Disclosure of Invention
Based on the above, it is necessary to provide a medical apparatus and a method for suturing the same, aiming at the technical problem that the choked flow tectorial membrane of the left atrial appendage occlusion device is too loose or too tight to suture the stent.
A method of suturing a membrane of a medical device, the medical device comprising a stent and a cover, the method comprising:
placing the cover film on the bracket;
Penetrating the middle part of the suture thread through the bracket at least four times and penetrating the covering film at least once to form a suture coil, and tying a first knot at the fixed end and the movable end of the suture thread;
Pulling the moving end of the suture to move along the first knot to adjust the size of the suture loop and then locking the suture loop.
In one embodiment, the tying the fixed end of the suture to the movable end comprises:
a first loop of knots is formed on the fixed end of the suture and the moving end of the suture is threaded out of the first loop of knots, after which the first loop of knots is tensioned.
In one embodiment, the suture film method further comprises tying a fixed end and a movable end of the suture with a second knot to lock the suture loop, comprising:
Forming a second knotting loop on the fixed end or the movable end of the suture, penetrating the movable end or the fixed end of the suture out of the second knotting loop, and tensioning the second knotting loop.
In one embodiment, the bracket comprises a plurality of bracket rods, a plurality of net openings are formed by surrounding adjacent bracket rods, holes are formed in the bracket rods, and the suture thread passes through the holes and/or the net openings;
the middle part of the suture thread is penetrated with the pore at least three times, and the middle part of the suture thread is penetrated with the tectorial membrane and the net mouth at least once.
In one embodiment, the suture loop is an 8-shaped double-ring-shaped suture loop, wherein one ring-shaped suture loop is formed by penetrating the covering film through the suture, the net opening and the pore, and the other ring-shaped suture loop is formed by penetrating the pore through the suture.
In one embodiment, the threading the middle portion of the suture through the stent at least four times and the covering at least once to form a suture loop comprises:
Penetrating a fixed end or a movable end of the suture line from a first side of the bracket to a second side of the bracket through the net opening at a first hole of the bracket and then penetrating the suture line to the covering film;
Penetrating the fixed or movable end of the suture from the first side of the stent to the second side of the stent at the first aperture after the fixed or movable end of the suture passes through the covering membrane into the first side of the stent;
at the second hole of the support, the fixed end or the movable end of the suture thread is penetrated from the second side of the support to the first side of the support, the first and second holes are sequentially distributed along the direction away from the tectorial membrane, and the first and second sides of the support respectively refer to the outer side, the inner side or the inner side and the outer side of the support.
In one embodiment, the threading the middle portion of the suture through the stent at least four times and the coating at least once includes:
penetrating the fixed or moving end of the suture from a first side of the scaffold to a second side of the scaffold at a first aperture of the scaffold;
Penetrating the fixed or movable end of the suture from the second side of the stent to the first side of the stent at the second aperture of the stent and then toward the cover;
After the fixed end or the movable end of the suture passes through the covering film and enters the second side of the bracket through the net opening, the fixed end or the movable end of the suture is penetrated into the first side of the bracket from the second side of the bracket at the second pore, the first pore and the second pore are sequentially distributed along the direction close to the covering film, and the first side and the second side of the bracket respectively refer to the outer side, the inner side or the inner side and the outer side of the bracket.
In one embodiment, the suture film method further comprises, prior to tying the fixed end and the movable end of the suture thread to form a first knot:
And a third knot is tied in the middle of the suture to avoid falling off the bracket after the suture is broken, wherein the third knot and the second knot are positioned on different sides of the bracket.
In one embodiment, the tying a third knot in the middle of the suture comprises:
And forming a third knotting loop in the middle of the suture line in a crossing way, winding the fixed end or the movable end of the suture line around the knotting area of the middle of the suture line for one turn and penetrating out of the third knotting loop, and then tensioning the third knotting loop.
According to the film sewing method of the medical instrument, the first knot can be firstly tied on the sewing thread to form the sewing coil between the bracket and the tectorial membrane, then the length of the sewing coil can be controlled in the film sewing process by utilizing the characteristic that the movable end of the sewing thread can move along the first knot, so that the sewing tightness of the tectorial membrane and the bracket is controlled, after the sewing tightness of the tectorial membrane and the bracket is controlled to be moderate, the second coil can be tied on the sewing thread to lock the sewing coil, and the defect that the length of the sewing coil cannot be adjusted after the sewing is dead is avoided. Therefore, the method for sewing the film adopts a method of combining a slipknot (namely a first knot) and a dead knot (namely a second knot) to cover the film on the bracket, is beneficial to controlling the sewing tightness of the film on the bracket, and can also avoid the defect that the length of a sewing coil can not be adjusted after the dead knot is tied. In addition, compared with the suture threading mode in the prior art, the suture thread firstly passes through the tectorial membrane and the bracket and then passes through the bracket for the second time to form a suture coil and is knotted and fixed at the net mouth of the bracket, the suture thread is threaded through the bracket at least four times and the tectorial membrane is threaded at least once, so that the stress points of the suture thread on the bracket and the tectorial membrane can be increased, the stress of a medical instrument in the suture thread coil locking process is more uniform, the structure and the form stability of the medical instrument are ensured, the condition that the suture thread coil is too large or too small due to inaccurate regulation of the suture thread coil caused by serious deformation of the medical instrument can be avoided, the distance between the fixed end and the movable end of the suture coil before knotting can be reduced, the fixed end and the movable end are knotted conveniently, the excessive force is not required to be used for knotting the fixed end and the movable end, and the suture coil is not accurate regulation caused by excessive deformation of the medical instrument caused by excessive stress.
