having the same outer diameter as the diameter of the target stoma, and the hollow structure is obtained. The hollow structure enables the diameter of the tube 222 of the cutting catheter 22 to be compressed or expanded to the target diameter. If the cutting catheter 22 is one, the cutting structure 221 of the cutting catheter 22 can be provided with 2 to 16 blades 2211. In this embodiment, the curvature of the blades 2211 can be 22.5° to 180°, and the angle of the blades 2211 can deviate from the circumference of the target stoma by -10° to +10°. In the single cutting catheter 22 embodiment, all blades 2211 can also be folded to shrink to the minimum size a', which can be seen from Figure 12 , but does not have an intermediate state.

[0105] Preferably, the leaflets 2211 are polished or cut to have a cross-section with one side thicker than the other, for example, at least part of the leaflets 2211 have a thickness gradually increasing from one end to the other end along the circumference of the tube body 222, or at least part of the leaflets 2211 have a thickness gradually increasing from both ends to the middle along the circumference of the tube body 222. For example, at least part of the leaflets 2211 are fusiform or drop-shaped or wedge-shaped. In this way, it is helpful for the expansion combination and retraction of the leaflets 2211.

[0106] Therefore, through the above structural design, the size of the stoma device delivery device can be much smaller than the target stoma size. That is, the stoma device provided in the embodiment can have a smaller intervention size for a specific stoma size, and in turn, such a stoma device can complete a larger size stoma.

[0107] In an application scenario, taking the stoma on the atrial wall as an example, and for multiple cutting catheters 22, the cutting of the target tissue can be completed through the following steps:

[0108] First, as shown in Figure 14 , the guide wire 10 is passed through the central catheter 21 to guide the cutting component 2 to the target organ position and find the target tissue on the atrial wall that needs to be cut;

[0109] Then, the guide wire 10 is withdrawn, and the puncture guide wire 11 is loaded into the central catheter 21 through the introduction sheath 12 and the introduction port 211;

[0110] After the puncture guide wire 11 is inserted into the cutting component 2, as shown in Figure 15 , the stoma device as a whole is pushed, so that the distal end of the central catheter 21 abuts against the target tissue that needs to be cut. Preferably, the central catheter 21 props up and tightens the target tissue towards the left atrium, so as to facilitate the pushing of the puncture guide wire 11, so that the puncture guide wire 11 penetrates the target object at the target tissue and forms a predetermined coiled shape on the opposite side of the target object, and the penetration and coiling state of the puncture guide wire 11 can be confirmed through development and perspective confirmation;

[0111] Then, as shown in Figure 16 , the outer sleeve 23 is retracted to release the cutting structure 221 of all the cutting catheters 22, and all the cutting structures 221 automatically expand to the intermediate state Figure 10 , and then each cutting catheter 22 is rotated in turn to make all the cutting structures 221 fully expand and combine to form a ring-shaped knife edge Figure 11 ;

[0112] Continuing to refer to Figure 16 , after combining to form a ring-shaped knife edge, the central catheter 21 and the puncture guide wire 11 are pulled to prop up and tighten the target tissue towards the right atrium, and at this time, the coiled structure of the puncture guide wire 11 pulls the target tissue that needs to be cut;

[0113] Afterwards, as shown in Figure 17 , the whole stoma device is pushed to make the distal end of the center catheter 21 abut against the target tissue to be cut, and the target tissue is preferably stretched by the center catheter 21 for puncture; Figure 18 ;

[0114] After the stoma 20 is formed, the center catheter 21 and the puncture guide wire 11 are pulled to pull the cut target tissue into the inner cavity of the cutting catheter 22, and then each cutting catheter 22 is rotated in turn to return to the intermediate state;

[0115] Then, as shown in Figure 18 , all cutting catheters 22, center catheter 21 and puncture guide wire 11 are withdrawn into the outer sleeve 23, and finally the whole stoma device is withdrawn to complete the stoma operation.

