CN217744573U - Ostomy device and ostomy system - Google Patents
Ostomy device and ostomy system Download PDFInfo
- Publication number
- CN217744573U CN217744573U CN202123448294.9U CN202123448294U CN217744573U CN 217744573 U CN217744573 U CN 217744573U CN 202123448294 U CN202123448294 U CN 202123448294U CN 217744573 U CN217744573 U CN 217744573U
- Authority
- CN
- China
- Prior art keywords
- positioning
- ostomy
- sheath
- stoma
- rod
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Images
Landscapes
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
The utility model provides an ostomy device, which comprises an ostomy piece and a sheath tube component, wherein the ostomy piece comprises an ostomy main body capable of expanding radially and a first positioning piece connected to the ostomy main body; the sheath tube component comprises a sheath core, a push rod and a sheath retracting combination, the push rod is movably sleeved on the sheath core along the axial direction, one end of the stoma main body is connected with the sheath core, the other end of the stoma main body is connected with the push rod, and the push rod moves relative to the sheath core to adjust the radial size of the stoma main body; the radial size of the stoma body can be adjusted to meet the requirements of different patients. The first positioning piece is in a bending state or a flattening state relative to the stoma body, and the sheath retracting combination moves axially relative to the sheath core so as to adjust the first positioning piece to be changed between the bending state and the flattening state; the first positioning piece is in a flattening state, so that the obstruction caused by the first positioning piece is avoided, the ostomy piece can be conveniently and smoothly recovered to the sheath tube, and the use is convenient. The utility model also provides a stoma system.
Description
Technical Field
The utility model relates to an intervene medical instrument technical field, especially relate to an it puts and is equipped with to make mouthful a mouthful system of making of device.
Background
Heart failure (abbreviated as heart failure) is a complex group of clinical syndromes in which the filling of the ventricles or the ability to eject blood is impaired due to any structural or functional abnormality of the heart, and its main clinical manifestations are dyspnea and fatigue (limited movement tolerance), and fluid retention (pulmonary congestion and peripheral edema). According to the left ventricular ejection fraction, the heart failure with reduced ejection fraction, the heart failure with preserved ejection fraction and the heart failure with the intermediate value of ejection fraction are divided. According to the time and speed of heart failure, it is classified into chronic heart failure and acute heart failure. After hospitalization, most acute heart failure patients partially relieve symptoms and turn into chronic heart failure; patients with chronic heart failure often need hospitalization due to acute exacerbation of various causes. Heart failure is the severe and terminal stage of various heart diseases, has high morbidity and is one of the most important cardiovascular diseases at present. There are left heart, right heart and whole heart failure according to the occurrence of heart failure.
Heart failure is a serious disease with high incidence and mortality. The incidence rate of heart failure in China is 2-3%, and is over 1200 ten thousand. The causes of heart failure include hypertension, coronary heart disease, myocardial infarction, valvular heart disease, atrial fibrillation, cardiomyopathy, etc. Cardiovascular diseases cause damage to the left ventricle, leading to pathological remodeling of the left ventricle and resulting in reduced cardiac function. Each time a myocardial infarction patient is successfully treated, a potential heart failure patient is brought about.
The clinical features of heart failure patients with preserved ejection fraction are exertional dyspnea, and among heart failure patients with preserved ejection fraction, there are many mechanisms that may lead to impaired exercise tolerance. Left ventricular relaxation disorder and increased stiffness in heart failure patients with preserved ejection fraction prevent end-diastolic volume increase in left ventricle during exercise, thereby increasing Pulmonary Capillary Wedge Pressure (PCWP) and Left Atrial Pressure (LAP), resulting in increased pulmonary congestion with poorer prognosis.
In treatment, at present, for heart failure with reduced ejection fraction, drugs such as heart strengthening drugs, diuretic drugs and vasodilator drugs are adopted, so that the progress of the exacerbation of the heart failure can be effectively slowed down. However, no drug or device has been available to date that can significantly reduce mortality or hospitalization risk in HFpEF patients. Cardiac Resynchronization Therapy (CRT) is not suitable for all heart failure patients, and 20% -30% of patients do not respond to cardiac resynchronization therapy. Left Ventricular Assist Device (LVAD) surgery requires extracorporeal circulation, with high incidence of traumatic complications and expensive and unavailable equipment. Heart transplantation is the final solution, but the source of donors is very limited.
Atrial shunt devices are implanted into the atrial septum via medical devices to form an artificial defect in the atrial septum. Shunting the left atrium to the right atrium, thereby reducing left atrial pressure. After the pressure of the left atrium is reduced, the pressure of the pulmonary artery and the pressure of the pulmonary capillary wedge are reduced, so that the symptoms of dyspnea, fatigue and the like of a patient are relieved.
Conventional interatrial septum ostomy methods, such as balloon interatrial septum ostomy, have a tendency for the myocardial tissue to recoil after the stoma and over time the stoma may shrink or even close completely. In order to solve the problem that the stoma is reduced or even closed, the prior art provides an ostomy bracket, which can respectively disclose an implant for atrial shunt. In the interatrial septum access procedure, the implant used for atrial shunt leaves a device at the access site that is prone to thrombosis or dislodgement of the device, forming an embolism. In addition, the passage is closed and the shunting action is lost, as endothelial attachment can cause the instrument opening to be blocked.
Another ostomy appliance comprises a cutting device and a grabbing device, wherein when the appliance performs ostomy on tissues, the grabbing device firstly positions and grabs partial tissues required to be cut; then, the cutting part of the tissue grabbed by the grabbing device is cut by the cutting part of the cutting device, and the cut part of the tissue is taken out of the body by the grabbing device, so that the stoma is formed. The ostomy appliance cuts endocardial tissue during surgery by means of a mechanical or high frequency electrotome, with a high risk of loosening during the operation of the gripping device or of causing the cut tissue to fall off and form emboli during retrieval. Furthermore, loosening of the grasping device can easily result in damage to other myocardial tissue if it is cut during the cutting process.
In addition, none of the existing interatrial septum ostomy techniques accurately adjusts the desired stoma diameter to meet the needs of different patients.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a satisfy the device of making a mouthful and be equipped with of different patient's demands make mouthful system of making mouthful device.
In order to solve the technical problem, the utility model provides an ostomy device, which comprises an ostomy piece and a sheath tube component, wherein the ostomy piece is used for forming an ostomy on tissue, and comprises an ostomy main body capable of expanding radially and a first positioning piece connected with the ostomy main body; the sheath tube assembly comprises a sheath core, a push rod and a sheath retracting combination, the push rod is movably sleeved on the sheath core along the axial direction, one end of the stoma body is connected to the sheath core, the other end of the stoma body is connected to the push rod, and the push rod moves relative to the sheath core to adjust the radial size of the stoma body; the sheath retracting combination is connected to the position, far away from the stoma body, of the first positioning piece, the first positioning piece is in a bending state or a flattening state relative to the stoma body, and the sheath retracting combination moves axially relative to the sheath core so as to adjust the first positioning piece to be changed between the bending state and the flattening state.
The utility model also provides an ostomy system, it is including making mouthful device, controller and melting the energy ware, the controller is used for control it makes the mouth to the tissue to make mouthful the device, melt the energy ware be used for give it provides and melts the energy to make mouthful the device.
The utility model discloses an ostomy device which comprises an ostomy piece and a sheath tube component connected with the ostomy piece, wherein the push rod of the sheath tube component moves axially relative to a sheath core to adjust the radial size of the ostomy main body, thereby meeting the requirements of different patients; in addition, when withdrawing the stoma spare to the sheath pipe, receive the sheath combination and be the exhibition flat state for adjusting first locating piece along axial displacement for the sheath core, avoid the hindrance that first locating piece formed, can conveniently retrieve the stoma spare to the sheath pipe smoothly, convenient to use, easy operation.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic view of an ostomy device according to a first embodiment of the present invention;
FIG. 2 is a schematic structural view of the sheath assembly of the ostomy member and adjustment mechanism of FIG. 1;
figure 3 is a schematic perspective view of the ostomy in figure 2;
figure 4 is a front structural view of the ostomy member of figure 3;
figure 5 is an exploded schematic view of the ostomy member and sheath core of figure 2;
figure 6 is a schematic view of another embodiment of the ostomy member and sheath core of figure 2;
FIG. 7 is a schematic view of one embodiment of the ostomy member, sheath core and push rod of FIG. 2;
FIG. 8 is a schematic view of yet another embodiment of the stoma, sheath core and pushrod of FIG. 2;
FIG. 9 is a schematic cross-sectional view of the housing and the adjustment assembly of the adjustment mechanism of FIG. 1;
figures 10-13 are schematic views of an ostomy process of the ostomy device of figure 1;
FIG. 14 is a schematic view of an ostomy device according to a second embodiment of the invention;
FIG. 15 is a schematic structural view of the sheath assembly of the ostomy member and adjustment mechanism of FIG. 14;
figure 16 is a schematic perspective view of the ostomy member of figure 15;
figure 17 is a front structural view of the ostomy member of figure 16;
figure 18 is a schematic perspective view of an ostomy member of an ostomy device according to a third embodiment of the invention;
figure 19 is a front structural view of the ostomy member of figure 18;
figure 20 is a schematic perspective view of an ostomy member of an ostomy device according to a fourth embodiment of the invention;
figure 21 is a front structural view of the ostomy member of figure 20;
figure 22 is a schematic perspective view of an ostomy member of an ostomy device according to a fifth embodiment of the invention;
figure 23 is a front structural view of the ostomy member of figure 22;
FIG. 24 is a schematic view of an ostomy member and sheath assembly of an ostomy device according to a sixth embodiment of the invention;
figure 25 is a schematic perspective view of the ostomy member of figure 24;
figure 26 is a front structural view of the ostomy member of figure 25;
figures 27-30 are schematic views of an ostomy process of the ostomy device of figure 24;
figure 31 is a schematic perspective view of an ostomy member of an ostomy device according to a seventh embodiment of the invention;
figure 32 is a front structural view of the ostomy member of figure 31;
figure 33 is a schematic perspective view of an ostomy member of an ostomy device according to an eighth embodiment of the invention;
figure 34 is a front structural view of the ostomy member of figure 32;
figure 35 is a schematic perspective view of an ostomy member of an ostomy device according to a ninth embodiment of the invention;
figure 36 is a front structural view of the ostomy member of figure 35;
figure 37 is a schematic perspective view of an ostomy member of an ostomy device according to a tenth embodiment of the invention;
figure 38 is a front structural view of the ostomy member of figure 37;
FIG. 39 is a schematic view of an ostomy member and sheath assembly of an ostomy device according to an eleventh embodiment of the invention;
figure 40 is a schematic perspective view of the ostomy in figure 39;
figure 41 is a front structural view of the ostomy member of figure 40;
FIG. 42 is a schematic view of an ostomy member of an ostomy device according to a twelfth embodiment of the invention;
FIG. 43 is a schematic view of an adjustment mechanism of an ostomy device according to a thirteenth embodiment of the invention;
FIG. 44 is a schematic view of an adjustment mechanism of an ostomy device according to a fourteenth embodiment of the invention;
fig. 45 is a schematic view of an ostomy system according to an embodiment of the invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.
For clarity of description, the end closer to the operator in the ostomy process will be referred to as the "proximal end" and the end further away from the operator will be referred to as the "distal end"; the axial direction refers to the direction of the central axis of the device, and the radial direction is the direction vertical to the central axis; the tissue between the left atrium and the right atrium of the present invention is called "interatrial septum"; the above definitions are for convenience of description only and should not be construed as limiting the present invention.
It should be noted that: the utility model discloses an ostomy device and ostomy system including but not limited to be applicable to the interatrial septum and make the mouth, can also be applicable to other tissues that need to make the mouth. In this context, the use of an ostomy device for a room partition will be described and illustrated as an example.
Referring to fig. 1 and 2, the present invention provides an ostomy device 100 comprising an ostomy member 20 and an adjusting mechanism 30 connected to the ostomy member 20. The ostomy member 20 is a stent having elastic expansion, the ostomy member 20 is used for forming an ostomy on tissue, and the ostomy member 20 includes a radially expandable ostomy main body 22 and a first positioning member 24 connected to the ostomy main body 22. The adjusting mechanism 30 comprises a sheath assembly 40, a housing 50, a diameter adjusting assembly 60, a sheath retracting adjusting assembly 70 and an outer sheath adjusting assembly 80, wherein the sheath assembly 40 is connected to the ostomy member 20, and the diameter adjusting assembly 60, the sheath retracting adjusting assembly 70 and the outer sheath adjusting assembly 80 are respectively arranged on the housing 50. The sheath tube assembly 40 comprises a sheath core 41, a push rod 43 and a sheath retracting combination 45, wherein the push rod 43 is axially movably sleeved on the sheath core 41, one end of the stoma body 22 is connected to the sheath core 41, the other end of the stoma body 22 is connected to the push rod 43, and the push rod 43 moves relative to the sheath core 41 to adjust the radial size of the stoma body 22; the sheath-retracting combination 45 is connected to the first positioning element 24 far away from the stoma body 22, the first positioning element 24 is in a bending state or a flattening state relative to the stoma body 22, and the sheath-retracting combination 45 moves axially relative to the sheath core 41 to adjust the first positioning element 24 to change between the bending state and the flattening state.
The ostomy device 100 of the present application comprises an ostomy member 20 and a sheath assembly 40 connected to the ostomy member 20, the push rod 43 of the sheath assembly 40 moving axially relative to the sheath core 41 can adjust the radial size of the ostomy body 22, thereby satisfying the needs of different patients; in addition, when withdrawing the stoma 20 to the sheath, the sheath withdrawing assembly 45 moves axially relative to the sheath core 41 to adjust the first positioning element 24 to be in a flattened state, so that the obstruction caused by the first positioning element 24 is avoided, the stoma 20 can be conveniently and smoothly withdrawn to the sheath, and the use is convenient and the operation is simple.
