CN113413244A

CN113413244A - Adjustable-bending conveying sheath tube and valve repairing system

Info

Publication number: CN113413244A
Application number: CN202110815648.4A
Authority: CN
Inventors: 王泽涛; 张伟伟; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2021-07-19
Filing date: 2021-07-19
Publication date: 2021-09-21

Abstract

The application relates to a conveying sheath pipe and valve repair system that can adjust and bend, this conveying sheath pipe that can adjust and bend includes: a main body section provided with a plurality of bores; the bending adjusting section is connected with the far end of the main body section and is a multilayer composite pipe body; at least two sets of pressure measurement, at least two sets of pressure measurement all set up in the outer wall surface of transfer curved section, and along the axial interval of transferring curved section sets up for detect the pressure in the left atrium and the right atrium simultaneously. To sum up, this application has effectively reduced the apparatus quantity of interveneeing the heart through the design that unites two into one adjustable bent sheath pipe and pressure measurement device to can carry out synchronous detection to the pressure of left atrium and right atrium when realizing the treatment to the mitral valve, guarantee heart pressure measurement result's accuracy.

Description

Adjustable-bending conveying sheath tube and valve repairing system

Technical Field

The application belongs to the technical field of medical equipment, and particularly relates to a bendable conveying sheath and a valve repair system.

Background

The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, and a normal healthy mitral valve can control the flow of blood from the left atrium to the left ventricle while avoiding the flow of blood from the left ventricle to the left atrium. The mitral valve includes a pair of leaflets, called the anterior leaflet and the posterior leaflet, which close completely when their edges are in apposition, preventing blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo organic or functional changes, the anterior and posterior leaflets of the mitral valve coapt poorly, whereby when the left ventricle of the heart contracts, the mitral valve fails to close completely, causing blood to regurgitate from the left ventricle into the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation". Tricuspid regurgitation is also treated by the same principle.

Transcatheter valve treatment refers to the treatment of mitral regurgitation by delivering various valve repair devices to the mitral valve via a delivery device such as a small-sized catheter, and by remote manipulation outside the patient's body, repairing or replacing the diseased mitral valve. Common delivery routes for valve repair devices are: the distal end of the mitral valve is reached through the femoral vein, the right atrium, the interatrial septum and the left atrium in sequence, and the path is long and has many bends. Existing delivery devices therefore typically employ multiple sleeved sheaths, an outer sheath for delivering the repair device from the right atrium to the left atrium across the interatrial septum, a middle sheath for adjusting the repair device to the mitral valve, and an inner sheath for delivering the repair device to the mitral valve.

When the mitral valve intervention operation is performed, the patient needs to be subjected to electrocardiographic monitoring and pressure monitoring of the left atrium and the right atrium all the time, so that doctors often need to additionally place heart pressure measuring catheters in the left atrium and the right atrium in the operation process, and the quantity of instruments for intervention in the heart during the operation is increased; in addition, since the valve repair device needs to perform a series of adjustment operations in the left atrium, during this operation, the pressure measurement catheter placed in the left atrium is easily deformed by squeezing and colliding, which affects the measurement result of the heart pressure, and at the same time, prolongs the operation time and increases the operation risk.

In summary, it is a technical difficulty in the art to ensure that interference between instruments intervening in the heart during the operation is reduced, and the results of simultaneous cardiac pressure measurement are not affected as much as possible, so as to complete valve repair.

Disclosure of Invention

In view of the problems in the prior art, the invention provides, in one aspect, an adjustable bending conveying sheath, including:

a main body section provided with a plurality of bores;

the bending adjusting section is connected with the far end of the main body section and is a multilayer composite pipe body;

at least two sets of pressure measurement, at least two sets of pressure measurement all set up in the outer wall surface of transfer curved section, and along the axial interval of transferring curved section sets up for detect the pressure in the left atrium and the right atrium simultaneously.

In certain embodiments, wherein at least one set of said pressure sensing devices is located at a distance in the range of 5mm to 20mm from the distal end of said turndown section; the distance range between the pressure detection device of at least one other group and the far end of the bending adjusting section is 30-50 mm.

In some embodiments, a traction wire is embedded in the pipe wall of the multilayer composite pipe body, at least two groups of the pressure detection devices are arranged along the length direction of the bending section in a non-same axial direction, and the extending direction of each pressure detection device and the extending direction of the traction wire form a 90-degree angle.

In certain embodiments, the pressure detection device comprises: the inner wall surface of the sensing body is connected with the outer wall surface of the bending adjusting section, and a pressure detection area is formed on the outer wall surface of the sensing body;

a pressure conducting portion through which the sensing body is connected with an external data processing device.

In certain embodiments, further comprising: the ablation device is arranged on the outer wall surface of the bending adjusting section, the distance range between the ablation device and the far end of the bending adjusting section is 5-25 mm, and the ablation device and any one of the pressure detection devices are not coaxial in the extending direction.

In some embodiments, the ablation device comprises: the inner wall surface of the ablation main body is connected with the outer wall surface of the bending adjusting section, and an ablation area is formed on the outer wall surface of the ablation main body;

an ablation conductive portion through which the ablation body is connected with an external ablation device.

In some embodiments, the ablation body comprises:

the far end of the first ablation part is connected to the near end inner cavity of the bending adjusting section, and the outer diameter of the first ablation part is gradually increased from the far end to the near end;

a waist part, the distal end of which is connected with the proximal end of the first ablation part;

the far end of the second ablation part is connected with the near end of the waist part, and the near end of the second ablation part is connected with the main body section;

the outer diameter of the waist part is smaller than the outer diameter of the first ablation part and the outer diameter of the second ablation part at the same time.