Therefore, the method for sewing the film provided by the application has the advantages that on one hand, the method of combining the slipknot (namely the first knot) with the dead knot (namely the second knot) is adopted to cover the film on the bracket, the sewing tightness of the film on the bracket is favorably controlled, the defect that the length of a sewing coil cannot be adjusted after the dead knot can be tied can be avoided, on the other hand, the middle part of the sewing thread is penetrated through the bracket at least four times and the film is penetrated through at least once to form the sewing coil, and the phenomenon that the sewing coil is excessively large or excessively small due to inaccurate regulation of the sewing coil caused by serious deformation of medical equipment can be avoided, so that the sewing tightness of the choking film and the bracket is moderate can be ensured.
The medical instrument comprises a bracket and a coating film, wherein the coating film is sewn on the bracket through a suture;
The middle part of the suture thread is penetrated with the bracket at least four times and is penetrated with the covering film at least once to form a suture loop, and the fixed end and the movable end of the suture thread are connected in a mode of tying a first knot so as to lock the suture loop.
In one embodiment, the medical apparatus further comprises a second knot, the fixed end and the movable end of the suture are connected by sequentially tying a first knot and a second knot, wherein the first knot is movable, and the second knot is used for locking the suture loop.
In one embodiment, a first knotting loop is formed on the fixed end of the suture and the movable end of the suture is threaded out of the knotting loop, and the first knotting loop forms the first knot after being tensioned;
the fixed end or the movable end of the suture is provided with a second knotting ring, the movable end or the fixed end of the suture is penetrated out of the second knotting ring, and the second knotting ring is tensioned to form the second knot.
In one embodiment, the fixed and movable ends of the suture are both located outside of the medical device.
In one embodiment, the support comprises a plurality of support rods, a plurality of net openings are formed by surrounding adjacent support rods, holes are formed in the support rods, and the suture thread is penetrated through the holes and/or the net openings.
In one embodiment, the distal end of the stent is folded inwardly or outwardly of the medical device to form a double-layered structure at the distal end of the stent, the double-layered structure having overlapping apertures, the suture loop being formed by threading the suture through the overlapping apertures, the mesh and the covering film.
In one embodiment, the suture loop is an 8-shaped double-ring-shaped suture loop, wherein one ring-shaped suture loop is formed by penetrating the covering film through the suture, penetrating the net mouth and the overlapped hole through the suture, and the other ring-shaped suture loop is formed by penetrating the overlapped hole through the suture.
In one embodiment, a first threading hole and a second threading hole are formed in the inner layer of the distal end of the bracket at intervals along the direction away from the covering film, a third threading hole and a fourth threading hole are formed in the outer layer of the distal end of the bracket at intervals along the direction away from the covering film, and the third threading hole overlaps with the first threading hole and the fourth threading hole overlaps with the second threading hole to form the overlapping hole;
One of the annular stitching coils is formed by penetrating the first threading hole, the third threading hole and the covering film through the suture thread, and the other annular stitching coil is formed by penetrating the first threading hole, the third threading hole, the second threading hole and the fourth threading hole through the suture thread.
In one embodiment, a third knot is formed in the middle of the suture, the third knot being configured to prevent the suture from falling off the stent after breaking, wherein the third knot is located on a different side of the stent than the second knot.
In one embodiment, a third knotting loop is formed in the middle of the suture in a crossing manner, and the fixed end or the movable end of the suture is wound around the knotting-free area of the middle of the suture for one turn and is penetrated out of the third knotting loop, and the third knotting loop forms the third knot after being tensioned.
According to the medical instrument, the first knot can be tied on the suture to form the suture loop between the support and the tectorial membrane, then the length of the suture loop can be controlled in the process of suturing the membrane by utilizing the characteristic that the movable end of the suture loop can move along the first knot, so that the suture tightness of the tectorial membrane and the support is controlled, after the suture tightness of the tectorial membrane and the support is controlled to be moderate, the second knot can be tied on the suture loop to lock the suture loop, and the defect that the length of the suture loop cannot be adjusted after the suture loop is tied is avoided.
In addition, compared with the suture threading mode in the prior art, the suture thread firstly passes through the tectorial membrane and the bracket and then passes through the bracket for the second time to form a suture coil and is knotted and fixed at the net mouth of the bracket, the suture thread is threaded through the bracket at least four times and the tectorial membrane is threaded at least once, so that the stress points of the suture thread on the bracket and the tectorial membrane can be increased, the stress of a medical instrument in the suture thread coil locking process is more uniform, the structure and the form stability of the medical instrument are ensured, the condition that the suture thread coil is too large or too small due to inaccurate regulation of the suture thread coil caused by serious deformation of the medical instrument can be avoided, the distance between the fixed end and the movable end of the suture coil before knotting can be reduced, the fixed end and the movable end are knotted conveniently, the excessive force is not required to be used for knotting the fixed end and the movable end, and the suture coil is not accurate regulation caused by excessive deformation of the medical instrument caused by excessive stress.
Therefore, the medical instrument provided by the application has the advantages that on one hand, the covering film is coated on the bracket by adopting a method of combining the slipknot (namely the first knot) and the dead knot (namely the second knot), which is favorable for controlling the sewing tightness of the covering film on the bracket, and the defect that the length of a sewing coil cannot be adjusted after the dead knot can be tied can be avoided, on the other hand, the middle part of a suture thread is penetrated through the bracket at least four times and the covering film is penetrated at least once to form the sewing coil, so that the phenomenon that the sewing coil is excessively large or excessively small due to inaccurate regulation of the sewing coil caused by serious deformation of the medical instrument can be avoided, and the sewing tightness of the choked covering film and the bracket is ensured to be moderate.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed, mechanically connected, electrically connected, directly connected, indirectly connected through an intervening medium, or in communication between two elements or in an interaction relationship between two elements, unless otherwise explicitly specified. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.
