Sheath base fixing mechanism and sheath tube clamping mechanism of bending-adjustable guide sheath

Abstract

The embodiment of the utility model provides a sheath tube fixing mechanism and a sheath tube clamping mechanism of a bending-adjustable guide sheath, which are mainly applied to bending-adjustable guide sheaths in the field of atrial fibrillation ablation treatment or bending-adjustable guide sheaths in the field of atrial fibrillation left auricle plugging. In the embodiment of the invention, the structures of the sheath base fixing mechanism and the sheath tube clamping mechanism are systematically designed, and the sheath base fixing mechanism is exemplarily explained. By means of the improved structure, the problems that in the bonding process, the yield is low, and labor hours are consumed can be solved, and the yield and efficiency of bonding of the adjustable bending sheath tube and the sheath base are improved.

Description

Technical Field

[0001] This application relates to the field of smart medical technology, and in particular to a sheath fixing mechanism and a sheath clamping mechanism for an adjustable bendable guide sheath. Background Technology

[0002] Adjustable bendable guide sheaths are used in cardiac electrophysiological therapy for establishing access to diagnostic or therapeutic catheters. The adjustable bendable sheath and sheath seat are crucial components. To enable the catheter to reach various parts of the heart chambers, the adjustable bendable sheath contains one or more pull wires. By pulling the pull wire at the proximal end of the sheath externally, the position of the distal end of the sheath within the heart chambers can be controlled. To facilitate the operator's judgment of the sheath's movement direction when the pull wire is pulled, one pull wire should generally be aligned with a side branch of the sheath seat. This requires accurate alignment of the sheath and sheath seat during assembly. Currently, the main assembly methods include bonding and injection molding, with bonding more easily achieving this requirement.

[0003] Currently, the bonding process for adjustable sheath tubes and sheath seats suffers from an unreasonable groove design. Due to manufacturing variations, the pull wire may experience slight axial helical displacement within the sheath tube, causing the proximal and distal pull wire positions to not be perfectly aligned. Since the movement of the pull wire originates from the distal end of the sheath, alignment should be performed using the distal pull wire, not the proximal one. Even after accurate alignment of the sheath tube pull wire and the sheath seat side support, the sheath tube is prone to rotation when squeezed by hand. This necessitates multiple adjustments to the sheath tube's orientation during bonding, resulting in low production efficiency and a high risk of product scrap.

[0004] Therefore, it is urgent to optimize the bonding process by improving the tooling structure, thereby increasing the product qualification rate and production efficiency. Utility Model Content

[0005] This application provides a sheath fixing mechanism and a sheath clamping mechanism for an adjustable bending guide sheath. By changing the structure, the problems of low pass rate and long working time in the bonding process can be solved, thereby improving the pass rate and efficiency of bonding the adjustable bending sheath and sheath seat.

[0006] In a first aspect, embodiments of this application provide a sheath seat fixing mechanism for an adjustable bending guide sheath, the sheath seat fixing mechanism including a cover plate, a left slider, a right slider, and a locking seat; the sheath seat has a side support;

[0007] The cover plate is disposed above the card holder, and the left slider and the right slider are respectively fixed on the left and right sides of the cover plate. The left slider and the right slider are respectively disposed on the left and right sides of the card holder and slide back and forth on the left and right sides of the card holder.

[0008] In one possible implementation, the cover plate includes a sheath seat side support groove, and the support includes a front sheath seat groove and a rear sheath seat groove;

[0009] The sheath seat side support slot is used to place the sheath seat side support, and the front sheath seat slot and the rear sheath seat slot are used to place the sheath seat body;

[0010] The sheath seat is fixed within the sheath seat fixing mechanism via the sheath seat side support groove, the front sheath seat groove, and the rear sheath seat groove.

[0011] In one possible implementation, the cover plate further includes a limiting boss, and the card holder further includes a limiting boss groove;

[0012] The limiting boss and the limiting boss groove are used to make the cover plate move forward until the sheath seat side support groove, the front sheath seat groove, and the rear sheath seat groove are accurately aligned and then stop moving.

[0013] In one possible implementation, the length of the limiting boss slide groove is at least 1.5 times the sum of the lengths of the front sheath seat groove and the rear sheath seat groove, and the width of the limiting boss slide groove is at least 1.2 times the width of the rear sheath seat groove.

[0014] In one possible implementation, the cover plate further includes a cover plate screw hole, the card seat further includes a left slide groove and a right slide groove, the left slider includes a first slider screw hole, a first slider screw, and a left slide table, and the right slider includes a second slider screw hole, a second slider screw, and a right slide table;

[0015] The first slider screw hole, the second slider screw hole, the first slider screw, the second slider screw, and the cover plate screw hole are used to fix the cover plate, the left slider, and the right slider;

[0016] The left slide and the right slide slide back and forth within the left slide groove and the right slide groove, respectively.

