CN114642497A

CN114642497A - Interatrial septum ostomy device and system

Info

Publication number: CN114642497A
Application number: CN202011518115.1A
Authority: CN
Inventors: 王永胜; 董元博; 高国庆
Original assignee: Hangzhou Nuosheng Medical Technology Co ltd
Current assignee: Hangzhou Nuosheng Medical Technology Co ltd
Priority date: 2020-12-21
Filing date: 2020-12-21
Publication date: 2022-06-21

Abstract

The invention discloses an interatrial septum stoma device and an interatrial septum stoma system, and relates to the field of medical instruments. According to the invention, the stoma part for cutting and ablating tissues is arranged on the periphery of the balloon, and the stoma part is driven by the balloon to realize the cutting function and the ablation function of the tissues, so that the tissues can be conveniently expanded to the target diameter, and the stoma is more uniform in shape and difficult to close; meanwhile, the tissue after the stoma can be ablated by utilizing the ablation function so as to obtain a more durable tissue stoma, reduce the hidden trouble caused by tissue resilience and reduce the risk of thrombus generation in and/or after the operation.

Description

Interatrial septum ostomy device and system

Technical Field

The invention relates to the field of medical equipment, in particular to an interatrial septum ostomy device and system.

Background

Interatrial septum ostomy is a treatment for heart failure that can be used to treat pulmonary hypertension (right-to-left shunting) or left heart failure (left-to-right shunting) by creating a shunt in the left and right atrial chambers through a stoma in a patient, the effectiveness of which has been clinically proven.

Among the current interatrial septum ostomies, like the sacculus interatrial septum ostomies, it utilizes current interatrial septum to make the mouthful device and treats, directly tears to a long banding stoma, and the postoperative easily has the trend that myocardial tissue kick-backs in the stoma department, causes the problem that the stoma reduces even closed.

Disclosure of Invention

The invention provides an interatrial septum ostomy device and system aiming at the problem that postoperative tissues are easy to rebound to cause stoma shrinkage and even closure when an existing device is used for performing interatrial septum ostomy.

The technical scheme provided by the invention for the technical problem is as follows:

in one aspect, the present invention provides a septal ostomy device comprising a stoma body comprising a radially expandable and contractible balloon,

an ostomy part for cutting and ablating tissues is arranged on the periphery of the balloon.

According to the interatrial septum ostomy device described above, the ostomy portion comprises a cutting blade for cutting tissue and the cutting blade is connected via a wire to a power source for ablating tissue.

According to the interatrial septum ostomy device, the ostomy portion comprises a cutting blade and an ablation electrode, the cutting blade is used for cutting the tissue, and the ablation electrode is connected with a power supply through a lead and is used for ablating the tissue.

According to the atrial septal ostomy device, the ablation electrodes and the cutting blades are arranged at intervals according to a preset interval, and at least one ablation electrode is arranged between every two adjacent cutting blades.

According to the interatrial septum ostomy device described above, the cutting blade is connected to the power source via a wire and is also used for ablating tissue.

According to the interatrial septum ostomy device, the ablation electrodes are distributed and arranged according to preset intervals, and the cutting blades are distributed and arranged on part or all of the ablation electrodes according to the preset intervals.

According to the interatrial septum ostomy device described above, the cutting blade is connected to a power source via a wire, or the cutting blade is electrically connected to the ablation electrode, to also be used for ablating tissue.

According to the interatrial septum ostomy device, the cutting blades and the ablation electrodes are mutually and uniformly distributed on the periphery of the balloon.

According to the atrial septal ostomy device, the cutting blade and the ablation electrode are bonded or welded on the balloon body.

According to the above described interatrial septum stoma device, the body of the cutting blade is a unitary body, or comprises a plurality of sub-blades arranged at predetermined spaced intervals, or comprises a plurality of sub-blades arranged in series.

According to the atrial septal ostomy device, one side of the cutting blade, which is in contact with the balloon body, is of a wavy structure, and the sunken part of the wavy structure is of a semicircular shape or a T-shaped shape.

According to the interatrial septum ostomy device, the transverse section of the cutting blade is triangular or trapezoidal, and the edge angle of the cutting blade ranges from 30 degrees to 40 degrees.

According to the atrial septal ostomy device, at least one end of the cutting blade in the extending direction of the cutting edge is provided with a smooth part which is transited to the balloon body.

According to the interatrial septum ostomy device, the balloon is in the shape of an elliptic cylinder or a 8-shaped cylinder in the inflated state.

In another aspect, the present invention also provides an interatrial septum ostomy system comprising a power supply, a delivery conduit and an interatrial septum ostomy device as described above, the power supply being adapted to supply electrical energy to the interatrial septum ostomy device, the ostomy body of the interatrial septum ostomy device being arranged in the delivery conduit in a collapsed state, the delivery conduit delivering the interatrial septum ostomy device to a predetermined position.

The technical scheme provided by the embodiment of the invention has the following beneficial effects:

the outer periphery of the balloon is provided with a stoma part for cutting and ablating tissues, the stoma part is driven by the balloon to realize the cutting function and the ablation function of the tissues, the tissues are conveniently expanded to the target diameter, the stoma shape is more uniform and the stoma is not easy to close; meanwhile, the tissue after the stoma can be ablated by utilizing the ablation function so as to obtain a more durable tissue stoma, reduce the hidden trouble caused by tissue resilience, obtain a continuous tissue stoma without implanting any instrument and cutting off and taking out a tissue block, and reduce the risk of thrombus generation in and/or after the operation.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic view of the schematic structure of the interatrial septum ostomy device of the invention;

FIG. 2 is a schematic view of a septum ostomy device according to the invention in a first embodiment;

FIG. 3 is a schematic view of a septum ostomy device according to a second embodiment of the invention;

