Detailed Description
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs, and the terms used herein are used for the purpose of describing particular embodiments only and are not intended to limit the invention, e.g., the terms "length," "width," "upper," "lower," "left," "right," "front," "rear," "vertical," "horizontal," "top," "bottom," "inner," "outer," etc., indicate orientations or positions based on the orientations or positions shown in the drawings, which are merely for convenience of description and are not to be construed as limiting the present invention.
The terms "comprising" and "having" and any variations thereof in the description of the invention and the claims and in the foregoing drawings are intended to cover non-exclusive inclusions, and the terms "first", "second", and the like in the description and the claims of the invention or the foregoing drawings are used for distinguishing between different objects and not for describing a particular sequential order. The meaning of "a plurality of" is two or more, unless specifically defined otherwise.
In the description of the invention and the claims and the above figures, when an element is referred to as being "fixed" or "mounted" or "disposed" or "connected" to another element, it can be directly or indirectly on the other element. For example, when an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element.
Furthermore, references herein to "an embodiment" mean that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the present invention. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments.
In the field of interventional medical devices, "proximal" and "distal" are terms of usage. Where "proximal" means the end of the medical device implanted in the body that is closer to the operator and "distal" means the end that is farther from the operator. And defines the "proximal" and "distal" ends of any component of the medical device in accordance with this principle. In addition, the position where the left atrium enters the left auricle is defined as the mouth of the left auricle, and the position in the left auricle adjacent to the entrance of the left auricle is defined as the neck of the left auricle. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle. "intermediate section" generally refers to a portion of any component of a medical device that is distinguished from both ends, and does not refer to only that portion of any component of a medical device that is located directly in the middle.
Embodiments of the present invention provide an occlusion device 100 that may be used to occlude the ostium of the left atrial appendage and may also be used to occlude the pores or defects of other internal tissues of a human or animal, including, but not limited to, atrial septal defects, ventricular septal defects, patent ductus arteriosus, patent foramen ovale, etc. For convenience of explanation, the occlusion device 100 will be described in detail below with respect to the occlusion of the left atrial appendage.
As shown in fig. 1 to 6, the plugging device 100 comprises a fixing portion 1 and a sealing portion 2, wherein the fixing portion 1 and the sealing portion 2 are generally disposed at intervals along the axial direction of the plugging device 100, specifically, the fixing portion 1 and the sealing portion 2 may be directly connected or indirectly connected through other components, the sealing portion 2 is located at the proximal end of the plugging device 100, and the fixing portion 1 is located at the distal end of the plugging device 100. The fixing part 1 is mainly used for entering a cavity waiting for plugging and is anchored on the inner wall of the cavity waiting for plugging. The sealing part 2 is mainly used for sealing to-be-sealed cavities. The cavity to be plugged described herein includes, but is not limited to, the left atrial appendage, an aneurysm, etc.
Illustratively, taking a left atrial appendage sealer as an example, when the left atrial appendage sealer 100 is implanted in the left atrial appendage, the fixing portion 1 is in a fully expanded state including, but not limited to, a column shape or an umbrella shape to closely fit with a cavity wall of the left atrial appendage so as to facilitate fixing the sealer 100 in the left atrial appendage, ensure that the left atrial appendage sealer 100 is effectively implanted in the left atrial appendage for a long time, and the sealing portion 2 is closely fitted to an opening or an inner cavity of the left atrial appendage after being released in the left atrial appendage to seal the left atrial appendage, prevent thrombus formed in the left atrial appendage from flowing into the left atrial appendage, and prevent blood flow of the left atrial appendage from flowing into the left atrial appendage.
Illustratively, the fixing portion 1 may include a fixing support frame 11, a covering film 12, an anchor 13 and a proximal restraint, wherein the fixing support frame 11 may be spliced by a support rod (not shown) with a circumferential gap, or woven into a mesh structure by a braiding wire, and then heat-set after being closed by the proximal restraint, and the overall shape thereof is not limited, so long as the released fixing portion 1 can fix the plugging device 100 at a specific position in the body. As shown in fig. 1, the inside or the outside of the fixing support 11 may be optionally covered with at least one coating 12 to further seal the left atrial appendage and prevent the stress of the left atrial appendage from being excessively concentrated on the surface of the fixing portion 1 while ensuring good sealing of the sealing portion 2.
In addition, in order to facilitate the long-term and effective implantation of the plugging device 100 in the left atrial appendage and avoid the problem of instrument embolism caused by falling off, at least one anchor 13 is disposed on the support rod or the braided wire of the fixed support frame 11, and the anchor 13 may be disposed on the fixed support frame 11 by welding, hot melting, entanglement, bonding, or the like, for example, and of course, the anchor 13 may be directly cut out from the fixed support frame 11 by integrally forming.
In particular, in this embodiment, the anchoring element 13 includes, but is not limited to, an anchor hook, etc., and as illustrated in fig. 1, the anchoring element 13 may preferably be an anchor, and the anchor may extend from a distal end to a proximal end of the fixing portion 1 and gradually deviate from the fixing portion 1, so that a tip of the anchor may more smoothly penetrate into an inner wall of a left atrial appendage and be firmly anchored to the inner wall of the left atrial appendage, so that the fixing portion 1 is stably anchored to the inner wall of the left atrial appendage on one hand, and the plugging device 100 is ensured to effectively plug the left atrial appendage for a long time, and on the other hand, the plugging device 100 is facilitated to be ensured to be tightly attached to the inner wall of the left atrial appendage during the contraction and extension of the left atrial appendage along with the heart.