[0017] In one possible implementation, the cover plate further includes a finger push groove for fingers to pinch and move the cover plate when the sheath is inserted and removed.

[0018] Secondly, this application provides a sheath clamping mechanism for an adjustable bending guide sheath, the sheath clamping mechanism including a left clamping block, a right clamping block, a left pressure plate, a right pressure plate and a base, the left clamping block and the right clamping block being used to clamp the sheath;

[0019] The left clamping block is positioned above the base and below the left pressure plate;

[0020] The right clamping block is positioned above the base and below the right pressure plate;

[0021] The base is located below the left pressure plate and the right pressure plate.

[0022] In one possible implementation, the left pressure plate, the right pressure plate, and the base are fixed by base screw holes, pressure plate screw holes, and pressure plate screws.

[0023] In one possible implementation, the left clamping block includes a left front protrusion and a left rear protrusion, and the right clamping block includes a right front protrusion and a right rear protrusion.

[0024] The outer width of the left front protrusion and the right front protrusion is greater than the width of the left pressure plate, the right pressure plate and the base;

[0025] The outer width of the left rear boss and the right rear boss is greater than the width of the left pressure plate, the right pressure plate and the base.

[0026] In one possible implementation, each of the left front boss, the right front boss, the left rear boss, and the right rear boss has a clamping screw hole and a spring on its outer side along the left-right direction.

[0027] In one possible implementation, the left clamping block further includes a left clamping tube groove; the right clamping block further includes a right clamping tube groove;

[0028] The left clamping groove and the right clamping groove form a first aperture, and the width of the first aperture is set to 0.8 times the outer diameter of the sheath.

[0029] In one possible implementation, the left clamping block further includes a left limiting groove, the right clamping block further includes a right limiting groove, and the base includes a left base groove, a right base groove, a left guide boss, a right guide boss, and a base boss.

[0030] The bottom of the left clamping block is placed inside the groove of the left base.

[0031] The bottom of the right clamping block is placed inside the right base groove.

[0032] The left guide boss is placed between the left front boss and the left rear boss;

[0033] The right guide boss is placed between the right front boss and the right rear boss;

[0034] The base boss is placed in the left limiting groove and the right limiting groove, and the width of the base boss is equal to the sum of the widths of the left limiting groove and the right limiting groove.

[0035] In one possible implementation, the base includes a left platform and a right platform;

[0036] The width of the left pressure plate is at least twice the width of the left side platform, the left front protrusion, and the left rear protrusion. The inner edge of the left pressure plate is flush with the inner edge of the left guide protrusion. The height of the left side platform is the same as the height of the left front protrusion and the left rear protrusion.

[0037] The width of the right pressure plate is at least twice the width of the right side platform, the right front protrusion, and the right rear protrusion; the inner edge of the right pressure plate is flush with the inner edge of the right guide protrusion, and the height of the right side platform is the same as the height of the right front protrusion and the right rear protrusion.

[0038] In one possible implementation, the distance between the outer edges of the left clamping block and the right clamping block and the inner edges of the left pressure plate and the right pressure plate is the same in the left-right direction;

[0039] The distance between the outer edges of the left and right clamping blocks and the inner edge of the base is the same.

[0040] In one possible implementation, the distance between the outer edges of the left clamp and the right clamp is at least 10 times the gap between the left clamp and the right clamp when the sheath is clamped.

[0041] Thirdly, embodiments of this application also provide an electronic device, which includes:

[0042] At least one processor;

[0043] and memory that is communicatively connected to at least one processor;

[0044] The memory stores instructions that can be executed by at least one processor to cause the electronic device to perform a method corresponding to any embodiment of the third aspect of the present application.

[0045] In summary, the adjustable bending guide sheath tube, sheath seat, bonding tooling, and usage method provided in this application can solve problems such as low pass rate and time consumption during the bonding process, and improve the pass rate and efficiency of bonding the adjustable bending sheath tube and sheath seat. Attached Figure Description

[0046] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0047] To more clearly illustrate the technical solutions in the embodiments of this disclosure or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0048] Figure 1 This utility model provides an assembly diagram of an adjustable bending sheath tube and sheath seat bonding fixture.

[0049] Figure 2 A schematic diagram of a sheath fixing mechanism component provided by this utility model;

[0050] Figure 3 A schematic diagram of a cover plate structure provided by this utility model;

[0051] Figure 4 A schematic diagram of a left and right slider structure provided by this utility model;

[0052] Figure 5 A schematic diagram of a card holder structure provided by this utility model;

[0053] Figure 6 A schematic diagram of a sheath clamping mechanism component provided by this utility model;

[0054] Figure 7 A schematic diagram of a left and right clamping block structure provided by this utility model;

[0055] Figure 8 A schematic diagram of a base structure provided by this utility model;

[0056] Figure 9 A schematic diagram of a left and right pressure plate structure provided by this utility model;

[0057] Figure 10 A schematic diagram of an adjustable bending sheath tube and sheath seat bonding method provided by this utility model.