FIG. 4 is a schematic view of a septum ostomy device according to a third embodiment of the invention;

FIG. 5 is a schematic view of a fourth embodiment of the interatrial septum ostomy device of the invention;

FIG. 6 is a schematic diagram of a septum manufacturing apparatus according to a first embodiment of the present invention applied to a septum ostomy system;

FIG. 7 is a schematic structural diagram of a second embodiment of a compartmental ostomy device of the invention for use in a compartmental ostomy system;

FIG. 8 is a schematic structural diagram of a third embodiment of a compartmental ostomy device of the invention for use in a compartmental ostomy system;

FIG. 9 is a schematic structural diagram of a fourth embodiment of a compartmental ostomy device of the invention in use in a compartmental ostomy system;

FIG. 10 is a schematic diagram of a fifth embodiment of an interatrial septum device of the present invention in use in an interatrial septum ostomy system;

FIG. 11 is a schematic view of a first embodiment of a cutting insert according to the present invention;

FIG. 12 is a second embodiment of a cutting insert according to the present invention;

FIG. 13 is a schematic view of a third embodiment of a cutting insert according to the present invention;

fig. 14 is a schematic view of a transverse cross-sectional configuration of a cutting blade provided in accordance with the present invention.

The labels in the figures illustrate:

1. an interatrial septum ostomy device; 11. a stoma body; 111. a balloon; 112. a stoma portion;

1', a interatrial septum ostomy device; 11', a stoma body; 111', balloon; 112', a stoma portion; 1121', cutting blade;

1' and atrial septal ostomy devices; 11' and a stoma body; 111 ", balloon; 112 ", a stoma portion; 1121 ", cutting blade; 1122', an ablation electrode;

1', a compartmental ostomy device; 11', a stoma body; 111', balloon; 112', a stoma portion; 1121 ", cutting blade; 1122', an ablation electrode;

1', atrial septal ostomy device; 11', a stoma body; 111', balloon; 112', a stomal portion; 1121 ", cutting blades; 1122' and an ablation electrode;

2. an interatrial septum ostomy system; 21. a delivery catheter; 22. an interatrial septum ostomy device; 221. a stoma body; 2211. a balloon; 2212. a stoma portion; 22121. a cutting blade; 23. a wire;

3. an interatrial septum ostomy system; 31. a delivery catheter; 32. an interatrial septum ostomy device; 321. a stoma body; 3211. a balloon; 3212. making a mouth; 32121. 32121', 32121 ″, cutting blade; 32122. an ablation electrode; 33. a wire;

4. an interatrial septum ostomy system; 41. a delivery catheter; 42. an interatrial septum ostomy device; 421. a stoma body; 4211. a balloon; 4212. a stoma portion; 42121. a cutting blade; 42122. an ablation electrode; 43. a wire;

5. an interatrial septum ostomy system; 51. a delivery catheter; 52. an interatrial septum ostomy device; 521. a stoma body; 5211. a balloon; 5212. a stoma portion; 52121. a cutting blade; 52122. an ablation electrode; 53. a wire;

6. an interatrial septum ostomy system; 61. a delivery catheter; 62. an interatrial septum ostomy device; 621. a stoma body; 6211. a balloon; 6212. a stoma portion; 62121. a cutting blade; 62122. an ablation electrode; 63. and (4) conducting wires.

Detailed Description

To make the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Referring to fig. 1, which is a schematic structural view of the interatrial septum ostomy device of the present invention, the interatrial septum ostomy device 1 comprises an ostomy body 11 for ostomy tissue, the ostomy body 11 may comprise a radially expandable and contractible balloon 111, the transformation of the balloon 111 from the contracted state to the expanded state may be achieved by pressurizing the balloon 111, and the transformation of the expanded state to the contracted state may be achieved by depressurizing the balloon 111.

On the outer circumference of the balloon 111, there is a stoma portion 112 for cutting and ablating tissue, it being understood that the stoma portion 112 is carried by the balloon 111 to perform the corresponding treatment operation: when the balloon 111 is changed from the contracted state to the expanded state, the stoma portion 112 is brought into contact with the tissue by the balloon 111 body and presses and cuts the tissue, thereby completing the cutting treatment operation of the tissue, and during the expansion or when the tissue is expanded to a target diameter, the ablation treatment operation of the stoma formed by the cutting is also completed; when the balloon 111 is changed from the inflated state to the deflated state, the stoma portion 112 is separated from the tissue and recovered by the balloon 111 body, thereby completing the recovery process operation.

In the atrial septal ostomy device 1 provided by the invention, the ostomy part 112 on the balloon 111 has the functions of cutting and ablating tissues, so that the tissues can be conveniently expanded to a target diameter, the formed ostomy caliber is more uniform and tends to be round-like, and the problem that the existing balloon ostomy is a long-strip wound which is directly torn and is easy to close can be avoided. Meanwhile, the tissue after the stoma can be ablated by using the ablation function so as to obtain a more durable tissue stoma, reduce hidden dangers brought by tissue resilience, obtain a persistent tissue stoma without implanting any instrument and cutting off and taking out tissue blocks, and reduce the risk of thrombus generation in and/or after the operation.

In the interatrial septum ostomy device 1 provided by the invention, the ostomy part 112 can be provided with a cutting blade to realize the cutting of tissues, and can also be provided with an ablation electrode to realize the ablation of the tissues; alternatively, the stoma portion 112 is provided with a cutting blade that performs both a cutting function and an ablation function.

