CN116407220A

CN116407220A - Valve treatment device

Info

Publication number: CN116407220A
Application number: CN202111676708.5A
Authority: CN
Inventors: 王永胜; 任弘; 陈杰; 高国庆
Original assignee: Hangzhou Nuona Biomedical Technology Co ltd
Current assignee: Hangzhou Nuona Biomedical Technology Co ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11
Also published as: WO2023125962A1

Abstract

The present invention relates to a valve treatment device. The valve treatment device comprises a sheath having a central axis; a first support assembly comprising a first operating member and a first support connected to the first operating member, the first support having a compressed configuration radially compressed and received within the sheath and an expanded configuration radially expanded upon release from the sheath, wherein the first support in the expanded configuration has a pre-curved arcuate surface extending away from the central axis of the sheath, the first operating member being adapted to be operated to conform the first support to a surface of the valve in the expanded configuration, wherein the pre-curve Qu Humian of the first support is convex towards the central axis of the sheath; and a cutting assembly comprising a second operating member and a cutting member coupled to the second operating member, the second operating member being adapted to be operated to fracture at least a portion of the valve.

Description

Valve treatment device

Technical Field

The invention relates to the field of medical instruments, in particular to a valve treatment device.

Background

The aortic valve is located between the left ventricle and the aorta and includes three leaflets apposed along commissures for inhibiting backflow of blood flow into the main artery into the left ventricle. In some cases, the surface of the aortic valve may be calcified, resulting in stiffening of the aortic valve and the appearance of symptoms such as the aortic valve not being closed or opened (or being opened to a small extent, i.e. stenosis). In addition, aortic valve bivalvulation deformity (BAV, bicuspid Aortic Valve), in which calcification is present at the valve leaflets and the two leaflets adhere to each other, is also one of the causes of aortic valve stenosis.

The valve structure can be softened by cutting calcium on the valve surface, so that the valve leaflet structure can recover elasticity, and the valve stenosis is relieved. However, for patients with severe aortic stenosis, treatment with transcatheter aortic valve replacement procedures is often required that have the advantages of low trauma, high safety, rapid postoperative recovery, etc. However, there is still a potential risk of coronary occlusion and restenosis after transcatheter aortic valve replacement. Cutting the valve prevents this risk.

Disclosure of Invention

In view of the above, the present invention aims to provide a valve treatment device that can solve the above-described problems.

To this end, in one aspect, the present invention provides a valve treatment device comprising a sheath having a central axis; a first support assembly comprising a first operating member and a first support connected to the first operating member, the first support having a compressed configuration radially compressed and received within the sheath and an expanded configuration radially expanded upon release from the sheath, wherein the first support in the expanded configuration has a pre-curved arcuate surface extending away from the central axis of the sheath, the first operating member being adapted to be operated to conform the first support to a surface of the valve in the expanded configuration, wherein the pre-curve Qu Humian of the first support is convex towards the central axis of the sheath; and a cutting assembly comprising a second operating member and a cutting member coupled to the second operating member, the second operating member being adapted to be operated to fracture at least a portion of the valve.

In some embodiments, the cutting member is configured to electrically connect with an ablation element to receive energy delivered by the ablation element, at least a portion of the valve being ruptured by non-contact.

In some embodiments, the cutting member comprises a cutting blade connected to the second operating member, the second operating member being adapted to be operated to cause the cutting blade to cut the valve between the first support and the cutting blade.

In some embodiments, the cutting blade is configured to electrically connect with an ablation element to receive energy delivered by the ablation element to cut at least a portion of the valve by contact.

In some embodiments, the first support has a connection end connected to the first handle, the first support comprising a first section that, in the expanded configuration, extends outwardly and distally from the connection end toward the central axis away from the sheath, the first section having a pre-curved arcuate surface.

In some embodiments, the first support further comprises a second section, the junction of the first section and the second section forming an abutment for abutting a surface of the valve, the second section extending proximally from the abutment in the expanded configuration, the end of the second section remote from the abutment being a free end, the second section having a pre-curved arcuate surface.

In some embodiments, in the expanded configuration, the second section extends from the abutment to the free end, bending first in a direction toward the proximal end and away from the central axis of the sheath, and further bending second in a direction toward the proximal end and toward the central axis of the sheath.

In some embodiments, the second section has a bend radius in the range of 1mm to 3 mm; and/or the included angle between the tangent line of the free end and the central axis of the sheath tube is in the range of 10-60 degrees.

In some embodiments, in a plane perpendicular to the central axis of the sheath, the maximum central angle corresponding to the two circumferential sides of the first support portion is in the range of 10 ° to 60 °; and/or the maximum width of the first supporting part along the circumferential direction of the sheath tube is in the range of 2 mm-20 mm.

In some embodiments, the first support is a resilient member configured to be elastically bendable from the compressed state to the expanded configuration upon withdrawal of an external compressive force.

In some embodiments, the first support is a single wire structure; or the first supporting part is a plurality of metal wire twisting structures; or the first supporting part is a multi-wire braided structure.

In some embodiments, the first support is a cut sheet metal structure, the first support including a plurality of support ribs, the plurality of support ribs circumscribing to form one or more grids.

In some embodiments, the first support portion has a first surface and a second surface on both sides in a thickness direction thereof, and the first support portion is provided with a relief portion recessed from the first surface toward the second surface or penetrating the first surface and the second surface, the relief portion being for passing the cutting blade therethrough to cut the valve.

In some embodiments, the first support portion has a first surface and a second surface on both sides in a thickness direction thereof, the first support portion is provided with a relief portion penetrating the first surface and the second surface, the relief portion is used for allowing the cutting blade to pass through to cut the valve, the first support assembly further comprises a protective sheet connected to the first support portion, and the protective sheet is configured to at least partially cover the relief portion to prevent the cutting blade from contacting the inner wall of the blood vessel.

In some embodiments, the protective sheet is configured to adhere to the second surface to cover the relief when not being abutted by the cutting blade, and to elastically deform and disengage from the second surface when being abutted by the cutting blade; or the protective sheet is configured to cover the relief portion without being abutted by the cutting blade and to have a distance from the second surface.

