CN116407231A - A delivery and puncture device - Google Patents

Abstract

The present invention is applicable to the technical field of medical devices, and provides a delivery and puncture device, including a sheath assembly and a puncture assembly detachably connected to the sheath assembly, the puncture assembly is connected to the proximal end of the sheath assembly, and the sheath assembly includes a For the delivery sheath of the delivery device, the puncture component includes a puncture needle that can be movably inserted in the delivery sheath, at least part of the delivery sheath is sleeved outside the puncture needle, and the distal end of the puncture needle can be exposed from the distal end of the delivery sheath Or it is accommodated in the distal end of the delivery sheath, and the proximal end of the puncture needle passes through the proximal end of the delivery sheath. The invention can effectively prevent the puncture needle from scratching the inner wall of the delivery sheath, reduce the risk of debris generation, and improve product safety. In addition, the puncture assembly can be detached from the sheath assembly after the puncture is completed. The sheath tube assembly can be used to deliver instruments, which reduces the time to establish multiple paths during the operation, improves the operation efficiency, and reduces the risk of the patient during the operation.

Description

A delivery and puncture device

technical field

The invention belongs to the technical field of medical devices, in particular to a delivery and puncture device.

Background technique

In some medical applications, it is often necessary to send medical devices to work in the left atrium. For example, in operations such as left atrial appendage occlusion, atrial fibrillation ablation, and mitral valve replacement, the blood vessels connected to the left atrium are intervened to the left atrium. Due to the tortuous complexity of the vascular pathways, it is almost impossible to deliver the device along these vessels to the left atrium. Therefore, at present, the most commonly used method for sending medical devices into the left atrium is to push the medical devices to the right atrium through venipuncture intervention, and enter the left atrium through interatrial septal puncture.

The traditional atrial septal puncture operation needs to be completed with the cooperation of two instruments, the delivery sheath and the puncture needle. During the operation, the delivery sheath is sent to the exact position first, and then the puncture needle is delivered to the body through the delivery sheath for puncture operation. The section of the distal end of the puncture needle is inclined to form a distal pointed structure, so as to easily puncture the interatrial septum. Due to the curved shape of the distal end of the atrial septal puncture needle and the curved structure of the blood vessel, when the atrial septal puncture needle is delivered in the delivery sheath, the tip of the atrial septal puncture needle is likely to scratch the inner surface of the delivery sheath, resulting in debris. crumbs. Once the debris enters the blood vessel, it is easy to generate thrombus and bring harm to the patient.

Contents of the invention

The purpose of the present invention is to provide a delivery and puncture device, which aims to solve the problem that the tip of the atrial septal puncture needle is easy to scratch the inner surface of the delivery sheath when performing atrial septal puncture in the prior art, causing debris to enter the blood vessel, which is harmful to the patient. Harmful technical issues.

The present invention is achieved as follows: a delivery and puncture device, comprising a sheath assembly and a puncture assembly detachably connected to the sheath assembly, the puncture assembly is connected to the proximal end of the sheath assembly, the sheath The tube assembly includes a delivery sheath for the delivery instrument, the puncture assembly includes a puncture needle movably inserted in the delivery sheath, at least part of the delivery sheath is sleeved outside the puncture needle, the The distal end of the puncture needle can be exposed from or accommodated in the distal end of the delivery sheath, and the proximal end of the puncture needle passes through the proximal end of the delivery sheath.

The beneficial effects of the present invention are: the present invention detachably combines the sheath assembly and the puncture assembly, and in the initial state, the puncture needle and the delivery sheath are sent to a designated position together. When needle insertion is required, the needle slides a short distance relative to the delivery sheath. Compared with the split assembly, the puncture needle of the present invention only needs a small displacement relative to the delivery sheath during puncture, which avoids the long-distance movement of the puncture needle in the delivery sheath. Adopting this structure can effectively prevent the puncture needle from scratching the inner wall of the delivery sheath, reduce the risk of debris generation, and improve product safety. In addition, the puncture assembly can be detached from the sheath assembly after the puncture is completed. The sheath tube assembly can be used to deliver instruments, which reduces the time to establish multiple paths during the operation, improves the operation efficiency, and reduces the risk of the patient during the operation.

Description of drawings

Fig. 1 is a structural schematic diagram 1 of a delivery and puncture device according to Embodiment 1 of the present invention;

FIG. 2 is a second structural schematic diagram of the delivery and puncture device according to Embodiment 1 of the present invention;

Fig. 3 is a longitudinal sectional view of the delivery and puncture device according to Embodiment 1 of the present invention;

Fig. 4 is a longitudinal sectional view of the sheath tube assembly according to Embodiment 1 of the present invention;

Fig. 5 is a schematic structural view of the sheath tube casing according to Embodiment 1 of the present invention;

Fig. 6 is a schematic structural diagram of a slider according to Embodiment 1 of the present invention;

Fig. 7 is a schematic structural view of a mounting part according to Embodiment 1 of the present invention;

Fig. 8 is a partial enlarged view B of Fig. 4;

Fig. 9 is a longitudinal sectional view of the puncture assembly according to Embodiment 1 of the present invention;

Fig. 10 is a partial longitudinal sectional view of the puncture assembly according to Embodiment 1 of the present invention;

Fig. 11 is a schematic structural view of the needle housing according to Embodiment 1 of the present invention;

Fig. 12 is a schematic structural diagram of a sliding member according to Embodiment 1 of the present invention;

Fig. 13 is a partial enlarged view A of Fig. 3;

Fig. 14 is a schematic diagram of the assembly of the first connecting part and the sheath tube casing according to the second embodiment of the present invention;

Fig. 15 is a schematic diagram of the assembly of the second connecting part and the needle housing according to the second embodiment of the present invention;

Fig. 16 is a schematic diagram of the assembly of the delivery and puncture device according to the third embodiment of the present invention;

Fig. 17 is a schematic diagram of the assembly of the first connecting part and the sheath tube casing according to the third embodiment of the present invention;

Fig. 18 is a schematic diagram of the assembly of the second connecting part and the needle housing according to the third embodiment of the present invention;

Fig. 19 is a schematic structural view of a locking device according to Embodiment 3 of the present invention;

Fig. 20 is a longitudinal sectional view of the distal end of the delivery sheath according to Embodiment 4 of the present invention;

Fig. 21 is a schematic diagram of the assembly of the puncture needle and the delivery sheath according to Embodiment 4 of the present invention;

FIG. 22 is a partially enlarged view C of FIG. 20 .