In some embodiments, the first ablation portion is a bowl at the proximal end and a constriction at the distal end, the radius of the cross section of the first ablation portion gradually decreases from the proximal end to the distal end; the second ablation portion is of a disc-shaped configuration or of the same configuration that is mirror symmetric to the first ablation portion.

In certain embodiments, the bend adjusting section comprises a plurality of segments, the hardness of the elastomer of the plurality of segments gradually decreasing in a proximal-to-distal direction.

To achieve the above object, in another aspect, the present invention provides a valve repair system comprising: the curvable delivery sheath and the valve repair device of any one of the preceding claims, wherein the valve repair device is movably mounted in the curvable delivery sheath.

Compared with the prior art, the application has the following beneficial effects at least:

this application is through the design that unites two into one adjustable curved sheath pipe and pressure measurement device to effectively reduced the apparatus quantity of interveneeing the heart, and can carry out synchronous detection to the pressure of left atrium and right atrium when realizing the treatment to the mitral valve, guarantee heart pressure measurement result's accuracy. In addition, because at the sheath pipe in-process of transferring the turn, pressure measurement will follow the sheath pipe and carry out the change of synchronization position, effectively avoid appearing interfering between the two to shorten operation time, reduce the operation risk.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and together with the description, serve to explain the principles of the application.

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art to obtain other drawings without inventive exercise.

Fig. 1 is a schematic structural view of a sheath in some embodiments.

Fig. 2 is a schematic structural diagram of a bend adjusting section in some embodiments.

Fig. 3 is a schematic diagram of a traction mechanism in some embodiments.

Fig. 4 is a schematic structural diagram of a pressure detection device in some embodiments.

Fig. 5 is a schematic diagram of the sheath engaged with the left and right atria in some embodiments.

FIG. 6 is a schematic diagram of a sheath according to some embodiments.

Fig. 7 is a schematic diagram illustrating the construction of an ablation device according to some embodiments.

Fig. 8 is a schematic diagram of an ablation device according to further embodiments.

FIG. 9 is a schematic diagram illustrating the sheath engaged with the left and right atria in some embodiments;

FIG. 10 is a schematic illustration of the valve repair device remaining in the body after the sheath has been withdrawn from the body in accordance with certain embodiments;

fig. 11 is a schematic structural diagram illustrating an ablation body in accordance with some embodiments.

Fig. 12 is a schematic diagram illustrating a sheath structure according to some embodiments.

Fig. 13 is a schematic structural view of an ablation body according to further embodiments.

Fig. 14 is a schematic structural view of a sheath according to another embodiment.

FIG. 15 is a schematic diagram of a bend adjustment section in some embodiments.

Detailed Description

In order to make the objects, 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 drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

Reference throughout this specification to "one embodiment," "an embodiment," "another embodiment," or "in certain embodiments" means that a particular reference element, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" or "in another embodiment" or "in some embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular elements, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

It should be understood that the terms "front", "back", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", and the like, are used for indicating the orientation or positional relationship, which is constructed and operated in a specific orientation based on the orientation or positional relationship shown in the drawings, and are used only for convenience of describing the present invention, but do not indicate that the device or element referred to must have a specific orientation, and thus, should not be construed as limiting the present application.

It is also noted that, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally formed; either directly or indirectly through intervening media, either internally or in any other relationship. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as appropriate.

In the description of the present application, it is still to 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 away from the operator; axial refers to a direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential refers to a direction around the axial direction.

The present application provides a valve repair system comprising: an adjustable curved delivery sheath 1000 and a valve repair device 2000, the valve repair device 2000 being movably threaded within the adjustable curved delivery sheath 1000, wherein the adjustable curved delivery sheath 1000 is configured to provide a delivery channel for the valve repair device 2000, and the valve repair device 2000 may be a valve clamping device, a prosthetic chordae implant, an annulus anchor, or the like. For ease of understanding, the specific structure of the bendable delivery sheath 1000 will be described in detail below with reference to the drawings, taking the valve clamping device as an example:

referring to fig. 1-5, in some embodiments, an adjustable bend delivery sheath 1000, comprises:

the main body section 1100, the main body section 1100 is provided with a plurality of bores to provide a supporting force for the entire delivery sheath 1000, playing a supporting role.

The bend-adjusting section 1200 is connected to the distal end of the main body section 1100, and is a multi-layer composite tube body that better achieves delivery of the valve repair device 2000 from the right atrium to the left atrium across the interatrial septum by adjusting the angle to accommodate the curved delivery path. Wherein, multilayer composite pipe body from interior to exterior includes in proper order: inner membrane 1201, woven mesh 1202, and elastomer 1203. Alternatively, the inner membrane 1201 is made of teflon, the mesh grid 1202 is made of a metal spring tube or a metal wire mesh grid tube, and the elastic body 1203 is made of thermoplastic plastics, and the thermoplastic plastics may be made of nylon, polyamide, block polyamide, polyurethane, etc. alone or copolymers of these thermoplastic plastics, which is not limited in this embodiment. Typically, during the overmolding process, the inner membrane 1201 is first placed over the rod, the mesh 1202 is then placed over the inner membrane 1201 in close proximity, and finally the thermoplastic material of the outer layer 1203 is melted to sufficiently fuse the inner membrane 1201 and mesh 1202 together to form a unitary body.