In some embodiments, the first operating member comprises a catheter or a pull wire slidably received within the sheath.

In some embodiments, the valve treatment device further comprises a second support assembly comprising: a second support portion having a compressed configuration radially compressed and received within the sheath and an expanded configuration released radially expanded from the sheath; and a third operating member connected to the second support portion, the third operating member being operable to cause the second support portion in the expanded configuration to cooperate with the first support portion in the expanded configuration to clamp the valve.

In some embodiments, the third operating member comprises a catheter or a pull wire slidably received within the sheath.

In some embodiments, a proximal end of the second support is fixedly connected to the first operating member, a distal end of the second support is fixedly connected to the third operating member, and the third operating member is configured to drive the distal end of the second support toward or away from the proximal end of the second support, thereby switching the second support between the expanded configuration and the compressed configuration.

In some embodiments, the first operating member comprises a catheter slidably disposed within the sheath, at least a portion of the third operating member is slidably disposed within the first operating member, the second support portion assumes a compressed configuration under the constraint of the first operating member, and the second support portion is self-expandable to an expanded configuration upon release from the first operating member.

In some embodiments, the cutting assembly further comprises a conveyor, an adjustment member coupled to the second operating member and slidably coupled to the conveyor, the support member being hinged to the adjustment member, the cutting blade being hinged to the support member and the conveyor, the second operating member being adapted to be operated to slide the adjustment member over the conveyor to thereby drive the support member to oscillate, thereby rotating the cutting blade relative to the conveyor.

In some embodiments, the delivery member is tubular and has a first opening extending axially through a sidewall thereof, the support member and the cutting blade being movable into the delivery member or extendable from the delivery member via the first opening.

In some embodiments, a chute is provided on a side wall of the conveying member, a protrusion is provided on the adjusting member, the protrusion is slidably embedded in the chute so that the adjusting member slides in the conveying member, and a sliding distance of the protrusion is limited by a length of the chute so as to limit a rotation angle range of the cutting blade relative to the conveying member.

In some embodiments, the adjustment member is provided with a receiving cavity facing the first opening, the support member and the cutting blade being capable of extending out of or retracting into the adjustment member via the receiving cavity.

When the valve treatment device disclosed by the invention is used for cutting a valve, the first operation piece is pushed so that the first supporting part accommodated in the sheath tube is initially released from the sheath tube to be attached to the valve, then the first operation piece is further pushed so that the first supporting part is further expanded to a fully expanded form, the valve is attached to the valve in a compliant manner and is pressed down, and the second operation piece is operated so that the valve is cut by the cutting piece. In particular, since the first support portion has a pre-curved surface, when the first support portion is released from the sheath tube, i.e., is not pressed by external pressure, the first support portion will automatically return to its pre-curved surface, and at the same time, the first operating member applies a pushing force proximally along the axial direction of the blood vessel, so that the first support portion is further curved along the pre-curved surface, thereby conforming to the valve and pressing the valve. During the cutting process, the valve is stably clamped under the upward impact action of blood flow and the downward pressing action of the first supporting part, and is not easy to float or free under the blood flow impact action, so that the cutting piece can cut the valve more stably and accurately. In addition, the valve is not required to be clamped by the supporting parts on two sides of the valve, the structure is simple and compact, and the damage risk to the valve is reduced.

Drawings

FIG. 1 is a perspective view of a valve treatment apparatus of a first embodiment of the present invention;

FIG. 2 is an exploded view of the valve treatment device of FIG. 1;

FIG. 3 is a simplified schematic diagram of the valve treatment apparatus of FIG. 1 supporting a valve;

FIG. 4 is a perspective view of a first support portion of the valve treatment apparatus of FIG. 1;

FIG. 5 is a side view of the first support section of FIG. 4;

FIG. 6 is a bottom view of the first support section of FIG. 4;

FIG. 7 is a schematic view of a relief portion of the cutting blade through the first support portion of FIG. 4;

FIG. 8 is a schematic view of a cutting blade extending into the relief portion of the first support portion of FIG. 4;

FIG. 9 is an alternative embodiment of the first support shown in FIG. 4;

FIG. 10 is an exploded view of a cutting assembly of the valve treatment device of FIG. 2;

FIG. 11 is a cross-sectional view of a cutting assembly of the valve treatment apparatus of FIG. 2;

FIG. 12 is a perspective view of another alternative embodiment of the cutting assembly shown in FIG. 10;

FIG. 13 is an exploded view of the cutting assembly of FIG. 12;

FIG. 14 is a perspective view of yet another alternative embodiment of the cutting assembly shown in FIG. 10;

FIG. 15 is a cross-sectional view of the cutting assembly of FIG. 14;

FIG. 16 illustrates the cutting blade of the cutting assembly of FIG. 15 in one of its extreme positions;

FIG. 17 illustrates the cutting blade of the cutting assembly of FIG. 15 in another extreme position;

FIG. 18 is a perspective view of a valve treatment apparatus of a second embodiment of the present invention;

FIG. 19 illustrates a compressed configuration of a second support portion of the valve treatment apparatus of FIG. 18;

FIG. 20 is a schematic illustration of an aortic valve bivalvulation deformity;

FIG. 21 illustrates cutting the adhesion between the leaflets of the aortic valve shown in FIG. 20 with the cutting blade of the valve treatment apparatus of the present invention;

FIG. 22 illustrates a middle position of the leaflets of the aortic valve shown in FIG. 20 cut with the cutting blade of the valve treatment apparatus of the present invention;

figure 23 shows the aortic valve after one of the leaflets is centered and cut by the cutting blade of the valve treatment apparatus of the present invention.

Detailed Description

The following detailed description of the invention refers to the accompanying drawings and the detailed description of the invention, so that the technical scheme and the beneficial effects of the invention are more clear. It is to be understood that the drawings are designed solely for the purposes of illustration and not as a definition of the limits of the invention, for which the dimensions are shown in the drawings for the purpose of clarity only and do not limit the true to scale.

It should be noted that, herein, the distal end refers to the end of the device away from the operator, and the proximal end refers to the end of the device close to the operator.