Referring to fig. 2, there is shown a schematic view of the atrial septal ostomy device of the present invention in a first embodiment. The atrial septal ostomy device 1 'comprises an ostomy body 11' for expanding atrial septal tissue, the ostomy body 11 'comprises a balloon 111' capable of expanding and contracting radially, an ostomy portion 112 'for realizing an ostomy function is arranged on the periphery of the balloon 111', the ostomy portion 112 'comprises a cutting blade 1121' for cutting tissue, and a metal portion is arranged on the cutting blade 1121 'and can be connected with a power supply through a lead for ablating tissue, so that the cutting blade 1121' can realize a cutting function and an ablating function on the tissue.

It is understood that when the cutting blade 1121 'is made of a metal material as a whole, the metal portion may be the body of the cutting blade 1121', and the metal material may be copper, silver, gold, stainless steel, nickel-titanium alloy, or the like. When the cutting blade 1121 'comprises a non-metallic material such as ceramic, the metal part may be disposed on a cutting surface or a non-cutting surface of the cutting blade 1121'.

As shown in fig. 2, the balloon 111 'is in the inflated state, the stoma portion 112' is specifically located at the middle or substantially middle position (also referred to as the waist position) of the balloon 111 ', three cutting blades 1121' are disposed on the stoma portion 112 ', the three cutting blades 1121' are uniformly distributed, each cutting blade 1121 'cuts tissue in a direction away from the center of the balloon 111' during the expansion of the balloon 111 'to form a quasi-circular stoma, and at this time, the cut tissue can be ablated in real time by the metal portion of the cutting blade 1121' that is energized.

The interatrial septum ostomy device 1 ' of the present embodiment may be delivered to the site to be dilated, i.e. the preset position, by a delivery catheter (not shown) via a delivery device (not shown), after the stoma 112 ' is at the site to be dilated, the cutting blade 2121 is powered on to an ablative energy source such as a radio frequency source, and the balloon 111 ' is slowly dilated by pressing the balloon 111 ', and the cutting blade 1121 ' on the balloon 111 ' will continuously cut the tissue at the stoma along the radial direction of the balloon 111 ' during the dilation. During the whole process, the RF energy continuously heats the tissue to contracture through the cutting blade 1121 'on the balloon 111' to achieve a desired shunt opening. Meanwhile, the uniformly distributed cutting blades 1121 'help the balloon 111' to easily expand the tissue to a target diameter, and the formed stoma aperture tends to be more circular-like, so that the problem that the existing balloon stoma is easily closed due to a long-strip wound which is directly torn can be solved. And the tissue of the stoma is ablated by the metal portion on the cutting blade 1121' so as to obtain a more durable tissue stoma and reduce the hidden trouble caused by tissue rebounding. After the pressure of the balloon 111' is released after the ablation is completed, the ostomy device is recovered through the catheter and withdrawn from the body, so that a continuous tissue stoma can be obtained without implanting any instruments and without cutting out and removing tissue masses, and the risk of thrombus during and/or after the operation is reduced.

It will be appreciated that in other embodiments, the number of cutting blades 1121 ' is preferably two or more, and is uniformly distributed over the stoma portion 112 ' at the entire periphery of the balloon 111 '. The number of cutting blades 1121 'may be determined based on the size of the balloon 111', the target diameter of the expansion, and the like.

In this embodiment, the balloon may be made of polymer materials such as nylon, PET (thermoplastic polyester, or saturated polyester), and silica gel, which are all insulating materials. The cutting blades 1121 'may be fixed on the outer surface of the balloon 111' by adhesion, in other embodiments, the body of the balloon 111 'or the waist portion thereof may also be made of a metal conductive material, the cutting blades 1121' are welded on the waist portion of the balloon 111 ', or are integrally formed with the balloon 111', and the portion of the body of the balloon 111 'except for the portion connected with the cutting blades 1121' is coated with an insulating structure, so as to obtain the body of the balloon 111 'meeting the cutting requirement and the conductive requirement, in this case, the material of the metal conductive material of the body of the balloon 111' or the waist portion thereof may be copper, silver, gold, stainless steel, nickel-titanium alloy, and the like.

Referring to fig. 3, which is a schematic view of the structure of the atrial septum ostomy device according to the second embodiment of the invention, the atrial septum ostomy device 1 "comprises a stoma body 11" for distracting the tissue of the atrial septum, the stoma body 11 "comprises a radially expandable and contractible balloon 111", and a stoma 112 "for achieving the stoma function is arranged on the outer circumference of the balloon 111", in the present embodiment, the stoma 112 "comprises a cutting blade 1121" and an ablation electrode 1122 ", wherein the cutting blade 1121" is used for incising the tissue, and the ablation electrode 1122 "is electrically connected with a power supply for ablating the tissue.

In this embodiment, the ablation electrodes 1122 "and the cutting blades 1121" may be arranged at intervals at a predetermined interval, at least one ablation electrode 1122 "is included between two adjacent cutting blades 1121", and the number of the cutting blades 1121 "and the number of the ablation electrodes 1122" may be determined according to the size of the balloon 111 ", the target diameter of the expansion, and other factors.

As shown in fig. 3, the stoma portion 112 ″ is located at the middle or substantially middle position of the balloon 111 ″, three cutting blades 1121 ″ are uniformly disposed on the stoma portion 112 ″, and a plurality of ablation electrodes 1122 ″ are uniformly arranged between the cutting blades 1121'. During "expansion" of the balloon 111 ", the individual cutting blades 1121" cut tissue in a direction away from the center of the balloon 111 "to form a circular-like stoma, while the energized ablation electrodes 1122" ablate the cut tissue and the area near the tissue in real time.

