Adjustable occlusion device and occlusion system

Abstract

The application discloses an adjustable plugging device and a plugging system, the plugging device comprises a first plugging disc, a second plugging disc and an adjusting assembly for adjusting the distance between the first plugging disc and the second plugging disc, the adjusting assembly comprises a first locking member connected with the first plugging disc and a second locking member connected with the second plugging disc, and the adjusting assembly has a locked state and an unlocked state, in the locked state, the first locking member and the second locking member are fixedly connected, and in the unlocked state, the first locking member and the second locking member are movably connected. The adjustable plugging device and the plugging system can quickly and conveniently plug a heart apex puncture port.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an adjustable occlusion device and occlusion system. Background Technology

[0002] Heart valve disease refers to single or multiple valvular diseases caused by structural or functional abnormalities of the valves, resulting in abnormal heart function and ultimately leading to heart failure.

[0003] Heart valve repair and replacement are common treatments for valvular heart disease. The surgery can be performed surgically or via interventional approaches. Interventional approaches typically include the transapical approach, the transseptal approach, and the transaortic arch approach. In transapical procedures, a puncture site is usually made at the apex of the heart, through which instruments are delivered to the heart chambers to repair or replace the valve. After the surgery, the apical puncture site is surgically sutured to prevent bleeding.

[0004] Currently, purse-string sutures are commonly used to seal the apical puncture site and prevent blood from leaking out. However, this method has several drawbacks: First, it requires multiple assistants, making the operation inconvenient and hindering rapid sealing of the apical puncture site, thus increasing surgical risks. Second, excessive or overly tight suturing of the heart tissue can impair cardiac function; if such problems occur, the sutures must be cut and re-sutured, affecting surgical efficiency. Third, if the patient's initial surgery is unsuccessful and requires a second operation, the apical suture site needs to be reopened, which can easily lead to tissue hyperplasia or infection. Summary of the Invention

[0005] The purpose of this invention is to provide an adjustable occlusion device and occlusion system that can quickly, conveniently and adjustablely occlude the apical puncture site.

[0006] To this end, the present invention provides an adjustable blocking device, which includes a first blocking disc, a second blocking disc, and an adjusting component for adjusting the distance between the first blocking disc and the second blocking disc. The adjusting component includes a first locking member connected to the first blocking disc and a second locking member connected to the second blocking disc. The adjusting component has a locked state and an unlocked state. In the locked state, the first locking member and the second locking member are fixedly connected. In the unlocked state, the first locking member and the second locking member are movably connected.

[0007] On the other hand, the present invention provides a occlusion system including the adjustable occlusion device and a conduit assembly having a receiving cavity, the occlusion device having a compression structure received within the receiving cavity and an expansion structure released from the receiving cavity.

[0008] The occlusion device of this invention seals the ventricular wall and lateral wall of the apical puncture site respectively using a first occlusion disc and a second occlusion disc. An adjusting component adjusts the distance between the first and second occlusion discs to prevent blood leakage from the apical puncture site. Furthermore, since the first locking member is connected to the first occlusion disc, and the second locking member is connected to the second occlusion disc, adjustment is only required in the unlocked state to adjust the distance between the first and second occlusion discs. Once the desired distance is reached, i.e., when blood leakage ceases, the adjusting component is switched to the locked state to fix the distance between the first and second occlusion discs. The entire process is quick, convenient, and adjustable, avoiding impact on cardiac function and effectively avoiding the defects of repeated suture cutting and suturing in existing technologies. Moreover, if the patient's surgery is unsuccessful and a second surgery is required, there is no need to cut the apical suture site; simply release the locking state of the adjusting component, retrieve the first and second occlusion discs, and then perform the second surgery. Attached Figure Description

