Rotating device and drive shaft for the rotating device

Abstract

The present invention relates to a rotating device and a driving shaft for the rotating device, aiming to improve the structure of the driving shaft to reduce the friction and friction loss between the driving shaft and the guide wire, avoid the problem of excessive friction between the guide wire and the driving shaft causing the guide wire to fail, thereby ensuring that the driving shaft can match the guide wire commonly used in clinical practice, improving the operability of the operation, and reducing the cost of the operation. The rotating device includes a tool and a driving shaft, wherein the tool is arranged at one end of the driving shaft and connected to the outer layer of the driving shaft, and the tool is used to perform a rotating motion under the drive of the outer layer. The driving shaft includes an outer layer and an inner layer, wherein the outer layer is a tubular structure; the inner layer is arranged in the accommodating space formed by the outer layer, and the inner layer has a central cavity for receiving an external mechanism therein; the outer layer rotates around the central cavity, and the inner layer rolls relative to the outer layer and the external mechanism to form rolling friction between the outer layer and the external mechanism through the inner layer.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a rotating device and a driving shaft used for the rotating device. Background Art

[0002] With the continuous development of percutaneous coronary intervention (PCI), the lesions involved are becoming more and more complex, and coronary artery calcification lesions have always been the difficulty and risk of interventional treatment, especially severe calcification lesions, or complex calcification lesions with distortion, angulation, and diffusion. Correct identification and evaluation of calcification lesions and selection of appropriate interventional treatment techniques are the key to improving the success rate of surgery, reducing surgery-related complications, and improving patients' short- and long-term prognosis.

[0003] Rotational atherectomy has become an indispensable treatment method for the successful completion of PCI. The principle of rotational atherectomy is to use a rotational atherectomy device to grind at high speed at the vascular lesion to remove calcified or fibrotic arteriosclerotic plaques, thereby opening the blood vessels blocked by plaques and obtaining a smooth vascular lumen to facilitate the subsequent implantation of stents. Common rotational atherectomy devices mainly include a flexible drive shaft and a rotational atherectomy head covered with wear-resistant materials such as diamond particles carried at the distal end of the flexible drive shaft. The flexible drive shaft drives the rotational atherectomy head to rotate at a high speed (in the range of approximately 150,000 rpm to 190,000 rpm), advancing forward to contact and grind and remove lesions. Since the inner lumen of the flexible drive shaft needs to be penetrated by a guide wire, and the high-speed friction between the flexible drive shaft and the guide wire is easy to wear the guide wire, for example, there is a risk of wearing the surface coating of the guide wire, welding the guide wire, and even untwisting the threaded segment at the front end of the guide wire.

[0004] Therefore, the current flexible drive shaft cannot match the commonly used guide wires in clinical practice (e.g. 0.014 inches), otherwise it is easy to damage the PTFE coating on the surface of the guide wire, and there is a risk of untwisting the threaded section, and even the guide wire may be worn off. For this reason, special guide wires with no coating on the surface and no threaded section at the front end are usually used in clinical practice. However, the flexibility and pushing performance of special guide wires are poor, which is not conducive to surgical operation and also increases the cost of surgery. Summary of the invention

[0005] In order to solve the above-mentioned technical problems, the purpose of the present invention is to provide a rotating device and a driving shaft for the rotating device, aiming to improve the structure of the driving shaft to reduce the friction and friction loss between the driving shaft and the guide wire, avoid the problem of guide wire failure caused by excessive friction between the guide wire and the driving shaft, melting, wear and untwisting of the guide wire, thereby ensuring that the driving shaft can match the guide wire commonly used in clinical practice, improve the operability of the operation, and reduce the cost of the operation.

[0006] To achieve the above-mentioned purpose, the present invention provides a driving shaft for a rotating device, which includes an outer layer and an inner layer; the outer layer is a tubular structure; the inner layer is arranged in the accommodating space formed by the outer layer, and the inner layer has a central cavity for receiving an external mechanism therein; wherein: the outer layer rotates around the central cavity, and the inner layer rolls relative to the outer layer and the external mechanism to form rolling friction between the outer layer and the external mechanism through the inner layer.

