Ostomy device and bipolar ostomy system

Abstract

The application discloses a stoma device and a bipolar stoma system. The stoma device comprises a puncture assembly, a first electrode, a second electrode and a sheath assembly. The puncture assembly comprises a mandrel and a puncture part arranged at the distal end of the mandrel. The first electrode is arranged around the mandrel and at the proximal end of the puncture part. The sheath assembly is arranged around the puncture assembly, and the second electrode is arranged at the distal end of the sheath assembly. The first electrode can move axially along the mandrel relative to the second electrode. The stoma device provided by the application can make the damage on both sides of the tissue relatively uniform, is less likely to heal and can avoid stoma failure. Meanwhile, the stoma device can avoid the heat damage caused by the negative plate in the monopolar stoma system.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to an ostomy device and a bipolar ostomy system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Heart failure (HF) is a complex clinical syndrome caused by various factors leading to abnormal changes in the structure and / or function of the heart, resulting in impaired ventricular systolic and / or diastolic function. The main manifestations include dyspnea, fatigue, and fluid retention (pulmonary congestion, systemic congestion, and peripheral edema). Based on left ventricular ejection fraction (LVEF), it is classified into heart failure with reduced ejection fraction, heart failure with preserved ejection fraction, and heart failure with intermediate ejection fraction. Based on the timing and rate of onset, it is classified into chronic heart failure and acute heart failure. Most patients with acute heart failure experience partial symptom relief after hospitalization but progress to chronic heart failure; patients with chronic heart failure often require hospitalization due to acute exacerbations caused by various triggers.

[0004] my country's aging population is intensifying, leading to a rise in the incidence of chronic diseases such as coronary heart disease, hypertension, diabetes, and obesity. While improved medical care has extended the survival time of heart disease patients, the prevalence of heart failure in my country continues to increase. A survey of 10,714 hospitalized heart failure patients in China showed that the in-hospital mortality rates for heart failure patients in 1980, 1990, and 2000 were 15.4%, 12.3%, and 6.2%, respectively. The leading causes of death were left ventricular failure (59%), arrhythmia (13%), and sudden cardiac death (13%). The China HF study showed a mortality rate of 4.1% for hospitalized heart failure patients.

[0005] The clinical feature of HFpEF (heart failure with preserved ejection fraction) is exertional dyspnea. Several mechanisms can contribute to decreased exercise tolerance in HFpEF patients. Left ventricular relaxation impairment and increased stiffness in HFpEF patients prevent the increase of left ventricular volume at end-diastole during exercise, leading to elevated pulmonary capillary wedge pressure (PCWP) and left atrial pressure (LAP), resulting in increased pulmonary congestion and a poor prognosis.

[0006] To date, no drugs or devices can significantly reduce mortality or hospitalization risk in patients with heart failure with paroxysmal pulmonary embolism (HFpEF). Clinically, creating an artificial defect (ostomy) at the atrial septum can establish a shunt between the left and right atria, allowing blood to flow from the left atrium to the right atrium, thereby reducing left atrial pressure. After the left atrial pressure decreases, pulmonary artery pressure and pulmonary capillary wedge pressure also decrease, thus alleviating symptoms such as dyspnea and fatigue in patients.

[0007] The aforementioned stomas are generally formed at the atrial septum using atrial shunt devices, radiofrequency ablation stomas, or radiofrequency cutting stomas. Atrial shunt devices are typically implanted into the atrial septum using minimally invasive surgery to create a shunt opening. Radiofrequency ablation stomas are created by slowly eroding the required aperture at the atrial septum using radiofrequency electrodes. Currently, radiofrequency ablation or cutting stomas primarily utilize expandable stents as carriers for the ablation electrodes. These are generally monopolar stoma devices, requiring a negative electrode plate to be attached to another part of the patient's body as a return electrode to form a radiofrequency circuit. Poor attachment of the negative electrode plate can cause thermal damage, and the high impedance, significant energy loss, and low energy utilization result in the need for substantial cutting or ablation energy at the stoma site. Excessive energy at the stoma site can easily lead to cardiac dysfunction. Summary of the Invention

[0008] Based on this, the present invention proposes a stoma device that can be used in a bipolar stoma system, which at least solves the technical problem that when a monopolar stoma system is cut, excessive damage is caused to one side of the tissue while insufficient damage is caused to the other side, making the stoma easy to heal and thus causing stoma failure. At the same time, it can avoid thermal damage that may be caused by the negative electrode plate in the monopolar stoma system.

[0009] To achieve this objective, the present invention adopts the following technical solution: The stoma device of the present invention includes: a puncture assembly, a first electrode, a second electrode, and a sheath assembly. The puncture assembly includes a mandrel and a puncture portion disposed at the distal end of the mandrel. The first electrode surrounds the mandrel and is located at the proximal end of the puncture portion. The sheath assembly is disposed around the puncture assembly, and the second electrode is disposed at the distal end of the sheath assembly. The first electrode can move axially relative to the second electrode along the mandrel.

[0010] In one embodiment, the distal end of the sheath assembly is provided with a receiving tube section, the distal opening diameter of the receiving tube section is adjustable, and the distal end of the second electrode is disposed at the distal end of the receiving tube section.

[0011] In one embodiment, the stoma device further includes a traction member, the distal end of which is connected to the distal end of the second electrode.

[0012] In one embodiment, the hardness of the receiving tube segment gradually increases from the distal end to the proximal end.

[0013] In one embodiment, the second electrode includes a plurality of fixing plates circumferentially disposed on the inner wall of the receiving tube segment; the sheath assembly further includes a catheter segment, a first perforation, and a second perforation, the first perforation being disposed at the distal end of the receiving tube segment and penetrating the side wall of the receiving tube segment, the second perforation being located at the distal end of the catheter segment, and the receiving tube segment being disposed at the distal end of the catheter segment; the catheter segment includes a first channel extending axially from the perforation towards the proximal end of the catheter segment; the stoma device further includes a traction member, the distal end of which is connected to the distal end of the fixing plates and passes through the first perforation to penetrate the distal side wall of the receiving tube segment, and extends axially along the receiving tube segment towards the proximal end, such that a portion of the traction member is located on the outside of the receiving tube segment, extending to the distal end of the catheter segment and penetrating the first channel through the second perforation; the stoma device further includes a handle assembly, the proximal end of which extends axially out of the catheter segment and connects to the handle assembly.

[0014] In one embodiment, the stoma device includes a cutting assembly, which includes a first support mechanism, a first cutting portion, and a second support mechanism. The distal end of the first support mechanism is connected to the proximal end of the puncture portion, and the first cutting portion is connected between the first support mechanism and the second support mechanism, such that the first support mechanism and the second support mechanism cooperate to fold and retract the first cutting portion onto the mandrel, or the first support mechanism and the second support mechanism cooperate to open the first cutting portion.

[0015] In one embodiment, the first tube segment is elastic in the vertical axial direction so that the distal opening diameter of the receiving tube segment is adjustable.

[0016] In one embodiment, the stoma device further includes a handle assembly comprising a first control member, a second control member, a third control member, and a handle housing. The first, second, and third control members are respectively disposed on the handle housing and are slidable along the axial direction of the handle housing. The stoma device further includes a traction member, the distal end of which is connected to the distal end of the receiving tube segment. The first control member is fixedly connected to the proximal end of the mandrel, the second control member is fixedly connected to the proximal end of the first sleeve, and the third control member is fixedly connected to the proximal end of the traction member. The third control member slides axially to pull or release the distal end of the receiving tube segment, thereby increasing or decreasing the diameter of the distal opening of the receiving tube segment.

[0017] In one embodiment, the stoma device further includes a first sleeve, the distal end of which is connected to the proximal end of the second support structure. The first sleeve is arranged around the mandrel, and the mandrel can move axially relative to the first sleeve to drive the distal end of the first support mechanism to move closer to or further away from the proximal end of the second support mechanism, thereby supporting the first cutting portion to expand away from the mandrel or retract closer to the mandrel.

[0018] In one embodiment, the receiving tube segment includes an adjacent first tube segment, a second tube segment, and a third tube segment, wherein the second tube segment is disposed near the end of the first tube segment, the third tube segment is disposed on the side of the second tube segment away from the first tube segment, the hardness of the second tube segment is greater than the hardness of the first tube segment, and the hardness of the third tube segment is greater than the hardness of the second tube segment.