As shown in fig. 2-4, the ostomy member 20 further comprises a push rod connection 27 at the proximal end of the ostomy body 22 and a sheath-core connection 28 at the distal end of the ostomy body 22. The pushrod 43 is connected to the pushrod connection section 27, the pushrod 43 or the pushrod connection section 27 is provided with a first marker 312, the sheath core 41 is provided with a second marker 314, and the pushrod 43 is moved axially relative to the sheath core 41 to bring the first marker 312 into alignment with the second marker 314 to determine the radial diameter of the stoma body 22.
The adjustment mechanism 30 is used to adjust the value of the radial dimension of the stoma body 22, which is determined from the alignment of the first indicium 312 with the second indicium 314. Thus, the value of the diameter of the stoma formed by the stoma body 22 of the ostomy device 100 of the present application can be accurately adjusted to meet the needs of different patients.
As shown in figures 2-4, the stoma body 22 comprises a stoma portion 221 at its middle, a first support 223 provided at the proximal end of the stoma portion 221, and a second support 225 provided at the distal end of the stoma portion 221; specifically, the first support part 223 is connected between the stoma part 221 and the pushrod connection part 27; the second support portion 225 is connected between the stoma portion 221 and the sheath core connection portion 28. The stoma portion 221 is connected to an ablation energy source, which supplies ablation energy to the stoma portion 221 so that the stoma portion 221 ablates tissue of the inner peripheral wall of the stoma. The source of ablative energy is not limited to a source of radiofrequency energy, but may also be: pulsed energy, laser energy, ultrasonic energy, microwave energy, cryogenic energy, thermal energy, or the like. The stoma portion 221 may be an ablation electrode provided to the stoma body 22, which ablation electrode is connected to an ablation energy source. In this embodiment, the stoma portion 221 comprises a plurality of ablation pieces 2210, each of the ablation pieces 2210 is electrically connected to an ablation energy source through a wire, the ablation pieces 2210 are used for ablating the inner circumferential surface of the stoma, and a plurality of the ablation pieces 2210 are circumferentially arranged around the stoma body 22.
The ostomy member 20 may be cut from a nickel alloy tube, the ostomy body 22 being a cylindrical frame structure after release to maintain the flow through of the atrial septum passageway; the ostomy member 20 may also be knitted from nickel alloy wire or may be processed by local knitting in combination with local tube cutting, and the different parts may be welded or fixed to each other by means of connectors. The tube is made of stainless steel, cobalt-chromium alloy or memory metal material or biocompatible non-metal material, such as nickel-titanium alloy material. The overall shape of the stoma body 22 may be any suitable shape such as a straight cylinder shape, a tapered shape, etc., and is not limited thereto.
In other embodiments, the ostomy member 20 is an electrically conductive metal frame made of an electrically conductive material, the ostomy portion 221 is an electrically exposed electrically conductive portion provided to the ostomy body 22, and the ostomy member 20 is electrically connected to the ablation energy source. Specifically, the ostomy member 20 is insulated over part or all of the outer surface except for the conductive portion on the ostomy part 221. Preferably, the entire outer surface of the ostomy member 20 except the outer peripheral surface of the ostomy portion 221 is insulated, i.e. one turn of electrically exposed area of the outer wall surface of the ostomy body 22. The insulating treatment may be, but is not limited to, coating an insulating coating or sleeving an insulating sleeve, and the like, and the insulating coating may be, but is not limited to, parylene, teflon, polyurethane, polyimide, or the like.
In other embodiments, the nickel alloy rod of the stoma body 21 may also be sleeved with an insulating sleeve in addition to the stoma portion 221.
The first supporting part 223 comprises a plurality of first supporting rods 2230, and the plurality of first supporting rods 2230 correspond to the plurality of ablation pieces 2210 one to one; the proximal end of each first support rod 2230 is attached to pusher attachment portion 27 and the distal end of each first support rod 2230 is attached to a respective ablation blade 2210. The second supporting portion 225 comprises a plurality of second supporting rods 2250, and the plurality of second supporting rods 2250 correspond to the plurality of ablation pieces 2210 one to one; the distal end of each second support bar 2250 is connected to the sheath-core connection 28, and the proximal end of each second support bar 2250 is connected to the corresponding ablation tile 2210. The stoma body 22 can radially expand or radially contract, and when the stoma body 22 is in an expanded state, every two adjacent ablation pieces 2210 are spaced apart from each other, at this time, the radial dimension of the stoma portion 221 is greater than the radial dimension of the proximal end of the first support 223 and the radial dimension of the distal end of the second support 255; when the stoma body 22 is radially contracted to the minimum diameter, there is no space or a small space between every two adjacent ablation pieces 2210, and at this time, the radial dimension of the stoma portion 221 is equal to or slightly greater than the radial dimension of the proximal end of the first support 223 and the radial dimension of the distal end of the second support 255. The value of the outer radial dimension of the stoma portion 221 determines the value of the inner diameter of the stoma, and the value of the radial dimension of the stoma portion 221 can be adjusted, so that the stoma 20 can form stomas of different inner diameter values.
In this embodiment, the stoma portion 221 includes 10 ablation pieces 2210, the 10 ablation pieces 2210 enclose a circle, and the push rod connection portion 27 and the sheath core connection portion 28 are both connecting cylinders; the plurality of ablation pieces 2210 are uniformly spaced along the circumferential direction of the stoma portion 221, the plurality of first support rods 2230 are uniformly connected to the push rod connecting portion 27 along the circumferential direction of the push rod connecting portion 27, and the plurality of second support rods 2250 are uniformly connected to the sheath-core connecting portion 28 along the circumferential direction of the sheath-core connecting portion 28. In other embodiments, the number of ablation segments 2210 can be set as desired, e.g., the stoma portion 221 can include, but is not limited to, 8, 9, 10, 11, or 12, etc.; the ablation segments 2210 may also define, but are not limited to, an ellipse, a polygon, and the like.
As shown in fig. 3 and 4, the first positioning member 24 includes a plurality of first positioning rods 241, one end of each first positioning rod 241 is connected to the stoma body 22, and the plurality of first positioning rods 241 are arranged in a circle along the circumference of the stoma body 22. The sheathing connection member 451 comprises a plurality of sheathing wires 4510, the sheathing wires 4510 correspond to the first locating rods 241 one by one, one end of each sheathing wire 4510 is connected to the end of the corresponding first locating rod 241 far away from the stoma body 22, and the other end of each sheathing wire 4510 is connected to the sheathing adjustment member 453. When the sheath retracting adjusting members 453 are axially and proximally slid relative to the sheath core 41 to tighten the sheath retracting wires 4510, each sheath retracting wire 4510 pulls the corresponding first positioning rod 241 from the bent state to the flattened state, and the first positioning rod 241 is elastically deformed. When the sheath retracting adjustment member 453 slides axially and distally relative to the sheath core 41 to release the sheath retracting wire 4510, the first positioning rod 241 is elastically restored from the flattened state to the bent state.
In this embodiment, the plurality of first positioning rods 241 correspond to the plurality of ablation pieces 2210 of the stoma portion 221 one by one, and specifically, the number of the plurality of first positioning rods 241 is 10. The ostomy member 20 further comprises a second positioning member 26, the first positioning member 24 and the second positioning member 26 being connected to the ostomy body 22, respectively. The first positioning member 24 and the second positioning member 26 can be bent or flattened relative to the stoma body 22, respectively; when the first and second positioning members 24, 26 are both in a flattened state relative to the stoma body 22, to facilitate the receiving of the stoma 20 into the sheath; when both the first positioning member 24 and the second positioning member 26 are bent relative to the ostomy main body 22, the ostomy member 20 is positioned into the stoma. The second positioning member 26 comprises a plurality of second positioning rods 261, one end of each second positioning rod 261 is connected to the stoma body 22, and the plurality of second positioning rods 261 are arranged in a circle along the circumferential direction of the stoma body 22. The second positioning rods 261 correspond to the ablation pieces 2210 of the stoma portion 221 one by one; specifically, the number of the second positioning rods 261 is 10.
The first positioning member 24 can be in a bent state or a flattened state relative to the stoma body 22, and the second positioning member 26 can be in a bent state or a flattened state relative to the stoma body 22. Specifically, when the first positioning member 24 is in a bent state with respect to the stoma body 22, each first positioning rod 241 extends away from the stoma portion 221 such that the distal end of the first positioning rod 241 is away from the stoma portion 221 in the radial direction of the stoma body 22; when the second positioning member 26 is bent with respect to the stoma body 22, each second positioning rod 261 extends away from the stoma portion 221 such that the distal end of the second positioning rod 261 is away from the stoma portion 221 in the radial direction of the stoma body 22. When the first positioning member 24 is in a flattened state relative to the stoma body 22, the first positioning member 24 is parallel to the first support 223, and in particular, each first positioning bar 241 is parallel to the first support bar 2230 corresponding to the first support 223; when the second positioning member 26 is in a flattened state with respect to the stoma body 22, the second positioning member 26 is parallel to the second support part 225, and in particular, each second positioning rod 261 is parallel to a corresponding second support rod 2250 of the second support part 225.
As shown in fig. 2-4, the first positioning rod 241 includes a first positioning portion 2412 connected to the stoma body 22 and a connecting portion 2416 connected to the first positioning portion 2412 away from the stoma body 22, and the sheathing wire 4510 is connected to the connecting portion 2416. That is, one end of the first positioning portion 2412 of each first positioning rod 241 is connected to the corresponding ablation piece 2210, and the connecting portion 2416 is connected to the other end of the first positioning portion 2412. When the first positioning member 24 is bent, the first positioning portion 2412 of each first positioning rod 241 extends obliquely from the stoma portion 221 toward the sheath assembly 40, i.e., the first positioning portion 2412 extends obliquely from the stoma portion 221 toward the push rod connecting portion 27; at this time, the first detents 2412 are for abutting tissue around one side of the stoma. The second positioning rod 261 includes a second positioning portion 2612 connected to the stoma body 22 and an extending portion 2614 connected to the second positioning portion 2612 and far away from the stoma body 22, and an end surface of the extending portion 2614 far away from the second positioning portion 2612 is provided with an arc surface, and the arc surface can prevent a tail end of the second positioning rod 261 from scratching tissues. In this embodiment, the end of the extension 2614 away from the second positioning portion 2612 is provided with a circular piece. In other embodiments, the end of the extension 2614 may be provided with, but not limited to, a ball or the like. One end of the second positioning portion 2612 of each second positioning rod 261 is connected to the corresponding ablation piece 2210, and the extension portion 2614 is connected to the other end of the second positioning portion 2612. When the second positioning member 26 is bent, the second positioning portion 2612 of each second positioning rod 261 extends obliquely from the stoma portion 221 in a direction away from the sheath assembly 40, that is, the second positioning portion 2612 extends obliquely from the stoma portion 221 in a direction toward the sheath-core connecting portion 28; at this time, the second fixing portion 2612 is used to abut against the tissue around the other side of the stoma.
The surface of the first positioning portion 2412 that fits the tissue may be, but is not limited to, an umbrella surface, a conical surface, or an arc surface; that is, the surface of the first positioning portion 2412 of the first positioning member 24, which is attached to the tissue, forms an umbrella surface, a conical surface, an arc surface, or the like. The surface of the second positioning portion 2612, which is attached to the tissue, may be, but not limited to, an umbrella surface, a conical surface, or an arc surface; that is, the second positioning portion 2612 of the second positioning member 26 and the tissue-jointed surface form an umbrella surface, a conical surface or an arc surface.
Preferably, the end of the connecting portion 2416 remote from the first positioning portion 2412 is configured as an arc surface, which can prevent the distal end of the first positioning rod 24 from scratching the tissue. The intersection of the first positioning portion 2413 and the connecting portion 2416 is in arc transition to avoid scratching the tissue. The intersection of the second positioning portion 2612 and the extension portion 2614 is in arc transition to avoid scratching the tissue.
In this embodiment, the first positioning portion 2412 is a bar-shaped structure, the first positioning portion 2412 includes a positioning section 2413 connected to the stoma body 22 and an extending section 2414 connected to one end of the positioning section 2413 far from the stoma body 22, the connecting portion 2416 is connected to the end of the extending section 2414 far from the positioning section 2413, and the sheath-retracting wire 4510 is connected to the connecting portion 2416. When the first positioning member 24 is bent with respect to the stoma body 22, the positioning section 2413 extends obliquely in a direction approaching the push rod connecting portion 27, and the extending section 2414 extends from the positioning section 2413 in a direction approaching the push rod connecting portion 27; preferably, the connection between the positioning section 2413 and the extending section 2414 is rounded to avoid scratching the tissue. The connecting portion 2416 is a circular piece connected to one end of the extending section 2414 away from the positioning section 2413; the connecting portion 2416 is provided with a connecting hole 2417.
The stoma body 22 is provided with a positioning development member 226, and specifically, the stoma body 22 is provided with the positioning development member 226 along its circumferential direction. The stoma body 22 is positioned in the stoma by positioning the developer 226; specifically, the positioning developing member 226 is provided on the stoma portion 221, and the positioning developing member 226 is provided at least one turn around in the circumferential direction of the stoma portion 221. Preferably, the positioning developing member 226 is provided with a circle at the central position of the stoma portion 221. The positioning development member 226 may be, but is not limited to, a development ring, a development wire, or several development spots, etc. The push rod connecting part 27 is provided with a first mark 312, and the first mark 312 may be, but is not limited to, a developing ring, a developing wire or several developing points; preferably, the developing ring surrounds at least one circle along the circumference of the push rod connecting portion 27, the developing wire surrounds at least one circle along the circumference of the push rod connecting portion 27, or the plurality of developing points surround at least one circle along the circumference of the push rod connecting portion 27.