At least two sets of pressure detection devices 1500 are all set up in the outer wall of section 1200 that transfers to bend, and set up along the axial interval of section 1200 that transfers to bend for detect the pressure in the left atrium and the right atrium simultaneously, so that real-time feedback operation effect. The number of the pressure detection devices 1500 in each group is at least one, but the number of the pressure detection devices 1500 is not limited in this embodiment, and theoretically, a plurality of pressure detection devices may be provided to improve the detection accuracy of the left atrium and the right atrium.

Specifically, referring to fig. 1, at least one set of first pressure detecting means 1500 is located at a distance ranging from 5mm to 20mm, preferably from 8mm to 12mm, from the distal end of the bending section 1200 for detecting the left atrium; the distance between the at least another set of second pressure detecting means 1500 and the distal end of the bending segment 1200 is in the range of 30mm to 50mm, preferably 35mm to 42mm, for detecting the right atrium. Therefore, in the mitral valve repair process, after the bendable delivery sheath 1000 is delivered from the right atrium to the left atrium across the interatrial septum, the pressure in the left atrium can be detected by at least one first pressure detection device 1500, and the pressure in the right atrium can be detected by at least one second pressure detection device 1500.

Optionally, in some embodiments, a drawing wire 1420 is embedded in the multi-layer composite pipe body, at least two sets of pressure detecting devices 1500 are disposed along the length direction of the bend adjusting section 1200 in a non-same axial direction, and an extending direction of each pressure detecting device 1500 is 90 ° to an extending direction of the drawing wire 1420. In conclusion, the position matching can be adopted to avoid that the pressure detection device 1500 fails or is inaccurate due to extrusion of the bending process of the bending-adjustable conveying sheath 1000 on the pressure detection device 1500, so as to ensure the accuracy of monitoring the pressure in the left atrium and the right atrium simultaneously. Of course, the at least two sets of pressure detecting devices 1500 are not limited to the positions shown in the above embodiments, and the at least two sets of pressure detecting devices 1500 may be disposed in the same axial direction, and the positions of the at least two sets of pressure detecting devices 1500 are not limited in the embodiments, as long as the at least two sets of pressure detecting devices 1500 are staggered to correspond to the left atrium and the right atrium, respectively.

In the above embodiment, referring to fig. 4, the pressure detection apparatus 1500 includes: a sensing body 1510 and a pressure conducting portion 1520. Wherein, the inner wall surface of the sensing body 1510 is connected with the outer wall surface of the bending section 1200, and the outer wall surface of the sensing body 1510 forms a pressure detection area for contacting with blood. The sensing body 1510 may be a resistive pressure sensor, a capacitive pressure sensor, a piezoelectric pressure sensor, an inductive pressure sensor, a thermoelectric pressure sensor, or a photoelectric pressure sensor. In other examples, the sensing body 1510 may be a silicon-based pressure device; to suppress noise during detection, the sensing body 1510 preferably employs a differential pressure sensor.

In an embodiment, the specific shape of the sensing body 1510 is not limited. Alternatively, referring to fig. 4, the sensing body 1510 is generally rectangular parallelepiped. The design of the cuboid can increase the contact area of the sensing body 1510 and the sheath 1000 while reducing the technical difficulty of the fabrication, thereby enhancing the connection strength of the sensing body 1510 and the sheath 1000. It is understood that the sensing body 1510 in other embodiments may also take on a regular or irregular three-dimensional shape such as an extended circle, ellipse, etc. In addition, since the diameter of the sheath 1000 generally used for mitral valve treatment through the interatrial septum is generally 7mm to 9mm, in order to increase the contact area and the connection strength while satisfying the requirement of entering the left atrium through the interatrial septum, the length of the rectangular parallelepiped is about 2.5mm to 10mm, preferably 4mm to 6 mm; the width is about 2.5mm to 8mm, preferably 3mm to 5.5 mm; while the height is about 0.6mm to 4mm, preferably 0.6mm to 2mm, in view of the overall size of the sheath 1000 after the completion of the assembly.

And a pressure conduction part 1520, through which the sensing body 1510 is connected with an external data processing device, for transmitting the blood pressure signal detected by the pressure detection region to the external data processing device for display. Illustratively, the pressure conducting portion 1520 may be provided as a pressure conducting wire. Alternatively, the pressure conducting wire may be an elongated flexible wire wound from a power wire covered with a layer of power wire and polymer. The external data processing device may be provided as a display screen.

In some embodiments, a first channel is formed in the bend adjusting section 1200 and corresponds to a plurality of cavities of the main body section 1100, such that the proximal end of the pressure conducting wire extends into the corresponding cavity after passing through the first channel, and finally is exposed from the proximal end of the main body section 1100, and the distal end of the pressure conducting wire is electrically connected to the sensing body 1510. Alternatively, the first channel may open on the inner membrane 1201 or on the mesh 1202, as long as a passage can be formed on the sheath.

In some embodiments, the inner wall of the sensing body 1510 has a wiring groove, and the pressure conduction line is connected to the sensing body 1510 through the wiring groove. Optionally, the depth of the wiring groove is at least greater than 0.05mm and the width of the wiring groove is at least greater than 0.05mm than the width of the pressure conduction line, so that the pressure conduction line can be entirely contained within the sensing body 1510. In order to improve the connection strength of the pressure conductive line to the sensing body 1510, a pad region may be provided on the pressure conductive line, thereby improving the connection strength by increasing the connection area of the pressure conductive line to the sensing body 1510. In other embodiments, the sensing body 1510 can be formed without a wiring groove, and the pressure conductive wires are directly fixed to the sensing body 1510. The connection between the pressure conduction line and the sensing body 1510 is not limited in this application, and the connection can be stably achieved.