[0019] In a second aspect, the present invention provides a bipolar stoma system, the bipolar stoma system comprising a radiofrequency ablation device and a stoma apparatus as described above, wherein the puncture assembly is electrically connected to the radiofrequency ablation device, and the first electrode and the second electrode are respectively electrically connected to the radiofrequency ablation device.

[0020] The stoma device provided by the present invention can make the damage on both sides of the tissue relatively uniform, making it less likely to heal and avoiding stoma failure; at the same time, it can avoid thermal damage that may be caused by the negative electrode plate in the monopolar stoma system. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the ostomy device provided in Embodiment 1 of the present invention;

[0022] Figure 2 for Figure 1 A sectional view;

[0023] Figure 2a for Figure 2 Enlarged view of point A in the middle;

[0024] Figure 3 for Figure 1 Exploded view;

[0025] Figure 4a for Figure 3 Enlarged view of point B in the middle;

[0026] Figure 4b This is a diagram showing the unfolded state of the cutting component provided in Embodiment 1 of the present invention;

[0027] Figure 5 This is a schematic diagram of the structure of the ostomy device sheath assembly provided in Embodiment 1 of the present invention;

[0028] Figure 6 for Figure 5Enlarged view of point C in the middle;

[0029] Figure 7 Adjustments accordingly Figure 6 A schematic diagram showing the distal opening of the middle containment tube section, which makes it funnel-shaped.

[0030] Figure 8 This is a diagram showing the state of the sheath assembly of the ostomy device provided in Embodiment 1 of the present invention being delivered to the right atrium side of the interatrial septum;

[0031] Figure 9 The stoma device provided in Embodiment 1 of the present invention and Figure 8 The state diagram of the handle component corresponding to the state in the diagram;

[0032] Figure 10 This is a diagram showing the state of the stoma device provided in Embodiment 1 of the present invention with the opening of the receiving tube segment expanded (diameter enlarged) and attached to the follicle of the oval.

[0033] Figure 11 The stoma device provided in Embodiment 1 of the present invention and Figure 10 The state diagram of the handle component corresponding to the state in the diagram;

[0034] Figure 12 This is a diagram showing the state of the puncture component of the stoma device provided in Embodiment 1 of the present invention puncturing the tissue at the fossa ovalis from one side of the interatrial septum (right atrium side) and bringing the cutting component to the other side of the interatrial septum (left atrium side);

[0035] Figure 13 The stoma device provided in Embodiment 1 of the present invention and Figure 12 The state diagram of the handle component corresponding to the state in the diagram;

[0036] Figure 14 This is a diagram showing the first cutting section of the stoma device provided in Embodiment 1 of the present invention unfolded on the other side of the interatrial septum (left atrium side);

[0037] Figure 15 The stoma device provided in Embodiment 1 of the present invention and Figure 14 The state diagram of the handle component corresponding to the state in the diagram;

[0038] Figure 16 This is a diagram showing the state of the stoma device provided in Embodiment 1 of the present invention cutting and creating a stoma at the fossa of the ovum;

[0039] Figure 17 The stoma device provided in Embodiment 1 of the present invention and Figure 16 The state diagram of the handle component corresponding to the state in the diagram;

[0040] Figure 18This is a diagram showing tissue damage caused by the stoma device of the present invention when the stoma is cut using a monopolar cutting system.

[0041] Figure 19 This is a diagram showing the tissue damage caused by the stoma device of the present invention when the stoma is cut using a bipolar cutting system.

[0042] Figure 20 A schematic diagram of the stoma device provided by the present invention applied to a unipolar stoma system;

[0043] Figure 21 A schematic diagram of the stoma device provided by the present invention applied to a bipolar stoma system;

[0044] Figure 22 This is a schematic diagram of the structure of the stoma device containing the tube segment and the conduit segment provided in Embodiment 2 of the present invention (the tube segment is flared and funnel-shaped in its natural state);

[0045] Figure 23 for Figure 23 Enlarged view of point D in the middle;

[0046] Figure 24 This is a schematic diagram of the structure of the stoma device containing the tube segment and the conduit segment provided in Embodiment 2 of the present invention; (the tube segment is in a non-flaring state under the traction of the traction member);

[0047] Figure 25 for Figure 24 Enlarged view at point E in the middle;

[0048] Figures 26a-26e The diagrams show the relative positions of the control components of the handle assembly in different states during surgery, as shown in Example 1.

[0049] The attached figures are labeled as follows:

[0050] 100. Stoma device,

[0051] 110. Puncture assembly; 111. Mandrel; 112. Puncture section;

[0052] 120. Cutting assembly; 121. Cutting electrode; 122. First cutting part; 123. First support mechanism; 1231. First connector; 1232. First connecting rod; 124. Second support mechanism; 1241. Second connector; 1242. Second connecting rod.

[0053] 130. Sheath assembly, catheter 1301; 131. Receiving tube segment; 132. First tube segment; 1321. First perforation; 133. Second tube segment; 134. Third tube segment; 135. Catheter segment; 1351. Second perforation; 136. Fixation plate; 137. Support structure;

[0054] 140. First cannula; 150. Traction element; 160. Oval fossa tissue; 161. Tissue damage area;

[0055] 200. Handle assembly; 210. First control element; 220. Second control element; 230. Third control element; 240. Handle housing Detailed Implementation

[0056] To make the objectives, technical solutions, and advantages of this invention clearer, exemplary embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this disclosure and to fully convey the scope of this disclosure to those skilled in the art.

[0057] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0058] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0059] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0060] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery system that delivers the medical device, closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device or delivery system are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0061] Example 1

[0062] Example 1 provides a stoma device 100, such as Figure 1-21 As shown, the stoma device is used to cut and create an opening in human tissue. The following description of the stoma device when creating an opening in tissue takes the example of an atrial septal stoma. The stoma device 100 includes a puncture assembly 110, a cutting assembly 120, and a sheath assembly 130.

[0063] like Figure 1-3 As shown, the puncture assembly 110 includes a mandrel 111 and a puncture part 112. The puncture part 112 is disposed at the distal end of the mandrel 111 and is used to puncture the interatrial septum tissue. The puncture part 112 serves as a puncture electrode and can be made of conductive metals such as stainless steel or Ni-TI alloy.

[0064] In addition, a low-resistance conductive coating and an insulating coating (not shown in the figure) can be sequentially coated on the outer surface of the mandrel 111. That is, the low-resistance conductive coating is coated on the mandrel 111, and the insulating coating is coated on the outer surface of the low-resistance conductive coating. The low-resistance conductive coating can be coated with conductive silver paste, conductive resin, silver-plated or gold-plated layers, or copper foil covering. The thickness of the low-resistance conductive coating is controlled at 0.05-0.2 mm to improve the conductivity of the mandrel 111 connected to the puncture part (as the puncture electrode). The insulating coating can be made of polymer materials such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), pyrene, nylon, and polyimide (PI) to provide insulation and self-lubrication and protect the conductive coating.

[0065] The cutting component 120 is disposed on the proximal side of the puncture section 112 and is arranged around the mandrel 111. When the puncture section 112 punctures the tissue, the cutting component 120 disposed on the proximal side of the puncture section 112 can pass through from one side of the interatrial septum tissue to the other side of the septum tissue together with the puncture section 112, so that the cutting component 120 can cut the septum tissue from the distal end to the proximal end. The sheath assembly 130 is arranged around the puncture component 110 and the cutting component 120, and the distal end of the sheath assembly 130 is provided with a receiving tube section 131, the distal opening diameter of which is adjustable.

[0066] Combination Figures 4a-4b The cutting assembly 120 includes a first cutting section 122, a first support mechanism 123, and a second support mechanism 124. The first cutting section 122 is connected between the first support mechanism 123 and the second support mechanism 124. The distal end of the first support mechanism 123 is connected to the proximal end of the puncture section 112. The proximal end of the first support mechanism 123 is connected to the first cutting section 122, and the distal end of the second support mechanism 124 is connected to the first cutting section 122. This allows the first support mechanism 123 and the second support mechanism 124 to cooperate in folding and retracting the first cutting section 122 onto the mandrel 111, or the first support mechanism 123 and the second support mechanism 124 to cooperate in opening the first cutting section 122. The degree of unfolding (or retraction) of the cutting assembly 120 forms an annular structure suitable for the required stoma size.