[0007] Optionally, the inner layer includes a plurality of rolling bodies, and the plurality of rolling bodies are distributed on the inner surface of the outer layer.

[0008] Optionally, a plurality of the rolling bodies are spirally wound along the axis of the outer layer to form a spiral structure.

[0009] Optionally, a plurality of the rolling bodies are spirally wound along the axis of the outer layer to form a continuous spiral structure, or a plurality of the rolling bodies are spirally wound along the axis of the outer layer to form a plurality of spiral structures distributed at intervals.

[0010] Optionally, a plurality of the rolling bodies are distributed around the axis of the outer layer to form a plurality of axially discontinuously distributed rings.

[0011] Optionally, the rolling body is a spherical roller, a spherical roller, a cylindrical roller, a needle roller or a tapered roller.

[0012] Optionally, a raceway is provided on the inner side of the outer layer, a plurality of the rolling bodies are movably distributed in the raceway, and a portion of the rolling bodies extends out of the raceway to contact the external mechanism.

[0013] Optionally, the material of the rolling element is polymer.

[0014] Optionally, slits are formed on the outer layer to allow fluid to flow through the slits to the inner surface and / or outer surface of the drive shaft.

[0015] Optionally, the outer layer is magnetically connected, clamped or embedded to the inner layer.

[0016] To achieve the above-mentioned purpose, the present invention also provides a rotating device, which includes a tool and any one of the driving shafts for the rotating device; the tool is arranged at one end of the driving shaft and connected to the outer layer of the driving shaft, and the tool is used to perform rotational motion under the drive of the outer layer.

[0017] Optionally, the tool and the drive shaft are separately molded structures, or the tool and the outer layer of the drive shaft are integrally molded structures.

[0018] Optionally, the tool is a grinding element.

[0019] The rotary device and the driving shaft for the rotary device provided by the present invention have at least one of the following advantages:

[0020] First, by designing a rollable inner layer on the drive shaft, the sliding friction between the drive shaft and the guide wire can be converted into rolling friction, effectively reducing the friction force and friction loss between the drive shaft and the guide wire, thereby avoiding the problems of surface coating wear, welding, and unwinding of the spiral segment caused by the high-speed rotation of the drive shaft, reducing the risk of guide wire failure, and enabling the drive shaft to match the commonly used guide wires in clinical practice, improving the operability of the operation, and reducing the cost of the operation;

[0021] Second, the inner layer design can be realized by using common rolling elements such as spherical rollers, spherical rollers, cylindrical rollers, needle rollers or tapered rollers, which has a simple structure and low processing cost;

[0022] Third, by limiting the material of the rolling element in the inner layer to polymer, the friction force and friction loss can be further reduced due to the low surface friction coefficient of polymer;

[0023] Fourthly, the outer layer with gaps facilitates the flow of fluids such as cooling and / or lubricating fluids into the inner surface and / or outer surface of the drive shaft, thereby further reducing wear and lowering the heat generated by friction. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0025] Figure 1 is a schematic structural diagram of a rotating device provided in Embodiment 1 of the present invention;

[0026] Figure 2 is an axial cross-sectional view of a drive shaft provided in Embodiment 1 of the present invention;

[0027] Figure 3 is a cross-sectional view of a drive shaft provided in Embodiment 1 of the present invention;

[0028] Figure 4 is a schematic structural diagram of a rotating device provided in Embodiment 2 of the present invention;

[0029] Figure 5 is an axial cross-sectional view of a drive shaft provided in Embodiment 2 of the present invention;

[0030] Figure 6 is along Figure 5 A cross-sectional view of the drive shaft obtained by cutting along the line AA of the drive shaft shown;

[0031] Figure 7 is along Figure 5 A cross-sectional view of the drive shaft obtained by cutting along the line BB of the drive shaft shown;

[0032] Figure 8 yes Figure 5 A partial enlarged view of the drive shaft shown;

[0033] Fig. 9 Schematic diagram of the structure of a retaining frame provided by an embodiment of the present invention.