[0009] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0010] Figure 1 This is a perspective view of a sealing system according to an embodiment of the present invention, wherein the sealing device is in a compressed configuration; Figure 2 for Figure 1 The diagram shows a three-dimensional schematic of the sealing system, in which the sealing device is in an expanded configuration; Figure 3 for Figure 2 A cross-sectional view of the plugging device and release assembly of the plugging system shown; Figure 4 for Figure 3 A three-dimensional schematic diagram of the adjusting assembly of the plugging device in the shown plugging system; Figure 5 for Figure 4 An exploded view of the adjustment component shown; Figure 6 for Figure 4 The cross-sectional view of the adjustment component is shown, with the adjustment component in a locked state; Figure 7 for Figure 4 The cross-sectional view of the adjustable component is shown, with the adjustable component in the unlocked state; Figure 8 for Figure 4Another perspective view of the adjustment assembly shown, in which the pull ring is connected across the second locking member; Figure 9 To and Figure 8 A three-dimensional schematic diagram of the tensioning component that mates with the adjustment assembly shown; Figure 10 for Figure 2 A three-dimensional schematic diagram of the sealing device of the sealing system shown; Figure 11 for Figure 10 A cross-sectional view of the sealing device shown; Figure 12 for Figure 11 A cross-sectional view of another alternative embodiment of the occlusion device with a biocompatible coating; Figure 13 for Figure 2 Exploded view of the sealing system shown; Figure 14A for Figure 1 The diagram shows a state of operation of the occlusion system, in which the occlusion device is delivered into the left atrium; Figure 14B for Figure 1 Another state diagram of the use of the shown plugging system, in which the first plugging disc of the plugging device is released and inflated; Figure 14C for Figure 1 Another state diagram of the occlusion system in use, in which the first occlusion disc of the occlusion device is attached to the ventricular wall; Figure 14D for Figure 1 The diagram shows another state of the occlusion system in use, in which the second occlusion disc of the occlusion device is released and inflated; Figure 14E for Figure 1 The diagram shows the final state of the occlusion system during use, where the occlusion device seals the apical puncture site, and the remaining components of the occlusion system are removed from the body. Detailed Implementation

[0011] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Furthermore, the embodiments described below can be combined with each other as long as there is no contradiction or conflict, and the same or similar concepts or processes may not be repeated in some embodiments.

[0012] First, it should be noted that in this article, "proximal end" refers to the end of the device or component closer to the operator. "Distal end" refers to the end of the device or component farther from the operator. "Axial" refers to the direction that coincides with or is parallel to the central axis of the device or component. "Radial" refers to the direction that is perpendicular or approximately perpendicular to the axial direction and along the radius or diameter of the device or component. "Circumferential" refers to the direction around the axial direction.

[0013] It is worth noting that the terms indicating orientation or positional relationship mentioned above are only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

[0014] refer to Figure 1 and Figure 2 An adjustable occlusion system 100 according to an embodiment of the present invention includes an adjustable occlusion device 10 and a catheter assembly 20 for delivering the occlusion device 10. The catheter assembly 20 has a receiving cavity 21. When the occlusion device 10 is received within the receiving cavity 21, the occlusion device 10 is positioned as follows: Figure 1 The compression configuration is shown. When the occlusion device 10 is released from the receiving cavity 21 (e.g., by retracting the conduit assembly 20 or by pushing the occlusion device 10 forward), the occlusion device 10 is in the form of... Figure 2 The expansion configuration is shown. Preferably, during occlusion, the occlusion device 10 expands from its compressed configuration to its expanded configuration. The occlusion device 10 is made of a material with shape memory function and is heat-set, so it can be stretched axially and contracted radially under external force, and expands back to its natural state after the external force is released. In the compressed configuration, the occlusion device 10 is elongated into a slender rod shape, which facilitates compression within the receiving cavity 21 of the catheter assembly 20 for delivery via the apex or via the catheter; in the expanded configuration, the occlusion device 10 returns to its natural state and has two generally flat, connected disc-shaped structures, namely occlusion discs, whose surfaces can respectively abut against both sides of the apical puncture site to seal the apical puncture site.

[0015] In some embodiments, the occlusion system 100 further includes a release assembly 30. A portion of the release assembly 30 is detachably connected to the occlusion device 10 through the conduit assembly 20. The occlusion device 10 can be easily operated via the release assembly 30. Furthermore, the release assembly 30 and the conduit assembly 20 are movable relative to each other to allow the occlusion device 10 to move relative to the conduit assembly 20 to receive release within or from the receiving cavity 21.

[0016] Preferably, for ease of operation, the occlusion system 100 further includes a handle assembly 40. At least a portion of the handle assembly 40 passes through the receiving cavity 21 of the catheter assembly 20, and the handle assembly 40 and the catheter assembly 20 are movable relative to each other. Thus, the occlusion device 10 can be released from the receiving cavity 21 of the catheter assembly 20 by retracting the catheter assembly 20 relative to the handle assembly 40, or the occlusion device 10 can be received in the receiving cavity 21 of the catheter assembly 20 by pushing the catheter assembly 20 forward relative to the handle assembly 40.