As shown in fig. 1, an embodiment of the present invention provides a method for suturing a membrane of a medical device, wherein the medical device includes a stent 100 and a coating 200, the method comprising:
s100, placing the covering film 200 on the bracket 100;
S200, threading the middle portion 310 of the suture 300 through the stent 100 at least four times (e.g., four times, five times, six times, etc.) and threading the cover film 200 at least once (e.g., once, twice, three times, etc.) to form a suture loop 311, and tying the fixed end 320 and the movable end 330 of the suture 300 with a first knot 340;
S300, pulling the moving end 330 of the suture 300, so that the moving end 330 of the suture 300 moves along the first knot 340 to adjust the size of the suture loop 311 and then lock the suture loop 311.
The knot in this document refers to a knot.
The above-mentioned method for suturing a membrane of a medical device is suitable for a medical device having a plugging function, such as a left atrial appendage occlusion device, and preferably, the medical device includes a membrane 200 and a stent 100. The following describes a method for suturing a membrane of a medical device using a left atrial appendage occluder as an example. As shown in fig. 2, the left atrial appendage occlusion device includes a stent 100 and a covering film 200, the covering film 200 is covered on the distal end and the waist of the stent 100 by a suture thread 300, the stent 100 may be made of an alloy material with biocompatibility and self-expansibility such as nickel-titanium alloy and stainless steel, the covering film 200 may be made of a polymer material such as PET (Polyethylene terephthalate, polyester resin), PTFE (Poly tetra fluoroethylene ), ePTFE (Expanded Polytetrafluoroethylene, expanded polytetrafluoroethylene), and the suture thread 300 may be made of a polymer material such as PET, ePTFE, PP (Polypropylene), PA (Polyamide ). Wherein the waist of the stent 100 refers to the portion of the stent 100 between the proximal end and the distal end, the proximal end of the stent 100 refers to the end of the stent 100 that is closer to the heart, and the distal end of the stent 100 refers to the end of the stent 100 that is farther from the heart.
As shown in fig. 3, in the above-mentioned method for suturing a membrane of a medical device, a first knot 340 may be tied to a suture thread 300 to form a suturing coil 311 between a stent 100 and a stent 200, then the size of the suturing coil 311 is controlled in the process of suturing the membrane by utilizing the characteristic that a moving end 330 of the suture thread 300 can move along the first knot 340, so as to control the suturing tightness of the stent 100 and the stent 200, and after the suturing tightness of the stent 100 and the stent 200 is controlled to be moderate, the suturing coil 311 can be locked, thereby avoiding the defect that the length of the suturing coil 311 cannot be adjusted after the suturing is tied. In addition, compared with the threading mode of the suture 300 in the prior art, the suture thread firstly passes through the tectorial membrane, the bracket and then passes through the bracket for the second time to form a suture coil and is knotted and fixed at the net mouth of the bracket, the suture thread loop is threaded through the bracket at least four times and is threaded through the tectorial membrane at least once, for example, see the threading mode shown in fig. 3, which can increase the stress points of the suture thread 300 on the bracket 100 and the tectorial membrane 200, so that the stress of the medical instrument is more uniform in the locking process of the suture thread loop 311, the structure and the shape stability of the medical instrument are ensured, thereby avoiding the inaccurate adjustment of the suture coil 311 caused by the inaccurate adjustment of the suture coil 311 due to the serious deformation of the medical instrument, reducing the distance of the fixed end 320 and the movable end 330 of the suture coil 300 before knotting, not only facilitating the knotting of the fixed end 320 and the movable end 330, but also avoiding the inaccurate adjustment of the suture coil 311 caused by the inaccurate adjustment of the medical instrument due to the occurrence of the deformation of the overlarge stress.
For step S100, the covering film 200 may be wrapped around the proximal end and the waist of the stent 100.
Regarding the threading position of the suture 300 on the stent 100, the step S200 is mainly related to the structure of the stent 200. Specifically, as shown in fig. 2, the stent 100 includes a plurality of stent struts 130, a plurality of openings 100a are formed by enclosing adjacent stent struts 130, the stent struts 130 are provided with apertures 130a (see fig. 3), and the suture thread 300 is threaded through the apertures 130a and/or the openings 100 a. It is understood that "threading" herein refers to threading the suture 300 from the inside of the stent 100 to the outside of the stent 100 or from the outside of the stent 100 to the inside of the stent 100, specifically, punching the stent rod 130, threading the suture 300 through the hole 130a (see fig. 3), threading the suture through the mesh 100a (see fig. 4) of the stent 100, and winding the suture 300 around the stent rod 130. It should be noted that, in order to facilitate description of how the middle portion of the suture 300 passes through the mesh opening 100a, fig. 4 only retains one stent rod 130 and other adjacent portions of the stent rods 130 intersecting with the same.
Optionally, the middle portion 310 of the suture 300 is threaded through the aperture at least three times, and the middle portion 310 of the suture 300 is threaded through the covering film 200 and the mesh 113a at least once. The mesh opening 113a has the characteristic of large area, so that the suture area of the covering film 200 overlapped with the mesh opening 113a can be increased, the suture position on the covering film 200 can be flexibly adjusted according to specific requirements, and in addition, the suture thread 300 penetrating through the gap 130a can be limited by the characteristic of small area, so that the stability of the shape and structure of the medical instrument after the suture is finished can be ensured.
In addition, regarding the structure of the suture 300, two examples are given below:
As shown in fig. 3 and 4, in the example (1), the suture loop 311 is a double-loop suture loop having an 8 shape, wherein one loop 3111 is formed by passing the suture 300 through the covering film 200, the net opening 100a, and the aperture 130 a/net opening 100a, and the other loop 3111 is formed by passing the suture 300 through the aperture 130 a/net opening 100 a. The double-loop sewing coil of the figure 8 shape not only facilitates the knitting but also can firmly sew the cover film 200 to the stent 100.