100-delivery and piercing device,

1-sheath assembly

11-delivery sheath tube, 111-bending piece, 113-isolator, 210a-distal end, 2101-main body, 2102-supporting part, 2103-covering part, 211-first through hole, 212-outer tube channel,

12- traction parts,

13-sheath tube housing, 131-second limit hole, 133-side slot, 135-slot,

14-Fixer,

15-second adjustment piece, 151-connecting thread, 153-second clamping part, 1531-ring groove, 155-groove,

17-slider, 171-thread, 173-plane,

19-mounting piece, 191-raised part, 193-hole,

3- Piercing component

31-puncture needle, 311-needle,

32-sealed steel pipe,

33-needle housing, 331-first thread segment, 333-first limiting hole, 335-groove,

35-first adjustment member, 351-first clamping part, 3511-ring groove, 353-needle insertion part, 3531-second thread segment, 355-avoiding groove,

37-Fixer,

39-slider, 391-body part, 3911-raised part, 393-outer part, 3931-hole, 3935-hole,

5-connector,

51-first connecting part, 511-resisting piece, 513-positioning groove,

53-second connecting part, 531-fastening piece, 533-positioning boss,

55-locking device, 551-clip, 553-clip hole, 555-clip slot.

Detailed ways

In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element at the same time. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present.

It should also be noted that the orientation terms such as left, right, up, and down in this embodiment are only relative concepts or refer to the normal use state of the product, and should not be regarded as limiting.

It should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally referred to as the "proximal end", and the end that is farther from the operator is referred to as the "distal end". ", and define the "proximal end" and "distal end" of any part of the medical device according to this principle. "Axial" generally refers to the length direction of the medical device when it is being transported, and "radial" generally refers to the direction perpendicular to the "axial" of the medical device, and the "axis" of any part of the medical device is defined according to this principle to" and "radial".

As shown in FIGS. 1 and 2 , a delivery and puncture device 100 provided in Embodiment 1 of the present invention includes a sheath assembly 1 , a puncture assembly 3 and a connector 5 . The sheath assembly 1 and the puncture assembly 3 are detachably connected. The puncture assembly 3 is connected to the proximal end of the sheath assembly 1 through a connecting piece 5 . The sheath assembly 1 and the puncture assembly 3 are combined into a detachable integrated structure.

As shown in FIG. 3 , the sheath assembly 1 of this embodiment includes a delivery sheath 11 , a traction member 12 , a sheath housing 13 , a fixing member 14 , a second adjustment member 15 , a sliding block 17 and a mounting member 19 .

As shown in FIG. 4 , the delivery sheath 11 of this embodiment is used for delivery of instruments. The delivery sheath 11 is disposed in a sheath housing 13 . The delivery sheath 11 is passed through the sheath casing 13 . The delivery sheath 11 is slidable relative to the sheath housing 13 . The delivery sheath 11 runs through the slider 17 . The proximal end of the delivery sheath 11 is inserted into the distal end of the mount 19 . The delivery sheath 11 is fixedly connected with the mounting part 19 . When the mounting part 19 moves axially, the delivery sheath 11 moves together with the mounting part 19 . In this embodiment, the delivery sheath 11 has certain elasticity. Under the action of external force, the delivery sheath 11 can be bent and deformed. By adjusting the shape of the delivery sheath 11 in the human body, the distal end of the delivery sheath 11 is directed to a predetermined position.

As shown in FIG. 4 , the traction member 12 of this embodiment controls the bending deformation of the delivery sheath 11 . In this embodiment, the distal end of the traction member 12 is connected to the distal end of the delivery sheath 11 . The proximal end of the traction member 12 is fixedly connected with the slider 17 . It can be understood that the traction member 12 is made of elastic metal or non-metallic material such as nickel-titanium wire. When the slider 17 pulls the traction member 12 along the proximal direction of the delivery sheath 11 , the connection between the traction member 12 and the delivery sheath 11 moves along the proximal direction of the delivery sheath 11 . Under the action of external force, the distal end of the delivery sheath 11 connected to the traction member 12 undergoes posture adjustment and bends. As shown in FIG. 2 , the bending angle of the delivery sheath 11 is α, and the range of α is 0° to 90°. In order to pull the delivery sheath 11 better and reduce the interference caused by the external pulling member 12 to the movement of the delivery sheath 11 , part of the pulling member 12 in this embodiment is built into the delivery sheath. Specifically, the tube wall of the delivery sheath 11 is provided with holes extending in the axial direction. The traction member 12 penetrates the tube wall of the delivery sheath 11 through the proximal end of the opening at a certain inclination angle, and then passes out from the tube wall of the delivery sheath 11 through the distal end of the opening. Finally, the distal end of the traction member 12 is fixedly connected to the distal end of the delivery sheath 11 .

As shown in FIG. 4 , the sheath tube housing 13 of this embodiment is used for installing the second adjustment member 15 , the slider 17 and the installation member 19 . The sheath tube housing 13 has an accommodating cavity for installing the slider 17 and the mounting piece 19 . As shown in FIG. 5 , the sheath tube assembly 1 is provided with a second limiting hole 131 . In this embodiment, the sheath tube housing 13 is provided with a second limiting hole 131 penetrating through the upper and lower side walls of the housing 13 . Certainly, in other embodiments, the second limiting hole 131 may also only penetrate through the upper sidewall or the lower sidewall of the sheath tube housing 13 . The second limiting hole 131 extends along the axial direction. The second limiting hole 131 communicates with the accommodating chamber of the sheath tube housing 13 . The second limiting hole 131 is used to limit the stroke of the mounting member 19 . Part of the mounting part 19 can move axially in the second limiting hole 131 . The second limiting hole 131 in this embodiment is generally a square structure. Of course, in other embodiments, the second limiting hole 131 may also be oval, or other shapes that are suitable for the sliding of the mounting part 19 and facilitate guiding the mounting part 19 . The axial length of the second limiting hole 131 is D1. D1 is the movable range of the mounting part 19 . The value of D1 should be determined according to the length of the puncture needle 31 extending out of the delivery sheath 11 , so as to ensure that the delivery sheath 11 can completely cover the puncture needle 31 when pushed forward.

