A calcification lesion removal device

Abstract

Some embodiments of the present specification provide a calcification lesion removal device, comprising: a support rod and a vibration head connected; the support rod can control the vibration head to retract in the delivery tube, and control the vibration head to extend from the front end of the delivery tube and unfold; the vibration head can generate vibration.

Description

Technical Field

[0001] This manual relates to the field of medical device technology, and in particular to a device for removing calcified lesions. Background Technology

[0002] Heart valve calcification is a degenerative change that occurs in the heart with age, closely related to factors such as age, hypertension, diabetes, hyperlipidemia, and calcium and phosphorus metabolism disorders. Heart valve calcification primarily affects the aortic valve, followed by the mitral valve, while tricuspid or pulmonary valve calcification is relatively rare. This may be related to the higher mechanical stress experienced by the valves in the left ventricular system; the aortic valve experiences greater impact and shear force changes, making it more prone to valvular surface damage, collagen fiber breakage, and subsequent chronic inflammation and calcium salt deposition. Calcified valves may experience functional changes, most commonly regurgitation, and in some cases, valvular stenosis.

[0003] If calcification of the heart valve causes problems with the valve's function, such as regurgitation due to valvular insufficiency or impaired blood flow due to valvular stenosis, surgical intervention is required. Surgical intervention typically includes heart valve replacement or minimally invasive calcification removal surgery. Therefore, this specification provides a device for removing calcified lesions. The calcification removal device provided in this specification can be used to remove calcified lesions on heart valves, as well as calcified lesions in other locations (such as blood vessel walls). Summary of the Invention

[0004] Some embodiments of this specification provide a device for removing calcified lesions, including: a support rod and a vibrating head, the support rod and the vibrating head being connected; the support rod is capable of controlling the vibrating head to retract into a delivery tube, and controlling the vibrating head to extend and unfold from the front end of the delivery tube; the vibrating head is capable of generating vibration.

[0005] In some embodiments, the vibrating head includes a folder and a capsule, the folder including at least two folding wings, the capsule being disposed on the surface of the folding wings; the folding wings are capable of folding or unfolding the capsule; the capsule is capable of generating vibration.

[0006] In some embodiments, the interior of the capsule is capable of containing gas and / or liquid, and at least one pair of electrodes are disposed inside the capsule, the at least one pair of electrodes being capable of acting on the gas and / or liquid inside the capsule to generate a shock wave.

[0007] In some embodiments, the calcified lesion removal device further includes a fluid tube communicating with the cyst, through which gas and / or liquid can be injected into or discharged from the cyst to achieve expansion or contraction of the cyst.

[0008] In some embodiments, the surface of the capsule is provided with a plurality of protrusions.

[0009] In some embodiments, the plurality of protruding teeth form one or more toothed rings, and a piston cylinder is disposed in the area enclosed by the toothed rings, the piston cylinder being able to recess into the interior of the bladder when the bladder contracts.

[0010] In some embodiments, the piston cylinder is integrally formed with the bladder body, and the wall thickness of the piston cylinder is less than the wall thickness of the bladder body.

[0011] In some embodiments, the capsule includes a first capsule and a second capsule disposed opposite to each other, and the folder includes a first folding wing and a second folding wing disposed opposite to each other. The first capsule is disposed on the inner surface of the first folding wing, and the second capsule is disposed on the inner surface of the second folding wing. When the first folding wing and the second folding wing are folded, the first capsule and the second capsule fit together. One or more toothed rings are provided on both the first capsule and the second capsule, and the position of the toothed ring on the first capsule corresponds to the position of the toothed ring on the second capsule.

[0012] In some embodiments, the support rod and the folding wing are rotatably connected, the folding wing is made of an elastic material, and the folding wing is in an unfolded state in its natural state; or, the support rod and the folding wing are connected by an opening and closing control mechanism, the opening and closing control mechanism being used to control the folding wing to fold or unfold.

[0013] In some embodiments, the calcified lesion removal device further includes the delivery tube; a hemostatic valve is provided at the middle or rear end of the delivery tube, the hemostatic valve being made of a flexible material and including a cross-shaped slit. Attached Figure Description

[0014] This specification will be further described by way of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting; in these embodiments, the same reference numerals denote the same structures, wherein:

[0015] Figure 1 This is a schematic diagram of the structure of the calcified lesion removal device according to some embodiments of this specification;

[0016] Figure 2 This is a schematic diagram of the connection between the support rod and the vibrating head according to some embodiments of this specification;

[0017] Figure 3 This is an exploded view of the support rod and vibrating head shown in some embodiments of this specification;

[0018] Figure 4 This is an exploded view of the support rod and vibrating head shown in some embodiments of this specification from another perspective.

[0019] Figure 5 This is a schematic diagram of a capsule with electrodes provided according to some embodiments of this specification;

[0020] Figure 6 This is a schematic diagram of a capsule provided with electrodes according to other embodiments of this specification;

[0021] Figure 7 This is a schematic diagram of the structure of the capsule according to some embodiments of this specification;

[0022] Figure 8 yes Figure 7 Enlarged view of point A in the middle;

[0023] Figure 9 This is a partial cross-sectional view of the capsule shown in some embodiments according to this specification;

[0024] Figure 10 This is a schematic diagram of the folded structure of the vibrating head according to some embodiments of this specification.

[0025] Figure 11 This is a schematic diagram of the folded structure of the vibrating head according to other embodiments of this specification;

[0026] Figure 12 yes Figure 11 Enlarged view of point B in the middle;

[0027] Figure 13 This is a schematic diagram of a delivery tube equipped with a hemostatic valve plate, as shown in some embodiments of this specification.

