Valve tissue cutting device and valve clamp recovery system

Abstract

The present invention provides a valve tissue cutting device, including a recovery part, wherein the distal end of the recovery part is open, the proximal end is gathered, the part is hollow and has a receiving cavity; the distal end of the recovery part is provided with a cutting portion; the cutting portion is used to cut valve tissue, and the receiving cavity is used to receive the excised valve tissue. The valve tissue cutting device combines cutting and recovery functions, the recovery part can support the valve tissue, can reduce the pulsation of the valve leaflet, and is conducive to the cutting portion to quickly cut the valve tissue, and the excised valve tissue can directly fall into the receiving cavity of the recovery part, which is convenient for recovery and not easy to slip. The present invention also provides a valve clamp recovery system including the valve tissue cutting device, which can be transported by a small-caliber adjustable curved sheath tube, causing less damage to the patient and simplifying the surgical procedure.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve tissue cutting device and a valve clamp recovery system. Background Art

[0002] See also Figure 1 The mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, while preventing the blood from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the papillary muscle of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2 When organic or functional changes occur in the leaflets of the mitral valve 1 or its related structures, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned. As a result, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Surgery usually uses surgical methods such as edge-to-edge suture to pull the anterior and posterior leaflets of the mitral valve toward each other and suture them to fix, thereby reducing the gap of the mitral valve to treat mitral regurgitation. In addition, there is a minimally invasive treatment method based on the principle of edge-to-edge valve surgery. The valve clamp is delivered to the mitral valve through an interventional catheter. The valve clamp includes a pair of forceps arms and clamping arms that can open and close relative to each other. The two sets of forceps arms and clamping arms can clamp the anterior and posterior leaflets of the mitral valve respectively, thereby pulling the leaflets closer to each other and reducing mitral regurgitation. Figure 3 and Figure 4 shown.

[0004] However, regardless of whether the patient undergoes edge-to-edge surgical repair or minimally invasive valve clip implantation, after surviving for several years, valvular stenosis or malapposition may occur again due to ventricular enlargement, rheumatic mitral valve, inflammatory valvular disease, severe valvular calcification, valve tissue hyperplasia caused by clamp compression and stimulation, and recurrent reflux or stenosis may occur, requiring secondary repair.

[0005] Before the secondary repair, the valve tissue at the sutured commissure must be removed, or the valve clamp and the valve tissue fixed together by the valve clamp must be removed.

[0006] The prior art discloses a heart valve cutting device, which establishes a channel from outside the patient to inside the patient through a large-sized trans-atrial septal or trans-apical sheath, through which a pair of distally connectable transmission catheters and capture catheters are respectively passed through the double-hole structure of the mitral valve, and then the cutting element for cutting the valve leaflets is delivered to the vicinity of the mitral valve through the transmission catheter, and then the valve clamp and valve tissue are removed, and the cut valve clamp is further recovered and withdrawn from the patient's body by removing the catheter. This cutting device has the following disadvantages: 1. The sheath needs to accommodate multiple catheters at the same time, so that the diameter of the sheath is large, which causes great damage to the patient; 2. The transmission catheter, capture catheter, cutting element and removal catheter need to be delivered to the vicinity of the mitral valve through the sheath in sequence, and the surgical operation steps are cumbersome and time-consuming; 3. Since the valve leaflets are always in an active state, cutting is difficult; 4. The valve clamp after removal needs to be docked by the removal catheter, and it is easy to slip during docking and withdrawal, and it is not easy to recover. Summary of the invention

[0007] In view of the deficiencies in the prior art, the present invention provides a valve tissue cutting device and a valve clamp recovery system. The valve tissue cutting device combines cutting and recovery functions, can quickly cut valve tissue, and the excised valve tissue or the valve clamp connected to the excised valve tissue can be directly recovered, which is easy to operate and not easy to slip. Furthermore, the valve tissue cutting device can be transported through a small-caliber adjustable curved sheath tube of the valve clamp recovery system, which causes little damage to the patient and simplifies the surgical procedure.

[0008] In order to solve the above technical problems, the present invention provides a valve tissue cutting device, which includes a recovery part, the distal end of which is open, the proximal end of which is gathered, and the part is hollow and has a receiving cavity; a cutting part is provided at the distal end of the recovery part; the cutting part is used to cut valve tissue, and the receiving cavity is used to receive the excised valve tissue.

[0009] The present invention also provides a valve clamp recovery system, comprising the aforementioned valve tissue cutting device and an adjustable bend sheath tube for conveying the valve tissue cutting device, wherein the valve tissue cutting device is movably inserted into the adjustable bend sheath tube, and the recovery part and the cutting part can extend from the distal end of the adjustable bend sheath tube.

[0010] The valve tissue cutting device and valve clamp recovery system provided by the present invention integrate the cutting function and the recovery function. The recovery part can support the valve tissue so that the cutting part can quickly cut the valve tissue, and the excised valve tissue or the valve clamp connected to the excised valve tissue can be directly accommodated in the accommodating cavity of the recovery part, which is convenient for recovery and not easy to slip. Furthermore, the valve tissue cutting device can be transported through a small-caliber adjustable curved sheath tube, which causes less damage to the patient and simplifies the surgical process. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0012] Figure 1 This is a schematic diagram of the mitral valve in its normal state.

[0013] Figure 2 This is a schematic diagram of a mitral valve disease.

[0014] Figure 3 Schematic diagram of the valve clip after implantation in the mitral valve.

[0015] Figure 4 yes Figure 3 Enlarged schematic diagram of part IV.

[0016] Figure 5 It is a schematic structural diagram of a valve tissue cutting device provided in the first embodiment of the present invention.

[0017] Figure 6 yes Figure 5 Enlarged schematic diagram of part VI.

[0018] Figure 7 yes Figure 6 Schematic diagram of the structure of the recycling parts.

