A left atrial appendage occluder distal end necking auxiliary device and necking method

Abstract

The application discloses a left auricle plugging device distal end necking auxiliary device and a necking method, which comprises a base, a guide lining core, a guide sleeve, a first necking sleeve, a second necking sleeve and a mounting sleeve, an inner ring for supporting the inner periphery of a support rod of the left auricle plugging device is arranged on the first necking sleeve, a positioning ring for positioning the support rod is arranged on the second necking sleeve, and an outer ring for fixing the outer periphery of the support rod is arranged on the mounting sleeve; the inner ring, the positioning ring and the outer ring are in the same radial direction, and a positioning groove corresponding to the support rod is arranged on the positioning ring; the first necking sleeve, the second necking sleeve and the mounting sleeve are cooperated, the inner ring, the positioning ring and the outer ring are fixed, the necking device is not limited by the structure of the left auricle plugging device, has universality, and the assembly mode that pipelines are directly sleeved can simplify operation steps and improve necking efficiency.

Description

Technical Field

[0001] This invention relates to the field of left atrial appendage occluder technology, specifically to a distal closure auxiliary device and closure method for a left atrial appendage occluder. Background Technology

[0002] A left atrial appendage occluder is delivered to the left atrial appendage via a catheter to prevent thrombus formation in the left atrial appendage due to atrial fibrillation, thus avoiding stroke caused by the thrombus ascending to the brain. Both the distal and proximal ends of the left atrial appendage occluder need to be fixed. When fixing the distal end of the existing left atrial appendage occluder, due to the large number of support rods, specific tooling needs to be made to fix the position of the distal end of the left atrial appendage occluder. However, the number of support rods and other parameters will vary for different types of occluders, and the tooling also needs to be adjusted accordingly. This results in difficulties in fixing the shape of the occluder, high tooling costs, and the complex and inconvenient operation of the fixing process using existing tooling, which affects processing efficiency. Summary of the Invention

[0003] Technical Objective: To address the shortcomings of existing left atrial appendage occluders, which require specific tooling for distal end fixation and different types of occluders require corresponding tooling, resulting in high cost and complex fixing procedures, this invention discloses an auxiliary device and method for distal end fixation of left atrial appendage occluders that can conveniently and accurately fix the distal structure of the left atrial appendage occluder.

[0004] Technical solution: To achieve the above technical objectives, the present invention adopts the following technical solution:

[0005] A distal end closing auxiliary device for a left atrial appendage occluder includes a base, a guide liner, a guide sleeve, a first closing sleeve, a second closing sleeve, and a mounting sleeve. The base has a mounting hole matching the diameter of the guide sleeve. The lower end of the guide sleeve extends into the mounting hole of the base. The guide liner passes through the guide sleeve and guides the first closing sleeve, the second closing sleeve, and the mounting sleeve, which are sequentially fitted onto the outer circumference of the guide sleeve from the inside out. The base has a fixing assembly for keeping the ends of the guide sleeve, the first closing sleeve, and the second closing sleeve near the base fixed. The first closing sleeve has an inner ring for supporting the inner circumference of the support rod at the distal end of the left atrial appendage occluder. The second closing sleeve has a positioning ring for positioning the support rod. The mounting sleeve has an outer ring for fixing the outer circumference of the support rod. The inner ring, the positioning ring, and the outer ring are in the same radial direction. The positioning ring has a positioning groove corresponding to the support rod.

[0006] Preferably, the fixing component includes a fixing pin, and the guide sleeve is provided with a pin hole for cooperating with the fixing pin. The fixing pin passes through the pin hole and its two ends rest on the upper surface of the mounting hole. The first closing sleeve and the second closing sleeve are each provided with a fixing groove for cooperating with the fixing pin at one end. The fixing groove is used to engage with the fixing pin, thereby restricting the rotation of the ends of the first closing sleeve and the second closing sleeve.