[0034] In the figure:

[0035] 10, 20-rotating device;

[0036] 1. 3-Drive shaft;

[0037] 11, 31-outer layer;

[0038] 12, 32-Inner layer;

[0039] 13, 33-central cavity;

[0040] 121, 321- rolling element;

[0041] 34-Rollway;

[0042] 2. 4- Tools;

[0043] 122-Retaining frame.

[0044] The same or similar reference numerals in the drawings represent the same or similar components. DETAILED DESCRIPTION

[0045] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are simplified and not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0046] As used in this specification, the singular forms "a", "an", and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise.

[0047] In the following description, for the convenience of description, "distal end" and "proximal end", "axial" and "circumferential" are used; "distal end" is the side away from the operator of the rotating device; "proximal end" is the side close to the operator of the rotating device; "axial" refers to the direction along the longitudinal axis of the rotating device; "circumferential" refers to the direction around the longitudinal axis of the rotating device; "inner side" refers to the longitudinal axis direction close to the drive shaft; "outer layer" is the side opposite to the "inner side". In the description of the present invention, unless otherwise specified, "multiple" means two or more, and "several" means that the number is not limited.

[0048] In addition, in the following description, a large number of specific details are provided to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features well known in the art are not described.

[0049] Embodiment 1

[0050] Figure 1 This is a schematic diagram of the structure of the rotating device provided in Embodiment 1 of the present invention. Figure 2 is an axial cross-sectional view of a driving shaft on a rotating device provided in Embodiment 1 of the present invention, Figure 3 It is a cross-sectional view of the driving shaft on the rotating device provided in the first embodiment of the present invention.

[0051] like Figure 1 As shown, the present embodiment provides a rotating device 10, which includes a drive shaft 1 and a tool 2. The distal end of the drive shaft 1 is connected to the tool 2 to drive the tool 2 to perform rotational motion. Generally, the drive shaft 1 is used to transmit torque and drive a tool such as a grinding element connected thereto to perform rotational motion. The rotating device 10 of the present embodiment can be used for intravascular surgery, such as removing tissue from a body passage, such as using a rotating device to remove calcified or fibrotic arteriosclerotic plaques in a blood vessel, thereby opening a blood vessel (including a coronary vessel, a peripheral vessel or other blood vessel) blocked by the plaque to obtain a smooth vascular lumen. The rotation speed of the tool 2 is, for example, in the range of 150,000 rpm to 190,000 rpm, so that the target tissue can be removed by high-speed rotation and grinding at the vascular lesion by the rotating device 10.

[0052] The drive shaft 1 and the tool 2 may be arranged coaxially or eccentrically. The tool 2 may be completely loaded on the drive shaft 1, for example, the tool 2 has a center hole, and the entire length of the center hole is sleeved on the drive shaft 1. The tool 2 may also be partially loaded on the drive shaft 1, for example, a portion of the length of the center hole is sleeved on the drive shaft 1. In addition, the distal end of the drive shaft 1 may also extend out of the tool 2. That is, the present invention does not specifically limit the connection relationship between the tool 2 and the drive shaft 1.

[0053] like Figure 2 As shown, the drive shaft 1 includes an outer layer 11 and an inner layer 12. The outer layer 11 is a tubular structure, preferably a flexible tubular structure. The inner layer 12 is arranged in the accommodating space formed by the outer layer 11, and the inner layer 12 has a central cavity 13 for receiving the guide wire (i.e., the external mechanism) therein, and the central cavity 13 allows the drive shaft 1 to advance and rotate relative to the guide wire. It should also be understood that if the outer layer 11 is a flexible tubular structure, the outer layer 11 can also bend and deform well when transmitting torque, that is, the outer layer 11 has good flexibility, and the outer layer 11 also has good pushing performance. And the tool 2 is connected to the distal end of the outer layer 11, so that the outer layer 11 drives the tool 2 to perform rotational motion. In this embodiment, the tool 2 and the drive shaft 1 can be a split molding structure, that is, the two are separately molded and then assembled together. In other embodiments, the tool 2 and the drive shaft 1 may also be an integrally molded structure. Specifically, the tool 2 and the outer layer 11 are an integrally molded structure. For example, a portion of the outer layer 11 has an enlarged diameter, and at least a section of the enlarged surface is covered with wear-resistant material to form a wear-resistant section of the outer layer. When the outer layer rotates at a high speed, the wear-resistant section can remove stenotic tissue from the blood vessel.