The ostomy member 20 is a radially telescopically expandable stent, in particular the ostomy member 20 may be an elastic metal supporting skeleton or an elastic non-metal supporting skeleton. In this embodiment, the ostomy member 20 is a nitinol stent, and when the ostomy device 100 is delivered through a sheath, the diameter of the ostomy member 20 may be contracted to a smaller state for delivery in the sheath; when the ostomy device 100 is released, the ostomy member 20 can automatically expand, and the push rod connecting part 27 is driven by the sheath assembly 40 to move axially relative to the ostomy portion 221 to adjust the outer diameter of the ostomy portion 221 so that the ostomy portion 221 can open the stoma at the interatrial septum to form a stoma of suitable diameter.
Preferably, the surface of the ostomy member 21 is coated with a heparin coating, which has an anticoagulant effect, can reduce adhesion of platelets, has a protective effect on the platelets, and better improves the blood compatibility of the ostomy device 100.
As shown in fig. 2, opposite ends of the ostomy member 20 are connected to the sheath core 41 and the push rod 43, respectively. In particular, the sheath core connection 28 of the ostomy 20 is connected to the sheath core 41 and the pushrod connection 27 of the ostomy 20 is connected to the pushrod 43. In this embodiment, the sheath core connecting portion 28 is fixedly connected to the distal end of the sheath core 41, and the push rod connecting portion 27 is fixedly connected to the distal end of the push rod 43; in particular, the sheath-core connection 28 is fixedly connected to the distal end of the sheath-core 41 by a conical head 283, the conical head 283 facilitating insertion of the ostomy member 20 into the stoma. The mark combination 310 is arranged on the ostomy member 20 and the sheath assembly 40, specifically, the sheath core 41 is provided with a second mark 314, and the first mark 312 on the push rod connecting part 27 and the second mark 314 on the sheath core 41 are combined into the mark combination 310. In this embodiment, the second indicia 314 is located adjacent the stoma body 22 and the pushrod 43 is moved axially relative to the sheath core 41 to bring the first indicia 312 into alignment with the second indicia 314. The push rod 43 is provided with a threading slot along the axial direction, the lead wire 432 is arranged in the threading slot, and the lead wire 432 is electrically connected between the ablation energy source and the stoma part 221.
In other embodiments, the mark combination 310 may also be disposed on the sheath assembly 40, i.e. the first mark 312 is disposed on the push rod 43, and the second mark 314 is disposed on the sheath core 41; specifically, the first mark 312 is located at the position of the push rod 43 close to the push rod connection portion 27, and the push rod 43 moves axially relative to the sheath core 41 to bring the first mark into alignment with the second mark.
When the first mark 312 is aligned with the second mark 314, the outer diameter dimension of the stoma portion 221 has a value a, which may be any value; alternatively, the range of A may be, but is not limited to, any value from 5mm to 15mm, e.g., A may be 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, etc.
Preferably, the first mark 312 is a first developing member, and the second mark 314 is a second developing member, specifically; specifically, the first mark 312 is at least one first developing member disposed on the push rod connecting portion 27 or the push rod 43, and the second mark 314 is at least one second developing member disposed on the sheath core 41. The first developing member may be, but is not limited to, a developing ring, a developing wire, or several developing points; preferably, the developing ring surrounds at least one circle along the circumference of the push rod connecting portion 27 or the push rod 43, the developing wire surrounds at least one circle along the circumference of the push rod connecting portion 27 or the push rod 43, or the plurality of developing points surround at least one circle along the circumference of the push rod connecting portion 27 or the push rod 43. The second developer may be, but is not limited to, a developer ring, a developer wire, or several developer points; preferably, the developing ring surrounds at least one circle along the circumferential direction of the sheath core 41, the developing wire surrounds at least one circle along the circumferential direction of the sheath core 41, or several developing points surround at least one circle along the circumferential direction of the sheath core 41. The developing ring, the developing wire or the developing point can be made of materials such as gold, platinum, tantalum and the like. The second development on the sheath core 41 may serve to position the stoma body 22 to the stoma, the stoma body 22 being adjusted by observing the position of the second development in the stoma.
As shown in fig. 2 and 5, the sheath core 41 has a plurality of second marks 314 arranged along the axial direction thereof, and the shaft 43 drives the shaft connecting portion 27 to move along the axial direction, so that the first marks 312 are respectively aligned with one of the second marks 314 to obtain different radial dimension values of the stoma body 22. Specifically, a plurality of second marks 314 are arranged at intervals along the sheath core 41, a first mark 312 is arranged on the push rod connecting portion 27, and during the process that the push rod 43 moves axially relative to the sheath core 41, the push rod 43 drives the first mark 312 on the push rod connecting portion 27 to align with one of the plurality of second marks 314, so as to obtain different values of the outer diameter of the stoma portion 221.
Optionally, the first indicia 312, during proximal to distal movement, is respectively aligned with one of the plurality of second indicia 314, and the value of the radial dimension of the stoma body 22 is gradually increased, i.e., the value of the outer diameter dimension of the stoma portion 221 is gradually increased; the first indicia 312, during distal to proximal movement, respectively aligns with one of the plurality of second indicia 314, and the value of the radial dimension of the stoma body 22, i.e., the value of the outer diameter dimension of the stoma portion 221, gradually decreases.
The number of second markers 314 on the sheath core 41 can be set as desired, such as 2, 3, 4, 5, or other numbers of second markers 314 can be provided. The stoma portion 221 has an outer diameter dimension value of B when the first indicia 312 is aligned with the proximal-most second indicia 314 and a value of C when the first indicia 312 is aligned with the distal-most second indicia 314, where C is greater than B. The outer diameter of the stoma portion 221 may have a value from B to C, which may optionally be, but not limited to, 5mm to 15mm. In this embodiment, four second marks 314 are disposed on the sheath core 41, and when the first mark 312 is aligned with one of the four second marks 314, the outer diameter of the stoma portion 221 may be, but is not limited to, 5mm, 7mm, 9mm, and 11mm. One ostomy member 20 in this embodiment can form an ostomy with accurately formed different inner diameter values, is convenient to use, and can meet the requirements of different patients.
As shown in fig. 2 and 6, the push rod connecting portion 27 has a plurality of the first marks 312 arranged along the axial direction thereof, the sheath core 41 is provided with a second mark 314, and the push rod connecting portion 27 is moved relative to the sheath core 41 along the axial direction to align the second mark 314 with one of the plurality of the first marks 312, respectively, so as to obtain different values of the radial dimension of the stoma body 22. Specifically, a plurality of first marks 312 are arranged at intervals along the plunger connecting portion 27, a second mark 314 is disposed on the sheath core 41, and during the axial movement of the plunger 43 relative to the sheath core 41, the plunger 43 drives one of the first marks 312 on the plunger connecting portion 27 to align with the second mark 314, so as to obtain different values of the outer diameter of the stoma portion 221.
Alternatively, as the plurality of first indicia 312 move proximally to distally, one of the plurality of first developers aligns with each of the second indicia 314, the value of the radial dimension of the stoma body 22 gradually increases, i.e., the value of the outer diameter dimension of the stoma portion 221 gradually increases; during the distal to proximal movement of the plurality of first indicia 312, a respective one of the plurality of first indicia 312 is aligned with a respective one of the second indicia 314, and the value of the radial dimension of the stoma body 22 is gradually reduced, i.e., the value of the outer diameter dimension of the stoma portion 221 is gradually reduced.
The number of the first marks 312 on the push rod connecting portion 27 may be set as required, for example, 2, 3, 4, 5 or other numbers of the first marks 312 may be set. The outer diameter dimension of the stoma portion 221 has a value of B when the second indicium 314 is aligned with the most proximal first indicium 312 and a value of C when the second indicium 314 is aligned with the most distal first indicium 312, where B is greater than C. The value of the outer diameter dimension of the stoma portion 221, C to B, may be any value in the range, and optionally, the value of C to B may be, but is not limited to, 5mm to 15mm. In this embodiment, when the four first marks 312 are disposed on the connecting rod portion 27, and the second mark 314 is aligned with one of the four first marks 312, the outer diameter of the stoma portion 221 may be, but is not limited to, 6mm, 7mm, 8mm, and 9mm. One ostomy member 20 of this embodiment can form an ostomy that accurately forms different inner diameter values, is convenient to use, and can meet the needs of different patients.
As shown in fig. 2 and 7, the push rod 43 is axially aligned with a plurality of first marks 312, the sheath core 41 is provided with a second mark 314, and the push rod 43 is axially moved relative to the sheath core 41 such that the second mark 314 is respectively aligned with one of the plurality of first marks 312 to obtain different values of the radial dimension of the stoma body 22. Specifically, the plurality of first marks 312 are disposed near the connecting portion 27 of the pushing rod, and the plurality of first marks 312 are arranged at intervals along the axial direction of the pushing rod 43, the sheath core 41 is provided with a second mark 314, and during the process that the pushing rod 43 moves relative to the sheath core 41 along the axial direction, the pushing rod 43 drives one of the plurality of first marks 312 thereon to align with the second mark 314, so as to obtain different outer diameter dimension values of the stoma portion 221.
Optionally, during the proximal to distal movement of the plurality of first indicia 312, one of the plurality of first indicia 312 is aligned with each of the second indicia 314, and the value of the radial dimension of the stoma body 22 is gradually increased, i.e., the value of the outer diameter dimension of the stoma portion 221 is gradually increased; during the distal to proximal movement of the plurality of first indicia 312, one of the plurality of first indicia 312 is aligned with each of the second indicia 314 and the value of the radial dimension of the stoma body 22 is gradually reduced, i.e., the value of the outer diameter dimension of the stoma portion 221 is gradually reduced.
The number of the first marks 312 on the push rod 43 can be set according to the requirement, such as 2, 3, 4, 5 or other numbers of the first marks 312 can be set. The stoma portion 221 has an outer diameter dimension value of B when the second indicia 314 is aligned with the most proximal first indicia 312 and a value of C when the second indicia 314 is aligned with the most distal first indicia 312, wherein B is greater than C. The value of the outer diameter dimension of the stoma portion 221, C to B, may be any value in the range, and optionally, the value of C to B may be, but is not limited to, 5mm to 15mm. In this embodiment, when the push rod 43 is provided with four first marks 312, and the second mark 314 is aligned with one of the four first marks 312, the outer diameter of the stoma portion 221 can be, but is not limited to, 6mm, 8mm, 10mm, and 12mm. One ostomy member 20 of this embodiment can form an ostomy that accurately forms different inner diameter values, is convenient to use, and can meet the needs of different patients.
As shown in fig. 2 and 8, the sheath core 41 is provided with a plurality of second marks 314 at intervals along the axial direction thereof, the push rod 43 is provided with a first mark 312, and the push rod 43 moves axially relative to the sheath core 41 to align the first mark 312 with one of the plurality of second marks 314 respectively, so as to obtain different radial dimension values of the stoma body 22, i.e. different outer diameter dimension values of the stoma portion 221.
Optionally, the first indicia 312, as it moves proximally to distally, is aligned with one of the plurality of second indicia 314, respectively, and the value of the radial dimension of the stoma body 22, and in particular, the value of the outer diameter dimension of the stoma portion 221, is gradually increased; as the first indicia 312 is moved distally towards proximally into alignment with a respective one of the plurality of second indicia 314, the value of the radial dimension of the stoma body 22, and in particular the value of the outer diameter dimension of the stoma portion 221, gradually decreases.
As shown in fig. 2, the stoma body 22 is sleeved on the sheath core 42 and has one end fixedly connected to the sheath core 42, and the sheath retracting assembly 45 moves axially relative to the sheath core 41 to adjust the first positioning element 24 to change between the bending state and the flattening state. The first locator 24 is for locating the stoma body 22 in a stoma when the first locator 24 is in a bent state; when the first positioning member 24 is in the flattened state, the first positioning member 24 is parallel to the ostomy main body 22, i.e. the first positioning member 24 does not prevent the ostomy member 20 from retracting into the outer sheath, which is convenient for use.
The sheath retracting assembly 45 comprises a sheath retracting connecting piece 451 and a sheath retracting adjusting piece 453, the sheath retracting connecting piece 451 is connected between the first positioning piece 24 and the sheath retracting adjusting piece 453, and the sheath retracting adjusting piece 453 moves axially along 41 relative to the sheath core to drive the sheath retracting connecting piece 451 to adjust the first positioning piece 24, so that the first positioning piece 24 is in a bending state or a flattening state. Specifically, the sheath retracting adjustment member 453 is axially slidably sleeved outside the sheath core 41, and the pushing rod 43 is axially slidably sleeved outside the sheath retracting adjustment member 453, that is, the sheath retracting adjustment member 453 is axially slidable relative to the pushing rod 43. Further, the sheath assembly 40 further includes an outer sheath 47 axially slidably sleeved outside the push rod 43, and the first positioning element 24 can be retracted into the outer sheath 47 in the flattened state.
Preferably, the sheathing wires 4510 are connected to the connecting portion 2416, and in particular, one end of each sheathing wire 4510, which is far away from the sheathing adjustment member 453, is connected to the connecting portion 2416 of the corresponding first positioning rod 241. In this embodiment, an end of the sheathing wire 4510 remote from the sheathing adjuster 453 is connected to the circular piece, and specifically, an end of the sheathing wire 4510 remote from the sheathing adjuster 453 is connected to the connection hole 2417 of the connection part 2416.
As shown in fig. 2, the sheath-retracting adjusting member 453 includes a sheath-retracting lever 4532, the sheath-retracting lever 4532 is axially slidably sleeved on the sheath core 41, and a plurality of sheath-retracting wires 4510 are connected to the sheath-retracting lever 4532; specifically, the end of the sheathing wire 4510 remote from the first locating bar 241 is connected to a sheathing pull rod 4532. When the sheathing pull rods 4532 slide axially and proximally relative to the sheath core 41 to tighten the sheathing wires 4510, each sheathing wire 4510 pulls the corresponding first positioning rod 241 from the bent state to the flattened state, and the first positioning rods 241 are elastically deformed; when the sheathing pull rod 4532 slides axially and distally relative to the sheath core 41 to release the sheathing wire 4510, the first location bar 241 is elastically restored from the flattened state to the bent state.