[0067] The cutting assembly 120 serves as a cutting electrode to cut and create an opening in the tissue. The cutting electrode 121 is electrically connected to the radiofrequency ablation device. According to the cutting assembly 120 provided by this invention, the main cutting part of the cutting electrode 121 is the first cutting section 122. Since the first cutting section 122 needs to be electrically connected to the radiofrequency ablation device, the first cutting section 122, as the main cutting part, can be connected to the mandrel 111 through its distal first support mechanism 123 and puncture section 112, thereby electrically connecting to the radiofrequency ablation device through the mandrel 111. In this case, the cutting electrode includes the first cutting section 122 and the first support mechanism 123. The first connecting rod 1232 in the first support mechanism 123 can be cut together with the first cutting section. The first cutting part 122 can also be electrically connected to the radiofrequency ablation device through its proximal second support mechanism 124 and first sleeve 140. In this case, the cutting electrode includes the first cutting part 122 and the second support mechanism 124. When it is electrically connected to the radiofrequency ablation device through the distal puncture part 112 and the mandrel 111, the cutting electrode 121 can also include the first cutting part 122, the first support mechanism 123, and the second support mechanism 124 as a whole cutting assembly. In this embodiment, the cutting electrode 121 is taken as an example as including the entire cutting assembly 120 including the first cutting part 122, the first support mechanism 123, and the second support mechanism 124, and the cutting electrode is electrically connected to the radiofrequency ablation device through the puncture part 112 and the mandrel 111. There is no specific limitation on the cutting electrode 121, as long as it can achieve electrical connection with the radiofrequency ablation device.

[0068] The distal end of the first support mechanism 123 is connected to the puncture section 112. The first support mechanism 123 includes a first connector 1231 and a plurality of first connecting rods 1232. The first connecting rods 1232 are disposed at the proximal end of the first connector 1231. The first connector 1231 is fixed around the spindle 111 at the proximal end of the puncture section 112 and connected to the puncture section 112. The distal end of the first connecting rod 1232 is rotatably connected to the proximal end of the first connector 1231, and the plurality of first connecting rods 1232 are arranged circumferentially around the spindle 111 from the proximal end of the first connector 1231, so that the proximal end of the first connecting rod 1232 can be connected to the puncture section 112. The movable connection point of the first connector 1231 (the far end of the first connecting rod) serves as a fulcrum, away from the spindle 111; the proximal ends of the plurality of first connecting rods 1232 are respectively connected to the first cutting part 122, so that the first cutting part 122 can be gathered on the spindle 111 or unfolded relative to the spindle 111 as the proximal ends of the plurality of first connecting rods 1232 approach the spindle 111, and the projection of the first cutting part 122 in the plane perpendicular to the spindle 111 after unfolding is annular. When the first cutting part 122 is folded and gathered on the spindle 111, the entire first cutting part 122 can surround the spindle 111 circumferentially and be attached to the spindle 111 in a wave-like manner. In this embodiment, the first connecting rods 1232 are evenly arranged along the circumference of the mandrel. When the first connecting rods 1232 and the first cutting part 122 are gathered together on the mandrel, the gap between the multiple first connecting rods 1232 is such that the first cutting part 122 can be arranged in the circumferential space of the mandrel without increasing the radial dimension too much. That is, the number of the first connecting rods 1232 is not limited here, and two, three, four, etc. can be evenly arranged along the circumference.

[0069] Combination Figures 4a-4b The second support mechanism 124 includes a second connector 1241 and a plurality of second connecting rods 1242. The second connector 1241 is disposed at the proximal end of the second connecting rod 1242 and sleeved on the spindle 111, so that the second connector 1241 can move axially relative to the spindle 111. The proximal end of the second connecting rod 1242 is rotatably connected to the second connector 1241, and the distal end of the second connecting rod 1242 is connected to the first cutting part 122. The plurality of second connecting rods 1242 are arranged circumferentially along the spindle 111 so that the second support mechanism 124 cooperates with the first support mechanism 123 to support the first cutting part 122. The second connector 1241 and the plurality of second connecting rods 1242 can be folded and gathered in the spindle 111 to reduce the outer diameter of the second support mechanism 124.

[0070] The stoma device also includes a first sleeve 140, the distal end of which is connected to the proximal end of a second support mechanism 124. The first sleeve 140 is arranged around a mandrel 111, and the mandrel 111 can move axially relative to the first sleeve 140. Through the relative movement of the first sleeve 140 and the mandrel 111, the distal end of the first support mechanism 123 and the proximal end of the second support mechanism 124 are moved closer or further apart, thereby causing the first cutting part 122 to expand away from the mandrel 111 or retract closer to the mandrel 111. The second support mechanism 124 is connected to the distal end of the first sleeve 140 through the proximal end of its second connector 1241.

[0071] Since the first connecting member 1231 is fixed to the mandrel 111 at the proximal end of the puncture part 112, the distal ends of the plurality of first connecting rods 1232 are rotatably connected to the proximal end of the first connecting member 1231, and the proximal ends of the plurality of second connecting rods 1242 are rotatably connected to the second connecting member 1241, when the first cutting part 122 needs to be unfolded, the mandrel 111 is retracted axially to cause relative movement between the mandrel 111 and the first sleeve 140, and the puncture part 112 drives the first connecting member 1231 to approach the second connecting member 1241 (in other embodiments, the first connecting member 1231 can also be pushed axially towards the distal end). A sleeve 140 causes relative movement between the mandrel 111 and the first sleeve 140, pushing the second connector 1241 to move axially toward the distal end relative to the mandrel 111 and closer to the first connector 1231. At this time, the second connecting rod 1242 rotates relative to the second connector 1241 with its proximal end as the fulcrum, and the first connecting rod 1232 rotates relative to the first connector 1231 with its distal end as the fulcrum. This causes the distal end of the second connecting rod 1242 and the proximal end of the first connecting rod 1232 to drive the first cutting part together to move radially away from the mandrel 111, causing the first cutting part 122 to unfold radially. When the first cutting part 122 needs to be retracted to the mandrel 111, the mandrel 111 is pushed forward along the axial direction to make the mandrel 111 and the first sleeve 140 move relative to each other (or the first sleeve 140 is pulled back to make the first sleeve 140 move towards the proximal end relative to the mandrel 111, thereby driving the second connector 1241 to move towards the proximal end along the axial direction to move away from the first connector 1231), so that the second connector 1241 and the first connector 1231 move away from each other along the axial direction.

[0072] A first support mechanism 123 is located at the distal end of the first cutting section 122, and a second support mechanism 124 is located at the proximal end of the first cutting section 122, together supporting the folding and unfolding of the first cutting section 122. The proximal ends of the plurality of first connecting rods 1232 and the distal ends of the plurality of second connecting rods 1242, when unfolded radially, are all similar to cones. The first support mechanism 123 and the second support mechanism 124 cooperate to support the first cutting section 122 to unfold radially, and the radial dimension of the first cutting section 122 can be adjusted to achieve room partition openings of different sizes.

[0073] The cutting assembly 120 of the stoma device 100 of the present invention has a more stable support mechanism, and the radial dimension of the first cutting part 122 can be adjusted at will. The first connecting member 1231 of the first support mechanism 123 can be configured as a sleeve structure fixed to the mandrel 111, and the second connecting member 1241 of the second support mechanism 124 can also be configured as a sleeve structure sleeved on the mandrel 111 but not fixed relative to the mandrel 111. By moving the second connecting member 1241 and the first connecting member 1231 axially relative to the mandrel 111, the proximal ends of the multiple first connecting rods 1232 and the distal ends of the multiple second connecting rods 1242 can be closed and opened, and the radial expansion of the first cutting part 122 can be supported, thereby adjusting the outer diameter of the annular first cutting part 122. When the second connector 1241 moves axially toward the first connector 1231 relative to the mandrel 111, the proximal ends of the plurality of first connecting rods 1232 and the distal ends of the plurality of second connecting rods 1242 move radially away from the mandrel 111, so that the first cutting portion 122 is attached to the mandrel 111, thereby reducing the outer diameter of the first cutting portion 122; when the second connector 1241 moves axially away from the first connector 1231 relative to the mandrel 111, the proximal ends of the plurality of first connecting rods 1232 and the distal ends of the plurality of second connecting rods 1242 move radially away from the mandrel 111, thereby increasing the outer diameter of the first cutting portion 122. The plurality of first connecting rods 1232 and the plurality of second connecting rods 1242, when spread out, are all umbrella-shaped, such as... Figure 4b As shown.

