WO2022127856A1 - Cutting tip, hypotube, sheath assembly, and removal device - Google Patents

Abstract

A cutting tip (300), having a threading channel (301) having openings at two ends. The cutting tip (300) comprises a cutting portion (310); the cutting portion (310) comprises a proximal end (302) and a distal end (304) disposed opposite to each other, and a first outer side surface (305) and a first inner side surface (306) disposed opposite to each other; the first outer side surface (305) and the first inner side surface (306) are disposed between the proximal end (302) and the distal end (304); the threading channel (301) runs through the proximal end (302) and the distal end (304); in a direction from the proximal end (302) to the distal end (304), the radial dimension of the first outer side surface (305) gradually decreases; the distal end (304) is provided with a plurality of notch grooves (3041) running through the first outer side surface (305) and the first inner side surface (306), and the plurality of notch grooves (3041) are arranged in the circumferential direction of the cutting tip (300).

Description

Cutting tips, hypotubes, sheath assemblies and retrieval devices technical field

The present invention relates to the technical field of medical devices, and in particular, to a removal device for removing an electrode lead long-term implanted in a patient and its cutting tip, hypotube and sheath tube assembly.

Background technique

Various medical procedures and surgical procedures require the implantation of cardiac leads, which may be pacemakers or defibrillators, in human or veterinary patients. Among them, the pacemaker is usually implanted in the subcutaneous tissue pocket of the patient's chest wall, and the multiple wires of the pacemaker extend from the pacemaker to the chamber of the patient's heart through veins; the wires of the cardiac defibrillator can be fixed in the heart The inner or outer part of the above cardiac electrode lead can be called an elongated structure. In fact, such elongated structures may also include catheters, sheaths, and various other devices.

In some cases, the lead implanted in the patient needs to be removed, such as when the lead implanted in the patient is disconnected and cannot transmit the signal, the electrode tip forms a large amount of fibrous (or calcified) tissue and the pacemaker cannot provide enough energy to run, lead site infection, clot or scar tissue blocking the vein, or other malfunction. Because the slender structure is implanted into the patient for a long time, there will be many fibrous (or calcified) tissues attached to the wire, which will make the wires stick together, between the wires and the blood vessel wall, or between the wires and the inner wall of the heart. The lead cannot be taken out directly. Forcibly taking out the lead will cause problems such as lead breakage, damage to the surrounding intact lead, damage to the blood vessel wall or the inner wall of the heart. In the current wire extraction technology, a wire extraction device is used. The wire extraction device generally uses the rotating sheath to rotate along a wire in the body to drive the rotation of the cutting tip at the distal end of the rotating sheath to cut the fibrous tissue. Purpose.

However, the cutting edge of the cutting head in the prior art is easy to contact with the vascular tissue, so that the vascular tissue is easily scratched by the cutting edge of the cutting head; and the cutting edge of the cutting head is not sharp enough, resulting in low cutting efficiency. In addition, the sheath tube in the prior art has insufficient flexibility after being implanted in a blood vessel, which makes it difficult for the rotating sheath tube to pass through the circuitous and complicated blood vessel passage, which is likely to cause great compression and damage to the blood vessel tissue.

SUMMARY OF THE INVENTION

In order to solve or at least alleviate one or more of the above-mentioned problems, a first aspect of the present invention provides a cutting tip with a threading channel open at both ends, the cutting tip comprising a first end and a second end arranged oppositely, and an opposite end. The first outer side and the first inner side are arranged, the first outer side and the first inner side are arranged between the first end and the second end, and the threading channel runs through the first end end and the second end, in the direction from the first end to the second end, the radial dimension of the first outer side surface gradually decreases; A plurality of notched grooves on the outer side surface and the first inner side surface, the plurality of notched grooves are arranged along the circumferential direction of the cutting tip.

A second aspect of the present invention also provides a cutting tip, comprising: a tip body having oppositely disposed proximal and distal ends, and oppositely disposed outer and inner peripheral surfaces, the outer peripheral surface and the inner peripheral surface a surface is disposed between the proximal end and the distal end, and the tip body is provided with a threading channel passing through the proximal end and the distal end; and

a plurality of tine structures located at the distal end and arranged along the circumference of the tip body, the tine structures comprising first and second oppositely disposed surfaces and connecting the first surface and all a transition surface between the second surfaces, the first surface is connected to the outer peripheral surface, the second surface is connected to the inner peripheral surface, the transition surface is located on the tine structure facing away from the tip the side where the body is located; wherein, the tine structure is cut off by the reference surface to form a first tangent line located on the transition surface and a second tangent line located on the first surface, the first tangent line and the The second tangent lines intersect and are arranged at an acute angle, and the reference plane is any plane passing through the central axis of the cutting tip and capable of truncating the tine structure.

A third aspect of the present invention further provides a sheath tube assembly, comprising a sheath tube and the above-mentioned cutting tip, the sheath tube has a proximal end surface, a distal end surface, and a side circumference disposed between the proximal end surface and the distal end surface surface, the sheath tube is provided with a tube hole passing through the proximal end surface and the distal end surface; and the cutting tip, the first end is connected with the side where the distal end surface of the sheath tube is located, And the threading channel and the pipe hole are communicated with each other.

A fourth aspect of the present invention also provides an extraction device for extracting an elongated structure implanted in the body, the extraction device includes a sheath tube assembly and a manipulation handle, where the manipulation handle and the proximal end surface of the sheath tube are located One side is connected, and the control handle is used to control the rotation of the sheath tube and the cutting tip, so as to cut the obstacle wrapping the elongated structure in the body.

A fifth aspect of the present invention further provides a hypotube, which has a proximal end surface, a distal end surface, and a side peripheral surface disposed between the proximal end surface and the distal end surface, and the hypotube is provided with A tube hole penetrating through the proximal end surface and the distal end surface, the side peripheral surface is provided with a plurality of array units spaced along the axial direction of the hypotube, and the array unit includes and the tube A plurality of slits connected with holes, the plurality of slits are arranged at intervals along the axial direction of the hypotube, and the extension direction of each of the slits is arranged at an angle with the axial direction of the hypotube ; Wherein, in any two adjacent slits on the side peripheral surface, the slit close to the proximal surface is relatively close to the distal surface of the slit in the circumferential direction of the hypotube All are deflected by equal angles to the same side.

A sixth aspect of the present invention also provides a sheath tube assembly, comprising: the above-mentioned hypotube; and

The cutting tip has a threading channel passing through opposite ends of the cutting tip, the cutting tip is connected to the side where the distal surface of the hypotube is located, and the threading channel and the tube hole communicate with each other.

A seventh aspect of the present invention also provides an extraction device for extracting an elongated structure implanted in the body, the extraction device includes a sheath tube assembly and a manipulation handle, the manipulation handle and the proximal end surface of the hypotube The side is connected, and the control handle is used to control the rotation of the hypotube and the cutting tip, so as to cut the obstacle wrapping the elongated structure in the body.

Description of drawings

In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the following briefly introduces the accompanying drawings used in the implementation manner. As far as technical personnel are concerned, other drawings can also be obtained based on these drawings without any creative effort.