The side wall of the sheath tube housing 13 is provided with a side slot 133 passing through the side wall. The side slot 133 is spaced apart from the second limiting hole 131 . The side slot 133 extends in the axial direction. The side slot 133 communicates with the accommodating chamber of the sheath tube housing 13 . The side slot 133 is used to limit the stroke of the slider 17 . Part of the slider 17 can move axially in the side slot 133 . The side slot 133 of this embodiment is substantially a square structure. Certainly, in other embodiments, the side slot 133 may also be oval, or other shapes suitable for sliding of the slider 17 and conducive to guiding the slider 17 . The axial length of the side slot 133 is D2. D2 is the range of motion of the slider 17. D2 can take different values according to the maximum angle of the required bending of the delivery sheath 11 .

The sheath tube housing 13 is provided with a groove 135 along the circumferential direction. The slot 135 is used to engage with part of the fixing member 14 .

As shown in FIG. 4 , the second adjustment member 15 is disposed outside the sheath tube housing 13 . The second adjusting member 15 includes a second clamping portion 153 and a connecting thread 151 spaced apart from the second clamping portion 153 . The connecting thread 151 is disposed at the distal end of the second adjustment member 15 , and the second clamping portion 153 is disposed at the proximal end of the second adjustment member 15 . The second clamping portion 153 is used to control the moving distance of the delivery sheath 11 in the axial direction. The connecting thread 151 is used to adjust the bending degree of the distal end of the delivery sheath 11 . In this embodiment, both the second clamping portion 153 and the connecting thread 151 are disposed on the inner surface of the second adjusting member 15 , and the connecting thread 151 and the second clamping portion 153 can move axially with the second adjusting member 15 at the same time. In other embodiments, the connecting thread 151 and the second clamping portion 153 can be respectively provided in different sub-components of the second adjusting member 15, as long as the connecting thread 151 and the second clamping portion 153 can move synchronously in the axial direction. Can.

The connecting thread 151 can rotate along the circumferential direction of the sheath tube housing 13 to make the delivery sheath tube 11 bendable. In this embodiment, the connecting thread 151 cooperates with the slider 17 and the traction member 12 , and the rotation of the connecting thread 151 drives the slider 17 to slide the traction member 12 proximally to make the distal end of the delivery sheath 11 bend. Specifically, during the rotating process of the connecting thread 151, the sliding block 17 is driven to move in the axial direction. During the moving process, the slider 17 pulls or releases the traction member 12, so that the distal end of the delivery sheath 11 is pulled or released, and the delivery sheath 11 is adjusted to bend.

The second locking part 153 can move along the axial direction of the sheath tube housing 13 to make the delivery sheath tube 11 slide relative to the sheath tube housing 13 . The second clamping part 153 is connected to the delivery sheath 11 , and the second clamping part 153 slides to drive the delivery sheath 11 to slide. In this embodiment, the second clamping part 153 is connected with the delivery sheath 11 through the mounting part 19 . In this embodiment, an annular groove 1531 is formed on the inner wall of the second clamping portion 153 along the circumference, and part of the mounting member 19 is engaged with the annular groove 1531 . When the second adjustment member 15 rotates in the circumferential direction, the installation member 19 is located in the annular groove 1531 and slides relative to the annular groove 1531 , and the installation member 19 will not hinder the rotation of the second adjustment member 15 . During the movement of the second clamping portion 153 in the axial direction, it drives the installation part 19 to move in the axial direction. The delivery sheath 11 then moves together with the mounting part 19 to realize the axial sliding of the delivery sheath 11 relative to the sheath housing 13 .

As shown in FIG. 4 , the slider 17 of this embodiment is used to cooperate with the traction member 12 to adjust the bending angle of the delivery sheath 11 . The slider 17 is disposed in the accommodating cavity of the sheath tube housing 13 . The distal end of the slider 17 is fixedly connected with the proximal end of the traction member 12 . The slider 17 is connected with the delivery sheath 11 through the traction member 12 . The sliding block 17 slides in the axial direction to tighten or release the traction member 12 to drive the distal end of the delivery sheath 11 to adjust the bend. The slider 17 adjusts the bending angle of the delivery sheath 11 through the moving direction and displacement. As shown in FIG. 6 , the slider 17 of this embodiment is substantially a square structure. Slider 17 has a flat surface 173 . The slide 17 is movably installed in the sheath tube housing 13 , and the plane 173 of the slide 17 is locked in the side slot 133 . The plane 173 can ensure that the slider 17 can only move axially and not rotate when performing the bending adjustment operation. Of course, in other embodiments, the slider 17 can also have other structures, but it should have a plane 173 matching with the side slot 133 . The sliding block 17 is provided with a matching structure connected with the second adjusting member 15 . Specifically, the slider 17 is provided with threads 171 . The slider 17 is movably installed in the sheath tube housing 13 , and the thread 171 passes through the side slot 133 . The thread 171 of the slider 17 and the thread of the connecting thread 151 are threads that cooperate with each other. At least part of the sliding block 17 is threadedly connected with the connecting thread 151 through the sheath tube housing 13 . The rotation of the connecting thread 151 drives the sliding block 17 to slide axially. The slider 17 slides toward the proximal end of the delivery sheath 11 , and during the sliding process of the slider 17 , the traction member 12 is tightened, and the distal end of the delivery sheath 11 bends.

As shown in FIG. 4 , the mounting part 19 of this embodiment is disposed in the accommodating chamber of the sheath tube housing 13 . The distal end of the mounting member 19 is fixedly connected to the proximal end of the delivery sheath 11 . The mounting part 19 can drive the delivery sheath 11 to move axially. As shown in FIG. 7 , the mounting part 19 of this embodiment is generally a square structure. A protruding portion 191 protruding radially outward is disposed on the outer wall of the mounting member 19 . In this embodiment, the protruding portion 191 is integrally formed with the body of the mounting part 19 . The installation part 19 is movably installed in the sheath tube housing 13 . After passing through the second limiting hole 131 , part of the protruding portion 191 is connected with the second locking portion 153 of the second adjusting member 15 . It can be understood that part of the protruding portion 191 is directly opposite to the second limiting hole 131 . That is, part of the protruding portion 191 is opposite to the hole wall of the second limiting hole 131 . The mounting member 19 is engaged in the annular groove 1531 of the second locking portion 153 through the protruding portion 191 , and can rotate relative to the second locking portion 153 .