In addition, as shown in fig. 1 and 2, the sealing part 2 may include at least a sealing support frame 21 and a distal end restraint (see fig. 2), wherein the sealing support frame 21 may be woven by a plurality of woven wires to form a mesh tube, and the distal end and the proximal end of the mesh tube may be respectively closed and fixed at the ports of the woven wires by the distal end restraint such as a sleeve, and then thermally shaped into a shape including but not limited to a disc shape, a column shape, a flat shape, or a plug shape.
Of course, at least one flow blocking membrane (not shown) may be provided inside and/or outside the sealing portion 2 to block blood flow from the left atrium to the left atrial appendage and to block thrombus from the left atrial appendage from entering the left atrium to ensure tight occlusion of the mouth of the left atrial appendage.
Specifically, the edge of the choke film may be secured to the woven wire at the edge of the seal 2 by means including, but not limited to, stitching, bonding, and the like. The size of at least one choke film on the sealing part 2 is equal to the disc surface of the sealing part 2, so that the disc surface of the sealing part 2 can be completely covered, and the tight sealing of the mouth of the left auricle is ensured.
The coating film 12 of the fixing portion 1 and the choke film of the sealing portion 2 are both made of a polymer material, and may be preferably, but not limited to, PTFE (Poly Tetra Fluoro Ethylene ) or PET (Poly ETHYLENE TEREPHTHALATE, polyethylene terephthalate).
In an embodiment of the present invention, as shown in fig. 1, to achieve a fixed connection between the fixing portion 1 and the sealing portion 2, the plugging device 100 further comprises a connection portion 3. In the use state of the plugging device 100, the connecting portion 3 is located between the fixing portion 1 and the sealing portion 2, and two ends of the connecting portion 3 are axially connected to the fixing portion 1 and the sealing portion 2, respectively.
Specifically, as shown in fig. 3, 6, 11, 13, 15, 17 or 21, the connection part 3 includes a first connection member 31 and a second connection member 32, where the first connection member 31 is connected to a proximal end of the fixing part 1, the second connection member 32 is connected to a distal end of the sealing part 2, and in an initial state, the first connection member 31 and the second connection member 32 are independent from each other, when the plugging device 100 is needed to be used, corresponding dimensions of the fixing part 1 and the sealing part 2 are determined, a suitable fixing part 1 and sealing part 2 are selected, and the fixing part 1 and the sealing part 2 are connected through the first connection member 31 and the second connection member 32 to achieve an assembled state, so that the fixing part 1 and the sealing part 2 can be individually packaged, transported, sold and stored as finished products, and when the plugging device 100 is needed to be used, the fixing part 1 and the sealing part 2 of a suitable specification are selected to be combined as needed.
In addition to manufacturing and transportation, more importantly, since the left atrial appendage occlusion requires an operator to introduce a sheath and measure the atrial appendage size during the implantation process and then implant an occlusion device of a proper size according to the measurement result, that is, the left atrial appendage occlusion is characterized in that the procedure of selecting the left atrial appendage occlusion is essentially one of the steps of the operation, and thus, the operator needs to prepare the left atrial appendage occlusion of various specifications or all specifications in advance because the size required by the user cannot be accurately determined, which clearly increases the cost.
In addition, it should be noted that the left atrial appendage occlusion device in the prior art is formed by fixing the size of each portion after the manufacturing is completed, that is, the corresponding specification is determined before the operator uses, the manufacturer manufactures the left atrial appendage occlusion device with various specifications to meet the common atrial appendage shape or size requirement, but since the atrial appendage size of each user cannot be predicted in advance, the common specifications in the prior art only have the change of the size (for example, the diameter of the fixing portion of the left atrial appendage occlusion device in the common specification is smaller than the diameter of the sealing portion by about 6-10 mm), if the size of the atrial appendage of the user cannot perfectly fit the size, the left atrial appendage occlusion device with a larger model specification can only be installed, and most importantly, if the size of the atrial appendage of the patient is relatively special (for example, the required diameter of the fixing portion and the sealing portion is close to even larger than the required diameter), the conventional preset specification is exceeded, the user can only choose to stop implantation, and the steps such as puncturing before implantation definitely become pure damage to the user, if the subsequent customization is completed, and if the subsequent customization is required to be re-customized again, the risk is huge.
Therefore, in the prior art, the size of the left atrial appendage occlusion device often cannot be completely adapted to the auricle, and there is a problem that the size of the left atrial appendage occlusion device exceeds the standard of the conventional left atrial appendage occlusion device, and therefore, by using the design that the fixing portion 1 and the sealing portion 2 can be assembled in this embodiment, after the size of the auricle is measured by the operator, the fixing portion 1 and the sealing portion 2 are assembled again, so that an occlusion device 100 capable of being well adapted to the auricle of the user is obtained, and clearly, the occlusion device 100 in this embodiment has better adaptability.