1 is a schematic structural diagram of an extraction device according to Embodiment 1 of the present invention;

2 is a schematic diagram of the hypotube carrying a cutting tip and implanting a blood vessel along the elongated structure in Embodiment 1;

Fig. 3 is the schematic diagram after the hypotube in Fig. 2 carries the cutting tip and rotates synchronously;

FIG. 4 is a schematic cross-sectional structure diagram along section line II-II in FIG. 1;

5 is a schematic structural diagram of a hypotube in Embodiment 1;

Fig. 6 is the partial enlarged structure schematic diagram of A place in Fig. 5;

7 is a schematic plan view of the axial extension of the hypotube in FIG. 5;

Fig. 8 is a partial enlarged structural schematic diagram at B in Fig. 7;

Fig. 9 is a partial enlarged structural schematic diagram with a section line at B in Fig. 7;

10a is a schematic cross-sectional structure diagram along section line A1-A1 in FIG. 9;

10b is a schematic cross-sectional structure diagram along section line A2-A2 in FIG. 9;

10c is a schematic cross-sectional structure diagram along section line A3-A3 in FIG. 9;

Figure 10d is a schematic cross-sectional structure diagram along section line A4-A4 in Figure 9;

Figure 10e is a schematic cross-sectional structure diagram along section line A5-A5 in Figure 9;

Figure 10f is a schematic cross-sectional structure along section line A6-A6 in Figure 9;

Fig. 11 is the plane unfolding schematic diagram after the hypotube in Fig. 7 is cut along its axial direction;

Fig. 12 is a partial enlarged structural schematic diagram at C in Fig. 11;

13 is a schematic plan view of the axial extension of the hypotube in the second embodiment;

FIG. 14 is a schematic diagram of a partially enlarged structure at D in FIG. 13;

15 is a schematic plan view of the axial extension of the hypotube in Embodiment 3;

Fig. 16 is a partial enlarged structural schematic diagram at E in Fig. 15;

17 is a schematic plan view of the axial extension of the hypotube in the fourth embodiment;

18 is a schematic structural diagram of a cutting tip in an embodiment;

FIG. 19 is a schematic structural diagram of the cutting portion in FIG. 18;

Figure 20 is a top view of the cutting tip of Figure 18;

Fig. 21 is a schematic cross-sectional structure diagram along section line III-III in Fig. 20;

Fig. 22 is a partial enlarged structural schematic diagram at F in Fig. 21;

23 is a schematic cross-sectional structure diagram of another embodiment along the section line III-III in FIG. 20;

Fig. 24 is a partial enlarged structural schematic diagram at G in Fig. 23;

Figure 25 is a top view of a cutting tip in one embodiment;

Figure 26 is a top view of a cutting tip in another embodiment;

27 is a schematic structural diagram of a cutting tip according to another embodiment;

Figure 28 is a top view of the cutting tip of Figure 27;

Figure 29 is a schematic diagram of a cross-sectional structure along section line IV-IV in Figure 28;

FIG. 30 is a partial enlarged schematic view of the structure at H in FIG. 29 .

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Furthermore, the following descriptions of the various embodiments refer to the accompanying drawings to illustrate specific embodiments in which the invention may be practiced. Directional terms mentioned in the present invention, such as "up", "down", "front", "rear", "left", "right", "inside", "outside", "side", etc., only Reference is made to the directions of the accompanying drawings, therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, in a specific orientation construction and operation, and therefore should not be construed as limiting the invention.

The present invention will be described in detail below with reference to the accompanying drawings and embodiments. The defined terms "proximal", "distal" and "axial" described herein are terms commonly used in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation; "proximal end" refers to the end close to the operator during the surgical operation; "axial" refers to the direction of the central axis of the device, and the radial direction is the distance from the center of the device. The axis is vertical.

Referring to FIGS. 1 , 2 and 3 , a first embodiment of the present invention provides a removal device 10 for peeling off the body tissue 30 attached around the elongated structure 20 implanted in the body, and extracting the elongated structure in the body Structure 20. Among others, the elongated structure 20 includes, but is not limited to, cardiac leads, nerve pacing and stimulation leads, catheters, sheaths, cannulae, and other tubular the like. For the sake of convenience, this paper will take the elongated structure 20 as the pacemaker lead as an example for description, and it should be understood that the distal end of the pacemaker lead is also connected with electrodes fixed on the heart.

The extraction device 10 includes a steering handle 100 , a sheath 200 connected to the distal end of the steering handle 100 , and a cutting tip 300 connected to the distal end of the sheath 200 . A threading lumen 11 for delivering the elongated structure 20 is provided in the extraction device 10 along its axial direction (FIG. 4). The threading lumen 11 extends from the distal end of the retrieval device 10 through the cutting tip 300 , the sheath 200 and at least a portion of the control handle 100 . During extraction of the elongated structure 20 from the body using the extraction device 10 , the proximal end of the elongated structure 20 is used to pass through the cutting tip 300 , the sheath 200 and the threading lumen 11 in the manipulation handle 100 in order from the extraction device 10 . Proximal extension. The manipulation handle 100 is used to control the rotation of the sheath tube 200 and the cutting tip 300 . The distal end of the cutting tip 300 has a blade for cutting the fibrous tissue wrapped around the elongated structure 20 in order to cut through or otherwise break the obstacles 30 encountered during the extraction of the elongated structure 20 .

Specifically, referring to FIGS. 1 and 4 , the joystick 100 includes a housing 110 , a driving member 120 and a rotating member 130 . The housing 110 is generally of a proximally sealed tubular structure. The proximal end of the housing 110 is provided with a fishtail-shaped end block 111 . The fishtail-shaped end block 111 includes two extensions extending radially outward from the tubular body of the housing 110 , and the two extensions are symmetrically arranged. The fishtail-shaped end block 111 can increase the contact area with the surgeon's fingers, which is convenient for operation. A receiving groove 112 is defined in the housing 110 along the axial direction. The distal end of the receiving groove 112 passes through the distal end surface of the housing 110 , and the proximal end of the receiving groove 112 extends into the end block 111 without passing through the proximal end surface of the end block 111 .

The driving member 120 and the rotating member 130 are at least partially accommodated in the receiving slot 112 . The proximal end of the sheath tube 200 is inserted into the receiving slot 112 from the distal end of the housing 110 and is connected to the rotating member 130 . During the movement of the driving member 120 from the distal end to the proximal end or from the proximal end to the distal end, the driving member 120 is used to drive the rotating member 130 to rotate, so that the rotating member 130 drives the sheath tube 200 and the The cutting tips 300 make synchronized movements.

In this embodiment, the driving member 120 includes a handle 121 and a driving rod 122 . The outer surface of the driving rod 122 is provided with a spiral groove 1221 . The driving rod 122 is disposed in the receiving groove 112 and extends along the axial direction of the extracting device 10 . The handle 121 is fixedly connected to the proximal end of the drive rod 122 . The casing 110 is provided with an axially extending guide groove 113 , and the guide groove 113 penetrates the side wall of the casing 110 . One end of the handle 121 enters the housing 110 through the guide groove 113 and is connected to the drive rod 122 , and the axial movement of the drive rod 122 is driven by the axial sliding of the handle 121 in the guide groove 113 .

The rotating member 130 includes a rotating sleeve 131 and a pipe joint 132 disposed in the receiving groove 112 . The tube connector 132 connects the distal end of the sheath tube 200 and the proximal end of the rotating sleeve 131 . The rotating sleeve 131 and the pipe joint 132 are limited in the axial direction of the extraction device 10 , that is, the rotating sleeve 131 and the pipe joint 132 cannot move in the axial direction. The driving rod 122 is passed through the rotating sleeve 131 , and the guide pin provided on the rotating sleeve 131 is inserted into the spiral groove 1221 . It can be understood that in other embodiments, the helical groove 1221 can also be opened on the rotating sleeve 131, and the guide pin is correspondingly arranged on the driving rod 122 at this time. With a long enough matching stroke, the axial length of the rotating sleeve can be increased according to the actual situation. In other embodiments, the driving rod can also be a screw, the outer thread of the screw is provided with an external thread, and the rotating sleeve is provided with an internal thread that cooperates with the screw, and the axial movement of the driving rod is converted into the rotary motion of the rotating sleeve through the thread cooperation. .