Illustratively, one annular suture loop 3111 of the suture loop 311 shown in FIG. 3 is formed by threading the cover 200 through the suture 300, the orifice 100a and the aperture 130a, the other annular suture loop 3111 is formed by threading the suture 300 through the aperture 130a, and one annular suture loop 3111 of the suture loop 311 shown in FIG. 4 is formed by threading the cover 200 through the suture 300, the orifice 100a on the waist of the stent 100 and the orifice 100a on the distal end of the stent 100, and the other annular suture loop 3111 is formed by threading the suture 300 through the orifice 100a on the distal end of the stent 100.
Regarding the wiring manner of the double-loop stitch coil 3111 in the shape of "8", 4 examples are given below, wherein for convenience of description, the first 2 examples are described taking the case that the support rod 130 is provided with the aperture 130a as an example, and the second 2 examples are described taking the case that the support rod 130 encloses the mesh opening 100a formed therein as an example:
as shown in fig. 5, in the example (1.1), the routing manner includes:
Step a1, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100 at the first aperture of the stent 100 and then towards the covering film 200;
Step b1, after the fixed end 320 or the movable end 330 of the suture 300 passes through the covering film 200 and enters the first side of the stent 100 through the mesh port 100a, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100 at the first hole;
Step c1, at the second aperture of the stent 100, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100, wherein the first and second apertures are sequentially distributed along the direction away from the covering film 200, and the first and second sides of the stent 100 refer to the outer side, the inner side, or the inner side and the outer side of the medical device comprising the covering film and the stent, respectively.
In the above steps, the first side of the stent 100 may be referred to as the outside of the medical device and the second side of the stent 100 may be referred to as the inside of the medical device, thus facilitating tying the end 320 of the suture 300 to the first knot 340. Note that the dashed arrow in fig. 5 represents the trend of the suture 300.
As shown in fig. 6, in the (1.2) th example, the routing manner includes:
Step a2, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100 at the first aperture of the stent 100;
Step b2, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the second side to the first side of the stent 100 at the second aperture of the stent 100, and then penetrating the suture to the covering film 200;
Step c2, after the fixed end 320 or the movable end 330 of the suture 300 passes through the covering film 200 and enters the second side of the stent 100 through the mesh 113a, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100 at the second hole, wherein the first hole and the second hole are sequentially distributed along the direction approaching to the covering film 200, and the first side and the second side of the stent 100 refer to the outer side, the inner side or the inner side and the outer side of the medical device respectively.
In the above steps, the first side of the stent 100 may be referred to as the outside of the medical device and the second side of the stent 100 may be referred to as the inside of the medical device, thus facilitating tying the end 320 of the suture 300 to the first knot 340. Note that the dashed arrow in fig. 6 represents the trend of the suture 300.
As shown in fig. 4, in the (1.3) th example, the routing manner includes:
Step a3, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100 at the first portal of the stent 100;
step b3, at the second portal of the stent 100, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the second side to the first side of the stent 100, and then penetrating the suture from the first portal to the second side of the stent 100;
Step c3, penetrating the fixed end 320 or the movable end 330 of the suture 300 through the covering film 200 and entering the first side of the stent 100 through a third net opening, wherein the third net opening, the first net opening and the second net opening are sequentially distributed along the direction away from the covering film 200, and the first side and the second side of the stent 100 refer to the outer side, the inner side or the inner side and the outer side of the medical instrument respectively.
In the above steps, the first side of the stent 100 may be referred to as the outside of the medical device and the second side of the stent 100 may be referred to as the inside of the medical device, thus facilitating tying the end 320 of the suture 300 to the first knot 340. Note that the dashed arrow in fig. 4 represents the trend of the suture 300.
As shown in fig. 7, in the (1.4) th example, the routing manner includes:
step a4, penetrating the fixed end 320 or the movable end 330 of the suture 300 through the covering film 200 and entering the second side of the stent 100 from the first side of the stent 100 through the first net opening;
Step b4, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100 at the second portal of the stent 100;
step c2, at the third net opening of the stent 100, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent to the second side of the stent 100, and then penetrating the suture to the first side of the stent 100 through the third net opening, wherein the first net opening, the second net opening and the third net opening are sequentially distributed along the direction away from the covering film 200, and the first side and the second side of the stent 100 respectively refer to the outer side, the inner side or the inner side and the outer side of the medical instrument.
In the above steps, the first side of the stent 100 may be referred to as the outside of the medical device and the second side of the stent 100 may be referred to as the inside of the medical device, thus facilitating tying the end 320 of the suture 300 to the first knot 340. Note that the dashed arrow in fig. 7 represents the trend of the suture 300.
Regarding the structure of the suture 300, an example of (2) th is given as follows:
As shown in fig. 8 and 9, the suture loop 311 is a wound double-loop suture loop 3111, wherein one loop 3111 is formed by passing the suture 300 through the covering film 200, the net opening 100a and the aperture 130 a/net opening 100a, the other loop 3111 is formed by passing the suture 300 through the aperture 130 a/net opening 100a, and one loop 3111 is enclosed outside the other loop 3111.
Regarding the wiring manner of the wound double loop stitch coil 3111, (2) examples are given below, wherein for convenience of description, these 2 examples are described taking the case where the bracket bar 130 is provided with the aperture 130a as an example:
As shown in fig. 8, in the example (2.1), the routing manner includes:
step a5, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100 at the first aperture of the stent 100;
Step b5, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent to the first side of the stent at the second aperture of the stent;
step c5, penetrating the fixed end 320 or the movable end 330 of the suture 300 through the covering film 200 and entering the second side of the stent 100 through the mesh opening 100a, and penetrating the suture into the first side of the stent through the second pores, wherein the first pores and the second pores are sequentially distributed along the direction away from the covering film 200, and the first side and the second side of the stent 100 refer to the outer side, the inner side or the inner side and the outer side of the medical instrument respectively.