[0019] Figure 8 yes Figure 7 An enlarged schematic diagram of part VIII in FIG.

[0020] Fig. 9 yes Figure 5 A schematic diagram of a portion of the structure of the valve tissue cutting device when the valve clamp is accommodated.

[0021] Fig.10 It is a structural schematic diagram of the valve clamp recovery system provided by the present invention.

[0022] Fig.11 yes Fig.10 Schematic diagram of the valve clamp retrieval system in Figure 1.

[0023] Figures 12 to 15 yes Fig.10 Schematic diagram of the use process of the valve clamp retrieval system.

[0024] Fig.16 It is a schematic structural diagram of a recovery component of a valve tissue cutting device provided in a second embodiment of the present invention.

[0025] Fig.17 It is a schematic structural diagram of a recovery component of a valve tissue cutting device provided in a third embodiment of the present invention.

[0026] Fig.18 yes Fig.17 A schematic diagram showing that the first conductive strip and the second conductive strip are at different positions.

[0027] Fig.19 yes Fig.18 Schematic diagram of a first conductive strip and a second conductive strip forming a closed circle.

[0028] Fig. 20 It is a schematic structural diagram of a recovery component of a valve tissue cutting device provided in a fourth embodiment of the present invention. DETAILED DESCRIPTION

[0029] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0030] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc., are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0031] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0032] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device. The above definitions are only for the convenience of expression and cannot be understood as limitations of the present invention.

[0033] Please also read Figures 5 to 9The present invention provides a valve tissue cutting device 100, comprising a recovery part 10, wherein the recovery part 10 is open at the distal end and gathered at the proximal end, and is hollow and provided with a receiving cavity. A cutting portion 20 is provided at the distal end of the recovery part 10, and the cutting portion 20 is used to cut valve tissue, and the receiving cavity is used to receive the resected valve tissue. It is understandable that when the valve tissue cutting device 100 is used to cut valve leaflets that are sutured together, the receiving cavity only receives valve tissue. When the valve tissue cutting device 100 is used to cut valve leaflets that are fixed together by implants such as mitral valve clamps, the receiving cavity also receives the valve clamp connected to the resected valve tissue.

[0034] In the present invention, the recovery component 10 can support the valve tissue and reduce the pulsation of the valve leaflets, which is conducive to the cutting part 20 to quickly cut the valve tissue, and the excised valve tissue can directly fall into the receiving cavity of the recovery component 10, which is easy to recover and not easy to slip.

[0035] Specifically, Figures 5 to 7 As shown, the recovery member 10 includes an elastic support that can be radially contracted and expanded, the elastic support is hollow to set a receiving cavity, and in the expanded state, the diameter of the elastic support gradually decreases from the distal end to the proximal end, that is, the elastic support is cup-shaped, cage-shaped or funnel-shaped. In this embodiment, the elastic support is a hollow cup-shaped.

[0036] The elastic support is made of a material with shape memory function, preferably a superelastic material such as nickel-titanium alloy. The recovery member 10 has a natural expansion state and a contraction state when subjected to force, so the recovery member 10 can be radially contracted to be transported from a curved blood vessel to the vicinity of the mitral valve in an interventional manner, and then restore the natural expansion state.

[0037] The elastic support may be formed by laser cutting of a tube made of nickel-titanium alloy, or may be formed by weaving, welding or sleeve-connecting a plurality of wires, rods or tubes made of nickel-titanium alloy.

[0038] Specifically, in this embodiment, the elastic support includes a plurality of support rods 11, the proximal ends of the support rods 11 converge to form a connecting ring 13, the plurality of support rods 11 are evenly arranged along the circumference of the connecting ring 13 to enclose the receiving cavity, and the cutting portion 20 is arranged at one end of all or part of the support rods 11 of the elastic support away from the connecting ring 13. Preferably, the cutting portion 20 is arranged at one end of each of the support rods 11 away from the connecting ring 13 to improve cutting efficiency.

[0039] At least one group of adjacent struts 11 extend from the connecting ring 13 to the distal end and cross-link to form a plurality of receiving units 110. In order to increase the area of ​​the receiving unit 110, the receiving unit 110 is preferably in a rhombus shape. A plurality of receiving units 110 surround a receiving cavity, and the cutting portion 20 is disposed at the distal end of at least some of the receiving units 110. Preferably, the cutting portion 20 is disposed at the distal end of each receiving unit 110 to improve cutting efficiency.

[0040] like Figure 7 As shown, in this embodiment, the axial length of each support rod 11 (i.e., the length along the axial direction of the recovery member 10) is equal, and the axial length of each receiving unit 110 (i.e., the length along the axial direction of the recovery member 10) is equal. The axial length of each support rod 11 is equal, so that different positions of the distal end opening of the recovery member 10 along the circumferential direction are in the same horizontal plane, which is conducive to the recovery member 10 supporting the valve tissue.

[0041] Each receiving unit 110 includes a receiving section 111 at a distal end, a retracting section 113 at a proximal end, and a pair of curved rods 115 connecting the receiving section 111 and the retracting section 113 .

[0042] The receiving section 111, the retracting section 113 and the pair of curved rods 115 connecting the receiving section 111 and the retracting section 113 of each receiving unit 110 may be integrally formed, or may be separately formed and connected by bonding, welding or sleeve connection. In this embodiment, the receiving section 111, the retracting section 113 and the pair of curved rods 115 are integrally formed.

[0043] The two adjacent curved rods 115 of each two adjacent receiving units 110 are connected to each other by bonding, welding, bundling or sleeve connection, and the rod diameter of the connection of the two curved rods 115 is equal to or greater than the sum of the rod diameters of the remaining parts of the two curved rods 115. In this embodiment, the middle parts of the two curved rods 115 are connected to each other, and the rod diameter of the connection of the middle parts of the two curved rods 115 is greater than the sum of the rod diameters of the remaining parts of the two curved rods 115, so that the connection between the two is firm, which is conducive to improving the structural stability of the elastic bracket.