In some embodiments, the pressure conducting portion 1520 may be omitted and the blood pressure signal sensed by the pressure detecting device 1500 output to an external data processing device via a wireless connection, such as bluetooth, wifi, or infrared transmission. On one hand, the manufacturing process of the sheath 1000 can be simplified, and on the other hand, the damage of the instrument to the blood vessel can be reduced by reducing the overall outer diameter of the sheath 1000.

This application has effectively reduced the apparatus quantity of interveneeing the heart through the design that unites two into one sheath pipe 1000 and pressure measurement device 1500 to can carry out synchronous detection to the pressure of left atrium and right atrium when realizing the treatment to the mitral valve, guarantee heart pressure measurement result's accuracy. In addition, because sheath 1000 is in the accent curved in-process, pressure measurement device 1500 will follow sheath 1000 and carry out the synchronous position change, effectively avoid appearing interfering between the two to improve and detect the accuracy.

In some embodiments, the bending adjustment section 1200 comprises a plurality of segments, and the stiffness of the plurality of segments decreases gradually from the proximal end to the distal end, so as to ensure that the proximal end can provide a supporting function during the bending adjustment process, and the distal end can provide the bending adjustment function. Alternatively, referring to FIGS. 2-3, the proximal section of the plurality of section outer layer elastomers 1203 has a durometer in the range of 40D to 80D and the distal section has a durometer in the range of 25D to 40D. The density of the plurality of segments of woven mesh 1202 decreases gradually in the proximal-to-distal direction. Specifically, referring to FIG. 2, mesh 1202 is divided into three segments from proximal to distal, with the density of three segments of mesh 1202 decreasing in sequence. The weaving density of the first section of woven mesh is 20 PPI-35 PPI, the weaving density of the second section of woven mesh is 35 PPI-45 PPI, the weaving density of the third section of woven mesh is 45 PPI-60 PPI, namely the weaving density of the first section of woven mesh is less than that of the second section of woven mesh and less than that of the third section of woven mesh, and each section of woven mesh 1202 is in smooth transition with each other. The knitting density of the first section of the far-end knitted net is low, the force value required by bending adjustment is low, the bending adjustment function is facilitated, and meanwhile the flexibility of the far-end is guaranteed. And the knitting density of the third section of knitting net at the near end is relatively high, so that the supporting effect in the bending adjusting process and the conveying process is good.

Alternatively, mesh 1202 may be formed by weaving, winding, etc. stainless steel wire or tungsten wire, etc. to provide support during the crimping process. The wires of mesh grid 1202 may be round or flat stainless steel wires of about 0.03mm to 0.30mm, preferably 0.05 x 0.15 for better support.

In the above embodiment, the bendable delivery sheath 1000 further comprises: a bend-adjusting handle 1300 is connected to the proximal end of the main body segment 1100 and connected to the distal end of the bend-adjusting segment 1200 via at least one pair of traction mechanisms 1400 for adjusting the bending of the bend-adjusting segment 1200 in different directions to adapt to the curved delivery path, thereby better achieving delivery of the valve repair device 2000 from the right atrium to the left atrium across the interatrial septum.

Alternatively, referring to fig. 1 and 3, the pulling mechanism 1400 includes: the anchoring ring 1410 and the drawing wire 1420 connected with the anchoring ring 1410 are provided with a bending control mechanism on the bending control handle 1300 connected with the proximal end of the main body segment 1100, and the drawing wire 1420 is connected between the anchoring ring 1410 and the bending control mechanism, so that the drawing wire 1420 can be controlled to transmit the pulling force to the anchoring ring 1410 by pulling the bending control mechanism at the proximal end, and further the pipe body connected with the anchoring ring 1410 is driven to bend.

Optionally, the anchoring ring 1410 is coaxially embedded in the distal elastomer 1203 of the multi-layer composite tube of the bending adjustment section 1200 and sleeved on the woven mesh 1202, and the pulling filament 1420 is distributed in the tube wall of the tube of the bending adjustment sheath 1000 and extends along the axial direction of the tube.

It will be appreciated that anchoring loop 1410 may also be coaxially embedded within mesh 1202, with the particular configuration that anchoring loop 1410 is coaxially embedded within distal mesh 1202 and sleeved over intima 1201. The pulling wires 1420 are distributed in the side walls of the inner membrane 1201 and extend in the axial direction of the tube, and the woven mesh 1202 covers the inner membrane 1201 and the pulling mechanism 1400 and covers the elastomer 1203 on the outer layer. At this time, since the pulling wire 1420 is provided inside the net 1202, the pulling force of the pulling wire 1420 is applied to the net 1202 after the pulling force is applied to the pulling wire 1420, so that the pulling wire 1420 is not separated from the elastic body 1203, thereby ensuring the stability of the bending process of the sheath tube 1000.

Further, anchor ring 1410 may be made of stainless steel, tungsten, platinum, iridium, or other metal or alloy having a thickness of about 0.15mm to 1.00 mm. The bore on anchor ring 1410 may be other shaped shapes besides circular, square, polygonal. The drawing wire 1420 may be a round or flat wire having a diameter of about 0.05mm to 0.40mm, or a stainless steel wire or a tungsten wire. The pull wire 1420 may be in the form of a single wire or a plurality of wires formed by winding a wire. The drawing wire 1420 is preferably a multi-strand wire formed by winding a plurality of stainless steel wires.

