CN213787674U - Atheromatous plaque rotary grinding and cutting instrument - Google Patents

Abstract

The utility model provides a rotational atherectomy instrument, which comprises a shell, a sliding mechanism, a driving component and a rotational grinding component, wherein the sliding mechanism, the driving component and the rotational grinding component are arranged on the shell; two ends of the shell are respectively provided with a front lead-out hole and a rear lead-out hole; the sliding mechanism comprises a support, a front movable rail pipe and a front static rail pipe, the support is in slidable fit with the shell along the longitudinal direction, the front movable rail pipe and the front static rail pipe are nested in a sliding mode, the front movable rail pipe is fixedly connected with the support, and the front static rail pipe is fixedly connected with the shell and clamped by the shell to limit radial movement of the front movable rail pipe and the shell. The driving assembly comprises a motor arranged on the support, a driving wheel connected with an output shaft of the motor and a driven wheel meshed with the driving wheel, and the hollow pipe shaft is pivoted with the support; the front side movable rail pipe and the front side static rail pipe are both positioned between the driven wheel and the front leading-out hole. The driving shaft of the utility model can be smoothly pushed along the axial direction, and the safety of the rotary grinding excision operation is high.

Description

Atheromatous plaque rotary grinding and cutting instrument

Technical Field

The utility model relates to a surgical cutting instrument especially relates to an atheromatous plaque grinds excision apparatus soon.

Background

Ischemic heart disease is a disease with high mortality in the world at present, and atherosclerosis is one of the causes of ischemic heart disease. The deposition of fat, fiber, and calcium from atherosclerotic plaque on the vessel wall can prevent the normal flow of blood, resulting in vessel occlusion. In China, the elderly and diabetics are prone to atherosclerosis, and may develop calcified lesions, increasing mortality. For the condition of light atherosclerosis symptom, the interventional balloon and stent treatment can push atherosclerotic plaque into the blood vessel wall so as to dredge the blood vessel, treat ischemic heart disease and peripheral artery disease. However, in the case of a heavily calcified lesion and a lesion in a specific site, such as a joint, a branch, and in-stent restenosis, the balloon and the stent cannot be fully expanded in the calcified vessel, and thus it is difficult to achieve an ideal therapeutic effect.

Rotational atherectomy is a clinical procedure for removing heavily calcified plaque. A rotational atherectomy device is powered directly by a motor, wherein the motor drives a drive shaft of a rotational atherectomy assembly through a gear train, thereby rotating a rotational atherectomy head at a distal end of the drive shaft to remove atheroma. To guide the drive shaft in rotation, a guide wire is disposed through the drive shaft. Since the rotational speed of the rotational head is typically 140,000-. In view of this, in a practical surgical procedure, multiple steps of withdrawing the orbital burr are arranged in addition to advancing the orbital burr. The current practice to achieve this is to pull the drive shaft back or advance it by reciprocating the motor. However, the existing rotational atherectomy device only designs a sliding mechanism for the motor, so that the driving shaft is easy to bend in the process of advancing the motor, which causes the phenomenon of blockage of the advancing action, thereby bringing higher surgical risks.

SUMMERY OF THE UTILITY MODEL

Based on the above current situation, the main objective of the present invention is to provide a rotational atherectomy device which can smoothly push the driving shaft and further improve the safety of the operation.

In order to achieve the above object, the utility model adopts the following technical scheme:

a rotational atherectomy device comprises a shell, a sliding mechanism, a driving assembly and a rotational grinding assembly, wherein the sliding mechanism, the driving assembly and the rotational grinding assembly are arranged on the shell;

the front end of the shell in the longitudinal direction is provided with a front lead-out hole, and the rear end of the shell is provided with a rear lead-out hole;

the sliding mechanism comprises a support, a front movable rail pipe and a front static rail pipe, the support is in slidable fit with the shell along the longitudinal direction of the shell, the front movable rail pipe and the front static rail pipe are mutually in slidable nesting arrangement, the front movable rail pipe is fixedly connected with the support, and the front static rail pipe is fixedly connected with the shell;

the driving assembly comprises a motor, a driving wheel and a driven wheel, the motor is mounted on the support, the driving wheel is connected with an output shaft of the motor, the driven wheel is meshed with the driving wheel, the driven wheel is provided with a central hole which is axially communicated, a hollow pipe shaft is arranged on the periphery of the central hole on the axial end face of the driven wheel, and the hollow pipe shaft is pivoted with the support; the front movable rail pipe and the front static rail pipe are both positioned between the driven wheel and the front lead-out hole;

the guide wire and the driving shaft sequentially penetrate through the central hole, the hollow pipe shaft, the intersection part of the inner cavities of the front movable rail pipe and the front fixed rail pipe and the front leading-out hole; the rear section of the guide wire also penetrates through the rear leading-out hole, the driving shaft is fixedly connected with the central hole, and a gap is formed between the driving shaft and the hollow pipe shaft.