In this embodiment, there are two protrusions 191 , which respectively pass through the upper and lower second limiting holes 131 of the sheath tube housing 13 . The two protrusions 191 are distributed symmetrically with respect to the axial direction of the sheath tube housing 13 , so that the force on the protrusions 191 as a whole is uniform, and the protrusions 191 can slide smoothly relative to the sheath tube housing 13 in the axial direction. In other embodiments, the number of the protrusions 191 is not limited, as long as the second regulator 15 can control the sliding of the delivery sheath 11 through the protrusions 191 . In other embodiments, the outer wall of the mounting member 19 is provided with a radially inwardly recessed groove, and the second clamping portion 153 includes a protrusion inserted into the groove.

In this embodiment, the mounting part 19 is connected to the second adjusting part 15 through the cooperation of the protrusion 191 and the annular groove 1531 . The installation part 19 is consistent with the movement of the second adjusting part 15 in the axial direction. When the second adjusting part 15 rotates, the ring groove 1531 rotates relative to the mounting part 19 , and the mounting part 19 remains stationary relative to the sheath tube housing 13 . When the second adjusting part 15 slides in the axial direction, the second clamping part 153 drives the mounting part 19 to slide in the axial direction of the sheath tube housing 13 , and eventually drives the delivery sheath 11 to move in the axial direction. The mounting part 19 is provided with a hole 193 along the axial direction. Holes 193 are used for part of piercing assembly 3 to penetrate.

The sheath assembly 1 of this embodiment can not only realize the bending adjustment of the delivery sheath 11, but also move the delivery sheath 11 in the axial direction. During the bending adjustment process of the delivery sheath 11, because the second adjustment member 15 of this embodiment includes the second clamping portion 153, the second adjustment member 15 can only rotate in the circumferential direction of the sheath tube housing 13, but not in the axial direction. Displacement occurs. In order to prevent the second clamping part 153 from being displaced to the proximal end due to the reaction force generated when the traction member 12 is pulled, or the second clamping part 153 is displaced to the proximal end due to human misoperation, as shown in Figure 4, this embodiment The example fixing member 14 can fix the second clamping portion 153 on the sheath tube housing 13 during the bending adjustment process. The fixing part 14 is disposed on the sheath tube housing 13 . The fixing part 14 can have various structures, and the fixing part 14 in this embodiment is a snap ring. Part of the fixture 14 fits in the groove 135 of the sheath housing 13 . As shown in FIG. 8 , a slot 155 is also provided on the corresponding second adjusting member 15 . A part of the fixing part 14 is stuck in the groove 135 of the sheath tube housing 13 , and the other part is stuck in the groove 155 of the second adjustment part 15 . In the initial state, the fixing part 14 acts as a positioning part, which can effectively prevent the displacement of the sheath tube housing 13 and the second regulating part 15 due to the influence of gravity or accidental contact. When an external force is used to axially push the second adjusting member 15 , the fixing member 14 will slide out of the groove 135 and stay in the groove 155 , and move synchronously with the second adjusting member 15 . That is, when a large force is applied to the second adjusting member 15, the fixing member 14 loses its positioning function, and the second adjusting member 15 can slide freely in the axial direction.

When the sheath tube assembly 1 adjusts the delivery sheath tube 11, the second adjustment member 15 is rotated. The thread of the connecting thread 151 cooperates with the thread 171 of the slider 17 , and the connecting thread 151 drives the slider 17 to slide along the side slot 133 of the sheath tube housing 13 . The sliding range of the slider 17 is D2. When the slider 17 slides toward the proximal end of the sheath tube housing 13 , the slider 17 tightens the traction member 12 , and the distal end of the delivery sheath tube 11 is bent. The slider 17 continues to slide proximally, and the bending angle α of the delivery sheath 11 gradually increases. When the slide block 17 slides toward the distal end of the sheath tube housing 13, the slide block 17 releases the traction member 12, and the bent distal end of the delivery sheath tube 11 is gradually reset. The slider 17 continues to slide toward the distal end, and the bending angle α of the delivery sheath 11 gradually becomes smaller.

When the sheath assembly 1 adjusts the delivery length of the delivery sheath 11 , the second adjusting member 15 is moved axially. The annular groove 1531 of the second clamping part 153 cooperates with the protrusion 191 , and the second clamping part 153 drives the mounting part 19 to move along the second limiting hole 131 of the sheath tube housing 13 . The second limiting hole 131 limits the axial stroke of the second regulating member 15 . The moving range of the mounting part 19 is D1. When the second adjusting part 15 moves toward the distal end of the sheath tube housing 13 , the mounting part 19 drives the delivery sheath 11 to move toward the distal end, and the delivery sheath 11 is delivered to the distal end. When the second adjusting member 15 moves toward the proximal end of the sheath tube housing 13 , the mounting member 19 drives the delivery sheath 11 to move toward the proximal end, and the delivery sheath 11 is retracted toward the proximal end.

As shown in FIG. 9 , the puncture assembly 3 of this embodiment includes a puncture needle 31 , a sealed steel pipe 32 , a needle housing 33 , a first adjustment member 35 , a fixing member 37 and a sliding member 39 .