In an initial state, the proximal end of the fixing portion 1 is connected to the first connecting member 31, the proximal end of the first connecting member 31 is a free end, wherein the fixing portion 1 is tied to the proximal end constraint member, the proximal end constraint member is the proximal end of the fixing portion 1, the first connecting member 31 can be directly used as the proximal end constraint member of the fixing portion 1 or can be integrally formed with the proximal end constraint member of the fixing portion 1, correspondingly, the distal end of the sealing portion 2 is tied to the distal end constraint member, the distal end constraint member is the distal end of the sealing portion 2, the distal end of the sealing portion 2 is connected to the second connecting member 32, and the distal end of the second connecting member 32 is a free end, wherein the second connecting member 32 can be directly used as the distal end constraint member of the sealing portion 2 or can be integrally formed with the distal end constraint member of the sealing portion 2, and the first connecting member 31 and the second connecting member 32 are mutually independent. Thereby, the fixing portion 1 and the sealing portion 2 are connected to each other by a connecting portion 3, and the connecting portion 3 includes a first connecting piece 31 and a second connecting piece 32 connected to the fixing portion 1 and the sealing portion 2, respectively.
In the present embodiment, the first and second connection members 31 and 32 are not meant to be specific, independent components, and the corresponding interconnectable parts formed by the processing of the fixing portion 1 and/or the sealing portion 2 may also be regarded as the first and/or second connection members. For the present embodiment, the fixing portion 1 and the sealing portion 2 may be independent of each other, and each may be individually packaged, transported, sold, stored, etc. as a finished product.
The plugging device 100 has the specification of M sets of the fixing portion 1 and the specification of N sets of the sealing portion 2, and the operator can prepare the fixing portion 1 and the sealing portion 2 with corresponding specifications to realize the plugging device 100 with m×n specifications, which greatly improves the specification selection of the plugging device 100.
It should be noted that, in the embodiment of the present invention, in order to simplify the structure of combining and splicing the fixing portion 1 and the sealing portion 2, the proximal constraint element of the fixing portion 1 and the distal constraint element of the sealing portion 2 are preferably hollow sleeves, if the proximal constraint element of the fixing portion 1 can meet the functional requirement of the first connection element 31 of the connection portion 3, the proximal constraint element of the fixing portion 1 can be used as the first connection element 31, or only the proximal constraint element of the fixing portion 1 needs to be slightly modified to be used as the first connection element 31, and similarly, the distal constraint element of the sealing portion 2 or the distal constraint element of the sealing portion 2 which is slightly modified can be used as the second connection element 32. Of course, the first connector 31 and the second connector 32 may be directly connected to the proximal constraint of the fixed part 1 and the distal constraint of the sealing part 2, respectively.
In summary, the plugging device 100 includes a fixing portion 1 and a sealing portion 2, wherein a first connector 31 of the fixing portion 1 and a second connector 32 of the sealing portion 2 are combined to form a connecting portion 3, and the connecting portion 3 is located between the fixing portion 1 and the sealing portion 2.
Embodiment one of the occluding device 100 of the present invention
In order to better understand the solution of the present invention by those skilled in the art, the following description will clearly and completely describe the solution of the first embodiment of the present invention with reference to fig. 1 to 6.
In a first embodiment of the present invention, as shown in fig. 1 to 6, to achieve the fixed connection between the first connecting member 31 and the second connecting member 32, the connecting portion 3 includes a locking structure 4, where the locking structure 4 includes a first fastening hole 41 and a telescopic first fastening buckle 42, one of the first connecting member 31 and the second connecting member 32 is provided with the first fastening hole 41, and the other is provided with the first fastening buckle 42. In this embodiment, a first fastening hole 41 is formed on a side wall of the first connecting piece 31, a first fastening buckle 42 is formed on a side surface of the second connecting piece 32, and when the first connecting piece 31 and the second connecting piece 32 are connected, the fixing portion 1 and the sealing portion 2 are connected through the first fastening hole 41 and the fastening connection of the first fastening hole 41.
In this embodiment, the portion of the locking structure 4 disposed or connected to the first connecting member 31 is denoted as a first portion, and the portion of the locking structure 4 disposed or connected to the second connecting member 32 is denoted as a second portion, where the first portion and the second portion are always in contact after assembly in order to achieve the limitation.
The first buckle 42 may be configured to be retractable by other structures such as a spring, or may be configured to be retractable by itself, and is not particularly limited herein. In addition, when the fixing portion 1 and the sealing portion 2 are fixedly connected, the first connector 31 may be sleeved on the second connector 32, or may be plugged on the second connector 32, and the specific structure, position, size, etc. of the components such as the first connector 31, the second connector 32, the first fastening hole 41, the first fastening hole 42, etc. may be determined.
When the fixing portion 1 and the sealing portion 2 are separated from each other, it is at least satisfied that the fixing portion 1 and the sealing portion 2 are separated from each other in the axial direction and/or that the fixing portion 1 and the sealing portion 2 are separated from each other in the radial direction. In order to achieve that the fixing portion 1 and the sealing portion 2 can be fixedly connected by the first buckle 42 and the first buckling hole 41 being clamped when the first connecting piece 31 and the second connecting piece 32 are connected, in this embodiment, if the first connecting piece 31 and the second connecting piece 32 are spliced mutually, the first buckle 42 and the first buckling hole 41 are matched to be regarded as anti-falling, but in the objective, the first buckle 42 and the first buckling hole 41 are matched to be a form of connection, that is, the first connecting piece 31 and the second connecting piece 32 limit the axial relative position and the radial relative position of the fixing portion 1 and the sealing portion 2 after being connected, so that the fixing portion 1 and the sealing portion 2 cannot be directly separated.