[0116] In another application scenario, the stoma on the atrial wall is taken as an example, and for a single cutting catheter 22, the cutting of the atrial wall can be completed by the following steps:

[0117] First, the guide wire 10 is passed through the center catheter 21 to guide the cutting member 2 to the target organ position and find the target tissue on the atrial wall to be cut;

[0118] Then, the guide wire 10 is withdrawn, and the puncture guide wire 11 is loaded into the center catheter 21 through the introduction sheath 12 and the introduction port 211;

[0119] After the puncture guide wire 11 is inserted into the cutting member 2, the whole stoma device is pushed to make the distal end of the center catheter 21 abut against the target tissue to be cut, and the target tissue is preferably stretched by the center catheter 21 for puncture, and then the puncture guide wire 11 is pushed to pass through the target object at the target tissue and form a coiled shape on the opposite side of the target object, and the puncture and coiling state of the puncture guide wire 11 can be confirmed by fluoroscopy;

[0120] Then, the outer sleeve 23 is withdrawn to release the cutting structure 221 of the cutting catheter 22, and the cutting structure 221 expands to an expanded state and forms a ring-shaped blade;

[0121] After the ring-shaped blade is formed, the center catheter 21 and the puncture guide wire 11 are pulled to stretch the target tissue in the right atrium direction, and at this time, the coiled structure of the puncture guide wire 11 pulls the target tissue to be cut;

[0122] Then, the cutting catheter 22 is pushed to complete the cutting and form a stoma 20 on the target tissue;

[0123] After the stoma 20 is formed, the central catheter 21 and the puncture guide wire 11 are pulled again, and the cut tissue is pulled into the inner cavity of the cutting catheter 22;

[0124] Then, the cutting catheter 22, the central catheter 21 and the puncture guide wire 11 are withdrawn into the outer sleeve 23 as a whole, and finally, the stoma device is withdrawn as a whole, and the stoma operation is completed.

[0125] In other application scenarios, the atrial wall stoma is taken as an example, and the central catheter 21 is replaced as a whole to complete the cutting of the atrial wall for the single cutting catheter 22, and the specific process is as follows:

[0126] First, the guide wire 10 is passed through the central catheter 21 to guide the cutting member 2 to the target organ position and find the target tissue to be cut on the atrial wall;

[0127] Then, the guide wire 10 and the central catheter 21 are withdrawn as a whole, and the entire puncture member 1 is inserted into the cutting member 2 from which the central catheter 21 is removed;

[0128] After the puncture guide wire 11 is inserted into the cutting member 2, the stoma device is pushed as a whole, and the distal end of the introduction sheath 12 is pressed against the target tissue to be cut, preferably, the introduction sheath 12 supports and tightens the target tissue to facilitate puncture, and then the puncture guide wire 11 is pushed to pass through the target object at the target tissue and form a coiled shape on the opposite side of the target object, and then the puncture and coiled state of the puncture guide wire 11 can be confirmed by fluoroscopy;

[0129] Then, the outer sleeve 23 is withdrawn, the cutting structure 221 of the cutting catheter 22 is released, the cutting structure 221 is automatically expanded to an expanded state, and a ring-shaped cutting edge is formed;

[0130] After the ring-shaped cutting edge is formed, the introduction sheath 12 and the puncture guide wire 11 are pulled to support and tighten the target cutting tissue in the right atrium direction, and at this time, the coiled structure of the puncture guide wire 11 pulls the target tissue to be cut;

[0131] Then, the cutting catheter 22 is pushed to complete the cutting and form a stoma 20 on the target tissue;

[0132] After the stoma 20 is formed, the central catheter 21 and the puncture guide wire 11 are pulled again, and the cut tissue is pulled into the inner cavity of the cutting catheter 22;

[0133] Then, the cutting catheter 22, the central catheter 21 and the puncture guide wire 11 are withdrawn into the outer sleeve 23 as a whole, and finally, the stoma device is withdrawn as a whole, and the stoma operation is completed.

[0134] Compared with the prior art, the stoma device provided by the present application has at least the following beneficial effects:

[0135] (1) The stomal appliance integrates a puncture function, which can reduce the use of surgical consumables, simplify the surgical procedure, and reduce the surgical manpower, time, and other resource inputs.