[0074] The cutting component 120 can be inserted from the right atrium side of the fossa oval to the left atrium side of the fossa oval along with the puncture component 110, and cut the tissue from the distal end to the proximal end. The cutting component 120 can be folded and gathered into the mandrel 111, and can be unfolded relative to the mandrel 111 to form a first cutting part 122 suitable for cutting tissue. The projection of the first cutting part 122 in the plane perpendicular to the mandrel 111 is annular, thereby enabling the tissue to be stomatized.

[0075] The radial dimension of the first cutting section 122 is adjustable to meet different stoma size requirements. Since the projection of the first cutting section 122 onto a plane perpendicular to the mandrel 111 is annular, the annular first cutting section 122 performs a complete cut along the outer edge of the tissue, thus completing the stoma. Therefore, the annular cutting component formed by the stoma device 100 of the present invention acts as a cutting electrode to cut tissue, resulting in higher stoma efficiency and shorter surgical time compared to the dispersed ablation stoma of the prior art. Therefore, the cutting component 120 of the stoma device 100 of the present invention, through the cooperation of a first support mechanism 123 and a second support mechanism 124, supports the radial expansion of the first cutting section 122, making the outer diameter of the first cutting section 122 adjustable. Furthermore, the projection of the first cutting section 122 onto a plane perpendicular to the mandrel 111 is annular, and the annular first cutting section 122 achieves complete tissue cutting.

[0076] The cutting assembly 120 can also have a membrane layer (not shown in the figure) between adjacent first connecting rods 1232 and their corresponding first cutting portions. The number of insulating membrane layers can be set according to the number of arc-shaped grids formed by circumferential division of the first connecting rods 1232 and the first cutting portions 122. The membrane layer can cover the corresponding arc-shaped grid and can unfold into an umbrella shape as the first cutting portions 122 unfold. During the entire cutting process of the cutting assembly 120 retracting to cut tissue, the membrane layer can form a closed space together with the receiving tube section 131 to help intercept the cut tissue and prevent the cut tissue from falling off. The membrane layer can be made of flexible polymer materials such as PTFE and silicone to form an insulating membrane layer. When the first connecting rod 1232 is part of the cutting electrode, setting the membrane layer as an insulating membrane layer can also prevent the cutting current density from decreasing and prevent cutting difficulties caused by increased cutting resistance.

[0077] like Figure 5-7 Combination Figure 1-3 As shown, the sheath assembly 130 includes a catheter 1301, which includes a receiving segment 131 and a catheter segment 135. Specifically, the sheath assembly 130 also includes the catheter segment 135, and the receiving segment 131 is disposed at the distal end of the catheter segment 135, thus positioning the receiving segment 131 at the distal end of the sheath assembly 130. The distal opening diameter of the receiving segment 131 is adjustable, forming an outwardly flared funnel shape at the distal end. This allows the receiving segment 131 to enclose the radially enlarged cutting component 120 as it cuts the interatrial septum tissue from distal to proximal, carrying the tissue towards the right atrium. This effectively contains the cut tissue, preventing it from escaping into the bloodstream and causing thrombosis.

[0078] Atrial septal puncture is generally performed by inserting the puncture from the right atrium toward the left atrium, combined with... Figure 3-4b , Figure 8 and Figure 12 After the puncture component 110 punctures the fossa ovalis at the interatrial septum from the right atrium, the cutting component 120 is extended along with the puncture component 110 to the left atrium side of the septum. The cutting component 120 is then extended to the desired stoma size on the left atrium side, and then retracted proximally so that the proximal end of the extended first cutting portion 122 adheres to the fossa ovalis for easy cutting. Figure 4b Combination Figure 14 and 16 As shown; at this time, the receiving tube segment 131 is expanded outward, and its distal end is attached to the tissue wall on the right atrium side. The cutting component 120 can cut the tissue proximally to create an opening. The tissue to be cut is located axially between the cutting component 120 and the receiving tube segment 131. As the cutting component 120 cuts the tissue proximally, it can be received together with the cut tissue in the receiving tube segment 131. Generally, the adjustable maximum inner diameter of the receiving tube segment 131 is greater than or equal to the maximum size of the required opening (the outer diameter of the first cutting part 122 when unfolded). This allows the cut tissue to be contained in the receiving tube segment 131 when the cutting component 120 cuts from the interatrial septum tissue along the left atrium side toward the right atrium side, further preventing tissue from falling out.

[0079] like Figure 5-7 As shown, the hardness of the receiving tube segment 131 gradually increases from the distal end to the proximal end. The receiving tube segment 131 includes adjacent first tube segment 132 and second tube segment 133. The second tube segment 133 is located at the proximal end of the first tube segment 132. The hardness of the second tube segment 133 is greater than that of the first tube segment 132, and the hardness increases sequentially from the distal end of the first tube segment 132 to the proximal end of the second tube segment 133. The inner diameter of the distal end of the first tube segment 132 is greater than the maximum outer diameter of the cutting assembly 120 after unfolding. Figure 3-4b The purpose of gradually increasing the hardness of the receiving tube segment 131 from the distal end to the proximal end is that when the distal end of the receiving tube segment is subjected to radial outward tension, the proximal end of the receiving tube segment can provide a certain support force for the fixing plate, and make the opening diameter of the distal end of the receiving tube segment 131 adjustable, making it easier to form a trumpet-shaped opening, which is beneficial for receiving the cut tissue and preventing the cut tissue from falling off.

[0080] The sheath assembly 130 may also be provided with fixing plates 136. Multiple fixing plates 136 are spaced apart circumferentially along the receiving tube section 131. Each fixing plate 136 is axially attached to the inner wall of the receiving tube section 131, with the distal end of the fixing plate 136 located at the distal end of the receiving tube section 131, provided that the distal end of each fixing plate 136 does not extend beyond the distal end of the receiving tube section 131. When the distal end of the fixing plate 136 is aligned with the opening of the distal end of the receiving tube section 131, and the distal end of the traction member 150 is connected to the distal end of the fixing plate 136, the traction member 150 exerts a greater outward expansion force on the distal end of the receiving tube section 131 with the help of the fixing plate 136, while the fixing plate 136 provides better axial support for the distal end of the receiving tube section 131.

[0081] The proximal ends of multiple retaining plates 136 extend to the proximal end of the receiving tube section 131 to support the axial direction of the receiving tube section 131, particularly the axial direction of the first tube section 132. Then, the distal end of the traction member 150 is fixed to the distal end of the retaining plate 136 so that the distal end of the retaining plate 136 is pulled by the traction member 150, causing the distal end of the retaining plate 136 to be tilted outward by a radially outward traction force. The function of the fixing plate 136 is twofold. First, in cooperation with the receiving tube segment 131, the fixing plate 136 is pulled to tilt outwards, thereby increasing the diameter of the opening at the distal end of the receiving tube segment 131. This supports the receiving tube segment 131 and prevents its axial deformation, especially preventing axial deformation of the distal part (first tube segment). Second, by making the fixing plate 136 a conductive material, a bipolar cutting stoma system can be formed with the cutting electrode 121. This creates a radio frequency circuit between the first electrode (cutting electrode 121), the tissue to be cut, and the second electrode (fixing plate 136), allowing bipolar radio frequency energy to be used to cut the tissue during stoma cutting.

[0082] Combination Figure 5-6 The stoma device 100 of the present invention further includes a third tube segment 134 in the receiving tube segment 131, wherein the third tube segment 134 is disposed on the side of the second tube segment 133 away from the first tube segment 132, the hardness of the third tube segment 134 is greater than the hardness of the second tube segment 133, and the hardness from the distal end of the first tube segment 132 to the proximal end of the third tube segment 134 increases sequentially, so that the hardness of the receiving tube segment 131 increases sequentially from the distal end to the proximal end.

