A sheath tube capable of multi-directional bending and a transcatheter intervention system

Abstract

The present application relates to a sheath tube capable of multi-directional bending and a transcatheter intervention system. The sheath tube capable of multi-directional bending includes: a main body section; a bending section connected to the distal end of the main body section. The bending section is a multi-layer composite tube body and includes a plurality of segments. The middle layer of the multi-layer composite tube body is a braided mesh, and the density of the braided mesh of the plurality of segments gradually decreases along the direction from the proximal end to the distal end; at least a pair of traction mechanisms, each pair of the traction mechanisms sequentially passes through the bending section and the main body section to adjust the bending angle of the bending section in different directions. In the present application, the density of the braided mesh at the distal end of the bending section is set to be the smallest, so that by only controlling the traction mechanism with a relatively small acting force, the distal end of the sheath tube can be quickly adjusted to the bending angle adapted to the delivery path, thereby effectively improving the bending performance of the bending section.

Description

Technical Field

[0001] This application belongs to the technical field of medical devices. Specifically, it relates to a sheath tube that can be bent in multiple directions and a transcatheter intervention system. Background Art

[0002] The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart. A normal and healthy mitral valve can control the blood flow from the left atrium to the left ventricle, while preventing the blood from flowing from the left ventricle to the left atrium. The mitral valve includes a pair of valve leaflets, called the anterior leaflet and the posterior leaflet. When the edges of the anterior leaflet and the posterior leaflet are aligned, the mitral valve can be completely closed, preventing the blood from flowing from the left ventricle to the left atrium. When there are organic or functional changes in the valve leaflets or their related structures of the mitral valve, the anterior leaflet and the posterior leaflet of the mitral valve do not align well. Thus, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, resulting in blood reflux from the left ventricle to the left atrium, thereby causing a series of pathophysiological changes, known as "mitral regurgitation". The same applies to tricuspid regurgitation.

[0003] The transcatheter valve intervention technology refers to delivering various valve repair devices to the mitral valve or the tricuspid valve through a catheter with a smaller diameter, and repairing the diseased mitral valve or tricuspid valve through remote operation outside the patient's body, thereby treating mitral regurgitation or tricuspid regurgitation.

[0004] Taking transcatheter mitral valve intervention as an example, the commonly used delivery path is: through the femoral vein, the right atrium, the atrial septum, and the left atrium, and finally reaching the mitral valve. Due to the long delivery path and multiple bends, the distal end of the existing sheath tube cannot be quickly adjusted to adapt to the bending angle of the delivery path or the treatment site, ultimately resulting in an extended operation time and increased surgical difficulty. Summary of the Invention

[0005] The purpose of this application is to provide a sheath tube that can be bent in multiple directions and a transcatheter intervention system to solve the technical problem that the distal end of the existing sheath tube cannot be quickly adjusted to adapt to the bending angle of the delivery path.

[0006] To achieve the above purpose, the first aspect of this application provides a sheath tube that can be bent in multiple directions, including:

[0007] A main body section;

[0008] A bending section, connected to the distal end of the main body section. The bending section is a multi-layer composite tube body and includes multiple segments. The middle layer of the multi-layer composite tube body is a braided mesh, and the density of the braided mesh of the multiple segments gradually decreases along the direction from the proximal end to the distal end;

[0009] At least one pair of traction mechanisms, each pair of the traction mechanisms sequentially passes through the bending section and the main body section to adjust the bending angle of the bending section in different directions.

[0010] To achieve the above object, a second aspect of the present application provides a transcatheter intervention system, including a guiding sheath and a sheath tube that can be bent in multiple directions as described in any one of the foregoing. The guiding sheath is a pre-shaped catheter or an adjustable catheter. A bending adjustment handle is further provided at the proximal end of the sheath tube that can be bent in multiple directions. A bending adjustment mechanism is provided on the bending adjustment handle. The proximal end of the traction wire of the sheath tube that can be bent in multiple directions is fixed to the bending adjustment mechanism. The sheath tube that can be bent in multiple directions is movably disposed in the guiding sheath, and the distal end of the sheath tube that can be bent in multiple directions extends out from the distal end of the guiding sheath.