[0058] Explanation of reference numerals in the attached figures:

[0059] 1-Sheath seat fixing mechanism; 2-Sheath tube clamping mechanism;

[0060] 3-Cover plate; 4-Left slider; 5-Right slider; 6-Card holder;

[0061] 7-Sheath seat side support groove; 8-Finger push groove; 9-Cover plate screw hole; 10-Limiting boss;

[0062] 11-Slider screw hole; 12-Slider screw; 13-Left slide; 14-Right slide;

[0063] 15-Front sheath seat groove; 16-Rear sheath seat groove; 17-Left slide groove; 18-Right slide groove; 19-Limiting boss slide groove;

[0064] 20-Left clamping block; 21-Right clamping block; 22-Left pressure plate; 23-Right pressure plate; 24-Base;

[0065] 25-Left front boss; 26-Left rear boss; 27-Right front boss; 28-Right rear boss; 29-Clamping block screw hole; 30-Spring; 31-Left clamping tube groove; 32-Right clamping tube groove; 33-Left limiting groove; 34-Right limiting groove;

[0066] 35-Left base groove; 36-Right base groove; 37-Left guide boss; 38-Right guide boss; 39-Base boss; 40-Left side platform; 41-Right side platform; 42-Base screw hole;

[0067] 43 - Pressure plate screw hole; 44 - Pressure plate screw;

[0068] 45-Sheath seat; 46-Side branch; 47-Adjustable bendable sheath; 48-Distal edge; 49-Alignment gap. Detailed Implementation

[0069] In the following description, when referring to the accompanying drawings, the same numbers in different drawings denote the same or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments are merely examples of apparatuses and methods consistent with some aspects of the embodiments of this application as detailed in the appended claims.

[0070] The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described again in some embodiments. The embodiments of this application will now be described with reference to the accompanying drawings.

[0071] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0072] The current bonding process for adjustable bendable sheaths and sheath seats mainly consists of four steps:

[0073] 1) Place the sheath seat in a slot with the side support of the sheath seat facing upwards.

[0074] 2) Align one of the pull lines at the proximal end of the adjustable bending sheath with the side support of the sheath seat, and pinch the sheath with your hand to prevent it from rotating.

[0075] 3) Apply a ring of glue to the part of the sheath tube that needs to be bonded to the sheath seat, and insert the glued part into the part of the sheath seat that needs to be bonded.

[0076] 4) After the sheath tube and sheath seat are fixed with glue, remove the sheath seat from the slot.

[0077] However, the above bonding process has the following three problems:

[0078] 1) The design of the slot is unreasonable. Only half of the height of the sheath seat can be fixed in the slot. When the sheath tube is inserted, it is easy to rotate or move, which causes the alignment of the sheath tube pull line and the side support of the sheath seat to be misaligned, resulting in product scrap.

[0079] 2) The pull wire may have a slight helical displacement in the axial direction due to differences in the manufacturing process. This means that the positions of the proximal and distal pull wires are not exactly in a straight line. The movement of the pull wire is caused by the distal end of the sheath. Therefore, the distal pull wire should be used for alignment during bonding, not the proximal pull wire.

[0080] 3) After the sheath tube pull wire and the sheath seat side support are accurately aligned, the sheath tube is easy to rotate when pinched by hand. The sheath tube position needs to be adjusted many times during bonding, which results in low production efficiency and easy product scrap.

[0081] To address the shortcomings of the existing bonding process for adjustable bend sheaths and sheath seats, a novel bonding fixture design and its application method are proposed to solve the problems of low pass rate and high labor time in the existing bonding process, thereby improving the pass rate and efficiency of bonding adjustable bend sheaths and sheath seats.

[0082] Figure 1 This is a schematic diagram of an assembly for bonding an adjustable bending sheath and sheath seat, as provided by this utility model. Figure 1 The adjustable bending sheath and sheath seat bonding fixture mainly consists of two parts: a sheath seat fixing mechanism 1 and a sheath clamping mechanism 2. The sheath seat fixing mechanism 1 is used to fix and position the sheath seat, while the sheath clamping mechanism 2 is used to clamp and position the adjustable bending sheath. After positioning, the sheath seat and sheath are coaxial within the fixture, and the pull wire inside the sheath and the side support of the sheath seat are on the same straight line. Through the coordinated use of these two mechanisms, the sheath and sheath seat can be accurately aligned and bonded.

[0083] Figure 2 This is a schematic diagram of a sheath fixing mechanism component provided by this utility model. Figure 2In the process, the sheath seat fixing mechanism includes a cover plate 3, a left slider 4, a right slider 5, and a retaining seat 6, and the sheath seat has a side support; wherein, the cover plate 3 is disposed above the retaining seat 6, the left slider 4 and the right slider 5 are respectively fixed on the left and right sides of the cover plate 3, the left slider 4 and the right slider 5 are respectively disposed on the left and right sides of the retaining seat 6, and slide back and forth on the left and right sides of the retaining seat 6.