Referring to fig. 1 and 2, a valve treatment apparatus 100 of a first embodiment of the present invention includes a sheath 10, a first support assembly 20, and a cutting assembly 30, which have central axes coincident. Alternatively, the sheath 10 may be made of hypotube or polymeric material. The first support assembly 20 includes a first operating member 23, a first support portion 21 at a distal end thereof. Alternatively, the first supporting portion 21 is connected to the first operating member 23 through a connecting end 219. It will be appreciated that in other embodiments, a plurality of first support portions 21 may be provided, which are distributed along the circumferential direction of the connecting end 219.

The first support portion 21 has a compressed form in which it is compressed in the radial direction and accommodated in the sheath 10 and is pressed against the inner wall of the sheath 10, and an expanded form in which it is self-deformed and expanded in the radial direction after being released from the sheath 10 as shown in fig. 1. Preferably, the first supporting portion 21 is an elastic member configured to be elastically bendable and deformable from the compressed configuration to the expanded configuration when the external pressure is released. The first support 21 may be converted to the compressed configuration by pulling the first operating member 23 rearward or pushing the sheath 10 forward to be received in the sheath 10. The first support 21 may be changed to the expanded configuration by being released from the sheath 10 by pushing the first operating member 23 forward or pulling the sheath 10 rearward.

In the expanded configuration of the first support portion 21, the first support portion 21 has a pre-curved surface extending outwardly from the connecting end 219 to a free end 213 in a direction away from the central axis L of the sheath 10, wherein the pre-curve Qu Humian projects towards the central axis of the sheath 10, in other words, the pre-curved surface encloses a groove facing away from the central axis of the sheath 10.

The cutting assembly 30 includes a second operating member 35 and a cutting blade 31 coupled to the second operating member 35. The cutting blade 31 is movable to a distal end of the first support 21 in the expanded configuration and is operated by the second operating member 35 to cut a valve located between the first support assembly 20 and the cutting assembly 30.

Referring to fig. 1 and 3, when it is desired to cut a valve, the valve treatment device 100 is delivered to the valve V to be cut (S1); by withdrawing the sheath 10 proximally or pushing the first support assembly 20 distally forward, the first support 21 housed within the sheath 10 is released from within the sheath 10 to transition from the compressed configuration to the expanded configuration (S2); conformably pressing the first support 21 in the expanded configuration against the first surface V1 of the valve V (S3); releasing the cutting blade 31 of the cutting assembly 30 at a second surface V2 of the valve V opposite to the first surface V1, such that the portion of the valve V to be cut is located between the first support 21 and the cutting blade 31 (S4); finally, the cutting blade 31 is driven again to cut the valve V. During the cutting process, since the first support portion 21 is supported on the first surface V1 of the valve V, the cutting blade 31 can stably and precisely cut the valve V, and the valve is supported by the first support portion 21, so that the structure is simplified. In particular, the valve treatment device of the present embodiment is particularly suitable for cutting aortic valves.

In practice, when the valve treatment apparatus 100 of the present embodiment is used to cut a human heart aortic valve, a small opening may be cut at the femoral artery, the sheath 10 may be inserted into a blood vessel from the small opening, and passed through the aortic arch, the ascending aorta, along the blood vessel, and to the aortic valve. At this time, the first surface V1 of each leaflet VL of the valve V encloses a sinus cavity, the first surface V1 of each leaflet VL serves as a sinus cavity wall of the sinus cavity, and the second surface V2 of each leaflet VL of the valve V is opposite to the blood flow of the heart. Since the first supporting portion 21 has the pre-curved surface, when the first supporting portion 21 is released from the sheath 10, that is, is not pressed by external pressure, the first supporting portion 21 will automatically return to its pre-curved surface, and at the same time, the first operating member 23 applies a pushing force proximally along the axial direction of the blood vessel, so that the first supporting portion 21 is further curved along the pre-curved surface, thereby conforming to the valve and pressing the valve. Therefore, the leaflet VL to be cut is stably held by the impact of the blood flow and the pressing action of the first supporting portion 21, and is not easily floated or dissociated by the impact of the blood flow, so that the cutting blade 31 can cut the leaflet VL more stably and accurately. In addition, the supporting parts are not required to be arranged on two sides of the valve leaflet VL so as to clamp the valve leaflet VL, so that the valve leaflet VL is simple in structure and the damage risk to the valve leaflet VL is reduced.

Preferably, the cutting blade 31 is also electrically connected to a high frequency ablator, wherein the rest of the cutting blade 31, except for its cutting tip or a portion of the cutting tip, is insulated (surface coating or spraying, etc. may be used) to ensure energy concentration (S5). In this way, the cutting blade 31 combines both mechanical and electrical cutting, and the cutting effect is better. When cutting, the cutting blade 31 may be secured and the entire cutting assembly 30 pulled proximally to cut the valve (S6.1). Alternatively, the cutting blade 31 may be independently moved along a circular path to cut the valve (S6.2).

In one embodiment, the cutting assembly 30 may also be configured to break at least a portion of the valve by non-contact. For example, the cutting assembly 30 includes a second operating member 35 and a cutting member, which may not be a sharp blade but rather a structure made of a material that can be electrically conductive, connected to the second operating member 35, which cutting member is electrically connected to an ablation element, which may be, for example, a high frequency ablation instrument, which receives energy delivered by the ablation element, through at least a portion of the non-contact, disrupted valve. At least part of the broken valve can penetrate the valve in the thickness direction, and calcification on the surface of the broken valve can be broken but the valve is not broken.

Referring to fig. 1, 4 and 5, preferably, in the expanded configuration of the first support 21, the first support 21 comprises an arcuate first section 211 extending outwardly and distally away from the central axis L of the sheath 10, and a second section 212 extending further proximally inwardly from the first section 211 to the free end 213, wherein the connection of the first section 211 and the second section 212 forms an abutment 210 for abutment with a leaflet VL. Such a first support 21 may more conformably conform to the sinus wall of the valve, thereby more stably supporting and positioning the valve. Further, the arc-shaped supporting part 210 of the first supporting part 21 is propped against the sinus cavity wall of the valve, so that the damage of the first supporting part 21 to the valve can be effectively prevented, and the positioning effect is good.