Preferably, the sheathing adjustment member 453 further comprises a sheathing connection cylinder 4534 axially sleeved on the sheath core 41, the sheathing connection cylinder 4534 is connected to the sheathing pull rod 4532, and the sheathing wires 4510 are connected to the sheathing connection cylinder 4534; specifically, the end of the ensheathing wire 4510 distal to the first locating bar 241 is connected to a ensheathing connector barrel 4534. Specifically, the sheathing connection barrel 4534 is fixedly connected to the distal end of the sheathing pull rod 4532.
Further, the circumferential wall of the sheathing connection cylinder 4534 is provided with a plurality of fixing holes 4535, the plurality of fixing holes 4535 are arranged in a circle along the circumferential direction of the sheathing connection cylinder 4534, and a plurality of sheathing wires 4510 are connected to the plurality of fixing holes 4535, respectively. Specifically, the ends of the sheath wires 4510 away from the first locating bar 241 are connected to the fixing holes 4535. The plurality of fixing holes 4535 correspond to the sheathing wires 4510 one by one, in the embodiment, the number of the sheathing wires 4510 is ten, the number of the fixing holes 4535 is ten, and the ten fixing holes 4535 are uniformly arranged at intervals in the circumferential direction of the sheath core 41.
Referring to fig. 2 and 5, the sheath core 41 is provided with a through-wire slot 412 along the axial direction, the sheath core 41 is provided with a plurality of through holes 413 communicating with the through-wire slot 412 near the first positioning rod 241, the sheath core 41 is provided with a plurality of through holes 415 communicating with the through-wire slot 412 near the sheath-retracting adjusting member 453, and the sheath-retracting wire 4510 is connected to the sheath-retracting adjusting member 453 after passing through the through holes 413, the through-wire slot 412 and the through holes 415. Specifically, one end of each sheath retracting wire 4510, which is away from the first positioning rod 241, sequentially passes through the through hole 413, the wire passing groove 412 and the through hole 415 and then is connected to the fixing hole 4535 corresponding to the sheath retracting adjusting element 453.
The plurality of penetrating holes 413 correspond to the plurality of first positioning rods 241 one by one, and the plurality of penetrating holes 413 are arranged in a circle along the circumferential direction of the sheath core 41; the plurality of outlet holes 415 correspond to the plurality of sheathing threads 4510 one by one, and the plurality of outlet holes 415 are arranged in a circle along the circumferential direction of the sheath core 41. In this embodiment, the number of the penetrating holes 413 is 10, and the 10 penetrating holes 413 are uniformly arranged at intervals in the circumferential direction of the sheath core 41 for one circle; the number of the perforation holes 415 is 10, and the 10 perforation holes 415 are arranged in a circle along the circumferential direction of the sheath core 41.
Preferably, the extending directions of the through hole 413 and the through hole 415 are inclined to the axial direction, so that the sheath retracting wire 4510 can smoothly slide in the through hole 413 and the through hole 415. Furthermore, an arc surface is arranged at the edge of the opening of the penetrating hole 413, and an arc surface is arranged at the edge of the opening of the penetrating hole 415, so that the sliding resistance of the sheath retracting wire 4510 is reduced, the abrasion of the sheath retracting wire 4510 is reduced, and the service life of the sheath retracting wire 4510 is prolonged.
In other embodiments, the number of the insertion holes 413 may not correspond to the number of the first positioning rods 241, for example, one insertion hole 413 corresponds to two first positioning rods 241, and both of the sheathing wires 4510 connected to the two first positioning rods 241 pass through one insertion hole 413.
Referring to fig. 1, 2 and 9, the housing 50 includes a first strip-shaped housing 51 and a second strip-shaped housing 53, and the first housing 51 and the second housing 53 are detachably connected to each other. The first housing 51 and the second housing 53 are connected to form a tubular structure. The diameter regulating component 60, the sheath retracting regulating component 70 and the outer sheath regulating component 80 are arranged on the tubular structure; the diameter adjustment assembly 60 is connected to the pushrod 43, and the diameter adjustment assembly 60 is used to control the movement of the pushrod 43 relative to the sheath core 41 to adjust the value of the radial dimension of the stoma body 22. The sheath retracting control assembly 70 is connected to the sheath retracting pull rod 4532, and the diameter control assembly 60 is used for controlling the sheath retracting pull rod 4532 to move relative to the sheath core 41 so as to adjust the first positioning element 24 to be in a flattening state or a bending state. The sheath adjustment assembly 80 is connected to the sheath 47, and the sheath adjustment assembly 80 is used to control the movement of the sheath 47 relative to the sheath core 41 to move or retract the ostomy member 20 out of or into the sheath 47.
The diameter adjustment assembly 60 includes a push rod driving member 61 connected to the push rod 43 and a push rod operating member 62 connected to the push rod driving member 61, wherein the push rod operating member 62 can drive the push rod driving member 61 to move axially so as to drive the push rod 43 to move axially relative to the sheath core 41, thereby achieving the adjustment of the radial dimension value of the stoma body 22. Specifically, the proximal end of the push rod 43 is connected to the push rod driver 61, the push rod operator 62 is rotatably connected to the housing 50, the rotational axis of the push rod operator 62 is collinear with the axis of the sheath core 41, the push rod driver 61 and the push rod operator 62 are threadedly engaged, and rotation of the push rod operator 62 relative to the housing 50 can cause the push rod driver 61 to move axially to drive the push rod 43 to move axially.
In this embodiment, the push rod operating element 62 is a first knob rotatably sleeved on the housing 50, an inner wall of the first knob is provided with an inner thread, the push rod driving element 62 is a first push rod sliding block arranged in an inner cavity of the first knob, and an outer wall of the first push rod sliding block is provided with an outer thread matched with the inner thread; the end of the push rod 43 remote from the ostomy member 20 is fixedly connected to said first push rod slider. Turning the first knob drives the first sliding rod to move axially relative to the sheath core 41, and the first sliding rod drives the pushing rod 43 to slide axially, so as to adjust the radial dimension value of the stoma body 22.
Preferably, the inner wall of the housing 50 is provided with a first position-limiting part 54 and a second position-limiting part 55 at intervals, the first position-limiting part 54 is located at the distal end of the push rod driver 61, and the second position-limiting part 55 is located at the proximal end of the push rod driver 61; the axial distance between the first position-limiting portion 54 and the second position-limiting portion 55 is the axial movement stroke of the push rod driver 61. That is, the push rod driver 61 can be stopped by the first and second position-limiting portions 54 and 55 during the axial movement. Specifically, the first limiting portion 54 and the second limiting portion 55 are both limiting blocks protruding from the inner wall of the housing 50. Further, the first position-limiting portion 54 and the second position-limiting portion 55 are both annular blocks protruding from the inner wall of the housing 50, the push rod 43 is axially slidably inserted into the distal annular block, and the sheath-retracting pull rod 4532 is axially slidably inserted into the proximal annular block.
The sheath retracting control assembly 70 is located at the proximal end of the diameter control assembly 60, the sheath retracting control assembly 70 includes a pull rod driving member 71 connected to the sheath retracting pull rod 4532 and a pull rod operating member 72 connected to the pull rod driving member 71, and the pull rod operating member 72 can drive the pull rod driving member 71 to move axially to drive the sheath retracting pull rod 4532 to move axially relative to the sheath core 41, so that the first positioning member 24 can be adjusted in a flattened state or a bent state. Specifically, the proximal end of the sheathing pull rod 4532 is connected to the pull rod driving member 71, the pull rod operating member 72 is rotatably connected to the housing 50, the rotational axis of the pull rod operating member 72 is collinear with the axis of the sheath core 41, the pull rod driving member 71 and the pull rod operating member 72 are threadedly engaged, and rotation of the pull rod operating member 72 relative to the housing 50 can axially move the pull rod driving member 71 to drive the sheathing pull rod 4532 to axially move.
In this embodiment, the pull rod operating element 72 is a second knob rotatably sleeved on the housing 50, the inner wall of the second knob is provided with an internal thread, the push rod driving element 62 is a second push rod sliding block arranged in the inner cavity of the second knob, and the outer wall of the second push rod sliding block is provided with an external thread matched with the internal thread; the end of the sheathing pull rod 4532 remote from the ostomy member 20 is fixedly connected to the second push rod slider. The second knob is rotated to drive the second push rod sliding block to move axially relative to the sheath core 41, and the second push rod sliding block drives the push rod 43 to slide axially, so as to adjust the first positioning element 24 to be in a flat state or a bent state.
Preferably, the inner wall of the housing 50 is provided with a third limiting part 56 and a fourth limiting part 57 which are spaced apart from each other, the third limiting part 56 is located at the distal end of the pull rod driving part 71, and the fourth limiting part 57 is located at the proximal end of the pull rod driving part 71; the axial distance between the third position-limiting portion 56 and the fourth position-limiting portion 57 is the axial movement stroke of the pull rod driving member 71. That is, the pull rod driving member 71 can be stopped by the third and fourth position-limiting portions 56 and 57 during the axial movement. Specifically, the third limiting portion 56 and the fourth limiting portion 57 are both limiting blocks protruding from the inner wall of the housing 50. Further, the third position-limiting portion 56 and the fourth position-limiting portion 57 are both annular blocks protruding from the inner wall of the housing 50, the sheath-retracting pull rod 4532 is axially slidably inserted into the distal annular block, and the sheath core 41 is axially slidably inserted into the proximal annular block.
Preferably, the proximal end of the sheath core 41 passes through the fourth position-limiting portion 57, the sheath core 41 is provided with a connection block 413 for connecting an external device, and the connection block 413 can be stopped at the fourth position-limiting portion 57.
The sheath control assembly 80 is located at a distal end of the diameter control assembly 60, the sheath control assembly 80 includes a sheath driving member 81 connected to the sheath 47 and a sheath operating member 82 connected to the sheath driving member 81, and the sheath operating member 82 can drive the sheath driving member 81 to move axially so as to drive the sheath 47 to move axially relative to the sheath core 41, thereby enabling the stoma 20 to move out or retract to the sheath 47. Specifically, the proximal end of the outer sheath 47 is connected to the sheath driving element 81, the sheath operating element 82 is rotatably connected to the housing 50, the rotation axis of the sheath operating element 82 is collinear with the axis of the sheath core 41, the sheath driving element 81 and the sheath operating element 82 are in threaded fit, and the rotation of the sheath operating element 82 relative to the housing 50 can drive the sheath driving element 81 to move axially to drive the outer sheath 47 to move axially.
In this embodiment, the sheath operating element 82 is a third knob rotatably sleeved on the housing 50, an inner thread is disposed on an inner wall of the third knob, the sheath driving element 81 is a third push rod sliding block disposed in an inner cavity of the third knob, and an outer wall of the third push rod sliding block is provided with an outer thread matched with the inner thread; the end of the outer sheath 47 remote from the ostomy member 20 is fixedly connected to said third push rod slider. Turning the third knob drives the third sliding rod to move axially relative to the sheath core 41, and the third sliding rod drives the sheath tube 47 to slide axially, so as to adjust the ostomy member 20 to move out or retract to the sheath tube 47.
Preferably, the inner wall of the housing 50 is provided with a fifth limiting part 58, and the fifth limiting part 58 is located at the distal end of the sheath driving part 81; the sheath driving element 81 is located between the first limiting portion 54 and the fifth limiting portion 58, and the axial distance between the first limiting portion 54 and the fifth limiting portion 58 is the axial movement stroke of the sheath driving element 81. That is, the sheath driving member 81 can be stopped by the first limiting portion 54 and the fifth limiting portion 58 during the axial movement. Specifically, the first limiting portion 54 and the fifth limiting portion 58 are both limiting blocks protruding from the inner wall of the housing 50. Further, the first position-limiting portion 54 and the fifth position-limiting portion 58 are both annular blocks protruding from the inner wall of the housing 50, and the outer sheath 47 is axially slidably inserted into the distal annular block.
As shown in fig. 9, in the present embodiment, the first housing 51 and the second housing 53 are connected by positioning pins and screws. In other embodiments, the first housing 51 and the second housing 53 may be, but are not limited to, snap fit, adhesive, etc. The interior of the housing 50 is provided with a sliding groove along the axial direction, and the proximal end of the sheath assembly 40, the push rod driving member 61, the pull rod driving member 71 and the sheath driving member 81 are all slidably accommodated in the sliding groove along the axial direction.
As shown in fig. 2, the ostomy device 100 further comprises a temperature sensor 224 provided to the ostomy main body 22, the temperature sensor 224 being electrically connected to the ablation power control system, the temperature sensor 224 being in contact with the inner circumferential surface of the stoma of the tissue to sense the temperature of the tissue. In this embodiment, the temperature sensor 224 is provided near the stoma portion 221.
Alternatively, the temperature sensor 224 may be, but is not limited to, a thermocouple or a thermistor.
The temperature sensor 224 can be fixedly attached to the stoma body 22 proximate to the stoma portion 221 by, but not limited to, medical adhesive or welding.
Referring to fig. 1-2 and 10-13 together, the ostomy device 100 may be used in conjunction with the ablation power source and power connection of the delivery device. The using method comprises the following steps:
the atrial septum 901 is punctured by a puncture mechanism, after puncturing, a guide wire is fed into the inferior vena cava 903, and the puncture kit is removed. Advancing outer sheath 47 over the guidewire into left atrium 906 and piercing tip 283 through interatrial septum 901 to left atrium 906; causing the ostomy member 20 to be delivered to the atrial septum 901 site and viewing and positioning the visualization member 226 in the atrial septum 901 tissue. Rotating sheath operator 82 on housing 50 proximally withdraws outer sheath 47 to release second positioning member 26 of ostomy member 20; continued rotation of sheath operator 82 withdraws outer sheath 47 into the right atrium to release the entire ostomy member 20.