[0084] Optionally, the cover plate 3, the left slider 4, the right slider 5, and the card holder 6 can be made of polymer materials such as polytetrafluoroethylene or nylon, or other materials. This application embodiment does not limit this.

[0085] Figure 3 A schematic diagram of a cover plate structure provided by this utility model. Figure 3 The components include: sheath seat side support groove 7, finger push groove 8, cover plate screw hole 9, and limiting boss 10.

[0086] Figure 4 This is a schematic diagram of a left and right slider structure provided by this utility model. Figure 4 The components include: slider screw hole 11, slider screw 12, left slide 13 and right slide 14.

[0087] Figure 5 This is a schematic diagram of a card holder structure provided by this utility model. Figure 5 The middle part includes a front sheath seat groove 15, a rear sheath seat groove 16, a left slide groove 17, a right slide groove 18, and a limiting boss slide groove 19.

[0088] The following combination Figures 2 to 5 The sheath fixing mechanism of this utility model is described in detail.

[0089] In one possible implementation, the cover plate 3 includes a sheath seat side support groove 7, and the mounting base 6 includes a front sheath seat groove 15 and a rear sheath seat groove 16; the sheath seat side support groove 7 is used to place the sheath seat side support, and the front sheath seat groove 15 and the rear sheath seat groove 16 are used to place the sheath seat body; the sheath seat is fixed in the sheath seat fixing mechanism by the sheath seat side support groove 7, the front sheath seat groove 15 and the rear sheath seat groove 16.

[0090] In one possible implementation, the cover plate 3 further includes a finger push groove 8, which is used to pinch the cover plate 3 for movement when the sheath is inserted and removed.

[0091] Understandably, the sheath seat side support groove 7 is used for placing the sheath seat side support, and the front sheath seat groove 15 and the rear sheath seat groove 16 are used for placing the sheath seat body. The cooperation of the two allows the sheath seat to be completely wrapped with the side support facing upwards and fixed in the tooling without rotation or shaking. The finger push groove facilitates the movement of the cover plate by the fingers when the sheath seat is put in and taken out.

[0092] In one possible implementation, the cover plate 3 further includes a limiting boss 10, and the card seat 6 further includes a limiting boss groove 19; the limiting boss 10 and the limiting boss groove 19 are used to make the cover plate 3 move forward until the sheath seat side support groove 7 and the front sheath seat groove 15 and the rear sheath seat groove 16 are accurately aligned and then stop moving.

[0093] In one possible implementation, the length of the limiting boss groove 19 is at least 1.5 times the sum of the lengths of the front sheath seat groove 15 and the rear sheath seat groove 16, and the width of the limiting boss groove 19 is at least 1.2 times the width of the rear sheath seat groove 16.

[0094] Understandably, in this embodiment of the application, the length of the limiting boss groove 19 is at least 1.5 times the sum of the lengths of the front sheath seat groove 15 and the rear sheath seat groove 16, so that the cover plate 3 and the left slider 4 and right slider 5 will not fall off due to sliding backward when the sheath seat is installed or removed. The width of the limiting boss groove 19 is at least 1.2 times the width of the rear sheath seat groove 16, so that the sheath seat can be held in place by the limiting boss of the cover plate and not move backward when it is bonded.

[0095] In one possible implementation, the cover plate 3 further includes a cover plate screw hole 9, the card holder 6 further includes a left slide groove 17 and a right slide groove 18, the left slider 4 includes a first slider screw hole, a first slider screw, and a left slide platform 13, and the right slider 5 includes a second slider screw hole 11, a second slider screw 12, and a right slide platform 14. The first slider screw hole, the second slider screw hole 11, the first slider screw, the second slider screw 12, and the screw hole of the cover plate 3 are used to fix the cover plate 3, the left slider 4, and the right slider 5; the left slide platform 13 and the right slide platform 14 slide back and forth in the left slide groove 17 and the right slide groove 18, respectively.

[0096] Understandably, in this embodiment, the first slider screw hole and the first slider screw are structures on the left slider 4 and are not marked in the figures. The second slider screw hole and the second slider screw are structures on the right slider 5, and the second slider screw hole is... Figure 4 Number 11, the second slider screw is Figure 4 Number 12.

[0097] Understandably, in this embodiment, the cover plate 3 and the left slider 4 and right slider 5 are fixed together by at least four sets of cover plate screw holes 9, slider screw holes 11 and slider screws 12. The left slide 13 and right slide 14 slide back and forth in the left slide groove 17 and right slide groove 18 respectively, thereby driving the cover plate 3 to move back and forth above the card seat. The size matching of the limiting boss 10 and the limiting boss slide groove 19 ensures that the cover plate 3 moves forward until the sheath seat side support slot 7 and the front sheath seat slot 15 and the rear sheath seat slot 16 are accurately aligned and then stops moving. At the same time, it ensures that when the adjustable bent sheath tube is inserted into the sheath seat for bonding, the sheath seat will not move backward due to force.