Preferably, the front static rail pipe is embedded in the inner cavity of the front movable rail pipe; the support includes first backup pad and the second backup pad of the vertical relative setting of casing, first pipe cover hole and second pipe cover hole have been seted up respectively in first backup pad and the second backup pad, the rail pipe fixed mounting is moved to the front side is in first pipe cover hole and second pipe cover hole.

Preferably, the casing includes half first shell and the half second shell, half first shell and the half second shell enclose to close and form and hold slide mechanism, drive assembly and the appearance chamber of grinding subassembly part structure soon, half first shell and the half second shell are followed the horizontal joint of casing is fixed the quiet rail pipe of front side.

Preferably, atheromatous plaque grinds excision apparatus still includes the pipe fitting joint, half first shell is followed with the second half the horizontal joint of casing is fixed the pipe fitting joint, the pipe fitting joint has the edge the connecting channel who vertically link up of casing, the front end of front side static rail pipe stretches into connecting channel and with connecting channel's internal face fixed connection.

Preferably, the inner wall surface of the first half shell is provided with a first clamping plate and a second clamping plate which extend towards the second half shell and are opposite to each other; the inner wall surface of the second half shell is provided with a third clamping plate and a fourth clamping plate which extend towards the first half shell and are opposite to each other;

the pipe fitting joint comprises a cylindrical pipe body and a flange arranged on the peripheral surface of the pipe body, one part of the flange is clamped between the first clamping plate and the second clamping plate, and the other part of the flange is clamped between the third clamping plate and the fourth clamping plate.

Preferably, the first clamping plate is spliced with the third clamping plate, the second clamping plate is spliced with the fourth clamping plate, a rear supporting hole is formed at the spliced position of the first clamping plate and the third clamping plate, and a front supporting hole is formed at the spliced position of the second clamping plate and the fourth clamping plate;

the flange is flush with the rear end face of the pipe body, the rear end face of the pipe body abuts against the front side faces of the first clamping plate and the third clamping plate, and the outer peripheral face of the pipe body is matched with the inner peripheral face of the front supporting hole; the outer peripheral surface of the front side fixed rail pipe is matched with the inner peripheral surface of the rear support hole.

Preferably, the sliding mechanism further comprises a rear side static rail pipe fixedly connected with the shell, the rear side static rail pipe is sleeved on the periphery of the guide wire, the front section of the rear side static rail pipe is embedded in the inner cavity of the driving shaft in a sliding mode, and the front side static rail pipe and the inner wall of the driving shaft are respectively provided with a layer of antifriction material.

Preferably, the atherectomy device further comprises a splint assembly comprising a first splint, a second splint, and a splint fastener, wherein,

the first clamping plate and the second clamping plate are arranged in an overlapped mode, and clamping holes which are communicated along the longitudinal direction of the shell are formed in the overlapped surface of the first clamping plate and the second clamping plate; a first through hole is formed in the first clamping plate, and a second through hole corresponding to the first through hole is formed in the second clamping plate;

the inner wall surface of the shell extends towards the first clamping plate or the second clamping plate to form a screw hole column, the end surface of the screw hole column is attached to the second clamping plate, and a screw hole of the screw hole column corresponds to the second through hole;

the rear side static rail pipe is clamped in the clamping hole, and the clamping plate fastener penetrates through the first through hole and the second through hole to be fixedly connected with the screw hole of the screw hole column, so that the clamping hole clamps the rear side static rail pipe.

Preferably, the first via hole, the second via hole and the screw hole column are respectively provided with two and are respectively positioned at two sides of the rear side static rail pipe; the overlapped surface of the first clamping plate is respectively provided with a first tenon and a first jack at two sides of the clamping hole, and the overlapped surface of the second clamping plate is respectively provided with a second tenon and a second jack at two sides of the clamping hole;

the first tenon and the second tenon are both of flat structures, and the length directions of the cross sections of the first tenon and the second tenon are perpendicular to the length direction of the clamping hole; the first plug tenon is in adaptive insertion with the second jack, and the second plug tenon is in adaptive insertion with the first jack.

Preferably, during the process that the driving assembly moves with the bracket in a reciprocating manner along the longitudinal direction of the shell, the rear side static rail pipe and the front side static rail pipe are always overlapped in a projection along the transverse direction of the shell; the friction reducing material arranged on the inner walls of the front side static rail pipe and the driving shaft is a friction reducing pipe arranged in a nested manner or a friction reducing coating arranged in a coating manner.