Optionally, the attachment of the pull wire 1420 to the anchoring ring 1410 may be as follows: the pull wire 1420 is doubled back over the distal face of the anchor ring 1410 and then looped back over the anchor ring 1410; or the pull wire 1420 is attached to the anchoring ring 1410 through a hole in the wall of the anchoring ring 1410; or the pull wire 1420 is doubled back around the hole on the distal face of the anchor ring 1410 and then looped back toward the anchor ring 1410. It is preferable to use the mode in which the drawing wire 1420 is folded in half to pass through the hole on the distal end surface of the anchoring ring 1410 and then reversely pass back to the anchoring ring 1410, and this connection mode is not easy to have stress concentration due to a relatively large force-bearing area when being drawn, so that the connection strength and stability can be ensured.

Specifically, referring to fig. 3, the pull wire 1420 is U-shaped, including first and second axially parallel segments, and a bend connected between the first and second segments. First section and second section are respectively along body axial extension, and the near-end of first section and second section is connected to and transfers curved control mechanism, and the distal end of first section and second section is worn to establish among anchor ring 1410 to link to each other with the flexion respectively, after anchor ring 1410 was walked around to the flexion, both ends linked to each other with first section and second section respectively. The distal end face of the anchoring ring 1410 is provided with a pair of adjacent notches, the distal ends of the first and second segments are respectively inserted into one of the notches, and the bending portion is exposed on the distal end face of the anchoring ring 1410 and spans the two adjacent notches, so as to connect the traction wire 1420 and the anchoring ring 1410 together.

Further, the outer surfaces of the first and second segments of the drawing wire 1420 are respectively surrounded by a ring of reinforcing wires, which can be thermally fused with the elastic body 1203 to form a wire passing channel for the drawing wire 1420, so that the first and second segments of the drawing wire 1420 are located in the reinforcing wires and can move in the axial direction. At this time, after the drawing wire 1420 receives the drawing force, the drawing force of the drawing wire 1420 also acts on the surrounding reinforcing wires, and the surrounding reinforcing wires cannot be easily separated from the elastic body 1203 which is integrally fastened by hot melting, so that the movement of the drawing wire 1420 can be further limited and guided, and the bending process of the sheath tube 1000 is ensured to be difficult to fail.

Specifically, the reinforcing wire is usually a metal wire such as a stainless steel wire or a tungsten wire, and preferably a stainless steel wire. The reinforcing wires are preferably of the same size as the stainless steel wires of woven mesh 1202, and the winding pitch is preferably greater than the wire spacing of woven metal mesh 1202. Therefore, the bending adjusting function of the adjustable bending sheath 1000 can be prevented from being influenced by the fact that the metal wires of the reinforcing wires are contacted with each other before the metal wires of the woven mesh 1202 are contacted with each other due to too small pitch among the wound reinforcing wires in the bending adjusting process of the adjustable bending sheath 1000.

It will be appreciated that in other embodiments, the first and second segments of the pull wire 1420 may be surrounded by other tubes that provide lumen access while being able to conform to bends without buckling, such as tubes made of teflon or polyurethane elastomer 1203.

Optionally, at least one developing unit is disposed at the bending section 1200 for indicating the position of the bending section 1200 under the radiation. In particular, the visualization unit is made of a radiopaque material, and may be in the form of a visualization ring, a visualization point, or the like. Preferably, the developing ring can be in the form of a developing ring with a thickness ranging from 0.05mm to 0.50mm and made of metal or alloy such as tantalum, tungsten, platinum and iridium.

Optionally, the valve repair device 2000 is provided as a valve clamping device comprising a pair of clamp arms for clamping the anterior and posterior leaflets of the mitral valve, respectively, such that when the anterior and posterior leaflets are drawn towards each other by the clamping device, the leaflet gap is reduced, thereby mitigating mitral regurgitation. In this process, because the palirrhea disappears, the pressure in left atrium can reduce, and the adjustable curved conveying sheath pipe 1000 of this application can monitor left atrium and right atrium pressure in real time, can reduce through the pressure of the front and back left atrium of judgement, real-time feedback operation effect. Meanwhile, the change of the pressure detection result of the right atrium can feed back whether the instrument touches and damages the heart wall in the operation process in real time, so that the heart damage can be better avoided, the operation success rate is further improved, and the safety of a patient is ensured.

The following illustrates the use of the adjustable curved delivery sheath 1000 provided in the embodiments, with the example of an antegrade transvenous approach across the interatrial septum into the left atrium:

the first step is as follows: the guide wire is advanced from the inferior vena cava to cross the interatrial septum into the left atrium by the puncture of the interatrial septum;

the second step is that: advancing the adjustable bend delivery sheath 1000 along the guidewire into the left atrium;

the third step: referring to fig. 5, the observation is performed by means of ultrasound and Digital Subtraction Angiography (DSA). The adjustable curved sheath 1000 is secured when at least one of the pressure sensing devices 1500 is viewed in the left atrium and at least one other of the pressure sensing devices 1500 is viewed in the right atrium.

The fourth step: the bending adjusting handle 1300 is manipulated to adjust the bending of the bending adjustable conveying sheath 1000 to a proper angle, then the valve repairing device 2000 is conveyed to the mitral valve along the inner cavity of the bending adjustable sheath 1000 to perform the valve repairing operation, and pressure monitoring is performed in the whole process through at least two groups of pressure detecting devices 1500 on the bending adjustable conveying sheath 1000.