The first embodiment includes, but is not limited to, the following two embodiments, specifically as follows:
In a first specific implementation manner of the first embodiment, as shown in fig. 1 to 3, a first jack 311 axially disposed in a jack is axially disposed at a proximal end of the first connecting member 31, a first fastening hole 41 communicated with the first jack 311 is disposed on a hole wall of the first jack 311, a limiting step is formed on an outer wall of the second connecting member 32, in this embodiment, the limiting step is defined as a first limiting step 321, and the second connecting member 32 is provided with a telescopic first fastening buckle 42, where the first fastening buckle 42 is radially exposed to the second connecting member 32. When the proximal end of the first connecting piece 31 is sleeved at the distal end of the second connecting piece 32, the first buckle 42 can enter the first buckling hole 41 from the first jack 311 and buckle in the first buckling hole 41, and the proximal end of the first connecting piece 31 is axially abutted with the first limiting step 321.
It will be appreciated that in this first embodiment, as shown in fig. 3, the first connector 31 and the second connector 32 are assembled axially, specifically, the first connector 31 and the second connector 32 may be axially relatively close, the distal end of the second connector 32 is axially inserted into the first receptacle 311 of the first connector 31, so that the proximal end of the first connector 31 is sleeved on the distal end of the second connector 32, and during the relative axial movement of the first connector 31 and the second connector 32 to achieve the sleeved fixing, the first buckle 42 exposed on the second connector 32 is pressed by the inner wall of the first connector 31 to be fully received in the second connector 32, so as to axially move along with the second connector 32 in the first receptacle 311, and when the first connector 31 and the second connector 32 are mutually moved to a position where the first buckle 42 and the first buckle 41 are opposite, the first buckle 42 may extend from the first receptacle 311 into the first buckle 41 to be buckled with the first buckle 41, so as to prevent the first connector 31 and the second connector 32 from being axially separated from the first connector 31.
In this first embodiment, as shown in fig. 2 and 3, in order to facilitate the installation of the first buckle 42 and ensure the scalability of the first buckle 42, a first spring 423 is disposed on the first buckle 42, and a mounting hole 323 is disposed on the second connector 32, and the mounting hole 323 is radially communicated with the outside, and the first spring 423 is radially installed in the mounting hole 323 and can be radially scaled. Understandably, the first buckle 42 may be exposed to the second connecting piece 32 through the mounting hole 323, and when being extruded by the inner wall of the first connecting piece 31, may be retracted into the mounting hole 323, and extend to the first buckle hole 41 under the resilience of the first spring 423 at the position of the first buckle hole 41, so as to be buckled with the first buckle hole 41, thereby realizing axial limitation.
In addition, as shown in fig. 2 and 3, when the first buckle 42 is buckled in the first buckle hole 41, that is, when the fixing portion 1 and the sealing portion 2 are fixedly connected in a combined fixing state, the proximal end of the first connecting member 31 is axially abutted against the first limiting step 321, that is, the second connecting member 32 can not move further distally relative to the first connecting member 31 through the locking of the side wall of the proximal end of the first connecting member 31, so that the buckling stability of the first buckle 42 and the first buckle hole 41 is ensured, and secondly, the locking of the first connecting member 31 and the second connecting member 32 in the direction from the proximal end to the distal end of the plugging device 100 is realized, so that the sealing portion 2 located in the left atrium can not be impacted in the direction of the mouth of the left atrium due to blood flow in the left atrium, and the connecting member 31 is driven to move away from the locking region towards the distal end position, so that the sealing portion 2 is separated from the fixing portion 1, and the plugging device 100 can be effectively implanted in a predetermined position for a long time.
Preferably, as shown in fig. 2 and 3, a stop surface 421 is disposed at the proximal end of the first buckle 42, and when the first buckle 42 extends into the first buckle hole 41, the stop surface 421 abuts against the wall of the first buckle hole 41 axially, so that the first buckle 42 and the first buckle hole 41 can be fixedly connected axially, and the second connector 32 can be prevented from going forward distally, so as to further improve the locking effect of the first connector 31 and the second connector 32 in the proximal-distal direction of the plugging device 100.
In addition, in the first embodiment or other embodiments, as shown in fig. 2 and 3, the distal outer wall of the first buckle 42 is provided with a guide surface 422 having a convex arc shape, so as to be more smoothly sleeved on the second connector 32 when the first connector 31 moves axially toward the second connector 32.
In the second embodiment of the first embodiment, the technical features of the second embodiment are substantially the same as those of the first embodiment, for example, the locking principle of the first limiting step 321 is the same, and the same parts of the second embodiment are not described herein, which mainly differ in that the specific fastening structure between the first connecting piece 31 and the second connecting piece 32 and the corresponding assembly principle are different.
In a second embodiment of the first embodiment, as shown in fig. 4 to 6, a first jack 311 radially disposed in the socket is axially provided at the proximal end of the first connector 31, the first jack 311 is a stepped hole with a smaller proximal hole diameter than the distal hole diameter, a first buckle 42 is axially exposed in the stepped hole toward the proximal end, and the first buckle 42 is illustratively located at the axial locking end side of the stepped hole, and the head axially extends into the first jack 311.