When using retrieval device 10 , the physician inserts the proximal end (the end near the physician) of an elongated structure 20 (eg, lead) in the patient's body into cutting tip 300 . The physician grasps the steering handle 100 and pushes the steering handle 100 distally (the end away from the physician) so that the sheath 200 and cutting tip 300 gradually enter the patient's blood vessel along the elongated structure 20 (eg, lead). When the resistance of pushing the manipulation handle 100 to the distal end is relatively large, it means that the cutting tip 300 is in contact with the tissue combined with the elongated structure 20. At this time, the operator (doctor) can control the driving member 120 to drive the rotating member 130 to rotate to drive the The sheath tube 200 and the cutting tip 300 rotate synchronously to cut the tissue surrounding the elongated structure 20 . Specifically, by pulling back the handle 121 to make it slide along the guide groove 113 to control the axial movement of the driving rod 122, the driving rod 122 and the rotating sleeve 131 are inserted into the helical groove 1221 through the guide pin to achieve cooperation, and the rotating sleeve 131 is in the shaft. Therefore, the axial movement of the driving rod 122 can drive the rotating sleeve 131 to rotate, and the rotation of the rotating sleeve 131 drives the pipe joint 132 to rotate, and then drives the sheath tube 200 and the cutting tip 300 to rotate synchronously through the rotation of the pipe joint 132, so that the The sharp cutting edge of the cutting tip 300 cuts the tissue combined around the elongated structure 20 to achieve separation of the elongated structure 20 from the tissue, so as to facilitate subsequent removal operations of the elongated structure 20 .

In this embodiment, preferably, the distal end of the housing 110 is further provided with a hollow soft rubber nozzle 400 , and the sheath tube 200 is passed through the soft rubber nozzle 400 . An outer sheath 500 may also be sheathed on the outer periphery of the distal end of the sheath tube 200 , and the proximal end of the outer sheath 500 is inserted into the soft rubber nozzle 400 . In other embodiments, both the soft rubber nozzle 400 and the outer sheath 500 can be omitted.

Referring to FIGS. 1 and 4 , the threading lumen 11 penetrates the cutting tip 300 , the sheath tube 200 , and the driving rod 122 . A guide port 1101 is provided at the proximal end of the housing 110, and a notch (not shown) that communicates with the cavity therein can be opened on the side wall of the driving rod 122. The notch is opposite to the guide port 1101. The cavity 11 is extended by the notch and guide port 1101 for the physician to remove the elongated structure 20 in the body.

Specifically, the sheath tube 200 may be a hypotube, so that the sheath tube 200 has sufficient flexibility and can easily pass through the tortuous and complicated vascular passage. Referring to FIGS. 5 and 6 , the hypotube is an elongated hollow tubular structure with openings at both ends. The hypotube defines in its axial direction a tube hole 11a penetrating the proximal end and the distal end of the hypotube, and the tube hole 11a can be understood as a part of the threading lumen 11 of the retrieval device 10 . Specifically, the hypotube has a proximal end surface 201, a distal end surface 202, and a side peripheral surface 203 disposed between the proximal end surface 201 and the distal end surface 202, and the tube hole 11a penetrates the hypotube The proximal face 201 and the distal face 202.

Referring to FIG. 7 and FIG. 8 , the hypotube is provided with a plurality of array units 210 a arranged at intervals in the axial direction of the hypotube on the side peripheral surface 203 . The array unit 210a includes a plurality of slits 210 communicating with the tube hole 11a. The plurality of slits 210 are arranged at intervals along the axial direction of the hypotube, and the extending direction of each slit 210 is arranged at an included angle with the axial direction of the hypotube. For example, FIGS. 7 and 8 illustrate the circumferential extension of each slit 210 along the hypotube, that is, the extending direction of each slit 210 is perpendicular to the axial direction of the hypotube. In addition, the extension lengths of each slit 210 are equal. Referring to FIGS. 9 and 10a-10f, it can also be understood that the included angles θ between the two ends of each slit 210 and the line connecting the central axis of the hypotube are equal. The regions without hatching lines shown in the schematic cross-sectional views in FIGS. 10a-10f are the regions where the slits 210 are located. The included angle θ between the two ends of each slit 210 and the central axis of the hypotube is 200° to 300°, that is, the vertical line connecting the two ends of each slit 210 to the central axis of the hypotube is 200° to 300°. The angle θ of the sector formed by the slit 210 is 200°˜300°, for example, 240°. In this way, the included angle θ within this value range can not only ensure that the circumferential dimension of the slit 210 is large enough to ensure the flexibility of the hypotube, but also avoid that the extended size of the slit 210 is too large, which may result in insufficient rigidity of the hypotube. Causes poor propulsion performance of the hypotube.

9 and 10a to 10f, in any two adjacent slits 210 on the side peripheral surface 203, the slit 210 close to the proximal end surface 201 is relatively close to the distal end surface 202 The slit 210 is in the hypotube are all deflected toward the same side by an equal angle α in the circumferential direction. α can be 60 degrees, that is, two adjacent slits 210 are arranged at an angle of 60 degrees in the circumferential direction of the hypotube, and at this time, six adjacent slits 210 can be regarded as one array unit 210a. 10a to 10f illustrate schematic cross-sectional views of six slits 210 in the same array unit 210a that are sequentially arranged in the axial direction of the coastal wave tubes. In more detail, the slits 210 illustrated in FIG. 10b are deflected counterclockwise by an angle α relative to the adjacent and distally located slits 210 illustrated in FIG. 10a ; the slits 210 illustrated in FIG. 10c are deflected counterclockwise relative to the slits 210 illustrated in FIG. 10a The angle 2α, that is, the counterclockwise deflection angle α relative to the slit 210 shown in FIG. 10b; the counterclockwise deflection angle 3α of the slit 210 shown in FIG. 10d relative to the slit 210 shown in FIG. The slit 210 is deflected by an angle α counterclockwise; the slit 210 shown in FIG. 10e is deflected by an angle 4α counterclockwise relative to the slit 210 shown in FIG. The illustrated slits 210 are deflected by an angle 5α counterclockwise relative to the slits 210 illustrated in FIG. 10a , ie by an angle a counterclockwise relative to the slits 210 illustrated in FIG. 10e .

Figures 10a-10f only take α as 60° as an example for description, of course, α can also take values of 30°, 72°, 90°, 120°, 180°, and so on. At this time, the value angle of α corresponds to 12, 5, 4, 3, and 2 slits 210 in the array unit 210a, respectively. It should be noted that the above α values are examples rather than exhaustive.

As described above, since each array unit 210a forms a cycle, the plurality of slits 210 of each array unit 210a are arranged at a uniform angle of 360° dislocation in the circumferential direction. In this way, the torsional performance of the hypotube at any position in the circumferential direction of 360° can be improved, and the uniformity of the torsional performance of the hypotube in the circumferential direction of 360° can be ensured. In more detail, referring to FIG. 2 and FIG. 3 , a user, such as a doctor, can hold the manipulation handle 100 to make the hypotube carry the cutting tip 300 through the circuitous and complex curved blood vessels, and at this time, control the manipulation handle 100 to rotate the hypotube and make it move. The distal cutting tip 300 is driven to cut the tissue 30 surrounding the elongated structure 20, and the circumferential position of the hypotube changes due to rotation. Based on the dislocation law of the circumferential angles of the multiple slits 210 of the hypotube, the uniformity of the torsional performance at any circumferential position of the hypotube can be ensured, and the phenomenon of the hypotube compressing and damaging the vascular tissue after rotating in the curved blood vessel will not occur. . In addition, when the hypotube drives the cutting tip 300 to complete the cutting action by rotating, the phenomenon of jamming and labor will not occur when the rotating driving force is applied to the proximal end of the hypotube, so that the removal process of the slender structure 20 such as the wire can be avoided. easier.

In fact, the above arrangement rules of the hypotubes are also explained as follows. Please refer to FIG. 11 and FIG. 12 , the two ends of any two adjacent slits 210 that are close to each other are spaced apart in the circumferential direction of the hypotube, and The separation distance T is equal, and the value range of the distance T is controlled between 2.83mm-2.93mm. A virtual line segment 40 is defined, and the virtual line segment 40 connects between the two ends of the two adjacent slits 230 that are close to each other. Then all virtual line segments 40 are connected end-to-end to form a hypotube that is wound around the hypotube and extends axially as a whole. Virtual spiral coil.