[0098] Figure 6 This is a schematic diagram of a sheath clamping mechanism component provided by this utility model. Figure 6 In this device, the sheath clamping mechanism includes a left clamping block 20, a right clamping block 21, a left pressure plate 22, a right pressure plate 23, and a base 24. The left and right clamping blocks are used to clamp the sheath. The left clamping block 20 is located above the base 24 and below the left pressure plate 22. The right clamping block 21 is located above the base 24 and below the right pressure plate 23. The base 24 is located below the left pressure plate 22 and the right pressure plate 23.

[0099] Figure 7 This is a schematic diagram of a left and right clamping block structure provided by this utility model. Figure 7 The components include: a left front boss 25, a left rear boss 26, a right front boss 27, a right rear boss 28, a clamping block screw hole 29, a spring 30, a left clamping tube groove 31, a right clamping tube groove 32, a left limiting groove 33, and a right limiting groove 34.

[0100] Figure 8 This is a schematic diagram of a base structure provided by this utility model. Figure 8 The middle part includes a left base groove 35, a right base groove 36, a left guide boss 37, a right guide boss 38, a base boss 39, a left side platform 40, a right side platform 41, and a base screw hole 42.

[0101] Figure 9 This is a schematic diagram of a left and right pressure plate structure provided by this utility model. Figure 9 The middle part includes a pressure plate screw hole 43 and a pressure plate screw 44.

[0102] The following combination Figures 6 to 9 The components of the sheath clamping mechanism of this utility model are described in detail.

[0103] In one possible implementation, the left pressure plate 22, the right pressure plate 23, and the base 24 are fixed by base screw holes 42, pressure plate screw holes 43, and pressure plate screws 44.

[0104] In one possible implementation, the left clamping block 20 includes a left front protrusion 25 and a left rear protrusion 26, and the right clamping block 21 includes a right front protrusion 27 and a right rear protrusion 28; the outer width of the left front protrusion 25 and the right front protrusion 27 is greater than the width of the left pressure plate 22, the right pressure plate 23 and the base 24; the outer width of the left rear protrusion 26 and the right rear protrusion 28 is greater than the width of the left pressure plate 22, the right pressure plate 23 and the base 24.

[0105] In one possible implementation, the left front boss 25, the right front boss 27, the left rear boss 26, and the right rear boss 28 are each provided with a clamping block screw hole 29 and a spring 30 on their outer sides in the left-right direction.

[0106] Understandably, in the embodiments of this application, the left front boss 25, the left rear boss 26, the right front boss 27 and the right rear boss 28 are each provided with a clamping block screw hole 29 and a spring 30 on their outer sides in the left and right directions, so that the left slider 4 and the right slider 5 slide open by spring compression when the sheath is inserted and removed, and when the sheath is clamped after being aligned, it is clamped by spring rebound and does not move back and forth or rotate left and right.

[0107] In one possible implementation, the left clamping block 20 further includes a left clamping tube groove 31; the right clamping block 21 further includes a right clamping tube groove 32; the left clamping tube groove 31 and the right clamping tube groove 32 form a first aperture, the size of which is set to 0.8 times the outer diameter of the sheath tube.

[0108] Understandably, in this embodiment, the frontal periphery width of the left front protrusion 26 and the right front protrusion 27, and the rearal periphery width of the left rear protrusion 26 and the right rear protrusion 28 are all greater than the left pressure plate 22, the right pressure plate 23, and the base 24, so that it is easier to apply force when the fingers pinch the left clamping block 20 and the right clamping block 21 and move them in the left and right directions respectively. The sheath has a pull wire inside, and the width of the gap (first aperture) formed by the left clamping groove 31 and the right clamping groove 32 is about 0.8 times the outer diameter of the adjustable bending sheath. When the sheath 47 is clamped, there is a gap with a width of at least 1 mm between the left and right clamping blocks. The width of this gap is at least twice the width of the pull wire inside the sheath, so that the pull wire inside the sheath can be observed from above during bonding, and its alignment can be made accurate by adjustment, that is, the pull wire is located in the middle of the gap.

[0109] In one possible implementation, the left clamping block 20 further includes a left limiting groove 33, the right clamping block 21 further includes a right limiting groove 34, and the base 24 includes a left base groove 35, a right base groove 36, a left guide straight boss 37, a right guide straight boss 38, and a base boss 39.

[0110] The bottom of the left clamping block 20 is placed inside the left base groove 35.

[0111] The bottom of the right clamping block 21 is placed inside the right base groove 36.