[0044] Preferably, in this embodiment, both opposite ends of each curved rod 115 are bent toward the axis of the elastic support (i.e., the recovery member 10), and the bending amplitude of the proximal end of each curved rod 115 is greater than the bending amplitude of the distal end, so that the distal diameter of the elastic support (i.e., the diameter of the portion where the receiving section 111 is located) is greater than the proximal diameter of the elastic support (i.e., the diameter of the portion where the folding section 113 is located), and the elastic support has a wider distal opening, which is conducive to the valve tissue or valve clamp falling into the receiving cavity of the elastic support from the distal opening; more preferably, the ratio of the distal diameter of the elastic support to the proximal diameter of the elastic support is 1.2-1.5, and the elastic support encloses a deeper, narrower and gradually shrinking receiving cavity, which is more in line with the shape of the valve clamp. Further preferably, in this embodiment, the portion where each curved rod 115 is connected to another curved rod 115 is concave toward the axis of the elastic support, so that the elastic support has a waist with a smaller diameter. Such a structure can reduce the radial force when the elastic support is deformed by external pressure, and is more conducive to the radial contraction of the elastic support for delivery in an invasive manner, for example, received in a transmission catheter 40 (such as Figure 5 shown).

[0045] As described above, in this embodiment, the elastic support is composed of a plurality of rhombus-shaped receiving units 110 arranged in a circle along the circumference of the connecting ring 13, and each two adjacent receiving units 110 are connected to each other through adjacent curved rods 115. The entire elastic support is integrally formed from a nickel-titanium alloy tube by laser cutting.

[0046] It is understandable that in other embodiments, the elastic bracket can be composed of a plurality of diamond-shaped receiving units 110 arranged in a circle along the circumference of the connecting ring 13, and two or more circles are continuously arranged along the axial direction of the connecting ring 13, so that the elastic bracket has a larger receiving space.

[0047] In other embodiments, the elastic bracket may also be composed of a plurality of annular corrugated support rods which are continuously arranged in one circle or multiple circles along the axial direction and connected together by welding or the like; in other embodiments, the elastic bracket may also be composed of a plurality of support rods which are staggered and connected to each other, and the elastic bracket may present a grid structure, which will not be elaborated here.

[0048] Please also read Figure 5 and Figure 7 The diameter of the connecting ring 13 at the proximal end of the elastic bracket is smaller than the diameter of the transmission catheter 40. The connecting ring 13 is provided with a connecting hole 131, and the connecting hole 131 is used to connect with a pushing member (not shown in the figure). The axial movement of the transmission catheter by the pushing member drives the recovery member 10 to extend out or be retracted into the transmission catheter 40.

[0049] Specifically, the pushing member is movably arranged in the transmission catheter 40. When the pushing member moves toward the distal end relative to the transmission catheter 40, the pushing member pushes the recovery member 10 to extend from the distal end of the transmission catheter 40 and restore the natural expansion state, and the connecting ring 13 is accommodated in the distal tube mouth of the transmission catheter 40; when the pushing member moves toward the proximal end relative to the transmission catheter 40, the pushing member pulls the recovery member 10 to move toward the proximal end, and the distal tube mouth of the transmission catheter 40 forces the recovery member 10 to radially contract to be accommodated in the transmission catheter 40.

[0050] The pusher may be a single-strand metal wire, or may be formed by twisting multiple metal wires, or may be a pusher tube mounted inside the transmission catheter 40. Preferably, the outside of the pusher may be covered with a smooth polymer layer to increase its permeability and flexibility and avoid tissue damage. In this embodiment, the pusher is a stainless steel cable made of three metal wires, and the stainless steel cable is welded to the connection hole 131.

[0051] The transmission catheter 40 is a hollow tube with a certain length, usually including a three-layer structure, the innermost layer is a PTFE inner membrane, the middle layer is a woven mesh woven from materials such as stainless steel wire, tungsten wire or nickel titanium wire, and the outermost layer is Pebax.

[0052] Please also read Figure 7 and Figure 8 The cutting portion 20 is disposed on at least a portion of the outer surface of the distal end of the recovery member 10 . When the distal end of the recovery member 10 is supported below the valve tissue, the valve tissue can be cut by the cutting portion 20 .

[0053] Preferably, in this embodiment, the cutting portion 20 is provided on the arc top surface of the end of the receiving section 111 at the distal end of each containing unit 110 of the recovery component 10 that contacts the valve tissue (i.e., the end away from the gathering section 113) and all the side surfaces connected to the arc top surface. When the distal end of the recovery component 10 is supported under the valve tissue, the soft valve tissue will cover the end of the receiving section 111 away from the gathering section 113, thereby contacting the arc top surface and all the side surfaces connected to the arc top surface at the same time. At this time, the cutting portion 20 provided on the arc top surface and all the side surfaces connected to the arc top surface can cut the valve tissue at the same time, and the cutting efficiency is relatively high.

[0054] In other embodiments, the cutting portion 20 can be disposed on the arc top surface of the distal receiving section 111 of each receiving unit 110 of the recycling component 10 and a portion of the side surface connected to the arc top surface, or only on the arc top surface.

[0055] In other embodiments, the cutting portion 20 may also be disposed on the arc top surface of the distal receiving section 111 of a portion of the receiving unit 110 of the recycling component 10 and a portion of the side surface connected to the arc top surface.

[0056] Among them, the cutting method of the cutting part 20 is selected from mechanical cutting, electric knife cutting, laser cutting, electromagnetic cutting, microwave cutting, ultrasonic knife cutting or semiconductor thermocoagulation knife. In this embodiment, the cutting part 20 adopts the cutting method of electric knife cutting, preferably radio frequency electric knife cutting. During the cutting process, the high-frequency current is transmitted through the conductor to cause the charged positive and negative ions in the valve tissue around the conductor to oscillate at a high speed. The high-speed oscillating ions generate a large amount of heat due to friction, which increases the temperature in the diseased tissue, and eventually denatures the protein in the diseased cells, loses water inside and outside the cells, and causes coagulative necrosis of the diseased tissue, thereby achieving radio frequency cutting. The operating frequency range of the radio frequency electric knife is 1500KHz~4500KHz. The skin effect of the current is strong, which can avoid accidents such as burns, and the thermal damage to the tissue is small.