[0011] Compared with the prior art, the present application has at least the following beneficial effects:

[0012] The present application provides a sheath tube that can be bent in multiple directions and a transcatheter intervention system. The sheath tube that can be bent in multiple directions includes: a main body section; a bending section connected to the distal end of the main body section. The bending section is a multi-layer composite tube body and includes multiple segments. The middle layer of the multi-layer composite tube body is a braided mesh, and the density of the braided mesh of the multiple segments gradually decreases along the direction from the proximal end to the distal end; at least a pair of traction mechanisms, each pair of the traction mechanisms sequentially passes through the bending section and the main body section to adjust the bending angle of the bending section in different directions. In the present application, the density of the braided mesh at the distal end of the bending section is set to be the smallest, so as to realize that only by applying a relatively small acting force to control the traction mechanism, the bending angle of the distal end of the sheath tube can be quickly adjusted to adapt to the conveying path or the treatment site, thereby effectively improving the bending performance of the bending section. And the density of the braided mesh at the proximal end of the bending section is set to be the largest, which can ensure that the proximal end of the bending section is not easily bent, thus providing a stable supporting effect for the conveying and bending of the sheath tube. Description of the Drawings

[0013] The drawings herein are incorporated into the specification and constitute a part of this specification, showing embodiments in line with the present application, and are used together with the specification to explain the principles of the present application.

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, without creative efforts, other drawings can also be obtained according to these drawings.

[0015] Figure 1 It is a schematic structural diagram of the sheath tube in Embodiment 1.

[0016] Figure 2 It is a schematic structural diagram of the bending section in Embodiment 1.

[0017] Figure 3 It is a schematic structural diagram of the cooperation between the traction wire and the braided mesh in Embodiment 1.

[0018] Figure 4 Schematic diagram of the structure of the reinforcing wire and the traction wire in Embodiment 1.

[0019] Figure 5 Comparison diagram of the winding pitch of the reinforcing wire and the distance between two adjacent metal wires in the braided net in Embodiment 1.

[0020] Figure 6 Schematic diagram of the structure of the traction wire and the braided net in Embodiment 2.

[0021] Figure 7 Schematic diagram of the structure of the sheath tube in Embodiment 3.

[0022] Figure 8 Schematic diagram of the structure of the bending adjustment section in Embodiment 3.

[0023] Figure 9 Usage state diagram of the sheath tube in cooperation with the atrial septum and the mitral valve respectively in Embodiment 3.

[0024] Figure 10 Usage state diagram after the bending adjustment section is bent towards the M direction in Embodiment 3.

[0025] Figure 11 Usage state diagram after the bending adjustment section is bent towards the A direction in Embodiment 3.

[0026] Figure 12 Usage state diagram after the bending adjustment section is bent towards the P direction in Embodiment 3.

[0027] Figure 13 Schematic diagram of the structure of the sheath tube in Embodiment 4. Detailed implementation manners

[0028] To make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are some but not all of the embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative efforts shall fall within the scope of protection of the present application.

[0029] It should be understood that the orientation or positional relationship indicated by "front", "rear", "upper", "lower", "left", "right", "longitudinal", "transverse", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. is based on the orientation or positional relationship shown in the drawings and is a specific orientation structure and operation, only for the convenience of describing the technical solution, rather than indicating that the device or element referred to must have a specific orientation. Therefore, it should not be construed as a limitation to the present application.

[0030] It should also be noted that, unless otherwise clearly specified and limited, terms such as "installation", "connection", "attachment", "fixation", "setting" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be directly connected, or indirectly connected through an intermediate medium, and can be the communication inside two components or the interaction relationship between two components. When a component is referred to as "on" or "under" another component, the component can be "directly" or "indirectly" located above the other component, or there may also be one or more intermediate components. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0031] In the description of this application, it should still be noted that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component far from the operator; the axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction around the axial direction.

[0032] Embodiment 1

[0033] Refer to Figures 1 - 5 , this application provides a sheath tube that can be bent in multiple directions, which is used to provide a delivery channel for interventional medical devices.