As shown in FIGS. 3 and 9 , the puncture needle 31 of this embodiment can be movably inserted in the delivery sheath 11 . At least part of the delivery sheath 11 is sheathed outside the puncture needle 31 . In this embodiment, the extension direction of the puncture needle 31 in the delivery sheath 11 is the same as the extension direction of the delivery sheath 11 . The distal end of the puncture needle 31 is adjacent to the distal end of the delivery sheath 11 . The proximal end of the puncture needle 31 passes through the proximal end of the delivery sheath 11 . The distal end of the puncture needle 31 in this embodiment can be exposed from the distal end of the delivery sheath 11 or accommodated in the distal end of the delivery sheath 11 . Specifically, the puncture needle 31 moves into the inside of the human body together with the delivery sheath 11 . When the puncture needle 31 is in the initial state, the puncture needle 31 is stationary relative to the delivery sheath 11 , and the distal end of the puncture needle 31 is accommodated in the distal end of the delivery sheath 11 . When the puncture needle 31 is in the needle insertion state, the puncture needle 31 can slide relative to the delivery sheath 11 . The distal end of the slid puncture needle 31 is exposed from the distal end of the delivery sheath 11 , and the puncture needle 31 punctures the affected part.

The puncture needle 31 is movably mounted on the needle casing 33 . The proximal end of the puncture needle 31 is inserted into the slider 39 . The puncture needle 31 is fixedly connected with the slider 39 . When the slider 39 moves axially, the puncture needle 31 moves together with the slider 39 .

As shown in accompanying drawings 3 and 9 , the sealed steel pipe 32 of this embodiment is set outside part of the puncture needle 31 . The proximal end of the sealed steel pipe 32 is fixedly connected with the proximal end of the puncture needle 31 . Specifically, the proximal end of the sealed steel pipe 32 is inserted into the sliding member 39 . There is a gap between the inner wall of the sealed steel pipe 32 and the outer wall of the puncture needle 31, and the gap communicates with the hole 3931 (see FIG. 12 ) of a part of the sliding part 39, which is used for the injection of physiological saline or the exhaust of the instrument during the operation. The distal end of the sealed steel tube 32 is inserted into the hole 193 (see FIG. 7 ) of the mounting part 19 of the sheath tube assembly 1 and can be pulled out from the hole 193 . There is clearance fit between the outer wall of the sealed steel pipe 32 and the inner wall of the hole 193 .

As shown in FIGS. 3 and 9 , the needle insertion housing 33 of this embodiment is used to carry the first adjusting member 35 and accommodate the sliding member 39 . The needle insertion housing 33 has an accommodating chamber for installing a sliding member 39 . As shown in FIG. 11 , the needle insertion housing 33 is provided with a first limiting hole 333 . In this embodiment, the needle insertion housing 33 is provided with a first limiting hole 333 passing through the upper and lower walls of the housing 33 , that is to say, the number of the first limiting holes 333 is two. Certainly, in other embodiments, the first limiting hole 333 may also only pass through the upper or lower housing wall of the needle housing 33 , that is to say, the number of the first limiting hole 333 is one. The first limiting hole 333 extends along the axial direction. The first limiting hole 333 communicates with the receiving cavity of the needle insertion housing 33 . The first limiting hole 333 is used to limit the stroke of the sliding member 39 . Part of the sliding member 39 can move axially in the first limiting hole 333 . The first limiting hole 333 in this embodiment is substantially a square structure. Certainly, in other embodiments, the first limiting hole 333 may also be elliptical, or other shapes suitable for the sliding of the sliding member 39 and conducive to guiding the sliding member 39 . The axial length of the first limiting hole 333 is D5. D5 is the range of motion of the sliding member 39, which can be taken as an appropriate value according to the distance to be advanced by the puncture needle 31. A first thread segment 331 is provided on the circumference of the needle casing 33 . The first thread segment 331 is disposed between the first limiting hole 333 and the distal end of the needle housing 33 . The first threaded segment 331 of the needle insertion housing 33 is used to cooperate with the first adjustment member 35 . The needle housing 33 is provided with a groove 335 along the circumferential direction. The slot 335 is used to engage with part of the fixing piece 37 .

As shown in FIG. 9 , the first regulating member 35 of this embodiment is connected to the needle housing 33 . The first regulating member 35 is sleeved outside the needle casing 33 . The first adjusting member 35 can move along the axial direction parallel to the needle housing 33 to make the puncture needle 31 slide relative to the delivery sheath 11 . The first regulating member 35 is connected with the puncture needle 31 for controlling the sliding of the puncture needle 31 . Specifically, the first adjusting member 35 includes a first clamping portion 351 and a needle insertion portion 353 spaced apart from the first clamping portion 351 . The first locking portion 351 is farther away from the distal end of the first regulating member 35 than the needle insertion portion 353 . The first clamping portion 351 slides along the axial direction parallel to the needle housing 33 to drive the puncture needle 31 to slide. When the thread 331 is screwed together with the needle insertion portion 353 and the first adjustment member 35 rotates along the circumference of the needle insertion housing 33 , the first adjustment member 35 can also drive the puncture needle 31 to slide axially. In this embodiment, the first clamping portion 351 and the needle insertion portion 353 are both provided on the inner surface of the first adjustment member 35 , and the first clamping portion 351 and the needle insertion portion 353 can simultaneously follow the axial direction of the first adjustment member 35 . move. In other embodiments, the first clamping portion 351 and the needle insertion portion 353 can be respectively provided in different subcomponents of the first adjusting member 35, as long as the first clamping portion 351 and the needle insertion portion 353 can be synchronized in the axial direction. Just move.

The first clamping portion 351 is movable along the axial direction of the needle-introducing housing 33 for axially sliding the puncture needle 31 relative to the needle-introducing housing 33 . The first clamping portion 351 is connected to the puncture needle 31 , and the sliding of the first clamping portion 351 drives the puncture needle 31 to slide. In this embodiment, the first clamping portion 351 is connected with the puncture needle 31 through the sliding member 39 . The connection between the first clamping portion 351 and the sliding member 39 can be in various ways. In this embodiment, the inner wall of the first clamping portion 351 is provided with an annular groove 3511 along the circumference, and part of the sliding member 39 is engaged with the annular groove 3511 . When the first clamping portion 351 moves in the axial direction, it drives the sliding member 39 to move in the axial direction. The puncture needle 31 then moves together with the sliding member 39 , so that the puncture needle 31 slides relative to the needle insertion housing 33 .