[0057] Specifically, Figure 7 and Figure 8 As shown, the cutting part 20 includes a plurality of conductors disposed on the distal outer surface of the recovery part 10 and disposed continuously or discontinuously along a circumference of the recovery part 10, each of the conductors conducts electricity at least on the surface in contact with the valve tissue, and the valve tissue is cut by an electric knife. Among them, the conductor is a bare metal disposed on the outer surface of the recovery part 10, or a metal electrode fixed on the outer surface of the recovery part 10. In this embodiment, the conductor is a metal electrode. In order to ensure safety, the outer surface of the recovery part 10 other than the conductor is insulated. The insulation method can be to coat the outer surface of the recovery part 10 with an insulating coating or to set an insulator between the outer surface of the recovery part 10 and the conductor. The material of the metal electrode includes but is not limited to 304 stainless steel, 321 stainless steel or 316 stainless steel, and the insulating coating includes but is not limited to PTFE coating, titanium nitride coating, parylene coating, etc. Considering the insulation reliability and process feasibility, the thickness of various insulating coatings should be ≥3μm.

[0058] In this embodiment, the valve tissue cutting device 100 further includes a radio frequency generator and a control device thereof (not shown in the figure), and the radio frequency generator and the control device thereof are electrically connected to each conductor, thereby forming a plurality of cutting portions 20 arranged continuously or discontinuously along the circumference of the recovery member 10. It is understandable that when other electric knife cutting, laser cutting, electromagnetic cutting, microwave cutting, ultrasonic knife cutting or semiconductor thermal coagulation knife is used, the corresponding energy generating device and the control device thereof should be used, and they should be electrically connected to the conductors of the cutting portion respectively.

[0059] like Figure 8 As shown, in order to further ensure safety, when the cutting method of electric knife cutting is adopted, the valve tissue cutting device 100 also includes at least one temperature sensor 21 electrically connected to at least one of the conductors, and the temperature sensor 21 is in contact with the valve tissue to indicate the temperature of the part of the valve tissue in contact with the conductor, thereby preventing the valve tissue from being damaged by excessively high local temperature. Specifically, in this embodiment, each of the conductors is provided with a temperature sensor 21 to indicate the temperature of the conductors in different circumferential positions of the recovery unit 10 in contact with the valve tissue.

[0060] It is understood that in other embodiments, the cutting portion 20 may also be a plurality of blades disposed at the distal end of the recovery member, the blades being disposed continuously or discontinuously along a circumference of the recovery member 10, each of the blades being in contact with the valve tissue to mechanically cut the valve tissue. During cutting, the operator may rotate the distal end of the valve tissue cutting device 100 so that the plurality of blades slowly rotate at the position in contact with the valve tissue, thereby completely removing the valve tissue.

[0061] Preferably, Figure 8 As shown, the valve tissue cutting device 100 also includes at least one developing portion 23 arranged at the distal end of the recovery member 10 and close to the cutting portion 20. The operator can adjust the position of the cutting portion 20 according to the position of the developing portion 23, so as to cut at the exact position of the valve tissue to remove the valve tissue.

[0062] The developing part 23 may be in the form of developing wire, developing point or developing film. The developing part 23 is made of a developing material with strong corrosion resistance and good biocompatibility, such as gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and other metal materials or alloys or composites of these metals. In this embodiment, the developing part 23 is a nickel-titanium alloy sheet containing tantalum. The developing part 23 is arranged at the distal end of each of the support rods 11, so that the operator can intuitively see the position of each of the cutting parts 20 and make corresponding adjustments.

[0063] Further, such as Figure 6 As shown, an adjustment mechanism is provided at the distal end of the recovery member 10 along the circumferential direction, and the adjustment mechanism is used to adjust the radial size of the distal end opening of the recovery member 10 .

[0064] Specifically, in the present embodiment, the receiving section 111 of each of the accommodating units 110 of the recovery component 10 is provided with a threading hole 117, and the adjustment mechanism includes a single control line 30, and the single control line 30 simultaneously passes through the threading holes 117 at different positions on the distal circumference of the recovery component 10, and the radial size of the distal opening of the recovery component 10 is adjusted by controlling the length of the single control line 30 passing through different circumferential positions of the recovery component 10.

[0065] See also Fig. 9 In this embodiment, tightening the single control line 30 can gradually close the distal opening of the recovery component 10, thereby driving the overall radial size of the recovery component 10 to decrease, which is beneficial for the radial contraction of the recovery component 10 to be accommodated in the transmission catheter 40; when the recovery component 10 arrives near the mitral valve with the transmission catheter 40 and extends from the distal end of the transmission catheter 40, the single control line 30 is released, and the recovery component 10 can be expanded and unfolded and supported under the valve tissue. It can be understood that when the cutting portion 20 at the distal end of the recovery component 10 cuts the valve tissue, slightly tightening the single control line 30 to reduce the distal opening of the recovery component 10 can reduce the cutting radius of the cutting portion 20 and avoid removing too much valve tissue. Moreover, after the distal opening of the recovery component 10 is closed, the pulsation of the valve tissue contained in the receiving cavity of the recovery component 10 or the shaking of the valve clamp can be slowed down, which is conducive to the cutting portion 20 to quickly cut the valve tissue. When the valve tissue cutting is completed, tighten the single control line 30 to completely close the distal opening of the recovery component 10 to prevent the valve tissue falling into the receiving cavity of the recovery component 10 or the valve clamp connected to the valve tissue from slipping out of the recovery component 10. Then the recovery component 10 can be retracted into the transmission catheter 40 to be withdrawn from the patient.