[0007] Preferably, the first constriction sleeve adopts a two-section structure, including a first positioning section near the base and a second positioning section away from the base. The inner ring is restricted between the first positioning section and the second positioning section. A groove and a boss are provided at the end of the inner ring that is close to the first positioning section to prevent the inner ring from rotating.

[0008] Preferably, the second constriction sleeve adopts a two-section structure, including a third positioning section located near the base and a fourth positioning section located away from the base. A positioning ring is located between the fourth positioning section and the third positioning section. The positioning ring and the end of the third positioning section are connected by a second slot and a second boss to restrict the rotation of the positioning ring relative to the third positioning section. The second slot is located between adjacent positioning slots on the positioning ring.

[0009] Preferably, a transition groove that communicates with the positioning groove is provided at one end of the third positioning section near the positioning ring.

[0010] Preferably, the mounting sleeve includes a fifth positioning segment and a sixth positioning segment for positioning the outer ring. The outer ring is located between the fifth and sixth positioning segments and corresponds to the inner ring and the positioning ring in the circumferential direction. The outer ring is connected to the fifth and sixth positioning segments by a rotatable fit. A guide groove consistent with the positioning groove is provided on the outer ring. The support rod at the distal end of the left atrial appendage occluder is pressed into the positioning groove through the guide groove. By rotating the outer ring, the guide groove and the positioning groove are offset from each other, thereby fixing the support rod of the left atrial appendage occluder.

[0011] Preferably, the inner ring, the positioning ring, and the outer ring are all provided with pin holes for relative locking. After the support rod is fixed at the end, the pin holes are aligned by rotating the outer ring, and the end pin is inserted for positioning and fixing.

[0012] The present invention also provides a method for distal closure of a left atrial appendage occluder, comprising the following steps:

[0013] S01. Insert the guide sleeve into the mounting hole of the base, and insert the fixing pin to fix the guide sleeve. Insert the guide core rod into the guide sleeve.

[0014] S02. Insert the first and second constricting sleeves in sequence and snap the ends into the fixing pins to restrict the rotation of the first and second constricting sleeves. The inner ring is restricted between the two pipe sections of the first constricting sleeve, and the positioning ring is restricted between the two pipe sections of the second constricting sleeve. The inner ring and the positioning ring are in the same radial position.

[0015] S03. Insert the proximal end of the left atrial appendage occluder through the outer periphery of the second closing sleeve, and then insert the installation sleeve.

[0016] S04. Press the distal support rods of the left atrial appendage occluder into the positioning groove one by one. The outer ring restricts the pressed-in support rod ends. Rotate the outer ring so that the pin holes on the outer ring correspond to the pin holes on the positioning ring and the inner ring. Insert the closing pin to lock and complete the closing and fixing of the distal end of the left atrial appendage occluder.

[0017] Preferably, in step S04, the process of pressing the support rod into the positioning groove includes: rotating the outer ring so that the guide groove on the outer ring corresponds to one of the positioning grooves on the positioning ring; pressing the support rod into the positioning groove along the guide groove, with the part of the support rod entering the guide groove lower than the inner side of the guide groove; rotating the outer ring again so that the guide groove on the outer ring is misaligned with the current positioning groove, thus restricting the support rod in the positioning groove; and then pressing the support rod into the corresponding positioning groove in sequence until all support rods are positioned and fixed. At this time, the pin hole on the outer ring corresponds to the pin hole on the positioning ring and the inner ring, and the guide groove on the outer ring is located in the area between adjacent positioning grooves on the positioning ring.

[0018] Beneficial effects: The distal closure auxiliary device and closure method for a left atrial appendage occluder provided by the present invention have the following beneficial effects:

[0019] 1. The present invention uses a first closing sleeve, a second closing sleeve and an installation sleeve in combination, and is fixed by an inner ring, a positioning ring and an outer ring. It is not limited by the structure of the left atrial appendage occluder itself, has universality, and the assembly method of direct connection of the tubing can simplify the operation steps and improve the closing efficiency.