[0017] In some embodiments, the handle assembly 40 is sleeved outside the release assembly 30, meaning the release assembly 30 passes through the handle assembly 40 for detachable connection to the blocking device 10. Furthermore, the handle assembly 40 and the release assembly 30 are movable relative to each other, allowing the release assembly 30 to operate the blocking device 10 independently of the handle assembly 40. It is understood that in other embodiments, the release assembly 30 and the handle assembly 40 may also be arranged differently; for example, the release assembly 30 and the handle assembly 40 may be fixedly connected. Alternatively, in other embodiments, the handle assembly 40 may be omitted.

[0018] refer to Figure 3 The occlusion device 10 includes a first occlusion disc 11, a second occlusion disc 12, and an adjustment assembly 13 for adjusting the distance between the first occlusion disc 11 and the second occlusion disc 12. The adjustment assembly 13 includes a first locking member 14 connected to the first occlusion disc 11 and a second locking member 15 connected to the second occlusion disc 12. Preferably, the adjustment assembly 13 is located at the center of the first occlusion disc 11 and the second occlusion disc 12 to better adjust the distance between them and to maintain the autocentricity of the occlusion device 10, preventing tilting during delivery, release, adjustment, or implantation.

[0019] Also refer to Figures 3 to 5 In some embodiments, the first locking member 14 includes a locking rod 141 and a locking head 142 connected to each other. The locking head 142 is used to connect with the first sealing disc 11. The locking rod 141 is inserted into the second locking member 15 to connect with the second locking member 15, and the locking rod 141 is also used for detachable connection with the release assembly 30.

[0020] Optionally, a first connecting sleeve 143 is fitted over the locking head 142, forming a first annular cavity 144 therebetween for gathering and fixing a portion of the first sealing disc 11. In some embodiments, the first sealing disc 11 is formed by weaving and heat-setting several nickel-titanium wires, with the ends of the wires gathered and housed in the first annular cavity 144, and fixed within the cavity by methods such as laser or plasma welding. It is understood that in other embodiments, the first sealing disc 11 may also be made of other materials with biocompatibility and shape memory properties. It is also understood that in other embodiments, the first sealing disc 11 may be formed using other processing methods, such as cutting from tubing.

[0021] Preferably, the first locking member 14 is threadedly connected to the release assembly 30. Optionally, the locking rod 141 has an internal thread 145. The release assembly 30 may include a longitudinally elongated release rod 31 and an operating part 32 connected to the proximal end of the release rod 31. The distal end of the release rod 31 has an external thread for threaded connection with the internal thread 145 of the locking rod 141. After the release rod 31 is threadedly connected to the locking rod 141, the first locking member 14 can be moved by moving the operating part 32 back and forth to adjust the distance between the first locking member 14 and the second locking member 15, thereby adjusting the distance between the first sealing disc 11 and the second sealing disc 12. After adjusting the first sealing disc 11 and the second sealing disc 12 to the ideal distance, rotating the operating part 32 to release the release rod 31 from the locking rod 141 will release the release assembly 30 from the first locking member 14. Of course, the operating part 32 may also be omitted from the release assembly 30; after the release rod 31 is threadedly connected to the locking rod 141, moving the release rod 31 back and forth will also move the first locking member 14.

[0022] The second locking member 15 includes a first ring portion 155 and a second ring portion 156 connected to each other. The first ring portion 155 is connected to the first locking member 14. The adjusting assembly 13 also includes a locking piece 16 and an elastic member 17, which are disposed within the first ring portion 155, i.e., within the second locking member. The elastic member 17 is connected to the locking piece 16. The second ring portion 156 is used to connect to the second sealing disc 12.

[0023] Optionally, a second connecting sleeve 157 is fitted over the second ring portion 156, forming a second annular cavity 158 therebetween for gathering and fixing a portion of the second sealing disc 12. Similar to the first sealing disc 11, in some embodiments, the second sealing disc 12 is also woven from several nickel-titanium wires, with the ends of the wires gathered and accommodated in the second annular cavity 158, and fixed within the second annular cavity 158 by methods such as laser or plasma welding. Similarly, it is understood that in other embodiments, the second sealing disc 12 may also be made of other materials with biocompatibility and shape memory properties. It is also understood that in other embodiments, the second sealing disc 12 may be formed using other processing methods, such as cutting from tubing.

[0024] refer to Figure 6 and Figure 7 The adjustment component 13 has a locked state and an unlocked state. For example... Figure 6 As shown, in the locked state, the first locking member 14 and the second locking member 15 are fixedly connected, that is, the first locking member 14 and the second locking member 15 are fixed relative to each other, thereby making the distance between the first sealing plate 11 and the second sealing plate 12 relatively fixed. Figure 7 As shown, in the unlocked state, the first locking member 14 and the second locking member 15 are movably connected, that is, the first locking member 14 and the second locking member 15 can move relative to each other in order to adjust the distance between the first sealing plate 11 and the second sealing plate 12.