[0066] In other embodiments, the adjustment mechanism may include multiple control lines 30, each of the multiple control lines 30 simultaneously passes through the threading holes 117 at different positions on the distal circumference of the recovery component 10, and the above-mentioned effect can also be achieved by controlling the length of any control line 30 passing through different circumferential positions of the recovery component 10 to adjust the radial size of the distal opening of the recovery component 10.

[0067] Please refer again Figure 5 The valve tissue cutting device 100 also includes the aforementioned transmission catheter 40 and an operating handle 50 disposed at the proximal end of the transmission catheter 40 , and the operating handle 50 includes a handle housing 51 and an adjusting wheel 53 and a pushing wheel 55 disposed on the handle housing 51 .

[0068] Among them, the pushing wheel 55 is connected to the proximal end of the aforementioned pushing member, and the pushing wheel 55 is rotated to drive the pushing member to move axially along the transmission catheter 40, thereby driving the recovery member 10 to extend or retract into the transmission catheter 40; the adjusting wheel 53 is connected to the adjusting mechanism (i.e., the control line 30) at the distal end of the recovery member 10, and the adjusting wheel 53 is rotated to control the length of the control line passing through different circumferential positions of the recovery member 10, thereby tightening or loosening the distal opening of the recovery member 10.

[0069] Optionally, in some embodiments, the valve tissue cutting device 100 further includes a pressure sensor (not shown) for detecting left atrial pressure, which is movably arranged in the transmission catheter 40 of the valve tissue cutting device 100 and extends from the distal end of the recovery member 10 to enter the left atrium, thereby timely confirming the "mitral regurgitation" through the patient's left atrial pressure and determining whether the removal of the valve tissue at the commissure is complete. The pressure sensor can be a commercial sensor commonly used on the market, and only needs to meet the clinical requirements of medical devices. It is preferably an umbrella-shaped pressure sensor with a smooth arc shape to avoid damage to the myocardium or chordae tendineae and valve tissue.

[0070] Please also read Fig.10 and Fig.11 The present invention also provides a valve clamp recovery system 1000, comprising the aforementioned valve tissue cutting device 100 and an adjustable curved sheath tube 200 for conveying the valve tissue cutting device 100. The valve tissue cutting device 100 is movably arranged in the adjustable curved sheath tube 200, and the recovery part 10 and the cutting part 20 of the valve tissue cutting device 100 can extend from the distal end of the adjustable curved sheath tube 200. When the adjustable curved sheath tube 200 conveys the valve tissue cutting device 100 to the vicinity of the mitral valve, the recovery part 10 at the distal end of the valve tissue cutting device 100 extends from the distal end of the adjustable curved sheath tube 200 to cut the valve tissue and recycle the excised valve tissue or the valve clamp connected to the excised valve tissue.

[0071] like Fig.11 As shown, the valve clamp retrieval system 1000 also includes a guide device 300 movably inserted into the adjustable bending sheath tube 200. The guide device 300 and the adjustable bending sheath tube 200 can be used in conjunction with each other or alternately in sequence to establish an interventional channel from outside the patient's body to inside the patient's body.

[0072] The guiding device 3000 includes a puncture guide wire (not shown) and a conical dilator. It is understandable that the structures of the adjustable bending sheath tube 200 and the guiding device 300 are similar to those of the commonly used adjustable bending sheath tubes and guiding devices in the prior art, and will not be described in detail here.

[0073] Preferably, in this embodiment, the valve clamp recovery system 1000 also includes a capture device 400 movably inserted into the valve tissue cutting device 100, and the distal end of the capture device 400 can be extended from the distal end of the valve tissue cutting device 100 to capture the valve clamp clamped on the constantly moving valve tissue, thereby reducing the shaking of the valve clamp, which is beneficial for the valve tissue cutting device 100 to quickly accommodate the valve clamp in the accommodating cavity of the recovery component 10 for subsequent cutting and recovery.

[0074] Specifically, the capture device 400 includes a capture catheter 410 with a certain axial length and a capture device 420 disposed at the distal end of the capture catheter 410, and the capture device 420 is used to be detachably connected to the valve clamp to capture the valve clamp. In this embodiment, the capture device 420 is a gooseneck snare, and the distal end of the valve clamp is provided with a groove, a protrusion or a hook. The valve clamp is connected to the capture device 400 by sleeve-fitting the gooseneck snare into the groove, protrusion or hook of the valve clamp, thereby capturing the valve clamp, so that the valve tissue can be cut by the valve tissue cutting device 100 at the position where the valve clamp contacts the valve clamp, thereby removing the valve clamp from the valve tissue.

[0075] In other embodiments, the capture device 420 may also be a capture ring, and the valve clamp may be connected to the capture device 400 by sleeve-fitting the capture ring into a groove, a protrusion or a hook of the valve clamp.

[0076] In other embodiments, the valve clamp may be provided with a through hole, and the capture device 420 may be a pair of claws that can be relatively opened and closed, and the valve clamp is connected to the capture device 400 by inserting a pair of claws into both ends of the through hole. Preferably, in order to reduce the outer diameter of the capture device 400, the proximal ends of the pair of claws are staggered.

[0077] It should be noted that the adjustable bending sheath tube 200, the guiding device 300 and the capturing device 400 respectively have operating handles close to the operator, and the operator controls the corresponding devices through the corresponding operating handles to realize the actions of moving forward, backward, capturing, and bending, which will not be elaborated on in detail.