As an example, the material of the hypotube can be selected from 304 stainless steel, and the slit 210 on the hypotube can be formed by laser cutting. 11 and 12, the circumferential length L of the slit 210 formed by laser cutting the hypotube is controlled within 8mm-12mm, preferably 10mm. The axial width S of the slit 210 is controlled at 0.275mm-0.3mm, preferably 0.3mm. The axial distance D between two adjacent slits 210 is controlled to be 0.775mm-0.825mm, preferably 0.8mm. In this embodiment, the plurality of slits 210 are arranged at equal intervals along the axial direction of the wave tube.

The proximal end of the cutting tip 300 is connected to the distal end of the hypotube, and the lumen of the cutting tip 300 communicates with the lumen of the hypotube 200 (ie, the tube hole 11a). The cutting tip 300 and the hypotube may be removably or fixedly connected. For example, the cutting tip 300 can be detachably connected to the hypotube by means of screw connection, snap connection, etc., or can be fixedly connected to the distal end of the hypotube by means of welding, bonding, or the like. Alternatively, the cutting tip 300 may be integrally formed with the hypotube, that is, the cutting tip 300 may be directly formed on the hypotube, for example, the cutting tip 300 may be formed at the distal end of the hypotube by turning.

Further, referring to FIG. 7 , the hypotube can be divided into a distal flexible section 202 and a proximal rigid section 204 in the axial direction. The distal face 202 of the hypotube is formed at the end of the flexible section 202 remote from the rigid section 204 . The proximal face 201 of the hypotube is formed at the end of the rigid section 204 remote from the flexible section 202 . The slits 210 are uniformly distributed in the flexible section 202 in the axial direction of the coastal wave tube according to the above rules, while the rigid section 204 does not have the slits 210 . The distal end of the flexible segment 202 is used for connection with the proximal end of the cutting tip 300 , and the proximal end of the flexible segment 202 is connected with the distal end of the rigid segment 204 . The proximal end of the rigid segment 204 is used to connect with the rotating member 130 . The rigid structure at the proximal end and the flexible structure at the distal end of the hypotube can take into account the pushing performance and the compliance performance of the hypotube after implantation in the blood vessel, and ensure a better clinical use effect. It will be appreciated that in other embodiments, the rigid section 204 may be omitted.

As an example, the axial length H1 of the flexible section 202 may be controlled at 400mm-450mm, preferably 425mm. The axial length H2 of the rigid section 204 can be controlled at 15mm-25mm, preferably 20mm.

As an example, the distance between any two adjacent array units 210a is the same, and the distance between any two adjacent slits 210 in the same array unit 210a is the same. Preferably, FIG. 12 shows that the spacing between any two adjacent slits 210 on the hypotube is equal, that is, it can be understood that the spacing between any two adjacent array units 210a is the same as any adjacent one in the same array unit 210a The two slits are equally spaced.

In other embodiments, as shown in FIG. 13 and FIG. 14 , the distance L2 between two adjacent array units 210 a is greater than the distance between any two adjacent slits 210 in the same array unit 210 a Spacing L1. This arrangement can ensure that the flexible segment 202 not only has good flexibility to pass through the circuitous and complicated blood vessel passages, but also can ensure sufficient rigidity to have good rigidity through the interval between the two adjacent array units 210a without the slit 210. Push performance. The size of the spacing L2 can be controlled to be 3 to 6 times the size of the spacing L1.

The extending direction of the slits 210 may be perpendicular to the axial direction of the hypotube, that is, the slits 210 extend along the circumferential direction of the hypotube. For ease of understanding, the extending direction of the slit 210 may be interpreted as a tangential extending direction of the slit 210 . In another embodiment, as shown in FIGS. 15 and 16 , each slit 210 may also be inclined to the axial direction of the hypotube at an included angle β, and the value of β is an acute angle. For example, the value range of β can be controlled within Between 60°-75°. The slit 210 and the axial direction of the hypotube are arranged at an included angle β to enhance the rotational driving force transmitted by the proximal end of the hypotube, so as to improve the cutting effect of the cutting tip 300 . Further, the slit 210 is inclined toward the side where the distal end surface 202 of the hypotube is located. When the hypotube is advanced in the blood vessel, the slit 210 is inclined toward the distal end of the hypotube, so that the vascular tissue is not easily embedded in the slit 210, or the tissue stuck in the slit 210 is more easily separated from the slit 210, so that the Avoid or mitigate damage to vascular tissue during advancement of the hypotube.

Referring again to FIG. 6 , as an example, in the axial direction of the hypotube, the maximum opening width of both ends of the slit 210 is greater than the opening width of the middle extension of the slit 210 . For example, FIG. 6 shows that the middle section of the slit 210 is a rectangular slotted hole structure, and the two ends of the slit 210 are substantially circular slotted hole structures. The diameter of the circular slotted hole structure is larger than the slot width of the rectangular elongated slotted hole structure in the axial direction of the hypotube, and the circular slotted hole and the rectangular elongated slotted hole preferably have a smooth transition to avoid local stress concentration. Since the maximum opening width of the opposite ends of each slit 210 in the axial direction of the hypotube is greater than the opening width of the middle section of the slit 210 in the axial direction, it is possible to avoid the opening width at both ends of the slit 210 when the hypotube is twisted. The stress concentration can damage the hypotube, improve the effect of tissue cutting and wire extraction, and at the same time increase the service life of the hypotube.

Referring to FIG. 17 , in another embodiment, the middle section of the slit 210 of the present application may not be a rectangular long slot structure, for example, the middle section of the slit 210 may be a substantially corrugated slot structure. The slot structure can be formed by connecting a plurality of S-shaped units in sequence. Of course, the shape of the middle section of the slit 210 in the present application is not limited thereto, and can also be any other shape.

It should be noted that although the above embodiments are described by taking the sheath tube 200 as a hypotube as an example, the sheath tube 200 in the above embodiment is only a preferred embodiment of the present application, and the sheath tube 200 in each embodiment of the present application It is also possible not to use a hypotube, that is, not to have the slit 210 structure.

Referring to Figures 18 and 19, a specific example of a cutting tip 300 is shown. The cutting tip 300 has threading channels 301 extending through opposite ends of the cutting tip 300 . The cutting tip 300 is connected to the distal end of the sheath 200, and the threading channel 301 communicates with the bore 11a so that the distal end of the elongated structure 20 such as a guide wire can pass through the threading channel 301 and the bore 11a in turn.

In this embodiment, the cutting tip 300 includes a cutting portion 310 and a connecting portion 320 . The cutting portion 310 includes opposing first ends 302 (proximal end) and second ends 304 (distal end), and opposing first outer sides 305 and first inner sides 306 . The first outer side surface 305 and the first inner side surface 306 are disposed between the first end 302 and the second end 304 , and the threading channel 301 penetrates the first end 302 and the second end 304 .

21 and 24 simultaneously, in the direction from the first end 302 to the second end 304, the radial dimension of the first outer side surface 305 gradually decreases. Further, in the direction from the first end 302 to the second end 304, the distance between each point on the cross-sectional shape of the first outer side surface 305 by the reference plane and the central axis of the cutting tip 300 gradually decreases, the said The reference plane is a plane perpendicular to the axial direction (ie, the central axis) of the cutting tip 300 . For example, as shown in the figures, the first outer side surface 305 may be a tapered surface, but is not limited thereto. In addition, the second end 304 is provided with a plurality of notched grooves 3041 extending to the first outer side surface 305 and the first inner side surface 306 , and the plurality of notched grooves 3041 are arranged along the circumferential direction of the cutting tip 300 . The bottom of the notch groove 3041 is spaced apart from the second end 302 .

In the direction from the first end 302 to the second end 304, the radial dimension of the first inner side surface 306 gradually increases. Further, in the direction from the first end 302 to the second end 304, the distance between each point on the cross-sectional shape of the first inner side surface 306 by the reference plane and the central axis of the cutting tip 300 gradually increases. The face is the plane perpendicular to the axial direction of the cutting tip 300 . This arrangement is such that after the proximal end (the end near the physician) of the elongated structure 20 (eg, lead) is inserted into the cutting tip 300 and the sheath 200 is advanced along the elongated structure 20 carrying the cutting tip 300, the reduced diameter The first inner side surface 306 can well protect the elongated structure 20 and will not cut or wear the elongated structure 20 . It can be understood that the first inner side surface 306 can also be parallel to the axial direction of the cutting tip 300 without considering the wear.