[0112] The left guide boss 37 is placed between the left front boss 25 and the left rear boss 26;

[0113] The right guide boss 38 is placed between the right front boss 27 and the right rear boss 28;

[0114] The base boss 39 is placed within the left limiting groove 33 and the right limiting groove 34, and the width of the base boss 39 is equal to the sum of the widths within the left limiting groove 33 and the right limiting groove 34. Alternatively, the width of the base boss 39 is approximately equal to the sum of the widths within the left limiting groove 33 and the right limiting groove 34.

[0115] Understandably, in this embodiment, when the clamping block 20, the right clamping block 21, and the base 24 are assembled, the bottom of the left clamping block 20 is placed in the left base groove 35, the bottom of the right clamping block 21 is placed in the right base groove 36, the left guide boss 37 is placed between the left front boss 25 and the left rear boss 26, the right guide boss 38 is placed between the right front boss 25 and the right rear boss 26, and the base boss 39 is placed in the left limiting groove 33 and the right limiting groove 34. The width of the base boss 39 is the same as the sum of the widths of the left limiting groove 33 and the right limiting groove 34, so that the left clamping block 20 and the right clamping block 21 can be completely closed in the unclamped state, so as to precisely control the width of the gap generated when clamping the sheath.

[0116] In one possible implementation, the base 24 includes a left platform 40 and a right platform 41; the width of the left pressure plate 22 is at least twice the width of the left platform 40, the left front protrusion 25, and the left rear protrusion 26; the inner edge of the left pressure plate 22 is flush with the inner edge of the left guide protrusion 37; the height of the left platform 40 is the same as the height of the left front protrusion 25 and the left rear protrusion 26; the width of the right pressure plate 23 is at least twice the width of the right platform 41, the right front protrusion 27, and the right rear protrusion 28; the inner edge of the right pressure plate 23 is flush with the inner edge of the right guide protrusion 38; the height of the right platform 41 is the same as the height of the right front protrusion 27 and the right rear protrusion 28.

[0117] In one possible implementation, the distance between the outer edges of the left clamping block 20 and the right clamping block 21 and the inner edges of the left pressure plate 22 and the right pressure plate 23 is the same in the left-right direction.

[0118] The distance between the outer edges of the left clamping block 20 and the right clamping block 21 and the inner edge of the base 24 is the same.

[0119] In one possible implementation, the distance between the outer edges of the left clamp 20 and the right clamp 21 is at least 10 times the gap between the left clamp 20 and the right clamp 21 when the sheath is clamped.

[0120] Understandably, in this embodiment, the left pressure plate 22, the right pressure plate 23, and the base 24 are fixed together by at least four sets of base screw holes, pressure plate screw holes, and pressure plate screws. The widths of the left pressure plate 22 and the right pressure plate 23 are at least twice the widths of the left platform 40, the right platform 41, the left front protrusion 25, the left rear protrusion 26, the right front protrusion 27, and the right rear protrusion 28, respectively. Their inner edges are flush with the inner edges of the left guide protrusion 37 and the right guide protrusion 38. The heights of the left platform 40 and the right platform 41 are the same as the heights of the left front protrusion 25, the left rear protrusion 26, the right front protrusion 27, and the right rear protrusion. In the left-right direction, the distance between the outer edges of the left clamping block 20 and the right clamping block 21 and the inner edges of the left pressure plate 22 and the right pressure plate 23, as well as the distance between them and the inner edges of the base 24, are the same, and are at least 10 times the gap between the left clamping block 20 and the right clamping block 21 when the sheath is clamped. By controlling the position and size as described above, the movement range of the left clamping block 20 and the right clamping block 21 is limited and guided within the specified area, so that they will not get stuck due to deviation during movement, which would lead to the sheath not being clamped tightly or being unable to be released.

[0121] Figure 10 A schematic diagram illustrating a bonding method for an adjustable bending sheath and sheath seat provided in this application. Figure 10 The sheath comprises several parts, including a sheath seat 45, side supports 46, an adjustable curved sheath tube 47, a distal edge 48, and an alignment slit 49. The sheath seat has side supports, and the adjustable curved sheath tube includes a pull wire. The specific method is as follows:

[0122] Step 1. Place the sheath seat 45 in the front sheath seat groove 15 and the rear sheath seat groove 16 of the card seat, so that the side support 46 of the sheath seat faces upward. Slide the fixing parts of the cover plate 3 and the left slider 4 and the right slider 5 forward until they can no longer move, that is, the limiting boss 10 of the cover plate 3 is completely located in the limiting boss groove 19 of the card seat 6, and the side support 46 is completely located in the sheath seat side support groove 7 of the cover plate 3.

[0123] Step 2. Hold the left front boss 25 and the left rear boss 26 or the right front boss 27 and the right rear boss 28 with your hands and apply horizontal force to the left or right, so that the left clamping block 20 slides to the left between the left pressure plate 22 and the left base groove 35, or the right clamping block 21 slides to the right between the right pressure plate 23 and the right base groove 36.