[0136] (2) The stomal appliance integrates the puncture function and the pulling function, that is, the puncture guide wire is automatically coiled into a pulling member after completing puncture. Such a design not only helps to reduce the intervention size, but also reduces the size of the transseptal puncture, that is, the damage to the pulled tissue is lower, and the pulling success rate is improved.

[0137] (3) The pulling member has good compliance and can be attached to the target tissue to prevent the cut tissue from falling off;

[0138] (4) Since the pulling member can be attached to the target tissue and can be visualized, the shape and position of the tissue block can be indirectly evaluated through the visualized shape and position of the pulling member, the monitoring ability of the tissue block during the operation is enhanced, and the safety of the operation is further improved.

[0139] (5) The conventional self-expanding structure will greatly reduce the axial strength and cutting ability to the tissue after being expanded to a certain extent, which may cause a safety risk of tissue tearing. However, the folding and expansion of the cutting structure can overcome the defects of the conventional self-expanding structure, ensure the axial strength and cutting ability to the tissue, and reduce the risk of tissue tearing and increase the safety of the operation.

[0140] It should be further noted that the common 14F-18F stomal appliance is prone to puncture site hematomas and other vascular complications after being inserted into the human body, and in critical cases, it may even affect the patient's life. According to the technical scheme provided by the present application, the stomal appliance can be made to be 10F or even thinner, which greatly reduces the vascular complications at the puncture site. Therefore, under the optimization of such a small size, the stomal appliance provided by the present application can still integrate the puncture function and simplify the surgical operation.

[0141] In general, the present application can solve the problem of the traditional cutting-type stomal appliance that the cut tissue is prone to falling off, which causes a major safety risk, and can also solve the problem of the common stomal appliance that the intervention size is too large. On the one hand, for a specific stomal size, the intervention size can be reduced to optimize the prognosis of the patient, on the other hand, for a specific intervention size, the stomal size can be increased to meet more stringent clinical requirements, and on the other hand, the surgical operation process is simplified, and the risk of cutting tissue falling off is reduced.

[0142] The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application in any way. Any modification or modification made by a person skilled in the art based on the above disclosure is within the protection scope of the technical scheme of the present application.

Claims

1. An ostomy appliance characterized in that, The application relates to a puncture device and a cutting device, and belongs to the technical field of medical devices. The puncture device comprises a puncture guide wire and an introduction sheath, the puncture guide wire comprises a predetermined structure at a distal end, the predetermined structure comprises a puncture needle, the puncture guide wire has a constrained state and an expanded state in which the predetermined structure is released from the constraint, the predetermined structure is composed of a linear body which is wound around the puncture needle in an interlaced arrangement, the predetermined structure further comprises a radiographic enhancement segment, in the expanded state, the puncture needle is bent towards the central axis of the radiographic enhancement segment in a coiled manner, so that the puncture needle can avoid the target object during the transition of the predetermined structure from the constrained state to the expanded state, the predetermined structure has a size which is not larger than the size of a target stoma, and a protrusion is arranged on the predetermined structure. The cutting device comprises an outer sleeve, a central catheter and a cutting catheter, the cutting catheter is movably inserted into the outer sleeve, the cutting catheter comprises a cutting structure at a distal end, the cutting structure can cut a target tissue on the target object after extending out of the distal end of the outer sleeve, either the introduction sheath or the central catheter is movably inserted into the cutting catheter, so that a stoma position on the target object is positioned by the part of the introduction sheath or the central catheter which extends out of the distal end of the outer sleeve. The puncture guide wire is movably inserted into the central catheter or the introduction sheath, the predetermined structure can extend out of the distal end of the cutting device, so that the target object is punctured by the puncture needle, and the predetermined structure can be released from the constraint to pull the target tissue after the puncture.

2. An ostomy appliance according to claim 1, characterised in that, The linear body is wound around the puncture needle in an interlaced arrangement to form a multi-layer conical spiral, the puncture needle is bent around the central axis of the multi-layer conical spiral at the top of the conical spiral, or the linear body is wound around the puncture needle in an interlaced arrangement to form a petal structure or a star structure, the puncture needle is bent around the central axis of the structure at the center of the petal structure or the star structure.

