Left ventricle volume reduction device and system thereof

Abstract

The left ventricular volume reduction system comprises a left ventricular volume reduction device and a conveying device corresponding to the left ventricular volume reduction device and is used for treating left ventricular wall tumors. The left ventricle volume reduction device comprises a special-shaped filling body which is located in a left ventricle after being implanted and released and a locking ring which is connected to the outer wall of the ventricle in a sleeving mode and matched with the filling body, the filling body located in the ventricle is fixed from the outer wall of the ventricle by changing the perimeter of the locking ring through mutual matching of the filling body and the locking ring, and displacement of the filling body is prevented; therefore, the purposes of reducing the volume of the lesion left ventricle, increasing the ejection fraction and improving the systolic function of the heart are achieved, and meanwhile the postoperative risk of complications such as thrombus and infectious endocarditis of a patient is reduced.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and relates to cardiac therapeutic devices, and in particular to a left ventricular volume reduction device and a system thereof. Background Art

[0002] Left ventricular aneurysm is a mechanical complication after myocardial infarction, and the incidence of ventricular aneurysm after myocardial infarction is 10%-30%. Left ventricular aneurysm is mainly caused by the dilation and thinning of the ventricular wall and full-thickness necrosis of the myocardium in the infarcted area after a large area of ​​myocardial infarction. The necrotic myocardium is gradually replaced by fibrous scar tissue, and the thin layer of ventricular wall in the lesion area bulges outward, thus forming a ventricular aneurysm. Left ventricular aneurysm will lose its ability to move or show abnormal movement when the heart contracts, affecting the contractile function of the left ventricle. It will also increase the volume of the left ventricle and reduce the ejection fraction of the left ventricle, resulting in insufficient blood supply. In addition, the blood flow in the bulging part of the local heart cavity is slow, and thrombosis is prone to occur.

[0003] At present, the main treatments for ventricular aneurysms include drug therapy, surgical treatment, and minimally invasive interventional treatment. Among them, drug therapy has a certain effect on the treatment of ventricular aneurysms, but it cannot improve the completely necrotic scar tissue, and can only be considered for the treatment of patients with mild ventricular aneurysms. Surgical ventricular reconstruction (SVR), which removes ventricular aneurysms and shrinks the left ventricle, has always been the most effective method for patients with heart failure after myocardial infarction to reduce end-diastolic volume, reduce ventricular wall tension, reduce myocardial load, and improve hemodynamics. However, according to studies, the 30-day mortality rate after SVR surgery is 5.3%, and the 5-year survival rate is only 70%.

[0004] Therefore, after comprehensive consideration, minimally invasive interventional treatment is currently more preferred for ventricular aneurysms. Existing minimally invasive interventional treatments mainly involve delivering a left ventricular volume reduction device into the ventricle to separate the normal tissue of the left ventricle from the ventricular aneurysm tissue, thereby reducing the volume of the left ventricle and improving the ejection fraction of the left ventricle. Figure 1 As shown. During use, the commonly used fixation method of the existing left ventricular volume reduction device is mainly to puncture the ventricular wall through the anchor device to fix the volume reduction device on the ventricular inner wall or penetrate the ventricular wall to fix it on the apex. Such a fixation method can easily cause complications such as thrombosis and infective endocarditis, increasing the postoperative risk of patients. Summary of the invention

[0005] The present invention provides a left ventricular volume reduction device and a system thereof to solve the problems existing in the prior art.

[0006] A filling body is used for implantation in the left ventricle to separate healthy tissue from ventricular aneurysm tissue. The filling body comprises an isolation part, a fixing part and a supporting part which are connected in sequence from the proximal end to the distal end, and there is a smooth transition between each part. The maximum diameter of the filling body is set at the isolation part, and the minimum diameter is set at the fixing part.

[0007] Among them, the isolation part is cylindrical, and the isolation part includes an upper top surface which is concave to form an inverted cone and a lower top surface which is placed corresponding to the junction of the normal ventricular wall and the ventricular aneurysm. The height of the isolation part is 5mm-12mm, and the diameter of the isolation part is 30mm-45mm.

[0008] Among them, the height of the fixing part is 3mm-8mm, the diameter of the fixing part is 8mm-15mm, the connection between the isolation part and the supporting part and the fixing part forms a U-shape with horizontal sides, and the horizontal length of the U-shape on one side is 11mm-15mm.

[0009] The support portion is ellipsoidal in shape, the bottom surface of the distal end of the support portion is a plane, the height of the support portion is 10 mm-20 mm, and the diameter of the support portion is 20 mm-30 mm.