[0078] Please also read Figure 12 to Figure 14 The use process of the valve clamp retrieval system 1000 provided in this embodiment is as follows:

[0079] Step 1: Select the approach of trans-apex-left ventricle-mitral valve, or the approach of trans-femoral vein-right atrium-atrial septum-left atrium-mitral valve, or the approach of trans-femoral artery-aortic arch-aortic valve-left ventricle-mitral valve, or the approach of trans-jugular vein-atrial septum-left atrium-mitral valve, and establish an interventional channel from outside the patient to inside the patient using the guide device 300 and the adjustable curved sheath tube 200;

[0080] Step 2: withdraw the guide device 300, push the valve tissue cutting device 100 and the capture device 400 that are installed together into the left ventricle through the adjustable sheath tube 200; push the entire valve tissue cutting device 100 toward the distal end, so that the distal end of the valve tissue cutting device 100 extends out from the distal end of the adjustable sheath tube 200;

[0081] Step 3: Turn the push wheel 53 ( Figure 5 As shown in FIG. 1 ), the retrieval member 10 at the distal end of the valve tissue cutting device 100 extends from the distal end of the transmission catheter 40, and the retrieval member 10 expands and unfolds; the entire capture device 400 is pushed toward the distal end, so that the capture device 420 at the distal end of the capture device 400 extends from the distal end of the retrieval member 10 to capture the valve clamp, as shown in FIG. Fig.12 As shown;

[0082] Step 4: After the valve clamp is captured, the valve tissue cutting device 100 is pushed to the distal end so that the valve clamp is accommodated in the accommodation cavity of the recovery member 10, and the adjustment wheel 53 is rotated ( Figure 5 as shown) to tighten the control line 30 ( Fig. 9 As shown), the distal opening of the recovery member 10 is closed, and the cutting radius of the cutting portion 20 at the distal end of the recovery member 10 is adjusted to avoid cutting too much valve tissue, such as Fig.13 As shown;

[0083] Step 5: Use the cutting part 20 to cut the attachment points of the valve clamp on the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve, thereby removing the valve clamp from the valve tissue, so that the removed valve clamp falls into the receiving cavity of the recovery part 10, as shown in FIG. Fig.14 As shown;

[0084] Step 6: Turn the push wheel 53 to move the recovery part 10 toward the proximal end and retract it into the transmission catheter 40; withdraw the capture device 400, the valve tissue cutting device 100 and the valve clamp accommodated in the valve tissue cutting device 100 from the patient's body through the adjustable curved sheath tube 200, and finally withdraw the adjustable curved sheath tube 200 to complete the operation.

[0085] Optionally, after the first step is completed, the end of the puncture guidewire of the guide device 300 can be passed over the valve clamp and extended in the opposite direction to the outside of the patient through the adjustable curved sheath tube 200. Thus, a pulling force is applied to the valve clamp through the puncture guidewire to reduce the fluctuation amplitude of the valve clamp with the pulsation of the valve leaflet, thereby facilitating the docking of the capture device 400 with the valve clamp.

[0086] After the fifth step is completed, the operator can withdraw the capture device 400, the valve tissue cutting device 100 and the valve clamp housed in the valve tissue cutting device 100, and then temporarily leave the adjustable bend sheath 200 in the patient's body, thereby performing a secondary interventional repair operation through the interventional channel, such as implanting an artificial heart valve.

[0087] It is understandable that the valve clamp recovery system 1000 provided by the present invention may not include the capture device 400. The recovery component 10 is supported under the valve tissue by the expanded and unfolded component. After the resection is completed, the valve clamp and the valve tissue can also fall directly into the receiving cavity of the recovery component 10. Then the recovery component 10 is radially contracted to be received in the transmission catheter 40 and withdrawn from the patient's body.

[0088] It is also understandable that Fig.15 As shown, when the valve clamp retrieval system 1000 does not include the capture device 400, the retrieval component 10 is supported under the valve tissue and the valve clamp is accommodated in the accommodating cavity of the retrieval component 10, since there is no capture device 400 to restrict the movement of the valve clamp, the end of the puncture guide wire 310 can be passed over the valve clamp, and a pulling force is applied to the valve clamp through the puncture guide wire 310 to reduce the fluctuation amplitude of the valve clamp with the pulsation of the valve leaflet, thereby preventing the valve clamp from slipping out of the accommodating cavity of the retrieval component 10.

[0089] The valve clamp recovery system 1000 provided by the present invention, the valve tissue cutting device 100 combines the cutting function and the recovery function, and the capture device 400 is penetrated in the valve tissue cutting device 100. The valve tissue cutting device 100 can be transported through a small-caliber adjustable curved sheath tube 200, which causes little damage to the patient and simplifies the surgical procedure.

[0090] See also Fig.16The structure of the valve tissue cutting device provided in the second embodiment of the present invention is similar to that of the valve tissue cutting device in the first embodiment, except that: in the second embodiment, the recovery part 10b (i.e., the elastic support) of the valve tissue cutting device includes at least one pair of positioning rods 15 symmetrically arranged along the axial direction, and the axial length of each of the positioning rods 15 (i.e., the length along the axial direction of the recovery part 10b) is greater than the axial length of the other support rods 11 of the recovery part 10b, and the distal end of each of the positioning rods 15 is closer to the axis of the recovery part 10b than the distal ends of the other support rods 11 (i.e., the receiving section 111).

[0091] Specifically, in this embodiment, the recovery component 10b includes a pair of positioning rods 15, and the pair of positioning rods 15 form a structure similar to a clamp arm. When the valve clamp is accommodated in the accommodating cavity of the recovery component 10b, the control line 30 (not shown) is tightened to close the distal opening of the recovery component 10b, so that the pair of positioning rods 15 are brought close to each other to form a buckle, thereby reducing the pulsation of the valve tissue and the movement amplitude of the valve clamp that moves with the pulsation of the valve tissue, which is beneficial for the cutting part 20 to cut the valve tissue.

[0092] Please also read Figures 17 to 19 The structure of the valve tissue cutting device provided in the third embodiment of the present invention is similar to that of the valve tissue cutting device in the first embodiment, except that: in the third embodiment, the cutting portion 20b includes a plurality of conductive strips arranged at the distal end of the recovery member 10 and extending along the circumference of the recovery member 10, and each of the conductive strips conducts electricity at least on the surface in contact with the valve tissue, so as to cut the valve tissue with an electric knife.

