Ventricular aneurysm sealing device

Abstract

The present application provides a ventricular aneurysm sealing device, which is used to isolate a ventricular aneurysm from a normal ventricular wall. The ventricular wall near the ventricular aneurysm is provided with a predetermined interface. The ventricular aneurysm sealing device includes: a lead wire; a guide unit, which has a hollow cavity, which is used to connect the predetermined interface; and a puncture unit, which has a puncture needle and a through hole provided at the proximal end of the puncture needle, the through hole is used for the lead wire to pass through, the puncture needle guides the lead wire through the cavity into the predetermined interface, and then punctures the two side walls of the ventricular wall near the ventricular aneurysm, thereby tightening the two ends of the lead wire and isolating the ventricular aneurysm from the normal ventricular wall. The ventricular aneurysm sealing device has a simple structure, is easy to manufacture, has a low manufacturing cost, can accurately locate the ventricular aneurysm, is simple to operate, has a light surgical trauma, and has a low risk.

Description

Technical Field

[0001] The embodiments of the present application relate to the field of medical device technology, and in particular to a ventricular aneurysm sealing device. Background Art

[0002] For people suffering from certain diseases, the existing treatment methods for the lesion area often make it difficult to accurately locate the lesion area, making the operation difficult and time-consuming.

[0003] Chinese patent CN109303581A discloses a left ventricular aneurysm fixation device and system thereof, including a frame and a film; the frame is overall in the shape of an umbrella rib, and the film is covered and sewn onto the frame. The patent fixes the bulging ventricular aneurysm through a minimally invasive combined interventional method.

[0004] Chinese patent CN209048207U discloses an enhanced ventricular aneurysm occlusion device, which also includes a skeleton and a film. Chinese patent CN209611210U discloses an implantable left ventricular aneurysm spiral occluder, the skeleton of which uses a conical spiral memory metal stent.

[0005] The above-mentioned devices cause great trauma to the human body, it is difficult to accurately locate the lesion area, the operation is difficult and the operation time is long. Therefore, there is an urgent need to provide a treatment method and device for the lesion area with more accurate positioning and lower risk. Summary of the invention

[0006] In view of the above problems, the present application provides a ventricular aneurysm sealing device to overcome the above problems or at least partially solve the above problems.

[0007] An embodiment of the present application provides a ventricular aneurysm sealing device for isolating a ventricular aneurysm from a normal ventricular wall. A predetermined interface is provided on the ventricular wall near the ventricular aneurysm. The ventricular aneurysm sealing device comprises: a lead wire; a guide unit having a hollow cavity for connecting the predetermined interface; and a puncture unit having a puncture needle and a through hole provided at the proximal end of the puncture needle, the through hole being used for the lead wire to pass through. The puncture needle guides the lead wire through the cavity into the predetermined interface, and then punctures the two side walls of the ventricular wall near the ventricular aneurysm, thereby tightening the two ends of the lead wire and isolating the ventricular aneurysm from the normal ventricular wall.

[0008] In an optional embodiment, the ventricular aneurysm sealing device includes multiple puncture units, wherein at least two puncture units are used to successively guide the two ends of the same lead wire through the two side walls of the ventricular wall near the ventricular aneurysm to tighten the two ends of the same lead wire.

[0009] In an optional embodiment, the ventricular aneurysm sealing device further comprises a protection unit, and the puncture needle guides the lead wire through the protection unit, so that when both ends of the lead wire are tightened, the protection unit adheres to the side wall.

[0010] In an optional embodiment, the ventricular aneurysm sealing device further includes two protection units, and when the two ends of the lead are tightened, the two protection units are respectively attached to the two side walls.

[0011] In an optional embodiment, the guide unit includes: a guide tube; and a protective sleeve having: an artificial blood vessel positioned at the predetermined interface and used to receive the guide tube; and a fixing member used to fix the guide tube.

[0012] In an optional embodiment, the fixing member includes: a first connecting sleeve, in which a sealing member is provided; a second connecting sleeve, which is cooperatively connected to the first connecting sleeve; the first connecting sleeve and the second connecting sleeve are connected in series with the artificial blood vessel.