[0083] The hardness of the receiving tube segment 131 gradually increases from the distal end to the proximal end, forming a gradient. The first tube segment 132, located at the distal end of the receiving tube segment, can be made of an elastic material to ensure elasticity in the vertical axial direction. For example, it can be made of 15-25d thermoplastic polyurethane elastomer (TPU), polyurethane (PU), silicone, etc., to meet the shape requirements after the distal end of the receiving tube segment is directly or indirectly stretched, so that the opening diameter of the distal end of the receiving tube segment is adjustable. The second tube segment 133 uses a 35-55D flexible material to provide a certain degree of deformation while providing a certain degree of support for the first tube segment. The third tube segment 134 uses a 55-72D material to provide good support for the fixing plate 136, so that the hardness of the receiving tube segment 131 composed of the first tube segment 132, the second tube segment 133, and the third tube segment 134 increases sequentially from the distal end to the proximal end. The third tube segment 134 has a higher hardness at its proximal end, which tends to provide support for the fixing plate 136, thus stably fixing the fixing plate 136 within the receiving tube segment 131. The fixing plate 136 is designed as a rigid plate. On the one hand, the traction force of the traction member acts directly on the distal end of the fixing plate 136, causing the distal end of the fixing plate to tilt outward and expand the distal end of the receiving tube segment outward. This prevents the axial traction force from acting directly on the distal end of the receiving tube segment, thus preventing axial compression of the receiving tube segment. In other words, the rigid fixing plate can support the receiving tube segment 131 and prevent the receiving tube segment 131 from being compressed axially.

[0084] The sheath assembly 130 also includes a first perforation 1321 and a second perforation 1351, combined with Figure 5-6The first perforation 1321 is located at the distal end of the receiving tube segment 131 and penetrates the side wall of the receiving tube segment 131. The second perforation 1351 is located on the proximal side of the third tube segment 134. Since the proximal end of the third tube segment 134 abuts against the distal end of the guide tube segment 135, the second perforation 1351 is located at the distal end of the guide tube segment 135. The number and position of the first perforation 1321 and the second perforation 1351 correspond one-to-one with the number and position of the fixing pieces. That is, multiple first perforations 1321 and multiple second perforations 1352 are provided, and the number corresponds to the number of fixing pieces. After the distal end of the traction member 150 is connected to the distal end of the fixing piece 136, it passes through the first perforation 1321 and thus penetrates the distal sidewall of the receiving tube section 131, and extends along the receiving tube section 131 towards the proximal end, so that part of the traction member 150 is located outside the receiving tube section 131, extending to the distal end of the conduit section 135, and passing through the second perforation 1351 into the first channel; the second perforation 1351 is used for the traction member 150 to pass through and extend into the conduit section 135, and the traction member 150 extends inside the conduit section 135 to the proximal end of the conduit section 135, so that the traction member 150 can provide traction force to the distal end of the receiving tube section 131, the distal end of the first tube section 132, or the distal end of the fixing piece 136 at the proximal end of the conduit section 135, thereby increasing the diameter of the distal opening of the receiving tube section 131 or the distal opening of the first tube section 132.

[0085] See Figures 1-3 In the stoma device 100 provided by the present invention, the sheath assembly 130 of the stoma device 100 is sleeved on the outside of the puncture assembly 110 and the cutting assembly 120. The proximal end of the puncture assembly 110, the proximal end of the cutting assembly 120 and the proximal end of the traction member 150 are respectively connected to the handle assembly 200 so that the puncture assembly 110 can puncture the tissue by operating the handle assembly 200. The cutting assembly 120 can be unfolded to cut the tissue from the distal end to the proximal end. The sheath assembly 130 can also be unfolded to adjust the distal diameter of the receiving tube section 131, so that the cutting assembly can cut the interatrial septum tissue from the distal end to the proximal end on the left atrium side. When the distal end of the receiving tube section 131 is in contact with the tissue wall on the right atrium side, the receiving tube section 131 can wrap the unfolded cutting assembly and the cut tissue to prevent the cut tissue from falling into the atrium.

[0086] An adjustable-opening receiving tube segment 131 is provided at the distal end of the sheath assembly 130. Before puncturing and cutting the tissue, the distal opening is adjusted to fit the size of the receiving and cutting assembly 120, and the distal opening of the receiving tube segment 131 is aligned with the tissue. After the tissue is cut, the cut tissue is received into the receiving tube segment 131. When the distal opening of the receiving tube segment 131 is restored to its normal diameter, the cut tissue in the receiving tube segment 131 is locked into the sheath, further preventing the cut tissue from escaping outward.

[0087] Combination Figure 5-7 The stoma device 100 also includes a traction member 150. The distal end of the traction member 150 can be directly connected to the distal end of the receiving tube segment 131. The distal end of the traction member 150 extends from the distal sidewall of the receiving tube segment 131 toward the proximal end to provide traction force to the distal end of the receiving tube segment. Alternatively, the distal end of the traction member 150 can be indirectly connected to the distal end of the receiving tube segment 131 through the fixing plate 136. The traction member 150 pulls the distal end of the fixing plate 136 outward, thereby causing the distal opening of the receiving tube segment 131 to expand outward.

[0088] When the fixing piece 136 is installed, multiple fixing pieces are spaced apart circumferentially on the inner wall of the receiving tube section 131. The distal end of the traction member 150 is connected to the distal end of the fixing piece 136 on the side near the receiving tube section 131. After the distal end of the traction member 150 is connected to the distal end of the fixing piece 136, it passes through the distal side wall of the receiving tube section 131 through the first through hole 1321 and extends from the distal end of the receiving tube section 131 along the axial direction of the receiving tube section 131 toward the proximal end, so that part of the traction member is located on the outside of the receiving tube section 131 and extends toward the proximal end to the second through hole 1351, and enters the first channel through the second through hole 1351. The distal sidewall of the receiving tube segment 131 is the same as the distal sidewall of the first tube segment 132. The distal end of the traction member 150 extends from the distal end of the first tube segment 132 outwards towards the proximal end of the receiving tube segment 131, and then passes through the second through-hole 1351 corresponding to the fixing piece 136 into the conduit segment 135. The traction member 150 provides traction force to the receiving tube segment 131, causing the distal opening of the first tube segment 132 to be subjected to an outward force, tilting the distal end outwards, thus causing the distal end of the receiving tube segment 131 to... The diameter of the tube increases and it becomes a trumpet shape; the distal end of the traction member 150 can also be connected to the distal end of the fixing plate 136 disposed on the inner wall of the receiving tube section 131. Under the traction force of the traction member 150, the fixing plate 136 is subjected to an outward force, and the fixing plate 136 causes the distal opening of the receiving tube section 131 or the distal opening of the first tube section 132 to expand outward, so that the diameter of the distal end of the receiving tube section 131 increases and becomes a trumpet shape; the traction member 150 can be made of metal and uses NI-TI or stainless steel traction wire.

[0089] In the stoma device 100 provided by the present invention, a receiving tube section 131 is provided at the distal end of the sheath assembly 130, and the distal opening of the receiving tube section 131 can be enlarged to facilitate the reception of cut tissue. By providing a traction member 150, the distal end of the traction member 150 is connected to the distal end of the receiving tube section 131 or the distal end of the fixing piece 136, and the proximal end extends to the proximal end of the catheter section 135. The proximal end of the traction member 150 passes through the catheter section 135 axially and is connected to the handle assembly 200. The traction member 150 can be pulled by the handle assembly 200 at the proximal end of the catheter section 135 to provide traction force to the distal end of the receiving tube section 131, so as to enlarge the distal opening of the receiving tube section 131.

[0090] Combination Figure 3 and Figure 4b The stoma device 100 also includes a first sleeve 140, which is arranged around the mandrel 111. The distal end of the first sleeve 140 is connected to the proximal end of the second support mechanism 124. The proximal ends of the second connector 1241 of the second support mechanism 124 can be fixed together by welding or other means. By operating the first sleeve 140, the first sleeve 140 can be moved axially relative to the mandrel 111. The second support mechanism 124 connected to the first sleeve 140 and the first support mechanism 123 cooperate to unfold or fold the cutting electrode 121.