[0034] The sheath tube that can be bent in multiple directions in Embodiment 1 includes a main body section 11000 and a bending section 12000. The proximal end of the main body section 11000 is connected to a bending handle and is used to support the sheath tube 10000; the bending section 12000 is connected to the distal end of the main body section 11000. The bending section 12000 is a multi-layer composite tube body, and the multi-layer composite tube body specifically includes: an inner layer 12030, an intermediate layer 12010, and an outer layer 12020 that are sequentially sleeved and welded together from the inside to the outside. During manufacturing, first place the inner layer 12030 on a lining rod, and then sequentially sleeve the intermediate layer 12010 and the outer layer 12020. Finally, melt the outer layer 12020 to make it fully integrated with the inner layer 12030 and the intermediate layer 12010 to form a whole. Among them, the inner layer 12030 is set as a polytetrafluoroethylene film to ensure that its inner wall is smooth and beneficial to the passing of medical devices such as guide wires or valve repair devices.

[0035] As Figure 2 shown, the intermediate layer 12010 is a spring tube or a braided net made of a metal material, preferably a braided net. Exemplarily, the braided net can be formed by braiding, winding, etc. with round or flat metal wires such as stainless steel wires or tungsten wires. Among them, the wire diameter range of the metal wire is 0.03 - 0.30 mm. In this embodiment, the intermediate layer 12010 is a braided net woven from flat stainless steel wires with a size of 0.05 × 0.15 mm.

[0036] Refer to Figure 2 Figure 2 , the bending section 12000 includes a plurality of segments, and the density of the braided mesh of the plurality of segments gradually decreases along the proximal to distal direction. Specifically, the braided mesh sequentially includes a first braided mesh 12011, a second braided mesh 12012, and a third braided mesh 12013 along the proximal to distal direction. Preferably, the density range of the first braided mesh 12011 is 45 PPI to 60 PPI, the density range of the second braided mesh 12012 is 35 PPI to 45 PPI, and the density range of the third braided mesh 12013 is 20 PPI to 35 PPI, so that the sheath 10000 can not only meet the proximal support function, but also does not affect the bending function of the distal end of the sheath, reduces the force value required for bending while ensuring the support, and effectively ensures the safety of the instrument.

[0037]

[0037] The bending section 12000 further includes at least a pair of traction mechanisms 13000. Each pair of traction mechanisms 13000 sequentially passes through the bending section 12000 and the main body section 11000 respectively to adjust the bending angle of the bending section 12000 in different directions. Preferably, a plurality of pairs of traction mechanisms 13000 are provided, and each pair of traction mechanisms 13000 corresponds to adjusting the bending angle of the bending section 12000 in one direction, and so on. Among them, the specific number of pairs of traction mechanisms 13000 can be increased or decreased according to needs. Theoretically, the more pairs of traction mechanisms 13000, the more bending angles of the bending section 12000. Refer to Figure 3 Figure 3 , in this embodiment, the traction mechanism 13000 is provided with four pairs, and the four pairs of traction mechanisms 13000 are equally spaced and distributed circumferentially on the bending section 12000 to achieve adjusting the bending angles of the bending section 12000 in at least four directions.

[0038] The braided mesh density at the distal end of the bending section 12000 is small, and the braided mesh density at the proximal end is large, so as to effectively improve the bending performance of the bending section 12000 by controlling the traction mechanism 13000 with only a small acting force, and then realize quickly adjusting the distal end of the sheath 10000 to the bending angle adapted to the delivery path or the treatment site, so as to deliver the distal end of the sheath 10000 near the mitral valve 20000, while ensuring that the proximal end of the bending section 12000 is not easily bent, thereby providing a stable supporting effect for the delivery and bending of the sheath 10000.

[0039] In order to further facilitate the deformation of the bending section 12000 to achieve rapid bending, refer to Figure 1, the outer layer 12020 of the bending adjustment section 12000 is made of an elastomer, and the hardness of the elastomers of multiple segments gradually decreases along the proximal to distal direction, so as to ensure that the proximal end of the bending adjustment section 12000 further provides a stable supporting effect for the delivery and bending adjustment of the sheath tube 10000, and the bending performance of the distal end of the bending adjustment section 12000 is further effectively improved. Preferably, the outer layer 12020 is made of a thermoplastic, and this thermoplastic can be composed of nylon, polyamide, block polyamide, polyurethane, etc. alone, or can be composed of copolymers of these thermoplastics. The hardness range of the elastomer of the outer layer of the first braided mesh is 30 - 50D, the hardness range of the elastomer of the outer layer of the second braided mesh is 50 - 65D, and the hardness range of the elastomer of the outer layer of the third braided mesh is 65 - 80D. In this embodiment, the hardness of the elastomer of the outer layer 12020 sleeved outside the first braided mesh 12011 is 35D, the hardness of the elastomer of the outer layer 12020 sleeved outside the second braided mesh 12012 is 55D, and the hardness of the elastomer of the outer layer 12020 sleeved outside the third braided mesh 12013 is 72D.