The needle-introducing part 353 can rotate along the circumferential direction of the needle-introducing housing 33 for axially sliding the puncture needle 31 relative to the needle-introducing housing 33 . In this embodiment, the needle insertion housing 33 is screwed to the needle insertion portion 353 . Specifically, the needle insertion part 353 is provided with a second thread segment 3531 matching the first thread segment 331 of the needle insertion housing 33 . The axial length of the second thread segment 3531 is D4, which can be an appropriate value according to the distance to be advanced by the puncture needle 31 . By turning the needle insertion part 353 , the needle insertion part 353 can move along the axial direction of the needle insertion housing 33 . Since the puncture needle 31 is fixed on the first adjustment member 35 through the sliding block 39 , the needle insertion portion 353 is connected with the puncture needle 31 . The rotation of the needle insertion part 353 drives the puncture needle 31 to slide axially.

As shown in FIG. 10 , a section of evacuation groove 355 for evacuation is provided inside the first adjusting member 35 . The first threaded section 331 of the needle casing 33 is located in the avoidance groove 355 . When the distance D3 between the first thread segment 331 and the second thread segment 3531 is the largest, the needle head 311 of the puncture needle 31 is completely retracted in the head end of the delivery sheath 11 . After pushing the first adjusting member 35 axially for a distance of D3, the first threaded segment 331 engages with the second threaded segment 3531 . Rotating the first adjusting member 35 can continue to push the first adjusting member 35 to travel a distance of D4, and D3+D4 is the total stroke that the first adjusting member 35 can move forward. Because the first adjusting member 35 drives the puncture needle 31 to move, D3+D4 is the total stroke that the puncture needle 31 can move forward. In order to avoid interference between the needle housing 33 and the slider 39 during the movement of the first adjusting member 35, the difference between the axial length D5 of the first limiting hole 333 and the axial length of the protrusion 391 on the sliding part 39 It should be greater than or equal to the sum of D3 and D4.

As shown in Figure 10, in order to prevent the first clamping part 351 from being displaced in the axial direction due to human misoperation, the fixing member 37 of this embodiment is used to fix the first clamping part 351 under the condition of a small external force. On the needle housing 33. The fixing part 37 is arranged on the needle casing 33 . The design and function of the fixing part 37 of the puncture assembly 3 and the fixing part 14 of the sheath tube assembly 1 are consistent. The fixing part 37 in this embodiment is a snap ring. One part of the fixing part 37 is stuck in the needle housing 33 , and the other part is stuck in the first adjusting part 35 . In the initial state, the fixing part 37 is used as a positioning part, and the fixing part 37 plays a positioning role for the first adjustment part 35, which can effectively prevent the displacement of the needle housing 33 and the first adjustment part 35 due to the influence of gravity or accidental contact. . When an external force is used to axially push the first adjustment member 35 , the fixing member 37 will slide out of the needle housing 33 and move synchronously with the first adjustment member 35 . That is, when a large force is applied to the first adjusting member 35, the fixing member 37 loses its positioning function, and the first adjusting member 35 can slide freely in the axial direction.

As shown in FIGS. 9 and 12 , the sliding member 39 of this embodiment includes a main body portion 391 and a circumscribed portion 393 . The main body portion 391 of the sliding member 39 is disposed in the receiving cavity of the needle insertion housing 33 for connecting with the first regulating member 35 . The main body portion 391 of the slider 39 is substantially square in shape. The outer wall of the main body portion 391 of the slider 39 is provided with a protruding portion 3911 protruding radially outward. In this embodiment, the protruding portion 3911 is integrally formed with the main body portion 391 . The slider 39 is movably installed in the needle casing 33 . Part of the protruding portion 3911 passes through the first limiting hole 333 and connects with the first locking portion 351 of the first adjusting member 35 . It can be understood that part of the protruding portion 3911 is directly opposite to the first limiting hole 333 . That is, part of the protruding portion 3911 is opposite to the hole wall of the first limiting hole 333 . The sliding member 39 is locked in the annular groove 3511 of the first locking portion 351 through the protruding portion 3911 , and can rotate around the axial direction relative to the groove 3511 . In this embodiment, there are two protrusions 3911 , which respectively pass through the two first limiting holes 333 of the needle insertion housing 33 . The two protrusions 3911 are distributed symmetrically with respect to the axial direction of the needle insertion housing 33 , so that the overall force on the protrusions 3911 is uniform, and the protrusions 3911 can slide smoothly relative to the needle insertion housing 33 in the axial direction. In other embodiments, the number of the protrusions 3911 is not limited, as long as the first adjustment member 35 can control the sliding of the needle insertion housing 33 through the protrusions 3911 . In other embodiments, a radially inwardly recessed groove is provided on the outer wall of the sliding member 39 , and the first clamping portion 351 includes a protrusion inserted into the groove.

In this embodiment, the sliding member 39 is connected to the first adjusting member 35 through the cooperation of the protrusion 3911 and the annular groove 3511 . The sliding member 39 is consistent with the movement of the first adjusting member 35 in the axial direction. When the first adjusting member 35 rotates, the ring groove 3511 rotates relative to the sliding member 39, and the rotating and axially moving first adjusting member 35 drives the sliding member 39 to slide along the axial direction of the needle housing 33, that is, the rotating first adjusting member 35 An adjusting member 35 drives the puncture needle 31 to move axially.

The circumscribed portion 393 of the slider 39 is disposed outside the needle housing 33 . The circumscribed portion 393 of the slider 39 includes a hole 3933 arranged in the axial direction and a hole 3931 arranged in the radial direction. The external part 393 of the slider 39 is used to connect with external instruments for operations such as exhausting, drawing blood, creating contrast medium, and the like. The hole 3931 communicates with the inner diameter of the sealed steel pipe 32 . The hole 3933 communicates with the inner diameter of the puncture needle 31 . The slider 39 is used to fix the puncture needle 31 . Specifically, the circumscribed portion 393 of the slider 39 is fixedly connected with the proximal end of the puncture needle 31 . The sliding member 39 can drive the puncture needle 31 to move in the axial direction.