[0091] Combination Figures 2a-3 The sheath assembly 130 has a support structure 137 inside the receiving tube section 131. The support structure 137 has a central cavity, which is suitable for the puncture assembly 110 and the cutting assembly 120 in the retracted state to pass through. The support structure 137 can be configured as a push rod with a central cavity, which can support the puncture assembly 110 and the cutting assembly 120. The distal end of the support structure 137 is inverted conical, and the outer diameter of the distal end of the support structure 137 gradually decreases from the proximal end to the distal end. The inverted conical portion of the distal end of the support structure 137 is located inside the receiving tube section 131, and there is a certain space between the inverted conical portion of the distal end of the support structure 137 and the tube body of the receiving tube section 131, so as not to restrict the deformation of the first tube section 132, the second tube section 133 and the third tube section 134. The proximal end of the support structure 137 can start from the distal end of the guide tube section 135 and extend towards the distal end. Since the outer diameter of the support structure 137 gradually decreases from the proximal end to the distal end, there is a gap between the support structure 137 and the receiving tube section 131, that is, the support structure 137 will not affect the deformation of the receiving tube section 131.

[0092] The conduit segment 135 also includes a first channel, which extends from the second perforation 1351 toward the proximal end along the axial direction of the conduit segment 135, and the second perforation 1351 communicates with the first channel. The first channel is provided so that the traction member 150 extends along the axial direction of the conduit segment 135, and a portion of the traction member 150 is disposed in the side wall of the conduit segment 135, which facilitates axial movement relative to the conduit segment 135, thereby realizing the traction of the distal end of the receiving tube segment 131.

[0093] Combination Figure 1-3 As shown, the stoma device 100 also includes a handle assembly 200, which includes a first control member 210, a second control member 220, a third control member 230, and a handle housing 240. The first control member 210, the second control member 220, and the third control member 230 are respectively disposed on the handle housing 240 and can slide along the axial direction of the handle housing 240. The handle housing 240 is provided with axial grooves corresponding to the positions of the first control member 210, the second control member 220, and the third control member 230, allowing each control member to slide axially.

[0094] The first control member 210 is fixedly connected to the proximal end of the mandrel 111 and is used to control the mandrel 111 to move axially. The second control member 220 is fixedly connected to the proximal end of the first sleeve 140 and is used to control the first sleeve 140 to move axially, thereby causing the first support mechanism 123 and the second support mechanism 124 to drive the first cutting part 122 to open (or close). The third control member 230 is fixedly connected to the proximal end of the traction member 150 and is used to control the traction member 150 to move axially, thereby applying a traction force to the distal end of the receiving tube section 131 or applying an outward expansion force to the distal end of the receiving tube section 131 through the traction fixing piece 136, so that the diameter of the distal end port of the receiving tube section 131 is adjustable.

[0095] The third control member 230 can slide axially to pull or release the distal end of the receiving tube segment, thereby increasing the diameter of the distal opening of the receiving tube segment or returning it to its original size. By operating the third control member 230 on the handle assembly 200 to slide axially along the handle assembly, the traction member 150 applies a traction force to the distal end of the receiving tube segment 131 or the distal end of the fixing piece 136, causing the distal end of the receiving tube segment 131 connected to the traction member 150 to expand outward, and the distal opening of the receiving tube segment 131 to increase and form a flared mouth. It can be understood that by adjusting the third control member 230 in the opposite direction and releasing the traction member 150, the receiving tube segment 131 will spring back to its original size.

[0096] The surgical procedure for the stoma device provided in Example 1 is exemplified by an atrial septal stoma. Figure 8-17 As shown:

[0097] First, such as Figure 8-9As shown, the sheath assembly 130 of the stoma device is delivered to the right atrium of the interatrial septum via interventional surgery, as... Figure 8 As shown, the state of the handle assembly 200 at this time is as follows: Figure 9 As shown;

[0098] Then, as Figure 10-11 As shown, relative to Figure 9 The handle assembly 200 pushes the third control component 230, which in turn drives the traction component 150 to pull the distal end of the receiving tube section 131, causing the distal opening of the receiving tube section 131 to open and expand into a trumpet shape. Figure 10 As shown, push the handle assembly 200 forward so that the distal end of the flared receiving tube segment 131 abuts against the fossa ovalis tissue. At this time, the handle assembly is in the following state: Figure 11 As shown;

[0099] like Figure 12-13 As shown, in Figure 11 Based on this, the first control member 210 is pushed forward. Since the distal puncture part 112 is fixed to the first connecting member 1231, pushing the first control member 210 forward will drive the puncture assembly 110 and the second control member 220 forward. The cutting assembly 120, along with the puncture part 112, punctures the tissue at the fossa ovalis from one side of the interatrial septum (right atrium side) and brings the cutting assembly to the other side of the interatrial septum (left atrium side), combined with... Figure 12 As shown.

[0100] like Figure 14-15 As shown, in Figure 13 Based on this, the first control member 210 is withdrawn, thereby driving the mandrel 111 to withdraw relative to the first sleeve 140, so that the puncture part 112 drives the first connecting member 1231 to approach the second connecting member 1241, so that the first connecting rod 1232 and the second connecting rod 1242 cooperate together to make the first cutting part 122 move away from the mandrel 111 and unfold into a ring.

[0101] like Figure 16-17 As shown, the first control member 210 and the second control member 220 are simultaneously retracted, so that the unfolded cutting electrode 121 (including the first cutting part 122, the first support mechanism 123 and the second support mechanism 124) is retracted axially to cut and create an opening in the atrial septum tissue, and the cut tissue is brought into the receiving tube segment on the right atrium side of the atrial septum that is attached to the atrial septum tissue and has a funnel-shaped opening at the distal end.

[0102] During the proximal movement of the first control element 210, an axial force (physical force) is provided to the cutting electrode 121 in the proximal direction. Compared to the ablation method in the prior art that utilizes the radial dimension of the stent to contract or expand and attaches an electrode to the stent, this provides an axial cutting force. Simultaneously, by utilizing radiofrequency energy and the axial force acting on the cutting electrode 121 in the proximal direction, a better cutting effect is achieved on the foramen ovale assembly. During radiofrequency cutting or radiofrequency ablation of the foramen ovale tissue, the cutting force applied to the cutting electrode is positively correlated with the cutting effect. Therefore, to achieve the same cutting effect, if the cutting electrode 121 can generate a larger cutting force, the required cutting energy is relatively smaller. When the required cutting effect can be achieved by outputting a smaller amount of radiofrequency energy to the foramen ovale tissue, cardiac dysfunction caused by excessive energy (exceeding 100W) can be largely prevented.

[0103] The stoma device 100 of the present invention can be applied to different tissue stoma systems, such as monopolar stoma systems or bipolar stoma systems. Figure 20 As shown, in the monopolar stoma system, the stoma system includes the stoma device 100 as described above and the radiofrequency ablation device 300. The radiofrequency ablation device 300 is electrically connected to the puncture assembly 110, and the radiofrequency ablation device 300 outputs radiofrequency energy to the puncture assembly 110. The stoma system can output radiofrequency energy to the puncture assembly 110 through the radiofrequency ablation device 300, and use monopolar radiofrequency energy to puncture the fossa ovalis tissue 160, puncturing from the right atrium to the left atrium. Using the stoma device 100 provided by the present invention, when puncturing the fossa ovalis tissue 160, radiofrequency energy can be omitted, and physical puncture can be performed directly using the puncture part 112 of the puncture assembly 110.

[0104] In the tissue stoma system provided in this embodiment, the inner wall of the receiving tube segment 131 is not provided with a fixing plate 136, and the distal end of the receiving tube segment 131 is directly connected to the distal end of the traction member. The distal end of the receiving tube segment 131 is pulled by the traction member, which increases the distal diameter of the receiving tube segment 131. Alternatively, a rigid fixing plate 136 can be provided on the inner wall of the receiving tube segment 131. The material of the fixing plate 136 can be a non-conductive material, such as a rigid polymer material. The fixing plate provides axial support for the receiving tube segment 131. In order to meet the requirement that the distal end of the receiving tube segment can be expanded, the first tube segment 132 is made of an elastic material. The rigid fixing plate can support the receiving tube segment 131 and prevent the receiving tube segment 131 from being compressed axially. In particular, the axial compression of the first tube segment 132 located at the distal end of the receiving tube segment 131 affects the effect of expanding the distal diameter of the receiving tube segment 131. The setting of the fixing plate 136 can prevent the situation where the distal diameter expansion effect is not good due to the axial compression of the receiving tube segment 131. In this invention, the radiofrequency ablation device 300 of the stoma device 100 is also electrically connected to the cutting component 120. The radiofrequency ablation device 300 outputs monopolar radiofrequency energy to the cutting component 120 in the stoma device for ablation. At this time, the radiofrequency power can be selected from 20W to 60W. The cutting component 120 ablates and cuts the tissue, and the cutting electrode and the negative electrode plate in the stoma device form a monopolar radiofrequency circuit, such as... Figure 20 As shown.