In the above steps, the first side of the stent 100 may be referred to as the outside of the medical device and the second side of the stent 100 may be referred to as the inside of the medical device, thus facilitating tying the end 320 of the suture 300 to the first knot 340. Note that the dashed arrow in fig. 8 represents the trend of the suture 300.
As shown in fig. 9, in the (2.2) th example, the routing manner includes:
Step a5, at the first aperture, threading the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100, and then through the cover 200 and into the first side of the stent 100 via the portal 100 a;
step b5, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100 at the first aperture;
step c5, at the second hole of the stent 100, penetrating the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100, wherein the first and second holes are sequentially distributed along the direction close to the covering film 200, and the first and second sides of the stent 100 refer to the outer side, the inner side or the inner side and the outer side of the medical apparatus respectively.
In the above steps, the first side of the stent 100 may be referred to as the outside of the medical device and the second side of the stent 100 may be referred to as the inside of the medical device, thus facilitating tying the end 320 of the suture 300 to the first knot 340. Note that the dashed arrow in fig. 9 represents the trend of the suture 300.
In application, the type and routing of the suture loop 3111 may be selected according to the structure of the stent 100, for example, as shown in fig. 10, the distal end of the stent 100 is turned over to the inside or outside of the stent 100, so that the distal end of the stent 100 forms a double-layer structure 110, and the suture loop 311 is formed by threading the suture 300 through the distal end of the stent 100 and the covering film 200. The distal end of the stent 100 is provided with the double-layer structure 110, so that the mechanical property of the stent 100 can be ensured, and the shape of the stent 100 can be ensured, so that the distal end structure of the stent 100 is matched with the left atrium mouth of the heart, and can be more firmly attached to the left atrium mouth. The stent 100 of the above-described structure may be connected to the covering film 200 by using the double-loop suture coil 3111 (see fig. 11 and 12) having the shape of "8" provided in the above-described example (1), or by using the double-loop suture coil 3111 (see fig. 13 and 14) having the shape of "wound" provided in the above-described example (2).
Here, as an example, the double-layer structure 110 of the stent 100 is provided with an aperture 130a, and the double-loop suture coil 3111 of the "8" shape or the double-loop suture coil 3111 of the wound type is inserted through the aperture 130 a. Specifically, as shown in fig. 10, the distal inner layer 112 of the stent 100 is provided with first and second threading holes 111a and 111b at intervals in a direction away from the covering film 200, the distal outer layer 111 of the stent 100 is provided with third and fourth threading holes 112a and 112b at intervals in a direction away from the covering film 200, the third threading hole 112a overlaps the first threading hole 111a, and the fourth threading hole 112b overlaps the second threading hole 111 b. Alternatively, the first, second, third and fourth threading holes 111a, 111b, 112a and 112b may be circular holes, square holes, or the like.
When the double loop suture loop 3111 is used, as shown in fig. 15 and 16, one loop suture loop 3111 is formed by threading a first threading hole 111a, a third threading hole 112a, a net mouth 130b and a cover film 200 through a suture 300, and the other loop suture loop 3111 is formed by threading a first threading hole 111a, a third threading hole 112a, a second threading hole 111b and a fourth threading hole 112b through the suture 300. The double-loop stitch 3111 may be threaded according to the routing scheme provided in the example (1.1), in which the first aperture is a region where the first through hole 111a overlaps the third through hole 112a, the second aperture is a region where the second through hole 111b overlaps the fourth through hole 112b, and the double-loop stitch 3111 may be threaded according to the routing scheme provided in the example (1.2), in which the second aperture is a region where the first through hole 111a overlaps the third through hole 112a, and the first aperture is a region where the second through hole 111b overlaps the fourth through hole 112 b.
When the wound double loop suture coil 3111 is used, as shown in fig. 12 and 13, one loop suture coil 3111 is formed by threading a third threading hole 112a, a fourth threading hole 112b, a net mouth 130b and a cover film 200 through the suture 300, and the other loop suture coil 3111 is formed by threading a first threading hole 111a, a third threading hole 112a, a second threading hole 111b and a fourth threading hole 112b through the suture 300. The double-loop stitch 3111 may be threaded according to the routing method provided in the example (1.5), in which the first aperture is an area where the first and third through holes 111a and 112a overlap, the second aperture is an area where the second and fourth through holes 111b and 112b overlap, and the double-loop stitch 3111 may be threaded according to the routing method provided in the example (1.6), in which the second aperture is an area where the first and third through holes 111a and 112a overlap, and the first aperture is an area where the second and fourth through holes 111b and 112b overlap.
In some embodiments of the present invention, as shown in FIG. 17, fixed end 320 and movable end 330 of suture 300 may be knotted 340 by forming a first knotting loop 370 on fixed end 320 of suture 300 and threading movable end 330 of suture 300 out of first knotting loop 370, followed by tensioning of first knotting loop 370. It will be appreciated that after first knotting loop 370 is tensioned, the moving end 330 of suture 300 is conformed to the first knotting loop 370. When the length of the suture loop 311 is adjusted, the moving end 330 of the suture 300 is moved along the first knotting loop 370 (see fig. 9) by pulling only the end of the moving end 330 of the suture 300 until the length of the suture loop 311 reaches a preset length. The knotting mode is convenient to operate, and reduces the difficulty of sewing the membrane.
In some embodiments of the present invention, as shown in FIG. 18, the suturing method further comprises a step S500 of tying the stationary end 320 and the movable end 330 of the suture 300 with a second knot 350 to lock the suture loop 311. Referring to fig. 19, the size of the suture loop 311 can be controlled during the suturing process by utilizing the characteristic that the moving end 330 of the suture 300 can move along the first knot 340, so as to control the suturing tightness of the stent 100 and the stent 200, and after the suturing tightness of the stent 100 and the stent 200 is controlled to be moderate, the suture loop 311 can be locked by tying the second knot 350.