In addition, the outer wall of the second connecting member 32 is formed with a first limiting step 321, and the distal end of the second connecting member 32 is concavely provided with a first fastening hole 41. When the proximal end of the first connecting piece 31 is sleeved at the distal end of the second connecting piece 32, the first buckle 42 can enter the first buckling hole 41 from the first jack 311 and buckle in the first buckling hole 41, and the proximal end of the first connecting piece 31 is axially abutted with the first limiting step 321.
In this second embodiment, as shown in fig. 6, fig. 6 is a schematic diagram illustrating an assembly principle of the first connecting member 31 and the second connecting member 32 fixedly connected by the locking structure 4 in the second embodiment of the present invention. The first connecting piece 31 and the second connecting piece 32 are assembled radially, specifically, the first connecting piece 31 and the second connecting piece 32 can be relatively close to each other radially, so that the distal end of the second connecting piece 32 is inserted into the first jack 311 of the first connecting piece 31 from the lateral direction, the proximal end of the first connecting piece 31 is sleeved on the distal end of the second connecting piece 32, in the process that the first connecting piece 31 and the second connecting piece 32 relatively move radially to realize sleeve fixation, the first buckle 42 extending radially into the first jack 311 is extruded by the second connecting piece 32 axially to completely withdraw from the first jack 311, and when the first connecting piece 31 and the second connecting piece 32 mutually move radially to a position where the first buckle 42 and the first buckle 41 are opposite, the first buckle 42 can extend from the first jack 311 to the first buckle 41 arranged at the distal end of the second connecting piece 32 so as to be buckled with the first buckle 41, and prevent the first connecting piece 31 and the second connecting piece 32 from being separated radially.
Illustratively, in this second embodiment, as shown in fig. 6, in order to facilitate the installation of the first buckle 42 and ensure the scalability of the first buckle 42, the first buckle 42 is provided with a first spring 423 axially disposed, and the first connector 31 is formed with an installation hole 323 (not shown) axially communicating with the first insertion hole 311 at the distal end of the first insertion hole 311, and the first spring 423 is axially installed in the installation hole 323 and can be axially scaled. Understandably, the first buckle 42 may extend into the first jack 311 through the mounting hole 323, and when being axially pressed by the second connecting piece 32, may retract into the mounting hole 323, and extend into the first buckle hole 41 under the resilience of the first spring 423 at the position of the first buckle hole 41, so as to be buckled with the first buckle hole 41, thereby realizing radial limitation.
Also illustratively, as shown in fig. 5 and 6, to be matched with the first jack 311 having a stepped hole shape, the distal end of the second connector 32 has a T-shaped plug portion 324, wherein the first fastening hole 41 is concavely formed at the top end of the T-shaped plug portion 324. It can be appreciated that the proximal end of the first connector 31 and the distal end of the second connector 32 are in a T-shaped concave-convex fit in the first jack 311, so that the T-shaped plugging portion 324 of the second connector 32 can be ensured to be fixed in the axial direction in the first jack 311, which is beneficial to ensuring the buckling stability of the first buckle 42 and the first buckle hole 41, and secondly, the locking of the first connector 31 and the second connector 32 in the axial direction and the radial direction of the plugging device 100 is realized, which is beneficial to ensuring the fixing stability of the sealing portion 2 located in the left atrium and the fixing portion 1 located in the left auricle, and ensuring that the sealing portion 2 and thus the plugging device 100 can be effectively implanted in a preset position for a long time.
Second embodiment of the occluding device 100 of the present invention
The main technical features of the second embodiment are substantially the same as those of the first embodiment, and are closer to the second specific implementation of the first embodiment, and the second embodiment is axially inserted by radial assembly, and radial limiting is performed. The same parts of the second embodiment and the first embodiment are not described again, and the main difference between the second embodiment and the first embodiment is that:
The specific structure of the locking structure 4 is different, and the related structures of the first connecting piece 31 and the second connecting piece 32 adapted to the locking structure 4 are correspondingly different.
In the second embodiment, as shown in fig. 7 to 11, the proximal end of the first connecting member 31 is axially provided with a socket radially provided with a second insertion hole 312, and the second insertion hole 312 is a stepped hole with a proximal hole diameter smaller than a distal hole diameter. The outer wall of the second connector 32 is formed with a limit step, which in this embodiment is defined as a second limit step 322, and the locking structure 4 includes a limit switch 43 that is axially movable to open or close the socket of the second jack 312. When the proximal end of the first connecting piece 31 is sleeved at the distal end of the second connecting piece 32, the limit switch 43 radially abuts against the outer wall of the second connecting piece 32 at the socket of the second jack 312, and the proximal end of the first connecting piece 31 axially abuts against the second limit step 322.