Preferably, the second section 212 of the first support 21 extends from the abutment 210 in a direction towards the proximal end and away from the central axis L of the sheath 10, and further extends in a direction towards the proximal end and towards the central axis L of the sheath 10 to the free end 213, which helps to prevent the free end 213 from scratching the blood vessel. The bending radius R of the second section 212 is preferably in the range of 1-3 mm, more preferably 1-2 mm, most preferably 1.5mm, which helps the first support 21 to rest more stably against the sinus wall of the valve. The angle α between the tangent to the free end 213 and the central axis L of the sheath 10 is preferably in the range of 10-60 °, more preferably 20-30 °, most preferably 26 °, which helps to more effectively prevent the free end 213 from scratching the blood vessel. It is also preferred that the tangent of the free end 213 is substantially parallel to the tangent of the initial section 211a of the first section 211. In other words, the angle between the tangent of the initial section 211a of the first section 211 and the central axis L of the sheath 10, i.e. the angle at which the initial section 211a of the first section 211 deviates from the central axis L of the sheath 10, is also preferably in the range of 10-60 °, more preferably 20-30 °, most preferably 26 °, which facilitates a better fitting of the first support 21 on the sinus cavity wall.

Referring to fig. 6, in a plane perpendicular to the central axis L of the sheath tube 10, the maximum central angle β corresponding to both circumferential sides of the first support portion 21 (i.e., the maximum included angle between the lines of the both circumferential sides of the first support portion 21 and the central axis L of the sheath tube 10, respectively) is in the range of 5 to 180 °, preferably in the range of 10 to 90 °, preferably in the range of 10 to 60 °, more preferably in the range of 30 to 40 °, and most preferably 33 °. The first support portion 21 of the present embodiment is more compact in structure than a support portion extending 360 degrees in the circumferential direction. Preferably, the free end 213 has the maximum central angle β, which helps the free end 213 of the first support 21 to more stably fit against the sinus cavity wall. The maximum width W of the first support portion 21 in the circumferential direction is preferably in the range of 2 to 20mm, and most preferably in the range of 5 to 10 mm. Preferably, the free end 213 has the maximum width W. In practice, the sinus cavity of the heart valve of the human body has a larger opening at the top and a narrower bottom. The width of the first support part 21 in the circumferential direction is too large to be easily inserted into the sinus floor; while the width of the first support 21 in the circumferential direction is too small to easily align and position the valve. The first support 21 of this embodiment not only allows for easy insertion into the sinus cavity bottom, but also allows for easy alignment and positioning of the valve for cutting the middle of the valve.

Referring again to fig. 4, as previously described, the first support 21 is preferably made of a material capable of elastically bending and deforming so that the first support 21 can be easily received to the sheath 10 while stably supporting the valve. More preferably, the first support 21 is made of a shape memory material, for example, nitinol. Thus, when the primary support 21 in its compressed configuration is released from the sheath 10, the primary support 21 can self-expand to its expanded configuration. In this embodiment, the first supporting portion 21 is formed by cutting and bending a metal sheet, and includes a plurality of supporting ribs 214. A plurality of support ribs 214 enclose one or more grids 215. In other embodiments, the first support 21 may be formed from wire in other ways. For example, the first support 21 may be a single wire structure. Alternatively, the first support 21 may be formed by twisting a plurality of wires. Alternatively, the first supporting portion 21 may be formed by braiding a plurality of wires.

Referring to fig. 4 and 7, it is also preferable that a relief portion 216 is provided on the first supporting portion 21 for relieving the cutting blade 31. In the present embodiment, both sides in the thickness direction of the first support portion 21 have a first surface 217 and a second surface 218. The relief portion 216 extends through a first surface 217 and a second surface 218 of the first support portion 21. The relief 216 may be formed by one of the grids 215. Preferably, the relief 216 is located approximately in the middle of the first section 211 of the first support 21 so that the cutting blade 31 can cut against the middle of the valve. The cutting blade 31 may cut through the relief 216 to a second surface 218 that protrudes from the first support. It will be appreciated that in other embodiments, as shown in fig. 8, the cutting blade 31 may extend into the relief portion 216 only to cut without penetrating the relief portion 216.

It will also be appreciated that in other embodiments, the relief portion may take other forms. As shown in fig. 9, the relief portion 216a is recessed from the first surface 217 of the first support portion 21 toward the second surface 218 of the first support portion 21 without penetrating the second surface 218 of the first support portion 21. When cutting, the cutting blade 31 extends into the escape portion 216a and is blocked by the ribs of the first support portion 21 made of solid material.

Referring again to fig. 1 and 2, in the present embodiment, the first support assembly 20 further preferably includes a protective sheet 22 connected to the first support 21. The protective sheet 22 may be made of a metal sheet having elasticity. The protective sheet 22 corresponds to the position of the relief portion 216 and covers the relief portion 216 to protect tissue (e.g., an inner wall of a blood vessel) from the cutting blade 31 penetrating the relief portion 216. In addition, the protective sheet 22 can also function as a visualization during surgery. Specifically, with the aid of the imager, when the cutting blade 31 is observed to pass through the relief 216 against the protective sheet 216 such that the protective sheet 216 is clear of the first support 21, indicating that the cutting blade 31 has pierced the valve to be cut, the cutting blade 31 may be secured at this point and the entire cutting assembly 30 may then be pulled proximally to cut the entire valve. This effectively solves the problem of the small cutting blade that it is inconvenient to observe by the imager if the cutting blade has pierced the valve. In this embodiment, the protection sheet 22 is configured to be attached to the second surface 218 of the first supporting portion 21 when not being abutted by the cutting blade 31 so as to cover the relief portion 216, and the protection sheet 22 is elastically deformed and separated from the second surface 218 of the first supporting portion 21 when being abutted by the cutting blade 31.

It will be appreciated that in other embodiments, the protective sheet 22 may be configured to be spaced from the second surface 218 of the first support portion 21 when not being abutted by the cutting blade 31, so long as the protective sheet is positioned to correspond to the relief portion 216 so as to protect tissue from the cutting blade 31 penetrating the relief portion 216.