Alternatively, as shown in FIG. 20, the fixed end 320 and the movable end 330 of the suture 300 may be knotted 350 by forming a second knotting loop 380 on the fixed end 320 or the movable end 330 of the suture 300 and threading the movable end 330 or the fixed end 320 of the suture 300 out of the second knotting loop 380, followed by tensioning the second knotting loop 380. As an example, a second loop 380 is formed on the fixed end 320 of the suture 300 and the moving end 330 of the suture 300 is threaded out of the second loop 380. As another example, a second loop 380 is formed on the moving end 330 of the suture 300 and the fixed end 320 of the suture 300 is threaded out of the second loop 380. The knotting mode is convenient to operate, and reduces the difficulty of sewing the membrane.
Regarding the number of second knots 350, 1 or more, for example, 2,3, 4, etc., may be provided depending on the length, thickness, length of suture 300 and the degree of locking desired for suture loop 311.
Of course, in other embodiments of the present invention, other methods may be used to form the structure, and the structure after formation may be as shown in fig. 21.
In some embodiments of the present invention, as shown in FIGS. 22-24, prior to tying the stationary end 320 and the movable end 330 of the suture 300 to form a first knot 340, the suture film method further comprises a step S400 of tying a third knot 360 in the middle portion 310 of the suture 300 to avoid detachment of the suture 300 from the stent 100 after breaking, wherein the third knot 360 is located on a different side of the stent 100 than the second knot 350. Knot locking structures (i.e., second knot 350, third knot 360) are formed on both the inner and outer sides of stent 100 and cannot be removed from stent 100 even if suture 300 breaks. As an example, the second wire knot 350 is located at the outer side of the bracket 100, the third wire knot 360 is located at the inner side of the bracket 100, and the maximum outer diameter of the third wire knot 360 is larger than the diameters of the first, second, third and fourth wire through holes 111a, 111b, 112a, 112b, so that the third wire knot 360 is prevented from being penetrated out of the bracket 100 from the inner side of the bracket 100 to the outer side of the bracket 100 through the first, second, third or fourth wire through holes 111a, 111b, 112a or 112 b.
In particular, in some embodiments of the present invention, as shown in FIG. 23, a third knot 360 is formed by intersecting the middle portion 310 of the suture 300 to form a third knotting loop 390, looping the fixed end 320 or the movable end 330 of the suture 300 around the knotted area of the middle portion 310 of the suture 300 and out of the third knotting loop 390, and then tensioning the third knotting loop 390. The knot formed by this type of method has a large volume such that the knot cannot pass smoothly through the stent 100. The third wire knot 360 is a dead knot. Of course, in other embodiments of the present invention, the third wire 360 may be formed in other ways, and the structure after formation thereof may be as shown in fig. 21.
Therefore, according to the method for sewing the film provided by the application, on one hand, the method of combining the slipknot (namely the first knot 340) and the dead knot (namely the second knot 350) is adopted to wrap the film 200 on the bracket 100, so that the sewing tightness of the film 200 on the bracket 100 is controlled, the defect that the length of the sewing coil 311 can not be adjusted after the dead knot is made can be avoided, and on the other hand, the middle part 310 of the sewing thread 300 is penetrated through the bracket 100 at least four times and the film 200 is penetrated at least once to form the sewing coil 311, so that the phenomenon that the sewing coil 311 is too large or too small due to inaccurate adjustment of the sewing coil 311 caused by serious deformation of a medical instrument can be avoided, and the sewing tightness of the blocking film and the bracket is ensured to be moderate.
Another embodiment of the present invention provides a medical device, as shown in FIG. 3, comprising a stent 100 and a cover film 200, wherein the cover film 200 is sewn on the stent 100 by a suture 300, a middle portion 310 of the suture 300 is threaded through the stent 100 at least four times and through the cover film 200 at least once to form a suture loop 311, and a fixed end 320 and a movable end 330 of the suture 300 are connected by a first knot 340 to lock the suture loop 311.
The medical instrument is suitable for medical instruments with the functions of blocking, such as left atrial appendage occluders, and the like, including tectorial membranes and stents.
As shown in fig. 3, in the medical apparatus, the first knot 340 may be tied to the suture 300 to form the suture loop 311 between the stent 100 and the stent 200, and then the size of the suture loop 311 may be controlled during the suture process by utilizing the characteristic that the moving end 330 of the suture 300 can move along the first knot 340, so as to control the suture tightness of the stent 100 and the stent 200, and after the suture tightness of the stent 100 and the stent 200 is controlled to be moderate, the suture loop 311 may be locked, thereby avoiding the defect that the length of the suture loop 311 cannot be adjusted after the suture is tied. In addition, compared with the threading mode of the suture 300 in the prior art, the suture thread firstly passes through the tectorial membrane, the bracket and then passes through the bracket for the second time to form a suture coil and is knotted and fixed at the net mouth of the bracket, the suture thread loop is threaded through the bracket at least four times and is threaded through the tectorial membrane at least once, for example, see the threading mode shown in fig. 3, which can increase the stress points of the suture thread 300 on the bracket 100 and the tectorial membrane 200, so that the stress of the medical instrument is more uniform in the locking process of the suture thread loop 311, the structure and the shape stability of the medical instrument are ensured, thereby avoiding the inaccurate adjustment of the suture coil 311 caused by the inaccurate adjustment of the suture coil 311 due to the serious deformation of the medical instrument, reducing the distance of the fixed end 320 and the movable end 330 of the suture coil 300 before knotting, not only facilitating the knotting of the fixed end 320 and the movable end 330, but also avoiding the inaccurate adjustment of the suture coil 311 caused by the inaccurate adjustment of the medical instrument due to the occurrence of the deformation of the overlarge stress.