[0054] In particular, the inner layer 12 is rollably disposed in the outer layer 11. In more detail, when the outer layer 11 rotates at high speed around the central cavity 13, the inner layer 12 rolls relative to the outer layer 11 and the guide wire in the central cavity 13, so that rolling friction is formed between the outer layer 11 and the guide wire, thereby reducing the friction between the drive shaft and the guide wire when the drive shaft rotates at high speed, avoiding the occurrence of the guide wire failure problem, solving the problem that the rotating device cannot match the commonly used guide wire, improving the operability of the operation, and reducing the cost of the operation.

[0055] Further, the present invention does not limit the processing method of the outer layer 11. For example, it can be woven from braided wire, or it can be cut from a tube spirally, or it can be spirally wound from a wire material. Alternatively, a tubular elastic member such as a bellows can also be selected, or a polymer tube can also be selected for the outer layer 11. Preferably, the outer layer 11 is a spring coil spirally wound from one or more strands of wire material, with large torque and good flexibility. More preferably, a gap is formed on the outer layer 11, and the gap allows fluid (such as saline and / or water or other fluids) to pass through and reach the inner surface and / or outer surface of the outer layer 11, so as to provide cooling and / or lubrication to the interface of the outer layer 11, the inner layer 12 and the guide wire, thereby further reducing wear and reducing heat. For example, gaps are formed between at least some of the coils of the spring coil to facilitate the flow of fluid. In addition, the coils of the spring coil can be independent of each other, that is, there is a gap between any adjacent coils, or some of the coils of the spring coil can be sealed and connected. The material of the outer layer 11 can be a metal material, a combination of multiple metal materials, or even a combination of metal materials and organic polymer materials. For example, the material of the outer layer 11 is one or more combinations of stainless steel, nickel, titanium, and tungsten. Preferably, the material of the outer layer 11 is stainless steel or nickel-titanium alloy, which ensures that the outer layer 11 has better flexibility and superelasticity, thereby ensuring that the drive shaft 1 has better compliance. There is no special requirement for the shape of the spirally wound wire, which can be a flat (such as rectangular) wire, or a round or elliptical wire.

[0056] like Figure 3 As shown, the inner layer 12 includes a plurality of rolling bodies 121, and the plurality of rolling bodies 121 are distributed on the inner surface of the outer layer 11. More specifically, the plurality of rolling bodies 121 are distributed around the axis of the outer layer 11 and define a central cavity 13. The present invention does not impose any particular restrictions on the shape of the rolling body 121. For example, the rolling body 121 may be a spherical roller, a spherical roller, a cylindrical roller, a needle roller or a tapered roller. Moreover, the inner layer 12 may include rolling bodies of different shapes or rolling bodies of the same shape. In this embodiment, the rolling body 121 is a spherical roller. The material of the rolling body 121 may be a metal material or a non-metal material. The metal material includes but is not limited to carbon steel, bearing steel, stainless steel, etc., and the non-metal material includes but is not limited to plastic, ceramic, etc. Further, the material of the rolling body 121 is preferably a material with a relatively low friction coefficient, such as a polymer, which can further reduce friction. The polymer may be one or more combinations of polytetrafluoroethylene (PTFE), polyimide, nylon, and polyetheretherketone (PEEK).

[0057] The present invention does not limit the arrangement of the rolling elements 121. In some embodiments, a plurality of rolling elements 121 are spirally wound along the axis of the outer layer 11 to form a spiral structure. For example, a plurality of rolling elements 121 are spirally wound along the axis of the outer layer 11 to form a continuous spiral structure, and the spiral structure covers the proximal end to the distal end of the outer layer 11. For another example, a plurality of rolling elements 121 are spirally wound along the axis of the outer layer 11 to form a plurality of spiral structures distributed at intervals. In this embodiment, Figure 2 As shown, a plurality of spherical rollers are spirally wound along the axis of the outer layer 11 to form a continuous spiral structure. In an alternative embodiment, a plurality of rolling bodies 121 can also be distributed around the axis of the outer layer 11 to form at least one circle, and the circle can be circular or elliptical. Optionally, a plurality of rolling bodies 121 are distributed around the axis of the outer layer 11 to form a plurality of circles, and the plurality of circles are axially intermittently distributed or axially adjacent to each other.