In this embodiment, the first operating member 23 preferably comprises a catheter or a traction wire slidably received in the sheath 10 and having a proximal end connected to a handle (not shown). The first operating member 23 is driven to slide within the sheath 10 by the handle so that the first supporting portion 21 can be moved into the sheath 10 or removed from the sheath 10. In this embodiment, the first operating member 23 comprises a catheter. The first operating member 23 is fixedly connected to the start end of the first section 211 via the connecting end 219.

The first support assembly 20 further includes a connection pipe 24 fixedly connected to the protection sheet 22. The connecting pipe 24 is sleeved on the first operating member 23 and is preferably fixedly connected with the first operating member 23. Thus, when the first operating member 23 drives the first supporting portion 21 to enter or move out of the sheath 10, the protecting piece 22 can also follow the first supporting portion 21 to enter or move out of the sheath 10 together, which is convenient to operate. Of course, in other embodiments, the connection tube 24 and the first operation member 23 may be independently driven, and thus the protection sheet 22 and the first support portion 21 may be independently driven.

In this embodiment, the cutting assembly 30 is received within the connecting tube 24, and the connecting tube 24 has a connecting tube opening 240 through a sidewall thereof to allow the cutting blade 31 to protrude from the connecting tube 24.

Referring to fig. 2, 10 and 11, in the present embodiment, the cutting assembly 30 includes a conveying member 32, an adjusting member 33 slidably connected to the conveying member 32, a supporting member 34 hinged to the adjusting member 33, and the cutting blade 31 hinged to the supporting member 34 and the conveying member 32, and the cutting blade 31 is configured to be driven to rotate by the linear movement of the adjusting member 33 along the conveying member 32 via the supporting member 34.

Specifically, referring to fig. 10, in this embodiment, the conveying member 32 has a tubular shape, and a first opening 320 extending axially and penetrating a sidewall thereof is provided. The regulating member 33 is accommodated in the conveying member 32. In this embodiment, the adjusting member 33 has a longitudinal rod shape, and a receiving cavity 330 facing the first opening 320 is disposed therein. Preferably, the receiving cavity 330 extends axially and radially through the adjustment member 33. The support 34 and the cutting blade 31 are movable to be accommodated in the accommodation chamber 330 of the regulating member 33 and thus also in the conveying member 32, and are extendable from the regulating member 33 and the conveying member 32 via the accommodation chamber 330 and the first opening 320 so that the cutting blade 31 performs cutting.

More specifically, the side wall of the conveying member 32 is provided with opposite elongated sliding grooves 321, preferably having two sets of opposite sliding grooves 321 arranged at intervals in the axial direction. Correspondingly, the adjusting member 33 is provided with two protruding

columns

331a, 331b. Each of the

bosses

331a, 331b is slidably engaged with the corresponding two slide grooves 321, such that the adjusting member 33 is slidably received in the conveying member 34. In particular, the sliding groove 321 can also limit the protruding

columns

331a and 331b, so as to limit the sliding displacement of the adjusting member 33, so as to prevent dead points during movement. Preferably, the support 34 is configured as a U-shaped member having a U-shaped opening 340 and its closed end is hinged to the adjustment member 33 by one of the bosses 331 a. The open end of the support 34 is hinged to a substantially central portion of the cutting blade 31. The end of the cutting blade 31 remote from its cutting tip is hinged to the conveying member 32 by a rotary shaft 310, wherein the rotary shaft 310 is inserted into opposite holes 322 in the conveying member 32. The two hinge points of the cutting blade 31, which are hinged to the supporting member 34 and the conveying member 32, are located on two radial sides of the adjusting member 33, that is, on two sides of the plane on which the central axes of the two protruding

columns

331a, 331b are located, in other words, the two hinge points of the cutting blade 31 and the two protruding

columns

331a, 331b are not located on the same plane, which effectively avoids dead points during movement.

When the cutting blade 31 is required to rotate, the second operating member 35 drives the adjusting member 33 to slide along the conveying member 32, the adjusting member 33 drives the supporting member 34 to swing, the supporting member 34 drives the cutting blade 31 to rotate around the rotating shaft 310, and the design of the U-shaped opening 340 and the accommodating cavity 330 ensures that the cutting blade 31 can rotate within a certain range. More specifically, when the second operating member 35 is pulled, the cutting blade 31 can be rotated in the clockwise direction as viewed in fig. 10 to receive the cutting tip thereof in the receiving cavity 330, so as to reduce the overall radial dimension of the cutting assembly 30 for convenient transportation; at this time, to prevent the dead point, a corresponding protrusion 331b may be used to abut against the cutting tip of the cutting blade 31, thereby forming a limit fit structure. When the second operating member 35 is pushed, the cutting blade 31 can be rotated in the counterclockwise direction as shown to extend its cutting tip out of the receiving cavity 330 for cutting; similarly, to prevent dead spots, the closed end of the support 34 may be utilized to abut the cutting tip of the cutting blade 31.

Referring again to fig. 2, in this embodiment, the valve treatment device further comprises a catheter 41 fixedly connected to both ends of the delivery member 32, and a driving shaft 42. A catheter 41 extends through the entire device for threading a guidewire for creating a passageway within the vessel to guide the entire device along the guidewire into the vessel. The drive shaft 42 may be used to attach another guidewire to enable the cutting assembly 30 to be moved entirely into or out of the sheath 10. In other words, in the present embodiment, the cutting assembly 30 and the first supporting assembly 10 are independently driven, respectively. It will be appreciated that in other embodiments, the cutting assembly 30 and the primary support assembly 10 may be fixedly coupled such that the cutting assembly 30 and the primary support assembly 10 may be driven into and out of the sheath 10 as a whole by the drive shaft 42. In this embodiment, the distal end of the cutting assembly 30 is also preferably connected to a tapered tip 43 as shown in fig. 18 to guide the entire device through the blood vessel, preventing the front end of the device from damaging tissue within the blood vessel.

It will be appreciated that in other embodiments, the cutting blade 31 may be driven in other configurations.