[0020] 2. The present invention uses a fixing pin to position and fix the guide sleeve, the first closing sleeve and the second closing sleeve, which makes the structure simple and easy to assemble and disassemble.

[0021] 3. The first closing sleeve, the second closing sleeve, and the installation sleeve of the present invention all adopt a two-section structure, which can quickly position and fix the inner ring, the positioning ring, and the outer ring. It is not limited by the structure of the left atrial appendage occluder itself, and has a wide range of applications. It can quickly close and fix the distal end of the left atrial appendage occluder, while saving tooling costs.

[0022] 4. The outer ring of the present invention can rotate relative to the positioning ring. After the support rod enters the positioning groove from the guide groove, the positioning ring is rotated, and the support rod is fixed by the structure of the positioning ring itself. Even if the support rods are fixed in sequence, the shape of the left atrial appendage occluder can be guaranteed, and the closing quality can be guaranteed. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below.

[0024] Figure 1 This is an assembly structure diagram of the sealing device of the present invention;

[0025] Figure 2 This is a cross-sectional view of the sealing device of the present invention along the center line of the mounting hole;

[0026] Figure 3 This is a structural diagram of the first constriction sleeve of the present invention;

[0027] Figure 4 This is a structural diagram of the second constriction sleeve of the present invention;

[0028] Figure 5 This is a structural diagram of the mounting sleeve for the present invention;

[0029] Figure 6 This is a structural diagram of the guide sleeve and base assembly of the present invention;

[0030] Figure 7 This is an enlarged view of the positioning ring structure of the present invention;

[0031] Figure 8 This is a diagram showing the support rod of the present invention being pressed into the positioning groove;

[0032] Figure 9 This is a diagram showing the finished state of the left atrial appendage occluder of the present invention;

[0033] Among them, 1-base, 2-guide liner, 3-guide sleeve, 4-first closing sleeve, 5-second closing sleeve, 6-installation sleeve, 7-installation hole, 8-support rod, 9-inner ring, 10-positioning ring, 11-outer ring, 12-positioning groove, 13-fixing pin, 14-fixing slot, 15-first positioning section, 16-second positioning section, 17-closing pin, 18-slot, 19-bore, 20-third positioning section, 21-fourth positioning section, 22-second slot, 23-second bore, 24-transition groove, 25-fifth positioning section, 26-sixth positioning section, 27-guide groove, 28-pin hole. Detailed Implementation

[0034] The present invention will now be described more clearly and completely by way of a preferred embodiment in conjunction with the accompanying drawings, but this does not limit the invention to the scope of the described embodiment.

[0035] like Figures 1-9 The diagram shows a distal closure auxiliary device for a left atrial appendage occluder disclosed in this invention, comprising a base 1, a guide liner 2, a guide sleeve 3, a first closure sleeve 4, a second closure sleeve 5, and a mounting sleeve 6. The base 1 has a mounting hole 7 matching the diameter of the guide sleeve. The lower end of the guide sleeve 3 extends into the mounting hole 7 of the base 1. The guide liner 2 passes through the guide sleeve 6, guiding the first closure sleeve 4, the second closure sleeve 5, and the mounting sleeve 6, which need to be sequentially fitted onto the outer circumference of the guide sleeve 6 from the inside out. The base 1 has... A fixing assembly is used to keep the guide sleeve 3, the first closing sleeve 4, and the second closing sleeve 5 fixed at one end near the base 1; the first closing sleeve 4 is provided with an inner ring 9 for supporting the inner circumference of the support rod 8 at the distal end of the left atrial appendage occluder; the second closing sleeve 5 is provided with a positioning ring 10 for positioning the support rod 8; the mounting sleeve 6 is provided with an outer ring 11 for fixing the outer circumference of the support rod 8; the inner ring 9, the positioning ring 10, and the outer ring 11 are in the same radial direction; the positioning ring 10 is provided with a positioning groove 12 corresponding to the support rod 8.