[0058] Furthermore, the connection method between the outer layer 11 and the inner layer 12 is not limited, for example, magnetic connection, clamp connection or embedded connection can be used. If it is a magnetic connection, the rolling body 121 can be configured to be magnetic and can be adsorbed on the outer layer 11; or the outer layer 11 can be configured to be magnetic. If it is a clamp connection, a retaining frame can be set on the outer layer 11 or the inner layer 12, partially wrapping the rolling body 121 and moving with the rolling body 121, for isolating the rolling body, and also for guiding the rolling body and retaining it in the outer layer.

[0059] Fig. 9 It is a way to realize that a retaining frame 122 is arranged on the inner layer 12. Fig. 9 As shown, the retaining frame 122 on the inner layer 12 is a thin-walled cylinder, and a plurality of holes or holes are provided on the retaining frame 122. The diameter of the holes or holes is larger than the outer diameter of the rolling body 121. The rolling body 121 is located in the holes or holes and can roll 360°. If it is an embedded connection, a raceway can be provided on the inner surface of the outer layer 11, and a plurality of rolling bodies 121 can be movably distributed in the raceway, and a portion of the rolling body 121 extends out of the raceway and contacts the guide wire. The shape of the raceway is determined according to the arrangement of the rolling bodies, such as a continuous spiral raceway, or a plurality of segmented spiral raceways, or at least one circle of circular or elliptical raceways. In this embodiment, the rolling body 121 is magnetically connected to the outer layer 11, such as Figure 3 shown.

[0060] Further, the inner diameter of the drive shaft 1 is configured to fit a commonly used guide wire, and optionally, the inner diameter of the drive shaft 1 ranges from 0.008 to 0.04 inches, which can match a commonly used 0.014-inch guide wire. In addition, the outer diameter of the drive shaft 1 is configured to fit a commonly used delivery sheath, and optionally, the outer diameter of the drive shaft 1 ranges from 0.02 to 0.08 inches.

[0061] Embodiment 2

[0062] The rotating device provided in this embodiment is basically the same as that in the first embodiment. Only the differences are described below, and the same parts are not described in detail.

[0063] Figure 4 is a schematic diagram of the structure of the rotating device provided in the second embodiment of the present invention, Figure 5 is a schematic cross-sectional view of a drive shaft provided in Embodiment 2 of the present invention, Figure 6 is along Figure 5 The cross-sectional view of the drive shaft cut along the AA line is shown. Figure 7 is along Figure 5 The cross-sectional view of the drive shaft cut along the BB line is shown. Figure 8 yes Figure 5 An enlarged view of a portion of the drive shaft is shown.

[0064] like Figure 4 and Figure 5 As shown, this embodiment provides a rotating device 20, which includes a drive shaft 3 and a tool 4. The drive shaft 3 includes an outer layer 31 and an inner layer 32. The outer layer 31 is a tubular structure, preferably a flexible tubular structure. The inner layer 32 is arranged in the accommodation space formed by the outer layer 31, and the inner layer 32 has a central cavity 33 for receiving a guide wire therein.

[0065] like Figures 5 to 8 As shown, a raceway 34 is disposed inside the outer layer 31, and multiple raceways 34 are disposed inside the outer layer 31, the multiple raceways 34 are spaced apart along the axial direction, and multiple rolling bodies 321 are evenly distributed around the central cavity 33 in each raceway 34. Figure 7 As shown, on a projection plane perpendicular to the axial direction, the shape of the raceway 34 is circular.

[0066] In this embodiment, the rolling body 321 is a cylindrical roller, part of which is exposed outside the raceway 34 and contacts the guide wire. In particular, the rolling body 321 is made of PTFE material.