FIG. 18 illustrates that the first end 302 is connected to the connecting part 320 , and the threading channel 301 penetrates the connecting part 320 and the cutting part 310 . The first end 302 is connected to the side where the distal end surface 202 of the sheath tube 200 is located through the connecting portion 320 .

Referring to FIGS. 20 and 21 , the connecting portion 320 has a second outer side surface 321 and a second inner side surface 322 arranged oppositely, the second outer side surface 321 intersects the first outer side surface 305 of the cutting portion 310 , and the second inner side surface 322 It intersects the first inner side surface 306 of the cutting portion 310 .

Referring to FIG. 22 , as an example, the second outer side surface 321 is parallel to the axial direction of the cutting tip 300 . The second inner side surface 322 includes a first side surface segment 3221 and a second side surface segment 3222 in sequence along the axial direction. The first side surface segment 3221 extends to the end of the connecting portion 320 facing away from the cutting portion 310, and the first side surface segment 3221 is parallel to the The axial direction of the cutting tip 300. The second side section 3222 is disposed between the first side section 3221 and the first inner side 306 , and the second side section 3222 and the first inner side 306 are smoothly connected, so that the second side section 3222 and the first inner side 306 are coplanar . The so-called "coplanarity" means that the radial dimensions of the two surfaces have the same variation law in the axial direction.

The first outer side surface 305 and the second outer side surface 321 are formed as the outer peripheral surface 31 of the cutting tip 300 , and the first inner side surface 306 and the second inner side surface 322 are formed as the inner peripheral surface 32 of the cutting tip 300 . It should be understood that in other embodiments, the second side section 3222 may be omitted, that is, the second inner side 306 only includes the first side section 3221 at this time, that is, the second inner side 306 is parallel to the axial direction of the cutting tip 300 flat.

It should be noted that, in other embodiments, the connecting portion 320 may also be omitted from the cutting tip 300 .

For the cutting tip 300 described above, referring to FIGS. 19 and 20 , the intersecting line formed by the intersection of the groove wall of the notch groove 3041 and the first outer side surface 305 can be used as the first cutting edge 3051 , and the groove wall of the notch groove 3041 is also connected to the first inner surface 305 . The intersection line formed by the intersection of the side surfaces 306 can be used as the second cutting edge 3061. Based on the cooperation between the first cutting edge 3051 outside the cutting tip 300 and the second cutting edge 3061 inside, the sharpness of the cutting tip 300 for cutting obstacles such as internal tissues can be improved. .

In addition, in the direction from the first end 302 to the second end 304, the radial dimension of the first outer side surface 305 gradually decreases, and at this time the notch groove 3041 is formed at the second end 304, that is, the notch groove 3041 is formed at the cutting tip The distal end of 300, so that the outer first cutting edge 3051 is not located at the radially outermost end of the cutting tip 300, and the cutting tip 300 is used to cut the slender structure 20 including the electrode lead with higher safety, because During the process of advancing the sheath tube 200 with the cutting tip 300 in the blood vessel, the maximum radial dimension of the first cutting edge 3051 of the cutting tip 300 is smaller than the radial dimension of the first end 302, that is, the first cutting edge 3051 is not easily connected to the vascular tissue. contact, thereby reducing or eliminating the risk of vascular tissue being scratched or scratched by the first blade 3051 .

19 and FIG. 20 , since the notch groove 3041 is recessed downward, for example, in an arc shape, the first outer side surface 305 is matched with the radially inwardly inclined first outer surface 305 to form a first blade 3051. 3051 has the following characteristics:

First, in the top view 20, both ends of the first blade 3051 are closer to the central axis, the middle of the first blade 3051 protrudes outward in the radial direction, and when the entire cutting tip rotates, the cutting formed by the first blade 3051 The track is an annular shape with the end of the first blade 3051 as the inner diameter and the middle of the first blade 3051 as the outer diameter, so it has a larger cutting surface and improves the cutting efficiency.

Second, in FIG. 19 , both ends of the first blade 3051 are higher in the axial direction, while the middle of the first blade 3051 is lower in the axial direction. When the entire cutting tip rotates, both ends of the first blade 3051 first touch tissue, and then as the entire cutting tip moves forward in the axial direction, only the middle of the first blade 3051 contacts the tissue, so the cut is sharper.

Third, during cutting, one end of the first cutting edge 3051 first contacts the tissue to cut the tissue. As the first cutting edge 3051 rotates and moves forward in the axial direction at the same time, until the middle of the first cutting edge 3051 contacts the tissue , the tapered first outer side surface 305 has a tendency to push the incision along the radially outer periphery of the tissue outward, reducing the cutting resistance.

It should be noted that, the first outer side surface 305 of the present application can be processed by one-knife cutting, so as to simplify the production process.

Further, as shown in FIGS. 18 and 19 , the cutting tip 300 may further include a plurality of mounting surfaces 303 , and the mounting surfaces 303 are located between the groove walls of two adjacent notched grooves 3041 , so that the two adjacent notches The grooves 3041 are spaced apart, and the mounting surface 303 is connected to and intersects the first outer side surface 305 and the first inner side surface 306, respectively. In addition, please refer to FIGS. 21 and 22 , which illustrate that the mounting surface 303 is perpendicular to the axial direction of the cutting tip 300 . In other embodiments, referring to FIGS. 23 and 24 , in order to improve the cutting sharpness of the cutting tip 300 , the mounting surface 303 may be arranged such that: in the direction from the first end 302 to the second end 304 , the mounting surface 303 is The distance between each point on the cross-sectional shape of the reference plane and the central axis of the cutting tip 300 gradually increases, wherein the reference plane is a plane perpendicular to the axial direction of the cutting tip 300 . In order to ensure the smoothness of the mounting surface 303, the mounting surface 303 can be regarded as a part of the tapered surface.

In other embodiments, the cutting tip 300 may also not have the mounting surface 303 . For example, referring to FIG. 25 , the groove walls of two adjacent notch grooves 3041 intersect to form an intersection line 3042, and both ends of the intersection line 3042 extend to the first outer side surface 305 and the first inner side surface 306, The line of intersection 3042 may be perpendicular or oblique to the axial direction of the cutting tip 300 . Alternatively, as shown in FIG. 26 , an interval area is formed between two adjacent notch grooves 3041 , and in the interval area, the first outer side surface 305 intersects the first inner side surface 306 .

27 and 28, there is shown a cutting tip 300 according to another embodiment, which is similar to the cutting tip shown in FIG. 18, except that the cutting tip 300 of this embodiment includes a plurality of tine structures 330 .

Preferably, a plurality of notched grooves 3041 may also be provided in this embodiment, and each notched groove 3041 is provided between two adjacent tine structures 330 . In this case, the location of each tine structure 330 corresponds to the corresponding mounting surface 303 of the cutting tip shown in FIG. 18 . It can be understood that in the embodiment with the tine structure 330, the notch groove 3041 can also be omitted.

The tine structure 330 includes an opposite first surface 331 and a second surface 332, and a transition surface 333 connecting the first surface 331 and the second surface 332. The first surface 331 is connected to the first outer side surface 305, and the first surface 331 is connected to the first outer surface 305. The two surfaces 332 are connected to the first inner side surface 306 , and the transition surface 333 is located on the side of the tine structure 330 facing away from the mounting surface 303 and is connected to the groove walls of the two adjacent notched grooves 3041 .

In this embodiment, the transition surface 333 includes a third surface 3331 and a fourth surface 3332 arranged along the circumference of the cutting tip 300 , and the third surface 3331 is opposite to the fourth surface 3332 . The third surface 3331 and the fourth surface 3332 are respectively connected with the groove walls of the two adjacent notched grooves 3041 . For example, the third surface 3331 and the groove wall of the adjacent notched groove 3041 are smoothly connected, preferably coplanar, and the fourth surface 3332 and the groove wall of the adjacent notched groove 3041 are smoothly connected, preferably coplanar . The second surface 332 is coplanar with the first inner side surface 306 , and the first surface 331 intersects the first outer side surface 305 .