Referring to fig. 6-10, in some embodiments, a transseptal ostomy may be performed with the same set of instruments for treating heart failure in patients with heart failure due to mitral regurgitation, if desired. The bendable delivery sheath 1000 further comprises: at least one group of ablation devices 1600, the ablation devices 1600 are arranged at the position of the outer wall surface of the bending adjusting section 1200 corresponding to the atrial septum. Optionally, the distance between the ablation device 1600 and the distal end of the bend adjustment segment 1200 is in the range of 5mm to 25mm, preferably 15mm to 20mm, so as to ensure that the ablation device 1600 will cross over the interatrial septum after the repair device is delivered from the right atrium to the left atrium across the interatrial septum during mitral valve repair to perform an ablation operation on tissue on the inner wall surface of the interatrial septum. Wherein the ablation device 1600 is not coaxial with the direction of extension of any of the pressure sensing devices 1500.

Specifically, referring to fig. 6-8, an ablation device 1600 includes: the ablation main body 1610 and the ablation conducting part 1620, the inner wall surface of the ablation main body 1610 is connected with the outer wall surface of the bending section 1200, and the outer wall surface of the ablation main body 1610 forms an ablation zone which is in contact with and ablates the interatrial septum, and the ablation zone does not ablate blood. The ablation body 1610 is connected to an external ablation device through an ablation conductive part 1620. Illustratively, the ablation conductive portion 1620 may be configured as an ablation conductive wire for transferring heat generated by an external ablation device to the ablation device 1600 for performing an atrial septostomy of a heart failure patient through the ablation device 1600.

Optionally, in some embodiments, a second channel is formed in the bend adjusting section 1200, the plurality of cavities of the main body section 1100 correspond to the second channel, and the proximal end of the ablation conductive wire passes through the corresponding second channel, extends into the corresponding cavity, and leaks out of the proximal end of the main body section 1100 to be electrically connected to the ablation body 1610. Alternatively, the second channel may be opened on the inner membrane 1201 or on the woven mesh 1202 as long as a passage can be formed on the sheath.

Alternatively, the ablation conductive wire and the ablation body 1610 may be connected to the sheath 1000 by bonding, heat fusing, welding, coating, etc., preferably by heat fusing. The ablation conducting wire can be made of a soft metal wire with high elasticity and low resistivity, such as a single-strand or multi-strand slender structure made of nickel-titanium wires, gold brass wires, stainless steel wires, tungsten wires, copper wires and the like.

Further, the outer side of the ablation conducting wire may also be coated with an insulating layer. Illustratively, the insulating layer may be plated with parylene insulating coating. The design of the insulating layer can isolate the loss of heat in the transmission process to concentrate energy on the ablation main body 1610, realize ablating the tissue on the inner wall surface of the atrial septum, and improve the utilization rate of energy. Meanwhile, the insulating layer can also form an insulating barrier for the contact between the ablation conducting wire and the sheath 1000 and the blood, so that the current density of the sheath 1000 and the blood is reduced, the heating degree of the blood by the current is reduced, and the risk of thrombus formation is reduced.

It will be appreciated that ablation device 1600 and pressure sensing device 1500 may be co-axial or may be non-axial, offset at an angle from each other, and preferably non-axial. More preferably, the sheath 1000 is axially aligned with the pull wire, so as to avoid the arc-shaped deformation of the bendable sheath during bending from pulling the ablation conductive wire, which eventually leads to displacement or failure of the ablation device 1600, thereby ensuring the accuracy and effectiveness of the atrial septal stoma using the apparatus.

In some embodiments, referring to fig. 6-8, ablation body 1610 is generally circular in shape conforming to the profile of bending sheath 1000, referred to simply as an ablating loop for ease of description. Specifically, the ablation ring is sleeved on the bend adjusting section 1200, and at this time, the outer wall surface of the ablation ring is in full contact with the atrial septum in the heart, so that the tissue on the inner wall surface of the atrial septum is ablated, and the endothelium near the rear of the atrial septum stoma is prevented from climbing and covering and blocking the stoma, thereby keeping the smooth of the stoma. Preferably, the ablating loop is made of a relatively highly elastic, radiopaque, low resistivity metal material, such as silver, copper, magnesium, NITI, stainless steel, aluminum, and the like. Wherein, in order to better adapt to the anatomical structure of the human body and achieve better ablation effect, the width can be about 0.5 mm-10 mm, preferably 0.8 mm-2 mm, the outer diameter is about 6 mm-12 mm, preferably 6 mm-9 mm, and the wall thickness is about 0.05 mm-4 mm, preferably 0.1 mm-1.5 mm.

Optionally, the inner wall surface of the ablation main body 1610 is provided with a wiring groove, and the ablation conducting wire is connected with the ablation ring through the wiring groove. Preferably, the depth of the wiring groove should be greater than the depth of the ablation conducting wire by at least 0.05mm, and the width of the wiring groove should be greater than the width of the ablation conducting wire by at least 0.05mm, so that the ablation conducting wire can be wholly accommodated in the wiring groove, and then the whole outer diameter of the instrument can be reduced. The ablation conducting wire can be fixedly connected with the ablation ring in an adhesion, fusion or welding mode. In order to ensure the fixed strength of connection, a pad area can be arranged on the lead wire, so that the connection area of the lead wire and the ablating ring is increased, and the fixed strength of connection is further enhanced. It will be appreciated that, with reference to fig. 8, the ablating loop is free of a wire slot, the ablating conductive wire is doubled over around the ablating loop, or the lead wire is threaded through an aperture in the wall of the ablating loop to attach to the ablating loop.

Alternatively, an insulating film, which may be a teflon film, a polyurethane film, a polyimide film, or the like, is provided on both the proximal and distal end faces of the ablation body 1610. The insulating film can form an insulating barrier on the side, facing blood, of the ablation ring surface, so that the current density passing through the blood in the ablation process is reduced, the heating of the blood by the ablation ring is reduced, and the risk of thrombosis is reduced.