[0036] Specifically, the fixing component includes a fixing pin 13. The guide sleeve 3 is provided with a pin hole for cooperating with the fixing pin 13. The fixing pin 13 passes through the pin hole and its two ends rest on the upper surface of the mounting hole 7. The first closing sleeve 4 and the second closing sleeve 5 are each provided with a fixing groove 14 for cooperating with the fixing pin 13 at one end. The fixing groove 14 is used to lock onto the fixing pin 13, thereby restricting the rotation of the ends of the first closing sleeve 4 and the second closing sleeve 5.

[0037] The guide sleeve 3, the first closing sleeve 4 and the second closing sleeve are fixed by a fixed pin 13, which makes connection and disassembly convenient and easy to operate. In addition, the inner ring 9, the positioning ring 10 and the outer ring 11 are all closing structures of the left atrial appendage occluder itself and are not limited by the support rod structure of the left atrial appendage occluder itself.

[0038] To facilitate convenient positioning and fixing of the inner ring, positioning ring, and outer ring, the first closing sleeve 4, the second closing sleeve 5, and the mounting sleeve 6 of this invention all adopt a two-section structure, such as... Figures 3-5 As shown, the first constriction sleeve 4 adopts a two-section structure, including a first positioning section 15 near the base 1 and a second positioning section 16 away from the base 1. The inner ring 11 is restricted between the first positioning section 15 and the second positioning section 16. At the end where the inner ring 11 and the first positioning section 15 are close to each other, there is a groove 18 and a boss 19 to prevent the inner ring 9 from rotating.

[0039] The second constriction sleeve 5 includes a third positioning section 20 located near the base 1 and a fourth positioning section 21 located away from the base 1. The positioning ring 10 is located between the fourth positioning section 21 and the third positioning section 20. The end of the positioning ring 10 and the third positioning section 20 are connected by a second slot 22 and a second boss 23 to restrict the rotation of the positioning ring 10 relative to the third positioning section 20. The second slot 22 is located between adjacent positioning slots on the positioning ring 10. A transition groove 24 communicating with the positioning slot 12 is provided at the end of the third positioning section 20 near the positioning ring 10, so that after the support rod is pressed into the positioning slot 12, part of it enters the transition groove 24 and does not affect the rotation of the outer ring 11.

[0040] The mounting sleeve 6 includes a fifth positioning section 25 and a sixth positioning section 26 for positioning the outer ring 11. The outer ring 11 is located between the fifth positioning section 25 and the sixth positioning section 26, corresponding circumferentially to the inner ring 9 and the positioning ring 10. The outer ring 11 is connected to the fifth positioning section 25 and the sixth positioning section 26 by a rotatable fit. A guide groove 27, which corresponds to the positioning groove 12, is provided on the outer ring 11. The support rod 8 at the distal end of the left atrial appendage occluder is pressed into the positioning groove 12 through the guide groove 27. Rotating the outer ring 11 causes the guide groove 27 to be offset from the positioning groove 12, thus fixing the support rod of the left atrial appendage occluder. Pin holes 28 for relative locking are provided on the inner ring 9, the positioning ring 10, and the outer ring 11. After the support rod 8 is fixed at the end, the pin holes 28 are aligned by rotating the outer ring 11, and the closing pin 17 is inserted for positioning and fixing.

[0041] Meanwhile, since the closing auxiliary devices of the present invention are all assembled by means of pipe sleeve connection, in order to facilitate the insertion and fixing of the closing pin 17, the guide sleeve 3 of the present invention can also adopt a two-section structure and set the interface at the position corresponding to the pin hole 2 to form a groove that opens the closing pin 17 so that the closing pin 17 can be smoothly inserted to fix the inner ring 9, the positioning ring 10 and the outer ring 11.

[0042] The present invention also provides a method for closing the distal end of a left atrial appendage occluder based on the above-mentioned closing auxiliary device, comprising the following steps:

[0043] S01. Insert the guide sleeve into the mounting hole of the base, and insert the fixing pin to fix the guide sleeve. Insert the guide core rod into the guide sleeve.