In some embodiments of the present invention, as shown in fig. 18, the medical device further comprises a second knot 350, the fixed end 320 and the movable end 33 of the suture 300 are connected by sequentially tying a first knot 340 and a second knot 350, wherein the first knot 310 is movable, and the second knot 350 is used for locking the suture loop 311. The medical apparatus can form a suture loop 311 between a stent 100 and a stent 200 by firstly tying a first knot 340 to the suture 300, then can control the length of the suture loop 311 in the process of suturing the stent by utilizing the characteristic that a movable end 330 of the suture 300 can move along the first knot 340, and further control the suture tightness of the stent 100 and the stent 200, and can lock the suture loop 311 by tying a second knot 350 to the suture 300 after the suture tightness of the stent 100 and the stent 200 is controlled to be moderate.
In some embodiments of the present invention, as shown in FIG. 20, a second knotting loop 380 is formed on either the fixed end 320 or the movable end 330 of the suture 300 and the movable end 330 or the fixed end 320 of the suture 300 is threaded out of the second knotting loop 380, the second knotting loop 380 being capable of being tensioned to form a second knot 350. The second wire knot 350 is simple in structure and convenient to operate. Of course, in other embodiments of the invention, the second wire knot 350 may take other configurations, such as the configuration shown in FIG. 21.
In some embodiments of the present invention, as shown in fig. 19, 20 and 22, the fixed end 320 and the movable end 330 of the suture 300 are both located outside of the stent 100. Thus, the fixed end 320, the movable end 330 of the suture 300 are facilitated to be tied with the first knot 340 and the second knot 350.
In some embodiments of the present invention, as shown in fig. 17, a first knotting loop 370 is formed on the fixed end 320 of the suture 300 and the moving end 330 of the suture 300 is threaded out of the first knotting loop 370, the first knotting loop 370 being capable of forming a first knot 340 upon tensioning. The first knots 340 are simple in structure and convenient to operate.
In some embodiments of the present invention, as shown in fig. 2, the stent 100 includes a plurality of stent rods 130, a plurality of mesh openings 113a are formed by surrounding adjacent stent rods 130, the stent rods 130 are provided with holes, and the suture 300 is threaded through the holes 130a and/or the mesh openings 100 a. In this way, whether the hole is opened in the bracket bar 130 can be considered according to the thickness of the bracket bar 130, so as to determine whether the suture 300 is threaded through the hole or the mesh 113 a.
Specifically, in some embodiments of the present invention, the middle portion 310 of the suture 300 is threaded through the aperture at least three times, and the middle portion 310 of the suture 300 is threaded through the covering film 200 and the portal 113a at least once. The mesh opening 113a has the characteristic of large area, so that the suture area of the covering film 200 overlapped with the mesh opening 113a can be increased, the suture position on the covering film 200 can be flexibly adjusted according to specific requirements, and in addition, the characteristic of small gap area can be utilized to limit the suture thread 300 penetrating through the covering film, so that the shape and the structure of the medical instrument after the suture are stable.
The particular manner in which the central portion 310 of the suture 300 is threaded is primarily related to the distal structure of the stent 100. In some embodiments of the present invention, as shown in fig. 2 and 10, the distal end of the stent 100 is turned towards the inside or outside of the stent 100, so that the distal end of the stent 100 forms a double-layered structure 110, which has overlapping pores, and the suture loop 311 is formed by threading the overlapping pores, the mesh opening 113a and the covering film 200 through the suture 300. Here, the inner layer and the outer layer of the double-layer structure 100 are provided with threading holes at the same position, and at least a part of the two threading holes overlap, and the overlapping position is called an "overlapping hole". The distal end of the stent 100 is provided with the double-layer structure 110, so that the mechanical property of the stent 100 can be ensured, and the shape of the stent 100 can be ensured, so that the distal end structure of the stent 100 is matched with the left atrium mouth of the heart, and can be more firmly attached to the left atrium mouth.
For the distal end of the stent 100 with the above-mentioned structure, as shown in fig. 11 and 12, in the embodiment of the present invention, the suture loop 311 is an "8" -shaped double-ring-shaped suture loop 3111, wherein one ring-shaped suture loop 3111 is formed by threading the covering film 200, the net opening 113a and the overlapping hole through the suture 300, and the other ring-shaped suture loop 3111 is formed by threading the overlapping hole through the suture 300. The double-ring-shaped seaming coil in the shape of the 8 not only can seam the tectorial membrane 200 on the bracket 100, but also can fix the inner layer and the outer layer at the far end of the bracket 100 for fastening, thereby ensuring the structural stability of the bracket 100. Of course, in other embodiments of the present invention, the stitch coil 311 may be a wound double loop stitch coil 3111 provided in the above embodiment (2).
As an example, as shown in fig. 11, the inner layer 112 of the double-layer structure 110 is provided with a first threading hole 111a and a second threading hole 111b at intervals along a direction away from the covering film 200, the outer layer 111 of the double-layer structure 110 is provided with a third threading hole 112a and a fourth threading hole 112b at intervals along a direction away from the covering film 200, the third threading hole 112a overlaps the first threading hole 111a and the fourth threading hole 112b overlaps the second threading hole 111b to form an overlapping hole, one annular suture ring 3111 is formed by threading the first threading hole 111a, the third threading hole 112a, the net mouth 113a and the covering film 200 through a suture 300, and the other annular suture ring 3111 is formed by threading the first threading hole 111a, the third threading hole 112a, the second threading hole 111b and the fourth threading hole 112b through the suture 300. Alternatively, the first, second, third and fourth threading holes 111a, 111b, 112a and 112b may be circular holes, square holes, or the like.