The atrial septum stoma device 1 ″ of the present embodiment may be delivered to the site to be dilated by a delivery catheter (not shown) via a delivery device (not shown), and after the stoma 112 ″ is located at the site to be dilated, the dilated balloon 111 ″ may drive the cutting blade 1121 ″ thereon to cut the tissue, thereby achieving the dilatation of the tissue. The uniformly distributed cutting blades 1121' help the balloon 111 ″ to easily expand the tissue to a target diameter, and the formed stoma aperture tends to be circular, the circular stoma aperture is not easy to close due to the tissue endothelium attachment growth, and the problem that the existing balloon stoma is easy to close for a directly torn strip wound is solved. Meanwhile, the tissue after the stoma can be ablated by the ablation electrode 1122' so as to obtain a more durable tissue stoma, reduce the hidden trouble caused by tissue rebound, and reduce the risk of thrombus generation during and/or after the operation.

In this embodiment, the cutting blade 1121 ″ may be adhesively secured to the outer surface of the balloon 111 ″, in which case the adhesive material may be polyamide or the like. Of course, the cutting blades 1121 "may also be formed on the outer surface of the balloon 111", i.e., by integrally forming the body of the balloon 111 "and the cutting blades 1121" on the balloon 111 ". The cutting blades 1121 ″ may be made of metal, such as stainless steel or nitinol. In some application scenarios, the cutting blade 1121 ″ may also be a non-metallic material, such as ceramic, etc.

It is understood that when the cutting blade 1121 "is made of metal, the cutting blade 1121" can also be connected with a power source through a wire to ablate the tissue, and in this case, both the cutting blade 1121 "and the ablation electrode 1122" have ablation functions.

In this embodiment, the ablation electrode 1122 ″ may be an external metal pad, and at this time, the ablation electrode 1122 ″ may be fixed on the balloon 111 ″ by welding or bonding. Of course, when the balloon 111 ″ is made of metal, the ablation electrode 1122 ″ may also be formed on the outer surface of the balloon 111 ″, that is, by integrally forming the metal electrode pad (as an ablation electrode) on the body of the balloon 111 ″, and the balloon 111 ″, in which case, the cutting blade 1121 ″ may be made of non-metal material or metal material.

In this embodiment, the ablation electrode 1122 ″ is preferably a flexible electrode, and the entire or outer surface thereof is preferably made of a metal with good electrical conductivity, such as copper, silver, gold, etc., and may be oval, rectangular with rounded corners, or other shapes.

Referring to fig. 4, there is shown a schematic view of a septum ostomy device according to a third embodiment of the present invention. The atrial septum stoma device 1 ″ comprises a stoma body 11 ″ which can prop apart atrial septum tissues, the stoma body 11 ″ specifically comprises a radially expandable and contractible balloon 111 ″, a stoma portion 112 ″ which specifically realizes a stoma function is arranged on the outer circumference of the balloon 111 ″, and the stoma portion 112 ″ comprises a cutting blade 1121 ″ and an ablation electrode 1122 ″, wherein the cutting blade 1121 ″ is used for cutting the tissues, and the ablation electrode 1122 ″ is connected with a power supply through a lead to ablate the tissues, which is different from the first and second embodiments in that the cutting blades 1121 ″ are arranged on the ablation electrode 1122', and correspond to each other.

As shown in FIG. 4, the balloon 111 "is in the inflated state, the stoma 112" is located at the middle or substantially middle position of the balloon 111 ", three ablation electrodes 1122" are uniformly distributed on the stoma 112 ", and one cutting blade 1121" is disposed on each ablation electrode 1121 ". During expansion of the balloon 111', the cutting blades 1121 "cut tissue in a direction away from the center of the balloon 111" to form a quasi-circular stoma, and at this time, the ablation electrode 1122 "under the cutting blades 1121" can ablate the cut tissue in real time. In addition, when the cutting blade 1121 "is made of a metal material, the cutting blade 1121" may also be connected to a power source through a wire, or the cutting blade 1121 "is electrically connected to the ablation electrode 1122", such as welding, that is, the cutting blade 1121 "may also be used to ablate tissue, so as to ablate tissue at a cutting position in multiple directions, thereby further improving the stability and aperture accuracy of a stoma.

The atrial septum stoma device 1 '″ of the present embodiment may be delivered to the site to be dilated by a delivery catheter (not shown) via a delivery device (not shown), and after the stoma portion 112' ″ is at the site to be dilated, the dilated balloon 111 '″ may drive the cutting blade 1121' ″ thereon to cut the tissue, thereby achieving the dilation of the tissue. Meanwhile, the uniformly distributed cutting blades 1121 '"help the balloon 111'" to easily expand the tissue to a target diameter, and the formed stoma aperture tends to be more circular-like, so that the problem that the existing balloon stoma is easily closed due to a long-strip wound which is directly torn can be solved. Meanwhile, the tissue of the stoma may be ablated by the ablation electrodes 1122' to obtain a more permanent tissue stoma, which may reduce the risk of tissue recoil, and a permanent tissue stoma may be obtained without implanting any instruments and without cutting and removing tissue mass, which may reduce the risk of thrombus during and after the operation.

It is understood that the number of the ablation electrodes 1122 ' may be determined according to the ablation requirement, and the ablation electrodes 1122 ' may be fixed on the balloon 111 ' by bonding or welding.

It will be appreciated that the cutting blade 1121 "may be a non-metallic material, in which case the cutting blade 1121" may be attached to the ablation electrode 1122 "by bonding or snapping; the cutting blade 1122 'may be made of a metal material, and the cutting blade 1121' may be integrally formed with the ablation electrode 1122 'or may be connected to the ablation electrode 1122' by bonding, welding or clipping.