[0013] In an optional embodiment, the first connecting sleeve and the second connecting sleeve are connected through magnetic cooperation.

[0014] In an optional embodiment, a one-way valve 50 with an opening facing the predetermined interface is provided in the guide tube, and the opening is used for passing the guide wire and the puncture unit.

[0015] In an optional embodiment, the proximal cavity of the guide tube is funnel-shaped, and the guide tube has a curved portion, and the curvature of the tube body of the curved portion is 60°-120°.

[0016] In an optional embodiment, the inner diameter of the guide tube gradually decreases from the proximal cavity to the distal cavity.

[0017] In an optional embodiment, a clamping groove is provided in the through hole for limiting the lead wire after the lead wire passes through the through hole.

[0018] In an alternative embodiment, the ventricular aneurysm comprises an aneurysm formed in the left ventricle or the right ventricle of the heart.

[0019] It can be seen from the above technical solutions that the ventricular aneurysm sealing device of the embodiment of the present application has a simple structure, is easy to manufacture, and has a low manufacturing cost. In addition, the ventricular aneurysm sealing device of the present application can form a predetermined interface near the ventricular aneurysm, guide the puncture unit through the guide unit to accurately locate the ventricular aneurysm, puncture the two side walls of the ventricular wall near the ventricular aneurysm, thereby tightening the two ends of the lead wire and isolating the ventricular aneurysm from the normal ventricular wall, which is simple to operate, has light surgical trauma, and has low risk. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0021] Figure 1 This is a schematic diagram of a ventricular aneurysm sealing device of the present application.

[0022] Figure 2 This is a cross-sectional view of the guide tube.

[0023] Figure 3 This is a schematic diagram of the puncture needle passing through the lead wire and the protection unit.

[0024] Figure 4 A schematic diagram of the protective cover.

[0025] Figure 5 Schematic diagram of the heart after ventricular aneurysm ligation.

[0026] Figure 6 Schematic diagram of the heart after resection of a ventricular aneurysm.

[0027] Component number

[0028] 10: ventricular aneurysm sealing device; 20: ventricular aneurysm; 30: normal ventricular wall; 40: predetermined interface; 50: one-way valve; 60: left ventricle; 70: right ventricle; 101: lead wire; 102: guide unit; 112: cavity; 103: puncture unit; 113: puncture needle; 123: through hole; 31: side wall; 122: guide tube; 132: protective sleeve; 1321: artificial blood vessel; 1322: fixing piece; 1301: first connecting sleeve; 1303: sealing piece; 1302: second connecting sleeve; 1304: gasket; 1305: silicone body; 1221: bending part; 109: protection unit. DETAILED DESCRIPTION

[0029] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments in the embodiments of the present application should fall within the scope of protection of the embodiments of the present application.

[0030] The "distal end" refers to the end of the ventricular aneurysm sealing device that is close to the preset interface when the ventricular aneurysm sealing device is in use. The "proximal end" refers to the end of the ventricular aneurysm sealing device that is far away from the preset interface when the ventricular aneurysm sealing device is in use. The "normal ventricular wall" refers to the tissue of the left ventricle or right ventricle that does not grow ventricular aneurysm.

[0031] One embodiment of the ventricular aneurysm sealing device of the present application is used to seal the ventricular aneurysm of the heart. Heart disease is the number one killer of human health. After a large area of ​​myocardial infarction in patients with coronary heart disease, the ventricular wall dilatation, thinning, and full-thickness necrosis of the myocardium occur in the infarcted area. The necrotic myocardium is gradually replaced by a fibrous scar ventricular wall. The thin layer of ventricular wall in the lesion area bulges outward, and the heart loses its ability to move or exhibits abnormal movement during contraction, forming a ventricular aneurysm, which is common in the left ventricle 60. Surgical resection of ventricular aneurysm is the most active and effective treatment measure, but ventricular aneurysm surgery is difficult, risky, and has a high mortality rate and complication rate, and requires a high level of the surgeon and his team. Existing minimally invasive cardiac ventricular aneurysm surgery is difficult to accurately locate, difficult to operate, and takes a long time.