[0010] Wherein, the filling body further comprises a flow-blocking membrane, and the flow-blocking membrane is arranged inside the filling body and is in contact with the upper top surface of the isolation part.

[0011] A locking ring is used to fix the filling body of the above-mentioned structure from the outer wall of the ventricle. The locking ring is arranged corresponding to the fixing part of the filling body and includes a fixed section and a stretchable section. The length of the fixed section is fixed, and the stretchable section can extend the length when an external force acts, and restore the original length when the external force is removed.

[0012] The fixed segment and the stretchable segment each have two segments, and each fixed segment is adjacently connected to each stretchable segment.

[0013] Wherein, the cross section of the fixing section is circular or square, and the diameter of the circle is 2mm-4mm.

[0014] The stretchable section comprises a plurality of spiral structures, the central angles of the spiral structures corresponding to their original lengths are 30°-60°, and the spiral wire diameters of the spiral structures are in the range of 0.5mm-1mm.

[0015] Wherein, the stretchable section includes a plurality of hollow grooves.

[0016] A conveying device is used to convey the locking ring described in the above structure to a predetermined position. The conveying device includes a fixed disk, a connecting rod and a control member. The locking ring is accommodated in the fixed disk. The proximal end of the fixed disk is connected to at least part of the control member through the connecting rod.

[0017] Wherein, the fixing plate includes an upper end cover and a lower end cover whose shapes are relatively matched to form a hollow space, and a placement block accommodated in the hollow space, and the placement block includes a cylindrical concave space for accommodating the locking ring.

[0018] Wherein, the lower end cover is provided with an installation groove corresponding to the concave space, and the control member includes a fixed release member accommodated in the concave space and the installation groove, a first pulling member connected to a part of the fixed release member, and a second pulling member connected to the locking ring.

[0019] Among them, the fixed release member includes a accommodating body, a limiting element at least partially inverted and accommodated in the accommodating body, an elastic element sleeved on the limiting element and accommodated in the accommodating body, and a stopper whose one end is connected to the first pulling member and the other end can movably abut against one end of the limiting element.

[0020] The conveying device acts on the locking ring, and the conveying device and the locking ring have an initial state, a stretched state and a released state.

[0021] The initial state is configured as follows: the limiting element is completely accommodated in the accommodating body, one end of the stopper is connected to the first pulling member, the other end of the stopper abuts against one end of the limiting element, and the other end of the limiting element extends out of the accommodating body and limits the locking ring;

[0022] The stretched state is configured as the locking ring being connected to the second pulling member, and the diameter of the locking ring is adjusted to a predetermined position in real time by controlling the movement of the second pulling member, and the fixing release member remains stationary at this time;

[0023] The release state is configured to withdraw the second pulling member connected to the locking ring, control the movement of the first pulling member, so that the blocking member is completely separated from the accommodating body, and the limiting element is accommodated in the accommodating body under the action of the elastic member, thereby completing the release of the locking ring.

[0024] A left ventricular volume reduction system comprises the filling body described in the aforementioned structure, the locking ring described in the aforementioned structure and the conveying device described in the aforementioned structure.

[0025] Compared with the prior art, the present invention has the following advantages:

[0026] The present invention provides a left ventricular volume reduction system, including a left ventricular volume reduction device and a corresponding delivery device, for treating left ventricular aneurysm. The left ventricular volume reduction device includes a specially shaped filling body located in the left ventricle after implantation and release, and a locking ring sleeved on the outer wall of the ventricular cavity and adapted to the filling body. Through the mutual cooperation between the two, the circumference of the locking ring is changed to fix the filling body located in the ventricle from the outer wall of the ventricular cavity to prevent it from shifting, thereby achieving the purpose of reducing the volume of the diseased left ventricle, improving the ejection fraction, and improving the cardiac contractile function, while reducing the postoperative risk of complications such as thrombosis and infective endocarditis in patients.

[0027] Figures and Description of Figures

[0028] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments consistent with the present invention and, together with the description, serve to explain the principles of the present invention.