When the ostomy member 20 is entirely released, the pull rod operator 72 is rotated to drive the sheath retracting adjustment member 453 axially and distally, and the sheath retracting adjustment member 453 releases the sheath retracting connection member 451 to slowly release the first positioning member 24. At this point, the atrial septum 901 will be confined between the first positioning member 24 and the second positioning member 26. The position of the stoma portion 221 on the atrial septum 901 can be adjusted by positioning the developer 226 on the stoma portion 221.
When the stoma portion 221 of the stoma 20 is adjusted to an appropriate position, the spindle operator 62 is rotated to adjust the value of the outer diameter dimension of the stoma portion 221. At this time, the specific position where the push rod 43 is advanced and the corresponding outer diameter dimension value of the stoma portion 221 can be determined by the first mark 312 on the push rod connecting portion 27 or the push rod 43 and the second mark 314 on the sheath core 41. When the value of the outer diameter of the stoma portion 221 is adjusted to an accurate value, the source of ablation energy may be released to ablate the stoma 905 of the atrial septum 901. At this time, the temperature sensor 224 located near the stoma portion 221 will detect the ablation temperature, and the detected ablation temperature is fed back to the external control module, which controls the output of the ablation energy device to prevent the ablation temperature from being too high and causing adverse effects to the patient.
When ablation is complete, adjustment of the push rod operator 62 adjusts the outer diameter dimension of the stoma portion 221 to a minimum value. Then, the pull rod operating member 72 is adjusted to drive the sheath retracting adjusting member 453 to move proximally in the axial direction, and the sheath retracting adjusting member 453 tightens the sheath retracting connecting member 451 to retract the adjusting first positioning member 24 to be parallel to the stoma body 22 so as to prevent the obstruction of the retracting of the stoma 20 to the outer sheath 47.
When both steps are completed, the adjustment sheath operator 82 advances the outer sheath 47 forward (i.e., distally) until it reaches the junction of the stoma body 22 and the conical head 283. At this point the ostomy member 20 will be fully retracted into the outer sheath 47 and the ostomy device 100 is removed from the body, resulting in an ostomy 905 of defined stoma diameter.
The ostomy body 22 of the ostomy device 100 in this embodiment is inserted into the stoma of the atrial septum 901, and the radial dimension of the ostomy portion 221 of the ostomy body 22 is adjusted by controlling the push rod 43 to slide relative to the sheath core 41 through the diameter control assembly 60; and the exact radial dimension value of the stoma portion 221 is determined by the alignment of the first mark 312 with the second mark 314. Specifically, the push rod operating member 62 is rotated to drive the push rod driving member 61 to move axially, so as to adjust the diameter of the peripheral wall of the stoma portion 221, and the first mark 312 and the corresponding second mark 314 are aligned according to the size of the stoma diameter, so that the stoma portion 221 can open the stoma on the atrial septum to form a stoma 905 with an accurate diameter value; in addition, the first positioning element 24 is adjusted to be in a flattened state by rotating the pull rod operating element 72 to drive the pull rod driving element 71 to move in the axial direction, so as to facilitate the retraction of the ostomy element 20 into the sheath tube 47.
Referring to fig. 14-17 together, the ostomy device 100a according to the second embodiment of the present invention has a structure similar to that of the first embodiment, except that: in the second embodiment, the structure of the ostomy 20a is slightly different from the structure of the ostomy 20 in the first embodiment, in particular: the first supporting portion 223 is provided with a first avoiding groove 2231 corresponding to the first positioning rod 241, and when the first positioning member 24 is in the flat state, the first positioning rod 241 is accommodated in the first avoiding groove 2231; the second support portion 225 is provided with a second space-avoiding groove 2251 corresponding to the second positioning rod 261, and when the second positioning element 26 is in the flat state, the second positioning rod 261 is received in the second space-avoiding groove 2251, so as to facilitate the recovery of the stoma component 20a into the outer sheath 47.
As shown in fig. 16 and 17, each first supporting rod 2230 of the first supporting portion 223 is provided with a first avoiding groove 2231, the first avoiding groove 2231 extends along a length direction of the first supporting rod 2230, and a width of the first avoiding groove 2231 is greater than a width of the first positioning rod 241; the distal end of the first positioning rod 241 is connected to the corresponding ablation piece 2210, and the first positioning rod 241 corresponds to the first avoiding groove 2231. Preferably, the first space-avoiding groove 2231 is formed in the middle of the first supporting rod 2230, the distal end of the first space-avoiding groove 2231 extends to the stoma portion 221, and the proximal end of the first space-avoiding groove 2231 extends to the pushrod connecting portion 27. Each second support bar 2250 of the second support part 225 is provided with a second avoiding groove 2251, the second avoiding groove 2251 extends along the length direction of the second support bar 2250, and the width of the second avoiding groove 2251 is greater than the width of the second positioning bar 261; the proximal end of the second positioning rod 261 is connected to the corresponding ablation piece 2210, and the second positioning rod 261 corresponds to the second avoiding groove 2251. Preferably, a second avoidance groove 2251 is formed in the middle of the second support bar 2250, and the proximal end of the second avoidance groove 2251 extends to the stoma portion 221, and the distal end of the second avoidance groove 2251 extends to the sheath-core connection portion 28.
In this embodiment, each first support bar 2230 of the first support portion 223 of the stoma piece 20a is provided with a first avoiding groove 2231, each second support bar 2250 of the second support portion 225 is provided with a second avoiding groove 2251, when the first positioning member 24 and the second positioning member 26 of the stoma piece 20a are in the unfolded state, the first positioning bar 241 is received in the first avoiding groove 2231, and the second positioning bar 261 is received in the corresponding second avoiding groove 2231, so as to facilitate the recovery of the stoma piece 20a.
Preferably, the connection between each first positioning rod 241 and the corresponding ablation piece 2210 is in a circular arc transition, and the connection between the positioning section 2413 and the extending section 2414 of the first positioning rod 241 is in a circular arc transition. The connecting portion of each second positioning rod 261 and the corresponding ablation piece 2210 is in a circular arc transition, and the connecting portion of the second positioning portion 2612 and the extension portion 2614 of the second positioning rod 261 is in a circular arc transition. The above-described rounded transition in the ostomy 20a in this embodiment facilitates implantation of the ostomy device 100a and avoids tissue damage of the ostomy 20a during use.
The usage of the ostomy device 100a of the second embodiment of the present application is the same as that of the first embodiment and will not be described herein again.
Referring to fig. 18 and 19 together, the structure of the ostomy device according to the third embodiment of the present invention is similar to that of the first embodiment, except that: the structure of the ostomy 20b in the third embodiment is slightly different from the structure of the ostomy 20 in the first embodiment; that is, the shape of each first support 2230 of the first support 223 and each second support 2250 of the second support 225 of the ostomy member 20b in the third embodiment is different from the first example; specifically, the method comprises the following steps:
in the third embodiment, each first supporting rod 2230 of the first supporting portion 223 is Y-shaped, the first supporting rod 2230 includes a bar-shaped first rod 2232 at a proximal end thereof and a V-shaped second rod 2234 at a distal end of the first rod 2232, and one end of the first rod 2232 is connected to a tip of the second rod 2234. The end of the first rod 2232 of the first support rod 2230 away from the second rod 2234 is connected to the push rod connecting portion 27, and the two ends of the second rod 2234 of the first support rod 2230 away from the first rod 2232 are respectively connected to the two adjacent ablation blades 2210. Every two adjacent second rod bodies 2234 are connected to the corresponding ablation pieces 2210 at intervals, and the two second rod bodies 2234 enclose a first avoiding groove 2231; the distal end of each first positioning rod 241 is connected to the corresponding ablation piece 2210, the first positioning rod 241 is located between the two second rod bodies 2234 of the ablation piece 2210, and the first positioning rod 241 faces the first avoiding groove 2231. When the first positioning element 24 is in the flattened state, the first positioning rod 241 is accommodated in the first avoiding groove 2231.
Each of the second support bars 2250 of the second support 225 has an inverted Y shape, and the second support bars 2250 include a bar-shaped first bar 2252 at a distal end thereof and an inverted V-shaped second bar 2254 at a proximal end of the first bar 2252, and the proximal end of the first bar 2252 is connected to the tip of the second bar 2234. One end of the first rod 2252 of the second support bar 2250, which is far away from the second rod 2254, is connected to the sheath-core connecting portion 28, two ends of the second rod 2254 of the second support bar 2250, which are far away from the first rod 2252, are connected to two adjacent ablation pieces 2210, each two adjacent second rods 2254 are connected to the corresponding ablation pieces 2210 at intervals, and the two second rods 2254 enclose a second avoiding groove 2251; the proximal end of each second positioning rod 261 is connected to the corresponding ablation piece 2210, the second positioning rod 261 is located between two second rods 2254 of the ablation piece 2210, and the second positioning rod 261 faces the second avoiding groove 2251. When the second positioning element 26 is in the flat state, the second positioning rod 261 is accommodated in the second avoiding groove 2251.
In this embodiment, each of the first support bars 2230 of the first support portions 223 is Y-shaped and each of the second support bars 2250 of the second support portions 225 is inverted Y-shaped, so that the stoma body 22 has a more stable structure and can better support a stoma at a room partition.
The use of the ostomy device of the third embodiment of the present application is the same as the first embodiment and will not be described herein again.
Referring to fig. 20 and 21, the ostomy device according to the fourth embodiment of the present invention has a similar structure to the ostomy device of the first embodiment, except that: the structure of the ostomy 20c in the fourth embodiment is slightly different from the structure of the ostomy 20 in the first embodiment; specifically, the method comprises the following steps:
in the fourth embodiment, each first positioning portion 2412 of the first positioning rod 241 is a V-shaped rod, each connecting portion 2416 is a circular piece connected to the tip of the V-shaped rod, two ends of the V-shaped rod far away from the connecting portion 2416 are connected to two opposite sides of the proximal end of the corresponding ablation piece 2210, and the connecting holes 2417 are opened on the circular piece. The end of the V-shaped rod distal to the connection 2416 is connected to the stoma body 22. The first supporting portion 223 comprises a plurality of first supporting rods 2230 in the shape of a bar, two first supporting rods 2230 are provided on each ablation piece 2210, the proximal ends of the ablation pieces 2210 are connected to the distal ends of the two first supporting rods 2230, and the proximal ends of two adjacent first supporting rods 2230 of each two adjacent ablation pieces 2210 are close to each other and fixedly connected to the pushing rod connecting portion 27. In this embodiment, the end of each first positioning rod 241 of each ablation piece 2210 far away from the connecting portion 2416 corresponds to the distal ends of the two first supporting rods 2230 of the ablation piece 2210.
In other embodiments, the end of each first positioning rod 241 of each ablation piece 2210 remote from the connecting portion 2416 is offset from the distal ends of the two first supporting rods 2230 of the ablation piece 2210, and specifically, the end of each first positioning rod 241 of each ablation piece 2210 remote from the connecting portion 2416 is located between the distal ends of the two first supporting rods 2230 of the ablation piece 2210. When the first positioning element 24 is in the flattened state, the first positioning rod 241 is received in the gap between the two corresponding first supporting rods 2230.
Two second positioning rods 261 are provided on each ablation piece 2210 of the stoma portion 221, and the extending portions 2614 of the two second positioning rods 261 are connected to the end portions away from the second positioning portion 2612. The second supporting portion 223 includes a plurality of second supporting rods 2250, two second supporting rods 2250 are disposed on each ablation piece 2210, the distal ends of the ablation pieces 2210 are connected to the proximal ends of the two second supporting rods 2250, and the distal ends of two adjacent second supporting rods 2250 of each two adjacent ablation pieces 2210 are close to each other and fixedly connected to the sheath-core connecting portion 28. In this embodiment, the ends of the two second positioning rods 261 far from the extension 2614 on each ablation piece 2210 correspond to the proximal ends of the two second supporting rods 2250 on the ablation piece 2210, respectively.
In other embodiments, the ends of the two second positioning rods 261 on each ablation strip 2210 remote from the extension portion 2614 are respectively offset from the proximal ends of the two second support rods 2250 on the ablation strip 2210. Specifically, the ends of the two second positioning rods 261 on each ablation tile 2210 distal to the extension 2614 are located between the distal ends of the two second support rods 2250 on the ablation tile 2210; when the second positioning element 26 is in the flattened state, the second positioning rod 261 is received in the gap between the two corresponding second support rods 2250.
In this embodiment, each ablation piece 2210 is connected with two first support rods 2230 and two second support rods 2250, each first positioning rod 241 is a V-shaped rod, two second positioning rods 261 are disposed on each ablation piece 2210 at intervals, and distal ends of the two second positioning rods 261 are connected; making the structure of the ostomy member 20c more robust and facilitating the support of the ostomy by the ostomy member 20 c.
The usage of the ostomy device of the fourth embodiment of the present application is the same as the first embodiment and will not be described herein again.