[0040] Refer to Figure 3 , the traction mechanism 13000 includes: an anchoring ring 13100 and a traction wire 13200. The anchoring ring 13100 is sleeved on the distal end of the braided mesh. The distal end of the traction wire 13200 is connected to the anchoring ring 13100. The proximal end of the traction wire 13200 extends along the axial direction of the braided mesh until it is connected to the bending adjustment mechanism on the bending adjustment handle, so that when the operator pulls the bending adjustment mechanism at the proximal end, the bending adjustment section 12000 connected to the anchoring ring 13100 can be driven to bend in the traction direction. Specifically, at least a pair of wire passing holes 13300 axially penetrate through the distal end face of the anchoring ring 13100. Preferably, the number of wire passing holes 13300 corresponds to the number of traction wires 13200 one by one.

[0041] After the traction wire 13200 is folded in half, each end correspondingly passes through the wire passing hole 13300 and extends along the axial direction of the braided mesh. Among them, the anchoring ring 13100 can be made of a metal or alloy tube such as stainless steel, tungsten, platinum-iridium with a thickness of 0.15 - 1.00 mm. The wire passing hole 13300 can be set in circular, square, polygonal and other special-shaped shapes. The traction wire 13200 can be a circular or flat metal wire with a diameter of about 0.05 - 0.40 mm. Preferably, stainless steel wire or tungsten wire is used. The form of the traction wire 13200 can be a single metal wire or a multi-strand wire formed by winding multiple metal wires. In this embodiment, the traction wire 13200 is a multi-strand wire formed by winding multiple stainless steel wires.

[0042] Specifically, refer to Figure 3, each pair of wire threading holes 13300 includes at least two adjacent wire threading holes 13300. The traction wire 13200 is in a U shape, which includes a first section and a second section with parallel axes, and a bent section connected between the first section and the second section. The first section and the second section of each traction wire 13200 are respectively distributed parallel to the side wall of the braided mesh, and the bent section passes through a pair of wire threading holes 13300 on the distal end face of the anchoring ring 13100 and spans across the connection between two adjacent wire threading holes 13300. Due to the relatively large force-bearing area during pulling, this connection method avoids stress concentration and can ensure the connection strength and stability. Each group of traction wires 13200 is respectively connected to a corresponding pair of wire threading holes 13300, and they are distributed on the side of the braided mesh. Preferably, four groups of adjacent traction wires 13200 are used in this embodiment.

[0043] Of course, the connection method between the traction wire 13200 and the anchoring ring 13100 can also adopt the following methods: the traction wire 13200 is folded in half, bypasses the wire threading hole 13300 of the anchoring ring 13100, and then winds back to the anchoring ring 13100 in the reverse direction; or the traction wire 13200 passes through the wire threading hole 13300 to connect the anchoring ring 13100.

[0044] To ensure the consistency between the bending direction of the bending section 12000 and the acting force direction, preferably, the main body section 11000 is a multi-chamber tube. Specifically, the multi-chamber tube is made of a high-hardness polymer material. Exemplarily, the multi-chamber tube can be directly extruded from materials such as nylon, block polyether amide, and polycarbonate, or can be formed by a hot melting method. The holes of the multi-chamber tube correspond to the positions of the wire threading holes 13300. Specifically, the first section and the second section of each traction wire 13200 pass through the anchoring ring 13100 and then respectively penetrate into the holes of the multi-chamber tube, so that the first section and the second section extend parallel to the tube wall of the braided mesh to the proximal end of the main body section 11000, thereby ensuring that the acting force received at the proximal end of the main body section 11000 can all act on the anchoring ring 13100, and finally ensuring that the bending direction of the bending section 12000 is consistent with the direction of the acting force.