[0025] Specifically, the first locking member 14 is generally cylindrical, and the second locking member 15 is also generally cylindrical. The second locking member 15 has a locking cavity 151, within which a locking piece 16 is movably mounted. The locking piece 16 has a first through hole 160 extending through itself along its thickness direction. The second locking member 15 has a second through hole 150 extending through itself along its axial direction. The first locking member 14 passes through the first through hole 160 of the locking piece 16 and is received within the second through hole 150. The locking piece 16 moves relative to the second locking member 15 to change the angle between the central axis of the first through hole 160 and the central axis of the second through hole 150.

[0026] exist Figure 6 In the locked state shown, the locking piece 16 is arranged obliquely relative to the first locking member 14 within the locking cavity 151. That is, the central axis of the first through hole 160 intersects with the central axis of the second through hole 150, forming a certain angle. At this time, the outer surface of the first locking member 14 is in frictional contact with the wall of the first through hole 160, causing the first locking member 14 to be unable to move relative to the locking piece 16, and thus unable to move relative to the second locking member 15.

[0027] exist Figure 7In the unlocked state shown, the locking piece 16 is arranged perpendicularly to the first locking member 14 within the locking cavity 151. That is, the central axis of the first through hole 160 coincides with, substantially coincides with, or is parallel to the central axis of the second through hole 150. Preferably, the first through hole 160 and the second through hole 150 have essentially the same shape, both being regular circular holes, and their central axes coincide. At this time, the first locking member 14 is in clearance fit with the first through hole 160, meaning the first locking member 14 does not contact the first through hole 160, and the first locking member 14 can move relative to the locking piece 16, and further relative to the second locking member 15. In other embodiments, if the shapes of the first through hole 160 and the second through hole 150 are different, for example, one is a circular hole and the other is an elliptical hole, their central axes may not coincide, but are parallel. However, the first locking member 14 can still pass through the first through hole 160 and the second through hole 150 sequentially within a continuous inner cavity.

[0028] In some embodiments, the locking piece 16 transitions from an unlocked state to a locked state via an elastic member 17 installed within the locking cavity 151. The elastic member 17 drives the locking piece 16 to move relative to the second locking member 15, thereby changing the angle between the central axis of the first through hole 160 and the central axis of the second through hole 150. The elastic member 17 is made of an elastic material or a shape memory material, preferably a metal material such as stainless steel or nickel-titanium alloy. Optionally, one end of the elastic member 17 abuts against the cavity wall of the locking cavity 151, and the other end abuts against the locking piece 16 to provide a resisting force to the locking piece 16, thereby changing the locking piece 16 from being placed vertically relative to the first locking member 14 to being placed at an angle relative to the first locking member 14. Preferably, the elastic member 17 is constructed as an elastic piece with an arcuate surface. This elastic piece has a third through hole 170 extending through itself along its thickness direction, and its arcuate surface is recessed in a direction away from the locking piece 16. The diameter of the third through hole 170 is preferably larger than the diameter of the first through hole 160. The first locking member 14 passes through both the first through hole 160 and the third through hole. The locking piece 16 is switched from the unlocked state to the locked state by the elastic sheet, which is simple and stable.

[0029] In some embodiments, the cavity wall of the locking cavity 151 includes a first abutment surface 152 and a second abutment surface 153 opposite to the central axis of the second through hole 150. The plane containing the first abutment surface 152 intersects the central axis of the second through hole 150. Optionally, the plane containing the second abutment surface 153 is parallel to the central axis of the second through hole 150. Therefore, when the locking piece 16 changes from the unlocked state to the locked state under the action of the elastic member 17, one side of the locking piece 16 abuts against the first abutment surface 152, and the other side abuts against the second abutment surface 153. The first abutment surface 152 effectively ensures that the locking piece 16 moves to an inclined position relative to the first locking member 14. More preferably, the locking piece 16 is generally square to increase the contact area between the locking piece 16 and the first abutment surface 152 and the second abutment surface 153, improving the stability of the locking piece 16 in the locked state. The locking piece 16 may be made of a metal such as stainless steel.