The rotational atherectomy device of the utility model is characterized in that a front movable rail pipe and a front static rail pipe are additionally sleeved on the periphery of the guide wire and the driving shaft, and the front static rail pipe is fixed relative to the shell; the front side moves the rail pipe because with support fixed connection, the front side moves the rail pipe and sets up each other nestedly with the quiet rail pipe of front side and constitute one set of axial sliding pair, consequently when utilizing support removal drive assembly, the front side moves the rail pipe and can remove along with the support, at this in-process, except having strengthened axial guide effect, the front side moves the rail pipe or the quiet rail pipe of front side and can also play the restraint effect to the drive shaft of radial inboard, prevent that the drive shaft from excessively buckling, thereby guarantee that axial thrust transmits smoothly to the head of revolving of locating the drive shaft distal end, guarantee promptly that the drive shaft advances smoothly along the axial, and then guarantee the security of atheromatous plaque rotary grinding excision operation.

Other advantages of the present invention will be described in the detailed description, and those skilled in the art can understand the technical advantages brought by the technical features and technical solutions through the descriptions of the technical features and the technical solutions.

Drawings

A preferred embodiment of a rotational atherectomy device in accordance with the present invention will now be described with reference to the accompanying drawings. In the figure:

FIG. 1 is a perspective view of a preferred embodiment of a rotational atherectomy device according to the present invention;

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

FIG. 3 is a perspective view of the bracket of FIG. 2;

FIG. 4 is a perspective view of the cleat assembly of FIG. 2;

FIG. 5 is an exploded view of the cleat assembly of FIG. 4;

fig. 6 is a perspective view of the second half shell of fig. 2;

FIG. 7 is an enlarged view of a portion of the structure of FIG. 6 at A;

fig. 8 is a perspective view of the first half shell of fig. 2;

FIG. 9 is a partial enlarged view of the structure at B in FIG. 8;

FIG. 10 is a schematic illustration in top plan view of the atherectomy device of FIG. 1;

FIG. 11 is a schematic cross-sectional view taken along line XI-XI in FIG. 10;

fig. 12 is an enlarged schematic view of a structure between two-dot chain lines S1 and S2 in fig. 11;

FIG. 13 is an enlarged partial view of FIG. 12 at C;

fig. 14 is an enlarged schematic view of a structure between two-dot chain lines S3 and S4 in fig. 11;

FIG. 15 is an enlarged partial schematic view of FIG. 14 at D;

fig. 16 is an enlarged schematic view of a structure between two-dot chain lines S5 and S6 in fig. 11;

FIG. 17 is an enlarged partial view of FIG. 16 at E;

fig. 18 is an enlarged schematic view of a structure between two-dot chain lines S7 and S8 in fig. 11;

FIG. 19 is an enlarged partial view of FIG. 18 at F;

fig. 20 is an enlarged schematic view of a structure between two-dot chain lines S9 and S10 in fig. 11;

FIG. 21 is an enlarged partial view of FIG. 20 at G;

fig. 22 is an enlarged schematic view of a structure between two-dot chain lines S11 and S12 in fig. 11;

FIG. 23 is an enlarged partial view of FIG. 22 at H;

fig. 24 is an enlarged schematic view of the structure between the two-dot chain lines S13 and S14 in fig. 11.

The reference numbers illustrate:

Detailed Description

Referring to fig. 1, 2, 6, 10, 11, 14-24, in one embodiment, the rotational atherectomy device of the present invention comprises a housing 10, a sliding mechanism (not labeled) disposed on the housing 10, a driving assembly 30 and a rotational atherectomy assembly 40, wherein the rotational atherectomy assembly 40 comprises a guide wire 41, a driving shaft 42 and a rotational atherectomy head 43 disposed at a distal end of the driving shaft 42;

the front end of the shell 10 in the longitudinal direction is provided with a front lead-out hole 10a, and the rear end is provided with a rear lead-out hole 10 b;

the sliding mechanism comprises a support 21, a front side movable rail pipe 22 and a front side static rail pipe 23, the support 21 is in slidable fit with the shell 10 along the longitudinal direction of the shell 10, the front side movable rail pipe 22 and the front side static rail pipe 23 are mutually in slidable nesting arrangement, the front side movable rail pipe 22 is fixedly connected with the support 21, and the front side static rail pipe 23 is fixedly connected with the shell 10;

the driving assembly 30 comprises a motor 31, a driving wheel 32 and a driven wheel 33, the motor 31 is mounted on the support 21, the driving wheel 32 is connected with an output shaft 311 of the motor 31, the driven wheel 33 is meshed with the driving wheel 32, the driven wheel 33 is provided with a central hole 331 which penetrates along the axial direction, a hollow tubular shaft 332 is arranged on the periphery of the central hole 331 on the axial end surface of the driven wheel 33, and the hollow tubular shaft 332 is pivoted with the support 21; the front side movable rail pipe 22 and the front side fixed rail pipe 23 are both positioned between the driven wheel 33 and the front leading-out hole 10 a;

the guide wire 41 and the driving shaft 42 sequentially pass through the central hole 331, the hollow tubular shaft 332, the intersection part of the inner cavities of the front movable rail tube 22 and the front fixed rail tube 23 and the front leading-out hole 10 a; the rear section of the guide wire 41 also passes through the rear exit hole 10b, the driving shaft 42 is fixedly connected with the central hole 331, and a gap is formed between the driving shaft 42 and the hollow tubular shaft 332.