[0045] Refer to Figure 3 and Figure 4The proximal end of the traction wire 13200 is embedded in the outer wall surface of the braided mesh, and the outer surface of the traction wire 13200 is wound with a reinforcing wire 13400, and the outer wall surface of the reinforcing wire 13400 is fixedly connected to the elastic body. Preferably, the reinforcing wire 13400 and the elastic body are hot-melted and fastened into one body to form a movement channel for the traction wire 13200. Therefore, after the traction wire 13200 is subjected to a pulling force, the pulling force on the traction wire 13200 is applied to the reinforcing wire 13400, and since the reinforcing wire 13400 is fixedly connected to the elastic body, it is ensured that the surrounding reinforcing wire 13400 and the elastic body will not separate, thereby effectively avoiding the failure of the device, and at the same time, under the supporting force of the braided mesh, even after the bending angle of the sheath tube 10000 exceeds 90 degrees, the traction wire 13200 can still comply with the bending without bending. Among them, the reinforcing wire 13400 is usually made of metal wire, and stainless steel wire or tungsten wire is used as an example. In this embodiment, stainless steel wire is preferred. It is understandable that in other embodiments, the first and second sections of the traction wire 13200 may be surrounded by other tubing that can provide an inner cavity channel and can adapt to bending without bending, such as a tubing made of polytetrafluoroethylene or polyurethane elastomer.

[0046] See also Figure 5 The wire diameter of the reinforcing wire 13400 is equal to the wire diameter of the metal wire used to make the braided mesh, and the winding pitch of the reinforcing wire 13400 is greater than the spacing between two adjacent metal wires in the braided mesh. The design of this embodiment can effectively prevent the reinforcing wires 13400 from touching each other before the metal wires of the braided mesh during the bending process of the sheath tube 10000 due to the pitch being too small, thereby affecting the bending function of the sheath tube 10000.

[0047] In order to facilitate the observation of the position of the bending adjustment section 12000, the bending adjustment section 12000 includes at least one developing unit, wherein the developing unit is made of non-radiopaque material. Exemplarily, a developing ring, a developing point and other forms can be used. In this embodiment, the developing unit adopts a developing ring, which is made of metal or alloy such as tantalum, tungsten, platinum iridium, and has a thickness range of 0.05 to 0.50 mm.

[0048] The proximal end of the multi-directionally bendable sheath is also provided with a bending handle, which is connected to the main section 11000 of the multi-directionally bendable sheath. The bending handle is provided with a bending mechanism, and the proximal end of the traction wire 13200 is fixed on the bending mechanism of the bending handle.

[0049] During the operation, the operator pulls different bending adjustment mechanisms at the proximal end to achieve bending of the bending adjustment section 12000 connected to the anchoring ring 13100 in different traction directions under the action of different traction wires 13200.

[0050] Furthermore, the present application also provides a transcatheter intervention system, including a guide sheath and the aforementioned multi-directionally bendable sheath tube, the guide sheath is a pre-molded catheter or a bendable sheath tube, the multi-directionally bendable sheath tube is movably inserted into the guide sheath, and the distal end of the multi-directionally bendable sheath tube extends from the distal end of the guide sheath. Therefore, the guide sheath and the multi-directionally bendable sheath tube cooperate together to adapt to more complex physiological and anatomical structures, which is more conducive to achieving transcatheter interventional treatment.

[0051] Embodiment 2

[0052] See also Figure 6 Compared with the multi-directionally bendable sheath tube of the first embodiment, the multi-directionally bendable sheath tube of this embodiment is different in that the proximal end of the traction wire 13200 is embedded in the inner wall surface of the braided mesh.

[0053] Specifically, the traction wire 13200 is distributed on the inner wall surface of the braided mesh and extends along the axial direction of the sheath 10000. When the traction wire 13200 is subjected to pulling force, the braided mesh will provide support force to the traction wire 13200, so that the traction wire 13200 will not separate from the outer layer 12020, ensuring that the device is not easy to fail during use.

[0054] In addition, in this embodiment, since the braided mesh can provide support for the traction wire 13200 when the traction wire 13200 is subjected to traction, there is no need to set a reinforcing wire 13400 surrounding the outside of the traction wire 13200, thereby reducing the production difficulty of the device and further reducing the production cost.