Referring to fig. 22 and 23, the ostomy device according to the fifth embodiment of the invention has a similar structure to the ostomy device of the first embodiment, except that: the structure of the ostomy 20d in the fifth embodiment is slightly different from the structure of the ostomy 20 in the first embodiment; specifically, the method comprises the following steps:
in the fifth embodiment, each first positioning portion 2412 of the first positioning rod 241 is a V-shaped rod, each connecting portion 2416 is a circular ring, the tip of the V-shaped rod extends obliquely towards the proximal end, the circular ring is connected to the tip of the V-shaped rod, and two ends of the V-shaped rod, which are far away from the connecting portion 2416, are respectively connected to two adjacent ablation pieces 2210. The first support 223 includes a plurality of first support rods 2230 having a bar shape, a distal end of each first support rod 2230 being connected to a corresponding ablation blade 2210, and a proximal end of the first support rod 2230 being connected to the pusher connecting portion 27. A first avoiding groove 2231 is formed between each adjacent two of the first supporting rods 2230, and when the first positioning member 24 is in the unfolded state, the first positioning rod 241 is received in the first avoiding groove 2231. Preferably, a first support rod 2230 is disposed in the middle of the proximal end of each ablation piece 2210, and first positioning portions 2412 are respectively connected to the proximal ends of the ablation pieces 2210 on two opposite sides of the first support rod 2230. Preferably, the connection portion 2416 of the first positioning rod 241 is in arc transition with the connection portion 2412 of the first positioning rod, and the first positioning portion 2412 is in arc transition with the connection piece of the ablation piece 2210, so as to avoid the first positioning rod 241 scratching the tissue.
Two second positioning rods 261 are provided on each ablation piece 2210 of the stoma portion 221, and the extending portions 2614 of the two adjacent second positioning rods 261 on each adjacent two ablation pieces 2210 are connected with the end portions away from the second positioning portion 2612. The second support 225 includes a plurality of second support bars 2250 having a bar shape, each second support bar 2250 having a proximal end connected to a corresponding ablation blade 2210, and a distal end connected to the sheath-core connecting part 28 of the second support bar 2250. A second space-avoiding groove 2251 is formed between each two adjacent second support bars 2250, and when the second positioning element 26 is in the extended state, the second positioning rod 261 is received in the corresponding second space-avoiding groove 2231. Preferably, a second support bar 2250 is disposed at a middle portion of a distal end of each ablation piece 2210, and second positioning portions 2612 are respectively connected to two opposite sides of the second support bar 2250 at the distal end of the ablation piece 2210. Preferably, the joint of the second positioning portion 2612 and the extension portion 2614 of each second positioning rod 261 is in arc transition, and the second positioning portion 2612 is in arc transition with the connecting piece of the ablation piece 2210, so as to avoid the second positioning rod 261 scratching tissue.
When the first positioning member 24 and the second positioning member 26 of the ostomy member 20d in this embodiment are in the unfolded state, the first positioning rod 241 is received in the first avoiding groove 2231, and the second positioning rod 261 is received in the corresponding second avoiding groove 2231, so as to facilitate the recovery of the ostomy member 20d.
The use of the ostomy device according to the fifth embodiment of the present application is the same as that of the first embodiment and will not be described herein again.
Referring to fig. 24-26 together, a sixth embodiment of the present application provides an ostomy device 100e having a structure similar to that of the first embodiment except that: the structure of the ostomy 20e in the sixth embodiment is slightly different from the structure of the ostomy 20 in the first embodiment, and the structure of the sheathing combination in the sixth embodiment is slightly different from the structure of the sheathing combination 45 in the first embodiment; specifically, the method comprises the following steps:
the first locator 24 is distal to the end of the stoma body 22, and the sheathing pull rod 45a is moved axially relative to the sheath core 41 to adjust the first locator 24. Specifically, the first positioning member 24 comprises a plurality of first positioning rods 241, a distal end of each first positioning rod 241 is connected to the stoma body 22, a plurality of first positioning rods 241 are arranged in a circle along the circumference of the stoma body 22, and a proximal end of each first positioning rod 241 is connected to the sheath retracting pull rod 45a. That is, the sheathing combination in the sixth embodiment is the sheathing combination 45 of the first embodiment, in which the sheathing connection member 451 (i.e., the sheathing wire 4510) and the sheathing connection tube 4534 are omitted, and the distal end of the sheathing pull rod 45a may be directly connected to the proximal end of the first positioning rod 241. The sheath retracting pull rod 45a slides relative to the sheath core 41 along the axial direction, and can adjust the first positioning rod 241 to be in a bending state or a flattening state.
The first positioning rod 241 comprises a first positioning portion 2412 connected to the stoma main body 22 and a connecting portion 2416 connected to the proximal end of the first positioning portion 2412, wherein the connecting portion 2416 is connected to the sheath retracting lever 45a; in the bent state of the first positioning member 24, the middle portion of each first positioning portion 2412 is bent away from the stoma body 22. Specifically, the distal end of the first positioning portion 2412 is connected to the stoma body 22, and one end of the connecting portion 2416, which is away from the first positioning portion 2412, is connected to the sheathing tension rod 45a.
As shown in fig. 25 and 26, in the present embodiment, the first positioning portion 2412 includes a positioning section 2413 and a supporting section 2414, the positioning section 2413 extends obliquely from the main stoma body 22 to a direction away from the main stoma body 22, the supporting section 2414 bends from the end of the positioning section 2413 to the main stoma body 2414 and extends obliquely to gather at the connecting portion 2416, and the positioning section 2413 is used for abutting against the tissue; optionally, the surfaces of the positioning sections 2413 of the first positioning rods 241, which are attached to the tissue of the atrial septum, are umbrella surfaces, conical surfaces, cambered surfaces, or the like. The connecting portion 2416 is inserted into the push rod connecting portion 27, and an end portion of the connecting portion 2416 away from the first positioning portion 2412 is connected to the sheath retracting pull rod 45a; specifically, the positioning section 2413 is a V-shaped rod, the supporting section 2414 is an arc-shaped rod, the distal end of the arc-shaped rod is connected to the tip end of the V-shaped rod, the proximal end of the arc-shaped rod bends toward the first supporting portion 223 and extends obliquely to converge on the connecting portion 2416, the end of the V-shaped rod far away from the supporting section 2414 is connected to the stoma main body 22, and specifically, the two ends of the V-shaped rod far away from the supporting section 2414 are respectively connected to the two adjacent ablation pieces 2210. Specifically, the connecting portion 2416 is a bar-shaped rod, a distal end of the bar-shaped rod is connected to a proximal end of the corresponding supporting section 2414, and the proximal end of the bar-shaped rod passes through the push rod connecting portion 27 and then is connected to the sheath retracting pull rod 45a.
In other embodiments, the connecting portion 2416 of the first positioning rod 241 is omitted, and the proximal end of the supporting segment 2414 gathers toward the push rod connecting portion 27 and passes through the first supporting portion 223 and then passes out of the inner cavity of the push rod connecting portion 27 to form a connecting portion, which is fixedly connected to the sheath retracting pull rod 45a.
Preferably, the positioning section 2413 of the first positioning portion 2412 is radiused to the connecting web of the support section 2414 to avoid tissue damage by the stoma 20e during use. The intersection of the first positioning portion 2412 and the connecting portion 2416 is in arc transition, so that the bending and flattening of the first positioning member 24 are smoother.
The first support 223 includes a plurality of first support rods 2230 having a bar shape, a distal end of each first support rod 2230 being connected to a corresponding ablation blade 2210, and a proximal end of the first support rod 2230 being connected to the pusher connecting portion 27. A first avoiding groove 2231 is formed between every two adjacent first supporting rods 2230, and when the first positioning member 24 is in the unfolded state, the first positioning rod 241 is received in the first avoiding groove 2231. Preferably, the middle portion of the proximal end of each ablation piece 2210 is connected to the distal end of the corresponding first support rod 2230, and the proximal ends of the ablation pieces 2210 are respectively connected to the first positioning portions 2412 at two opposite sides of the first support rod 2230.
Two second positioning rods 261 are provided on each ablation piece 2210 of the stoma portion 221, the end portions of the second positioning portions 2612 of the two adjacent second positioning rods 261 away from the stoma portion 221 on each adjacent two ablation pieces 2210 are close to each other and contact with each other, and the extension portion 2614 of each second positioning rod 261 extends from the end of the second positioning portion 2612 in a bending manner in a direction away from the stoma portion 221. The second support part 225 includes a plurality of second support bars 2250 having a bar shape, each second support bar 2250 having a proximal end connected to the corresponding ablation piece 2210, and a distal end connected to the sheath-core connection part 28 of the second support bar 2250. A second avoiding groove 2251 is formed between each two adjacent second support rods 2250, and when the second positioning element 26 is in the extended state, the second positioning rod 261 is received in the corresponding second avoiding groove 2231. Preferably, a second support bar 2250 is disposed at a middle portion of a distal end of each ablation piece 2210, and second positioning portions 2612 are respectively connected to two opposite sides of the second support bar 2250 at the distal end of the ablation piece 2210. Preferably, the joint of the second positioning portion 2612 and the extension portion 2614 of each second positioning rod 261 is in arc transition, and the second positioning portion 2612 is in arc transition with the connecting piece of the ablation piece 2210, so as to avoid the second positioning rod 261 scratching tissue.
As shown in fig. 24, the distal end of the push rod 43 is connected to the push rod connecting portion 27, and the connecting portion 2416 of the first positioning member 24 is connected to the distal end of the sheath retracting lever 45a. As shown in figures 9, 24, 27-30, the ostomy device 100e is used in combination with the ablation power supply and power connection wires of the delivery device. The using method comprises the following steps:
the atrial septum 901 is punctured with a puncture mechanism, after puncturing, a guidewire is fed into the inferior vena cava 903, and the puncture kit is removed. Advancing the outer sheath 47 over the guidewire into the left atrium 906 and piercing the conical tip 283 through the interatrial septum 901 to the left atrium 906; causing the ostomy member 20e to be delivered to the atrial septum 901 site and viewing and positioning the visualization member 226 in the atrial septum 901 tissue. Rotating sheath operator 82 on housing 50 proximally withdraws outer sheath 47 to release second positioning member 26 of ostomy member 20 e; continued rotation of sheath operator 82 withdraws outer sheath 47 into the right atrium to release the entire ostomy member 20e.
When the stoma component 20e is released, the pull rod operating member 72 is rotated to move the sheath retracting pull rod 4532 axially and distally, and the sheath retracting pull rod 4532 adjusts the first positioning member 24 to release slowly. At this point, the atrial septum 901 will be confined between the first positioning member 24 and the second positioning member 26. The position of the stoma portion 221 on the atrial septum 901 can be adjusted by positioning the developer 226 on the stoma portion 221.
When the stoma portion 221 of the stoma 20e is adjusted to an appropriate position, the pusher operator 62 is rotated to adjust the value of the outer diameter dimension of the stoma portion 221. At this time, the specific position where the push rod 43 is advanced and the corresponding outer diameter dimension value of the stoma portion 221 can be determined by the first mark 312 on the push rod connecting portion 27 or the push rod 43 and the second mark 314 on the sheath core 41. When the value of the outer diameter of the stoma portion 221 is adjusted to an accurate value, the source of ablation energy may be released to ablate the stoma 905 of the atrial septum 901. At this time, the temperature sensor 224 located near the stoma portion 221 will detect the ablation temperature, and the detected ablation temperature is fed back to the external control module, which controls the output of the ablation energy device to prevent the ablation temperature from being too high and causing adverse effects to the patient.
When ablation is complete, adjustment of the push rod operator 62 adjusts the value of the outer diameter dimension of the stoma portion 221 to a minimum. The pull rod operator 72 is then adjusted to move the retraction pull rod 4532 proximally in the axial direction, and the retraction pull rod 4532 adjusts the first positioning member 24 to retract to be parallel to the stoma body 22 to prevent obstruction of retraction of the stoma 20 to the outer sheath 47. When both steps are completed, the adjustment sheath operator 82 advances the outer sheath 47 forward (i.e., distally) until it reaches the junction of the stoma body 22 and the conical head 283. At this point the ostomy member 20 will be fully retracted into the outer sheath 47 and the ostomy device 100e is removed from the body, resulting in an ostomy 905 of defined stoma diameter.
The ostomy body 22 of the ostomy device 100e in this embodiment is inserted into the stoma of the atrial septum 901, and the radial dimension of the ostomy portion 221 of the ostomy body 22 is adjusted by controlling the sliding of the pushing rod 43 relative to the sheath core 41 through the diameter adjusting component 60; and determining an accurate radial dimension value of the stoma portion 221 by the alignment of the first indicium 312 with the second indicium 314, such that the stoma portion 221 can distract the stoma at the atrial septum to form a stoma 905 of an accurate diameter value; in addition, the pull rod driving member 71 is driven to move axially by rotating the pull rod operating member 72 to drive the sheath retracting pull rod 45a to slide axially to directly adjust the first positioning member 24 to be in a flattened state, so as to facilitate the retraction of the ostomy member 20 into the sheath tube 47. Since the first positioning member 24 is directly connected to the sheath retracting pull rod 45a, compared with the first embodiment, the ostomy device 100e of the sixth embodiment omits the sheath retracting connecting tube 4534 and the sheath retracting connecting member 451, thereby saving material cost, avoiding connection and penetration of the sheath retracting, reducing manufacturing process and greatly reducing manufacturing cost; in addition, the direct connection of the first positioning member 24 to the sheath retracting lever 45a can improve the service life of the ostomy device 100 e.
Referring to fig. 31 and 32, the ostomy device according to the seventh embodiment of the present application is similar to the sixth embodiment in structure, except that: the structure of the ostomy 20f in the seventh embodiment is slightly different from the structure of the ostomy 20e in the sixth embodiment; in particular, the ram connection 27 comprises a number of connecting tabs 272, which connecting tabs 272 are arranged one turn in the circumferential direction of the ostomy member 20f, i.e. the connecting tabs 272 are arranged one turn in the circumferential direction of the sheath core relative to each other; the proximal ends of the support sections 2414 of the plurality of first positioning rods 241 converge toward the push rod coupling portion 223 and pass through the push rod coupling portion 223 to form a coupling portion 2416.