In this embodiment, the housing 10 may serve as a support or shield component common to multiple components, for example, the housing 10 may provide a relatively enclosed space to provide shielding for components mounted inside the housing 10. The housing 10 may be provided with a sliding rail and/or a sliding groove for the sliding connection of the bracket 21, and a plurality of components including the front side stationary rail tube 23 may be directly and indirectly fixed or installed on the housing 10, for example, the housing 10 may be provided with accessories such as a power interface, a control button or knob, a switch, and the like.

The bracket 21 of the slide mechanism may refer to the prior art, for example, how to facilitate the slidable fitting of the bracket 21 with the housing 10, in addition to the structure related to the front side stationary rail pipe 23. The front movable rail tube 22 and the front stationary rail tube 23 are nested to form a set of sliding pair, which means that the front movable rail tube 22 can be located in the inner cavity of the front stationary rail tube 23 or can be nested on the periphery of the front stationary rail tube 23. It can be understood that, under the condition of the same pipe wall thickness, the outer diameters of the front side moving rail pipe 22 and the front side static rail pipe 23 are larger than the outer diameter of the driving shaft 42, so that the bending strength of the front side moving rail pipe 22 and the front side static rail pipe 23 is larger than that of the driving shaft 42. And because the front side moving rail pipe 22 and the front side static rail pipe 23 are not used for extending into the human blood vessel, and according to the invention, contrary to the requirement of easy bending, the front side moving rail pipe 22 and the front side static rail pipe 23 require a sufficiently high bending strength, so that the front side moving rail pipe 22 and the front side static rail pipe 23 can be made of a material with a higher strength under the condition that the pipe wall is less than or equal to the pipe wall of the driving shaft 42.

The driving assembly 30 is different from a driving mode of an air turbine, and adopts a structure that a motor 31 drives a gear. Although the present embodiment exemplifies one unit of the driving gear and the driven gear, it is a simple alternative to the technical elements for those skilled in the art to provide a plurality of driven gears. Even the structure of omitting the driving wheel 32 and the driven wheel 33 can be regarded as the driving structure of the driving assembly 30, which is equivalent, because in the case that the maximum rotation speed of the motor 31 is high enough, the hollow output shaft 311 can be used for the guide wire 41 and the driving shaft 42 to pass through, and the driving shaft 42 and the output shaft 311 are convenient to be fixedly connected. It can be understood that, on the premise that the output power of the motor 31 is sufficient, the requirement for the maximum rotating speed of the motor 31 can be reduced by the speed-increasing transmission of the driving wheel 32 and the driven wheel 33, so that the material purchasing cost of the motor 31 can be reduced. To reduce rotational friction between the driven pulley 33 and the bracket 21, a bearing sleeve may be provided around the hollow spool 332.

The utility model discloses an improvement point does not lie in the rotational grinding subassembly 40, consequently, the rotational grinding subassembly 40 can adopt prior art, for example in prior art's rotational grinding subassembly 40 in order to compromise the high bending strength (the ability of higher resistance bending) of near section to and be used for stretching into the human vascular flexibility, drive shaft 42 is usually including being used for forming the near section of drive shaft 42, integrated into one piece's near section drive shaft 421 usually, and be used for forming the drive shaft 42 far section and possess the stranded silk drive shaft 422 that easily stretches into the human vascular flexibility. In this manner, the proximal end of the multi-strand drive shaft 422 may be welded to the proximal drive shaft 421, and the rotational atherectomy head 43 with abrasive particles such as silicon carbide may be secured to the distal end of the multi-strand drive shaft 422.

The rotational atherectomy device of the utility model is additionally sleeved with the front movable rail tube 22 and the front static rail tube 23 at the periphery of the guide wire 41 and the driving shaft 42, and the front static rail tube 23 is fixed relative to the shell 10; because the front movable rail tube 22 is fixedly connected with the support 21, and the front movable rail tube 22 and the front stationary rail tube 23 are nested with each other to form a set of axial sliding pair, when the drive assembly 30 is moved by using the support 21, the front movable rail tube 22 can move along with the support 21, in the process, besides the axial guiding function is enhanced, the front movable rail tube 22 or the front stationary rail tube 23 can also play a role in restraining the driving shaft 42 at the radial inner side, so that the driving shaft 42 is prevented from being excessively bent, and the axial thrust is ensured to be smoothly transmitted to the rotational head 43 arranged at the far end of the driving shaft 42, that is, the driving shaft 42 is ensured to be smoothly pushed forward along the axial direction, and the safety of the rotational atherectomy is ensured.