As shown in fig. 12 and 13, in an alternative embodiment, the cutting assembly 30a includes a conveying member 32a, an adjusting member 33a slidably coupled to the conveying member 32a, a supporting member 34a hinged to the adjusting member 33a, and a cutting blade 31a hinged to the supporting member 34a and the conveying member 32a, and the cutting blade 31a is configured to be driven to rotate by the linear movement of the adjusting member 33a along the conveying member 32a via the supporting member 34 a.

Specifically, the conveying member 32a has a tubular shape, and is provided with a first opening 320a extending axially and penetrating a sidewall thereof, and two diametrically opposite elongated first sliding grooves 321a extending axially. The adjusting member 33a is generally tubular and is accommodated in the conveying member 32a, and has an accommodating cavity 330a extending axially and penetrating a sidewall thereof, and two radially opposite elongated second sliding grooves 332a extending axially, wherein the accommodating cavity 330a faces the first opening 320a. It will be appreciated that in other embodiments, the adjustment member may take other shapes and/or configurations. The support 34a is configured as a U-shaped member having a U-shaped opening 340 a. The closed end of the supporting member 34a is connected to a boss 341a, the boss 341a penetrates the adjusting member 33a and is rotatably connected thereto, and the boss 341a is slidably engaged into the first sliding groove 321a. The open end of the support 34a is hinged to a substantially middle portion of the cutting blade 31 a. The end of the cutting blade 31a remote from the cutting tip thereof is hinged to the conveying member 32a by a rotation shaft 310a, wherein a recess 342a recessed from one side thereof is provided at a substantially middle position of the supporting member 34a, and the rotation shaft 310a penetrates through the end of the cutting blade 31a remote from the cutting tip thereof and sequentially penetrates through the recess 342a of the supporting member 34a, the second sliding groove 332a of the adjusting member 33a to be rotatably connected to the conveying member 32a, wherein the rotation shaft 310a is slidably connected to the second sliding groove 332 a.

When the adjusting member 33a is driven by the second operating member 35 to slide in the conveying member 32a, the boss 341a slides in the first sliding slot 321a along with the adjusting member 33a, so as to drive the supporting member 34a to swing, and the supporting member 34a drives the cutting blade 31a to rotate around the rotating shaft 310 a. More specifically, when the second operating member 35 pushes the regulating member 33a to slide forward (distally), the boss 341a slides from right to left (shown in fig. 13) within the first sliding groove 321a, and the second sliding groove 332a slides forward with respect to the rotating shaft 310a, the supporting member 34a swings to disengage the rotating shaft 310a from the groove 342a, and the cutting blade 31a can be rotated to have its cutting tip protrude from the receiving cavity 330a to perform cutting; when the second operating member 35 pulls the adjusting member 33a to slide backward, the boss 341a slides from left to right in the first sliding groove 321a, and the second sliding groove 332a slides backward with respect to the rotating shaft 310a, the supporting member 34a swings such that the groove 342a is engaged with the rotating shaft 310a again, and the cutting blade 31a can be rotated such that the cutting tip thereof is received in the receiving cavity 330 a.

Still alternatively, as shown in fig. 14 and 15, in another alternative embodiment, the cutting assembly 30b includes a conveying member 32b, an adjusting member 33b slidably coupled to the conveying member 32b, a supporting member 34b hinged to the adjusting member 33b, and a cutting blade 31b hinged to the supporting member 34b and the conveying member 32b, and the cutting blade 31b is configured to be driven to rotate by a linear motion of the adjusting member 33b along the conveying member 32b via the supporting member 34 b.

Specifically, the conveying member 32b has a tubular shape, and is provided with a first opening 320b extending axially and penetrating a sidewall thereof, and two diametrically opposite elongated first sliding grooves 321b extending axially. The regulator 33b has a generally T-shaped cross section with a short length, and is slidably accommodated in the conveyor 32 b. The support 34b is configured as a U-shaped member having a U-shaped opening 340 b. The closed end of the supporting member 34b is connected to a boss 341b, the boss 341b penetrates the adjusting member 33b and is rotatably connected thereto, and the boss 341b is slidably engaged into the first sliding groove 321b. The open end of the support 34b is hinged to a substantially middle portion of the cutting blade 31 b. The end of the cutting blade 31b remote from the cutting tip thereof is hinged to the conveying member 32b by a rotation shaft 310 b.

When the adjusting member 33b is driven by a second operating member (e.g. a guide wire) to slide in the conveying member 32b, the boss 341b slides in the first sliding groove 321b, so as to drive the supporting member 34b to swing, and the supporting member 34b drives the cutting blade 31b to rotate around the rotating shaft 310 b. Fig. 16 shows that by pushing the adjusting member 33b, the cutting blade 31b is rotated counterclockwise to a limit position where the cutting tip thereof is received in the U-shaped opening 340b, and fig. 17 shows that by pulling the adjusting member 33b, the cutting blade 31b is rotated clockwise to another limit position where the cutting tip thereof is away from the U-shaped opening 340 b.

Referring to fig. 18, a valve treatment device 200 of the second embodiment of the present invention is generally similar to the valve treatment device 100 of the first embodiment, and the details thereof are not repeated here. The valve treatment device 200 of the second embodiment of the present invention differs from the valve treatment device 100 of the first embodiment mainly in that: the valve treatment apparatus 200 of the present embodiment further includes a second support assembly 50, wherein the cutting assembly 30 is positioned within the second support assembly 50.

Specifically, the first supporting portion 221 of the present embodiment may employ the first supporting portion 21 of the previous embodiment, which is not described herein. The second support assembly 50 includes a second support portion 51 at a distal end thereof, and a third operating member 53 fixedly connected to the second support portion 51, specifically, a proximal end of the second support portion 51 is connected to the third operating member 53, and a distal end of the second support portion 51 is freely movable. The second supporting portion 51 has a compressed configuration shown in fig. 19 to be compressed in the radial direction and accommodated in the sheath 10, and a substantially balloon-shaped, net-shaped expanded configuration shown in fig. 18 to be released from the sheath 10 and expanded in the radial direction, the distal end of the second supporting portion 51 being moved proximally when expanded, and the first supporting portion 221 being located proximally of the second supporting portion 51 in the expanded configuration of the first supporting portion 221 and the expanded configuration of the second supporting portion 51. The second support 51 may be made of nitinol, stainless steel, or other suitable material. The third operating member 53 may comprise a catheter or a pull wire slidably received within the sheath 10. Further, in the present embodiment, the third operating member 53 is slidably received in the first operating member 23 configured as a catheter. When the third operating member 53 pulls the second supporting portion 51 to be received in the first operating member 23, the second supporting portion 51 assumes a compressed configuration as shown in fig. 19 under the constraint of the first operating member 23. And when the third operating member 53 pushes the second supporting portion 51 to release it from the first operating member 23 and the sheath 10, the second supporting portion 51 self-expands to the expanded configuration shown in fig. 18.