[0105] When applied to bipolar ostomy systems, such as Figure 21 As shown, the main difference between the bipolar ostomy system and its corresponding ostomy device and the monopolar ostomy system is that the bipolar ostomy system can be used for bipolar radiofrequency power, including a radiofrequency ablation device 300 and a conductive fixing plate. The fixing plate 136 is disposed in the receiving tube section 131. The fixing plate 136 is a rigid fixing plate and is made of a conductive material, such as stainless steel, Ni-TI alloy, etc.

[0106] The bipolar stoma system provides a stoma system for cutting and creating openings in human tissue. Its stoma device includes a puncture assembly 110, a first electrode, a second electrode, and a sheath assembly 130. When applied to a bipolar stoma system, the system also includes a radiofrequency ablation device 300, with the first and second electrodes electrically connected to the radiofrequency ablation device 300. For example... Figure 1-3 As shown, the puncture assembly 110 includes a mandrel 111 and a puncture portion 112 disposed at the distal end of the mandrel 111; the first electrode is the cutting electrode 121, i.e., as shown... Figures 4a-4bAs shown, the first electrode (cutting electrode 121) surrounds the mandrel 111 and is located at the proximal end of the puncture portion 112; the sheath assembly 130 is arranged around the puncture assembly 110, and the second electrode is arranged at the distal end of the sheath assembly 130. Since the mandrel 111 can move axially relative to the sheath assembly 130, the first electrode can move axially relative to the second electrode along with the mandrel 111.

[0107] The cutting electrode can be the entire cutting assembly or a part of it, as long as it facilitates electrical connection between the cutting electrode and the radiofrequency ablation device. That is, the bipolar stoma device includes a cutting assembly, and the cutting assembly includes a first electrode. When the first electrode is the entire cutting assembly, the first electrode extends proximally through the puncture part 112 and the mandrel 111 welded to the first connector 1231 and is electrically connected to the radiofrequency ablation device. The second electrode is a fixing piece that serves as a return electrode and can extend proximally through the traction member 150 and be electrically connected to the radiofrequency ablation device. The first electrode - tissue in the fossa ovalis - second electrode - traction member (pulling wire) - radiofrequency ablation device form a circuit to cut and ablate the tissue in the fossa ovalis.

[0108] Because the distal end of the sheath assembly 130 is provided with a receiving tube section 131, the distal opening diameter of which is adjustable, a second electrode is disposed at the distal end of the sheath assembly 130, and the distal end of the second electrode is disposed at the distal end of the receiving tube section 131, with the proximal end of the second electrode extending to the proximal end of the receiving tube section 131. The second electrode includes a plurality of fixing plates 136, which are circumferentially disposed on the inner wall of the receiving tube section 131. The fixing plates 136 are elongated, with the distal end of the fixing plates 136 located at the distal end of the receiving tube section 131, and the proximal end of the fixing plates 136 extending to the proximal end of the receiving tube section 131. The stoma device also includes a traction element, the distal end of which is connected to the distal end of the second electrode. The fixing plate 136 of the receiving tube segment 131 is electrically connected to the radiofrequency ablation device 300. The fixing plate 136 of the receiving tube segment 131 can be electrically connected to the radiofrequency ablation device 300 via the traction element 150. When the radiofrequency ablation device outputs bipolar radiofrequency power, the tissue at the fossa of the ovum is cut and ablated through a circuit formed by the cutting electrode of the cutting assembly 120, the tissue at the fossa of the ovum, the fixing plate, the traction element (pulling wire), and the radiofrequency ablation device. After the puncture is completed and the cutting electrode 121 is deployed, the radiofrequency ablation device 300 outputs bipolar radiofrequency power, and the cutting assembly 120 performs bipolar cutting of the tissue. On the one hand, for a monopolar stoma system, the high-frequency current passes through other tissues in the body, resulting in higher impedance during monopolar cutting. However, when applied to the bipolar stoma system described above, bipolar radiofrequency power can be output, with the cutting electrode acting as the active electrode and the fixation plate as the return electrode. There is no need to attach a negative electrode plate to other parts of the body as a return electrode, avoiding thermal damage to the patient caused by poor negative electrode plate adhesion. On the other hand, in this bipolar stoma system, the electrode functions are performed at the specific surgical site. Only the tissue to be cut, which is in contact with the electrode, is included in the circuit. The current loop flows between the active and return electrodes, having no impact on other tissues. Furthermore, the impedance is low, energy loss is low, and energy utilization is high, allowing for the use of less cutting energy. Finally, during cutting, the cutting electrode and the fixation plate (as the return electrode) are on both sides of the tissue to be cut, preventing unilateral excessive tissue damage. Figure 18 The tissue damage area 161 formed using the monopolar stoma technique is shown. Figure 18 Excessive damage on one side of the stoma injury area and insufficient damage on the other side can easily lead to stoma failure due to inadequate healing. This results in relatively uniform damage on both sides of the tissue, making healing even more difficult. Figure 19 As shown.

[0109] In the bipolar stoma system provided by this invention, after the puncture assembly 110 punctures the tissue, the first electrode (cutting electrode) and the second electrode (fixation plate) can move relative to each other along the axial direction, so that the first electrode and the second electrode are respectively positioned on both sides of the tissue to be cut. The first electrode, along with the puncture electrode, is inserted to the left atrium and adheres to the tissue. The fixation plates, serving as the second electrode, are circumferentially spaced along the inner wall of the distal segment of the sheath assembly 130. Multiple fixation plates 136 are located on the right atrium side of the tissue being cut and are in contact with the tissue. Therefore, the tissue can be uniformly cut, forming a stoma that is difficult to heal. In the formed radiofrequency circuit, bipolar radiofrequency energy is output by the radiofrequency ablation device 300 to cut and create a stoma. The stoma effect diagram is shown below. Figure 19 As shown.

[0110] Additionally, a first thermocouple (not shown in the figure) can be placed on the first electrode, which serves as the cutting electrode. The first thermocouple can be placed on the inner or outer surface of the cutting electrode to monitor the temperature of the cutting electrode during operation. The radiofrequency ablation device 300 is electrically connected to the thermocouple and acquires the first temperature detected by the first thermocouple. The radiofrequency ablation device 300 outputs radiofrequency power to the radiofrequency circuit based on the acquired first temperature. During tissue cutting, the radiofrequency ablation device 300 can automatically control the required output radiofrequency power based on the temperature feedback from the thermocouple, ensuring that the electrode temperature is controlled below 75°C during cutting. This prevents blood from clotting on the electrode due to excessive temperature during cutting, thus preventing thrombus formation. It is understood that a second thermocouple (not shown in the figure) can also be placed on the puncture site, which serves as the puncture electrode, to monitor the puncture temperature.

[0111] The stoma device 100 also includes a sheath assembly 130, in which a fixing piece for the second electrode is disposed within and located at the distal end of the sheath assembly 130. The distal end of the second electrode and the distal opening of the sheath assembly 130 are in contact with the tissue. Therefore, the second electrode can be delivered to the vicinity of the tissue to be cut through the sheath assembly 130 and can further adhere to the tissue to form an effective component of the bipolar radiofrequency circuit for cutting the tissue.

[0112] like Figure 3 -4 combination Figure 14 As shown, the mandrel 111 is inserted into the sheath assembly 130, and the puncture portion 112 at the distal end of the mandrel 111 is connected to the first electrode (cutting electrode). The first electrode cuts the tissue from the distal end to the proximal end (from the left atrium side to the right atrium side) under the drive of the mandrel 111. By operating the mandrel 111, the puncture of the tissue can be completed, and the first electrode can be delivered to the other side of the tissue. The puncture portion 112 and the first electrode (cutting electrode) can be controlled simultaneously by the mandrel 111 alone. It can be seen that the stoma device 100 provided by the present invention is more convenient to operate, more conducive to the stoma surgery and shortens the operation time.