[0093] like Fig.17 As shown, in this embodiment, each of the conductive strips is an arc-shaped metal strip disposed at the distal end of each receiving unit 110 of the recycling unit 10. When the recycling unit 10 is in a naturally expanded state, the conductive strips form a discontinuous annular structure, preferably a circular ring. A gap is left between each two adjacent conductive strips, and the cutting portion 20b is equivalent to a discontinuous metal conductive ring. When the cutting portion 20b of this structure is received in the transmission conduit 40 (not shown in the figure), the radial compression force required is small, and the outer diameter of the compressed cutting portion 20b is small.

[0094] The number of the conductive strips is 3-12, preferably 4-8. In this embodiment, the number of the conductive strips is 8.

[0095] Furthermore, the difference from the first embodiment is that, in this embodiment, the adjustment mechanism at the distal end of the recovery member 10 includes at least two control wires 30, and the at least two control wires 30 alternately pass through different circumferential positions of the distal end of the recovery member 10, and the radial size of the distal opening of the recovery member 10 is adjusted by controlling the length of the at least two control wires 30 passing through different circumferential positions of the recovery member 10. Specifically, in this embodiment, the plurality of conductive strips include a first conductive strip 21 and a second conductive strip 22, and the first conductive strip 21 and the second conductive strip 22 are sequentially arranged at intervals along the circumference of the recovery member 10; the adjustment mechanism includes two control wires 30, one of which passes through the threading hole 117 on each of the receiving units 110 provided with the first conductive strip 21 in sequence, and the other control wire 30 passes through the threading hole 117 on each of the receiving units 110 provided with the second conductive strip 22 in sequence, thereby dividing the plurality of conductive strips into two groups of conductive strips connected to different control wires 30. Fig.18 As shown, when the tightening degrees of the two control lines 30 are different, the first conductive strip 21 and the second conductive strip 22 can be located at different positions in the radial direction of the recovery member 10; Fig.19 As shown, when the two control lines 30 are tightened to different degrees, the distal end of the recovery member 10 is in a partially retracted state. At this time, the plurality of conductive strips form a closed annular structure, the first conductive strip 21 is located on the inner side of the annular structure, the second conductive strip 22 is located on the outer side of the annular structure, and the adjacent first conductive strips 21 and second conductive strips 22 are partially stacked. The cutting portion 20b is a continuous metal conductive ring, which can not only simultaneously cut the entire valve clamp and the contact point of the valve tissue, but also significantly improve the cutting efficiency and success rate due to the power superposition caused by the stacking of adjacent conductive strips, thereby saving operation time.

[0096] The arc length of each conductive strip along the circumference of the recovery member 10 is equal or unequal. In this embodiment, the arc length of the first conductive strip 21 is smaller than the arc length of the second conductive strip 22. When the distal end of the recovery member 10 is completely retracted by tightening the two control wires 30, the first conductive strips 21 with shorter arc lengths can be surrounded by the second conductive strips 22 with longer arc lengths, which is beneficial to reducing the outer diameter of the recovery member 10 in the retracted state, so that the recovery member 10 can be transported and stored with a transmission catheter 40 with a smaller diameter, making the overall outer diameter of the valve tissue cutting device smaller.

[0097] See also Fig. 20The structure of the valve tissue cutting device provided in the fourth embodiment of the present invention is similar to that of the valve tissue cutting device in the first embodiment, except that: in the fourth embodiment, the adjustment mechanism of the distal end of the recovery member 10 is different. Specifically, in this embodiment, the adjustment mechanism includes a plurality of control lines 30, each of which passes through the threading holes 117 on the two axially symmetrical receiving units 110 of the recovery member 10 at the same time, that is, each of the control lines 30 passes through two axially symmetrical positions of the distal end of the recovery member 10 at the same time, and the radial size of the distal opening of the recovery member 10 is adjusted by controlling the length of the plurality of control lines 30 passing through different circumferential positions of the recovery member 10. Therefore, when the operator controls the plurality of control lines 30 with different tightening degrees, the radial size of the distal opening of the recovery member 10 at different circumferential positions can be made different, thereby making the cutting radius of the cutting portion 20 at the distal end of the recovery member 10 different, so as to adapt to valve clamps or mitral valve anatomical structures of different sizes.

[0098] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A valve tissue cutting device, It is characterized in that It includes a transmission catheter and a recovery piece, wherein the recovery piece can be movably inserted into the transmission catheter, the distal end of the recovery piece is open, the proximal end is gathered, the recovery piece is hollow and has a receiving cavity; the distal end of the recovery piece is provided with a cutting portion; the cutting portion is used to cut valve tissue, and the receiving cavity is used to receive the excised valve tissue; an adjusting mechanism is circumferentially arranged at the distal end of the recovery piece, and the adjusting mechanism is used to adjust the radial size of the distal opening of the recovery piece to adjust the cutting radius of the cutting portion; the adjusting mechanism includes at least one control line, and at least one of the control lines passes through different circumferential positions of the distal end of the recovery piece at the same time, and the length of at least one of the control lines passing through different circumferential positions of the recovery piece is controlled to adjust the radial size of the distal opening of the recovery piece.

2. The valve tissue cutting device according to claim 1, It is characterized in that The recovery component includes an elastic support that can radially contract and expand. The elastic support is hollow to set the receiving cavity. In the expanded state, the diameter of the elastic support gradually decreases from the distal end to the proximal end.

3. The valve tissue cutting device according to claim 2, It is characterized in that The elastic support includes a plurality of support rods, the proximal ends of the plurality of support rods converge to form a connecting ring, the plurality of support rods are evenly arranged along the circumference of the connecting ring to surround the receiving cavity, and the cutting portion is arranged at one end of all or part of the support rods of the elastic support away from the connecting ring.