[0030] refer to Figure 8 and Figure 9 In some embodiments, the locking piece 16 transitions from a locked state to an unlocked state via a pulling member 18. The pulling member 18 is connected to the locking piece 16. When it is necessary to adjust the distance between the first locking member 14 and the second locking member 15, the pulling member 18 is pulled to move the locking piece 16 toward the elastic member 17, thereby changing the locking piece 16 from being tilted relative to the first locking member 14 to being perpendicular to the first locking member 14, i.e., changing it to the unlocked state. At this time, the first locking member 14 can move relative to the second locking member 15, thus adjusting the distance between the first locking member 14 and the second locking member 15, and consequently adjusting the distance between the first sealing disc 11 and the second sealing disc 12. After adjusting the first sealing disc 11 and the second sealing disc 12 to the ideal distance, the pulling force of the pulling member 18 is released. At this time, the locking piece 16 moves under the elastic force of the elastic member 17 to be tilted relative to the first locking member 14, and the first locking member 14 can no longer move relative to the second locking member 15, i.e., fixing the distance between the first sealing disc 11 and the second sealing disc 12.

[0031] In some embodiments, the second locking member 15 has a traction hole 154 penetrating its sidewall. Specifically, the locking cavity 151 penetrates the sidewall of the second locking member 15 to form the traction hole 154. The pulling member 18 includes a U-shaped pulling ring 181 and a pulling line 182 connected to both ends of the pulling ring 181. The pulling ring 181 crosses and overlaps a surface of the locking piece 16 via the traction hole 154, which faces away from the elastic member 17. Thus, simply pulling the pulling line 182 can pull the pulling ring 181 to move the locking piece 16 to a position perpendicular to the first locking member 14.

[0032] Furthermore, to improve the strength of the traction ring 181 and reduce the risk of it breaking under stress, the traction ring 181 is constructed by bending and shaping a metal wire into a double-wire structure, and preferably, a fixing sleeve 183 is used to firmly connect the two ends of the metal wire. Preferably, the traction wire 182 is flexible, with one end passing sequentially through the gap between the two wires at both ends of the traction ring 181 and bent to form a double-wire traction structure. This double-wire traction structure also improves the strength of the traction wire 182 and reduces the risk of it breaking under stress.

[0033] refer to Figure 10 and Figure 11 In some embodiments, the maximum diameter of the second occlusion disc 12 is smaller than the maximum diameter of the first occlusion disc 11. During the procedure, the first occlusion disc 11 is adapted to be implanted into the ventricle to conform to the intraventricular wall, and the second occlusion disc 12 is adapted to conform to the apical wall of the heart. The larger overall profile of the first occlusion disc 11 and the smaller overall profile of the second occlusion disc 12 can better conform to the cardiac anatomy.

[0034] The first occlusion disc 11 has a first surface 111 and a second surface 112 facing each other, wherein the first surface 111 is opposite to the second occlusion disc 12. To facilitate better fit of the first occlusion disc 11 to the ventricular wall, preferably, the first surface 111 is circular, with a diameter preferably in the range of 25mm to 35mm. More preferably, the second surface 112 tapers gradually towards the direction away from the first surface 111 into the first annular cavity 144 and connects with the first locking member 14. More preferably, the second surface 112 is conical.

[0035] The second occlusion disc 12 has a first surface 121 and a second surface 122 opposite to each other, wherein the first surface 121 is opposite to the first occlusion disc 11. To facilitate better fit of the second occlusion disc 12 against the apical wall and prevent blood leakage from the apical puncture site, preferably, the first surface 121 is concave and tapered towards the second surface 122, more preferably conical, thereby creating a negative pressure between the first surface 121 and the apical wall, allowing the first surface 121 to be tightly fastened to the apical wall. Further, the maximum diameter of the first surface 121 is preferably in the range of 20mm to 30mm. The second surface 122 is preferably circular and connected to the second locking member 15.

[0036] Optionally, the first occlusion disc 11 has anchors 113 on its first surface 111. Thus, when the first occlusion disc 11 is implanted into the ventricle and abuts against the ventricle wall, the anchors 113 can penetrate the tissue, preventing displacement of the first occlusion disc 11. Similarly, the second occlusion disc 12 has anchors 123 on its first surface 121. Thus, when the second occlusion disc 12 is abutted against the apical wall of the heart, the anchors 123 can penetrate the tissue, preventing displacement of the second occlusion disc 12.

[0037] The method of forming anchors 113 and 123 is not limited. They can be woven, cut, integrally formed with the first sealing plate 11 / second sealing plate 12, or manufactured separately and installed on the first sealing plate 11 / second sealing plate 12. The number of anchors 113 and 123 on the first sealing plate 11 and the second sealing plate 12 is preferably 3 to 10, more preferably 6, which ensures stable anchoring force and avoids excessive anchors damaging the tissue or increasing the diameter of the first sealing plate 11 and the second sealing plate 12.