[0124] Step 3. Place the adjustable curved sheath 47 into the left clamping groove 31 and the right clamping groove 32. The distal edge 48 of the sheath should be no more than 20mm away from the front edge of the left clamping block 20 and the right clamping block 21. Release the sheath so that the left clamping groove 31 and the right clamping groove 32 clamp the sheath under the spring action, leaving an alignment gap 49 of at least 1mm. Rotate the sheath with a little force so that one of its distal pull lines is in the middle of the alignment gap.

[0125] Step 4. After the sheath tube 47 and sheath seat 45 are placed into the corresponding tooling and aligned, they will no longer shift within the tooling and their central axes will be on the same straight line. Apply adhesive to the bonding area of ​​the sheath tube 47, move the sheath tube clamping mechanism 2 and the sheath tube horizontally to the appropriate position, and insert the adhesive-coated area into the bonding area of ​​the sheath seat.

[0126] Step 5. After the sheath tube 47 and sheath seat 45 are bonded together, confirm again that the pull line of the sheath tube 47 is in the middle of the alignment gap. Then repeat step 2 and use your hands to slide the left clamp 20 and right clamp 21 apart, and remove the sheath tube 47 horizontally.

[0127] Step 6. Slide the cover plate 3 and the fixing parts of the left slider 4 and right slider 5 backward until the sheath seat is fully exposed, and remove the sheath seat 45.

[0128] The adjustable-bend guide sheath provided in this application, comprising a sheath tube and a sheath seat, is applicable to atrial fibrillation ablation treatment. This sheath assists diagnostic mapping catheters and therapeutic ablation catheters in reaching various locations within the cardiac chambers. After assembling and bonding the sheath tube and sheath seat using this tooling, the distal end and collateral branches of the sheath exhibit good planarity. During mapping and ablation, the bending direction and angle of the distal end of the sheath can be determined by the orientation of the lateral collateral branches and X-ray images, guiding the catheter to reach the desired location more quickly and accurately, thus improving the success rate and efficiency of the procedure.

[0129] The adjustable-bend guiding sheath provided in this application, including a sheath tube and a sheath seat, can also be applied to the field of left atrial appendage occlusion in atrial fibrillation. This sheath is used to deliver the left atrial appendage occlusion device to the desired treatment site. After assembling and bonding the sheath tube and sheath seat using this tooling, the distal end of the sheath and its collateral branches have good coplanarity. The operator can determine the bending direction and angle of the distal end of the sheath tube based on the orientation of the lateral branches and X-ray images, allowing for smoother passage through the interatrial septum to the left atrial appendage orifice. The sheath orifice can then be adjusted to a suitable position to complete the delivery and placement of the occlusion device.

[0130] The mechanism components described in this application significantly improve the product qualification rate, effectively ensuring the alignment accuracy of the adjustable bending sheath and sheath seat bonding, and minimizing potential failure risks. The positions of the adjustable bending sheath and sheath seat after alignment can be fixed using tooling, preventing misalignment during bonding after a single adjustment, eliminating the need for multiple adjustments and confirmations, and reducing average working time by 25%. The new tooling is simple to operate, highly acceptable to employees, and requires a short training period, minimizing the impact of the turnover of new and experienced employees on the adjustable bending sheath and sheath seat bonding process.

[0131] In the several embodiments provided in this application, it should be understood that the disclosed apparatus and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of modules is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple modules or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between apparatuses or modules may be electrical, mechanical, or other forms.

[0132] Other embodiments of this application will readily occur to those skilled in the art upon consideration of the specification and practice of the disclosure herein. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not disclosed herein. The specification and examples are to be considered exemplary only, and the true scope of this application is indicated by the claims.

[0133] It should be understood that this application is not limited to the precise structure described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope.

Claims

1. A sheath hub fixation mechanism for an adjustable bend guide sheath, the sheath hub fixation mechanism comprising: The sheath seat fixing mechanism comprises a cover plate, a left sliding block, a right sliding block and a clamping seat, and the sheath seat has side branches; The cover plate is arranged above the clamping seat, the left and right sliding blocks are fixed on the left and right sides of the cover plate respectively, and the left and right sliding blocks are arranged on the left and right sides of the clamping seat and slide forward and backward on the left and right sides of the clamping seat respectively.

2. The hub fixation mechanism of claim 1, wherein The cover plate comprises sheath seat side branch clamping grooves, and the clamping seat comprises front and rear sheath seat clamping grooves; The sheath seat side branch clamping grooves are used for placing the sheath seat side branches, and the front and rear sheath seat clamping grooves are used for placing the sheath seat main body; The sheath seat is fixed in the sheath seat fixing mechanism through the sheath seat side branch clamping grooves, the front and rear sheath seat clamping grooves.