[0055] Embodiment 3

[0056] See also Figures 7 - 12 Compared with the multi-directionally adjustable sheath of the first embodiment, the multi-directionally adjustable sheath of the present embodiment is different in that the bending section 12000 is pre-bent and shaped, and the bending and shaping shape is that the proximal end of the bending section 12000 points to the atrial septum 30000, and the distal end of the bending section 12000 points to the mitral valve 20000. Therefore, the transcatheter interventional system of the present embodiment is particularly suitable for transcatheter mitral valve repair therapy.

[0057] In the present embodiment, the bending adjustment section 12000 is pre-bent and shaped in a natural state, and is designed to have a certain spatial angle, so that a valve repair device such as a valve clamp can be quickly moved across the atrial septum 30000, and adjusted from the left atrium to the vicinity of the mitral valve 20000, thereby only requiring slight fine-tuning of the sheath 10000 to bend the bending adjustment section 12100 to a position facing the mitral valve 20000, thereby making it more convenient to adjust the valve repair device to face the mitral valve 20000, thereby reducing surgical operation time and reducing surgical difficulty.

[0058] ReferenceFigures 7 - 9 , the bending section 12000 sequentially includes, along the direction from the distal end to the proximal end: a connected bending part 12100, a first bending part 12200, a transition part 12300, and a second bending part 12400.

[0059] Among them, the second bending part 12400 is not coplanar with the main body section 11000 and is connected in communication at a first preset angle. Specifically, the included angle range between the projection of the main body section 11000 on the X plane and the projection of the second bending part 12400 on the X plane is 20° to 50°, and the angle range between the projection of the main body section 11000 on the Z plane and the projection of the second bending part 12400 on the Z plane is 0° to 20°.

[0060] The second bending part 12400 is not coplanar with the transition part 12300 and is connected in communication at a second preset angle. Specifically, the included angle range between the projection of the second bending part 12400 on the X plane and the projection of the transition part 12300 on the X plane is 20° to 50°, and the angle range between the projection of the second bending part 12400 on the Z plane and the projection of the transition part 12300 on the Z plane is 0° to 20°.

[0061] The transition part 12300 is not coplanar with the first bending part 12200 and is connected in communication at a third preset angle. Specifically, the included angle range between the projection of the transition part 12300 on the X plane and the projection of the first bending part 12200 on the X plane is 0° to 35°, and the angle range between the projection of the transition part 12300 on the Y plane and the projection of the first bending part 12200 on the Y plane is 0° to 15°.

[0062] The first bending part 12200 is not coplanar with the bending part 12100 and is connected in communication at a fourth preset angle. Specifically, the included angle range between the projection of the first bending part 12200 on the X plane and the projection of the bending part 12100 on the X plane is 0° to 35°, and the angle range between the first bending part 12200 on the Y plane and the bending part 12100 on the Y plane is 0° to 15°.

[0063] Thus, when the sheath tube 10000 in this embodiment is delivered from the inferior vena cava to the right atrium, when the bending part 12100, the first bending part 12200, and the transition part 12300 are sequentially delivered to the atrial septum 30000, at this time, under the action of the first bending part 12200, the bending part 12100 is bent to basically point to the mitral valve 20000, and under the action of the second bending part 12400, the transition part 12300 is basically oriented towards the atrial septum 30000, that is to say, refer to Figure 9, the second bending portion 12400 points to the interatrial septum 30000, the transition portion 12300 straddles the interatrial septum 30000, and the first bending portion 12200 directs the bending adjustment portion 12100 towards the mitral valve 20000. Therefore, with the above design, only slight fine-tuning is required to direct the orientation of the bending adjustment portion 12100 towards the mitral valve 20000, so that the valve repair device can be more conveniently adjusted to point to the mitral valve 20000, reducing the surgical operation time and the surgical difficulty.

[0064] To better indicate the different positions of the bending adjustment section 12000 in the human body, three imaging units are provided in this embodiment. Specifically: one imaging unit is provided at the distal end of the anchoring ring 13100 to indicate the most distal position at the front end; the other two imaging units are spaced apart on the transition portion 12300 to indicate straddling the interatrial septum 30000; and the distance range between the two imaging units is 4-10 mm, preferably 6.5 mm.