[0038] refer to Figure 12 In some embodiments, a biocompatible membrane 114 is provided on the outer side of the first occlusion disc 11 to better prevent blood leakage after the first occlusion disc 11 is implanted into the ventricle. Optionally, the biocompatible membrane 114 is a PTFE (polytetrafluoroethylene) membrane. Alternatively or additionally, a biocompatible membrane is provided on the inner side of the first occlusion disc 11.

[0039] Similarly, a biocompatible membrane 124 is provided on the outer side of the second occlusion disc 12 to better prevent blood leakage after the second occlusion disc 12 is abutted to the apex of the heart. Optionally, the biocompatible membrane 124 is a PTFE (polytetrafluoroethylene) membrane. Alternatively or additionally, a biocompatible membrane is provided on the inner side of the second occlusion disc 12.

[0040] Preferably, the first sealing disc 11 and the second sealing disc 12 are integrally formed. In this case, the connection portion of the first sealing disc 11 and the second sealing disc 12 corresponding to the adjustment component 13 is also preferably provided with a (e.g., woven) biocompatible membrane 134, so as to prevent blood leakage and promote tissue growth, avoid failure of the sealing device 10, and extend the life of the sealing device 10.

[0041] Understandably, the first sealing disc 11 and the second sealing disc 12 can also be formed separately and then connected together by the adjustment assembly 13. In this case, the outer periphery of the adjustment assembly 13 is preferably provided with a (e.g., woven) biocompatible membrane 134, which can also prevent blood leakage while promoting tissue growth, avoiding failure of the sealing device 10, and extending the life of the sealing device 10.

[0042] refer to Figure 2 and Figure 13In some embodiments, the release assembly 30 further includes a limiting portion 33 sleeved on the release lever 31. The limiting portion 33 is adjacent to the operating portion 32. Correspondingly, the handle assembly 40 has a first limiting groove 41. The limiting portion 33 slidably engages with the first limiting groove 41. When the limiting portion 33 is received within the first limiting groove 41, it effectively prevents the release assembly 30 from rotating autonomously relative to the handle assembly 40, thereby preventing the release assembly 30 from accidentally releasing from the first locking member 14. When the operator pulls the release assembly 30 backward or pushes the handle assembly 40 forward to release the limiting portion 33 from the first limiting groove 41, the release assembly 30 can be rotated relative to the handle assembly 40 to release the release assembly from the first locking member 14. In other embodiments, the release assembly 30 may have a limiting groove, and the handle assembly 40 may have a limiting portion.

[0043] In some embodiments, the handle assembly 40 includes an elongated rod-shaped guide shaft 42 and a handle 43 connected to the proximal end of the guide shaft 42. The guide shaft 42 has a first guide cavity 421 for guiding the release lever 31 and two second guide cavities 422 for guiding the pull wire 182. The proximal end of the guide shaft 42 has an axially extending first limiting rib 423 and one or more circumferentially extending circular second limiting ribs 424.

[0044] Optionally, the handle 43 includes a first housing 430 and a second housing 431 arranged radially opposite to each other. The first housing 430 and the second housing 431 together enclose a first limiting groove 41, an axially extending second limiting groove 432, one or more circumferentially extending third limiting grooves 433, and an axially extending receiving groove 434. A first limiting rib 423 engages with the second limiting groove 432 to prevent relative circumferential rotation between the handle 43 and the guide shaft 42. A second limiting rib 424 engages with a corresponding third limiting groove 433 to prevent relative axial movement between the handle 43 and the guide shaft 42. The handle 43 also includes a slider 435 slidably connected within the receiving groove 434, and the slider 435 is connected to the pull wire 182.

[0045] Optionally, the first housing 430 and the second housing 431 are snap-fitted together. Further, a first end cap 438 is threadedly connected to the proximal end of the handle 43 to securely connect the first housing 430 and the second housing 431 together. The first end cap 438 has a through hole for the limiting portion 33 of the release assembly 30 to pass through to the proximal end of the handle 43.