In some embodiments of the invention, the middle portion 310 of the suture 300 is threaded through the stent 100 at least twice and the middle portion 310 of the suture 300 is threaded through the cover 200 at least once. In this way, it can be ensured that the fixed end 320 and the movable end 330 of the suture 300 can be located at the side of the stent 100 after the covering film 200 and the stent 100 are penetrated in the middle of the suture 300, and the fixed end 320 and the movable end 330 of the suture 300 are conveniently tied with the first knot 340 instead of being located at the side of the covering film 200 and the other end being located at the side of the stent 100, and excessive pulling of the covering film 200 in the process of adjusting the length of the suture coil 311 can be avoided, thereby preventing the covering film 200 from being pulled off the stent 100. The specific number of times that the middle portion 310 of the suture 300 is threaded through the stent 100 and the covering film 200 is mainly related to the manner in which the middle portion 310 of the suture 300 is threaded, for example, as shown in fig. 19, when the middle portion 310 of the suture 300 is threaded according to the "8" shaped route, the middle portion 310 of the suture 300 is threaded through the stent 100 three times, and the middle portion 310 of the suture 300 is threaded through the covering film 200 once.
Wherein the central portion 310 of the suture 300 is threaded in a manner primarily related to the distal structure of the stent 100. In some embodiments of the present invention, as shown in fig. 10, the distal end of the stent 100 is folded back toward the inside or outside of the stent 100 so that the distal end of the stent 100 forms a double-layered structure 110, and a suture loop 311 is formed by threading the distal end of the stent 100 with the cover film 200 via a suture 300. The distal end of the stent 100 is provided with the double-layer structure 110, so that the mechanical property of the stent 100 can be ensured, and the shape of the stent 100 can be ensured, so that the distal end structure of the stent 100 is matched with the left atrium mouth, and can be more firmly attached to the left atrium mouth.
For the distal end of the stent 100 with the above-mentioned structure, as shown in fig. 11, in the embodiment of the present invention, the suture loop 311 is an "8" -shaped double-ring-shaped suture loop, wherein one ring-shaped suture loop 3111 is formed by threading the cover film 200 through the suture 300 and the stent 100, and the other ring-shaped suture loop 3111 is formed by threading the suture 300 through the stent 100. The double-ring-shaped seaming coil in the shape of the 8 not only can seam the tectorial membrane 200 on the bracket 100, but also can fix the inner layer and the outer layer at the far end of the bracket 100 for fastening, thereby ensuring the structural stability of the bracket 100. As an example, as shown in fig. 10 and 11, a first threading hole 111a and a second threading hole 111b are provided at intervals in a direction away from the covering film 200 in the distal inner layer 112 of the stent 100, a third threading hole 112a and a fourth threading hole 112b are provided at intervals in a direction away from the covering film 200 in the distal outer layer 111 of the stent 100, the third threading hole 112a corresponds to the first threading hole 111a, the fourth threading hole 112b corresponds to the second threading hole 111b, one of the annular suture loops 3111 is formed by threading the first threading hole 111a, the third threading hole 112a and the covering film 200 through the suture 300, and the other annular suture loop 3111 is formed by threading the first threading hole 111a, the third threading hole 112a, the second threading hole 111b and the fourth threading hole 112b through the suture 300. Alternatively, the first, second, third and fourth threading holes 111a, 111b, 112a and 112b may be circular holes, square holes, or the like.
In some embodiments of the present invention, as shown in fig. 22 and 24, the middle portion 310 of the suture 300 is formed with a third knot 360, the third knot 360 being used to prevent the suture 300 from falling off the stent 100 after breaking, wherein the third knot 360 is located on a different side of the stent 100 than the second knot 350. Knot locking structures (i.e., second knot 350, third knot 360) are formed on both the inner and outer sides of stent 100 and cannot be removed from stent 100 even if suture 300 breaks. As an example, the second wire knot 350 is located at the outer side of the bracket 100, the third wire knot 360 is located at the inner side of the bracket 100, and the maximum outer diameter of the third wire knot 360 is larger than the diameters of the first, second, third and fourth wire through holes 111a, 111b, 112a, 112b, so that the third wire knot 360 is prevented from being penetrated out of the bracket 100 from the inner side of the bracket 100 to the outer side of the bracket 100 through the first, second, third or fourth wire through holes 111a, 111b, 112a or 112 b.
Specifically, in some embodiments of the present invention, as shown in fig. 23, the middle portion 310 of the suture 300 is crossed to form a third knotting loop 390 and the fixed end 320 or the movable end 330 of the suture 300 is looped around the unknotted area of the middle portion 310 of the suture 300 and is threaded out of the third knotting loop 390, and the third knotting loop 390 can form a third knot 360 after being tensioned. The knot of this type of construction has a large bulk such that the knot cannot pass smoothly through the stent 100. The third wire knot 360 is a dead knot. Of course, in other embodiments of the present invention, the third wire knot 360 may take other configurations, such as the configuration shown in fig. 21.
Therefore, according to the medical apparatus provided by the application, on one hand, the method of combining the slipknot (namely the first knot 340) and the dead knot (namely the second knot 350) is adopted to cover the covering film 200 on the support 100, so that the suture tightness of the covering film 200 on the support 100 is controlled, the defect that the length of the suture coil 311 can not be adjusted after the dead knot is made can be avoided, on the other hand, the middle part 310 of the suture 300 is penetrated through the support 100 at least four times and the covering film 200 is penetrated at least once to form the suture coil 311, and the condition that the suture coil 311 is too large or too small due to inaccurate adjustment of the suture coil 311 caused by serious deformation of the medical apparatus can be avoided, so that the suture tightness of the choke covering film and the support is moderate can be ensured.
The left atrial appendage occlusion stent is taken as an example in the present invention, but it should be understood by those skilled in the art that the stent may be a medical device with an opening or a closing structure such as an aortic stent, a filter screen stent, a venous stent, etc.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.