Referring to fig. 5, there is shown a schematic view of a fourth embodiment of the interatrial septum ostomy device of the invention. The atrial septum stoma device 1 "comprises a stoma body 11" for spreading apart atrial septum tissue, the stoma body 11 "specifically comprises a radially expandable and contractible balloon 111", a stoma portion 112 "for specifically realizing a stoma function is arranged on the outer circumference of the balloon 111", the stoma portion 112 "comprises a cutting blade 1121" and an ablation electrode 1122 ", wherein the cutting blade 1121" is used for cutting tissue, and the ablation electrode 1122 "is connected with a power supply through a lead wire to ablate the tissue, which is different from the previous embodiment in that the cutting blade 1121" is arranged on a part of the ablation electrode 1122 ".

As shown in FIG. 5, with the balloon 111 "in the inflated state, the stoma 112" is located at or substantially at the middle of the balloon 111 ", with a piece of cutting blade 1121" provided on three of the ablation electrodes 1122 "evenly distributed over the stoma 112". During the expansion of the balloon 111 ", the individual cutting blades 1121" cut the tissue in a direction away from the center of the balloon 111 "to form a circular-like stoma, and at this time, the portion of the ablation electrode 1122" under the cutting blades 1121 "can ablate the cut tissue in real time, and the portion of the ablation electrode 1122" between the ablation cutting blades 1121 "also ablates the tissue. Similarly, when the cutting blade 1121 "is made of metal material, it can also be connected to a power source through a wire, or the cutting blade 1121" is electrically connected to the ablation electrode 1122 "such as welding, i.e., the cutting blade 1121" can also be used for ablating tissue, so as to further achieve multi-directional ablation of tissue at the cutting position, and further improve the stability and aperture accuracy of the stoma.

It will be appreciated that, again, the cutting blade 1121 "may be a non-metallic material, in which case the cutting blade 1121" may be attached to the ablation electrode 1122 "by bonding or snapping; the cutting blades 1122 'may be made of a metal material, and the cutting blades 1121' may be integrally formed with the ablation electrodes 1122 'or may be connected to the ablation electrodes 1122' by bonding, welding or clipping.

The atrial septum stoma device 1 "of the present embodiment may be delivered to the site to be dilated by a delivery catheter (not shown) via a delivery device (not shown), and after the stoma 112" is at the site to be dilated, the dilated balloon 111 "may drive the cutting blade 1121" thereon to perform tissue dissection, thereby achieving tissue dilation. Meanwhile, the uniformly distributed cutting blades 1121 "also help the balloon 111" to easily expand the tissue to a target diameter, and the formed stoma aperture tends to be circular-like, so that the problem that the existing balloon stoma is easily closed due to a long-strip wound which is directly torn can be avoided. Meanwhile, the tissue of the stoma can be ablated by the ablation electrode 1122 'under the cutting blade 1121' and between adjacent cutting blades, the ablation effect is better, a more durable tissue stoma can be obtained, the hidden danger caused by tissue rebounding can be reduced, and a persistent tissue stoma can be obtained without implanting any instrument and taking out tissue blocks, and the risk of thrombus generation in and after the operation is reduced.

Fig. 6 is a schematic structural diagram of a first specific application example of the interatrial septum manufacturing device of the present invention applied to an interatrial septum ostomy system. The interatrial septum ostomy system 2 comprises a power source (not shown), a delivery device (not shown), a delivery catheter 21 and an interatrial septum ostomy device 22 movably arranged on the delivery catheter 21, wherein the delivery device (not shown) is used to drive the interatrial septum ostomy device 22 along the delivery catheter 21 to the site to be dilated, and the power source is used to provide the interatrial septum ostomy device 22 with electrical energy for ablation.

The interatrial septum ostomy device 22 of this particular application corresponds to the configuration of the first embodiment of fig. 2, wherein the interatrial septum ostomy device 22 comprises an ostomy body 221, the ostomy body 221 comprising a balloon 2211, where the balloon 2211 is in a full inflated state, being in the shape of an elliptic cylinder. An opening 2212 is arranged in the middle of the elliptic cylinder of the balloon 2211, three cutting blades 22121 for cutting tissues are arranged on the opening 2212, the three cutting blades 22121 are uniformly distributed on the opening 2212 to form a structure surrounding the short axis circumference of the elliptic cylinder, and the cutting blades 22121 are connected with a power supply through a lead 23 to ablate the tissues.

In this application example, the cutting blade 22121 has a blade structure having a metal portion electrically connected to a power source via the lead 23, and in this case, the cutting blade 22121 has both a function of cutting a tissue and a function of ablating the tissue.

In operational use, the interatrial septum ostomy device 22 is first placed into the delivery catheter 21 with the balloon 2211 in a deflated state in the interatrial septum ostomy device 22. Thereafter, the stent is conveyed to a site to be expanded, i.e., a preset position, through the conveying pipe 21 by the driving of the conveyor. Then, the balloon 2211 is pressurized to inflate the balloon 2211 and finally inflated to a set size to expand the tissue to a target diameter, while during inflation of the balloon 2211, the tissue is cut by the cutting blades 22121, the uniformly distributed cutting blades 2121 help the balloon 2211 to easily expand the tissue to the target diameter, and the formed stoma aperture tends to be more circular-like, which can avoid the problem that the existing balloon stoma is easily closed due to a long-strip wound which is directly torn. Meanwhile, the cutting blade 22121 with the metal part can also melt the cut tissue so as to obtain a more durable tissue stoma, reduce the hidden danger caused by tissue rebound and better improve the retraction phenomenon of the tissue after stoma; and a continuous tissue stoma can be obtained without implanting any instruments and without cutting out and removing tissue masses, reducing the risk of thrombus during and/or after surgery.

Fig. 7 is a schematic structural diagram of a second specific application example of the interatrial septum manufacturing device of the present invention applied to an interatrial septum ostomy system. The interatrial septum ostomy system 3 also comprises a power source (not shown), a delivery device (not shown), a delivery catheter 31 and an interatrial septum ostomy device 32 movably arranged on the delivery catheter 31, the delivery device (not shown) being adapted to drive the interatrial septum ostomy device 32 along the delivery catheter 31 against the site to be dilated and the power source being adapted to supply the interatrial septum ostomy device 32 with electrical energy for ablation.