Further, in the direction from the first end 302 to the second end 304, the distance between the third surface 3331 and the fourth surface 3332 gradually decreases until the third surface 3331 and the fourth surface 3332 intersect to form a cutting line 3333, and the cutting line 3333 Both ends extend to the first surface 331 and the second surface 332 . It should be understood that the third surface 3331 and the fourth surface 3332 may not intersect but be connected by another plane. In addition, the transition surface 333 may be an arc surface with continuous transition, and at this time, the third surface 3331 and the fourth surface 3332 may be coplanar.

It should be noted that the tine structure 330 in the present application also has the following structural features: with reference to FIGS. 29 and 30 , the tine structure 330 is cut off by the reference surface to form the first section located on the transition surface 333 The line 41, and the second tangent line 42 located on the first surface 331, the first tangent line 41 and the second tangent line 42 intersect and are arranged at an acute angle γ. The reference plane is any plane passing through the central axis of the cutting tip 300 and capable of cutting off the tine structure 330 . Since the first tangent line 41 and the second tangent line 42 are formed to intersect and form an acute angle, the intersection line formed by the intersection of the transition surface 333 and the first surface 331 can well improve the cutting sharpness of the cutting tip 300 and ensure that the body wraps finely. The tissue of the long structure 20 can be cut and removed smoothly.

In addition, as shown in FIG. 27 , the cutting body 340 of the cutting tip 300 of this embodiment replaces the structure of the cutting portion 310 and the connecting portion 320 that are provided separately in the above embodiment. In other words, the cutting body 340 of this embodiment can also be understood as The cutting part 310 and the connecting part 320 are included. In this embodiment, as shown in FIG. 27 , the cutting body 340 has a proximal end 341 and a distal end 342 arranged oppositely, and the outer peripheral surface 31 and the inner peripheral surface 32 arranged oppositely, the outer peripheral surface 31 is disposed between the proximal end 341 and the distal end 342 . The threading channel 301 passes through the proximal end 341 and the distal end 342 . A plurality of tine structures 330 are located at the distal end 342 and are arranged circumferentially of the tip body 340. The first surface 331 is connected to the outer peripheral surface 31 , the second surface 332 is connected to the inner peripheral surface 32 , and the transition surface 333 is located on the side of the tine structure 330 facing away from the tip body 340 .

It should be understood that the proximal end 341 described above can be understood as the end of the connecting portion 320 for connecting with the sheath tube 200, and the distal end 342 can be understood as the end of the cutting portion 310 used for setting the tine structure 330, namely the aforementioned the second end 304 . In other embodiments, the cutting body 340 may only include the cutting portion 310 , and the cutting portion 310 is connected to the sheath tube 200 . In another embodiment, the cutting body 340 may include a cutting portion 310 and a connecting portion 320 that are respectively formed and connected to each other, and the connecting portion 320 is connected to the sheath tube 200 . This application does not make any limitation here.

Referring to FIG. 29 , the maximum radial dimension D1 of the tine structure 330 is smaller than the radial dimension D2 of the portion of the first outer side surface 305 on the side where the first end 302 is located, that is, the tine structure 330 The maximum radial dimension D1 is smaller than the maximum radial dimension D2 of the first outer side surface 305 , which can also be understood as the maximum radial dimension D1 of the tine structure 330 is smaller than the maximum radial dimension D2 of the outer peripheral surface 31 . In this way, when the sheath tube 200 carries the cutting tip 300 and is advanced along the elongated structure 20 in the blood vessel, the risk of contact between the tines 330 and the vascular tissue can be reduced, thereby reducing or eliminating the vascular tissue being affected by the tines 330 The risk of scratches or scratches increases the success rate of clinical operations.

Referring to FIG. 30 , in this embodiment, in the direction from the first end 302 to the second end 304 , or in the direction from the proximal end 341 to the distal end 342 , the first The distance M1 of the tangent line 41 to the central axis of the cutting tip 300 increases gradually, and the distance M2 of the second tangent line 42 to the central axis of the cutting tip 300 may also appear to gradually increase. In this way, the tip of the formed tine structure 330 appears to be directed outward, and the first surface 305 appears to be retracted. Such a structure can greatly increase the sharpness of the tine structure 330 and ensure that the tissue surrounding the elongated structure 20 can be relatively Cut off easily.

Specifically, the angle formed by the first tangent line 41 formed after the tine structure 330 is cut by the reference plane and the central axis of the cutting tip 300

It may be 60° to 85°, preferably 80°. The included angle of the value range

It can be ensured that the cutting sharpness of the transition surface 333 is not too large or too small. In addition, any first tangent line 41 formed after the tine structure 330 is cut off by the reference surface can be equal to the angle formed by the central axis of the cutting tip 300, so that the transition surface 333 can ensure uniform cutting when cutting tissue in the circumferential direction sex.

Specifically, the angle formed by the second tangent line 42 formed after the tine structure 330 is cut off by the reference surface and the central axis of the cutting tip 300 may be

It is 5° to 30°, preferably 15°. The included angle of the value range

It can ensure that the sharpness of the first surface 331 is not too large or too small. In addition, any second tangent line 42 formed after the tine structure 330 is cut off by the reference surface can be equal to the angle formed by the central axis of the cutting tip 300, so that the cutting of the first surface 331 when cutting tissue in the circumferential direction can be ensured uniformity.

It should be noted that the above only exemplifies specific implementations of the present invention. Without departing from the principles of the embodiments of the present invention, and the features in each embodiment are not mutually exclusive, they can be implemented in any combination, such as , the sheath tube of any of the above-mentioned embodiments can be combined with the cutting tip of any of the above-mentioned embodiments.

The above are the implementations of the embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present invention, several improvements and modifications can also be made. These improvements and modifications are also It is regarded as the protection scope of the present invention.

Claims (65)