Specifically, a plurality of connecting pieces 272 correspond to a plurality of ablation pieces 2210 of the stoma portion 221 one by one, a first supporting rod 2230 is connected between each connecting piece 272 and the corresponding ablation piece 2210, and a connecting portion 2416 of each first positioning rod 241 is located between two adjacent connecting pieces 272. Preferably, the distal ends of the first support rods 2230 are connected to a middle portion of the proximal ends of the respective ablation blades 2210, and the proximal ends of the first support rods 2230 are connected to a middle portion of the distal ends of the respective attachment tabs 727.
In this embodiment, each of the attachment tabs 272 is a circular arc segment that is arranged in a circular ring configuration along the circumference of the ostomy main body 22.
In other embodiments, each connecting piece 272 can also be, but is not limited to, a rectangular piece, a circular piece, an oval piece, a polygonal piece, or the like.
In the embodiment, a gap is formed between every two adjacent connecting sheets 727 in the push rod connecting part 27, so that when the ostomy piece 20f is assembled to the sheath tube assembly 40, the supporting section 2414 is conveniently inserted into the push rod connecting part 27 from the gap and then connected with the sheath retracting pull rod 45a; the first positioning rod 241 is more conveniently and simply connected with the push rod connecting portion 27, and efficiency is improved.
The usage of the ostomy device of the seventh embodiment of the present application is the same as the first embodiment and will not be described herein again.
Referring to fig. 33-34 together, the eighth embodiment of the present application provides an ostomy device having a similar structure to the sixth embodiment except that: the structure of the ostomy 20g in the eighth embodiment is slightly different from the structure of the ostomy 20e in the sixth embodiment; that is, the shape of each first support 2230 of the first support 223 of the ostomy member 20g and the shape of each second support 2250 of the second support 225 in the eighth embodiment are different from those in the sixth embodiment; and the structure of the first positioning rod 241 and the structure of the second positioning rod 261 in the eighth embodiment are different from those in the sixth embodiment. Specifically, the method comprises the following steps:
in the eighth embodiment, each of the first supporting rods 2230 of the first supporting portion 223 is Y-shaped, the first supporting rod 2230 includes a first rod 2232 having a bar shape at a proximal end thereof and a second rod 2234 having a V shape at a distal end of the first rod 2232, and one end of the first rod 2232 is connected to a tip of the second rod 2234. The end of the first rod 2232 of the first support rod 2230 away from the second rod 2234 is connected to the push rod connecting portion 27, and the two ends of the second rod 2234 of the first support rod 2230 away from the first rod 2232 are respectively connected to the two adjacent ablation blades 2210. Every two adjacent second rod bodies 2234 are connected to the corresponding ablation pieces 2210 at intervals, and the two second rod bodies 2234 enclose a first avoiding groove 2231; the positioning section 2413 and the supporting section 2414 of each first positioning rod 241 are bar-shaped rods, the end of the positioning section 2413 far away from the supporting section 2414 is connected to the corresponding ablation piece 2210, and the end of the supporting section 2414 far away from the positioning section 2413 passes through the push rod connecting part 27 to form a connecting part 2416. Specifically, the push rod connection portion 27 is a connection barrel, and the proximal ends of the support sections 2414 of the first positioning rods 241 are gathered towards the connection barrel to pass through the connection barrel to form a connection portion 2416. The first positioning rod 241 is located between the two second rods 2234 of the ablation plate 2210, and the first positioning rod 241 faces the first avoiding groove 2231. When the first positioning element 24 is in the flattened state, the first positioning rod 241 is accommodated in the first avoiding groove 2231. The connection portion 2416 is a tube inserted into the inner cavity of the push rod connection portion 27.
Each of the second support bars 2250 of the second support 225 has an inverted Y shape, and the second support bars 2250 include a bar-shaped first bar 2252 at a distal end thereof and an inverted V-shaped second bar 2254 at a proximal end of the first bar 2252, and the proximal end of the first bar 2252 is connected to the tip of the second bar 2234. One end of the first rod 2252 of the second support bar 2250, which is far away from the second rod 2254, is connected to the sheath-core connecting portion 28, two ends of the second rod 2254 of the second support bar 2250, which are far away from the first rod 2252, are connected to two adjacent ablation pieces 2210, each two adjacent second rods 2254 are connected to the corresponding ablation pieces 2210 at intervals, and the two second rods 2254 enclose a second avoiding groove 2251; the second positioning portion 2612 and the extension portion 2614 of each second positioning rod 261 are both bar-shaped rods, the proximal end of the extension portion 2614 is connected to the corresponding ablation piece 2210, the second positioning rod 261 is located between two second rod bodies 2254 of the ablation piece 2210, and the second positioning rod 261 faces the second avoiding groove 2251. When the second positioning element 26 is in the flat state, the second positioning rod 261 is accommodated in the second avoiding groove 2251.
In this embodiment, each of the first support bars 2230 of the first support portions 223 is Y-shaped and each of the second support bars 2250 of the second support portions 225 is inverted Y-shaped, so that the stoma body 22 has a more stable structure and can better support a stoma at a room partition.
Preferably, the joint of the positioning section 2413 and the support section 2414 of each first positioning rod 241 is in arc transition; the connection part of each first positioning rod 241 and the ablation piece 2210 is in arc transition; the joint of the second positioning portion 2612 and the extension portion 2614 of each second positioning rod 261 is in arc transition; the connection between each second positioning rod 261 and the ablation piece 2210 is in arc transition; to avoid the ostomy member 20g scratching the tissue.
The usage of the ostomy device of the eighth embodiment of the present application is the same as that of the sixth embodiment, and is not described herein again.
Referring to fig. 35-36 together, a ninth embodiment of the present application provides an ostomy device having a similar structure to the sixth embodiment except that: the structure of the ostomy 20h in the ninth embodiment is slightly different from the structure of the ostomy 20e in the sixth embodiment; that is, the shape of each first support 2230 of the first support 223 and each second support 2250 of the second support 225 of the ostomy member 20h in the ninth embodiment is different from that of the sixth embodiment; and the structure of the first positioning rod 241 and the structure of the second positioning rod 261 in the ninth embodiment are different from those in the sixth embodiment. Specifically, the method comprises the following steps:
in the ninth embodiment, each first supporting rod 2230 of the first supporting portion 223 is Y-shaped, the first supporting rod 2230 includes a bar-shaped first rod 2232 at a proximal end thereof and a V-shaped second rod 2234 at a distal end of the first rod 2232, and one end of the first rod 2232 is connected to a tip of the second rod 2234. The end of the first rod 2232 of the first support rod 2230 away from the second rod 2234 is connected to the push rod connecting portion 27, and the two ends of the second rod 2234 of the first support rod 2230 away from the first rod 2232 are respectively connected to the two adjacent ablation blades 2210. Each adjacent two second rods 2234 are connected to the corresponding ablation strip 2210 in a spaced-apart manner. The positioning section 2413 of each first positioning rod 241 is a V-shaped rod, the supporting section 2414 of the first positioning rod 241 is a bar-shaped rod, the bar-shaped rod is connected to the tip end of the V-shaped rod, and two ends of the positioning section 2413 far away from the supporting section 2414 are respectively connected to two adjacent ablation pieces 2210, so that the positioning section 2413 corresponds to the corresponding second rod 2234; the end of the supporting section 2414 far from the positioning section 2413 passes through the corresponding first rod 2232 near the pushrod connecting portion 27, and then extends from the inner cavity of the pushrod connecting portion 27. When the first positioning rod 24 is in the flat state, the positioning section 2413 is attached to the corresponding second rod 2234, and the supporting section 2414 is attached to the corresponding first rod 2232.
Each first supporting rod 2230 of the second supporting portion 225 has an inverted Y shape, the first supporting rod 2230 includes a bar-shaped first rod 2252 at a distal end thereof and an inverted V-shaped second rod 2254 at a proximal end of the first rod 2252, and one end of the first rod 2252 is connected to a tip of the second rod 2254. The end of the first shaft 2252 of the first supporting rod 2230 away from the second shaft 2254 is connected to the sheath-core connecting part 28, and the ends of the second shaft 2254 of the first supporting rod 2230 away from the first shaft 2232 are connected to two adjacent ablation pieces 2210 respectively. Each adjacent two second rods 2234 are connected to the corresponding ablation strip 2210 in a spaced-apart manner. The second positioning portion 2612 of each second positioning rod 261 is of an inverted Y-shaped structure, the second positioning portion 2612 of the second positioning rod 261 is a strip-shaped rod, and two ends of the second positioning portion 2612 far away from the extension portion 2614 are respectively connected to the two adjacent ablation pieces 2210, so that the second positioning portion 2612 corresponds to the corresponding second rod body 2254; the extension part 2614 extends away from the end of the second positioning part 2612 in a direction away from the mouthpiece part 221. When the second positioning rod 261 is in the flat state, the second positioning portion 2612 is attached to the corresponding second rod body 2234, and the extending portion 2614 is attached to the corresponding first rod body 2232.
In this embodiment, since each of the first support bars 2230 of the first support portions 223 is Y-shaped, each of the second support bars 2250 of the second support portions 225 is Y-shaped, the positioning section 2413 is Y-shaped, and the second positioning portion 2612 is Y-shaped, the stoma main body 22 is more stable in structure and can better support a stoma at a room partition.
Preferably, the connection between the positioning segment 2413 and the support segment 2414 of each first positioning rod 241 is radiused to avoid scoring the tissue by the stoma 20 g.
The usage of the ostomy device of the ninth embodiment of the present application is the same as that of the sixth embodiment, and is not described herein again.
Referring to fig. 37-38 together, a tenth embodiment of the present application provides an ostomy device having a structure similar to that of the sixth embodiment except that: the structure of the ostomy 20i in the tenth embodiment is slightly different from the structure of the ostomy 20e in the sixth embodiment; that is, the shape of each first support 2230 of the first support 223 of the ostomy member 20e and the shape of each second support 2250 of the second support 225 in the tenth embodiment are different from those in the sixth embodiment; and the structure of the first positioning rod 241 and the structure of the second positioning rod 261 in the tenth embodiment are different from those in the sixth embodiment. Specifically, the method comprises the following steps:
in the tenth embodiment, the first supporting portion 223 includes a plurality of first supporting rods 2230, two first supporting rods 2230 are connected to each ablation piece 2210, specifically, the distal ends of two first supporting rods 2230 are connected to two opposite sides of the proximal end of the corresponding ablation piece 2210, and the proximal ends of two first supporting rods 2230 are connected to the rod connecting portion 27 after approaching each other; a first space-avoiding groove 2231 is formed between the two first supporting rods 2230. The first positioning portion 2412 includes a positioning section 2413 and a supporting section 2414, the end of the positioning section 2413 far from the supporting section 2414 is connected to the corresponding ablation piece 2210, and the end of the supporting section 2414 far from the positioning section 2413 is bent towards the first supporting portion 223 and passes through the proximal end of the corresponding first avoiding groove 2231 to be connected to the connecting portion 2416. In this embodiment, the connection portion 2416 is a cylinder inserted into the inner cavity of the push rod connection portion 27, and the distal end of the support section 2414 is connected to the distal end of the cylinder; the proximal end of the barrel is connected to the distal end of a sheath retracting lever 45a. When the first positioning rod 241 is in the expanded state, the first positioning rod 241 is accommodated in the first avoiding groove 2231.
The second supporting portion 225 comprises a plurality of second supporting rods 2250, each ablation piece 2210 is connected to two of the second supporting rods 2250, the proximal ends of the two second supporting rods 2250 are connected to two opposite sides of the distal end of the corresponding ablation piece 2210, and the distal ends of the two second supporting rods 2250 are connected to the pushing rod connecting portion 27 after approaching each other; a second space-avoiding groove 2251 is formed between the two second support bars 2250. The second positioning rod 261 includes a strip-shaped second positioning portion 2612 and a strip-shaped extending portion 2614, and an end portion of the second positioning portion 2612 away from the extending portion 2614 is connected to the corresponding ablation piece 2210. The distal end of the extension 2614 is provided with a circular plate. When the second positioning element 26 is in the expanded state, the second positioning rod 261 is received in the corresponding second avoiding groove 2231.
The push rod connecting portion 27 in this embodiment is a connecting cylinder, the positioning section 2413 and the supporting section 2414 are both bar-shaped structures, the connecting portion 2416 is a cylinder body movably penetrating through the connecting cylinder along the axial direction, and the proximal ends of the supporting sections 2414 of the plurality of first positioning rods 241 are gathered together.
In this embodiment, since two first support rods 2230 are connected to the proximal end of each ablation piece 2210, two second support rods 2250 are connected to the distal end of each ablation piece 2210, and the support section 2414 of each first positioning portion 2412 passes through the corresponding first clearance groove 2231 and then is connected to the connection portion 2416, the structure of the stoma member 20i is more stable, and a stoma opening in a room partition can be better supported.
Preferably, the connection between the positioning segment 2413 and the support segment 2414 of each first positioning rod 241 is radiused to avoid scoring the tissue by the stoma 20 g.
The usage of the ostomy device of the tenth embodiment of the present application is the same as the sixth embodiment, and is not repeated herein.
Referring to fig. 39-41 together, the eleventh embodiment of the present application provides an ostomy device having a similar structure to that of the sixth embodiment except that: the structure of the stoma 20j and the structure of the sheath assembly 40a in the eleventh embodiment are slightly different from the structure of the stoma 20e and the structure of the sheath assembly 40 in the sixth embodiment; specifically, the method comprises the following steps: the pushrod connection 27 comprises a plurality of connecting tabs 272, which connecting tabs 272 are arranged in a circle in the circumferential direction of the ostomy member 20j, i.e. the connecting tabs 272 are arranged in a circle spaced from each other in the circumferential direction of the sheath core; the proximal ends of the support sections 2414 of the first positioning rods 241 converge toward the rod connecting portion 223 to a position close to the outer peripheral surface of the rod connecting portion 27 to form a connecting portion 2416. That is, the connection portion 2416 of the first positioning member 24 is sleeved outside the push rod connection portion 27.