Further, referring to fig. 2, fig. 3, fig. 6-fig. 11, and fig. 20-fig. 22, in an embodiment, the front stationary rail tube 23 is embedded in the inner cavity of the front moving rail tube 22; the bracket 21 includes a first supporting plate 211 and a second supporting plate 212 which are oppositely arranged in the longitudinal direction of the housing 10, the first supporting plate 211 and the second supporting plate 212 are respectively provided with a first pipe sleeve hole 213 and a second pipe sleeve hole 214, and the front movable rail 22 is fixedly installed in the first pipe sleeve hole 213 and the second pipe sleeve hole 214.

In the present embodiment, since the front stationary rail pipe 23 is fitted into the inner cavity of the front movable rail pipe 22, there is no fear of interference with the front stationary rail pipe 23 when the bracket 21 moves relative to the front stationary rail pipe 23. And because the front side moving rail tube 22 penetrates through the first supporting plate 211 and the second supporting plate 212 of the bracket 21, the sliding pair of the front side static rail tube 23 and the front side moving rail tube 22 can be conveniently extended into the bracket 21, so that the axial structural compactness of the atherectomy device is ensured while the guiding and radial restraining effects are ensured.

Further, referring to fig. 1-3, 11, 14 and 15, in an embodiment, the housing 10 includes a first half shell 11 and a second half shell 12, the first half shell 11 and the second half shell 12 enclose to form a cavity for accommodating the sliding mechanism, the driving assembly 30 and a partial structure of the rotational grinding assembly 40, and the first half shell 11 and the second half shell 12 are clamped and fixed to the front stationary rail 23 along a transverse direction of the housing 10.

In this embodiment, the first half shell 11 and the second half shell 12 are used for clamping the front fixed rail tube 23 while enclosing to form an internal cavity, so as to improve the compactness of the mounting structure.

Further, the atherectomy device further comprises a pipe fitting joint 50, wherein the first half shell 11 and the second half shell 12 are clamped and fixed on the pipe fitting joint 50 along the transverse direction of the shell 10, the pipe fitting joint 50 is provided with a connecting channel 51 which penetrates along the longitudinal direction of the shell 10, and the front end of the front side static rail pipe 23 extends into the connecting channel 51 and is fixedly connected with the inner wall surface of the connecting channel 51.

In this embodiment, since the pipe fitting joint 50 is sleeved at the front end of the front static rail pipe 23, the front static rail pipe 23 is clamped and fixed indirectly by using a pipe fitting structure, which is equivalent to locally increasing the wall thickness of the front static rail pipe 23, so as to ensure the axial firmness, even though the clamping force is larger in the transverse direction of the housing 10, the radial balanced clamping of the front static rail pipe 23 can be ensured, and the front static rail pipe 23 and the front movable rail pipe 22 can be kept in a good slidable fit relationship. It will be appreciated that a bypass fitting in communication with the connecting passage 51 may also be provided on the tubing fitting 50 to facilitate delivery of a liquid for cooling, such as saline, to the periphery of the rotational atherectomy head 43.

Further, a first locking plate 111 and a second locking plate 112 extending toward the second half shell 12 and facing each other are provided on the inner wall surface of the first half shell 11; a third clamping plate 121 and a fourth clamping plate 122 which extend towards the first half shell 11 and are opposite to each other are arranged on the inner wall surface of the second half shell 12;

the pipe joint 50 includes a tubular body 52 and a flange 53 disposed on an outer peripheral surface of the tubular body 52, wherein a portion of the flange 53 is clamped between the first clamping plate 111 and the second clamping plate 112, and another portion is clamped between the third clamping plate 121 and the fourth clamping plate 122.

Further, the first clamping plate 111 is spliced with the third clamping plate 121, the second clamping plate 112 is spliced with the fourth clamping plate 122, a rear supporting hole 13 is formed at the spliced position of the first clamping plate 111 and the third clamping plate 121, and a front supporting hole 14 is formed at the spliced position of the second clamping plate 112 and the fourth clamping plate 122;

the flange 53 is flush with the rear end face of the tube body 52, the rear end face of the tube body 52 abuts against the front side faces of the first clamping plate 111 and the third clamping plate 121, and the outer peripheral face of the tube body 52 is matched with the inner peripheral face of the front support hole 14; the outer peripheral surface of the front stationary rail pipe 23 is fitted to the inner peripheral surface of the rear support hole 13.

In this embodiment, the flange 53 of the pipe joint 50 is respectively clamped with the first half shell 11 and the second half shell 12, so that the positioning of the pipe joint 50 is ensured, and the pipe joint 50 can be prevented from moving axially. The flange 53 of the fitting 50 and the rear end of the tube 52 abutting the first and second clips 111, 112 may help axially position or position the fitting 50.

The tubular body 52 of the tubular fitting 50 can ensure the positional accuracy of the tubular fitting 50 in the radial direction by fitting with the front support hole 14. For the front static rail pipe 23, the support of the front static rail pipe 23 by the rear support hole 13 is different from the fixed connection of the front static rail pipe 23 and the inner wall surface of the connecting channel 51, and the support of the rear support hole 13 is a transition and supplement of the connection, and prevents the stress concentration from occurring between the outer peripheral surface of the front static rail pipe 23 and the end surface of the pipe body 52 adjacent to the front static rail pipe 23.

Further, referring to fig. 2, fig. 3, fig. 10-fig. 11, fig. 14 and fig. 15, in an embodiment, the sliding mechanism further includes a rear static rail pipe 24 fixedly connected to the housing 10, the rear static rail pipe 24 is sleeved on the periphery of the guide wire 41, a front section of the rear static rail pipe 24 is slidably embedded in an inner cavity of the driving shaft 42, and a layer of anti-friction material is respectively disposed on inner walls of the front static rail pipe (22) and the driving shaft (42).

In this embodiment, during the process of pulling back the driving shaft 42, the driving shaft 42 and the guide wire 41 located at the rear side of the motor 31 may be bent, thereby preventing the driving shaft 42 from retracting. The periphery of the driving shaft 42 at the rear section is sleeved with the rear side static rail pipe 24, so that the driving shaft 42 at the rear section can be restrained and guided, the driving shaft 42 at the rear section is prevented from being excessively bent, and the smoothness of the retraction of the driving shaft 42 is guaranteed. It is to be understood that even prior art atherectomy assemblies 40 may be designed in accordance with the present invention, such as the front stationary rail tube 23, the front moving rail tube 22, with a pre-adapted design. Preferably, in the embodiment where the driving shaft 42 includes the proximal driving shaft 421 and the multi-strand driving shaft 422, the proximal driving shaft 421 is fixedly connected to the central hole 331 of the driven wheel 33, and the proximal driving shaft 421 is located in the inner cavity of the rear static rail tube 24. Friction between the front stationary rail pipe and the drive shaft, and between the drive shaft and the rear stationary rail pipe can be reduced by providing a layer of friction reducing material on each of the inner walls of the front stationary rail pipe 23 and the drive shaft 42.

4-6, 12 and 13, in one embodiment, the atherectomy device further comprises a clamp assembly 60, the clamp assembly 60 comprising a first clamp 61, a second clamp 62, and a clamp fastener 63, wherein,

the first clamping plate 61 and the second clamping plate 62 are arranged in an overlapped mode, and clamping holes 64 which penetrate through the housing 10 in the longitudinal direction are formed in the overlapped surface of the first clamping plate 61 and the second clamping plate 62; a first through hole 611 is formed in the first clamping plate 61, and a second through hole 621 corresponding to the first through hole 611 is formed in the second clamping plate 62;

the inner wall surface of the housing 10 extends towards the first clamping plate 61 or the second clamping plate 62 to form a screw hole column 123, the end surface of the screw hole column 123 is attached to the second clamping plate 62, and the screw hole of the screw hole column 123 corresponds to the second via hole 621;

the rear static rail pipe 24 is clamped in the clamping hole 64, and the clamping plate fastener 63 passes through the first through hole 611 and the second through hole 621 to be fixedly connected with the screw hole of the screw hole column 123, so that the clamping hole 64 clamps the rear static rail pipe 24.

Due to the relative structure of the axial movement, the coaxiality and the straightness also affect the smoothness of the forward or backward movement of the driving shaft 42. In this embodiment, through setting up splint subassembly 60, utilize the cooperation of splint hole 64 and the quiet rail pipe 24 of rear side of splint subassembly 60, on the one hand conveniently fix the quiet rail pipe 24 of rear side, on the other hand has also guaranteed the quiet rail pipe 24 position accuracy nature of rear side, so can guarantee drive shaft 42 along axial displacement's smooth and easy nature at this link of the quiet rail pipe 24 of rear side.

Further, referring to fig. 4-6 again, in an embodiment, two first via holes 611, two second via holes 621 and two screw holes 123 are disposed respectively on two sides of the rear stationary rail pipe 24. The overlapped surface of the first clamping plate 61 is respectively provided with a first tenon 612 and a first jack 613 at two sides of the clamping hole 64, and the overlapped surface of the second clamping plate 62 is respectively provided with a second tenon 622 and a second jack 623 at two sides of the clamping hole 64; the first tenon 612 and the second tenon 622 are both flat structures, and the length direction of the cross section of the first tenon 612 and the second tenon 622 is perpendicular to the length direction of the clamping hole 64; the first plug-in tenon 612 is inserted into the second plug-in hole 623 in a matching manner, and the second plug-in tenon 622 is inserted into the first plug-in hole 613 in a matching manner.

In this embodiment, in order to ensure the accuracy of splicing the clamping holes 64, the inserting tenon and the inserting hole are mutually arranged on the overlapped surfaces of the first clamping plate 61 and the second clamping plate 62, so that the half-grooves for splicing the clamping holes 64 on the two clamping plates are prevented from being dislocated transversely on the casing 10, thereby ensuring the good matching between the rear static rail pipe 24 and the clamping holes 64 and further ensuring the smoothness of the driving shaft 42 moving along the axial direction.

Further, referring to fig. 16 and 7, in an embodiment, during the process that the driving assembly 30 reciprocates along the longitudinal direction of the housing 10 along with the bracket 21, the projections of the rear static rail pipe 24 and the front static rail pipe 23 along the transverse direction of the housing 10 are always overlapped.

In this embodiment, the rear static rail pipe 24 and the front static rail pipe 23 always overlap in the transverse projection of the housing 10, that is, the overlapping length of the rear static rail pipe 24 and the front static rail pipe 23 in the axial direction is always greater than zero, so that in the entire forward pushing and retracting stroke of the driving shaft 42, the radial constraint and the axial guidance of the driving shaft 42 are continuous and complete, and the smoothness of the driving shaft 42 moving in the axial direction is more comprehensively ensured. In order to reduce the friction force, the friction reducing material disposed between the front static rail tube 22 and the inner wall of the driving shaft 42 is preferably a friction reducing tube disposed in a nested manner or a friction reducing coating disposed thereon.

It will be appreciated by those skilled in the art that the above-described preferred embodiments may be freely combined, superimposed, without conflict.

It will be understood that the above-described embodiments are illustrative only and not restrictive, and that various obvious and equivalent modifications and substitutions may be made in the details described herein by those skilled in the art without departing from the basic principles of the invention.

Claims (10)

1. A rotational atherectomy device comprises a housing (10), and a sliding mechanism, a driving assembly (30) and a rotational atherectomy assembly (40) which are arranged on the housing (10), wherein the rotational atherectomy assembly (40) comprises a guide wire (41), a driving shaft (42) and a rotational atherectomy head (43) arranged at the distal end of the driving shaft (42); it is characterized in that the preparation method is characterized in that,

the front end of the shell (10) in the longitudinal direction is provided with a front lead-out hole (10a), and the rear end of the shell is provided with a rear lead-out hole (10 b);

the sliding mechanism comprises a support (21), a front movable rail pipe (22) and a front static rail pipe (23), the support (21) is in slidable fit with the shell (10) along the longitudinal direction of the shell (10), the front movable rail pipe (22) and the front static rail pipe (23) are nested in a mutually slidable manner, the front movable rail pipe (22) is fixedly connected with the support (21), and the front static rail pipe (23) is fixedly connected with the shell (10);

the driving assembly (30) comprises a motor (31), a driving wheel (32) and a driven wheel (33), the motor (31) is mounted on the support (21), the driving wheel (32) is connected with an output shaft (311) of the motor (31), the driven wheel (33) is meshed with the driving wheel (32), the driven wheel (33) is provided with a center hole (331) which penetrates through in the axial direction, a hollow tubular shaft (332) is arranged on the periphery of the center hole (331) on the axial end face of the driven wheel (33), and the hollow tubular shaft (332) is pivoted with the support (21); the front movable rail pipe (22) and the front static rail pipe (23) are both positioned between the driven wheel (33) and the front lead-out hole (10 a);

the guide wire (41) and the driving shaft (42) sequentially penetrate through the central hole (331) and the hollow tubular shaft (332), and the intersection part of the inner cavities of the front movable rail tube (22) and the front static rail tube (23) and the front leading-out hole (10a) are formed; the rear section of the guide wire (41) also passes through the rear lead-out hole (10b), the driving shaft (42) is fixedly connected with the central hole (331), and a gap is formed between the driving shaft (42) and the hollow tubular shaft (332).

2. The rotational atherectomy device of claim 1, wherein the anterior stationary rail tube (23) is embedded within the lumen of the anterior moving rail tube (22); support (21) include in the vertical relative first backup pad (211) and the second backup pad (212) that set up of casing (10), first pipe cover hole (213) and second pipe cover hole (214) have been seted up respectively on first backup pad (211) and second backup pad (212), front side moves rail pipe (22) fixed mounting in first pipe cover hole (213) and second pipe cover hole (214).

3. The atherectomy device according to claim 1 or 2, wherein the housing (10) comprises a first half shell (11) and a second half shell (12), the first half shell (11) and the second half shell (12) enclosing a cavity for accommodating the sliding mechanism, the driving assembly (30) and a part of the structure of the rotational atherectomy assembly (40), and the first half shell (11) and the second half shell (12) clamping the front static rail tube (23) along a transverse direction of the housing (10).

4. The rotational atherectomy device of claim 3, further comprising a tube fitting (50), wherein the first half shell (11) and the second half shell (12) are clamped and fixed to the tube fitting (50) along a transverse direction of the housing (10), the tube fitting (50) has a connecting channel (51) which is longitudinally through the housing (10), and a front end of the front static rail tube (23) extends into the connecting channel (51) and is fixedly connected to an inner wall surface of the connecting channel (51).

5. The rotational atherectomy device of claim 4,

a first clamping plate (111) and a second clamping plate (112) which extend towards the second half shell (12) and are opposite to each other are arranged on the inner wall surface of the first half shell (11); a third clamping plate (121) and a fourth clamping plate (122) which extend towards the first half shell (11) and are opposite to each other are arranged on the inner wall surface of the second half shell (12);

the pipe fitting joint (50) comprises a cylindrical pipe body (52) and a flange (53) arranged on the outer peripheral surface of the pipe body (52), one part of the flange (53) is clamped between the first clamping plate (111) and the second clamping plate (112), and the other part of the flange is clamped between the third clamping plate (121) and the fourth clamping plate (122).

6. The rotational atherectomy device of claim 5,

the first clamping plate (111) is spliced with the third clamping plate (121), the second clamping plate (112) is spliced with the fourth clamping plate (122), a rear supporting hole (13) is formed at the spliced position of the first clamping plate (111) and the third clamping plate (121), and a front supporting hole (14) is formed at the spliced position of the second clamping plate (112) and the fourth clamping plate (122);

the flange (53) is flush with the rear end face of the pipe body (52), the rear end face of the pipe body (52) is abutted against the front side faces of the first clamping plate (111) and the third clamping plate (121), and the outer peripheral face of the pipe body (52) is matched with the inner peripheral face of the front support hole (14); the outer peripheral surface of the front side fixed rail pipe (23) is matched with the inner peripheral surface of the rear support hole (13).

7. The rotational atherectomy device according to claim 1, wherein the sliding mechanism further comprises a rear static rail tube (24) fixedly connected to the housing (10), the rear static rail tube (24) is sleeved on the periphery of the guide wire (41), the front section of the rear static rail tube (24) is slidably embedded in the inner cavity of the drive shaft (42), and a layer of friction reducing material is disposed on each of the inner walls of the front static rail tube (23) and the drive shaft (42).

8. The rotational atherectomy device of claim 7,

the atherectomy device further comprises a clamp assembly (60), the clamp assembly (60) comprising a first clamp (61), a second clamp (62), and a clamp fastener (63), wherein,

the first clamping plate (61) and the second clamping plate (62) are arranged in an overlapped mode, and clamping holes (64) which penetrate through the shell (10) in the longitudinal direction are formed in the overlapped surface of the first clamping plate (61) and the second clamping plate (62); a first through hole (611) is formed in the first clamping plate (61), and a second through hole (621) corresponding to the first through hole (611) is formed in the second clamping plate (62);

a screw hole column (123) is arranged on the inner wall surface of the shell (10) in an extending mode towards the first clamping plate (61) or the second clamping plate (62), the end surface of the screw hole column (123) is attached to the second clamping plate (62), and a screw hole of the screw hole column (123) corresponds to the second through hole (621);

the rear side static rail pipe (24) is clamped in the clamping hole (64), the clamping plate fastener (63) penetrates through the first through hole (611) and the second through hole (621) to be fixedly connected with a screw hole of the screw hole column (123), and the clamping hole (64) is used for clamping the rear side static rail pipe (24).

9. The rotational atherectomy device of claim 8,

the first through hole (611), the second through hole (621) and the threaded hole column (123) are respectively arranged at two sides of the rear side static rail pipe (24); a first tenon (612) and a first jack (613) are respectively arranged on the two sides of the clamping hole (64) on the superposed surface of the first clamping plate (61), and a second tenon (622) and a second jack (623) are respectively arranged on the two sides of the clamping hole (64) on the superposed surface of the second clamping plate (62);

the first tenon (612) and the second tenon (622) are both flat structures, and the length direction of the cross section of the first tenon (612) and the length direction of the cross section of the second tenon (622) are perpendicular to the length direction of the clamping hole (64); the first plug tenon (612) is in adaptive splicing with the second jack (623), and the second plug tenon (622) is in adaptive splicing with the first jack (613).

10. The rotational atherectomy device according to any of claims 7 to 9, wherein the projections of the posterior static rail tube (24) and the anterior static rail tube (23) in the transverse direction of the housing (10) are always kept overlapping during the reciprocating movement of the drive assembly (30) with the stent (21) in the longitudinal direction of the housing (10); the antifriction materials arranged on the inner walls of the front side static rail pipe (23) and the driving shaft (42) are antifriction pipes arranged in a nested manner or antifriction coatings arranged in a coating manner.

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