The structure of the application example is different from that of the specific application example:

the interatrial septum ostomy device 32 in this particular application corresponds to the construction of the second embodiment in fig. 3, wherein the interatrial septum ostomy device 32 comprises an ostomy body 321, the ostomy body 321 comprising a balloon 3211, where the balloon 3211 is in an inflated state and is likewise in the shape of an elliptic cylinder. A stoma portion 3212 is arranged at the middle position of the elliptic cylindrical body of the balloon 3211, three cutting blades 32121 for cutting tissue are arranged on the stoma portion 3212, and the three cutting blades 32121 are uniformly distributed on the stoma portion 3212 to form a structure around the short axis circumference of the elliptic cylindrical body. An ablation electrode 32122 is disposed between adjacent cutting blades 32121, and the ablation electrode 32122 is connected to a power source via a lead 33 for ablating tissue. Here, the shape of the ablation electrode 32122 includes, but is not limited to, an elliptical configuration.

In this specific application example, the ablation electrodes 32122 and the cutting blades 32121 are disposed at intervals, and at least one ablation electrode 32122 is disposed between two adjacent cutting blades 32121. Further, the ablation electrodes 32122 may also be disposed at predetermined intervals. As shown in fig. 7, in one embodiment, adjacent ablation electrodes 32122 are equally spaced apart, and three ablation electrodes 32122 are disposed between adjacent cutting blades 3212.

In operational use, as with the first embodiment, during inflation of the balloon 3211, the tissue is cut with the cutting blades 32121, the evenly distributed cutting blades 32121 facilitate easier expansion of the balloon 3211 to a target diameter, and the resulting stoma opening is more rounded, avoiding the problem of easy closure of a long wound, which is a direct tear in a conventional balloon stoma. Meanwhile, the arranged ablation electrode 32122 can ablate tissues so as to obtain a more durable tissue stoma, reduce the risk of thrombus generation in and after the operation, also reduce the hidden trouble caused by tissue resilience, and reduce the risk of thrombus generation in and/or after the operation.

Fig. 8 is a schematic structural diagram of a third specific application example of the interatrial septum manufacturing device of the present invention applied to an interatrial septum ostomy system. The interatrial septum ostomy system 4 also comprises a power source (not shown), a delivery device (not shown), a delivery catheter 41 and an interatrial septum ostomy device 42 movably arranged on the delivery catheter 41, whereby the interatrial septum ostomy device 42 is driven along the delivery catheter 41 by the delivery device (not shown) to the site to be dilated and the power source provides the interatrial septum ostomy device 42 with electrical energy for ablation.

The interatrial septum ostomy device 42 includes a stoma body 421, the stoma body 421 including a balloon 4211, where the balloon 4211 is in an inflated state and is likewise in the shape of an elliptical cylinder. A stoma portion 4212 is arranged at the middle position of the elliptic cylinder of the balloon 4211, three cutting blades 42121 for cutting tissues are arranged on the stoma portion 4212, and the three cutting blades 42121 are uniformly distributed on the stoma portion 4212 to form a structure surrounding the short axis of the elliptic cylinder in the circumferential direction. An ablation electrode 42122 is disposed between adjacent cutting blades 42121, and the ablation electrode 42122 is connected to a power source via a lead 43 for ablating tissue.

The present embodiment is a variant structure corresponding to the second embodiment in fig. 7, except that the cutting blade 42121 in the present embodiment may be made of metal, in this case, the cutting blade 42121 may be further connected to the lead 43 to ablate tissue, in this case, both the cutting blade 42121 and the ablation electrode 42122 may ablate the cut tissue and the tissue around the cut tissue, and the ablation effect is better.

Fig. 9 is a schematic structural diagram of a fourth specific application example of the interatrial septum manufacturing device of the invention applied to an interatrial septum ostomy system. The interatrial septum ostomy system 5 likewise comprises a power source (not shown), a delivery device (not shown), a delivery catheter 51 and an interatrial septum ostomy device 52 movably arranged on the delivery catheter 51, whereby the delivery device (not shown) is used to drive the interatrial septum ostomy device 52 along the delivery catheter 51 against the site to be dilated and the power source provides the interatrial septum ostomy device 52 with electrical energy for ablation.

The structure difference from the specific application example is as follows:

the interatrial septum ostomy device 52 in this particular application corresponds to the construction of the fourth embodiment in fig. 5, wherein the interatrial septum ostomy device 52 comprises an ostomy body 521, the ostomy body 521 comprising a balloon 5211, where the balloon 5211 is in an inflated state and is likewise in the shape of an elliptic cylinder. A stoma portion 5212 is arranged at the middle position of the elliptic cylinder of the balloon 5211, three cutting blades 52121 and a plurality of ablation electrodes 52122 for cutting tissues are arranged on the stoma portion 5212, the ablation electrodes 52122 are distributed at preset intervals, the three cutting blades 52121 are respectively arranged on part of the ablation electrodes 52122, and the cutting blades 52121 are distributed at preset intervals to form a structure surrounding the short axis circumference of the elliptic cylinder. The ablation electrode 52122 is connected to a power source via lead 53 for ablating tissue. And the cutting blade 52121 can also be connected to a power source via a wire, or the cutting blade 52121 can be electrically connected to the ablation electrode 52122, such as by welding, i.e., the cutting blade 52121 can also be used for ablating tissue, so as to ablate tissue at the cutting site in multiple directions, and further improve the stability and aperture accuracy of the stoma.