In the second embodiment, as shown in fig. 11, fig. 11 is a schematic diagram illustrating an assembly principle of the second embodiment in which the first connecting member 31 and the second connecting member 32 are fixedly connected by the locking structure 4. The first connecting piece 31 and the second connecting piece 32 are radially assembled, specifically, after the limit switch 43 is manually pushed to axially move towards the distal end direction to open the second jack 312 in the shape of a stepped hole on the first connecting piece 31, the first connecting piece 31 and the second connecting piece 32 can be relatively close to each other in a radial direction, so that the distal end of the second connecting piece 32 is laterally inserted into the first jack 311 of the first connecting piece 31, the proximal end of the first connecting piece 31 is further sleeved on the distal end of the second connecting piece 32, and in the process that the first connecting piece 31 and the second connecting piece 32 relatively move in the radial direction to realize sleeve fixation, when the distal end of the second connecting piece 32 is completely located at one side of the limit switch 43 facing the second jack 312, the limit switch 43 can axially extend to the outer wall side of the second connecting piece 32 from the radial gap between the outer wall of the second connecting piece 32 and the hole wall of the second jack 312, so that the distal end of the second connecting piece 32 is radially limited at the position corresponding to the second jack 312, and the second connecting piece 32 is prevented from moving out of the second connecting piece 32 in the radial direction from the second jack 312 to be separated from the first connecting piece 31.
In the second embodiment, the second jack 312 is radially opened or closed by controlling the limit switch 43, so that the first connector 31 and the second connector 32 can be assembled or disassembled.
It should be noted that, in the present embodiment, the connection of the fixing portion 1 or the sealing portion 2 is not prohibited from being movable, but the fixing portion 1 and the sealing portion 2 of the present embodiment cannot be separated from the second connecting member 32 without unlocking after the assembly is completed.
For example, as shown in fig. 9 to 11, to achieve the function of opening or closing the second jack 312 of the limit switch 43, the limit switch 43 includes an L-shaped shutter 432 and a second spring 431, wherein the second spring 431 is axially disposed at a terminal end side of the second jack 312, and a vertical plate (not shown) of the L-shaped shutter 432 is axially connected to the L-shaped shutter 432 at a proximal end thereof, at least partially disposed in the first jack 311, and a horizontal plate of the L-shaped shutter 432 radially extends to the outside from the first jack 311 or is disposed in a socket of the first jack 311 for manual axial pushing and pulling of the L-shaped shutter 432.
Embodiment III of the occluding device 100 of the present invention
The main technical features of the third embodiment are substantially the same as those of the first embodiment, and the same parts of the third embodiment and the first embodiment are not repeated, which are different from those of the first embodiment in that the specific structure of the locking structure 4 is different, and the related structures of the first connecting member 31 and the second connecting member 32 adapted to the locking structure 4 are correspondingly different.
In the third embodiment, as shown in fig. 12 to 15, the locking structure 4 includes a screwing structure 44, a limiting step (defined as a third limiting step 45 in this embodiment), and an anti-falling elastic ring 46, where, when the proximal end of the first connecting member 31 and the distal end of the second connecting member 32 are plugged, the first connecting member 31 is fixedly connected with the second connecting member 32 through the screwing structure 44, and at a position where the first connecting member 31 and the second connecting member 32 axially butt, the anti-falling elastic ring 46 is sleeved on the first connecting member 31 or the second connecting member 32 provided with the third limiting step 45 and axially abuts against the third limiting step 45.
When the fixing portion 1 and the sealing portion 2 are fixedly connected, the first connecting member 31 may be sleeved on the second connecting member 32, or may be inserted in the second connecting member 32, and similarly, the anti-falling elastic ring 46 may be sleeved on the first connecting member 31 or the second connecting member 32, specifically, may be determined according to the specific structure, position, size, etc. of the parts such as the first connecting member 31, the second connecting member 32, the screwing structure 44, etc., and generally, only when the two are sleeved, the first connecting member 31 and the second connecting member 32 may not be reversely unscrewed and come loose from each other, and may not be detached after the two are connected. And the specific requirements can be determined according to actual needs.
It should be noted that, the specific structure of the screwing structure 44 may be various, so long as the first connector 31 and the second connector 32 can be fixedly connected by relatively rotating the first connector 31 and the second connector 32 when the first connector 31 and the second connector 32 are plugged.
In the third embodiment, as shown in fig. 12 to 15, the screwing structure 44 includes an internal thread 441 and an external thread 442, wherein one of the proximal end of the first connecting member 31 and the distal end of the second connecting member 32 is provided with the internal thread 441, the other is provided with the external thread 442, the proximal end of the first connecting member 31 is screwed into the distal end of the second connecting member 32 by the engagement of the internal thread 441 and the external thread 442, the third limiting step 45 is located at the terminating end side of the external thread 442, and the anti-release elastic ring 46 is sleeved on the external thread 442 at the starting end side of the internal thread 441.
As shown in fig. 12 and 13, fig. 13 is a schematic diagram illustrating an assembly principle of the first connecting member 31 and the second connecting member 32 fixedly connected by the locking structure 4 in the third embodiment of the present invention. Specifically, the proximal end of the first connecting member 31 is provided with an internal thread 441, the distal end of the second connecting member 32 is provided with an external thread 442, the third limiting step 45 is disposed on the second connecting member 32 where the external thread 442 is located, and the anti-disengagement elastic ring 46 is sleeved on the second connecting member 32 where the external thread 442 is located on the proximal end side of the first connecting member 31. When the distal end of the second connecting member 32 is inserted into the proximal end of the first connecting member 31, the second connecting member 32 and the first connecting member 31 are manually rotated relatively, and the proximal end of the first connecting member 31 and the distal end of the second connecting member 32 are fixedly screwed by engaging the internal thread 441 of the first connecting member 31 with the external thread 442 of the second connecting member 32.