[0046] Preferably, a first groove 436 is provided at the proximal end of the handle 43 to accommodate a first silicone ring 437, thereby sealing the first end cap 438, the first housing 430, and the second housing 431. Further, the first silicone ring 437 is fitted onto the limiting portion 33 to achieve a sealed connection between the limiting portion 33 and the handle 43. Moreover, when the first end cap 438 is tightened onto the proximal end of the handle 43, the first silicone ring 437 uses its own deformation to compress the limiting portion 33, thus securing the limiting portion 33 to the handle 43. When the first end cap 438 is loosened from the handle 43, the first silicone ring 437 no longer compresses the limiting portion 33, at which point the release assembly 30 and the handle assembly 40 can move relative to each other.

[0047] In some embodiments, the conduit assembly 20 includes an elongated rod-shaped conduit 22. A second end cap 23 is threaded to the proximal end of the conduit 22. The second end cap 23 has a through hole through which the guide shaft 42 of the handle assembly 40 passes to the proximal end of the conduit assembly 20. Preferably, the proximal end of the conduit 22 has a second groove 220 for receiving a second silicone ring 221 to seal the second end cap 23 and the conduit 22. Further, the second silicone ring 221 is fitted onto the guide shaft 42 to achieve a sealed connection between the guide shaft 42 and the conduit 22. Furthermore, when the second end cap 23 is tightened onto the proximal end of the conduit 22, the second silicone ring 221 uses its own deformation to compress the guide shaft 42 to securely connect the guide shaft 42 to the conduit 22. When the second end cap 23 is loosened from the conduit 22, the second silicone ring 221 no longer compresses the guide shaft 42, at which point the handle assembly 40 and the conduit assembly 20 can move relative to each other.

[0048] refer to Figures 14A to 14E As an example, the specific usage method / surgical method of the occlusion system in this embodiment includes: Step S1: As Figure 14A As shown, a pathway is established through the catheter assembly 20 to deliver the occlusion device 10 to the left atrium via the apical puncture site.

[0049] Step S2: As Figure 14B As shown, loosen the second end cap 23 and pull the conduit assembly 20 back relative to the handle assembly 40 to completely release the first sealing disc 11 from the conduit 22. At this time, the first sealing disc 11 expands to its expanded state. Step S3: As Figure 14C As shown, tighten the second end cap 23 and retract the entire occlusion system until the first occlusion disc 11 is against the ventricular wall. At this point, the entire occlusion system can be slightly retracted to prevent blood from spilling out.

[0050] Step S4: As Figure 14DAs shown, loosen the second end cap 23 again, and pull the catheter assembly 20 back relative to the handle assembly 40 to completely release the second occlusion disc 12 from the catheter 22. At this time, the second occlusion disc 12 expands on the outer wall of the apex of the heart (afterwards, for ease of operation, the second end cap 23 can be selectively tightened to fix the catheter assembly 20 and the handle assembly 40); observe the blood flow. If blood overflows, adjust the distance between the first occlusion disc 11 and the second occlusion disc 12.

[0051] Specifically, the method for adjusting the distance between the first sealing disc 11 and the second sealing disc 12 includes: sliding the slider 435 backward to tighten the traction line 182, at which time the adjusting component 13 is switched to the unlocked state; loosening the first end cap 438, moving the release component 30 back and forth through the operating part 32, and then moving the first locking member 14 back and forth to adjust the distance between the first sealing disc 11 and the second sealing disc 12; after observing that there is no blood leakage from the puncture site, pushing the slider 435 forward to release the traction line 182, at which time the adjusting component 13 is switched to the locked state, and the distance between the first sealing disc 11 and the second sealing disc 12 is fixed, thus completing the adjustment.

[0052] During the operation, if after the occlusion device 10 is released, it is found that the occlusion device 10 clamps the tissue too tightly, resulting in limited cardiac function or unsuccessful occlusion, the traction line 182 can be tightened again to unlock the adjustment component 13. Then the distance between the first occlusion disc 11 and the second occlusion disc 12 can be adjusted and locked, thereby avoiding the defects of repeated cutting and suturing in the prior art.

[0053] Step S5: As Figure 14E As shown, after the occlusion device 10 is adjusted to the ideal position, the handle assembly 40 is pushed forward relative to the release assembly 30 until the limiting part 33 is released from the first limiting groove 41. Then, the release assembly 30 is rotated relative to the handle assembly 40 to release the release assembly 30 from the first locking member 14. Finally, one end of the traction line 182 connected by the U-shape is pulled, the traction line 182 is removed, and the catheter assembly 20, handle assembly 40, and release assembly 30 are removed from the body, leaving the occlusion device 10 to block the apical puncture site.