In operational use, as with the previous embodiment, during inflation of the balloon 5211, the cutting blades 52121 are used to cut tissue, the evenly distributed cutting blades 52121 help the balloon 5211 to more easily expand the tissue to a target diameter, and the resulting stoma opening is more rounded, avoiding the problem of easy closure of an elongated wound that is directly torn by a conventional balloon stoma. Meanwhile, the arranged ablation electrode 52122 can also ablate tissues so as to obtain a more durable tissue stoma, reduce the hidden trouble caused by tissue resilience, and obtain a continuous tissue stoma without implanting any instrument and cutting off and taking out tissue blocks, thereby reducing the risk of thrombus generation during and/or after the operation.

It will be appreciated that, as a variation of this particular application, a cutting blade 52121 may be provided on each ablation electrode 52122, in which case the atrial septal ostomy device corresponds to the configuration of the third embodiment of fig. 4, to accomplish the same: the problem that the existing balloon stoma is easily closed due to a directly torn strip wound is solved. Meanwhile, the arranged ablation electrode can also ablate tissues so as to obtain a more durable tissue stoma, reduce hidden dangers caused by tissue resilience, obtain a continuous tissue stoma without implanting any instrument or cutting off and taking out tissue blocks, and reduce the risk of thrombus generation in and/or after the operation.

Referring to fig. 10, a schematic structural diagram of a fifth specific application example of the interatrial septum manufacturing device of the present invention in an interatrial septum ostomy system is shown. The interatrial septum ostomy system 6 also includes a power source (not shown), a delivery device (not shown), a delivery catheter 61 and an interatrial septum ostomy device 62 movably disposed on the delivery catheter 61, the delivery device (not shown) being adapted to drive the interatrial septum ostomy device 62 along the delivery catheter 61 against the site to be dilated, and the power source being adapted to provide the interatrial septum ostomy device 62 with electrical energy for ablation.

The structure difference from the specific application example is as follows:

the interatrial septum ostomy device 62 in this particular application example comprises an ostomy body 621, the ostomy body 621 comprising a balloon 6211 in an inflated, loaded, form of a 8-shaped cylinder. The 8-shaped columnar body is provided with a stoma portion 6212 at a recessed position, the stoma portion 6212 is provided with three cutting blades 62121 for cutting tissue, and the three cutting blades 62121 are uniformly distributed on the stoma portion 6212 to form a structure surrounding the minor axis of the elliptic columnar body in the circumferential direction. An ablation electrode 62122 is disposed between adjacent cutting blades 62121, and an ablation electrode 62122 is connected to a power source via a lead 63 for ablating tissue. Here, the shape of the ablation electrode 62122 includes, but is not limited to, a rounded rectangular configuration.

In other embodiments, the number of cutting blades 62121 and ablation electrodes 62122 described above can be determined based on the size of the balloon 6211, the target diameter of the dilation, and the like.

In other embodiments, the distribution of the cutting blades 62121 of the 8-shaped cylindrical balloon 6211 and the ablation electrodes 62122, as well as the connection to the power source, may also include, but are not limited to, the distribution and connection relationships of fig. 2-9, and will not be described herein again.

In operational use, as with the previous embodiment, during inflation of the balloon 6211, the tissue is cut using the cutting blades 62121, the evenly distributed cutting blades 62121 help the balloon 6211 to more easily expand the tissue to a target diameter, and the resulting stoma opening is more rounded, avoiding the problem of an easily closed elongated wound that is a direct tear in a conventional balloon stoma. Meanwhile, the arranged ablation electrode 62122 can also ablate tissues so as to obtain a more durable tissue stoma, and also can reduce the hidden trouble caused by tissue rebound and reduce the risk of thrombus generation in and/or after the operation. It is understood that the balloon 6211 may also be other shapes, such as a drop shape.

Referring to fig. 11 to 13, fig. 11 is a schematic structural view of a first application of the cutting insert of the present invention; FIG. 12 is a schematic view of a second embodiment of a cutting insert according to the present invention; fig. 13 is a schematic view of a third application of the cutting insert of the present invention. As shown in fig. 11, referring to the cutting blade structure in fig. 6, the side of the cutting blade 32121 contacting the balloon body is in a wave-like structure, and the concave portion of the wave-like structure is in a T shape. As shown in fig. 12, in order to correspond to a variant structure shown in fig. 11, the recessed portion of the wavy structure of the cutting blade 32121' is semicircular.

In fig. 11 and 12, the overall flexibility of the cutting blade can be improved by the wavy structure, so as to better match the expansion and contraction structure of the balloon, and avoid unnecessary cutting.

It will be appreciated that the body of the cutting blade of fig. 11 and 12 is in the shape of a rounded rectangle, which may also be trapezoidal or rounded, etc., depending on the tissue cutting requirements.

In the cutting blade provided by the invention, at least one end of the cutting blade in the extending direction of the cutting edge is preferably provided with a smooth part which is transited to the balloon body, namely, the smooth part is arranged at the position of the end part round corner R corresponding to the end part round corner R in the figures 11 and 12, so that the situation that the end part of the cutting blade does not need to be cut can be avoided, and the relative accuracy of cutting is ensured.

As shown in fig. 13, in another variation of the cutting blade, the cutting blade 32121 "includes a plurality of sub-blades arranged at predetermined intervals, so as to also achieve the purpose of improving the overall flexibility of the cutting blade 32121". Here, the sub-blades are T-shaped structures, the cutting edges are located on the transverse portion of the T-shaped structures, and the vertical portion of the T-shaped structures is used for connecting with the balloon. In another variation of the structure of fig. 13, the cutting blade 32121 ″ may include a plurality of sub-blades arranged in a row, each sub-blade being arranged relatively more compactly.