3. The ostomy appliance of claim 1, wherein, The puncture guide wire further comprises a proximal support segment and a distal soft segment, the distal soft segment is connected with the predetermined structure at a distal end, the proximal end of the distal soft segment is connected with the proximal support segment, and the distal soft segment is softer than the proximal support segment.

4. The ostomy appliance of claim 1, wherein, When the introduction sheath is movably inserted into the cutting catheter, the puncture guide wire is movably inserted into the introduction sheath, or when the central catheter is movably inserted into the cutting catheter, a proximal end of the central catheter is provided with an introduction port which is used for being connected with a distal end of the introduction sheath, and the puncture guide wire is used for being inserted into the central catheter through the introduction sheath and the introduction port.

5. The ostomy appliance of claim 4, wherein, The outer diameter of the distal end of the introduction sheath is smaller than the outer diameter of the proximal end, and the inner diameter of the introduction sheath matches the outer diameter of the puncture guide wire.

6. The ostomy appliance of claim 4, wherein, When the introducing sheath is inserted into the cutting catheter, the distal end of the introducing sheath extends 1mm-10mm beyond the distal end of the outer sleeve, so as to position the stoma site through the part of the introducing sheath extending beyond the distal end of the outer sleeve; when the central catheter is inserted into the cutting catheter, the distal end of the central catheter extends 1mm-10mm beyond the distal end of the outer sleeve, so as to position the stoma site through the part of the central catheter extending beyond the distal end of the outer sleeve.

7. The ostomy appliance of claim 1, wherein, The cutting catheter is integrally formed from a raw tube material, and the outer diameter of the raw tube material is less than or equal to the diameter of the target stoma. The cutting catheter further comprises a tube body with a hollow structure, and the distal end of the tube body is connected with the cutting structure, and the cutting structure comprises a plurality of blades arranged along the circumference of the tube body. The cutting structure has a folded state when being constrained in the outer sleeve and an expanded state after extending beyond the distal end of the outer sleeve. In the folded state, the diameter of the cutting structure is less than the diameter of the target stoma, and all the blades have overlapping parts in the circumferential direction. In the expanded state, the diameter of the cutting structure is equal to the diameter of the target stoma, and all the blades are distributed on the same circumference and jointly enclose a complete annular cutting edge.

8. An ostomy appliance according to claim 7, characterised in that, The number of the cutting catheters is one, and the outer diameter of the raw tube material for preparing the one cutting catheter is equal to the diameter of the target stoma.

9. The ostomy appliance of claim 7, wherein, The number of the cutting catheters is multiple, and each cutting catheter is integrally formed from a raw tube material, and the outer diameter of each raw tube material is less than the diameter of the target stoma, and the sum of the outer diameters of all the cutting catheters is equal to the diameter of the target stoma.

10. An ostomy appliance according to claim 9, characterised in that, The cutting structure of each cutting catheter has a folded state when being constrained in the outer sleeve and an expanded state after extending beyond the distal end of the outer sleeve. In the folded state, the diameter of the cutting structure of each cutting catheter is less than the diameter of the target stoma, and the blades of each cutting structure are distributed on different circumferences, and the blades distributed on each circumference have overlapping parts in the circumferential direction. In the expanded state, the diameter of the cutting structure of each cutting catheter is equal to the diameter of the target stoma, and the blades of all the cutting structures are distributed on the same circumference and jointly enclose a complete annular cutting edge.

11. An ostomy appliance according to claim 9, characterised in that, The outer diameters of all the cutting catheters are the same.

12. The ostomy appliance of claim 7, wherein, At least part of the blades have a thickness gradually increasing from one end to the other end along the circumference of the tube body, or at least part of the blades have a thickness gradually increasing from both ends to the middle part along the circumference of the tube body.

13. The ostomy appliance of claim 7, wherein, The inner diameter of the outer sleeve is less than or equal to the diameter of the target stoma, and the angle of each blade deviating from the circumference of the target stoma is -10°-+10°, and in the expanded state, the sum of the arc lengths of all the blades is equal to the circumference length of the circumference of the target stoma.

Images