1. A cutting tip with a threading channel open at both ends, characterized in that the cutting tip comprises a cutting portion, and the cutting portion comprises a proximal end and a distal end that are arranged oppositely, and a first outer side that is oppositely arranged and a first inner side, the first outer side and the first inner side are provided between the proximal end and the distal end, and the threading channel runs through the proximal end and the distal end , in the direction from the proximal end to the distal end, the radial dimension of the first outer side is gradually reduced; A plurality of notched grooves on the inner side surface, the plurality of notched grooves are arranged along the circumferential direction of the cutting tip.
2. The cutting tip according to claim 1, characterized in that, in the direction from the proximal end to the distal end, each point on the cross-sectional shape of the first outer side by the reference plane and the central axis of the cutting tip The distance between them gradually decreases, and the reference plane is a plane perpendicular to the axial direction of the cutting tip.
3. The cutting tip according to claim 1, wherein in a direction gradually approaching from the proximal end to the distal end, each point on the cross-sectional shape of the first inner surface by the reference plane and the middle of the cutting tip The distance between the axes gradually increases, the reference plane being a plane perpendicular to the axial direction of the cutting tip.
4. The cutting tip according to any one of claims 1-3, wherein the groove walls of two adjacent notch grooves intersect to form an intersection line, and both ends of the intersection line extend to the first outer side surface and the the first inner side.
5. The cutting tip according to any one of claims 1-3, wherein an interval area is formed between two adjacent notch grooves, and in the interval area, the first outer side surface intersects the first outer side surface. An inner side.
6. The cutting tip according to any one of claims 1-3, characterized in that, the cutting tip further comprises a plurality of mounting surfaces, and the mounting surfaces are located between the groove walls of two adjacent notch grooves, so as to The two adjacent notch grooves are spaced apart, and the mounting surface is connected between the first outer side surface and the first inner side surface.
7. 6. The cutting tip according to claim 6, wherein, in the direction from the proximal end to the distal end, each point on the cross-section of the mounting surface by the reference plane and the central axis of the cutting tip are between each other. The distance between them gradually increases, and the reference plane is a plane perpendicular to the axial direction of the cutting tip.
8. The cutting tip according to any one of claims 1 to 3, wherein the cutting portion further comprises a plurality of tines, each of which is disposed between two adjacent notched grooves, so that the The tine structure includes opposing first and second surfaces, and a transition surface connecting the first surface and the second surface, the first surface is connected to the first outer side, the The second surface is connected with the first inner side surface, the transition surface is located at the distal end surface of the cutting tip and connected with the groove walls of the two adjacent notch grooves; after the tine structure is cut off by the reference surface A first tangent line located on the transition surface and a second tangent line located on the first surface are formed, the first tangent line and the second tangent line intersect and are arranged at an acute angle, and the reference surface passes through the Cuts the central axis of the tip and is able to truncate any plane of the tine structure.
9. 9. The cutting tip of claim 8, wherein the maximum radial dimension of the tine structure is smaller than the radial dimension of the portion of the first outer side surface on the side where the proximal end is located.
10. The cutting tip according to claim 8 or 9, wherein the distance from the first tangent to the central axis of the cutting tip gradually increases in the direction from the proximal end to the distal end.
11. 11. The cutting tip of claim 10, wherein the distance from the second tangent to the central axis of the cutting tip gradually increases in a direction from the proximal end to the distal end.
12. The cutting tip according to any one of claims 8 to 11, wherein the transition surface comprises a third surface and a fourth surface arranged along the circumference of the cutting tip, the third surface and the The fourth surface is opposite to each other, and the third surface and the fourth surface are respectively connected with the groove walls of the two adjacent notch grooves.
13. 13. The cutting tip of claim 12, wherein in a direction from a proximal end to a distal end, the distance between the third surface and the fourth surface gradually decreases until the third surface and the first surface The four surfaces intersect to form a cutting line, and the two ends of the cutting line extend to the first surface and the second surface.
14. The cutting tip according to claim 12 or 13, wherein the third surface is smoothly connected with the groove wall of the notch groove connecting the third surface to achieve coplanarity, and the fourth surface is connected with the first surface. The groove walls of the four-surface notch groove are coplanar, and the second surface is coplanar with the first inner side surface.
15. The cutting tip according to any one of claims 1 to 14, wherein the cutting tip further comprises a connecting portion, the connecting portion is connected with the proximal end of the cutting portion, and the threading channel penetrates the a cutting part and the connecting part, the connecting part has a second outer side surface and a second inner side surface arranged oppositely, the second outer side surface intersects with the first outer side surface, and the second inner side surface and the The first inner sides meet.
16. 16. The cutting tip of claim 15, wherein the second outer side surface is parallel to the axial direction of the cutting tip, the second inner side surface includes a first side surface section, and the first side surface section extends to the The connecting portion faces away from one end of the cutting portion, and the first side section is parallel to the axial direction of the cutting tip.
17. 17. The cutting tip of claim 16, wherein the second inner side surface comprises a second side surface segment, the second side surface segment is disposed between the first side surface segment and the first inner side surface, the The second side section is smoothly connected with the first inner side, so that the second side section and the first inner side are coplanar.
18. A cutting tip, characterized in that it comprises:

    The tip body has a proximal end and a distal end oppositely arranged, and an outer peripheral surface and an inner peripheral surface oppositely arranged, the outer peripheral surface and the inner peripheral surface are arranged between the proximal end and the distal end During the time, the tip body is provided with a threading channel passing through the proximal end and the distal end; and

    a plurality of tine structures located at the distal end and arranged along the circumference of the tip body, the tine structures comprising first and second oppositely disposed surfaces and connecting the first surface and all a transition surface between the second surfaces, the first surface is connected to the outer peripheral surface, the second surface is connected to the inner peripheral surface, the transition surface is located on the tine structure facing away from the tip the side where the body is located; wherein, the tine structure is cut off by the reference surface to form a first tangent line located on the transition surface and a second tangent line located on the first surface, the first tangent line and the The second tangent lines intersect and are arranged at an acute angle, and the reference plane is any plane passing through the central axis of the cutting tip and capable of truncating the tine structure.
19. 19. The cutting tip of claim 18, wherein the distance from the first tangent to the central axis of the cutting tip gradually increases in the direction from the proximal end to the distal end.
20. The cutting tip according to claim 19, wherein the angle formed by the first tangent line formed after the tine structure is cut off by the reference surface and the central axis of the cutting tip is 60°˜85° .
21. The cutting tip according to claim 19 or 20, wherein any first tangent line formed after the tine structure is cut off by the reference surface is equal to the included angle formed by the central axis of the cutting tip.
22. The cutting tip according to any one of claims 19 to 21, wherein the distance from the second tangent to the central axis of the cutting tip gradually increases in the direction from the proximal end to the distal end .
23. The cutting tip according to claim 22, wherein the angle formed by the second tangent line formed after the tine structure is cut off by the reference surface and the central axis of the cutting tip is 5°˜30°.
24. The cutting tip according to claim 22 or 23, wherein any second tangent line formed after the tine structure is cut off by the reference surface is equal to the included angle formed by the central axis of the cutting tip.
25. 25. The cutting tip of any one of claims 18 to 24, wherein the transition surface includes a third surface and a fourth surface that are arranged and oppositely disposed along the circumference of the tip body, and are located at the proximal end The distance between the third surface and the fourth surface gradually decreases toward the distal end.
26. 26. The cutting tip of claim 25, wherein the intersection of the third surface and the fourth surface forms a cutting line, the two ends of the cutting line extending to the first surface and the second surface.
27. 27. The cutting tip of any one of claims 18 to 26, wherein the largest radial dimension of the cutting tip is smaller than the largest radial dimension of the outer peripheral surface.
28. 28. The cutting tip of claim 27, wherein the outer peripheral surface includes a first outer side, the inner peripheral surface includes a first inner side opposite the first outer side, and the first outer side is opposite to the first outer side. The first surface intersects, the first inner surface is connected with the second surface, the radial dimension of the first outer surface gradually decreases in the direction from the proximal end to the distal end, and the cutting The largest radial dimension of the tip is smaller than the radial dimension of the portion of the first outer side surface on the side where the distal end is located.
29. 28. The cutting tip according to claim 28, wherein in the direction from the proximal end to the distal end, each point on the cross-sectional shape of the first outer side surface by the reference plane and the central axis of the cutting tip The distance between them gradually decreases, and the reference plane is a plane perpendicular to the axial direction of the cutting tip.
30. 28. The cutting tip according to claim 28, wherein, in the direction from the proximal end to the distal end, each point on the cross-sectional shape of the first inner side surface is defined by the reference plane and the central axis of the cutting tip The distance between them increases gradually, and the reference plane is a plane perpendicular to the axial direction of the cutting tip.
31. 31. The cutting tip of claim 30, wherein the first inner side and the second surface are smoothly connected to achieve coplanarity of the first inner side and the second surface.
32. The cutting tip according to claim 30, wherein the outer peripheral surface further comprises a second outer side surface, and the inner peripheral surface further comprises a second inner side surface disposed opposite to the second outer side surface; The outer side intersects the first outer side, and the second inner side intersects the first inner side.
33. 33. The cutting tip of claim 32, wherein the second outer side is parallel to an axial direction of the cutting tip, the second inner side includes a first side extending to the tip At the proximal end of the body, the first side is parallel to the axial direction of the cutting tip.
34. The cutting tip of claim 33, wherein the second inner side further comprises a second side, the second side is disposed between the first side and the first inner side, the first side The two side surfaces are smoothly connected with the first inner side surface, so that the second side surface and the first inner side surface are coplanar.
35. A sheath assembly, comprising:

    The sheath tube has a proximal end surface, a distal end surface, and an outer peripheral surface disposed between the proximal end surface and the distal end surface, and the sheath tube is provided with a penetrating through the proximal end surface and the distal end surface. pipe holes; and