[0028] Reference numerals: 10 for calcified lesion removal device; 11 for support rod; 12 for vibrating head; 121 for folding device; 1211 for folding wing; 1212 for first folding wing; 1213 for second folding wing; 122 for cyst body; 1221 for first cyst body; 1222 for second cyst body; 1223 for cyst body symmetry axis; 1224 for adhesive; 123 for positive electrode plate; 124 for negative electrode plate; 1231 for positive electrode lead; 1241 for negative electrode lead; 125 for fluid tube; 126 for piston cylinder; 127 for suction hole; 128 for protruding tooth; 129 for toothed ring; 13 for rotating shaft; 14 for hemostatic valve plate; 141 for cross slit; 20 for delivery tube; 30 for calcified plaque; 40 for aortic valve. Detailed Implementation

[0029] To more clearly illustrate the technical solutions of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are merely some examples or embodiments of this specification. For those skilled in the art, these drawings can be applied to other similar scenarios without creative effort. Unless obvious from the context or otherwise specified, the same reference numerals in the drawings represent the same structures or operations.

[0030] As indicated in this specification and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" are not specifically singular and may include plural forms. Generally, the terms "comprising" and "including" only indicate the inclusion of explicitly identified steps and elements, which do not constitute an exclusive list, and the method or apparatus may also include other steps or elements. The term "based on" means "at least partially based on." The term "some embodiments" means "at least one embodiment"; the term "other embodiments" means "at least one additional embodiment," and the relevant definitions of other terms will be given in the description below.

[0031] Since the product placement or usage position in this instruction manual can be changed at will, the directional terms such as "up," "down," "left," "right," "front," and "back" used in this instruction manual only indicate relative positional relationships and are not used to define absolute positional relationships. In addition, the terms "front end" and "distal end" in this instruction manual refer to the end away from the surgical operator, while "rear end," "proximal end," and "terminal end" refer to the end closer to the surgical operator.

[0032] This specification provides a calcification removal device that can be used to pulverize calcifications in valves to improve the flexibility and mobility of the valve leaflets. For example, the device can be used to pulverize calcifications in the leaflets of the aortic valve. As another example, it can be used to pulverize calcifications in other valves (such as the mitral, tricuspid, and pulmonary valves). The device can be used to treat and remove calcifications from valve leaflets alone, or for preparing the "landing zone" for transcatheter valve implantation. In some embodiments, the device can be used as a preparatory step for transcatheter aortic valve implantation to allow valve implantation in severely calcified or asymmetrically calcified autologous valves, increasing the cross-sectional area of ​​the implanted valve and reducing the risk of paravalvular leakage. In some embodiments, the device can also be used in angioplasty to remove calcifications from the patient's vessel wall and lumen. As an example only, this calcification removal device can also be used in kidney stone surgery and gallstone surgery.

[0033] In some embodiments, such as Figure 1 As shown, the calcified lesion removal device 10 may include a support rod 11 and a vibrating head 12, the support rod 11 being connected to the vibrating head 12. In some embodiments, the support rod 11 may be movably connected (e.g., rotatably connected) to the vibrating head 12, and the vibrating head 12 may be movable relative to the support rod 11. The support rod 11 can control the vibrating head 12 to retract into the delivery tube 20, and can control the vibrating head 12 to extend and unfold from the front end of the delivery tube 20. The vibrating head 12 is capable of generating vibration. The vibrating head 12 can be used to generate vibration to target calcified lesions (such as...) Figure 1 The calcified plaque 30 shown is broken up, thereby reducing its size and / or causing it to detach. In some embodiments, the broken calcified plaque 30 is small enough to flow with the blood without affecting other parts of the body (such as other parts of the heart or blood vessels). In some embodiments, the vibrating head 12 can be driven by a piston cylinder disposed on its surface (e.g., Figure 6-8 The piston cylinder 126 in the middle adsorbs the broken calcified plaques 30. Regarding this, it can be found that... Figure 6-8 Further description can be found in its embodiments. The support rod 11 can be used to support the vibrating head 12 and control its unfolding and folding. The delivery tube 20 can be used to deliver the support rod 11 and the vibrating head 12 to the target location. The target location here can refer to a suitable location for fragmenting calcified lesions. For example, when performing a fragmentation surgery on calcified lesions of the aortic valve 40, the target location could be… Figure 1 The aortic valve 40 shown is located above the aortic valve. For example, during gallstone surgery, the target location could be near the bile duct wall.

[0034] In this embodiment, during the delivery of the support rod 11 and the vibrating head 12, the vibrating head 12 can retract into the delivery tube 20 under the control of the support rod 11. This avoids damage to the blood vessel during the movement of the support rod 11 and the vibrating head 12, and also facilitates the movement of the delivery tube 20 within the blood vessel. Once the delivery tube 20 reaches the target position, the support rod 11 can be manipulated to control the vibrating head 12 to extend from the front end of the delivery tube 20, thereby breaking up the calcified lesions. In some embodiments, the delivery tube 20 can be delivered to the target position first, and then the support rod 11 and the vibrating head 12 can be delivered through the delivery tube 20.

[0035] In some embodiments, such as Figure 2-4As shown, the vibrating head 12 may include a folder 121 and a capsule 122. The folder 121 may include at least two folding wings 1211. The capsule 122 is disposed on the surface of the folding wings 1211. The folding wings 1211 can drive the capsule 122 to fold or unfold, and the capsule 122 can generate vibration. The folding or unfolding of the capsule 122 can refer to the capsule 122 contracting and closing or opening in a specific manner. For example, as... Figure 10-11 As shown, the capsule 122 can be folded up in the direction of the double arrows until it fits snugly; this process is called folding. Conversely, the capsule 122 can be opened in the opposite direction of the double arrows; this process is called unfolding.

[0036] In some embodiments, such as Figure 2-3 As shown, the upper surface (or outer surface) of the folding wing 1211 is connected to the support rod 11, and the lower surface (or inner surface) of the folding wing 1211 is connected to the upper surface of the capsule 122. The outer surface of the folding wing 1211 can refer to the surface facing outwards when folded; the inner surface of the folding wing 1211 can refer to the surface facing inwards when folded. In some embodiments, the connection methods between the folding wing 1211 and the support rod 11, and between the folding wing 1211 and the capsule 122, may include bonding, screw connection, snap-fit ​​connection, etc. This is merely an example. Figure 4 As shown, the folding wing 1211 and the capsule 122 can be connected by adhesive 1224. In some embodiments, a fluid tube 125 is also provided inside the support rod 11, which passes through the folding wing 1211 and communicates with the interior of the capsule 122. For more details about the fluid tube 125, please refer to [link to relevant documentation]. Figure 5-6 and its embodiments.