4. The valve tissue cutting device according to claim 3, It is characterized in that At least one group of adjacent support rods extend from the connecting ring to the distal end and are cross-linked to form a plurality of receiving units, and the plurality of receiving units surround the receiving cavity. The cutting portion is disposed at the distal end of at least a portion of the receiving units.

5. The valve tissue cutting device according to claim 4, It is characterized in that Each of the receiving units comprises a receiving section at a distal end, a folding section at a proximal end, and a pair of curved rods connecting the receiving section and the folding section, and the adjacent two curved rods of each two adjacent receiving units are connected to each other.

6. The valve tissue cutting device according to claim 5, It is characterized in that The rod diameter at the connection point of the two bent rods is equal to or greater than the sum of the rod diameters of the remaining parts of the two bent rods.

7. The valve tissue cutting device according to claim 5, It is characterized in that The two opposite ends of each curved rod are bent toward the axis of the recovery member, and the bending amplitude of the proximal end of each curved rod is greater than the bending amplitude of the distal end; the portion where each curved rod is connected to another curved rod is concave toward the axis of the recovery member.

8. The valve tissue cutting device according to claim 3, It is characterized in that The elastic support comprises at least one pair of positioning rods symmetrically arranged along the axial direction, the axial length of each positioning rod is greater than the axial length of the support rod, and the distal end of each positioning rod is closer to the axis of the elastic support than the distal end of the support rod.

9. The valve tissue cutting device according to claim 1, It is characterized in that The cutting portion is arranged on at least a portion of the outer surface of the distal end of the recovery member, and the cutting method of the cutting portion is selected from at least one of mechanical cutting, electric knife cutting, laser cutting, electromagnetic cutting, microwave cutting, ultrasonic knife cutting or semiconductor thermal coagulation knife cutting.

10. The valve tissue cutting device according to claim 9, It is characterized in that The cutting part includes a plurality of blades arranged at the distal end of the recovery member, the blades are arranged continuously or discontinuously along a circumference of the recovery member, and each of the blades contacts the valve tissue to mechanically cut the valve tissue.

11. The valve tissue cutting device according to claim 9, It is characterized in that The cutting part includes a plurality of conductors arranged at the distal end of the recovery part. The conductors are arranged continuously or discontinuously along a circumference of the recovery part. Each conductor conducts electricity at least on the surface in contact with the valve tissue, so as to cut the valve tissue with an electric knife.

12. The valve tissue cutting device according to claim 11, It is characterized in that The conductor includes a metal electrode disposed on the outer surface of the distal end of the recovery member, and the remaining outer surface of the recovery member except for the conductor is insulated.

13. The valve tissue cutting device according to claim 11, It is characterized in that The conductor includes a plurality of conductive strips disposed at the distal end of the recovery member and extending along the circumference of the recovery member, and each of the conductive strips conducts electricity at least on a surface in contact with valve tissue.

14. The valve tissue cutting device according to claim 13, It is characterized in that When the recovery element is in an expanded state, the plurality of conductive strips form a discontinuous annular structure, and a gap is left between each two adjacent conductive strips.

15. The valve tissue cutting device according to claim 14, It is characterized in that The plurality of conductive strips include a first conductive strip and a second conductive strip, and the first conductive strip and the second conductive strip are arranged in sequence and spaced apart along the circumference of the recovery component; the recovery component is folded together so that the plurality of conductive strips form a closed annular structure, the first conductive strip is located on the inner side of the annular structure, the second conductive strip is located on the outer side of the annular structure, and adjacent first conductive strips and second conductive strips are partially overlapped.

16. The valve tissue cutting device according to claim 14, It is characterized in that The arc lengths of each of the conductive strips along the circumference of the recovery member are equal or unequal.

17. The valve tissue cutting device according to claim 11, It is characterized in that The valve tissue cutting device further comprises at least one temperature sensor electrically connected to at least one of the electrical conductors, wherein the temperature sensor is in contact with the valve tissue to indicate the temperature of a portion of the valve tissue in contact with the electrical conductor.

18. The valve tissue cutting device according to claim 11, It is characterized in that The valve tissue cutting device also includes an energy generating device and a control device thereof, and the energy generating device and the control device thereof are electrically connected to the conductor.

19. The valve tissue cutting device according to claim 18, It is characterized in that The electrosurgical cutting is radio frequency electrosurgical cutting, and the energy generating device is a radio frequency generator.

20. The valve tissue cutting device according to claim 1, It is characterized in that The valve tissue cutting device further comprises at least one developing portion, and the at least one developing portion is arranged at the distal end of the recovery member and close to the cutting portion.

21. The valve tissue cutting device according to claim 1, It is characterized in that The valve tissue cutting device also includes a pushing member movably inserted into the transmission catheter, the distal end of the pushing member is connected to the proximal end of the recovery member, and the pushing member moves along the axial direction of the transmission catheter to drive the recovery member to extend out or be retracted into the transmission catheter.

22. The valve tissue cutting device according to claim 1, It is characterized in that The valve tissue cutting device also includes an operating handle arranged at the proximal end of the transmission catheter, and the operating handle includes a handle housing and a pushing wheel and an adjusting wheel arranged on the handle housing.

23. A valve clamp retrieval system, It is characterized in that It comprises a valve tissue cutting device as described in any one of claims 1 to 22 and an adjustable bend sheath tube for conveying the valve tissue cutting device, wherein the valve tissue cutting device is movably inserted into the adjustable bend sheath tube, and the recovery part and the cutting part can extend from the distal end of the adjustable bend sheath tube.

24. The recovery system of claim 23, It is characterized in that The valve clamp recovery system also includes a capture device, which is movably disposed in the valve tissue cutting device to capture the valve tissue removed by the valve tissue cutting device or the valve clamp connected to the valve tissue.

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