The puncture needle 31 is connected with the first adjusting member 35 through a sliding member 39 . The puncture needle 31 is driven to advance twice through the way that the first adjusting member 35 first slides axially and then rotates. The first step of needle insertion is to move the first regulating member 35 in the axial direction. The annular groove 3511 of the first clamping portion 351 cooperates with the protrusion 391 , and the first clamping portion 351 drives the slider 39 to move along the first limiting hole 333 of the needle insertion housing 33 . The first limiting hole 333 limits the axial stroke of the first regulating member 35 . Specifically, the first adjusting member 35 moves toward the distal end of the needle insertion housing 33 , and the sliding member 39 drives the puncture needle 31 to move toward the distal end, pushing the puncture needle 31 to travel a distance D3 . The second needle insertion step is to rotate the needle insertion part 353 in the circumferential direction, the second threaded section 3531 of the needle insertion part 353 cooperates with the first threaded section 331 of the needle insertion housing 33, and the first adjusting part 35 drives the sliding part 39 slides along the needle housing 33. Specifically, by rotating the first adjusting member 35 , the puncture needle 31 can be continuously pushed to travel a distance of D4, and D3+D4 is the total stroke that the puncture needle 31 can move forward. The puncture assembly 3 first adopts a sliding method to adjust the delivery length of the puncture needle 31, and then uses a rotating fine-tuning method so that the puncture needle 31 can extend forward, withdraw backward, extend forward again, and withdraw backward again. Etc., to puncture human tissue, not only can avoid the too long advance of the axial direction to puncture the tissue that does not need to be punctured, but also can gradually expand the puncture aperture to improve the puncture efficiency.

The delivery and puncture device 100 of this embodiment can be independently disassembled into a sheath tube assembly 1 and a puncture needle assembly 3 . Specifically, the needle casing 33 is detachably connected to the sheath casing 11 . The connecting piece 5 is connected to the needle casing 33 and the sheath casing 11 . Specifically, as shown in FIG. 13 , the connecting member 5 includes two first connecting parts 51 and second connecting parts 53 that match each other. The first connecting portion 51 is disposed on the sheath tube housing 13 , and the second connecting portion 53 is disposed on the needle housing 33 . Specifically, the first connecting portion 51 is connected to the proximal end of the sheath housing 13 , and the second connecting portion 53 is connected to the distal end of the needle housing 33 . The first connecting portion 51 and the second connecting portion 53 may have various structures suitable for detachment, for example, the first connecting portion 51 and the second connecting portion 53 are threaded sections that match each other or clips that match each other.

In this embodiment, the first connecting portion 51 and the second connecting portion 53 are thread segments that match each other. Specifically, the first connecting portion 51 is fitted and fixed on the proximal end of the sheath tube housing 13 . The first connecting portion 51 is engaged with the sheath tube housing 13 . The inner cavity of the first connecting portion 51 is provided with internal threads. The second connecting portion 53 is provided with an external thread matched with the first connecting portion 51 along the circumferential direction. The second connecting portion 53 is disposed at the distal end of the needle housing 33 . In this embodiment, the second connecting portion 53 is integrally formed with the needle housing 33 . When the sheath tube assembly 1 and the puncture assembly 3 need to be combined, the second connecting part 53 is screwed into the lumen of the first connecting part 51 until the sheath tube housing 13 and the needle housing 33 are completely fitted. The second connecting portion 53 is engaged with the thread of the first connecting portion 51 , and the needle casing 33 is threadedly connected with the sheath casing 13 . When the delivery and puncture device 100 needs to be disassembled, the second connection part 53 and the first connection part 51 are unscrewed, and the sheath tube assembly 1 and the puncture assembly 3 are separated.

As shown in Figures 14 and 15, it is the delivery and puncture device 100 provided by Embodiment 2 of the present invention. The structure of the second embodiment is similar to that of the first embodiment, the main difference lies in the specific structures of the first connection part 51 and the second connection part 53 . The first connecting portion 51 and the second connecting portion 53 in this embodiment are snap-fit pieces that match each other.

As shown in FIG. 14 , the first connecting portion 51 is disposed at the proximal end of the sheath tube housing 13 . The first connecting portion 51 is a hollow structure. At least one resisting piece 511 is disposed on an end surface of the first connecting portion 51 . The resisting member 511 is recessed inward along the axial direction. The resisting member 511 is in the shape of a groove as a whole. Specifically, four resisting pieces 511 are evenly distributed around the center of the first connecting portion 51 in this embodiment. In order to quickly dock with the second connecting part 53 , the end surface of the first connecting part 51 is further provided with a positioning groove 513 . In this embodiment, the first connecting portion 51 is integrally formed with the sheath tube housing 13 .

As shown in FIG. 15 , the second connecting portion 53 is disposed at the distal end of the needle housing 33 . The end surface of the second connecting portion 53 is provided with a fastening part 531 matching the abutting part 511 , and the length of the fastening part 531 along the circumferential direction is smaller than that of the abutting part 511 along the circumferential direction, which facilitates quick disassembly of both. The fastening part 531 protrudes outward along the axial direction. The buckle 531 is hook-shaped as a whole. A positioning boss 533 matching the positioning groove 513 is disposed on an end surface of the second connecting portion 53 to prevent relative rotation between the second connecting portion 53 and the first connecting portion 51 . In this embodiment, the second connecting part 53 is integrally formed with the needle housing 33; the axial height of the fastening part 531 is greater than the axial height of the positioning boss 533, which is convenient to reduce the axial length of the entire system, and the system fits more compactly .

When the sheath tube assembly 1 and the puncture assembly 3 need to be combined into one body, the second connecting part 53 is inserted into the first connecting part 51 . Specifically, the fastening part 531 is first inserted into the resisting part 511, and the fastening part 531 and the resisting part 511 cooperate with each other, so that the needle housing 33 and the sheath tube housing 13 are snapped together; The positioning groove 513 cooperates so that the axes of the sheath tube assembly 1 and the puncture assembly 3 coincide to ensure that the second connecting part 53 cannot rotate relative to the first connecting part. Understandably, in other embodiments, the engaging member 531 may be a groove, and the resisting member 511 may be in the shape of a boss. When the delivery and puncture device 100 needs to be disassembled, the second connection part 53 and the first connection part 51 are separated, and the sheath tube assembly 1 and the puncture assembly 3 are separated.