[0029] In order to more clearly illustrate the embodiments of the present invention 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, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0030] Figure 1 is prior art;

[0031] Figure 2 is a schematic diagram of the overall structure of a left ventricular volume reduction device in some embodiments;

[0032] Figure 3 Schematic diagram of the structure of the filling body in some embodiments;

[0033] Figure 4 Schematic diagram of the overall structure of the lock ring and its conveying device in some embodiments;

[0034] Figure 5 and Figure 6 Schematic diagram of the structure of the locking ring before and after stretching in some embodiments;

[0035] Figure 7 Schematic diagram of the structure of the lock ring in some other alternative embodiments;

[0036] Figure 8 Schematic diagram of the structure of the conveying device corresponding to the locking ring in some embodiments;

[0037] Fig. 9 is a cross-sectional schematic diagram of a fixed disk in some embodiments;

[0038] Fig.10 is a cross-sectional schematic diagram of a fixing and releasing device in some embodiments;

[0039] Fig.11 Schematic diagram of the initial state of the lock ring in some embodiments;

[0040] Fig.12 It is a partial enlarged schematic diagram of the fixing and releasing device of the locking ring in the initial state in some embodiments;

[0041] Fig.13 Schematic diagram of the stretched state of the locking ring in some embodiments;

[0042] Fig.14 Schematic diagram of the release state of the lock ring in some embodiments;

[0043] Fig.15 It is a partial enlarged schematic diagram of the fixing and releasing device in the released state of the lock ring in some embodiments;

[0044] Figures 16 to 20 Schematic diagram of the implantation process of the left ventricular filling device and system thereof in some embodiments. DETAILED DESCRIPTION

[0045] For the convenience of description, the direction close to the operator is defined as the proximal end, and the direction away from the operator is defined as the distal end. In addition, the direction close to the normal ventricular cavity is defined as the top of the filling device, and the direction close to the bulging apex is defined as the bottom of the filling device. The length direction of the filling device when being transported is defined as the axial direction, and the direction perpendicular to the axial direction is defined as the radial direction.

[0046] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on certain embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0047] References to "one embodiment", "an embodiment", "in another embodiment" or "in certain embodiments" throughout the specification are intended to include in at least one embodiment the specific referenced elements, structures or features described in relation to that embodiment. Thus, the phrases "in one embodiment" or "in an embodiment" or "in another embodiment" or "in certain embodiments" appearing in different locations throughout the specification do not necessarily all refer to the same embodiment. Furthermore, specific elements, structures or features may be combined in any appropriate manner in one or more embodiments.

[0048] The present invention provides a left ventricular volume reduction system 1, comprising a left ventricular volume reduction device 10 and a corresponding delivery device 20, for treating left ventricular aneurysm. Figure 2 As shown, the left ventricular volume reduction device 10 includes a filling body 100 and a locking ring 200. Through the cooperation between the two, the purpose of reducing the volume of the diseased left ventricle, increasing the ejection fraction, and improving the cardiac contractile function is achieved. At the same time, the postoperative risk of causing complications such as thrombosis and infective endocarditis in patients is reduced.

[0049] It is particularly emphasized that in actual operation, the filling body 100 is located in the left ventricle LV after being implanted and released, and is used to separate the normal ventricular tissue of the left ventricle LV from the ventricular aneurysm VA tissue. The locking ring 200 is sleeved on the outer wall of the ventricle and cooperates with the filling body 100 to fix the filling body 100 located in the ventricle from the outer wall of the ventricle by changing the circumference of the locking ring 200 to prevent it from shifting.

[0050] In some embodiments, in combination Figure 3 As shown, the filling body 100 is configured as a volume-reducing ball, and the filling body 100 as a whole is formed into a spherical mesh structure similar to the shape of an "8" with protruding ends and an inwardly recessed middle part. Specifically, the filling body 100 is divided into three parts from the proximal end to the distal end, the proximal end is an isolation part 102, the inwardly recessed middle part is a fixing part 104, and the distal end is a supporting part 106. Among them, the diameters of the two ends are large, the diameter of the middle part is small, and there is a smooth transition between the two parts. Through such an overall setting, it is convenient to cooperate with the locking ring 200, and at the same time, it can prevent the uncontrolled movement of the locking ring 200, so that the fixing of the filling body 100 can be well achieved.

[0051] Optionally, the overall height range of the filling body 100 is 20mm-40mm, and the overall maximum diameter R1 is 30mm-45mm, so as to adapt well to the physiological structure of the diseased heart, completely isolate and fill the ventricular aneurysm VA, and achieve the purpose of reducing the volume of the left ventricle LV.