[0065] Refer to Figures 9 - 12 , the usage process of the multi-directionally bendable sheath tube of this embodiment is as follows:

[0066] Refer to Figure 9 , first, the sheath tube 10000 is delivered along the inferior vena cava to the left atrium, and positioned by means of medical imaging equipment such as CT, ultrasound or angiography through the imaging ring on the sheath tube 10000, so as to place the transition portion 12300 at the position of the interatrial septum 30000. At this time, due to the pre-bending and shaping of the bending adjustment section 12000, the bending adjustment portion 12100 just points to the L junction position of the mitral valve 20000;

[0067] After that, by observing the delivery path in real time, the bending angle of the sheath tube 10000 is adjusted in real time: Exemplarily, refer to Figure 10 , if it is necessary to bend the distal end of the sheath tube 10000 towards the vicinity of the M junction, a traction force in the M direction needs to be applied to the traction wire 13200 to drive the bending adjustment portion 12100 to bend in the M direction, so as to bend the distal end of the sheath tube 10000 towards the vicinity of the M junction; Similarly, refer to Figure 11 , if it is necessary to bend the distal end of the sheath tube 10000 towards the vicinity of the A junction, a traction force in the A direction is applied to the traction wire 13200 to drive the bending adjustment portion 12100 to bend in the A direction, so as to bend the sheath tube 10000 towards the vicinity of the A junction; Refer to Figure 12, if it is necessary to bend the distal end of the sheath tube 10000 to be close to the P junction position, a traction force in the P direction is applied to the traction wire 13200 to drive the bending portion 12100 to bend in the P direction, so as to bend the sheath tube 10000 to be close to the P junction position. In summary, in this embodiment, only a slight fine adjustment of the sheath tube 10000 is required to bend the bending portion 12100 to the position facing the mitral valve 20000, so that the valve repair device can be more conveniently adjusted to point to the mitral valve 20000, reducing the surgical operation time and the surgical difficulty.

[0068] Embodiment 4

[0069] Refer to Figure 13 , compared with the multi-directionally bendable sheath tube of Embodiment 1, the difference of the multi-directionally bendable sheath tube of this embodiment is that the main body section 11000 is a multi-layer composite tube body and is integrally formed with the bending section 12000.

[0070] In this embodiment, the structure of the main body section 11000 is not a separate multi-lumen tube, but adopts the same design as that of the bending section 12000, that is: the main body section 11000 is also arranged as a multi-layer composite tube body, and in the production process, it can be directly integrally hot-melted with the bending section 12000 without additional secondary connection processing, thereby effectively simplifying the process and production steps, and further effectively improving the efficiency and reducing the production cost.

Claims

1. A sheath tube that can be bent in multiple directions, characterized in that, Comprising: A main body section; A bending section, connected to the distal end of the main body section, the bending section being a multi-layer composite tube body and including a plurality of segments, the middle layer of the multi-layer composite tube body being a woven mesh, and the density of the woven mesh of the plurality of segments gradually decreasing along the direction from the proximal end to the distal end; At least one pair of traction mechanisms, each pair of the traction mechanisms respectively passing through the bending section and the main body section in sequence to adjust the bending angles of the bending section in different directions; the outer layer of the multi-layer composite tube body is an elastomer, and the hardness of the elastomer of the plurality of segments gradually decreases along the direction from the proximal end to the distal end; a reinforcing wire is wound around the outside of the traction wire, and the outer surface of the reinforcing wire is fixedly connected to the elastomer; The traction mechanism includes an anchoring ring, the anchoring ring is sleeved on the distal end of the woven mesh, and at least one pair of wire-passing holes are axially penetrated through the distal end surface of the anchoring ring. After the traction wire is folded in half, each end portion respectively passes through one of the wire-passing holes and extends along the axial direction of the woven mesh; The traction wire is embedded in the outer wall surface or the inner wall surface of the woven mesh.

2. The sheath tube capable of multi-directional bending according to claim 1, wherein The bending section sequentially includes a first section, a second section, and a third section along the direction from the proximal end to the distal end. The density range of the woven mesh of the first section is 45 - 60 PPI, the density range of the woven mesh of the second section is 35 - 45 PPI, and the density range of the woven mesh of the third section is 20 - 35 PPI.