[0054] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An adjustable sealing device, characterized in that, The sealing device includes a first sealing disc, a second sealing disc, and an adjusting assembly for adjusting the distance between the first sealing disc and the second sealing disc. The adjusting assembly includes a first locking member connected to the first sealing disc and a second locking member connected to the second sealing disc. The adjusting assembly has a locked state and an unlocked state. In the locked state, the first locking member and the second locking member are fixedly connected. In the unlocked state, the first locking member and the second locking member are movably connected. The second locking member has a locking piece with a first through hole and a second through hole. The locking piece moves relative to the second locking member to change the angle between the central axis of the first through hole and the central axis of the second through hole. The first locking member passes through the locking piece via the first through hole and is housed in the second through hole. In the locked state, the central axis of the first through hole and the central axis of the second through hole form an angle so that the first locking member is in frictional contact with the first through hole. In the unlocked state, the central axis of the first through hole and the central axis of the second through hole coincide or are parallel so that the first locking member is not in contact with the first through hole.

2. The adjustable sealing device according to claim 1, characterized in that, The first locking element includes a locking rod and a locking head that are connected to each other, and the locking rod is connected to the second locking element.

3. The adjustable sealing device according to claim 1, characterized in that, The second locking member includes a first ring portion and a second ring portion that are connected to each other, with the first ring portion connected to the first locking member.

4. The adjustable sealing device according to claim 1, characterized in that, The second locking member has a first abutting surface and a second abutting surface opposite to the first abutting surface relative to the central axis of the second through hole. The plane of the first abutting surface intersects the central axis of the second through hole, and the plane of the second abutting surface is parallel to the central axis of the second through hole. The opposite sides of the locking piece abut against or separate from the first abutting surface and the second abutting surface, respectively.

5. The adjustable sealing device according to claim 1, characterized in that, The second locking member also includes an elastic element connected to the locking piece. The elastic element drives the locking piece to move relative to the second locking member, thereby changing the angle between the central axis of the first through hole and the central axis of the second through hole.

6. The adjustable sealing device according to claim 1, characterized in that, The first sealing disc has a first surface and a second surface opposite to each other. The first surface is opposite to the second sealing disc and is circular. The second surface gradually tapers away from the first surface until it connects with the first locking member.

7. The adjustable sealing device according to claim 1, characterized in that, The second sealing disc has a first surface and a second surface opposite to each other. The first surface is concave and tapered toward the second surface opposite to the first sealing disc, and the second surface is circular and connected to the second locking member.

8. The adjustable sealing device according to claim 1, characterized in that, Anchor spikes are provided on the surfaces of the first sealing disc and the second sealing disc opposite to each other and / or on the surfaces of the second sealing disc and the first sealing disc opposite to each other.

9. The adjustable sealing device according to claim 1, characterized in that, At least one of the outer side of the first sealing disc, the inner side of the first sealing disc, the outer side of the second sealing disc, the inner side of the second sealing disc, and the outer periphery of the adjustment assembly is provided with a biocompatible coating.

10. A sealing system, characterized in that, The invention includes an adjustable occlusion device according to any one of claims 1 to 9, and a catheter assembly having a receiving cavity, the occlusion device having a compression configuration received within the receiving cavity and an expansion configuration released from the receiving cavity.

11. The sealing system according to claim 10, characterized in that, The second locking member of the adjustable blocking device is provided with a locking piece and an elastic member connected to the locking piece. The blocking system also includes a pulling member connected to the locking piece, which is used to pull the locking piece toward the elastic member until the first locking member and the second locking member are moved and connected.

12. The sealing system according to claim 11, characterized in that, The second locking member is provided with a traction hole penetrating its side wall. The traction member includes a U-shaped traction ring and traction lines connected to both ends of the traction ring. The traction ring is connected to the surface of the locking piece opposite to the elastic member via the traction hole.

13. The sealing system according to claim 10, characterized in that, The occlusion system further includes a release component that is detachably connected to the first locking member through the conduit assembly, wherein, in the unlocked state, the release component is used to drive the first locking member to move relative to the second locking member.

14. The sealing system according to claim 13, characterized in that, The occlusion system further includes a handle assembly that is at least partially inserted through the receiving cavity of the catheter assembly and slidably connected to the catheter assembly, the release assembly being detachably connected to the first locking member through the inner cavity of the handle assembly.

15. The sealing system according to claim 14, characterized in that, One of the handle assembly and the release assembly is provided with a limiting part, and the other is provided with a limiting groove. When the limiting part is received in the limiting groove, the release assembly is anti-rotationally connected to the handle assembly. When the limiting part is released from the limiting groove, the release assembly can rotate relative to the handle assembly.

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