[0037] In some embodiments, such as Figure 2-3 As shown, at least two folding wings 1211 may include a first folding wing 1212 and a second folding wing 1213, and a capsule 122 may include a first capsule 1221 and a second capsule 1222. The first capsule 1221 is connected to the lower surface of the first folding wing 1212, and the second capsule 1222 is connected to the lower surface of the second folding wing 1213. When the first folding wing 1212 and the second folding wing 1213 respectively move along... Figure 10 When folded in the direction indicated by the double-headed arrows, the first folding wing 1221 and the second folding wing 1222 can be brought together and folded until the lower surfaces of the first folding wing 1221 and the second folding wing 1222 are in contact. Conversely, when the first folding wing 1212 and the second folding wing 1213 are folded in the direction indicated by the double-headed arrows, the first folding wing 1221 and the second folding wing 1213 are respectively folded together and folded together. Figure 10 When the bidirectional arrows in the diagram are rotated in the opposite direction, the lower surfaces of the first capsule 1221 and the second capsule 1222 can be separated from each other and unfold.

[0038] In some embodiments, the first capsule 1221 and the second capsule 1222 are symmetrically arranged along the capsule symmetry axis 1223 (e.g., ...). Figure 6 (As shown). In some embodiments, the first capsule 1221 and the second capsule 1222 can be two independent capsules. The interiors of the first capsule 1221 and the second capsule 1222 can be interconnected, or they can be non-interconnected. In other embodiments, the first capsule 1221 and the second capsule 1222 can be different parts of the same capsule 122. For example, the first capsule 1221 and the second capsule 1222 can be two parts of the same capsule 122 divided by the capsule axis of symmetry 1223.

[0039] For more details on how the folding wing 1211 folds or unfolds the capsule 122, please refer to [link to relevant documentation]. Figure 10-12 Its embodiments are not described in detail here.

[0040] In some embodiments, the shape of the upper surface (or outer surface) of the folding wing 1211 can be adapted to the cross-sectional shape of the inner cavity of the delivery pipe 20, so that the outer surface of the folding wing 1211 can better adapt to the inner wall of the delivery pipe 20 after it is fully closed, thereby making full use of the space inside the delivery pipe 20. Here, the cross-sectional shape of the inner cavity of the delivery pipe 20 can refer to the cross-section of the inner cavity of the delivery pipe 20 along its own length direction.

[0041] In some embodiments, by way of example only, combined Figure 1-3 As shown, the inner cavity of the delivery tube 20 has a circular cross-sectional shape, and the folding wing 1211 is an arc-shaped plate that arches outward from the side opposite to the capsule 122. The upper surface (or outer surface) of the capsule 122 is in contact with the lower surface (or inner surface) of the folding wing 1211. In this embodiment, since the inner cavity of the delivery tube 20 has a circular cross-sectional shape, by setting the folding wing 1211 as an arc-shaped plate, its outer surface can form an approximately cylindrical shape after the folding wing 1211 is fully closed, so as to make full use of the space inside the delivery tube 20. In other embodiments, the cross-sectional shape of the inner cavity of the delivery tube 20 can be other shapes, such as elliptical. Correspondingly, the folding wing 1211 can be a U-shaped plate, and its outer surface can form an approximately elliptical cross-section after the folding wing 1211 is fully closed.

[0042] In some embodiments, the shape of the folding wing 1211 is not limited to... Figure 2-3 The curved plate shown, for example, the folding wing 1211, can also be a plate-like or shell-like structure with regular shapes such as circles, rectangles, triangles, or squares. In some embodiments, the folding wing can be an irregularly shaped plate-like or shell-like structure. By way of example only, the folding wing 1211 can be a circular plate, the edges of which can be folded together relative to the center of the circular plate to form an umbrella-like structure.

[0043] In some embodiments, the vibration of the bladder 122 can be generated by a mechanical vibration device. By way of example only, the mechanical vibration device can be a vibrator. In some embodiments, the mechanical vibration device can be disposed inside the bladder 122. In some embodiments, the mechanical vibration device can be directly or indirectly connected to the bladder to transmit vibration to the bladder.

[0044] In some embodiments, the vibration of the capsule 122 can be achieved by using a pulse signal generated by a high-voltage pulse generator to act on the shock wave generated by the conductive liquid and / or gas.

[0045] In some embodiments, the interior of the capsule 122 is capable of containing gas and / or liquid, and at least one pair of electrodes is disposed inside the capsule 122. The at least one pair of electrodes can act on the gas and / or liquid inside the capsule 122 to generate a shock wave. This is merely an example. Figure 5-6 As shown, a positive electrode plate 123 and a negative electrode plate 124 are respectively disposed inside the first capsule 1221 and the second capsule 1222. The positive electrode plate 123 is connected to a positive lead 1231, and the negative electrode plate 124 is connected to a negative lead 1241. The positive lead 1231 and the negative lead 1241 can be connected to an external high-voltage pulse generator (not shown in the figure). The pulse signal generated by the high-voltage pulse generator can act on the liquid and / or gas inside the capsule 122 through the positive electrode plate 123 and the negative electrode plate 124 to generate shock waves, thereby causing the capsule 122 to vibrate. In some embodiments, when the first capsule 1221 and the second capsule 1222 are independent capsules, electrode pairs can be disposed inside the first capsule 1221 and the second capsule 1222 respectively, thereby generating shock waves in the first capsule 1221 and the second capsule 1222 respectively.

[0046] In some embodiments, to allow the high-voltage pulse signal to effectively act on the gas and / or liquid within the capsule 122 and generate a shock wave, the conductivity of the gas and / or liquid may be less than a set threshold. In some embodiments, the conductivity of the gas and / or liquid may be in the range of 0.6 s / m to 0.9 s / m. In some embodiments, the conductivity of the gas and / or liquid may be in the range of 0.65 s / m to 0.85 s / m. In some embodiments, the conductivity of the gas and / or liquid may be in the range of 0.7 s / m to 0.8 s / m. In some embodiments, the liquid contained within the capsule 122 may include physiological saline. In some embodiments, the gas contained within the capsule 122 may contain a conductive medium, such as carbon powder. In some embodiments, the capsule 122 may contain a combination of gas and liquid. For example, the capsule 122 may contain a combination of physiological saline and air.