[0044] S02. Insert the first and second constricting sleeves in sequence and snap the ends into the fixing pins to restrict the rotation of the first and second constricting sleeves. The inner ring is restricted between the two pipe sections of the first constricting sleeve, and the positioning ring is restricted between the two pipe sections of the second constricting sleeve. The inner ring and the positioning ring are in the same radial position.

[0045] S03. Insert the proximal end of the left atrial appendage occluder through the outer periphery of the second closing sleeve, and then insert the installation sleeve.

[0046] S04. Press the distal support rods of the left atrial appendage occluder into the positioning groove one by one. The outer ring restricts the end of the pressed support rod. Rotate the outer ring so that the pin hole on the outer ring corresponds to the pin hole on the positioning ring and the inner ring. Insert the closing pin to lock it, and complete the closing and fixing of the distal end of the left atrial appendage occluder. Then remove the sleeves one by one to finally obtain the closed left atrial appendage occluder structure.

[0047] In step S04, the process of pressing the support rod into the positioning groove includes: rotating the outer ring so that the guide groove on the outer ring corresponds to one of the positioning grooves on the positioning ring; pressing the support rod into the positioning groove along the guide groove, with the part of the support rod entering the guide groove lower than the inner side of the guide groove; rotating the outer ring again so that the guide groove on the outer ring is offset from the current positioning groove, thus restricting the support rod in the positioning groove; and then pressing the support rod into the corresponding positioning groove in sequence until all support rods are positioned and fixed. At this time, the pin hole on the outer ring corresponds to the pin hole on the positioning ring and the inner ring, and the guide groove on the outer ring is located in the area between adjacent positioning grooves on the positioning ring.

[0048] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A left atrial appendage occluder distal cuff assisting device, characterized in that, The system includes a base (1), a guide liner (2), a guide sleeve (3), a first closing sleeve (4), a second closing sleeve (5), and a mounting sleeve (6). The base (1) has a mounting hole (7) matching the diameter of the guide sleeve. The lower end of the guide sleeve (3) extends into the mounting hole (7) of the base (1). The guide liner (2) passes through the guide sleeve (3) and guides the first closing sleeve (4), the second closing sleeve (5), and the mounting sleeve (6) that need to be fitted onto the outer circumference of the guide sleeve (3) from the inside out. The base (1) also has a structure for holding the guide sleeve (3), the first closing sleeve (4), the second closing sleeve (5), and the mounting sleeve (6). The first sleeve (4) and the second sleeve (5) are fixed at one end near the base (1); the first sleeve (4) is provided with an inner ring (9) for supporting the inner circumference of the support rod (8) at the distal end of the left atrial appendage occluder; the second sleeve (5) is provided with a positioning ring (10) for positioning the support rod (8); the mounting sleeve (6) is provided with an outer ring (11) for fixing the outer circumference of the support rod (8); the inner ring (9), the positioning ring (10) and the outer ring (11) are in the same radial direction; the positioning ring (10) is provided with a positioning groove (12) corresponding to the support rod (8); The fixing component includes a fixing pin (13), and the guide sleeve (3) is provided with a pin hole for cooperating with the fixing pin (13). The fixing pin (13) passes through the pin hole and its two ends are placed on the upper surface of the mounting hole (7). The first closing sleeve (4) and the second closing sleeve (5) are provided with fixing slots (14) for cooperating with the fixing pin (13) at the end near the fixing pin (13). The fixing slots (14) are engaged with the fixing pin (13) to restrict the rotation of the ends of the first closing sleeve (4) and the second closing sleeve (5). The first constriction sleeve (4) adopts a two-section structure, including a first positioning section (15) near the base (1) and a second positioning section (16) away from the base (1). The inner ring (9) is restricted between the first positioning section (15) and the second positioning section (16). At the end where the inner ring (9) and the first positioning section (15) are close to each other, there is a slot (18) and a boss (19) to prevent the inner ring (9) from rotating.