[0052] The isolation part 102 is cylindrical as a whole and is located at the proximal end of the filling body 100. It is mainly used to separate the normal ventricular wall of the left ventricle LV from the ventricular aneurysm VA. The isolation part 102 includes an upper top surface 102a at the proximal end and a lower top surface 102b opposite to the upper top surface 102a. In order to better simulate the physiological apical structure, the upper top surface 102a of the isolation part 102 is concave to form an inverted cone. Since the maximum diameter of the ventricular aneurysm VA is located at the aneurysm body mouth, that is, the junction of the normal ventricular wall and the ventricular aneurysm VA. In order to completely isolate the ventricular aneurysm VA, the lower top surface 102b of the isolation part 102 is placed at the junction of the normal ventricular wall and the ventricular aneurysm VA. At the same time, the range of the height H1 of the isolation part 102 is 5mm-12mm. According to the diameter of the actual aneurysm VA aneurysm body mouth, the maximum diameter R1 of the filling body 100 is set in the isolation part 102, and the maximum diameter R1 is set to 30mm-45mm. In this way, the ventricular aneurysm VA can be completely isolated.

[0053] The proximal end of the fixing part 104 is smoothly connected to the distal end of the isolation part 102. In order to better accommodate the locking ring 200 and fix the entire filling body 100 from the outer wall of the ventricle, the connection between the isolation part 102 and the support part 106 and the fixing part 104 forms a "U" shape with horizontal and horizontal sides with the fixing part 104. Among them, in order to adapt to different myocardial wall thicknesses and facilitate the subsequent locking ring 200 to be completely accommodated and fixed in the "U" structure, the horizontal length of the single-side "U" shape is 11mm-15mm, that is, the diameter R2 of the fixing part 104 is 8mm-15mm, which is the minimum diameter of the filling body 100. Further, the concave U shape is located in the middle and upper part of the filling body 100, and the height from the top surface 102a of the filling body 100 can be set to 8mm-20mm, that is, the height H2 of the fixing part 104 is 3mm-8mm. By setting it in this way, the locking ring 200 can be well fixed to prevent it from shifting.

[0054] In other embodiments, the fixing portion 104 may also be provided with two or more "U" shapes that are recessed inwardly and horizontally on both sides, and the filling body 100 may be fixed by two or more locking rings 200, thereby further improving the fixing ability of the filling body 100.

[0055] The proximal end of the support portion 106 is smoothly connected to the distal end of the fixing portion 104, and the support portion 106 is mainly used to fill the remaining ventricular aneurysm VA gap and support the entire volume reduction device 10. The overall shape of the support portion 106 is an ellipsoid, and the bottom surface of the distal end is a plane. This setting can not only better fill the ventricular aneurysm VA, but also better provide support for the entire volume reduction device 10. Further, in order to conform to the conical structure of the apex and block the downward movement of the locking ring 200, the height H3 of the support portion 106 is set to 10mm-20mm, and the diameter R3 is set to 20mm-30mm.

[0056] In addition, the filling body 100 further includes a flow-blocking membrane 108, which is disposed inside the filling body 100 and attached to the upper top surface 102a of the isolation portion 102, and is used to block blood flow from entering the ventricular aneurysm VA. The flow-blocking membrane 108 is mainly made of a high-biocompatible polymer material.

[0057] It should be noted that the filler body 100 is woven from a light metal nickel-titanium alloy. This is because the nickel-titanium alloy material has superelasticity and shape memory functions, which can be easily shaped and transported. In addition, the nickel-titanium alloy is light in weight and will not put too much extra weight on the heart. And the nickel-titanium alloy has a certain strength and is not easy to break.

[0058] In some embodiments, in combination Figure 4As shown, in order to cooperate with the filling body 100, the filling body 100 located in the ventricle can be fixed from the outer wall of the ventricle to prevent the filling body 100 from shifting. A locking ring 200 adapted to the shape of the filling body 100 and a conveying device 210 corresponding to the locking ring 200 are provided. The locking ring 200 is accommodated in the distal end of the conveying device 210 thereof, and is used to fix the filling body 100 located in the ventricle from the outer wall of the ventricle. The conveying device 210 corresponding to the locking ring 200 is used to convey the locking ring 200 to a suitable predetermined position, and to realize the rapid and accurate release of the locking ring 200.

[0059] In some embodiments, in combination Figure 5 and Figure 6 As shown, the locking ring 200 is a circular ring structure as a whole, and can also be a combination of circular or square shapes. The locking ring 200 includes a fixed section 202 and a stretchable section 204. Among them, the length of the fixed section 202 is fixed, and it plays the main role of fixing the filling body 100. The stretchable section 204 is a variable section, which can extend its length when an external force is applied, and restore its original length when the external force is removed. It is mainly used to expand the overall diameter of the locking ring 200 through stretching force, so as to facilitate the locking ring 200 to be inserted from the apex of the heart to the corresponding concave part of the fixed part 104 of the filling body 100. Then it returns to its original diameter and cooperates with the fixed section 202 to fix the filling body 100 in the ventricle.