Optionally, at least one visualization portion is also provided on the ablation body 1610 for better positioning. Wherein, the material of the developing part can be selected from but not limited to: an alloy or composite of metals such as gold, platinum iridium, tantalum, etc.

the first step is as follows: the guide wire is advanced from the inferior vena cava across the interatrial septum into the left atrium by puncture of the interatrial septum;

the third step: referring to fig. 5, it is observed by means of DSA and the like. When the ablation device 1600 of the adjustable bending delivery sheath 1000 is just at the interatrial septum, the adjustable bending sheath 1000 is fixed. At this time, at least one of the at least two groups of pressure detection devices 1500 on the bending-adjustable sheath 1000 may be used to monitor the pressure of the left atrium system, and the other group of pressure detection devices 1500 may be used to monitor the pressure of the right atrium system, and may simultaneously perform pressure detection of the left atrium and the right atrium during the operation, so as to determine whether the pressure of the left atrium is reduced by the pressure difference before and after the operation of the left atrium, and further feed back the operation effect in real time; meanwhile, the pressure detection change of the right atrium can feed back whether the instrument touches and damages the heart wall in the operation process in real time, so that the heart damage can be better avoided, the operation success rate is further improved, and the safety of a patient is ensured.

The fourth step: referring to fig. 9, the bending adjusting handle 1300 is manipulated to adjust the bending of the bendable delivery sheath 1000 to a proper angle, and then the valve repair device 2000 is delivered to the mitral valve along the lumen of the bendable delivery sheath 1000 for performing the valve repair operation, and during the operation, pressure monitoring is performed through at least two sets of pressure detecting devices 1500 on the bendable delivery sheath 1000.

The fifth step: referring to fig. 10, when the interventional procedure is completed, if the operator believes that the patient should be treated for further heart failure due to mitral regurgitation using the adjustable bending delivery sheath 1000, an external ablation device may be connected to transfer heat generated by the external ablation device to the electrodes of the ablation apparatus 1600 to perform a transseptal ostomy on the heart failure patient by ablation to eliminate the pressure differential between the left atrium and the right atrium.

And a sixth step: the adjustable-bending delivery sheath 1000 and the guide wire are withdrawn from the body, and valve repair surgery and atrial septal ostomy are completed.

In some embodiments, referring to fig. 11-14, ablation body 1610 is not circular in shape conforming to the outer shape of sheath 1000, but rather is irregularly shaped, specifically ablation body 1610 includes: a first ablation portion 1611, a waist portion 1612, and a second ablation portion 1613.

The first ablation part 1611 is located at the distal end of the ablation main body, the distal end of the first ablation part is connected to the proximal end inner cavity of the bending section 1200, and the outer diameter of the first ablation part 1611 gradually increases from the distal end to the proximal end. Referring to fig. 9, first ablation portion 1611 is bowl-shaped at a proximal end and has a neck at a distal end, with a cross-sectional radius that tapers from the proximal end to the distal end. Specifically, the first ablation part 1611 integrally includes a tapered curved surface with an outer diameter smoothly increasing from a distal end to a proximal end, and the distal end of the first ablation part 1611 is integrally shrunk and accommodated in the TIP head, wherein in order to better conform to the process of the sheath 1000 entering the left atrium from the right atrium, and avoid unnecessary trauma to the heart, a taper angle of the constriction is set to be 30-80 degrees, preferably 30-45 degrees, an outer diameter of the constriction at the distal end of the tapered curved surface is 6-12 mm, an outer diameter of the bowl at the proximal end is 8-20 mm, preferably 10-14 mm, a connection curvature of the distal end and the proximal end is 30-80 degrees, preferably 45-60 degrees, an overall length of the first ablation part 1611 is 15-25 mm, and the first ablation part is connected with the body of the sheath 1000 through the distal TIP head.

A waist 1612 having a distal end connected to the proximal end of the first ablation portion 1611 for ablating atrial septal tissue. Specifically, the whole body is of an inward concave structure, the distal end of the waist portion 1612 is connected with the proximal end of the first ablation portion 1611, in order to enable the tissue of the interatrial septum to just surround the waist portion 1612 when the interatrial septum is spanned, the outer diameter of the waist portion 1612 is set to be 6 mm-16 mm, preferably 8 mm-12 mm, and the width is 3 mm-10 mm, preferably 3 mm-5 mm.

A second ablation portion 1613, located at the proximal end of the ablation body, has its distal end connected to the proximal end of the waist 1612 and its proximal end connected to the body section 1100. Specifically, referring to fig. 11-12, second ablation portion 1613 is a disk-shaped structure that is configured to abut the atrial septum tissue wall to prevent sheath 1000 from being pushed over, causing the ablation area to move away from the atrial septum or partially contact the atrial septum, and to provide a stop via the proximal disk. The disk-shaped member is provided with an outer diameter of 8mm to 20mm, preferably 8mm to 12mm, and a width of 5mm to 25mm, preferably 10mm to 15 mm.

Optionally, the waist 1612 has an outer diameter that is less than both the outer diameter of the first ablation portion 1611 and the outer diameter of the second ablation portion 1613, such that better ablation of the atrial septum is achieved without additional damage to the tissue.

Optionally, the first ablation part 1611 and the second ablation part 1613 of the ablation main body 1610 may be further provided with an insulation film, and in this case, the ablation function is performed only through the intermediate transition waist part 1612, so that the current density passing through blood during ablation can be reduced, the degree of heating of the ablation part to blood can be reduced, and the risk of thrombosis can be reduced.