[0113] The purpose of increasing the diameter of the distal opening of the receiving tube segment 131 is to form a larger opening, which makes it easier to receive the cut tissue into the receiving tube segment 131; the purpose of fitting the distal opening of the receiving tube segment 131 with the fossa ovalis tissue is to allow the second electrode (conductive fixing piece) disposed on the inner wall of the receiving tube segment 131 to fit together with the receiving tube segment 131 with the fossa ovalis tissue, and participate in the formation of the radiofrequency circuit in the bipolar ostomy system. Figure 21 The illustration shows a stoma device provided by the present invention applied to a bipolar stoma system. The radiofrequency ablation device 300 outputs radiofrequency energy. Based on the first thermocouple placed on the first electrode or the second electrode, or the impedance change in the radiofrequency circuit, the output radiofrequency energy is further controlled to form a radiofrequency circuit between the first electrode, the fossa ovalis tissue 160, the second electrode, and the radiofrequency ablation device 300, thereby cutting the fossa ovalis tissue 160. It can be seen that the bipolar stoma system provided by the present invention forms a circuit only between the first electrode, the tissue to be cut, and the second electrode; its current only acts on the fossa ovalis tissue and has no effect on other tissues of the human body.

[0114] Example 2

[0115] Example 2 proposes another ostomy device, such as Figure 22-26e As shown, the features that are the same as or can be reused in the stomach device of Embodiment 2 and the occlusion device of Embodiment 1 will not be described again here. The main difference is that the distal end of the traction member 150 is located inside the receiving tube section 131. Since the fixing piece 136 is located on the inner wall of the receiving tube section 131, and the distal end of the traction member 150 is also located inside the receiving tube section, the distal end of the traction member 150 can be directly connected to the distal end of the fixing piece 136 without the need to provide a perforation at the distal end of the receiving tube section 131. A perforation is only provided on the inner side of the distal end of the conduit section 135, which allows the traction member to pass through the first channel. After the distal end of the traction member 150 is connected to the distal end of the receiving tube section 131 or the distal end of the fixing piece 136, it extends towards the proximal end, passes through the perforation into the first channel, and extends axially along the first channel within the conduit section 135 until it extends out from the proximal end of the conduit section 135 and is fixedly connected to the third control member 230. In this embodiment, the receiving tube section 131 of the stoma device is in a flared, funnel-shaped state in its natural state, such as... Figure 22-23 As shown; the distal end of the receiving tube segment 131 or the fixing piece 136 at the distal end of the receiving tube segment 131 can be pulled by the traction member 150 to provide a radial force to the receiving tube segment 131 to contract towards the radial center, so that the receiving tube segment is in a non-flared state, such as Figure 24-25 As shown. It is understandable that, as Figures 26a-26b When the third control element 230 moves to the distal end, the traction element 150 is released, and the receiving tube section 131 can return to its natural flared shape, combined with Figure 22-23 As shown.

[0116] In this embodiment, compared with the structure of the receiving tube segment in Embodiment 1, the only difference is that the receiving tube segment 131, which is in its natural non-flared state, is changed to a flared state, and the connection between the fixing piece 136 and the traction member 150 is adapted, as well as the way the traction member 150 enters the first channel of the catheter segment 135. Therefore, the surgical operation process is only different from that in Embodiment 1, where the third control member 230 controls the traction member 150 to make the distal end of the receiving tube segment 131 flared or non-flared. The control steps and directions of the first control member 210 for the mandrel 111 and the second control member 220 for the first sleeve 140 are the same. The only difference between the operation steps of the stoma device during the operation and those in Embodiment 1 is that... Figures 26a-26b The third control component 230 needs to be pushed forward to relax the traction component 150, allowing the receiving tube segment 131 to return to its natural flared shape. Then, the flared receiving tube segment 131 is placed against the tissue. The diameter of the distal opening of the receiving tube segment 131 is increased to create a larger opening, making it easier to receive the cut fossa ovale tissue into the receiving tube segment 131.

[0117] like Figures 26c-26e As shown, the operation steps for the first control element 210 and the second control element 220 can be referred to the operation steps for tissue puncture and cutting using the stoma device in Embodiment 1.

[0118] It is understood that the stoma device provided in this embodiment can also form a monopolar or bipolar stoma system during the tissue cutting process, depending on the setting of the fixation plate. For details, please refer to Embodiment 1, which will not be repeated here.

[0119] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An ostomy device, characterized in that, The stoma device includes a puncture assembly, a first electrode, a second electrode, a sheath assembly, and a traction device. The puncture assembly includes a mandrel and a puncture portion disposed at the distal end of the mandrel. The first electrode surrounds the mandrel and is located proximally to the puncture portion. The sheath assembly surrounds the puncture assembly, and a receiving tube section is provided at the distal end of the sheath assembly. The rigidity of the receiving tube section gradually increases from the distal end to the proximal end, and the distal opening diameter of the receiving tube section is adjustable. The second electrode is disposed at the distal end of the sheath assembly, and the distal end of the second electrode is located at the distal end of the receiving tube section. The distal end of the traction device is connected to the distal end of the second electrode, and pulling the traction device can adjust the distal opening diameter of the receiving tube section. The first electrode can move axially relative to the second electrode along the mandrel.

2. The ostomy device according to claim 1, characterized in that, The second electrode includes multiple fixing plates, which are circumferentially disposed on the inner wall of the receiving tube segment. The sheath assembly also includes a catheter segment, a first perforation, and a second perforation. The first perforation is disposed at the distal end of the receiving tube segment and penetrates the side wall of the receiving tube segment. The second perforation is located at the distal end of the catheter segment, and the receiving tube segment is disposed at the distal end of the catheter segment. The catheter segment includes a first channel, which extends axially from the second perforation towards the proximal end of the catheter segment. The distal end of the traction member is connected to the distal end of the fixing plates and passes through the first perforation, thereby penetrating the distal side wall of the receiving tube segment and extending axially along the receiving tube segment towards the proximal end, such that a portion of the traction member is located on the outside of the receiving tube segment, extending to the distal end of the catheter segment and penetrating the first channel through the second perforation. The stoma device also includes a handle assembly, with the proximal end of the traction member extending axially out of the catheter segment and connected to the handle assembly.

3. The ostomy device according to claim 1, characterized in that, The stoma device includes a cutting assembly, which includes a first support mechanism, a first cutting section, and a second support mechanism. The distal end of the first support mechanism is connected to the proximal end of the puncture section. The first cutting section is connected between the first support mechanism and the second support mechanism, so that the first support mechanism and the second support mechanism cooperate to fold and retract the first cutting section onto the mandrel, or the first support mechanism and the second support mechanism cooperate to open the first cutting section.

4. The ostomy device according to claim 3, characterized in that, The stoma device further includes a first sleeve, the distal end of which is connected to the proximal end of the second support mechanism. The first sleeve is arranged around the mandrel, and the mandrel can move axially relative to the first sleeve to drive the distal end of the first support mechanism and the proximal end of the second support mechanism to move closer or further away from each other, thereby supporting the first cutting part to expand away from the mandrel or retract closer to the mandrel.

5. The ostomy device according to claim 4, characterized in that, The stoma device further includes a handle assembly, which includes a first control element, a second control element, a third control element, and a handle housing. The first, second, and third control elements are respectively disposed on the handle housing and are slidable along the axial direction of the handle housing. The distal end of the traction element is connected to the distal end of the receiving tube segment. The first control element is fixedly connected to the proximal end of the mandrel, the second control element is fixedly connected to the proximal end of the first sleeve, and the third control element is fixedly connected to the proximal end of the traction element. The third control element slides axially to pull or release the distal end of the receiving tube segment, thereby increasing or reducing the diameter of the distal opening of the receiving tube segment.

6. The ostomy device according to claim 1, characterized in that, The receiving tube segment includes an adjacent first tube segment, a second tube segment, and a third tube segment. The second tube segment is located near the end of the first tube segment, and the third tube segment is located on the side of the second tube segment away from the first tube segment. The hardness of the second tube segment is greater than that of the first tube segment, and the hardness of the third tube segment is greater than that of the second tube segment.

7. The ostomy device according to claim 6, characterized in that, The first pipe section is elastic in the direction of the vertical axis so that the diameter of the distal opening of the receiving pipe section is adjustable.

8. A bipolar ostomy system, characterized in that, The stoma system includes a radiofrequency ablation device and a stoma apparatus as described in any one of claims 1-7, wherein the puncture assembly is electrically connected to the radiofrequency ablation device, and the first electrode and the second electrode are respectively electrically connected to the radiofrequency ablation device.

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