[0060] Optionally, according to the minimum diameter R3 of the fixing portion 104 of the filling body 100 , in order to better achieve the fixing effect of the filling body 100 , the overall diameter of the locking ring 200 is 10 mm-20 mm in a normal state.

[0061] It is particularly noted that, in order to facilitate symmetrically expanding the diameter of the locking ring 200 , the fixed section 202 and the stretchable section 204 each have two sections, and each fixed section 202 and each stretchable section 204 are adjacently connected.

[0062] In order to have a certain strength and reduce its own weight, the fixing section 202 is made of nickel-titanium alloy or stainless steel, and is set to be a hollow cylindrical shape with a circular cross-section and a diameter of 2mm-4mm.

[0063] The stretchable section 204 is set to a spiral structure similar to a spring, so that it can be better stretched and deformed when subjected to external force. The stretchable section 204 is set between the two fixed sections 202, and the head and tail ends are respectively connected to the fixed section 202. The stretchable section 204 includes multiple spirals. Under normal conditions, the pitch between the single spirals of the stretchable section 204 is small, that is, the axial distance between the centers of two adjacent circles of the multiple spirals is small, and the multiple spirals are arranged more densely at this time. When the stretchable section 204 is subjected to external force and is in a stretched state, the pitch between the single spirals of the stretchable section 204 becomes larger, that is, the axial distance between the centers of two adjacent circles of the multiple spirals becomes larger, and the multiple spirals are arranged more sparsely at this time. In other words, the restoring force of the spiral can also be changed by the change in pitch, thereby changing the fixing ability of the lock ring 200. The smaller the change in pitch, the smaller the restoring force, and the weaker the fixing ability. On the contrary, the fixing ability is stronger.

[0064] In some embodiments, in order to ensure that the stretchable segment 204 can expand the lock ring 200 to an appropriate diameter and restore the length to the initial state without affecting the overall fixing ability of the lock ring 200, the corresponding central angle CA of a single stretchable segment 204 is set to 30°-60°. Furthermore, the number of spirals of the stretchable segment 204 ranges from 5 to 10, and the diameter of the spiral is 0.5 mm to 1 mm, so as to ensure that the stretchable segment 204 has a certain strength and can also provide sufficient locking ability.

[0065] It is particularly emphasized that the stretchable section 204 is also made of nickel-titanium alloy material, which, on the one hand, allows the entire locking ring 200 to be implanted into the human body. On the other hand, due to the superelasticity and shape memory function of the material itself, it can ensure that the entire locking ring 200 can return to its original state after being stretched, thereby ensuring the fixing function of the locking ring 200.

[0066] In other embodiments, in combination Figure 7As shown, another alternative locking ring 200 structure is provided. The locking ring 200 is annular as a whole, and also includes a fixed section 202 and a stretchable section 204, both of which are made of nickel-titanium alloy material. Among them, the fixed section 202 is a non-variable section with a square cross-section. The stretchable section 204 is a variable section, which can extend its length when an external force is applied, and restore its original length when the external force is removed. The stretchable section 204 includes a plurality of hollow grooves, and the plurality of hollow grooves are formed by cutting. Under normal conditions, the hollow grooves of the stretchable section 204 remain square, and the overall diameter of the locking ring 200 does not change. When the locking ring 200 needs to be fixed, the plurality of cutting grooves in the stretchable section 204 of the locking ring 200 are gradually stretched, and the hollow grooves gradually change into arc-shaped connections, thereby expanding the diameter of the locking ring 200, until the locking ring 200 can be completely inserted into the heart and the stretching stops. The stretchable section 204 is then released, and due to the specific properties of the nickel-titanium alloy material, the stretchable section 204 will return to its original state, thereby fixing the filling body 100.

[0067] In some embodiments, in combination Figure 8 As shown, the conveying device 210 corresponding to the locking ring 200 is used to convey the locking ring 200 of the above structure to a predetermined position. The conveying device 210 includes a fixed disk 212, a connecting rod 214 and a control member 216. The locking ring 200 of the above structure is accommodated in the fixed disk 212, and the proximal end of the fixed disk 212 is connected to at least part of the control member 216 through the connecting rod 214. The fixed disk 212 is used to accommodate and fix the locking ring 200, the control member 216 is used to control the release of the locking ring 200, and the connecting rod 214 is used to connect the fixed disk 212 and the control member 216.