    The cutting tip according to any one of claims 1 to 34, wherein the proximal end is connected to the side where the distal surface of the sheath tube is located, and the threading channel and the tube hole communicate with each other.
36. The sheath tube assembly according to claim 35, wherein the cutting tip and the sheath tube are integrally formed; or, the cutting tip and the sheath tube are detachably connected.
37. The sheath tube assembly according to claim 35 or 36, wherein the sheath tube is a hypotube.
38. A removal device for removing an elongated structure implanted in the body, characterized in that it comprises:

    The sheath assembly of any one of claims 35 to 37; and

    The control handle is connected to the side where the proximal end surface of the sheath tube is located, and the control handle is used to control the rotation of the sheath tube and the cutting tip, so as to cut the obstacle wrapping the elongated structure in the body.
39. A hypotube is characterized in that it has a proximal end surface, a distal end surface, and a side peripheral surface disposed between the proximal end surface and the distal end surface, and the hypotube is provided with a penetrating part extending through the proximal end surface and the distal end surface. The tube holes on the end surface and the distal surface, the side peripheral surface is provided with a plurality of array units spaced along the axial direction of the hypotube, and the array unit includes a plurality of array units communicated with the tube holes. a plurality of slits, the plurality of slits are arranged at intervals along the axial direction of the hypotube, and the extending direction of each of the slits is arranged at an included angle with the axial direction of the hypotube; wherein, in the Among any two adjacent slits on the side peripheral surface, the slits close to the proximal end surface are all facing the same side in the circumferential direction of the hypotube relative to the slits close to the distal end surface. Deflection by equal angles.
40. The hypotube of claim 39, wherein the hypotube comprises a flexible section and a rigid section, the distal end face is formed at an end of the flexible section remote from the rigid section, the proximal The end face is formed at the end of the rigid section away from the flexible section, and the slits are uniformly arranged on the flexible section.
41. The hypotube according to claim 40, wherein the axial length of the flexible section is 400 mm to 450 mm, and the axial length of the rigid section is 15 mm to 25 mm.
42. The hypotube according to any one of claims 39-41, wherein the spacing between any two adjacent slits in the same array unit is equal; The distance between them is equal.
43. The hypotube according to claim 42, wherein the spacing between two adjacent array units is greater than the spacing between any two adjacent slits in the same array unit.
44. The hypotube according to any one of claims 39 to 43, wherein a vertical line connecting two ends of each of the slits to the central axis of the hypotube and a fan shape formed by the slits The angle of the zone is 200° to 300°.
45. The hypotube according to any one of claims 39 to 44, wherein the extending direction of the slit forms an acute angle with the axial direction of the hypotube, and the slit faces toward the distal end surface The side is inclined.
46. The hypotube according to any one of claims 39 to 44, wherein the extending direction of the slit is perpendicular to the axial direction of the hypotube, and the slit is along the axis of the hypotube. Circumferential extension.
47. The hypotube according to claim 46, wherein in the axial direction of the hypotube, the maximum opening width of both ends of the slit is greater than the opening width of the middle extending section of the slit.
48. The hypotube according to claim 47, wherein the middle part of the slit is a rectangular slot extending along the circumferential direction of the hypotube, and the two ends of the slit are connected to the rectangular slot The connected circular slot, the diameter of the circular slot is larger than the width of the rectangular slot in the axial direction of the hypotube.
49. A sheath assembly, comprising:

    A hypotube as claimed in any one of claims 39 to 48; and

    The cutting tip has a threading channel passing through opposite ends of the cutting tip, the cutting tip is connected to the side where the distal surface of the hypotube is located, and the threading channel and the tube hole communicate with each other.
50. The sheath tube assembly according to claim 49, wherein the cutting tip and the hypotube are integrally formed; or, the cutting tip and the hypotube are detachably connected.
51. 49. The sheath assembly of claim 49, wherein the cutting tip comprises a cutting portion including a first end proximate the hypotube and a second end remote from the hypotube, The threading channel runs through the first end and the second end, and in the direction from the first end to the second end, the radial dimension of the cutting portion gradually decreases; the cutting portion also It has a first outer side surface and a first inner side surface located between the first end and the second end, and the first outer side surface is provided at the second end through to the first inner side surface and along the A plurality of notched grooves are arranged in the circumferential direction of the cutting portion.
52. The sheath tube assembly according to claim 51, wherein in a direction gradually approaching from the first end to the second end, each point on the cross-sectional shape of the first outer side surface by the reference plane and the cutting tip The distance of the central axis gradually decreases, and the reference plane is a plane perpendicular to the axial direction of the cutting tip.
53. The sheath tube assembly according to claim 52, wherein in a direction gradually approaching from the first end to the second end, the first inner side surface is cut by the reference plane. The distance of the point from the central axis of the cutting tip increases gradually.
54. The sheath tube assembly according to claim 52 or 53, wherein the cutting part further comprises a plurality of mounting surfaces, and the mounting surfaces are located between the groove walls of two adjacent notched grooves, so that the The two adjacent notch grooves are spaced apart, and the mounting surface is connected between the first outer side surface and the first inner side surface.
55. The sheath tube assembly according to claim 54, characterized in that, in a direction gradually approaching from the first end to the second end, each point on the cross-sectional shape of the reference surface is connected to the mounting surface. The distance of the central axis of the cutting tip gradually increases.
56. The sheath tube assembly according to any one of claims 51-53, wherein the cutting portion further comprises a plurality of tines, and each of the tines is disposed in two adjacent notched grooves In between, the tine structure includes a first surface and a second surface arranged oppositely, and a third surface and a fourth surface arranged oppositely, the first surface is connected with the first outer side, the second surface The surface is connected with the first inner side surface, and the third surface and the fourth surface are respectively connected with the groove walls of the two adjacent notch grooves.
57. The sheath tube assembly of claim 56, wherein in a direction from the first end to the second end, the distance between the third surface and the fourth surface gradually decreases to the point where the third surface and the The fourth surfaces intersect to form cut lines that extend to the first and second surfaces.
58. 57. The sheath assembly of claim 56 or 57, wherein the tine structure is intersected with a first tangent and a second tangent by a reference plane passing through the central axis of the cutting tip plane, the first tangent line is formed in the area between the first surface and the second surface, the second tangent line is formed on the first surface, the first tangent line and the second Tangents intersect and are set at an acute angle.
59. The sheath assembly of claim 58, wherein the distance from the first tangent to the central axis of the cutting tip gradually increases in a direction from the first end to the second end.
60. The sheath tube assembly of claim 59, wherein the distance from the second tangent to the central axis of the cutting tip gradually increases in a direction from the first end to the second end.
61. The sheath assembly of any one of claims 56 to 60, wherein the third surface is coplanar with a groove wall of a notch groove connecting the third surface, and the fourth surface is coplanar with a groove wall connecting the third surface The groove walls of the notch grooves on the fourth surface are coplanar; the second surface is coplanar with the first inner side surface.
62. The sheath assembly according to any one of claims 51 to 61, wherein the cutting tip includes a connecting portion, the connecting portion is connected to the first end of the cutting portion, and the threading channel passes through the connecting portion. the connecting part and the cutting part, the connecting part is connected with the side where the distal surface of the hypotube is located; the connecting part has a second outer side and a second inner side arranged oppositely, and the second The outer side intersects the first outer side, and the second inner side intersects the first inner side.
63. 62. The sheath assembly of claim 62, wherein the second outer side is parallel to the axial direction of the cutting tip, and the second inner side includes a first side extending to the One end of the connecting portion faces away from the cutting portion, and the first side surface is parallel to the axial direction of the cutting tip.
64. The sheath assembly of claim 63, wherein the second inner side comprises a second side disposed between the first side and the first inner side, the second side The second side surface is smoothly connected with the first inner side surface, so that the second side surface and the first inner side surface are coplanar.
65. A removal device for removing an elongated structure implanted in the body, characterized in that it comprises:

    The sheath assembly of any one of claims 49 to 64; and

    a control handle, connected to the side where the proximal end surface of the hypotube is located, the control handle is used to control the rotation of the hypotube and the cutting tip to cut the obstacle wrapping the elongated structure in the body thing.

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