2. The distal end closing auxiliary device for a left atrial appendage occluder according to claim 1, characterized in that, The second constriction sleeve (5) adopts a two-section structure, including a third positioning section (20) located near the base (1) and a fourth positioning section (21) located away from the base (1). The positioning ring (10) is located between the fourth positioning section (21) and the third positioning section (20). The end of the positioning ring (10) and the third positioning section (20) are connected by a second slot (22) and a second boss (23) to restrict the positioning ring (10) from rotating relative to the third positioning section (20). The second slot (22) is located between adjacent positioning slots on the positioning ring (10).

3. The distal end closing auxiliary device for a left atrial appendage occluder according to claim 2, characterized in that, A transition groove (24) is provided at one end of the third positioning section (20) near the positioning ring (10) and is connected to the positioning groove (12).

4. The distal end closing auxiliary device for a left atrial appendage occluder according to claim 2, characterized in that, The installation sleeve (6) includes a fifth positioning section (25) and a sixth positioning section (26) for positioning the outer ring (11). The outer ring (11) is located between the fifth positioning section (25) and the sixth positioning section (26) and corresponds to the inner ring (9) and the positioning ring (10) in the circumferential direction. The outer ring (11) is connected to the fifth positioning section (25) and the sixth positioning section (26) by a rotating fit. A guide groove (27) consistent with the positioning groove (12) is opened on the outer ring (11). The support rod (8) at the distal end of the left atrial appendage occluder is pressed into the positioning groove (12) through the guide groove (27). The outer ring (11) is rotated so that the guide groove (27) and the positioning groove (12) are offset from each other to fix the support rod of the left atrial appendage occluder.

5. The distal end closing auxiliary device for a left atrial appendage occluder according to claim 4, characterized in that, The inner ring (9), the positioning ring (10) and the outer ring (11) are provided with pin holes (28) for relative locking. After the support rod (8) is fixed, the pin holes (28) are aligned with each other by rotating the outer ring (11) and the closing pin (17) is inserted for positioning and fixing.

6. A method for closing the distal end of a left atrial appendage occluder, using an auxiliary device for closing the distal end of a left atrial appendage occluder as described in claim 5, characterized in that, Including the following steps: S01. Insert the guide sleeve into the mounting hole of the base, and insert the fixing pin to fix the guide sleeve. Insert the guide core rod into the guide sleeve. S02. Insert the first and second constricting sleeves in sequence and snap the ends into the fixing pins to restrict the rotation of the first and second constricting sleeves. The inner ring is restricted between the two pipe sections of the first constricting sleeve, and the positioning ring is restricted between the two pipe sections of the second constricting sleeve. The inner ring and the positioning ring are in the same radial position. S03. Insert the proximal end of the left atrial appendage occluder through the outer periphery of the second closing sleeve, and then insert the installation sleeve. S04. Press the distal support rods of the left atrial appendage occluder into the positioning groove one by one. The outer ring restricts the pressed-in support rod ends. Rotate the outer ring so that the pin holes on the outer ring correspond to the pin holes on the positioning ring and the inner ring. Insert the closing pin to lock and complete the closing and fixing of the distal end of the left atrial appendage occluder.

7. A method for distal closure of a left atrial appendage occluder according to claim 6, characterized in that, In step S04, the process of pressing the support rod into the positioning groove includes: rotating the outer ring so that the guide groove on the outer ring corresponds to one of the positioning grooves on the positioning ring; pressing the support rod into the positioning groove along the guide groove, with the part of the support rod entering the guide groove lower than the inner side of the guide groove; rotating the outer ring again so that the guide groove on the outer ring is offset from the current positioning groove, thus restricting the support rod in the positioning groove; and then pressing the support rod into the corresponding positioning groove in sequence until all support rods are positioned and fixed. At this time, the pin hole on the outer ring corresponds to the pin hole on the positioning ring and the inner ring, and the guide groove on the outer ring is located in the area between adjacent positioning grooves on the positioning ring.

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