[0068] In some embodiments, the combination Fig. 9 As shown, the fixed disk 212 is located at the far end of the conveying device 210, and the fixed disk 212 includes an upper end cover 2122, a lower end cover 2126, and a placement block 2124 accommodated in the hollow space 2120. The upper end cover 2122 is arranged on the upper end surface of the placement block 2124 to prevent the lock ring 200 from falling out during the conveying process. The placement block 2124 is provided with a cylindrical concave space 2124a for loading and accommodating the lock ring 200 of the aforementioned structure. The lower end cover 2126 is arranged under the lower end surface of the placement block 2124, and is provided with a mounting groove 2126a corresponding to the concave space 2124a of the placement block 2124, for placing at least part of the control member 216.

[0069] The control member 216 includes a fixing release member 2162 accommodated in the concave space 2124a and a mounting groove 2126a corresponding to the concave space 2124a, a first pulling member 2164 connected to a portion of the fixing release member 2162, and a second pulling member 2166 connected to the aforementioned structural locking ring 200.

[0070] In some embodiments, in combination Fig.10 As shown, the fixed release member 2162 includes a accommodating body 2162a, a limiting element 2162b at least partially inverted and accommodated in the accommodating body 2162a, an elastic element 2162c sleeved on the limiting element 2162b and accommodated in the accommodating body 2162a, and a stopper 2162d whose one end is connected to the first pulling member 2164 and the other end can movably abut against one end of the limiting element 2162b.

[0071] Among them, combined Fig.10 As shown, the receiving body 2162a is configured as a receiving groove, and the receiving body 2162a is cylindrical as a whole, and a circular hole 2162a1 is provided in the middle of the cylinder, one end of the circular hole 2162a1 is closed, and the other end is not closed, and the diameter of the circular hole 2162a1 is slightly larger than the maximum diameter of the limiting element 2162b, and the depth of the circular hole 2162a1 is also slightly larger than the total height of the limiting element 2162b, so that the limiting element 2162b can be completely accommodated in the circular hole 2162a1 without blocking the release of the lock ring 200. A groove 2162a2 is provided on one side of the receiving body 2162a, and the groove 2162a2 is communicated with the circular hole 2162a1, and the groove 2162a2 is used to accommodate the stopper 2162d, and the stopper 2162d can move freely in the groove 2162a2.

[0072] The limiting element 2162b is configured as a pin, and has a "T"-shaped structure with a small diameter at one end and a large diameter at the other end. The limiting element 2162b is at least partially inverted and accommodated in the accommodating body 2162a, and the small diameter end can be exposed from the accommodating body 2162a.

[0073] The elastic element 2162c is configured as a spring. The elastic element 2162c is inserted from an end with a small diameter of the limiting element 2162b and fits with an end with a large diameter.

[0074] The blocker 2162d is configured as a baffle, and the shape of the blocker 2162d is adapted to the shape of the groove 2162a2. One end of the blocker 2162d is connected to the first pulling member 2164. The blocker 2162d is accommodated in the groove 2162a2 and can move freely under the control of the first pulling member 2164, so that the other end of the blocker 2162d can be movably abutted against one end of the limiting element 2162b.

[0075] In some embodiments, a first pulling member channel 2126b is provided on the upper end surface of the lower end cover 2126, which is used to provide a moving space for the first pulling member 2164 and limit the position of the first pulling member 2164 to prevent it from shifting in other directions. One end of the first pulling member 2164 is connected to the stopper 2162d, which is used to control the free movement of the stopper 2162d forward and backward, thereby achieving the fixing and release of one end of the locking ring 200 by the limiting element 2162b.

[0076] A second pulling member channel 2124b is provided at the proximal end of the placement block 2124, which is used to provide a moving space for the second pulling member 2166 and limit the position of the second pulling member 2166 to prevent it from deviating in other directions. The second pulling member 2166 passes through the second pulling member channel 2124b and bypasses the locking ring 200 in a U-shape, so that the second pulling member 2166 can control the stretching and recovery of the length of the locking ring 200 and the final release.

[0077] It is particularly emphasized that the first pulling member 2164 and the second pulling member 2166 are both in the shape of thin and long threads, and are both made of polymer materials, and can also be made of metal materials such as stainless steel, nickel-titanium alloy, etc., and have a certain strength and are not easy to break.