And when the proximal end of the first connecting piece 31 is fixedly screwed with the distal end of the second connecting piece 32, that is, when the fixing portion 1 and the sealing portion 2 of the plugging device 100 are combined and fixed into a whole, the proximal end of the anti-drop elastic ring 46 is axially abutted with the third limiting step 45, and the distal end is axially abutted with the proximal end of the first connecting piece 31, so as to prevent the second connecting piece 32 and the first connecting piece 31 from being loose, and the specific anti-drop principle is at least three of the following:
(1) In the process of relative rotation and axial movement of the second connecting piece 32 and the first connecting piece 31, the anti-drop elastic ring 46 can provide certain compression deformation to generate pretightening force, so that friction force is generated on the threaded connecting surface, friction resistance between the first connecting piece 31 and the second connecting piece 32 is increased, damping rotation of the first connecting piece 31 and the second connecting piece 32 is realized, loosening is avoided, the elasticity of the anti-drop elastic ring 46 can keep stability of the pretightening force, and the plugging device 100 can still keep a fastened state in the process of being impacted by blood flow and contracting and stretching along with heart in vivo.
(2) When the plugging device 100 is impacted by blood flow, the elastic anti-falling elastic ring 46 can absorb and disperse a part of energy to reduce the transmission of vibration to the position 3 of the threaded connection part, thereby being beneficial to reducing the loosening risk of the threaded connection and improving the stability and reliability of the threaded connection structure of the first connecting piece 31 and the second connecting piece 32.
(3) The anti-loosening elastic ring 46 can fill up a small gap or looseness of the threaded connection structure of the first connecting piece 31 and the second connecting piece 32 due to manufacturing and installation errors, so as to provide additional fastening force, compensate loosening of the threaded connection, and help to maintain the fastening state of the threads and prevent loosening.
It should be noted that, there are various arrangements of the anti-disengagement elastic ring 46, and in particular, in the first embodiment of the third embodiment, as shown in fig. 12 and 13, the anti-disengagement elastic ring 46 is independently arranged. Illustratively, the anti-slip collar 46 is preferably a glue pad.
Alternatively, in the second embodiment of the third embodiment, as shown in fig. 14 and 15, the anti-drop spring 46 is integrally formed on the first connecting member 31 or the second connecting member 32 provided with the female screw 441. Illustratively, the anti-disengagement collar 46 is integrally formed at the proximal end of the first connecting member 31 with the internal thread 441, and is sleeved on the second connecting member 32 with the external thread 442, and the outer wall of the anti-disengagement collar 46 is flush with the second connecting member 32.
It is particularly important that in this embodiment, the anti-slip collar 46 is necessary because the fixing portion 1 and the sealing portion 2 are required to rotate in the end of the release and release of the cable, or the contraction and relaxation of the heart after implantation also brings about a change in angle, and only the threaded connection is unreliable (rattling and rotation occur even if the arrangement is opposite to the rotation direction of the cable conveyance).
Fourth embodiment of the occluding device 100 of the present invention
The main technical features of the fourth embodiment are substantially the same as those of the third embodiment, for example, the first axial insertion is performed and then the first connecting piece 31 and the second connecting piece 32 are fixed by their relative rotation, and the same parts of the fourth embodiment and the third embodiment are not described in detail, which is mainly different from the third embodiment in that:
The specific structure of the screwing structure 44 is different, and the assembly principle of the fixed connection of the corresponding first connecting piece 31 and the second connecting piece 32 is also different.
In the fourth embodiment, as shown in fig. 16 to 19, when the proximal end of the first connecting member 31 and the distal end of the second connecting member 32 are plugged together, in order to achieve the fixed connection between the first connecting member 31 and the second connecting member 32 by the relative rotation of the first connecting member 31 and the second connecting member 32, the screwing structure 44 includes a boss 443 and a locking screw hole 444 having at least one locking point 4441, the third limiting step 45 is located on the side of the boss 443 facing away from the locking screw hole 444, and the anti-release spring 46 is located on the starting end side of the locking screw hole 444.
In addition, one of the proximal end of the first link 31 and the distal end of the second link 32 is provided with a boss 443, and the other is provided with a locking screw hole 444. After the proximal end of the first link 31 is inserted into the distal end of the second link 32, the boss 443 can reach the locking point 4441 along the locking screw hole 444 by the relative rotation of the first link 31 and the second link 32 to be in locking engagement with the locking point 4441.
As shown in fig. 16 to 19, fig. 17 and 19 are schematic views illustrating the assembly principle of the first connecting member 31 and the second connecting member 32 fixedly connected by the locking structure 4 according to the fourth embodiment. Specifically, the proximal end of the first connecting member 31 is provided with a locking screw hole 444, the distal end of the second connecting member 32 is provided with a boss 443, the third limiting step 45 is disposed on the second connecting member 32 where the boss 443 is located, and the anti-disengagement elastic ring 46 is sleeved on the second connecting member 32 where the boss 443 is located at the proximal end side of the first connecting member 31. When the distal end of the second connecting member 32 is inserted into the proximal end of the first connecting member 31, the second connecting member 32 and the first connecting member 31 are manually rotated relatively, and in the relative rotation process of the two, the boss 443 reaches the locking point 4441 along the direction from the starting end to the ending end of the locking screw hole 444, and is in concave-convex fit with the locking point 4441, so as to stay at the position of the locking point 4441, thereby realizing the relative rotation locking of the second connecting member 32 and the first connecting member 31.