It will be appreciated that the cutter body structure illustrated in fig. 11-13 may be applied to any of the cutting inserts of fig. 2-10. Of course, the cutting blade may be provided without the wavy structure and/or without the sub-blade structure according to different cutting requirements.

Referring to fig. 14, a schematic diagram of a transverse cross-sectional structure of a cutting blade according to the present invention is provided, which can correspond to the cutting blade structure in fig. 6, the transverse cross-section of the cutting blade 32121 is wedge-shaped, the triangular tip at the upper portion is a cutting edge, and a preferred cutting edge angle range is 30 degrees to 40 degrees, which can both improve the cutting sharpness and ensure the cutting safety. It is understood that in some variations, the transverse cross-section of cutting blade 32121 may also be trapezoidal shaped to accommodate different cutting needs.

It will be appreciated that the transverse cross-sections of the cutting blades illustrated in figures 2 to 13 may all correspond to the transverse cross-sectional configuration of the present figure.

It is understood that the structures shown in fig. 1 to 14 are all relatively regular structures, and in the actual production process, the structures shown in fig. 1 to 14 can be changed into other irregular structures according to actual needs.

With reference to fig. 1 to 14, the interatrial septum ostomy device and the interatrial septum ostomy system provided by the invention have the advantages that the ostomy part for cutting and ablating tissues is arranged on the periphery of the balloon, the ostomy part is driven by the balloon to realize the cutting function and the ablation function of the tissues, the tissues can be expanded to a target diameter, and meanwhile, the tissues after the ostomy can be ablated by using the ablation function, so that a more durable tissue ostomy can be obtained, the hidden danger caused by tissue rebounding is reduced, and the risk of thrombus generation during and/or after the operation is reduced.

In various embodiments and specific application examples provided by the invention, the balloon is preferably a non-compliant balloon, the diameter of the balloon is relatively inconspicuous with the increase of the expansion pressure of the balloon, the balloon has higher bursting pressure, and the size of the balloon is easier to control. It can be understood that the balloon can also be applied to cryoablation, and in this case, the cutting function and the ablation function of the tissue can be realized only by arranging the cutting blade and adding the liquid refrigerant into the balloon without arranging the ablation electrode.

Because the invention can cut and ablate the tissue in real time, therefore the invention can overcome: the existing balloon interatrial septum ostomy has the tendency of myocardial tissue rebounding after the stoma, which may cause the problems of stoma shrinkage and even closure; in the existing interatrial septum surgery devices such as an interatrial septum cutting and grabbing device, an atrial shunt implantation device and the like, under the condition that the interatrial septum cutting and grabbing device is adopted for treatment, the grabbing device has the hidden trouble of loosening in the surgery, or the cut tissue falls off to form embolism when the device is recovered; under the condition of adopting the atrial shunt implantation device for treatment, the potential hazard of high thrombosis probability exists, or the potential hazard of embolism formation caused by the falling of an instrument exists.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. An interatrial septum ostomy device comprising an ostomy body including a radially expandable and contractible balloon, characterized in that:

2. The atrial septal ostomy device of claim 1, wherein the stoma portion comprises a cutting blade for cutting tissue and the cutting blade is connected to a power source via a lead for ablating tissue.

3. The interatrial septum ostomy device of claim 1, wherein the ostomy portion includes a cutting blade for cutting tissue and an ablation electrode connected to a power source via a wire for ablating tissue.

4. The atrial septal ostomy device of claim 3, wherein the ablation electrodes are spaced apart from the cutting blades by a predetermined distance, and at least one ablation electrode is disposed between two adjacent cutting blades.

5. The atrial septal ostomy device of claim 4, wherein the cutting blade is connected to a power source via a wire for further ablation of tissue.

6. The atrial septal ostomy device of claim 3, wherein the ablation electrodes are disposed at a predetermined pitch distribution, and the cutting blades are disposed at a predetermined pitch distribution on part or all of the ablation electrodes.

7. The atrial septal ostomy device of claim 6, wherein the cutting blade is connected to a power source via a lead wire or the cutting blade is electrically connected to the ablation electrode for further use in ablating tissue.

8. The atrial septal ostomy device of any one of claims 3-7, wherein the cutting blades and the ablation electrodes are evenly distributed with each other on the circumference of the balloon.

9. The atrial septal ostomy device of any one of claims 3-7, wherein the cutting blades, the ablation electrodes are bonded or welded to the balloon body.

10. The interatrial septum ostomy device of any one of claims 2-7, wherein the body of the cutting blade is unitary, or comprises a plurality of sub-blades arranged at a predetermined spacing distance, or comprises a plurality of sub-blades arranged in a consecutive arrangement.

11. The interatrial septum ostomy device according to any one of claims 2-7, wherein the side of the cutting blade contacting the balloon body is of a wave-like structure, and the concave portion of the wave-like structure is of a semicircular shape or a T-shape.

12. The interatrial septum ostomy device of any one of claims 2-7, wherein the transverse cross-section of the cutting blade is triangular or trapezoidal, and the cutting edge angle of the cutting blade ranges between 30 degrees and 40 degrees.

13. The interatrial septum ostomy device according to any one of claims 2-7, wherein at least one end of the cutting blade in the direction of extension of the cutting edge is provided with a smooth portion transitioning to the balloon body.

14. The atrial septal ostomy device of any one of claims 1-7, wherein the balloon in the inflated state has a shape of an elliptic cylinder or a figure-8 cylinder.

15. Interatrial septum ostomy system, comprising a power source for supplying electrical energy to the interatrial septum ostomy device, a delivery conduit in which the ostomy body of the interatrial septum ostomy device is arranged in a collapsed state, and an interatrial septum ostomy device according to any of claims 1-14, which is delivered to a predetermined position by the delivery conduit.