[0032] The specific implementation of the embodiment of the present application is further explained below in conjunction with the accompanying drawings of the embodiment of the present application.

[0033] See also Figures 1 to 6 In a specific implementation of the present application, a ventricular aneurysm sealing device 10 is provided, which is used to isolate a ventricular aneurysm 20 from a normal ventricular wall 30, and a predetermined interface 40 is provided on the ventricular wall near the ventricular aneurysm 20. The ventricular wall near the ventricular aneurysm does not limit the distance between the nearby ventricular wall and the ventricular aneurysm, that is, for different ventricular aneurysms, the predetermined interface 40 can be positioned according to specific circumstances. The ventricular aneurysm can be a ventricular aneurysm formed in the left ventricle 60 or the right ventricle 70 of the heart, etc. Taking the ventricular aneurysm commonly formed in the left ventricle 60 of the heart as an example, the predetermined interface 40 can be provided on the outer wall of the left ventricle 60.

[0034] The ventricular aneurysm sealing device 10 includes: a lead 101; a guide unit 102, which has a hollow cavity 112 for connecting the predetermined interface 40; and a puncture unit 103, which has a puncture needle 113 and a through hole 123 arranged at the proximal end of the puncture needle 113, the through hole 123 is used for the lead 101 to pass through, the puncture needle 113 guides the lead 101 through the cavity 112 into the predetermined interface 40, and then punctures the two side walls 31 of the ventricular wall near the ventricular aneurysm, thereby tightening the two ends of the lead 101 and isolating the ventricular aneurysm from the normal ventricular wall. The ventricular aneurysm sealing device 10 of the present application can accurately locate the ventricular aneurysm area, is simple to operate, has light surgical trauma, low risk, and low cost.

[0035] The lead wire 101 may be a rivet wire or any other suitable linear body. The guide unit 102 may be a tubular body. In one embodiment of the present application, the guide unit 102 includes: a guide tube 122; and a protective sleeve 132, the protective sleeve 132 having: an artificial blood vessel 1321, which is positioned at the predetermined interface 40 and is used to receive the guide tube 122; and a fixing member 1322, which is used to fix the guide tube 122. The structure of the fixing member 1322 may have various forms. In an optional embodiment, the fixing member 1322 may be set as a hollow ring to facilitate connecting the fixing member 1322 and the artificial blood vessel 1321 in series.

[0036] In one embodiment of the present application, the fixing member 1322 includes: a first connecting sleeve 1301, in which a sealing member 1303 is provided; a second connecting sleeve 1302, which is connected to the first connecting sleeve 1301; the first connecting sleeve 1301 and the second connecting sleeve 1302 are connected in series with the artificial blood vessel 1321. Thus, the guide tube 122 can be inserted into the fixing member 1322 and the artificial blood vessel 1321, and contact or enter the right ventricle 70 through the predetermined interface 40. In one embodiment of the present application, the sealing member 1303 includes a gasket 1304 and a silicone body 1305 that are detachably connected or fixedly connected, and the gasket 1304 and the silicone body 1305 can play a sealing role. However, the structure and material of the sealing member 1303 are not limited thereto, and can also be any other suitable structure and material.

[0037] The first connecting sleeve 1301 and the second connecting sleeve 1302 are connected by magnetic matching or by other matching connection methods such as snap-fitting. The first connecting sleeve 1301 and the second connecting sleeve 1302 can be fixedly connected or detachably connected. In one embodiment of the present application, the first connecting sleeve 1301 is a magnetic ring sleeve wrapped in a silicone sleeve, and the second connecting sleeve 1302 is a steel sleeve formed of magnetic conductive stainless steel, and the magnetic ring sleeve and the steel sleeve are connected by magnetic matching. In another embodiment of the present application, a magnetic ring can be embedded in the steel sleeve, which has a magnetic pole opposite to that of the magnetic ring sleeve, and a magnetic matching connection is achieved through opposite attraction.