In some embodiments, referring to fig. 13 and 14, the second ablation portion 1613 may also be configured with a waist in the middle, both ends of the second ablation portion having the same configuration as the first ablation portion, and a mirror-symmetrical configuration with the same taper angle. It is understood that in other embodiments, the ablation body 1610 can have any other shape as long as the distal end has a transition structure, and the transition structure can smoothly transition to the ablation portion, and all of the shapes are within the scope of the present embodiment.

When the ablation main body 1610 is manufactured, firstly, a nickel titanium tube with the outer diameter of 3 mm-15 mm and the wall thickness of 0.2 mm-1.5 mm is cut into connected strips by adopting a laser cutting mode, the cut nickel titanium tube is placed in a shaping mold, and is placed in an electric heating type circulating air box furnace for carrying out shaping heat treatment for 10-18 minutes under the conditions of 450-650 ℃ (preferably 500 ℃). After taking out and cooling to room temperature, the shaping mold is removed, and the ablation body 1610 in this embodiment is obtained.

It is understood that the ablation body 1610 of the present embodiment can also be made of a stainless steel wire, a cobalt-chromium alloy wire, or a nickel-titanium wire with certain elasticity, which is woven and then shaped, and is preferably made of nickel-titanium.

In some embodiments, referring to fig. 15, in order to better conform to the position and structure of the left atrium, the right atrium and the atrial septum when the sheath 1000 crosses the atrial septum from the right atrium into the left atrium, the distal end of the sheath 1000 is pre-bent and shaped in a natural state. Specifically, the bending section 1200 sequentially includes, in the distal-to-proximal direction: the bending adjusting part 1210, the transition part 1220 and the connecting part 1230 are communicated, and the included angle between the projection of the bending adjusting part 1210 in the direction perpendicular to the bending adjusting direction and the projection of the connecting part 1230 in the direction perpendicular to the bending adjusting direction ranges from 15 degrees to 50 degrees, preferably from 25 degrees to 40 degrees. Thus, when the adjustable bending sheath 1000 is passed from the right atrium into the left atrium across the interatrial septum, the bending portion 1210 passes through the interatrial septum to reach the left atrium, the transition portion 1220 is passed across the interatrial septum, and the connection portion 1230 is located in the right atrium. At this moment, because transition portion 1220 is a crooked circular arc to compliance interatrial space's shape that can be better, and then reduce the stress effect to interatrial space, simultaneously because the distal end of sheath pipe 1000 is moulding in advance, reduce the follow-up accent angle that needs the accent curved, reduced sheath pipe 1000 and transferred the required power value of curved, further guarantee sheath pipe 1000's security, greatly reduced the operation risk.

Optionally, the ablation device 1600 is disposed on an outer wall surface of the transition portion 1220, wherein at least one group of the pressure detection devices 1500 is disposed on the outer wall surface of the bending portion 1210, and at least another group of the pressure detection devices 1500 is disposed on the outer wall surface of the connection portion 1230.

Optionally, the hardness of the thermoplastic material of the outer layer of the distal sheath 1000 decreases from the proximal end to the distal end in sequence, and the bending portion 1210 is 30-40D pebax, the transition portion 1220 is 50-60D pebax, and the connection portion 1230 is 65-75D pebax.

Claims

1. An adjustable-bend conveying sheath, comprising:

a main body section provided with a plurality of bores;

2. The tunable delivery sheath according to claim 1, wherein a distance between at least one of the pressure detecting devices and the distal end of the tunable section is in a range of 5mm to 20 mm; the distance range between the pressure detection device of at least one other group and the far end of the bending adjusting section is 30-50 mm.

3. The adjustable-bend conveying sheath pipe according to claim 1 or 2, wherein a drawing wire is embedded in a pipe wall of the multilayer composite pipe body, at least two groups of the pressure detection devices are arranged along the length direction of the adjustable-bend section in a non-same axial direction, and an extending direction of each pressure detection device and an extending direction of the drawing wire are 90 degrees.

4. The adjustable bend delivery sheath of claim 1, wherein the pressure detection device comprises: the inner wall surface of the sensing body is connected with the outer wall surface of the bending adjusting section, and a pressure detection area is formed on the outer wall surface of the sensing body;

5. The adjustable bend delivery sheath of claim 1, further comprising: the ablation device is arranged on the outer wall surface of the bending adjusting section, the distance range between the ablation device and the far end of the bending adjusting section is 5-25 mm, and the ablation device and any one of the pressure detection devices are not coaxial in the extending direction.

6. The adjustable bend delivery sheath of claim 5, wherein the ablation device comprises: the inner wall surface of the ablation main body is connected with the outer wall surface of the bending adjusting section, and an ablation area is formed on the outer wall surface of the ablation main body;

7. The adjustable bend delivery sheath of claim 6, wherein the ablation body comprises:

8. The adjustable bend delivery sheath of claim 7, wherein the first ablation portion is proximal bowl-shaped and distal necked-down having a cross-sectional radius that tapers from the proximal end to the distal end; the second ablation portion is of a disc-shaped configuration or of the same configuration that is mirror symmetric to the first ablation portion.

9. The adjustable bend delivery sheath of claim 1, wherein the adjustable bend segment comprises a plurality of segments having a progressively decreasing durometer of the elastomer in a proximal-to-distal direction.

10. A valve repair system, comprising: the steerable delivery sheath and valve repair device of any of claims 1-9, wherein the valve repair device is removably mounted within the steerable delivery sheath.