3. The sheath tube capable of multi-directional bending according to claim 2, wherein, The hardness range of the elastomer of the first section is 30 - 50 D, the hardness range of the elastomer of the second section is 50 - 65 D, and the hardness range of the elastomer of the third section is 65 - 80 D.

4. The sheath tube capable of multi-directional bending according to claim 1, characterized in that, The traction mechanism includes: a traction wire, the distal end of the traction wire is connected to the anchoring ring, and the proximal end of the traction wire extends along the axial direction of the woven mesh.

5. The sheath tube capable of multi-directional bending according to claim 1, wherein The woven mesh is woven by a plurality of metal wires. The wire diameter of the reinforcing wire is substantially the same as the wire diameter of the metal wire, and the winding pitch of the reinforcing wire is greater than the distance between two adjacent metal wires in the woven mesh.

6. The sheath tube capable of multi-directional bending according to any one of claims 1 to 5, characterized in that, The bending section is pre-bent and shaped.

7. The sheath tube capable of multi-directional bending according to claim 6, wherein The bending section sequentially includes, along the direction from the distal end to the proximal end: a connected bending portion, a first bending portion, a transition portion, and a second bending portion. The second bending portion is not coplanar with the main body section and is connected at a first preset angle.

8. The sheath tube capable of multi-directional bending according to claim 7, wherein The included angle range between the projection of the main body section on the X plane and the projection of the second bending portion on the X plane is 20° - 50°, and the angle range between the projection of the main body section on the Z plane and the projection of the second bending portion on the Z plane is 0° - 20°.

9. The sheath tube capable of multi-directional bending according to claim 7, characterized in that, The second bending portion is not coplanar with the transition portion and is connected at a second preset angle.

10. The sheath tube capable of multi-directional bending according to claim 9, wherein The included angle range between the projection of the second bending portion on the X plane and the projection of the transition portion on the X plane is 20° - 50°, and the angle range between the projection of the second bending portion on the Z plane and the projection of the transition portion on the Z plane is 0° - 20°.

11. The sheath tube capable of multi-directional bending according to claim 7, characterized in that, The transition portion is not coplanar with the first bending portion and is connected at a third preset angle.

12. The sheath tube capable of multi-directional bending according to claim 11, characterized in that, The included angle range between the projection of the transition part on the X plane and the projection of the first bending part on the X plane is 0° to 35°, and the included angle range between the projection of the transition part on the Y plane and the projection of the first bending part on the Y plane is 0° to 15°.

13. The sheath tube capable of multi-directional bending according to claim 7, characterized in that, The first bending part and the bending adjustment part are not coplanar and are connected in communication at a fourth preset angle.

14. The sheath tube capable of multi-directional bending according to claim 13, wherein, The included angle range between the projection of the first bending part on the X plane and the projection of the bending adjustment part on the X plane is 0° to 35°, and the included angle range between the Y plane of the first bending part and the Y plane of the bending adjustment part is 0° to 15°.

15. The sheath tube capable of multi-directional bending according to claim 1, characterized in that, The main body section is a multi-lumen tube. The positions of the multiple holes of the multi-lumen tube correspond to the position of the wire threading hole. The end of the traction wire extends into the corresponding hole cavity of the multi-lumen tube after passing through the wire threading hole.

16. The sheath tube capable of multi-directional bending according to claim 7, wherein The bending adjustment section includes at least one imaging unit.

17. The sheath tube capable of multi-directional bending according to claim 16, wherein The number of the imaging units is three. One of the imaging units is arranged at the distal end of the anchoring ring, and the other two imaging units are arranged at intervals on the transition part.

18. A transcatheter intervention system, characterized in that, It includes a guiding sheath and the multi-directionally bendable sheath tube according to any one of claims 1 to 17. The guiding sheath is a pre-shaped catheter or a bendable catheter. A bending adjustment handle is further provided at the proximal end of the multi-directionally bendable sheath tube. A bending adjustment mechanism is provided on the bending adjustment handle. The proximal end of the traction wire of the multi-directionally bendable sheath tube is fixed on the bending adjustment mechanism. The multi-directionally bendable sheath tube is movably inserted into the guiding sheath, and the distal end of the multi-directionally bendable sheath tube extends out from the distal end of the guiding sheath.

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