[0038] The guide tube 122 may be provided with a one-way valve 50 with an opening toward the predetermined interface 40, and the opening is used to pass the guide wire 101 and the puncture unit 103. The rear end cavity 112 of the guide tube 122 is funnel-shaped, and the guide tube 122 has a curved portion 1221. After a large number of experiments conducted by the inventor, when the curvature of the curved portion 1221 is 60°-120°, the position of the puncture needle 113 to puncture the side wall 31 of the ventricular wall near the ventricular aneurysm can be adjusted relatively easily by adjusting the curved portion 1221.

[0039] The inner diameter of the guide tube 122 from the rear end cavity 112 to the front end cavity 112 can be gradually reduced. The structure of the one-way valve 50 can effectively prevent the blood inside the heart from flowing back and spraying out through the guide tube 122.

[0040] In one embodiment of the present application, the ventricular aneurysm sealing device 10 includes a plurality of puncture units 103, wherein at least two puncture units 103 are used to successively guide the two ends of the same lead wire 101 through the two side walls 31 of the ventricular wall near the ventricular aneurysm, respectively, so as to tighten the two ends of the same lead wire 101. For example, taking ventricular aneurysm as an example, if the ventricular aneurysm sealing device 10 includes two puncture units 103, the through hole 123 of one of the puncture units 103 passes through the lead wire 101, guides one end of the lead wire 101 through the two side walls 31 of the ventricular wall near the ventricular aneurysm, and reaches the outside of the left ventricle 60, and the through hole 123 of the other puncture unit 103 passes through the other end of the lead wire 101, guides the other end of the lead wire 101 through the two side walls 31 of the ventricular wall near the ventricular aneurysm, and reaches the outside of the left ventricle 60, thereby the two ends of the lead wire 101 can be tied into a knot on the outside of the left ventricle 60, and the ventricular aneurysm is isolated from the normal ventricular wall. By repeatedly using more pairs of puncture units 103, multiple knots can be tied on the outside of the left ventricle 60 to more firmly isolate the ventricular aneurysm from the normal ventricular wall.

[0041] In one embodiment of the present application, the ventricular aneurysm sealing device 10 further includes a protection unit 109, and the puncture needle 113 guides the lead wire 101 through the protection unit 109, so that when the two ends of the lead wire 101 are tightened, the protection unit 109 is attached to the side wall 31. In an optional embodiment, the ventricular aneurysm sealing device 10 includes two protection units 109, and when the two ends of the lead wire 101 are tightened, the two protection units 109 are attached to the two side walls 31 respectively.

[0042] like Figure 1 and Figure 3 As shown, when the puncture needle 113 enters the guide unit 102, one of the puncture needles 113 can guide the lead wire 101 through one of the protection units 109, and when the puncture needle 113 passes through the outside of the left ventricle 60, the lead wire 101 is guided through another protection unit 109, and when the other puncture needle 113 passes through the outside of the left ventricle 60 as described above, the lead wire 101 is also guided through the other protection unit 109, and when the two ends of the lead wire 101 are tied tightly on the outside of the left ventricle 60, one of the protection units 109 is attached to the interventricular septum between the right ventricle 70 and the left ventricle 60, and the other protection unit 109 is attached to the outside of the left ventricle 60. The number of protection units 109 is not limited to two, and more protection units 109 can be selected according to specific circumstances, such as the size of the protection unit 109. The protection unit 109 can be a biocompatible gasket.

[0043] In one embodiment of the present application, a slot is provided in the through hole 123 to limit the lead wire 101 after the lead wire 101 passes through the through hole 123 to prevent it from slipping out of the through hole 123. A handle may be provided at the proximal end of the puncture needle 113 to facilitate the insertion of the puncture needle 113 into the guide unit 102. The one-way valve 50 may be a 2-4 leaflet valve with an opening toward a preset interface, and the material may be soft silicone or other available materials.