[0047] In some embodiments, such as Figure 4-6 As shown, a device for removing calcified lesions (e.g., Figure 1 The calcified lesion removal device 10 may include a fluid tube 125, which may communicate with the interior of the cyst 122. Gas and / or liquid can be injected into the interior of the cyst 122 through the fluid tube 125 (the flow direction of the liquid or gas is as follows). Figure 5-6 (As indicated by the arrow in the image) or discharged from inside cyst 122. This is just an example, such as... Figure 4-6 As shown, the fluid tube 125 can be disposed in the inner cavity of the support rod 11, which is connected to the upper surface (or outer surface) of the folding wing 1211. The fluid tube 125 passes through the folding wing 1211 and communicates with the interior of the capsule 122. In another example, the same fluid tube 125 can simultaneously connect the interior of the first capsule 1221 and the interior of the second capsule 1222. The positive lead 1231 and the negative lead 1241 can pass through the fluid tube 125 and be connected to an external high-voltage pulse generator. In some embodiments, injecting gas and / or liquid into the capsule through the fluid tube 125, or discharging gas and / or liquid from the capsule 122, can achieve the expansion or contraction of the capsule 122.

[0048] In some embodiments, combined with Figure 6-7 , Figure 9 As shown, a piston cylinder 126 may be provided on the surface of the bladder 122, and the piston cylinder 126 can be recessed into the interior of the bladder 122 when the bladder 122 contracts. It is understood that when the liquid and / or gas in the bladder 122 decreases, the bladder 122 will contract, causing the piston cylinder 126 to recess into the bladder 122 (the direction of the recess is as shown in the diagram). Figure 9 (As shown by the arrow in the image). Accordingly, when the piston cylinder 126 is recessed into the interior of the bladder 122, the piston cylinder 126 will form an adsorption hole 127 with the inner wall of the bladder 122 (as shown by the arrow in the image). Figure 9 As shown), and a negative pressure is formed within the adsorption pore 127 to break up the calcified plaques (e.g., Figure 1 The calcified plaques 30) are adsorbed into the adsorption pores 127, thus facilitating the removal of the calcified plaques from the patient's body.

[0049] In some embodiments, the wall thickness of the piston cylinder 126 may be less than the wall thickness of the bladder 122, so that when the bladder 122 contracts, the piston cylinder 126 will be recessed into the interior of the bladder 122 preferentially over other parts of the bladder 122 (e.g., the lower surface of the bladder 122), thereby making it easier to form an adsorption hole 127 with negative pressure.

[0050] In some embodiments, the ratio of the wall thickness of the piston cylinder 126 to the wall thickness of the bladder 122 can be in the range of 0.5 to 0.9. In some embodiments, the ratio of the wall thickness of the piston cylinder 126 to the wall thickness of the bladder 122 can be in the range of 0.6 to 0.8. In some embodiments, the ratio of the wall thickness of the piston cylinder 126 to the wall thickness of the bladder 122 can be in the range of 0.65 to 0.75.

[0051] In some embodiments, the wall thickness of the piston cylinder 126 may be in the range of 0.01 mm to 1 mm. In some embodiments, the wall thickness of the piston cylinder 126 may be in the range of 0.1 mm to 0.8 mm. In some embodiments, the wall thickness of the piston cylinder 126 may be in the range of 0.2 mm to 0.6 mm. In some embodiments, the wall thickness of the piston cylinder 126 may be the same at all locations. In some embodiments, the wall thickness of the piston cylinder 126 may not be exactly the same at all locations. For example, the wall thickness at the center of the piston cylinder 126 may be less than the wall thickness at the edge of the piston cylinder 126. The center of the piston cylinder 126 may refer to the end of the piston cylinder 126 near the lower surface of the bladder 122. When the wall thickness of the piston cylinder 126 is not exactly the same at all locations, the wall thickness of the piston cylinder 126 may be the average value of the wall thickness at all locations of the piston cylinder 126. In some embodiments, the wall thickness of the bladder 122 and / or the piston cylinder 126 may be a measurement value under natural conditions.

[0052] In some embodiments, the piston cylinder 126 is integrally formed with the capsule 122. For example, the piston cylinder 126 may be formed by hot pressing of the capsule 122 using a mold. Alternatively, the piston cylinder 126 may be formed by blow molding of the capsule 122, wherein the wall thickness of the formed piston cylinder 126 is less than the wall thickness of the capsule 122.

[0053] In some embodiments, the piston cylinder 126 and the bladder body 122 can be independent structures. In some embodiments, the surface of the bladder body 122 may have an opening, and the piston cylinder 126 may be disposed in the opening and sealed to the bladder body 122. In some embodiments, the piston cylinder 126 may be made of a rigid material or a flexible material. In some embodiments, the rigid material may include stainless steel, and the flexible material may include thermoplastic resin (PE), nylon, polytetrafluoroethylene (PTFE), etc. In some embodiments, the material used to make the piston cylinder 126 may be the same as the material used to make the bladder body 122.

[0054] In some embodiments, combined with Figure 6-7 and Figure 9As shown, both the first capsule 1221 and the second capsule 1222 can be provided with multiple piston cylinders 126. Correspondingly, when the lower surface (or inner surface) of the first capsule 1221 is in contact with the lower surface of the second capsule 1222, the lower surface of the first capsule 1221 can cover the adsorption holes 127 on the second capsule 1222, and vice versa, thereby protecting the calcified plaques (e.g., within the adsorption holes 127) from adsorption. Figure 1 The calcified plaques 30) are blocked to prevent them from leaking out of the adsorption pores 127, making it easier to remove the calcified plaques from the patient's body.