[0078] Combination Figure 11-Figure 15 As shown, the working principle of the locking ring 200 to fix and release the filling body 100 under the action of the corresponding conveying device 210 is described in detail.

[0079] like Fig.11 and Fig.12 As shown, in the initial state, since the distance between the stopper 2162d and the lower end surface of the placement block 2124 is smaller than the initial original length of the elastic element 2162c, the elastic element 2162c in the accommodating body 2162a will be compressed and deformed, the first pulling member 2164 is connected to one end of the stopper 2162d and does not move, the stopper 2162d is completely accommodated in the groove 2162a2, the end of the large diameter of the limiting element 2162b abuts against the other end of the stopper 2162d, the limiting element 2162b is prevented from moving downward, and the end of the small diameter of the limiting element 2162b extends out of the accommodating body 2162a and the upper end cover 2122 to limit one side of the lock ring 200. At this time, the second pulling member 2166U-shaped passes through the other side opposite to the lock ring 200, but there is no force between the two, and the lock ring 200 is not stretched.

[0080] like Fig.13As shown, in the stretched state, the first pulling member 2164 and the entire fixing release member 2162 do not change and remain consistent with the initial state. The second pulling member 2166 controls the stretching movement of the other side of the locking ring 200. Because one side of the locking ring 200 is fixed and blocked by the fixing release member 2162, when the second pulling member 2166 controls the stretching movement of the other side of the locking ring 200, the diameter of the locking ring 200 can be adjusted in real time. When gradually stretched to a diameter suitable for fixing the filling body 100, the diameter is maintained and the filling body 100 is fixed.

[0081] like Fig.14 and Fig.15 As shown, in the released state, the second pulling member 2166 is withdrawn to release one side of the tension lock ring 200. Then control the first pulling member 2164 so that the blocking member 2162d is completely moved out of the accommodating body 2162a. When the blocking member 2162d is completely moved out of the accommodating body 2162a through the control of the first pulling member 2164, the elastic element 2162c that has been compressed and deformed will restore its deformation. However, since the lower end surface of the placement block 2124 will never change, the elastic element 2162c that has restored its deformation will give the limiting element 2162b a force toward the bottom of the accommodating body 2162a. Under the action of the elastic element 2162c, the limiting element 2162b will move downward along the circular hole 2162a1 of the accommodating body 2162a, and the small diameter end of the limiting element 2162b will also be completely accommodated in the accommodating body 2162a. At this time, the locking ring 200 is no longer fixed and blocked, and there are no other restrictions on the outside, so it can be completely released.

[0082] In addition, for ease of understanding, Figure 16-Figure 20 As shown, the implantation process of the left ventricular volume reduction device 10 and the system 1 thereof of the present invention is briefly described:

[0083] Step 1: Combine Fig.16 As shown, a passage is established through the aortic catheter path, and the delivery sheath 112 in the delivery device 110 corresponding to the filling body 100 is pushed to the left ventricle LV apical aneurysm VA;

[0084] Step 2: Combine Fig.17 As shown, the push rod 114 in the corresponding delivery device 110 is connected to the filling body 100, and the filling body 100 is slowly delivered to the ventricle LV along the delivery sheath 112, and at this time, the filling body 100 is straightened and contracted in the delivery sheath 112;

[0085] Step 3: Combine Fig.18As shown, fix the delivery sheath 112, slowly push the push rod 114, and push the filling body 100 out of the delivery sheath 112. At this time, the filling body 100 is fully opened and restored to the original state, and then the position of the filling body 100 is adjusted until the isolation part 102 of the filling body 100 is completely attached to the ventricular wall;

[0086] Step 4: Combine Fig.19 As shown, the locking ring 200 is adjusted and expanded to a suitable diameter using the delivery device 210 corresponding to the locking ring 200, and then inserted from the apex of the heart, and the locking ring 200 is pushed to the concave position on the side of the fixing portion 104 of the filling body 100;

[0087] Step 5: If Fig. 20 As shown, the locking ring 200 is then released, so that its diameter gradually decreases until it is completely contracted. The locking ring 200 completes the fixation of the filling body 100, and all the conveying devices are withdrawn from the body.

[0088] It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0089] The above description is only a specific embodiment of the present invention, so that those skilled in the art can understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention.

Claims

1. A filling body for implantation in the left ventricle to separate healthy tissue from ventricular aneurysm tissue. It is characterized in that The filling body comprises an isolating part, a fixing part and a supporting part which are connected in sequence from the proximal end to the distal end, and there is a smooth transition between each other. The maximum diameter of the filling body is set at the isolating part, and the minimum diameter is set at the fixing part.