[0044] The present application also provides a ventricular aneurysm sealing device 10 as described above, comprising: passing the lead wire 101 through the through hole 123, and the puncture needle 113 guiding the lead wire 101 through the cavity 112 of the guide unit 102 into the predetermined interface 40, and then piercing the two side walls 31 of the ventricular wall near the ventricular aneurysm, thereby tightening the two ends of the lead wire 101 and isolating the ventricular aneurysm from the normal ventricular wall.

[0045] As an embodiment of an operation method, the ventricular aneurysm sealing device 10 includes at least two puncture units 103, and the through hole 123 of one of the puncture units 103 passes through the lead wire 101, and one end of the lead wire 101 is guided through the two side walls 31 of the ventricular wall near the ventricular aneurysm to the outside of the left ventricle 60. The through hole 123 of the other puncture unit 103 passes through the other end of the lead wire 101, and the other end of the lead wire 101 is also guided through the two side walls 31 of the ventricular wall near the ventricular aneurysm to the outside of the left ventricle 60, thereby the two ends of the lead wire 101 can be tied to form a knot on the outside of the left ventricle 60 to isolate the ventricular aneurysm from the normal ventricular wall. The other puncture units 103 can complete the puncture according to the above method, and can also be tied to form a knot on the outside of the left ventricle 60.

[0046] In an optional embodiment, the ventricular aneurysm sealing device 10 includes at least two protection units 109. When the two ends of the lead wire 101 are tightened, at least the two protection units 109 are respectively attached to the two side walls 31. Specifically, when the puncture needle 113 enters the guide unit 102, one of the puncture needles 113 can guide the lead wire 101 to pass through one of the protection units 109. When the puncture needle 113 passes through the outside of the left ventricle 60, the lead wire 101 is guided to pass through another protection unit 109. When the other puncture needle 113 passes through the outside of the left ventricle 60 as described above, the lead wire 101 is also guided to pass through the other protection unit 109. Then, when the two ends of the lead wire 101 are tied tightly on the outside of the left ventricle 60, one of the protection units 109 is attached to the interventricular septum between the right ventricle 70 and the left ventricle 60, and the other protection unit 109 is attached to the outside of the left ventricle 60. The number of the protection units 109 is not limited to two, and more protection units 109 may be selected according to specific circumstances, such as the size of the protection units 109 .

[0047] In one embodiment, one end of a section of artificial blood vessel 1321 is inserted into the second connecting sleeve 1302, and the other end is positioned on a preset interface of the outer wall of the right ventricle 70 of the heart with ventricular aneurysm by suturing technology to establish a channel, and the sealing member 1303 of the first connecting sleeve 1301 is sleeved on the distal end of the guide tube 122, and the guide tube 122 is inserted into the second connecting sleeve 1302 and the artificial blood vessel 1321. At this time, the second connecting sleeve 1302 is connected with the first connecting sleeve 1301. In another embodiment, the second connecting sleeve 1302 and the first connecting sleeve 1301 are automatically attracted and closed by magnetism.

[0048] As another embodiment of an operating method, a small hole is minimally invasively made on the patient's chest wall, and one end of a section of artificial blood vessel 1321 is inserted into a steel sleeve, and the other end is positioned on a preset interface on the outer wall of the right ventricle 70 of the heart with ventricular aneurysm through a small incision suture technique to establish a channel. A guide tube 122 is taken, and the silicone body 1305 of the magnetic ring sleeve is sleeved on the distal end of the guide tube 122. The guide tube 122 is inserted into the steel sleeve and the artificial blood vessel 1321. At this time, the magnetic ring sleeve and the steel sleeve are automatically sucked and closed. Under ultrasound guidance, the guide tube 122 is inserted into the right ventricle 70 through the preset interface and against the ventricular septum; the puncture needle 113 is taken, the thread end of the rivet wire is inserted through the through hole 123 and clamped into the card slot, the thread tail is penetrated with an inner gasket, the needle handle of the puncture needle 113 is pinched, and the puncture needle 113 is inserted into the guide tube 122 through the middle seam of the one-way valve 50 in the posterior cavity of the tube, enters the right ventricle 70, pierces the ventricular septum, passes through the left ventricle 60, avoids the ventricular aneurysm area, and punctures The thread end is then inserted into the through hole 123 of another puncture needle 113, and the above steps are repeated until the other puncture needle 113 pierces the side wall 31 of the left ventricle 60. Then, the other puncture needle 113 is inserted into the outer gasket, the thread head and thread end are pulled out, the rivet wire is tightened, and the rivet is tightened. More pairs of puncture needles 113 are used to repeat the riveting operation multiple times, so that the ventricular aneurysm can be further tightened and closed to cause necrosis.