When cutting the valve, the second support part 51 can be pushed forward by the third operation member 53 to release from the first operation member 23 and the sheath 10, at this time the second support part 51 self-expands to its expanded configuration, and then the whole device is slowly withdrawn so that the second support part 51 is gently supported on the lower surface of the valve; pushing the first operating member 23 forward again to release the first supporting portion 221 from the sheath 10 to self-deform to the expanded configuration, and pressing the first supporting portion 221 against the upper surface of the valve, at this time, the valve is stably clamped between the first supporting portion 221 and the second supporting portion 51; the cutting blade 31 in the second support 51 in the shape of a ball cage is then driven to pass through the mesh of the second support 51 in the expanded configuration so that the cutting blade 31 reaches a position where it is able to cut the valve, i.e. a cut can be made. When such a device is used to cut a heart valve in a human body, the valve can be stably held by the first support 221 and the second support 51 even when the heart contractions are encountered without pumping blood outwards (i.e., without impacting the blood flow of the valve upwards). In this case, the first support 221 may not need to excessively press down the valve and may also keep the valve stable.

Alternatively, the first operating member 23 may be pushed forward first, so that the first supporting portion 221 is released from the sheath 10 to be self-deformed to the expanded configuration, and the first supporting portion 221 is pressed against the upper surface of the valve; then the third operating member 53 is pushed forward again, so that the second supporting portion 51 is released from the first operating member 23 and the sheath 10, at which time the second supporting portion 51 self-expands to the expanded configuration and the second supporting portion 51 is lifted to be supported on the lower surface of the valve; at this time, the valve is stably clamped between the first support 221 and the second support 51; the cutting blade 31 in the second support 51 in the shape of a ball cage is then driven to pass through the mesh of the second support 51 in the expanded configuration so that the cutting blade 31 reaches a position where it is able to cut the valve, i.e. a cut can be made. When such a device is used to cut a heart valve in a human body, the valve can be stably held by the first support 221 and the second support 51 even when the heart contractions are encountered without pumping blood outwards (i.e., without impacting the blood flow of the valve upwards). In this case, the first support 221 may not need to excessively press down the valve and may also keep the valve stable.

It will be appreciated that in other embodiments, the second support 51 may be driven in other ways to transition between its compressed and expanded configurations. For example, the proximal end of the second support portion 51 may be fixedly connected to the first operation member, and the distal end of the second support portion 51 may be fixedly connected to the third operation member. When the second supporting portion 51 needs to be made to assume the compressed configuration, the proximal end of the second supporting portion 51 is fixed, and the distal end of the second supporting portion 51 is driven away from the proximal end of the second supporting portion 51 by the third operating member, so that the second supporting portion 51 is axially compressed to assume the compressed configuration. When the second supporting portion 51 needs to be expanded, the proximal end of the second supporting portion 51 is fixed, and the distal end of the second supporting portion 51 is driven to approach the proximal end of the second supporting portion 51 by the third operating element, so that the second supporting portion 51 is radially expanded to assume the expanded configuration. In this case, the third operating element is preferably in the form of a traction wire. In this case, the third operating element may be housed in the first operating element or may be provided in the sheath 10 side by side with the first operating element.

The use of any of the foregoing valve treatment devices will be described in the following by way of example. Fig. 20 is a schematic representation of an aortic valve bivalvulation deformity. As shown, the aortic valve includes three leaflets VL. An adhesion AD exists between adjacent leaflets VL, and calcifications CA are also adhered to each leaflet VL. The adhesions AD and calcifications CA limit the normal opening and closing of the valve leaflet VL.

Fig. 21 shows that the adhesive AD between the leaflets VL of the aortic valve shown in fig. 20 is cut by the cutting blade 31 of the valve treatment apparatus of any of the foregoing embodiments to separate the two leaflets VL, thereby restoring the normal opening and closing functions of the valve. The method can effectively solve the problem of stenosis of the native valve caused by adhesion and fibrosis at the valve juncture, and can also be used for solving the problem of valve She Nianlian caused by structural valve degeneration after a valve replacement operation.

Fig. 22 shows a central position of the leaflets of the aortic valve shown in fig. 20 cut with the cutting blade 31 of the valve treatment apparatus of any of the foregoing embodiments so that the leaflets are separated into two pieces. This can effectively prevent the risk of coronary occlusion after a transcatheter aortic valve replacement procedure, with simple operation of the procedure. Fig. 23 shows the aortic valve after one of the leaflets is centered cut by the cutting blade 31 of the valve treatment apparatus of any of the previous embodiments.

It will be appreciated that in other embodiments, the valve treatment device of any of the foregoing embodiments may also be used in any suitable situation where a valve is to be cut, e.g., the valve treatment device of any of the foregoing embodiments may also be used to cut calcifications on a valve, etc.

The above description is merely of a preferred embodiment of the present invention, the protection scope of the present invention is not limited to the above-listed examples, and any simple changes or equivalent substitutions of the technical solutions that can be obviously obtained by those skilled in the art within the technical scope of the present invention disclosed in the present invention fall within the protection scope of the present invention.

Claims

1. A valve treatment device, the valve treatment device comprising:

a sheath having a central axis;

a first support assembly comprising a first operating member and a first support connected to the first operating member, the first support having a compressed configuration radially compressed and received within the sheath and an expanded configuration radially expanded upon release from the sheath, wherein the first support in the expanded configuration has a pre-curved arcuate surface extending away from the central axis of the sheath, the first operating member being adapted to be operated to conform the first support to a surface of the valve in the expanded configuration, wherein the pre-curve Qu Humian of the first support is convex towards the central axis of the sheath; and

A cutting assembly including a second operating member and a cutting member coupled to the second operating member, the second operating member adapted to be operated to fracture at least a portion of the valve.