And when the proximal end of the first connecting piece 31 is fixedly screwed with the distal end of the second connecting piece 32, that is, when the fixing portion 1 and the sealing portion 2 of the plugging device 100 are combined and fixed into a whole, the proximal end of the anti-release elastic ring 46 axially abuts against the third limiting step 45, and the distal end axially abuts against the proximal end of the first connecting piece 31, so as to prevent the second connecting piece 32 and the first connecting piece 31 from being released.
It should be noted that the insertion hole of the first connector 31 may be provided with an internal thread 441, and the distal end of the second connector 32 may be provided with an external thread 442, or the insertion hole of the first connector 31 may be a light hole, and the distal end of the second connector 32 may be a polished rod. The principle of the anti-disengagement elastic ring 46 for achieving the anti-disengagement is basically similar to that of the anti-disengagement elastic ring 46 in the third embodiment, and will not be described herein.
Specifically, there are various arrangements of the anti-disengagement elastic ring 46, and in the first embodiment of the fourth embodiment, as shown in fig. 16 and 17, the anti-disengagement elastic ring 46 is independently arranged. Illustratively, the anti-slip collar 46 is preferably a glue pad.
Alternatively, in the second embodiment of the fourth embodiment, as shown in fig. 18 and 19, the anti-drop spring 46 is integrally formed on the first connector 31 or the second connector 32 provided with the locking screw hole 444. Illustratively, the anti-disengagement collar 46 is integrally formed at the proximal end of the first connecting member 31 with the locking screw hole 444, and is sleeved on the second connecting member 32 with the boss 443, and the outer wall of the anti-disengagement collar 46 is flush with the second connecting member 32.
Illustratively, to form a helical spring structure, the first connector 31 or the proximal constraint of the anchor 1 may be machined to a spring structure to achieve the same function of the rubber pad described above.
Fifth embodiment of the occluding device 100 of the present invention
The main technical features of the fifth embodiment are substantially the same as those of the first embodiment, and the same parts of the fifth embodiment and the first embodiment are not repeated, which are different from those of the first embodiment in that the specific structure of the locking structure 4 is different, and the related structures of the first connecting member 31 and the second connecting member 32 adapted to the locking structure 4 are correspondingly different.
In the fifth embodiment, as shown in fig. 20 and 21, fig. 21 is a schematic diagram illustrating an assembly principle of the first connecting member 31 and the second connecting member 32 fixedly connected by the locking structure 4 in the fifth embodiment of the present invention. The locking structure 4 includes a second fastening hole 47, a second fastening buckle 48, and a limiting step (in this embodiment, the limiting step is defined as a fourth limiting step 49), wherein the second fastening hole 47 is concavely formed on the outer wall of the second connecting piece 32, the second fastening buckle 48 has elasticity, and the second fastening buckle 48 is disposed on the side wall of the first connecting piece 31 or integrally formed on the first connecting piece 31, and in a natural state, the second fastening buckle 48 laterally inclines to extend into the third inserting hole 313, specifically, in this embodiment, the second fastening buckle 48 gradually inclines from the proximal end to the distal end toward the center of the third inserting hole 313.
In addition, the fourth limiting step 49 is formed on the outer wall of the second connecting piece 32, the proximal end of the first connecting piece 31 is axially provided with the third insertion hole 313, when the first connecting piece 31 is sleeved on the second connecting piece 32, the proximal end of the second buckle 48 after being pressed and returned is clamped in the second buckle hole 47, and the proximal end of the first connecting piece 31 is axially abutted against the fourth limiting step 49.
As shown in fig. 20 and 21, the first connector 31 and the second connector 32 are assembled axially, specifically, the first connector 31 and the second connector 32 may be relatively close to each other axially, the distal end of the second connector 32 is inserted into the first receptacle 311 of the first connector 31 from the axial direction, so that the proximal end of the first connector 31 is sleeved on the distal end of the second connector 32, and during the axial forward movement of the distal end of the second connector 32 relative to the first connector 31, the second buckle 48 extending into the third receptacle 313 is pressed by the outer wall of the second connector 32 to withdraw radially away from the center of the third receptacle 313, so that the distal end of the second connector 32 is smoothly moved further distally, and when the first connector 31 and the second connector 32 are moved to a position where the second buckle 48 and the second buckle 47 are opposite to each other, the second buckle 48 can extend from the third receptacle 313 to the first buckle 41 under the self-resilience force to prevent the second connector 32 from withdrawing axially relative to the first connector 31.
Preferably, the second buckle 48 is integrally formed on the first connecting piece 31, and the first connecting piece 31 may be a proximal constraint piece of the fixing portion 1, and since the proximal constraint piece of the fixing portion 1 is generally made of a material with elasticity and good deformation memory such as nitinol, the structure of the connecting portion 3 is greatly simplified, and the separate manufacturing and installation of the fixing portion 1 and the sealing portion 2 are facilitated. Further preferably, the free end of the second catch 48 may be provided with a barb arrangement which in turn better snaps into and is restrained within the second catch aperture 47.
The foregoing description is only of the preferred embodiments of the invention and is not intended to limit the invention. Various modifications and variations of the present invention will be apparent to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.