[0055] In some embodiments, such as Figure 7 As shown, the positions of the plurality of piston cylinders 126 on the first folding wing 1212 and the plurality of piston cylinders 126 on the second folding wing 1213 can correspond one-to-one. This one-to-one correspondence means that the number of piston cylinders 126 on the first bladder 1221 is the same as the number of piston cylinders 126 on the second bladder 1222, and the piston cylinders 126 on the first bladder 1221 are axially symmetrical with respect to the piston cylinders 126 on the second bladder 1222 (e.g., symmetrically distributed along the bladder's axis of symmetry 1223). Correspondingly, when the first bladder 1221 and the second bladder 1222 are attached, the adsorption holes 127 on the first bladder 1221 (e.g., ...) Figure 9 The adsorption pores 127 in the first capsule 1221 and the adsorption pores on the second capsule 1222 can correspond one-to-one. At this time, the adsorption pores of the first capsule 1221 and the second capsule 1222 are both in a closed or nearly closed state, thereby more effectively preventing calcification plaques in the adsorption pores (e.g., Figure 1 Calcified plaques (30) leak out.

[0056] In some embodiments, the lower surface of the capsule 122 (i.e., the surface of the capsule 122 away from the folding wing 1211) may be provided with multiple protrusions. In some cases, when the capsule 122 comes into contact with the valve or calcified lesions thereon, the protrusions can abut against the valve and / or the calcified lesions thereon, thereby making the capsule 122 fit more firmly against the valve and reducing the slippage of the capsule 122 relative to the valve. In other cases, the protrusions can cut into the calcified lesions of the valve, and the vibration of the capsule 122 will cause the protrusions to cut the calcified lesions, further improving the fragmentation efficiency and effect of the calcified lesions. In still other cases, when the liquid and / or gas in the capsule 122 increases, the capsule 122 will become full and expand. The expanded capsule 122 will squeeze the protrusions, further increasing the friction between the protrusions and the valve, which can not only more effectively reduce the slippage of the capsule 122 relative to the valve, but also improve the cutting efficiency of the protrusions on the calcified lesions.

[0057] In some embodiments, the protrusion and the sac 122 can be made of the same material or different materials. For example, when the protrusion and the sac 122 are made of different materials, the protrusion can be fixed to the outer surface of the sac 122 by injection molding or thermoforming. Alternatively, when the protrusion and the sac 122 are made of the same material, they can be integrally molded.

[0058] In some embodiments, the shape of the protrusions may include regular shapes such as pyramidal, hemispherical, striped, truncated trapezoidal, and cylindrical. In some embodiments, the shape of the protrusions may also be any irregular shape. In some embodiments, multiple protrusions may be uniformly or non-uniformly distributed on the lower surface of the capsule 122. In some embodiments, multiple protrusions may be distributed in an array on the lower surface of the capsule 122.

[0059] In some embodiments, combined with Figure 7-9 As shown, the protrusion can be a tooth 128. The end of the tooth 128 that is away from the cyst body 122 is sharper, which can cut into the calcified lesion more smoothly and has a stronger cutting effect on the calcified lesion.

[0060] In some embodiments, combined with Figure 7-8 As shown, multiple protruding teeth 128 can form one or more toothed rings 129. The toothed rings 129 can further increase the friction between the cyst body 122 and the calcified lesion, making the cyst body 122 more firmly in contact with the calcified lesion.

[0061] In some embodiments, the shape of the toothed ring 129 may include regular shapes such as circular rings, rectangular rings, elliptical rings, triangular rings, and polygonal rings. This is merely an example. Figure 7-8 As shown, the toothed ring 129 is circular in shape. In some embodiments, the toothed ring 129 can be any irregular ring shape. In some embodiments, the plurality of protruding teeth 128 of the toothed ring 129 can be spaced apart by a certain distance to form blood channels. The arrangement of blood channels can facilitate blood flow, thereby effectively reducing the occurrence of blood vessel blockage.

[0062] In some embodiments, the protruding teeth 128 can be used in conjunction with the piston cylinder 126 to improve the efficiency of further removal of calcified plaques. In some embodiments, in conjunction with Figure 7-9As shown, multiple toothed rings 129 are provided on both the first capsule 1221 and the second capsule 1222, and the positions of the toothed rings 129 on the first capsule 1221 correspond one-to-one with the positions of the toothed rings 129 on the second capsule 1222. A piston cylinder 126 is provided within the area enclosed by each toothed ring 129. Accordingly, when the first capsule 1221 and the second capsule 1222 are attached, the toothed rings 129 on the first capsule 1221 can abut against the corresponding toothed rings 129 on the second capsule 1222, thereby removing calcified plaques (e.g., Figure 1 The calcified plaques 30 in the adsorption pores 127 are surrounded by the toothed ring 129, which can more effectively block the calcified plaques in the adsorption pores 127, thereby more effectively preventing the calcified plaques from leaking out.

[0063] In some embodiments, when the first capsule 1221 and the second capsule 1222 are attached together, the toothed ring 129 on the first capsule 1221 can engage with the corresponding toothed ring 129 on the second capsule 1222 to form a closed or nearly closed cavity, thereby further improving the blocking effect on calcified plaques.

[0064] In some embodiments, combined with Figure 10-11 As shown, the angle formed between the lower surface of the first folding wing 1212 and the lower surface of the second folding wing 1213 can be called the deployment angle α. A larger deployment angle α indicates a greater degree of deployment of the capsule 122. Conversely, a smaller deployment angle α indicates a smaller degree of deployment of the capsule 122. In some embodiments, the deployment angle α can be between 0° and 270°. In some embodiments, the deployment angle α can be between 0° and 240°. In some embodiments, the deployment angle α can be between 0° and 180°. This is merely an example. Figure 11 In the illustrated embodiment, the unfolding angle α (not shown in the figure) is 0°, at which point the capsule 122 can be considered to be in a completely closed state. In another example, such as Figure 3 As shown, the unfolding angle α (not shown in the figure) is 180°, at which point the capsule 122 can be considered to be in a fully unfolded state (i.e., the capsule 122 is unfolded to the maximum extent).

[0065] In some embodiments, the unfolding angle α can be adjusted according to the shape of the lesion site, so that the surface of the cyst 122 can better conform to the lesion site, thereby improving the effectiveness and efficiency of calcified plaque removal. This is only an example, combined with... Figure 1-2As shown, when removing calcified lesions on the surface of the aortic valve 40, since the surface of the aortic valve 40 is approximately planar, the unfolding angle (not shown in the figure) can be adjusted to 180°, making the lower surface of the sac 122 (i.e., the side of the sac 122 away from the folding wing 1211) planar, so that the sac 122 fits against the surface of the aortic valve 40. In some embodiments, the surface of the sac 122 can be a flexible surface, so that the sac 122 can adapt to the shape of the valve to a certain extent when it fits against the valve (or lesion site), thereby improving the fit between the sac 122 and the valve.

[0066] In some embodiments, combined with Figure 10-12 As shown, the support rod 11 and the folding wing 1211 are rotatably connected. The folding wing 1211 is made of an elastic material and is in an unfolded state in its natural state. In this specification, "natural state" can refer to a state where no external force is applied. This is merely an example, combined with... Figure 11-12 As shown, the calcified lesion removal device 10 may further include a rotating shaft 13, which is connected to the support rod 11. The rotating shaft 13 is along the width direction of the folding wing 1211 (e.g., Figure 7 The arrow "X" (indicated by the direction of the arrow) passes through the folding wing 1211, which can rotate relative to the rotation axis 12. In this embodiment, when both the folding wing 1211 and the capsule 122 are outside the delivery tube 20, the folding wing 1211 is in its natural state without external force, and its elasticity allows it and the capsule 122 to remain in an unfolded state. When the support rod 11 is manually retracted into the delivery tube 20, it will cause the folding wing 1211 and the capsule 122 to move together into the delivery tube 20. When the upper surface of the folding wing 1211 abuts against the delivery tube 20, it will cause the folding wing 1211 to move relative to the rotation axis 13 along... Figure 11 The folding mechanism folds in the direction indicated by the double-headed arrows, thereby causing the capsule 122 to fold and retract. As the support rod 11 continues to move, the remaining part of the folding wing 1211 will also retract into the delivery tube 20 until the folding wing 1211 and the capsule 122 are completely retracted into the delivery tube 20, at which point the capsule 122 is in a completely closed state.

[0067] In some embodiments, the stiffness of the folding wing 1211 can be greater than the stiffness of the capsule 122, so that the folding wing 1211 can move along... Figure 11 When folded in the direction indicated by the double-headed arrows, the bladder 122 can be smoothly brought together and closed. In some embodiments, the material used to make the folding wing 1211 may include thermoplastic polyurethane rubber (TPU), nickel-titanium alloy, etc. In some embodiments, the material used to make the bladder 122 may include polytetrafluoroethylene, polyvinyl chloride (PVC), nylon, latex, etc.

[0068] In some embodiments, such as Figure 10 As shown, the calcified lesion removal device 10 may also include an opening and closing control mechanism (not shown in the figure). The support rod 11 and the folding wing 1211 can be connected through the opening and closing control mechanism, which can be used to control the folding wing 1211 to fold or unfold.

[0069] In some embodiments, the opening and closing control mechanism can achieve the folding or unfolding of the folding wing 1211 through the cooperation of mechanical structures. As an example only, the opening and closing control mechanism may include a first telescopic arm (not shown in the figure) and a second telescopic arm (not shown in the figure), the first ends of the first telescopic arm and the first ends of the second telescopic arm may be disposed on the support rod 11 (such as the outer wall of the support rod 11). The second ends of the first telescopic arm and the second ends of the second telescopic arm are respectively connected in the length direction of the folding wing 1211 (e.g., along the longitudinal direction). Figure 7 (As indicated by the arrow "Y" in the diagram) The two ends of the folding wing 1211. Since the middle part of the folding wing 1211 is rotatably connected to the support rod 11, when the first and second telescopic arms extend, they can abut against the two ends of the folding wing 1211 along its length, causing the folding wing 1211 to fold. When the first and second telescopic arms retract, they can pull the two ends of the folding wing 1211 apart along its length, thereby unfolding the folding wing 1211. In some embodiments, the unfolding angle of the folding wing 1211 can be adjusted by controlling the extension distance of the first and second telescopic arms to suit different usage environments.

[0070] In some embodiments, the opening and closing control mechanism may include a control handle (not shown) and a control button (not shown) disposed on the control handle. The control button can control the extension and retraction of the first telescopic arm and the second telescopic arm. For example, the first telescopic arm and the second telescopic arm may be connected to an external drive mechanism (e.g., a hydraulic mechanism), and the control button can control the drive mechanism to drive the first telescopic arm and the second telescopic arm to extend and retract. By providing a control handle and a control button on the control handle, it is easier for the operator to adjust the unfolding angle of the folding wing 1211, thus improving operational convenience.

[0071] In some embodiments, the opening and closing control mechanism can drive the folding or unfolding of the folding wing 1211 in an electro-actuated manner. As an example only, magnetic blocks (not shown) and electromagnets (not shown) are respectively provided at both ends along the length direction of the folding wing 1211. When the coil of the electromagnet is not energized, the electromagnet is not magnetic, so the elasticity of the folding wing 1211 allows itself and the capsule 122 to remain in an unfolded state. When the coil is energized, the electromagnet generates magnetism, and the two ends of the folding wing 1211 along the length direction fold due to the mutual attraction between the electromagnet and the magnetic blocks.

[0072] In some embodiments, the stronger the magnetism of the electromagnet, the greater the force driving the folding wing 1211 to fold, the greater the degree of folding of the folding wing 1211, and the smaller the unfolding angle. Conversely, the weaker the magnetism of the electromagnet, the smaller the force driving the folding wing 1211 to fold, the smaller the degree of folding of the folding wing 1211, and the larger the unfolding angle. Therefore, the unfolding angle of the folding wing 1211 can be adjusted by controlling the magnetic strength of the electromagnet.

[0073] In some embodiments, the magnetic strength of the electromagnet is positively correlated with the current intensity and the number of turns in the coil. Specifically, the stronger the current and the more turns the coil has, the stronger the magnetic strength of the electromagnet. Conversely, the weaker the current and the fewer the turns the coil has, the weaker the magnetic strength of the electromagnet. Therefore, the magnetic strength of the electromagnet can be adjusted by controlling the magnitude of the current in the coil and the number of turns, thereby adjusting the unfolding angle of the folding wing 1211.

[0074] In some embodiments, combined with Figure 1 , Figure 11 and Figure 13 As shown, the support rod 11 controls the vibrating head 12 to extend and unfold from the front end of the delivery tube 20, and a hemostatic valve plate 14 is provided in the middle or rear end of the delivery tube 20. Among these features, Figure 11 The vibrating head 12 is located at the front end of the conveying pipe 20. Figure 11 The end where the hemostasis valve 14 is located is the rear end of the delivery tube 20. In this embodiment, by providing the hemostasis valve 14, on the one hand, it can prevent blood in the delivery tube 20 from flowing out of the inlet of the delivery tube 20 when the support rod 11 is inserted into the delivery tube 20 from the inlet at the rear end of the delivery tube 20. On the other hand, the hemostasis valve 14 can be used to support and fix the support rod 11, preventing the support rod 11 from shaking randomly inside the delivery tube 20.

[0075] In some embodiments, combined with Figure 11 and Figure 13As shown, the hemostatic valve plate 14 may include a cross-shaped slit 141, and the hemostatic valve plate 14 may be made of a flexible material. In this embodiment, since the hemostatic valve plate 14 is made of a flexible material, it has a certain elasticity, allowing the support rod 11 to pass through the cross-shaped slit 141 into the delivery tube 20; correspondingly, the portion of the hemostatic valve plate 14 corresponding to the cross-shaped slit 141 will protrude into the delivery tube 20 and undergo elastic deformation. Under the action of elastic restoring force, the hemostatic valve plate 14 will abut against and adhere to the side wall of the support rod 11, achieving a sealed connection or near-sealed connection, thereby preventing blood from flowing out of the delivery tube 20. Furthermore, since the force exerted by the hemostatic valve plate 14 on the side wall of the support rod 11 is basically consistent around the perimeter, the support rod 11 can be kept in a relatively stable state, thereby effectively preventing the support rod 11 from shaking. In some embodiments, the flexible material used to make the hemostatic valve plate 14 may include rubber, plastic, silicone, etc. In some embodiments, in addition to the cross-shaped slit 141, the hemostatic valve plate 14 may also include a star-shaped slit, a straight slit, a hole, etc.

[0076] In some embodiments, the delivery tube 20 may be one of the components of the calcification lesion removal device 10. In some embodiments, the delivery tube 20 may be a component independent of the calcification lesion removal device 10.

[0077] In some applications, when the calcification removal device 10 is used to remove calcifications on the heart valves, it is necessary to use the delivery tube 20 to deliver the vibrating head 12 to the aortic valve 40 via the femoral artery. To accommodate these applications, in some embodiments, the tip of the delivery tube 20 is configured to be selectively bent at a certain angle (e.g., Figure 1 and Figure 13 (As shown). Before the tip of the delivery tube 20 reaches above the aortic valve 40, the tip of the delivery tube 20 can remain straight to allow movement within the tissue lumen. When the tip of the delivery tube 20 reaches a specific position, it can be bent at a certain angle to facilitate movement of the vibrating head 12 (e.g., Figure 1 The vibrating head 12) is aligned with and fits the aortic valve 40.

[0078] In this embodiment, bending the front end of the conveying pipe 20 at a certain angle can mean that the axis of the front end of the conveying pipe 20 rotates at a certain angle relative to the axis of the rear end of the conveying pipe 20. For example, in Figure 13 In the embodiment shown, the axis of the front end of the conveying pipe 20 can be considered to be rotated 180° relative to the axis of the rear end of the conveying pipe 20.

[0079] In some embodiments, the calcification lesion removal device 10 may include a bending control mechanism (not shown) that controls the bending or straightening of the delivery tube 20. By way of example only, the bending control mechanism may include a traction rope (not shown) disposed within the delivery tube 20, which may be a steel wire rope. A first end of the traction rope is fixed to the front end of the delivery tube 20, and a second end of the traction rope extends from the rear end of the delivery tube 20. In some embodiments, when the traction rope is in its natural state, the front end of the delivery tube 20 is in a bent state (e.g., Figure 13 The front end of the delivery tube 20 bends to the left of its own axis. When the second end of the traction rope is pulled, the first end of the traction rope causes the front end of the delivery tube 20 to gradually straighten. In some embodiments, when the traction rope is in its natural state, the front end of the delivery tube 20 is in a straight state; when the traction rope is pulled, the traction rope can cause the front end of the delivery tube 20 to bend.

[0080] In some embodiments, the front end of the delivery pipe 20 is unilaterally bendable, meaning that the front end of the delivery pipe 20 can only be bent to one side. For example, Figure 13 The tip of the delivery tube 20 shown can only be bent to the left of its own axis. Accordingly, since the delivery tube 20 can only be bent on one side, when the delivery tube 20 is in the straight position, it can remain straight even if the operator continues to pull the traction rope, making it easier for the delivery tube 20 to move in the femoral artery.

[0081] In some embodiments, the angle of bending at the tip of the delivery pipe 20 before it is straightened is positively correlated with the stroke of the traction rope. Therefore, the operator can adjust the angle of bending at the tip of the delivery pipe 20 by controlling the stroke of the traction rope to adapt to more usage environments.

[0082] In some embodiments, the bending angle of the front end of the conveying pipe 20 can be in the range of 0° to 180°. In some embodiments, the bending angle of the front end of the conveying pipe 20 can be in the range of 0° to 120°. In some embodiments, the bending angle of the front end of the conveying pipe 20 can be in the range of 0° to 60°.

[0083] The operation of the calcification lesion removal device 10 in some embodiments of this specification is as follows: First, the front end of the delivery tube 20 can be delivered to the target position. During this process, the bending angle of the delivery tube can be controlled (e.g., by a bending control mechanism). After the front end of the delivery tube 20 reaches the target position, the support rod 11 and the vibrating head 12 can be delivered to the target position using the delivery tube 20, and the vibrating head 12 can be extended and unfolded from the front end of the delivery tube 20 by control (e.g., by an opening and closing control mechanism). After the vibrating head 12 unfolds, the vibration of the vibrating head 12 can be used to break up the calcification lesions on the valve. During the fragmentation of calcified lesions, the vibrating head 12 can be moved (e.g., the support rod 11 can be controlled to rotate the vibrating head 12) and the unfolding angle of the vibrating head 12 can be controlled to achieve a better fragmentation effect. After the fragmentation operation is completed, at least part of the liquid and / or gas in the capsule 122 can be extracted through the delivery tube 20 to cause the capsule 122 to shrink, and the fragmented calcified plaques can be adsorbed through the negative pressure adsorption holes 127 formed on the surface of the capsule 122. Finally, the vibrating head 12 is controlled to shrink into the delivery tube 20 and withdraw from the delivery tube 20 to remove the calcified plaques from the patient's body.

[0084] The beneficial effects that the calcification lesion removal device in the embodiments of this specification may bring include, but are not limited to: (1) By connecting the support rod and the vibrating head, and by controlling the vibrating head to contract within the delivery tube and to extend and unfold from the front end of the delivery tube, the support rod and the vibrating head can be used to prevent damage to blood vessels during transportation, and the delivery tube can be moved more easily within the blood vessels; (2) By adapting the shape of the upper surface (or outer surface) of the folding wing to the cross-sectional shape of the inner cavity of the delivery tube, the outer surface of the folding wing can better adapt to the inner wall of the delivery tube after it is fully closed, thereby making full use of the space inside the delivery tube; (3) By setting a fluid tube, gas and / or liquid can be injected into the cyst through the fluid tube, or gas and / or liquid can be discharged from the cyst, thereby enabling the expansion or contraction of the cyst; (4) By setting a piston cylinder on the surface of the cyst, when the piston cylinder is recessed into the interior of the cyst, the piston cylinder will form an adsorption hole with the inner wall of the cyst, and a negative pressure will be formed in the adsorption hole to adsorb the broken calcification plaques into the adsorption hole, and from (5) By making the positions of the multiple piston cylinders on the first folding wing correspond one-to-one with the positions of the multiple piston cylinders on the second folding wing, the adsorption holes of the first sac and the second sac are in a closed or nearly closed state when the first sac and the second sac are attached, thus more effectively preventing the calcified plaques in the adsorption holes from leaking out; (6) By setting multiple protrusions on the lower surface of the sac, on the one hand, the protrusions can abut against the valve and / or the calcified lesions on it, thus making the sac and the valve more firmly attached. This reduces the sliding of the cyst relative to the valve. On the other hand, the protrusion can cut into the calcified lesion of the valve, and the vibration of the cyst will drive the protrusion to cut the calcified lesion, further improving the fragmentation efficiency and fragmentation effect of the calcified lesion; (7) By setting a hemostatic valve in the middle or rear end of the delivery tube, on the one hand, it can prevent the blood in the delivery tube from flowing out of the inlet of the delivery tube when the support rod enters the delivery tube from the inlet at the rear end of the delivery tube; on the other hand, the hemostatic valve can be used to support and fix the support rod, preventing the support rod from shaking randomly in the delivery tube. It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects that may be produced can be any one or a combination of the above, or any other possible beneficial effects.

[0085] The basic concepts have been described above. Obviously, for those skilled in the art, the detailed disclosure above is merely illustrative and does not constitute a limitation of this specification. Although not explicitly stated herein, those skilled in the art may make various modifications, improvements, and corrections to this specification. Such modifications, improvements, and corrections are suggested in this specification and therefore remain within the spirit and scope of the exemplary embodiments described herein.

Claims

1. A device for removing calcified lesions, characterized in that, include: A support rod and a vibrating head, wherein the support rod and the vibrating head are connected; The support rod can control the vibrating head to retract into the conveying pipe, and control the vibrating head to extend and unfold from the front end of the conveying pipe; The vibrating head is capable of generating vibration; The vibrating head includes a folder and a capsule, the folder including at least two folding wings, and the capsule disposed on the surface of the folding wings; The folding wing can cause the capsule to fold or unfold. The capsule is capable of vibration.

2. The calcified lesion removal device according to claim 1, characterized in that, The capsule is capable of containing gas and / or liquid, and at least one pair of electrodes are disposed inside the capsule, which can act on the gas and / or liquid inside the capsule to generate a shock wave.

3. The calcified lesion removal device according to claim 1, characterized in that, The calcified lesion removal device also includes a fluid tube that is connected to the cyst body. Gas and / or liquid can be injected into or discharged from the cyst body through the fluid tube to achieve the expansion or contraction of the cyst body.

4. The calcified lesion removal device according to claim 1, characterized in that, The surface of the capsule is provided with multiple protruding teeth.

5. The calcified lesion removal device according to claim 4, characterized in that, The plurality of protruding teeth form one or more toothed rings, and a piston cylinder is provided in the area enclosed by the toothed rings. The piston cylinder is capable of being recessed into the interior of the bladder when the bladder contracts.

6. The calcified lesion removal device according to claim 5, characterized in that, The piston cylinder is integrally formed with the bladder body, and the wall thickness of the piston cylinder is less than the wall thickness of the bladder body.

7. The calcified lesion removal device according to claim 5, characterized in that, The capsule includes a first capsule and a second capsule disposed opposite to each other, and the folder includes a first folding wing and a second folding wing disposed opposite to each other. The first capsule is disposed on the inner surface of the first folding wing, and the second capsule is disposed on the inner surface of the second folding wing. When the first folding wing and the second folding wing are folded, the first capsule and the second capsule fit together. One or more of the toothed rings are provided on both the first capsule and the second capsule, and the position of the toothed ring on the first capsule corresponds to the position of the toothed ring on the second capsule.

8. The calcified lesion removal device according to claim 1, characterized in that, The support rod and the folding wing are rotatably connected. The folding wing is made of an elastic material and is in an unfolded state in its natural state; or... The support rod and the folding wing are connected by an opening and closing control mechanism, which is used to control the folding wing to fold or unfold.

9. The calcified lesion removal device according to claim 1, characterized in that, The calcified lesion removal device also includes the delivery pipe; The delivery tube is provided with a hemostatic valve plate in the middle or rear end. The hemostatic valve plate is made of flexible material and includes a cross-shaped slit.

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