2. The filling body according to claim 1, It is characterized in that The isolation part is cylindrical, and includes an upper top surface that is concave to form an inverted cone and a lower top surface that is placed corresponding to the junction of the normal ventricular wall and the ventricular aneurysm. The height of the isolation part is 5mm-12mm, and the diameter of the isolation part is 30mm-45mm.

3. The filling body according to claim 1, It is characterized in that The height of the fixing part is 3mm-8mm, the diameter of the fixing part is 8mm-15mm, the connection between the isolation part and the support part and the fixing part forms a U-shape with horizontal sides, and the horizontal length of the U-shape on one side is 11mm-15mm.

4. The filling body according to claim 1, It is characterized in that The support portion is ellipsoidal in shape, the bottom surface of the distal end of the support portion is a plane, the height of the support portion is 10 mm-20 mm, and the diameter of the support portion is 20 mm-30 mm.

5. The left ventricular volume reduction device according to claim 2, It is characterized in that The filling body further comprises a flow-blocking film, which is arranged inside the filling body and is in contact with the upper top surface of the isolation part.

6. A locking ring for fixing the filling body described in any one of claims 1 to 5 to the outer wall of the ventricle, the locking ring being arranged corresponding to the fixing portion of the filling body and comprising a fixed section and a stretchable section, the fixed section having a fixed length, the stretchable section being able to extend in length when an external force is applied and to restore to its original length when the external force is removed.

7. The locking ring according to claim 6, It is characterized in that The fixed section and the stretchable section each have two sections, and each fixed section is adjacently connected to each stretchable section.

8. The locking ring according to claim 7, It is characterized in that The cross section of the fixing section is circular or square, and the diameter of the circle is 2 mm-4 mm.

9. The locking ring according to claim 8, It is characterized in that The stretchable section comprises a plurality of spiral structures, the central angles of the spiral structures corresponding to their original lengths are 30°-60°, and the spiral wire diameters of the spiral structures are in the range of 0.5mm-1mm.

10. The lock ring according to claim 6, It is characterized in that The stretchable section includes a plurality of hollow grooves.

11. A conveying device for conveying the locking ring of any one of claims 6 to 10 to a predetermined position, the conveying device comprising a fixed disk, a connecting rod and a control member, the locking ring being accommodated in the fixed disk, and the proximal end of the fixed disk being connected to at least a portion of the control member via the connecting rod.

12. The conveying device according to claim 11, It is characterized in that The fixing plate comprises an upper end cover and a lower end cover which are relatively matched in shape to form a hollow space, and a placement block accommodated in the hollow space, wherein the placement block comprises a cylindrical concave space for accommodating the locking ring.

13. The conveying device according to claim 12, It is characterized in that The lower end cover is provided with a mounting groove corresponding to the concave space, and the control member includes a fixing release member accommodated in the concave space and the mounting groove, a first pulling member connected to a part of the fixing release member, and a second pulling member connected to the locking ring.

14. The conveying device according to claim 13, It is characterized in that The fixed release member includes a housing body, a limiting element at least partially inverted and accommodated in the housing body, an elastic element sleeved on the limiting element and accommodated in the housing body, and a stopper having one end connected to the first pulling member and the other end movably abutting against one end of the limiting element.

15. The conveying device according to claim 14, It is characterized in that The conveying device acts on the locking ring, and makes the conveying device and the locking ring have an initial state, a stretched state and a released state, wherein: The initial state is configured as follows: the limiting element is completely accommodated in the accommodating body, one end of the stopper is connected to the first pulling member, the other end of the stopper abuts against one end of the limiting element, and the other end of the limiting element extends out of the accommodating body and limits the locking ring; The stretched state is configured as the locking ring being connected to the second pulling member, and the diameter of the locking ring is adjusted to a predetermined position in real time by controlling the movement of the second pulling member, and the fixing release member remains stationary at this time; The release state is configured to withdraw the second pulling member connected to the locking ring, control the movement of the first pulling member, so that the blocking member is completely separated from the accommodating body, and the limiting element is accommodated in the accommodating body under the action of the elastic member, thereby completing the release of the locking ring.

16. A left ventricular volume reduction system, comprising the filling body according to any one of claims 1 to 5, the locking ring according to any one of claims 6 to 10, and the delivery device according to any one of claims 11 to 15.

Images