[0067] As described above, the distal end of the drive shaft disclosed in the embodiment of the present invention is connected to a tool, such as Figure 1 or Figure 4 In an exemplary embodiment, the tool is a rotary cutting tool such as a blade or a grinding crown. The tool may also include a sensor, etc., to facilitate obtaining data about the lumen and / or a site of interest (such as a lesion) in the lumen, such as position, distance, temperature, contact force, etc.

[0068] The above discloses the preferred implementation of the present invention, but the present invention is not limited to the scope disclosed in the above embodiments. Any content that is changed based on the structure provided in the above embodiments belongs to the scope of protection of the present invention. For example, in order to further reduce friction, a polymer material can be coated on the outer layer and the inner layer to form a polymer coating, and the polymer coating is preferably a PTFE coating with a low friction coefficient. Those skilled in the art can draw inferences from the content of the above embodiments.

[0069] In summary, according to the technical solution provided by the embodiment of the present invention, by designing a rollable inner layer on the drive shaft, the sliding friction between the drive shaft and the guide wire can be converted into rolling friction, thereby effectively reducing the friction force and friction loss between the drive shaft and the guide wire, thereby avoiding problems such as surface coating wear, welding, and unwinding of spiral segments caused to the guide wire when the drive shaft rotates at high speed, reducing the risk of guide wire failure, and enabling the drive shaft to match the guide wire commonly used in clinical practice, thereby improving the operability of the operation and reducing the cost of surgery.

[0070] The above description is only a description of the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. Any changes and modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention defined by the claims.

Claims

1. A drive shaft for a rotating device, characterized in that: It comprises an outer layer and an inner layer; the outer layer is a tubular structure; the inner layer is arranged in the accommodating space formed by the outer layer, and the inner layer has a central cavity for receiving the guide wire therein; wherein: the outer layer rotates around the central cavity, and the inner layer rolls relative to the outer layer and the guide wire so as to form rolling friction between the outer layer and the guide wire through the inner layer; the distal end of the outer layer is used to connect with a tool to drive the tool to perform rotational motion; the inner layer comprises a plurality of rolling bodies, which are distributed on the inner surface of the outer layer and are distributed around the axis of the outer layer and define the central cavity; the material of the rolling body is a polymer; a gap is formed on the outer layer to allow the fluid to flow through the gap to the inner surface and / or outer surface of the drive shaft.

2. The drive shaft for a rotating device according to claim 1, characterized in that: A plurality of rolling bodies are spirally wound along the axis of the outer layer to form a spiral structure.

3. The drive shaft for a rotating device according to claim 2, characterized in that: A plurality of the rolling bodies are spirally wound along the axis of the outer layer to form a continuous spiral structure, or a plurality of the rolling bodies are spirally wound along the axis of the outer layer to form a plurality of spiral structures distributed at intervals.

4. The drive shaft for a rotating device according to claim 1, characterized in that: The plurality of rolling bodies are distributed around the axis of the outer layer to form a plurality of axially discontinuously distributed rings.

5. The drive shaft for a rotating device according to any one of claims 1 to 4, characterized in that: The rolling body is a spherical roller, a spherical roller, a cylindrical roller, a needle roller or a tapered roller.

6. The drive shaft for a rotating device according to any one of claims 1 to 4, characterized in that: A raceway is arranged on the inner side of the outer layer, a plurality of rolling bodies are movably distributed in the raceway, and a part of the rolling bodies extends out of the raceway to contact the guide wire.

7. The drive shaft for a rotating device according to claim 1 or 2, characterized in that: The outer layer is connected to the inner layer by magnetic connection, clamp connection or embedding connection.

8. A rotating device, characterized in that: It comprises a tool and a driving shaft for a rotating device as described in any one of claims 1 to 7; the tool is arranged at one end of the driving shaft and connected to the outer layer of the driving shaft, and the tool is used to perform rotational motion under the drive of the outer layer.

9. The rotating device according to claim 8, characterized in that: The tool and the drive shaft are separately formed structures, or the tool and the outer layer of the drive shaft are integrally formed structures.

10. The rotating device according to claim 8, characterized in that The tool is a grinding element.

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