Specifically, a plurality of connecting plates 272 correspond to a plurality of ablation pieces 2210 of the stoma portion 221 one by one, a first supporting rod 2230 is connected between each connecting plate 272 and the corresponding ablation piece 2210, and a connecting portion 2416 of each first positioning rod 241 is located between two adjacent connecting plates 272. Preferably, the distal end of the first support rod 2230 is connected to the middle of the proximal end of the corresponding ablation pad 2210, and the proximal end of the first support rod 2230 is connected to the middle of the distal end of the corresponding connecting pad 727.
As shown in fig. 39, the sheath assembly 40a includes a sheath core 302, a push rod 43 axially slidably sleeved on the sheath core 302, a sheath retracting rod 45a axially slidably sleeved on the push rod 43, and an outer sheath 305 axially slidably sleeved on the sheath retracting rod 45a; the sheath core connection 28 of the ostomy member 20j is fixedly connected to the distal end of the sheath core 302, the pushrod connection 27 of the ostomy member 20j is fixedly connected to the distal end of the pushrod 43, and the connection 2416 is fixedly connected to the distal end of the sheath retracting pull rod 45a.
The usage of the ostomy device of the eleventh embodiment of the present application is the same as that of the sixth embodiment, and is not described herein again.
Referring to fig. 42, an ostomy device according to a twelfth embodiment of the present application is similar in structure to the ostomy device according to the eleventh embodiment, except that: the plunger connecting portion 27 is a connecting tube, and the connecting portions 2416 of the first positioning levers 241 of the first positioning member 24 are provided around the outer periphery of the plunger connecting portion 27.
The usage of the ostomy device of the twelfth embodiment of the present application is the same as that of the eleventh embodiment, and is not described herein again.
Referring to fig. 43, the structure of an ostomy device provided by a thirteenth embodiment of the present application is similar to that of the first embodiment, except that: the mark combination further includes a third mark 315 disposed on the housing 50 and a fourth mark 316 disposed on the push rod operating element 62, and the push rod operating element 62 moves relative to the housing 50 to drive the fourth mark 316 to align with the third mark 315. Referring to fig. 9 and fig. 43, the push rod operating element 62 rotates relative to the housing to drive the push rod driving element 61 to move axially, and the push rod driving element 61 drives the push rod 43 to slide axially, so as to adjust the outer diameter of the stoma; when the fourth mark 316 is aligned with the third mark 315, the outer diameter of the stoma portion is dimensioned, e.g. to a value C. C may be any value, e.g., C may be 6mm, 7mm, 8mm, 9mm, 10mm, 12mm, etc. The third mark 315 is a mark or symbol provided on the housing 50, and the fourth mark 316 is a mark or symbol provided on the push-lever operation member 62.
In this embodiment, a plurality of third marks 315 are arranged on the outer surface of the housing 50 near the push-rod operating member 62 along the circumferential direction of the housing 50, and a fourth mark 316 is disposed on the outer surface of the push-rod operating member 62 near the plurality of third marks 315; the rotation of the push rod operating member 62 relative to the housing 50 drives the push rod connecting portion 27 to move axially, so that the fourth mark 316 is aligned with one of the third marks 315, respectively, to obtain different radial dimension values of the stoma portion.
Referring to fig. 44, a fourteenth embodiment of the present application provides an ostomy device having a structure similar to that of the thirteenth embodiment except that: a third marking 315 is provided on the outer surface of the housing 50 adjacent the push-stick operator 62; a plurality of fourth marks 316 are arranged along the circumferential direction of the push-stick operating member 62 near the third mark 315 by the push-stick operating member 62; rotation of the plunger actuator 62 relative to the housing 50 causes the plunger coupling portion 27 to move axially such that the third mark 315 is aligned with one of the fourth marks 316 to obtain different radial dimension values of the stoma portion.
In other embodiments, the marking combination of the ostomy device comprises only the first mark 312 provided on the push rod 43 or the push rod connection 27 and the second mark 314 provided on the sheath core 41; or the marking combination of the ostomy device comprises only the third marking 315 and the fourth marking 316 provided between the housing 50 and the push-stick operator 62.
Referring to fig. 45, the present application further provides an ostomy system comprising an ostomy device according to any of the above embodiments, a controller 110, and an ablation energy source 120, the controller 110 being adapted to control the ostomy device to ostomy tissue, the ablation energy source 120 being adapted to provide ablation energy to the ostomy device. In this embodiment, the ablation energy source 120 is a radio frequency power source which is electrically connected to the lead 432 of the ostomy device via the controller 110 such that the stoma portion 221 is electrically connected to the radio frequency power source, the stoma portion 221 contacting the atrial septum and ablating the stoma.
The foregoing is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also regarded as the protection scope of the present invention.
Claims (22)
1. An ostomy device, characterized in that it comprises:
an ostomy member for forming an ostomy on tissue, the ostomy member comprising a radially expandable ostomy body and a first positioning element connected to the ostomy body; and
the sheath tube assembly comprises a sheath core, a push rod and a sheath retracting combination, the push rod is movably sleeved on the sheath core along the axial direction, one end of the stoma body is connected to the sheath core, the other end of the stoma body is connected to the push rod, and the push rod moves relative to the sheath core to adjust the radial size of the stoma body; the sheath retracting combination is connected to the position, far away from the stoma body, of the first positioning piece, the first positioning piece is in a bending state or a flattening state relative to the stoma body, and the sheath retracting combination moves axially relative to the sheath core so as to adjust the first positioning piece to be changed between the bending state and the flattening state.
2. The ostomy device of claim 1, wherein the ostomy member further comprises a push rod connection at the proximal end of the ostomy body, the push rod being connected to the push rod connection, the push rod or the push rod connection being provided with a first marking, the sheath core being provided with a second marking, the push rod being axially movable relative to the sheath core to bring the first marking into alignment with the second marking to determine the radial diameter of the ostomy body.
3. The ostomy device of claim 2, wherein the first indicia is a first visualization and the second indicia is a second visualization.
4. The ostomy device of claim 3, wherein the sheath-core arranges a plurality of the second developing members along an axial direction thereof, and the push rod drives the push rod connecting portion to move along the axial direction to align the first developing member with one of the plurality of second developing members, respectively, to obtain different radial dimension values of the stoma body.
5. The ostomy device of claim 3, wherein the push rod connecting portion or push rod arranges a plurality of the first developing members along an axial direction thereof, and the push rod moves relative to the sheath core along the axial direction to align the second developing member with one of the plurality of the first developing members, respectively, to obtain different values of radial dimension of the stoma body.
6. The ostomy device according to any one of claims 3-5, wherein the first and second developing members are developing rings, developing wires or developing dots.
7. Ostomy device according to any of claims 1-5, wherein the ostomy body is provided with a positioning visualization along its circumference.
8. The ostomy device according to any one of claims 1-5, wherein the sheathing combination comprises a sheathing connection member and a sheathing adjustment member, the sheathing connection member is connected between the first positioning member and the sheathing adjustment member, and the sheathing adjustment member moves axially relative to the sheath core to drive the sheathing connection member to adjust the first positioning member.
9. The ostomy device of claim 8, wherein the first positioning member comprises a plurality of first positioning rods, one end of each first positioning rod is connected to the stoma body, the plurality of first positioning rods are arranged in a circle along the circumference of the stoma body, the sheathing connection member comprises a plurality of sheathing wires, the plurality of sheathing wires are in one-to-one correspondence with the plurality of first positioning rods, one end of each sheathing wire is connected to the end of the corresponding first positioning rod away from the stoma body, and the other end of each sheathing wire is connected to the sheathing adjustment member.
10. The ostomy device of claim 9, wherein the first positioning rod comprises a first positioning portion connected to the ostomy body and a connecting portion connected to the first positioning portion remote from the ostomy body, the sheathing wire being connected to the connecting portion.
11. The ostomy device of claim 10, wherein the first positioning portion is a strip-shaped structure, the first positioning portion comprises a positioning section connected to the ostomy main body and an extending section connected to an end of the positioning section far away from the ostomy main body, the connecting portion is connected to a distal end of the extending section far away from the positioning section, and the sheathing wire is connected to the connecting portion.
12. The ostomy device of claim 10, wherein the first positioning portion connecting portion is a V-shaped bar, the connecting portion being connected to a tip of the V-shaped bar, an end of the V-shaped bar remote from the connecting portion being connected to the ostomy body.
13. The ostomy device of claim 9, wherein the sheath retracting adjusting member comprises a sheath retracting pull rod, the sheath retracting pull rod is axially slidably sleeved on the sheath core, and a plurality of sheath retracting wires are connected to the sheath retracting pull rod.
14. The ostomy device of claim 13, wherein the sheath retraction adjusting member further comprises a sheath retraction connecting cylinder axially sleeved on the sheath core, the sheath retraction connecting cylinder is connected to the sheath retraction pull rod, and a plurality of the sheath retraction wires are connected to the sheath retraction connecting cylinder.
15. The ostomy device of claim 1, wherein the sheathing combination comprises a sheathing pull rod movably sleeved on the sheath core in the axial direction, the sheathing pull rod is connected to an end of the first positioning member away from the ostomy body, and the sheathing pull rod moves in the axial direction relative to the sheath core to adjust the first positioning member.
16. The ostomy device of claim 15, wherein the first positioning member comprises a plurality of first positioning rods, each first positioning rod having a distal end connected to the stoma body, the plurality of first positioning rods being arranged in a circle around the circumference of the stoma body, and each first positioning rod having a proximal end connected to the sheathing pull rod.
17. The ostomy device of claim 16, wherein the first positioning bar comprises a first positioning portion connected to the ostomy body and a connecting portion connected to a proximal end of the first positioning portion, the connecting portion being connected to the sheathing pull rod, and a middle portion of each first positioning portion is curved away from the ostomy body in the bent state of the first positioning member.
18. The ostomy device of claim 17, wherein the first positioning portion comprises a positioning section extending obliquely away from the ostomy body and a supporting section bent from a distal end of the positioning section towards the ostomy body and extending obliquely to the connecting portion, the positioning section being adapted to abut against the tissue.
19. The ostomy device of claim 18, wherein the ostomy member further comprises a push rod connecting portion disposed at the proximal end of the ostomy body, the push rod being connected to the push rod connecting portion, the push rod connecting portion being a connecting cylinder, the positioning section and the supporting section being bar-shaped rods, the proximal ends of the supporting sections of the first positioning rods being gathered towards the connecting cylinder and passing through the connecting cylinder to form the connecting portion.
20. The ostomy device of claim 18, wherein the ostomy member further comprises a push rod connecting portion disposed at the proximal end of the ostomy main body, the push rod is connected to the push rod connecting portion, the push rod connecting portion is a connecting cylinder, the positioning section and the supporting section are both bar structures, the connecting portion is a cylinder body movably disposed in the connecting cylinder along the axial direction, and the proximal ends of the supporting sections of the first positioning rods gather the cylinder body.
21. The ostomy device of claim 18, wherein the positioning section is a V-shaped bar, the distal end of the support section being connected to the tip of the V-shaped bar, the end of the V-shaped bar distal to the support section being connected to the ostomy body.
22. An ostomy system, characterized by: an ostomy device according to any of claims 1-21 comprising a controller for controlling the ostomy device for ostomy tissue, an ablation energy source for providing ablation energy to the ostomy device, and an ostomy device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202123448294.9U CN217744573U (en) | 2021-12-31 | 2021-12-31 | Ostomy device and ostomy system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202123448294.9U CN217744573U (en) | 2021-12-31 | 2021-12-31 | Ostomy device and ostomy system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN217744573U true CN217744573U (en) | 2022-11-08 |
Family
ID=83868593
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202123448294.9U Active CN217744573U (en) | 2021-12-31 | 2021-12-31 | Ostomy device and ostomy system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN217744573U (en) |
-
2021
- 2021-12-31 CN CN202123448294.9U patent/CN217744573U/en active Active
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US10398547B2 (en) | Implant with anchoring device for heart valve disease | |
| US10639060B2 (en) | Method and catheter for creating an interatrial aperture | |
| US9775636B2 (en) | Devices, systems, and methods for treating heart failure | |
| US20220110679A1 (en) | Atrial septostomy device | |
| EP1042990B1 (en) | Ablation catheter for isolating a pulmonary vein | |
| US6610056B2 (en) | Multi-function surgical instrument | |
| EP3892212A1 (en) | Thrombus removal device | |
| US20140114246A1 (en) | Apparatus and method for targeting a body tissue | |
| CN112603524B (en) | Interatrial septum tissue stoma device and interatrial septum group weaving mouth system | |
| CN211934206U (en) | Valve tissue cutting device and valve clamp recovery system | |
| CN113693782A (en) | Valve dilator and valve dilation system | |
| CN212346702U (en) | Multi-component interatrial septum stoma system and interatrial septum stoma device thereof | |
| CN217744573U (en) | Ostomy device and ostomy system | |
| US20210346045A1 (en) | Leaflet grasping and cutting device | |
| CN212346703U (en) | Adjustable interatrial septum ostomy device | |
| CN212630960U (en) | Valve dilator and valve dilation system | |
| CN111166462A (en) | Interatrial septum stoma device and interatrial septum stoma system with improved ablation effect | |
| CN116407254A (en) | Ostomy device and ostomy system | |
| CN116407256A (en) | Ostomy device and ostomy system | |
| CN116407255A (en) | Adjustable interatrial septum ostomy device | |
| CN113116468A (en) | Valve tissue cutting device and valve clamp recovery system | |
| CN217040239U (en) | Atrium ostomy device | |
| US20220287842A1 (en) | Percutaneous minimally invasive posterior ventricular artificial chordae devices and systems and methods for repair of mitral regurgitation in a beating heart | |
| US20230301784A1 (en) | Surgical system for excising a valve | |
| CN112998839A (en) | Adjustable interatrial septum ostomy device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant |