CN116250900A - Rotary grinding system and driving handle thereof - Google Patents

Abstract

The invention relates to a rotary grinding system and a driving handle thereof, wherein the driving handle comprises a handle shell, a driving assembly and a telescopic guide piece, the driving assembly is arranged in the handle shell and can move along a rotary grinding guide wire, the telescopic guide piece is arranged along a guide wire cavity of the handle shell and is provided with a first guide channel, a driving shaft and the rotary grinding guide wire are movably arranged in the first guide channel in a penetrating mode, the far end of the first telescopic guide piece is connected with the handle shell, the telescopic guide piece is connected with the driving assembly in a linkage mode, and when the driving assembly and the driving shaft move along the rotary grinding guide wire, the telescopic guide piece moves in the handle shell in a telescopic mode. According to the rotary grinding system and the driving handle thereof, the first guide channel of the telescopic guide piece is utilized to radially support and axially guide the driving shaft and the rotary grinding guide wire penetrating through the first guide channel, so that a large-scale operation platform is not required to be configured to maintain axial movement guide of structures such as the rotary grinding guide wire or the rotary grinding guide pipe, and the like, so that the operation portability of the driving handle is improved.

Description

Rotary grinding system and driving handle thereof

Technical Field

The invention relates to the technical field of interventional medical treatment, in particular to a rotary grinding system and a driving handle thereof.

Background

Atherosclerosis is commonly found in arteries of lower limbs, is characterized by thickening of the tube wall and narrowing of the lumen due to formation of fibrous lipid plaques in the intima of the arteries, and is mainly distributed in the intima of the popliteal and below the knee arteries, and due to stenosis or even blockage of the arterial lumen of lesions, diseases such as ischemia and gangrene of the lower limbs are caused, and limping and amputation are often caused if the patients are not treated in time. Atherosclerotic plaques may exhibit different characteristics depending on the plaque's texture, and currently in medical practice, are often pretreated with atherectomy devices for severely calcified lesions. The principle of adopting the atherosclerosis excision device for treatment is that the track rotary grinding device is used for high-speed rotary grinding at the vascular lesion, so as to remove calcified or fibrotic arteriosclerosis plaques, open the blood vessels blocked by the plaques, obtain smoother blood vessel cavity gain and facilitate the subsequent placement of the drug saccule and the stent. Peripheral arterial plaque orbital rotational atherectomy has become a means for removing atheromatous plaque with more clinical application when interventional therapy is performed on stenotic lesions at openings and bifurcations of vascular intima and on angled, eccentric, long-segment and punctate stenotic lesions.

The current peripheral track rotary grinding catheter system mainly comprises a control host, a driving handle, a driving shaft and a rotary grinding head, wherein the control host controls a driving assembly in the driving handle to drive the driving shaft to rotate at a high speed, and the driving assembly is moved back and forth, so that the rotary grinding head connected to the distal end of the driving shaft removes lesions from grinding, and plaques or calcified lesions are ablated into tiny micro-particles (smaller than the diameter of red blood cells). The peripheral arterial orbital rotational atherectomy is adopted for treatment, so that the method can be suitable for severe calcified lesions, the orbital rotational atherectomy is firstly used for preprocessing the lesions, preparing a lumen, then a medicine balloon or a bracket is put in, the success rate of interventional therapy is improved, and meanwhile, the occurrence of complications is reduced.

However, in order to meet the guiding requirement of the axial movement stroke of the driving assembly in the driving handle, the driving handle is heavy in overall structure, large in operation platform and inconvenient to operate.

Disclosure of Invention

Based on the above, a driving handle and a rotary grinding system comprising the driving handle are provided to solve the problem of inconvenient operation.

In one aspect, an embodiment of the present invention provides a driving handle, including:

a handle housing having a guidewire lumen extending through a proximal end and a distal end of the handle housing for passing a rotational atherectomy guidewire therethrough;

the driving assembly is arranged in the handle shell and can move along the rotary grinding guide wire, the driving assembly is used for driving the driving shaft to rotate around the rotary grinding guide wire, and the driving shaft is sleeved on the rotary grinding guide wire;

the first flexible guide piece is arranged along the guide wire cavity, a first guide channel is formed, the driving shaft and the rotary grinding guide wire movably penetrate through the first guide channel, the distal end of the first flexible guide piece is connected with the handle shell, the first flexible guide piece is connected with the driving assembly in a linkage manner, and when the driving assembly and the driving shaft move along the rotary grinding guide wire, the first flexible guide piece moves in a telescopic manner in the handle shell.

On the other hand, the invention provides a rotary grinding system which comprises the driving handle, a rotary grinding guide wire and a rotary grinding guide tube, wherein the rotary grinding guide wire penetrates through the guide wire cavity, the proximal end of the rotary grinding guide wire extends out of the proximal end of the guide wire cavity, the rotary grinding guide tube is sleeved on the rotary grinding guide wire, and the proximal end of the rotary grinding guide tube is connected with the distal end of the driving shaft.

According to the rotary grinding system and the driving handle thereof, the driving handle comprises the handle shell, the driving assembly and the first telescopic guide piece, the first telescopic guide piece is connected with the driving assembly in a linkage manner, when the driving assembly and the driving shaft move along the rotary grinding guide wire, the first telescopic guide piece moves in the handle shell in a telescopic manner, so that the driving assembly cannot be interfered to move along the rotary grinding guide wire, the requirement that the driving assembly moves along the rotary grinding guide wire with the rotary grinding guide wire for a sufficient stroke is met, and as the first guide channel of the first telescopic guide piece can play a role of radially supporting and axially guiding structures such as the driving shaft and the rotary grinding guide wire penetrating through the first guide piece, a large-sized operation platform is not required to be configured to maintain axial movement guide of the structures such as the rotary grinding guide wire or the rotary grinding guide wire, so that the operation portability of the driving handle is improved.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other embodiments of the drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic diagram of a rotational grinding system according to an embodiment;

FIG. 2 is a schematic view showing an internal structure of a driving handle of the rotary grinding system according to an embodiment;

FIG. 3 is a schematic view of the telescopic structures of the first telescopic guide and the second telescopic guide in the driving handle of the rotary grinding system according to an embodiment during the movement of the driving assembly;

FIG. 4 is a schematic view of the structure of the telescopic guide in the driving handle of the rotational atherectomy system according to one embodiment;

FIG. 5 is an enlarged partial schematic view of the portion A of the telescoping guiding structure shown in FIG. 4;

fig. 6 is a schematic cross-sectional view showing a partial structure of a driving handle of the rotational grinding system according to an embodiment.

Reference numerals illustrate: 100. a spin grinding system; 10. a drive handle; 10a, a guidewire lumen; 11. a handle housing; 11a, a first housing; 11b, a second housing; 111. a first support portion; 112. a second supporting part; 113. a third supporting part; 114. a fourth supporting part; 12. a drive assembly; 13. a telescoping guide; 13A, a first telescoping guide; 13B, a second telescoping guide; 131. a sleeve; 131a, a first sleeve; 131b, a second sleeve; 132. a rolling member; 1311. a first limit part; 1312. a second limit part; 1313. a third limit part; 133. a lubricating coating; 134. a liquid through hole; 14. a wire locking assembly; 15. a track; 20. spin grinding the guide wire; 30. spin grinding the catheter; 31. rotating a grinding head; 32. and a transmission flexible shaft.

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It should be noted that, as the terms "proximal" and "distal" are used as terms of orientation, which are terms commonly used in the field of interventional medical devices, where "proximal" refers to an end of the device that is close to the operator when the device is in operation, and "distal" refers to an end of the device that is far away from the operator when the device is in operation, for example, in the rotational grinding system 100 shown in fig. 1, the left end of the driving handle 10 is the proximal end of the driving handle 10, and the right end of the driving handle 10 is the distal end of the driving handle 10.

In the embodiments of the present invention, axial refers to a direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular to the axial direction.

Referring to fig. 1 and 2, the present invention provides a rotational atherectomy system 100 comprising a drive handle 10, a rotational atherectomy guidewire 20, and a rotational atherectomy catheter 30. The proximal ends of the rotational atherectomy guidewire 20 and rotational atherectomy catheter 30 are both connected to the drive handle 10. The rotational atherectomy guidewire 20 serves as a structural member for establishing a path within the body for guiding the rotational atherectomy catheter 30 into a location in the vessel where rotational atherectomy is desired. Specifically, the rotational grinding guide tube 30 is sleeved on the rotational grinding guide wire 20, and the rotational grinding guide tube 30 can be rotated around the rotational grinding guide wire 20 by operating the driving handle 10, and the rotational grinding guide tube 30 moves along the rotational grinding guide wire 20 so that the rotational grinding guide tube 30 is rotationally ground under the guide of the rotational grinding guide wire 20. In the present invention, the term "moving along" an elongated structure means moving one structure along another structure, and means moving the one structure along the axial direction of the other structure. Taking the example of the rotational atherectomy catheter 30 moving along the rotational atherectomy wire 20, the rotational atherectomy catheter 30 moves along the rotational atherectomy wire 20, i.e., the rotational atherectomy catheter 30 moves axially along the rotational atherectomy wire 20.

The inventors have found that the travel of the rotational atherectomy catheter 30 along the axial direction of the rotational atherectomy guidewire 20 can affect the quality of the rotational atherectomy. For example, when the rotational grinding catheter 30 is controlled to perform the rotational grinding operation by operating the driving handle 10, the rotational grinding catheter 30 is likely to have too small displacement along the axial direction of the rotational grinding catheter 20 to open the diseased blood vessel, and this requires to increase the axial movement stroke of the rotational grinding catheter 30 relative to the rotational grinding catheter 20. However, when the driving handle 10 is provided with a long guide rail to meet the adjustment requirement of the axial movement stroke of the rotational grinding catheter 30, the overall structure of the driving handle 10 is heavy, a large operation platform is required to be configured, and the operation convenience is poor. The inventor continuously explores and improves the structure of the driving handle 10, and under the condition of meeting the movement stroke of the rotary grinding guide tube 30 along the rotary grinding guide wire 20 in the axial direction, the driving handle 10 is light and convenient, and the rotary grinding guide tube 30 is easy to operate and control to perform rotary grinding operation.

Specifically, the drive handle 10 includes a handle housing 11, a drive assembly 12, and a telescoping guide 13. The handle housing 11 is used for facilitating the operator to hold for performing the spin-grinding operation. The handle housing 11 has a guidewire lumen 10a extending through the proximal end of the drive handle 10 and the distal end of the drive handle 10, the guidewire lumen 10a being for passing a rotational atherectomy guidewire 20. Referring to fig. 1, the rotational atherectomy guidewire 20 is threaded through the guidewire lumen 10a, the proximal end 20a of the rotational atherectomy guidewire 20 extends out of the proximal end of the guidewire lumen 10a, and the distal end 20b of the rotational atherectomy guidewire 20 extends out of the distal end of the guidewire lumen 10 a. It will be appreciated that the rotational atherectomy guidewire 20 may be moved along the guidewire lumen 10a to penetrate the rotational atherectomy guidewire 20 into the vessel and guide the rotational atherectomy catheter 30 to move axially within the vessel.

A drive assembly 12 is disposed within the handle housing 11 and is used to drive a drive shaft (not shown) about the rotational atherectomy guidewire 20. Specifically, the driving shaft is sleeved on the rotary grinding guide wire 20, and the driving shaft rotates around the rotary grinding guide wire 20 and drives the rotary grinding guide pipe 30 to rotate around the rotary grinding guide wire 20 under the driving of the driving assembly 12, so that the rotary grinding guide pipe 30 performs rotary grinding operation.

The drive assembly 12 is movable within the handle housing 11 along the rotational atherectomy guidewire 20 such that the rotational atherectomy catheter 30 coupled to the drive assembly 12 will also move along the rotational atherectomy guidewire 20 along with the drive assembly 12, and the rotational atherectomy catheter 30 will move back and forth through the blood vessel while rotating to facilitate removal of calcified or fibrillated arteriosclerotic plaque and opening of plaque-occluded blood vessels as the rotational atherectomy catheter 30 is used to polish arteriosclerotic plaque in diseased blood vessels.

The telescopic guide 13 is disposed along the guide wire lumen 10a, the telescopic guide 13 is connected with the driving assembly 12 in a linkage manner, and when the driving assembly 12 moves along the rotational grinding guide wire 20 together with the driving shaft, the telescopic guide 13 moves telescopically in the handle housing 11. The telescoping guide 13 is capable of providing support for an elongate element, such as a rotational atherectomy guidewire 20 or rotational atherectomy catheter 30, within the guidewire lumen 10a during telescoping movement. Specifically, the telescopic guide 13 is formed with a guide channel, the guide channel plays a role in radially supporting and axially guiding the structure penetrating therein, wherein the radial support can play a role in supporting in the radial direction, so that the structure penetrating in the guide channel cannot generate large completeness, and correspondingly, the axial guide can move along the axial direction for the structure penetrating therein, so that the guide channel plays a guide effect on the structure penetrating therein.

Since the telescoping guide 13 can move telescopically and can serve as a radial support and axial guide for structures threaded through the guide channel as the drive assembly 12 moves along the rotational atherectomy guide wire 20 along with the drive shaft, the drive handle 10 does not need to be configured with a large operating platform to maintain axial movement guidance of structures such as the rotational atherectomy guide wire 20 or rotational atherectomy guide tube 30. Moreover, since the telescoping guide 13 can move telescopically, it does not interfere with the movement of the drive assembly 12 along the rotational atherectomy guidewire 20, satisfying the need for the drive assembly 12 to move a sufficient stroke along the rotational atherectomy guidewire 20 with the rotational atherectomy catheter 30. Based on this, the arrangement of the telescopic guide 13 effectively improves the portability of the operation of the drive handle 10.

The telescopic guide 13 is provided at a different position in the handle housing 11, and the elements penetrating the guide passage of the telescopic guide 13 are different, so that the objects supported and guided by the telescopic guide 13 are also different.

The structure of the drive handle 10 will be further described below with respect to the structural arrangement of the telescopic guide 13 in the handle housing 11, respectively.

As shown in connection with fig. 1 and 2, the proximal side of the drive assembly 12 and the distal side of the drive assembly 12 are each provided with a telescoping guide 13. For convenience of explanation, the telescopic guide 13 located at the distal end side of the driving assembly 12 is referred to as a "first telescopic guide 13A", the telescopic guide 13 located at the proximal end side of the driving assembly 12 is referred to as a "second telescopic guide 13B", and accordingly, a guide passage formed by the first telescopic guide 13A is referred to as a "first guide passage", and a guide passage formed by the second telescopic guide 13B is referred to as a "second guide passage". A first telescoping guide 13A and a second telescoping guide 13B are connected to the distal side of the drive assembly 12 and the proximal side of the drive assembly 12, respectively, as shown in connection with fig. 3. When the drive assembly 12 moves distally within the handle housing 11, the first telescoping guide 13A collapses and the second telescoping guide 13B expands; as the drive assembly 12 moves proximally within the handle housing 11, the first telescoping guide 13A expands and the second telescoping guide 13B contracts. In this embodiment, the distal end of the first telescopic guide 13A is connected to the handle housing 11, the proximal end of the first telescopic guide 13A is connected to the driving assembly 12, and the rotational grinding guide wire 20 and the driving shaft sleeved on the rotational grinding guide wire 20 are together inserted into the first guiding channel of the first telescopic guide 13A, so that the first telescopic guide 13A can radially support and axially guide the driving shaft and the rotational grinding guide wire 20 located in the driving shaft.

The distal end of the second telescopic guide 13B is connected to the driving assembly 12, and the proximal end of the second telescopic guide 13B is connected to the handle housing 11, so that the second telescopic guide 13B is driven to move telescopically when the driving assembly 12 moves axially in the handle housing 11. The proximal end of the driving shaft is connected with the driving assembly 13, and the proximal end of the rotational grinding guide wire 20 penetrates out of the proximal end of the driving shaft and penetrates through the second guiding channel of the second telescopic guiding piece 13B, so that the portion, extending out of the proximal end of the driving shaft, of the rotational grinding guide wire 20 can be radially supported and axially guided by the second telescopic guiding piece 13B, the rotational grinding guide wire 20 is not easy to bend in the direction deviating from the circumferential direction, and stability of the rotational grinding guide wire 20 is ensured.

It should be noted that the first telescopic guide 13A and the second telescopic guide 13B are not necessarily simultaneously present, and rather, one of them is removed, and the other can still exert the corresponding action and effect. For example, in some embodiments, the drive handle 10 is provided with a first telescoping guide 13A, specifically, a distal end of the first telescoping guide 13A is connected to the handle housing 11, a proximal end of the first telescoping guide 13A is connected to the drive assembly 12, and the first telescoping guide 13A is in turn coupled to the drive assembly 12 such that the drive assembly 12 can move the first telescoping guide 13A in telescoping motion as the drive assembly 12 moves axially relative to the handle housing 11. Because the driving shaft is arranged in the first guide channel in a penetrating way, the driving shaft and the rotary grinding guide wire 20 positioned in the driving shaft can be radially supported and axially guided in the telescopic movement process of the first telescopic guide piece 13A, so that the rotary grinding guide wire 20 and the driving shaft maintain good coaxiality and are not easy to bend in the direction deviating from the circumferential direction, and the stability of rotary grinding operation is ensured. It should be noted that the proximal end of the first telescopic guide 13A may be connected to the driving assembly 12, so as to implement a linkage connection therebetween. In some embodiments, the first telescopic guide 13A may also be penetrating the driving assembly 12 to realize linkage connection with the driving assembly 12. Specifically, the first telescopic guide 13A is threaded through the driving assembly 12, so that the proximal end of the first telescopic guide 13A extends out from the proximal end side of the driving assembly 12, and therefore, the portion of the first telescopic guide 13A extending out of the proximal end side of the driving assembly 12 can be utilized to support and guide the portion of the rotating grinding guide wire 20 near the proximal end side of the driving assembly 12, so that the first telescopic guide 13A can support the driving shaft and the rotating grinding guide wire 20 located in the driving shaft at the distal end side of the driving assembly 12, and meanwhile, the partial structure of the rotating grinding guide wire 20 located at the proximal end side of the driving assembly 12 can also be supported, and the rotating grinding guide wire 20 is further enabled to be integrally stable, so that the rotating grinding guide wire 20 can stably guide the rotating grinding guide tube 30 to perform rotating grinding, and the rotating grinding stability is improved.

When 2 or more telescopic guides 13 are provided in the handle housing 11 of the drive handle 10, the telescopic guides 13 may be identical or different in structure. As shown in fig. 3, in some embodiments, when the first telescoping guide 13A and the second telescoping guide 13B take the same structure, the first telescoping guide 13A and the second telescoping guide 13B are different in size.

The structure of the telescopic guide 13 will be described below, the structure of the first telescopic guide 13A may be any one of the telescopic guides 13 below, and the structure of the second telescopic guide 13B may be any one of the telescopic guides 13 below.

Specifically, as shown in connection with fig. 3, the telescopic guide 13 includes 2 or more bushings 131,2 or more bushings 131 that are sleeved with each other and are capable of relative telescopic movement in the axial direction.

In order to further understand the structure of the telescopic guide 13, the structure of the telescopic guide 13 will be further described below by taking the telescopic guide 13 including the first sleeve 131a and the second sleeve 131b sleeved on the first sleeve 131a as an example.

As shown in fig. 4, rolling members 132 are provided between the first sleeve 131a and the second sleeve 131b which are coupled to each other, and specifically, rolling members 132 are loaded between the outer wall of the first sleeve 131a and the inner wall of the second sleeve 131b. When the first and second bushings 131a and 131b relatively move in the axial direction, the rolling member 132 rolls between the outer wall of the first bushing 131a and the inner wall of the second bushing 131b, and smoothness of the telescopic movement of the first and second bushings 131a and 131b relative to each other is improved by the rolling member 132.

In the embodiment in which the telescopic guide 13 includes 2 or more bushings 131, rolling members 132 are disposed between any 2 bushings 131 disposed adjacently, and when the telescopic guide 13 performs telescopic motion, the rolling members 132 are in rolling contact with the corresponding bushings 131, so that sliding friction between the bushings 131 is reduced by using the rolling members 132, smoothness of telescopic motion between the bushings 131 is improved, and the telescopic guide 13 is flexible as a whole.

In order to improve the movement stability of the rolling element 132 during the telescopic movement of the telescopic guide element 13 and avoid the influence of the random movement of the rolling element 132 on the sliding-assisting effect, a limiting structure is arranged between the adjacent sleeves 131, so that the movement area of the rolling element 132 is limited by the limiting structure. As shown in fig. 4, taking the structure between the first sleeve 131a and the second sleeve 131b as an example, the first and second stopper portions 1311 and 1312 are formed on the side of the inner wall of the second sleeve 131b, and the rolling member 132 is limited in the region Q defined between the first and second stopper portions 1311 and 1312 so that the rolling member 132 does not slip out from between the first and second sleeves 131a and 131b.

As shown in fig. 4 and 5, a third limiting portion 1313 is formed at one end of the first sleeve 131a, and the third limiting portion 1313 is used to abut against the first limiting portion 1311 to limit the ultimate telescopic length of the first sleeve 131a relative to the second sleeve 131b.

The first stopper 1311 may be an annular protrusion surrounding the axial direction of the second sleeve 131b. For example, the pipe wall of the second sleeve 131b is pressed inward, so that part of the pipe wall of the second sleeve 131b is concaved inward to form an annular protrusion, and the structure is convenient for processing.

The second stopper 1312 may have the same structure as the first stopper 1311. In some embodiments, the structure of the second stopper 1312 may also be different from the structure of the first stopper 1311. For example, the second limiting portion 1312 is formed at one end of the second sleeve 131b for the first sleeve 131a to protrude, and specifically, the second limiting portion 1312 is formed by bending a wall of the second sleeve 131b corresponding to the end portion inwards. For another example, the second limiting portion 1312 and the second sleeve 131b may be in a split structure, and specifically, an annular blocking piece may be connected to an end portion of the second sleeve 131b, so that the annular blocking piece forms the second limiting portion 1312. It is understood that the diameter of the inner ring of the annular flap is adapted to the outer diameter of the first sleeve 131a such that the first sleeve 131a is movably extended from the inner ring of the annular flap into the second sleeve 131b. The annular blocking piece may be connected to the second sleeve 131b by welding, glue connection, screw connection, or the like, which is not limited herein.

The third stopper 1313 may be formed by a portion of the wall structure of the first sleeve 131a expanding outwardly. For example, as shown in fig. 4 and 5, the third limiting portion 1313 formed by expanding the pipe wall of the end portion of the first sleeve 131a outwardly has a bell mouth shape, and when the first sleeve 131a moves axially in the second sleeve 131b to a point where the third limiting portion 1313 contacts the first limiting portion 1311, the first sleeve 131a reaches a maximum length extending from the second sleeve 131b, and the first sleeve 131a cannot continue the extending movement from the second sleeve 131b. In other embodiments, the third stopper 1313 may be a protrusion formed on the outer wall of the first sleeve 131a, which is not limited herein.

It should be noted that, since the rolling element 132 is constrained between the first limiting portion 1311 and the second limiting portion 1312, and when the third limiting portion 1313 abuts against the first limiting portion 1311, the first sleeve 131a may be further limited to extend from the second sleeve 131b, so that the first sleeve 131a and the second sleeve 131b always have a tube section nested with each other, so as to facilitate ensuring the coaxiality of the first sleeve 131a and the second sleeve 131b, and improving the stability of the relative telescopic motion of the first sleeve 131a and the second sleeve 131b.

In some embodiments, when the first sleeve 131a and the second sleeve 131b are in the maximum extended position, the third stop 1313 abuts the first stop 1311 to limit the first sleeve 131a from continuing to extend from the second sleeve 131b, and the length of the tube segment nested between the first sleeve 131a and the second sleeve 131b is 2cm to 5cm, such as 2cm, 3cm, 4cm, or 5cm. By controlling the length of the pipe sections nested with each other between the first sleeve 131a and the second sleeve 131b to be in the range of 2cm to 5cm, it is possible to ensure good coaxiality of the first sleeve 131a and the second sleeve 131b while avoiding excessively long pipe sections nested with each other so that a telescopic stroke as long as possible is obtained between the first sleeve 131a and the second sleeve 131b.

Based on the position where the first sleeve 131a is inserted into the corresponding second stopper 1312 of the second sleeve 131b, the lengths of the pipe sections nested with each other can be understood as the distance between the first stopper 1311 and the second stopper 1312 without considering the design error and the assembly error between the structures.

It should be noted that, the first sleeve 131a and the second sleeve 131b are cylindrical tubes, but the inner wall is not limited to be cylindrical, for example, in some embodiments, the first sleeve 131a and the second sleeve 131b are correspondingly formed with a first abutting surface and a second abutting surface, the first abutting surface and the second abutting surface are all planes parallel to the axial direction of the telescopic guide 13, the first abutting surface and the second abutting surface are parallel to each other, and the rolling member 132 rolls and abuts against the first abutting surface and the second abutting surface.

The rolling members 132 are preferably spherical balls or cylindrical balls.

As shown in fig. 4, the outer wall of the first sleeve 131a and/or the inner wall of the second sleeve 131b is provided with a lubrication coating 133, and the rolling members 132 are in contact with the lubrication coating 133 to improve the smoothness of the first sleeve 131a and the second sleeve 131b under the rolling support of the rolling members 132. The material of the lubricating coating 133 is preferably polytetrafluoroethylene grease.

Referring to fig. 5, a liquid through hole 134 is formed in a wall of the first sleeve 131a, and the liquid through hole 134 is used for allowing liquid to flow to the rolling element 132. The liquid passing through the liquid passing hole 134 may be cooling liquid or lubricating liquid at the position where the rolling element 132 is located.

For example, in some embodiments, the fluid passage holes 134 may pass a cooling fluid to the location of the rolling elements 132 to cool the rolling elements 132. Further, the handle housing 11 is formed with a liquid storage chamber near the proximal end to store the cooling liquid.

For another example, in some embodiments, the lubricant may be introduced into the position of the rolling element 132 through the liquid through hole 134, so as to reduce friction during movement by using the lubrication effect of the lubricant, so that the rolling element 132 can smoothly slide or roll along with the telescopic movement of the telescopic guiding element 13, reduce the jamming phenomenon, and improve the operation feel of an operator and the flexibility of axially moving the driving assembly 12.

In some embodiments, a support portion for supporting the telescopic guide 13 is provided in the handle housing 11. The number of the support portions may be one or plural, and for example, 2 or more support portions may be provided in the handle housing 11.

For ease of understanding, the structural arrangement of the support portion of the handle housing 11 will be further described below by taking the example in which the first telescopic guide 13A and the second telescopic guide 13B are provided in the handle housing 11.

As shown in fig. 2, a first support portion 111 and a second support portion 112 are provided in the handle housing 11, and the first support portion 111 and the second support portion 112 are provided at intervals in the axial direction of the handle housing 11 and serve to support the first telescopic guide 13A. The first telescopic guide 13A is kept disposed along the guidewire lumen 10a of the handle housing 11 by the first support portion 111 and the second support portion 112.

A third supporting portion 113 and a fourth supporting portion 114 are provided in the handle housing 11, and the third supporting portion 113 and the fourth supporting portion 114 are provided at intervals in the axial direction of the handle housing 11 and serve to support the second telescopic guide 13B. The second telescopic guide 13B is kept disposed along the guidewire lumen 10a of the handle housing 11 by the third support portion 113 and the fourth support portion 114.

The support portion may be a part of the structure of the handle housing 11, for example, the support portion is a rib plate protruding from an inner wall of the handle housing 11, and a hole for the corresponding telescopic guide 13 to pass through is formed in the rib plate, and it is understood that the hole is formed on the axis of the guide wire cavity 10a, so that the telescopic guide 13 passing through the hole is positioned along the guide wire cavity 10 a. In some embodiments, after the telescopic guide 13 is penetrated in the hole, the telescopic guide 13 is fixedly connected with the rib plate by using glue, so that the rib plate not only can play a supporting role on the telescopic guide 13, but also plays a limiting role on the position of the telescopic guide 13 connected with the rib plate, and the connection stability between the telescopic guide 13 and the rib plate is improved, thereby being beneficial to stably supporting and guiding the structure penetrated in the telescopic guide 13 during telescopic movement in the handle shell 11.

As shown in fig. 6, the handle housing 11 includes a first housing 11a and a second housing 11b, and the first housing 11a and the second housing 11b may be connected by a buckle, or may be connected by a connecting member such as a screw or a bolt, so that the assembly of the driving assembly 12 and the telescopic guide 13 in the handle 10 into the handle housing 11 may be facilitated by combining the first housing 11a and the second housing 11 b.

In the embodiment in which the support portion is a rib plate protruding from the inner wall of the handle housing 11, rib plates are disposed at positions corresponding to the inner walls of the first housing 11a and the second housing 11b, grooves are formed in the rib plates, and after the first housing 11a and the second housing 11b are matched, the grooves in the rib plates disposed oppositely are matched to form holes for penetrating the telescopic guide 13. With this structural arrangement, when the telescopic guide 13 is mounted, the telescopic guide 13 can be mounted into the groove of the first housing 11a or the second housing 11b along the guidewire lumen 10a, and then the first housing 11a and the second housing 11b are buckled, so that the mounting of the telescopic guide 13 can be completed.

In some embodiments, as shown in connection with fig. 2, the drive handle 10 includes a locking wire assembly 14, the locking wire assembly 14 being disposed within the handle housing 11 and on the proximal side of the drive assembly 12. In this embodiment, the wire locking assembly 14 is used for locking the rotational grinding guide wire 20 penetrating through the guide wire cavity 10a, so that the rotational grinding guide wire 20 cannot axially move or axially rotate along with the rotational grinding catheter 30 during rotational grinding, so that the rotational grinding guide wire 20 stably guides the rotational grinding catheter 30 to perform rotational grinding, and rotational grinding stability is improved. The structure of the wire locking assembly 14 is not limited herein, and the wire locking assembly 14 may be a clip, or may be a jackscrew penetrating the handle housing 11, so long as the wire locking assembly 14 can fix the rotational grinding guide wire 20 relative to the handle housing 11 when needed.

In embodiments where the drive handle 10 includes a wire locking assembly 14, the proximal end of the second telescoping guide 13B may be pulled using the wire locking assembly 14. Specifically, the proximal end of the second telescoping guide 13B is connected to the locking wire assembly 14 and the distal end of the second telescoping guide 13B is connected to the drive assembly 12. Thus, when the driving assembly 12 moves axially in the handle housing 11, the driving assembly 12 approaches to or departs from the wire locking assembly 14, so that the second telescopic guide 13B between the driving assembly 12 and the wire locking assembly 14 is stretched or compressed, and then the telescopic movement of the second telescopic guide 13B along with the axial movement of the driving assembly 12 is realized, and the length of the driving handle 10 is reduced as much as possible while the axial movement stroke requirements of the driving assembly 12 and the rotary grinding guide tube 30 are met, so that the driving handle 10 can operate the rotary grinding operation lightly.

Referring again to fig. 1, the rotational atherectomy catheter 30 includes a rotational atherectomy head 31, a drive flexible shaft 32, and a sheath (not shown). The spinning head 31 has an olive shape, and a distal end portion of the spinning head 31 may be provided with particles for enhancing friction, for example, diamond particles of 20 to 30 microns in size. Thus, the rotating grinding head 31 has better grinding effect on the particles at the far end part when grinding the arteriosclerosis plaques in the diseased blood vessel.

The rotary grinding head 31 can be driven by a transmission flexible shaft 32. Specifically, the rotating grinding head 31 is connected to the distal end of the transmission flexible shaft 32, and the proximal end of the transmission flexible shaft 32 is connected to the distal end of the driving shaft, so that when the driving assembly 12 drives the driving shaft to rotate, the driving shaft drives the rotating grinding head 31 to rotate through the transmission flexible shaft 32. In some embodiments, the distal end of the drive shaft is provided with a first engagement portion (not shown), the proximal end of the drive flexible shaft 32 is provided with a second engagement portion (not shown) for mating with the first engagement portion, and the engagement of the first engagement portion and the second engagement portion is used to connect the drive flexible shaft 32 to the drive shaft, which in turn may move the drive flexible shaft 32. Further, a limiting sleeve can be sleeved on the driving shaft or the transmission flexible shaft 32, and after the first engaging part and the second engaging part are matched, the limiting sleeve is pushed to a position for coating the first engaging part and the second engaging part in the axial direction, so that the first engaging part and the second engaging part are limited to be separated, and the connection stability between the driving shaft and the transmission flexible shaft 32 is improved.

With continued reference to fig. 1, in some embodiments, a track 15 is provided within the handle housing 11 for supporting the drive assembly 12 to facilitate stability of the drive assembly 12 in axial movement within the handle housing 11. After adjusting the axial position of the drive assembly 12 within the handle housing 11, the rotational atherectomy catheter 30, which is coupled to the drive assembly 12 via a drive shaft, can be moved within the blood vessel to abrade the arteriosclerotic plaque in the diseased vessel, ultimately opening the vessel.

The transmission flexible shaft 32 is a flexible pipe fitting, and the lumen of the transmission flexible shaft 32 can be used for the rotary grinding guide wire 20 to pass through, so that the rotary grinding head 31 is conveniently pushed to a position needing rotary grinding along the rotary grinding guide wire 20 by the transmission flexible shaft 32. During rotational atherectomy, the drive assembly 12 moves axially within the handle housing 11, and the drive flexible shaft 32 moves axially with the drive shaft to move the rotational atherectomy guide wire 20 along the rotational atherectomy guide wire 31 within the lesion vessel (e.g., a distance of 4cm each time back and forth) to incrementally abrade the atherosclerotic plaque. It will be appreciated that during the rotational atherectomy, when the rotational atherectomy head 31 is slightly resisted by the atherosclerotic plaque, the rotational atherectomy head 31 may be pushed distally by the drive flexible shaft 32, facilitating the rotational atherectomy head 31 to maintain good contact with the atherosclerotic plaque to ensure the abrasive effect. Of course, rather than say that the rotating burr 31 needs to remain in contact with the atherosclerotic plaque at all times, to avoid damaging tissue at that localized location by the rotating burr 31 remaining too long in the same location in the diseased vessel, it is preferable to withdraw the rotating burr 31 proximally while rotating for a certain period of time. For example, each 25 seconds of rotational atherectomy, the rotational atherectomy head 31 is retracted proximally to clear the atherosclerotic plaque. This prevents the spin head 31 from being easily scalded by long-time spin-grinding and from being easily thrombosed by release of chips during the spin-grinding.

The sheath may be made of polytetrafluoroethylene material. The sheath tube is sleeved on the outer side of the transmission flexible shaft 32, so that damage to the blood vessel wall caused by the transmission flexible shaft 32 in the rotational grinding process is avoided, and then the sheath tube can play a role in protecting the blood vessel wall. In addition, in the rotational grinding process, cleaning liquid can be injected into the rotational grinding position through the sheath tube, so that friction damage and thermal damage are reduced, and particles falling in the rotational grinding process can be washed away in time by using the cleaning liquid, so that blood flow embolism is avoided. The washing liquid may be physiological saline.

In some embodiments, the rotational atherectomy guidewire 20 may be made from a stainless steel material. The diameter and length of the rotational atherectomy guidewire 20 are not limited as long as the rotational atherectomy procedure is applicable. For example, the length of the spin-grind guidewire 20 is 300cm. The material and the specification of the rotary grinding wire 20 are not limited herein.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (13)

1. A drive handle, comprising:

a handle housing having a guidewire lumen extending through a proximal end and a distal end of the handle housing for passing a rotational atherectomy guidewire therethrough;

the driving assembly is arranged in the handle shell and can move along the rotary grinding guide wire, the driving assembly is used for driving the driving shaft to rotate around the rotary grinding guide wire, and the driving shaft is sleeved on the rotary grinding guide wire;

the first flexible guide piece is arranged along the guide wire cavity, a first guide channel is formed, the driving shaft and the rotary grinding guide wire movably penetrate through the first guide channel, the distal end of the first flexible guide piece is connected with the handle shell, the first flexible guide piece is connected with the driving assembly in a linkage manner, and when the driving assembly and the driving shaft move along the rotary grinding guide wire, the first flexible guide piece moves in a telescopic manner in the handle shell.

2. The drive handle according to claim 1, wherein the first telescoping guide comprises 2 or more bushings, 2 or more of the bushings being nested within each other and capable of relative telescoping movement in an axial direction.

3. The drive handle according to claim 2, wherein rolling elements are provided between any adjacently disposed 2 bushings, said rolling elements being in rolling contact with the respective bushings upon telescoping movement of said first telescoping guide.

4. The drive handle according to claim 2, wherein the first telescoping guiding member comprises a first sleeve and a second sleeve sleeved on the first sleeve, wherein a rolling member is loaded between an outer wall of the first sleeve and an inner wall of the second sleeve, and the rolling member rolls between the outer wall of the first sleeve and the inner wall of the second sleeve when the first sleeve and the second sleeve relatively move in an axial direction.

5. The drive handle according to claim 4, wherein the first sleeve and the second sleeve are formed with a first abutting surface and a second abutting surface, respectively, the first abutting surface and the second abutting surface are planes parallel to the axial direction of the first telescopic guide, the first abutting surface and the second abutting surface are parallel to each other, and the rolling member is in rolling abutting contact with the first abutting surface and the second abutting surface.

6. The drive handle according to claim 4, wherein the outer wall of the first sleeve and/or the inner wall of the second sleeve is provided with a lubricating coating, and the rolling element is in contact with the lubricating coating.

7. The drive handle of claim 6, wherein a fluid passage is formed in a wall of the first sleeve, the fluid passage being configured to allow fluid to flow to the rolling element.

8. The driving handle as set forth in claim 4 wherein said second sleeve has a first and a second stopper formed on a side thereof on which an inner wall thereof is located, said rolling member being limited between said first and second stoppers.

9. The drive handle of claim 8, wherein a third limit portion is formed at one end of the first sleeve, the third limit portion being configured to abut against the first limit portion to limit the ultimate telescopic length of the first sleeve relative to the second sleeve.

10. The drive handle of claim 1, wherein the proximal end of the first telescoping guide is connected to the drive assembly or the first telescoping guide is threaded through the drive assembly such that the proximal end of the first telescoping guide extends from the proximal side of the drive assembly.

11. The drive handle of claim 1, comprising a second telescoping guide, a proximal end of the second telescoping guide being coupled to the handle housing and defining a second guide channel along the guidewire lumen, the rotational atherectomy guidewire movably disposed through the second guide channel, the first telescoping guide and the second telescoping guide being coupled to a proximal side of the drive assembly and a distal side of the drive assembly, respectively, the first telescoping guide collapsing when the drive assembly is moved distally within the handle housing, the second telescoping guide expanding when the drive assembly is moved proximally within the handle housing, the first telescoping guide expanding when the drive assembly is collapsed.

12. The drive handle of claim 11, wherein the second telescoping guide has the same structure as the first telescoping guide.

13. A rotational atherectomy system comprising the drive handle of any one of claims 1-12, a rotational atherectomy guidewire and a rotational atherectomy catheter, the rotational atherectomy guidewire being threaded into the guidewire lumen with the proximal end of the rotational atherectomy guidewire extending beyond the proximal end of the guidewire lumen, the rotational atherectomy catheter being sleeved onto the rotational atherectomy guidewire, and the proximal end of the rotational atherectomy catheter being connected to the distal end of the drive shaft.

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