[0049] like Figure 5 As shown, the aneurysm is sealed by riveting. If the aneurysm is not too large, it can be left unresected. If resection is required, the effect is as follows Figure 6 shown.

[0050] The operating method of the present application can accurately locate the ventricular aneurysm area, is simple to operate, has light surgical trauma, low risk, and low cost.

[0051] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A ventricular aneurysm sealing device, used to isolate a ventricular aneurysm from a normal ventricular wall, wherein the ventricular wall near the ventricular aneurysm is provided with a predetermined interface, characterized in that: The aneurysm sealing device comprises: lead; a guide unit having a hollow cavity for connecting to the predetermined interface; and A puncture unit, comprising a puncture needle and a through hole at the proximal end of the puncture needle, the through hole being used for the lead wire to pass through the cavity, and the puncture needle guides the lead wire into the predetermined interface, and then punctures two side walls of the ventricular wall near the ventricular aneurysm, thereby tightening the two ends of the lead wire and isolating the ventricular aneurysm from the normal ventricular wall; Wherein, the guiding unit comprises: a guide tube; and The protective sleeve comprises: an artificial blood vessel, which is positioned at the predetermined interface and is used to receive the guide tube; and a fixing member, which is used to fix the guide tube; the fixing member comprises: A first connecting sleeve, wherein a sealing member is provided inside the sleeve; A second connecting sleeve, which is connected with the first connecting sleeve in cooperation with each other, and the first connecting sleeve and the second connecting sleeve are connected in series with the artificial blood vessel; The guide tube is provided with a one-way valve with an opening toward the predetermined interface, and the opening is used to pass the lead wire and the puncture unit. The proximal cavity of the guide tube is funnel-shaped, and the guide tube has a curved portion, and the curvature of the tube body of the curved portion is 60°-120°.

2. The ventricular aneurysm sealing device according to claim 1, characterized in that: The ventricular aneurysm sealing device comprises a plurality of puncture units, wherein at least two puncture units are used to successively guide two ends of the same lead wire through two side walls of the ventricular wall near the ventricular aneurysm, so as to tighten the two ends of the same lead wire.

3. The ventricular aneurysm sealing device according to claim 1, characterized in that: The ventricular aneurysm sealing device also includes a protection unit, and the puncture needle guides the lead wire to pass through the protection unit, so that when the two ends of the lead wire are tightened, the protection unit is attached to the side wall.

4. The ventricular aneurysm sealing device according to claim 3, characterized in that: The ventricular aneurysm sealing device comprises two protection units. When the two ends of the lead are tightened, the two protection units are respectively attached to the two side walls.

5. The ventricular aneurysm sealing device according to claim 1, characterized in that: The first connecting sleeve is connected to the second connecting sleeve through magnetic matching.

6. The ventricular aneurysm sealing device according to claim 1, characterized in that: The inner diameter of the guide tube gradually decreases from the proximal cavity to the distal cavity.

7. The ventricular aneurysm sealing device according to claim 1, characterized in that: A clamping groove is arranged in the through hole, which is used to restrict the lead wire after the lead wire passes through the through hole.

8. The ventricular aneurysm sealing device according to claim 1, characterized in that: The ventricular aneurysm includes an aneurysm formed in the left ventricle or the right ventricle of the heart.

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