3. The hub fixation mechanism of claim 2, wherein, The cover plate further comprises a limiting convex platform, and the clamping seat further comprises a limiting convex platform sliding groove; The limiting convex platform and the limiting convex platform sliding groove are used for stopping the movement of the cover plate when the cover plate moves forward to the sheath seat side branch clamping grooves and the front and rear sheath seat clamping grooves and the alignment is accurate.

4. The hub fixation mechanism of claim 3, wherein The length of the limiting convex platform sliding groove is at least 1.5 times the sum of the lengths of the front and rear sheath seat clamping grooves, and the width of the limiting convex platform sliding groove is at least 1.2 times the width of the rear sheath seat clamping groove.

5. The hub fixation mechanism of any of claims 1-4, wherein, The cover plate further comprises a cover plate screw hole, the clamping seat further comprises a left sliding groove and a right sliding groove, the left sliding block comprises a first sliding block screw hole, a first sliding block screw and a left sliding platform, and the right sliding block comprises a second sliding block screw hole, a second sliding block screw and a right sliding platform; The first sliding block screw hole, the second sliding block screw hole, the first sliding block screw, the second sliding block screw and the cover plate screw hole are used for fixing the cover plate, the left sliding block and the right sliding block; The left sliding platform and the right sliding platform slide forward and backward in the left sliding groove and the right sliding groove respectively.

6. The hub fixation mechanism of any of claims 1-4, wherein, The cover plate further comprises a finger pushing groove, which is used for pinching the cover plate with fingers when the sheath seat is put in and taken out.

7. A sheath tube clamping mechanism of an adjustable bend guide sheath, characterized by, The sheath tube clamping mechanism comprises a left clamping block, a right clamping block, a left pressing plate, a right pressing plate and a base, and the left and right clamping blocks are used for clamping the sheath tube; The left clamping block is arranged above the base and below the left pressing plate; The right clamping block is arranged above the base and below the right pressing plate; The base is arranged below the left and right pressing plates.

8. The clamping mechanism of claim 7, wherein, The left and right pressing plates and the base are fixed through a base screw hole, a pressing plate screw hole and a pressing plate screw.

9. The clamping mechanism of claim 7, wherein, The left clamping block comprises a left front convex platform and a left rear convex platform, and the right clamping block comprises a right front convex platform and a right rear convex platform; The peripheral width of the left front convex platform and the right front convex platform is greater than the width of the left and right pressing plates and the base; The peripheral width of the left rear convex platform and the right rear convex platform is greater than the width of the left and right pressing plates and the base.

10. The clamping mechanism of claim 9, wherein, The left front convex platform, the right front convex platform, the left rear convex platform and the right rear convex platform are respectively provided with a clamping block screw hole and a spring on the outer side in the left-right direction.

11. The clamping mechanism of claim 9, wherein, The left clamping block further comprises a left clamping tube groove, and the right clamping block further comprises a right clamping tube groove; The left clamping tube groove and the right clamping tube groove form a first aperture, and the width of the first aperture is set to 0.8 times the outer diameter of the sheath tube.

12. The clamping mechanism of claim 11, wherein, The left clamp block further comprises a left limiting slot, the right clamp block further comprises a right limiting slot, and the base comprises a left base slot, a right base slot, a left straight guiding boss, a right straight guiding boss, and a base boss; The bottom of the left clamp block is placed in the left base slot, The bottom of the right clamp block is placed in the right base slot, The left straight guiding boss is placed between the left front boss and the left rear boss; The right straight guiding boss is placed between the right front boss and the right rear boss; The base boss is placed in the left limiting slot and the right limiting slot, and the width of the base boss is equal to the sum of the widths of the left limiting slot and the right limiting slot.

13. The clamping mechanism of claim 12, wherein, The base comprises a left side platform and a right side platform; The width of the left pressing plate is at least 2 times the width of the left side platform, the left front boss, and the left rear boss, the inner side edge of the left pressing plate is flush with the inner side edge of the left straight guiding boss, and the height of the left side platform is the same as the height of the left front boss and the left rear boss; The width of the right pressing plate is at least 2 times the width of the right side platform, the right front boss, and the right rear boss, the inner side edge of the right pressing plate is flush with the inner side edge of the right straight guiding boss, and the height of the right side platform is the same as the height of the right front boss and the right rear boss.

14. The clamping mechanism according to any one of claims 7-13, characterized in that In the left-right direction, the distance between the outer side edges of the left clamp block and the right clamp block and the inner side edges of the left pressing plate and the right pressing plate is the same; The distance between the outer side edges of the left clamp block and the right clamp block and the inner side edge of the base is the same.

15. The clamping mechanism of claim 14, wherein, The distance between the outer side edges of the left clamp block and the right clamp block is at least 10 times the gap between the left clamp block and the right clamp block when the sheath is clamped.

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