2. The valve treatment device of claim 1, wherein the cutting member is configured to electrically connect with an ablation element to receive energy delivered by the ablation element to commissure at least a portion of the valve by non-contact.

3. The valve treatment device of claim 1, wherein the cutting member comprises a cutting blade coupled to the second operating member, the second operating member adapted to be operated to cause the cutting blade to cut the valve between the first support and the cutting blade.

4. The valve treatment device of claim 3, wherein the cutting blade is configured to electrically connect with an ablation element to receive energy delivered by the ablation element to cut at least a portion of the valve by contact.

5. The valve treatment device of claim 1, wherein the first support has a connection end connected to the first operating member, the first support comprising a first section that, in the expanded configuration, extends outwardly and distally from the connection end toward the central axis away from the sheath, the first section having a pre-curved arcuate surface.

6. The valve treatment device of claim 5, wherein the first support further comprises a second section, the junction of the first section and the second section forming an abutment for abutting a surface of the valve, the second section extending proximally from the abutment in the expanded configuration, the end of the second section remote from the abutment being a free end, the second section having a pre-curved arcuate surface.

7. The valve treatment device of claim 6, wherein in the expanded configuration, the second section extends from the abutment portion to the free end, bending first in a direction proximal and away from the central axis of the sheath, and further in a direction proximal and toward the central axis of the sheath.

8. The valve treatment device of claim 6, wherein the second section has a radius of curvature in the range of 1mm to 3 mm; and/or the included angle between the tangent line of the free end and the central axis of the sheath tube is in the range of 10-60 degrees.

9. The valve treatment device of claim 1, wherein a maximum central angle corresponding to both circumferential sides of the first support portion in a plane perpendicular to the central axis of the sheath is in a range of 10 ° to 60 °; and/or the maximum width of the first supporting part along the circumferential direction of the sheath tube is in the range of 2 mm-20 mm.

10. The valve treatment device of claim 1, wherein the first support is a resilient member configured to resiliently flex from the compressed state to the expanded state upon withdrawal of an external compressive force.

11. The valve treatment device of claim 1, wherein the first support is a single wire structure; or the first supporting part is a plurality of metal wire twisting structures; or the first supporting part is a multi-wire braided structure.

12. The valve treatment device of claim 1, wherein the first support is a cut sheet metal structure, the first support including a plurality of support ribs, the plurality of support ribs circumscribing to form one or more grids.

13. The valve treatment device according to claim 3, wherein the first support portion has a first surface and a second surface on both sides in a thickness direction thereof, and the first support portion is provided with a relief portion recessed from the first surface toward the second surface or penetrating the first surface and the second surface, the relief portion being for passing the cutting blade therethrough to cut the valve.

14. The valve treatment device of claim 3, wherein the first support portion has a first surface and a second surface on both sides in a thickness direction thereof, the first support portion being provided with a relief portion penetrating the first surface and the second surface for passing the cutting blade therethrough to cut the valve, the first support assembly further comprising a protective sheet connected to the first support portion, the protective sheet being configured to at least partially cover the relief portion to prevent the cutting blade from contacting an inner wall of a blood vessel.

15. The valve treatment device of claim 14, wherein the valve treatment device comprises,

the protective sheet is configured to be attached to the second surface so as to cover the avoiding portion when not being abutted by the cutting blade, and is elastically deformed and separated from the second surface when being abutted by the cutting blade; or (b)

The protective sheet is configured to cover the relief portion without being abutted by the cutting blade and has a distance from the second surface.

16. The valve treatment device of claim 1, wherein the first operating member comprises a catheter or a pull wire slidably received within the sheath.

17. The valve treatment device of claim 16, further comprising a second support assembly, the second support assembly comprising:

a second support portion having a compressed configuration radially compressed and received within the sheath and an expanded configuration released radially expanded from the sheath; and

and a third operating member connected to the second support portion, the third operating member being operable to cause the second support portion in the expanded configuration to cooperate with the first support portion in the expanded configuration to clamp the valve.

18. The valve treatment device of claim 17, wherein the third operating member comprises a catheter or a pull wire slidably received within the sheath.

19. The valve treatment device of claim 18, wherein a proximal end of the second support is fixedly connected to the first operating member, a distal end of the second support is fixedly connected to the third operating member, and the third operating member is configured to drive the distal end of the second support toward or away from the proximal end of the second support to switch the second support between the expanded configuration and the compressed configuration.

20. The valve treatment device of claim 18, wherein the first operating member comprises a catheter slidably disposed within the sheath, at least a portion of the third operating member is slidably disposed within the first operating member, the second support portion assumes a compressed configuration under the constraint of the first operating member, and the second support portion is self-expanding to an expanded configuration upon release from the first operating member.

21. The valve treatment device of claim 3, wherein the cutting assembly further comprises a delivery member, an adjustment member coupled to the second operating member and slidably coupled to the delivery member, and a support member hinged to the adjustment member, the cutting blade hinged to the support member and the delivery member, the second operating member being adapted to be operated to slide the adjustment member over the delivery member to thereby drive the support member to oscillate, thereby rotating the cutting blade relative to the delivery member.

22. The valve treatment device of claim 21, wherein the delivery member is tubular and has a first opening extending axially through a sidewall thereof, the support member and the cutting blade being movable into or out of the delivery member via the first opening.

23. The valve treatment device of claim 22, wherein a chute is provided on a side wall of the delivery member, wherein a post is provided on the adjustment member, wherein the post is slidably received in the chute such that the adjustment member slides within the delivery member, and wherein a sliding distance of the post is defined by a length of the chute to define a range of rotational angles of the cutting blade relative to the delivery member.

24. The valve treatment device of claim 23, wherein the regulator is provided with a receiving cavity facing the first opening, the support and the cutting blade being capable of extending out of or retracting into the regulator via the receiving cavity.