As shown in FIG. 16 , it is a delivery and puncture device 100 provided by Embodiment 3 of the present invention. The structure of the third embodiment is similar to that of the first embodiment, and the main difference lies in the specific structure of the connector 5 . The connecting piece 5 of this embodiment includes not only the first connecting portion 51 and the second connecting portion 53 , but also a locking device 55 .

As shown in FIG. 17 , the first connecting portion 51 is disposed at the proximal end of the sheath tube housing 13 . The first connecting portion 51 is a hollow structure. A positioning groove 513 is disposed on an end surface of the first connecting portion 51 . In this embodiment, the first connecting portion 51 is integrally formed with the sheath tube housing 13 .

As shown in FIG. 18 , the second connecting portion 53 is disposed at the distal end of the needle housing 33 . A positioning boss 533 matching the positioning groove 513 is disposed on an end surface of the second connecting portion 53 . In this embodiment, the second connecting portion 53 is integrally formed with the needle housing 33 .

As shown in FIG. 19 , the locking device 55 is generally an openable and closable annular structure. The opening and closing part of the locking device 55 is provided with a buckle 551 and a buckle hole 553 that match each other. The buckle 551 is inserted into the buckle hole 553 , and the buckle 551 cooperates with the buckle hole 553 to close the locking device 55 . The inner wall of the locking device 55 is provided with a locking groove 555 along the circumferential direction. The assembled width of the second connecting portion 53 and the first connecting portion 51 is consistent with the width of the locking groove 555 .

When the sheath tube assembly 1 and the puncture assembly 3 need to be combined into one body, the second connecting part 53 is inserted into the first connecting part 51 . Specifically, the positioning boss 533 cooperates with the positioning groove 513, so that the axes of the sheath tube assembly 1 and the puncture assembly 3 coincide to ensure the accuracy of positioning. Open the locking device 55 and fit it on the joint of the second connecting part 53 and the first connecting part 51 . Specifically, the clip slot 555 wraps around the second connecting portion 53 and the first connecting portion 51 . The locking device 55 is buckled, and the locking groove 555 fastens and fixes the second connecting portion 53 and the first connecting portion 51 . When the delivery and puncture device 100 needs to be disassembled, the locking device 55 is removed, the second connection part 53 and the first connection part 51 are separated, and the sheath tube assembly 1 and the puncture assembly 3 are separated.

As shown in Figures 20 and 21, it is the delivery and puncturing device 100 provided by Embodiment 4 of the present invention. The structure of the fourth embodiment is similar to that of the first embodiment, the main difference lies in the structure of the delivery sheath 11 .

As shown in FIGS. 21 and 22 , the delivery sheath 11 also includes a bend adjustment piece 111 . The bend adjuster 111 is disposed within the distal end 210a of the delivery sheath 11 . The bending parts are elastic. The bending part is a hollow tubular structure. The traction member 12 is connected between the slider (not shown) and the bending member 111 . When the slider drives the bending member 111 and the traction member 12 to slide towards the proximal end of the delivery sheath 11, the bending member 111 bends toward the proximal end of the delivery sheath 11, so that the distal end of the delivery sheath 11, the puncture needle 31 The distal end of the delivery sheath is bent towards the proximal end of the delivery sheath 11.

In this embodiment, the distal end 210a of the delivery sheath 11 includes a main body portion 2101 and a support portion 2102 connected to the main body portion 2101 . The support portion 2102 protrudes from the main body portion 2101 along the proximal end facing away from the delivery sheath 11 . The bend adjusting member 111 is sleeved on the outer surface of the supporting portion 2102 . The radially inward projection of the bending member 111 falls on the radially inward projection of the support portion 2102 .

The delivery sheath 11 is provided with a first through hole 211 . The first through hole 211 runs through the proximal end (not shown) of the delivery sheath 11 and the distal end 210 a of the delivery sheath 11 . That is, the first through hole 211 passes through the main body portion 2101 and the support portion 2102 . The first through hole 211 is used for receiving the puncture needle 31 .

The delivery sheath 11 is also provided with an outer tube channel 212 , and the outer tube channel 212 is spaced apart from the first through hole 211 . The outer tube channel 212 runs through the main body portion 2101 . The outer tube channel 212 is disposed in the delivery sheath 11 , and the extension direction of the outer tube channel 212 is the same as that of the first through hole 211 . The distal end of the traction member 12 extends to the bend adjustment member 111 along the outer tube channel 212 through the side wall of the delivery sheath 11 , and is fixedly connected to the bend adjustment member 111 . In other embodiments, the bending member 111 can be omitted. At this time, the pulling member 12 is directly fixed on the distal end 210 a of the delivery sheath 11 , and the pulling member 12 pulls the distal end 210 a of the delivery sheath 11 to bend. In other embodiments, the traction member 12 is directly fixed on the distal end 210 a of the delivery sheath 11 , and is not connected with the bending adjustment member 111 . The traction member 12 pulls the distal end 210 a of the delivery sheath 11 to bend under the action of an external force, and the bending adjustment member 111 bends together with the delivery sheath 11 . After the external force is removed, the bending adjustment member 111 returns to its original shape, and at the same time, the elastic force of the bending adjustment member 111 restores the original shape to restore the delivery sheath 11 to its original shape.

In this embodiment, the delivery sheath 11 further includes a spacer 113 , and the spacer 113 is a hollow tubular structure. The spacer 113 is disposed on the outer wall of the bend adjustment member 111 . The spacer 113 may be formed of a polymer material. Part of the traction member 12 is accommodated in the spacer 113 . The distal end of the traction member 12 passes through the inner cavity of the spacer 113 and is fixedly connected with the support portion 2102 .

In this embodiment, the distal end 210a of the delivery sheath 11 further includes a covering portion 2103 . The covering part 2103 covers the spacer 113 , and the covering part 2103 covers the part of the supporting part 2102 exposed from the main part 2101 . The proximal end of the covering part 2103 is flush with the distal end of the main body part 2101, so as to avoid the formation of a height difference between the covering part 2103 and the main part 2101 and affect the withdrawal of the delivery sheath 11 from the human body.

The covering portion 2103 also covers the outer wall of the bend adjusting member 111 , so that the bend adjusting member 111 is firmly accommodated in the delivery sheath 11 and prevents the bend adjuster 111 from falling out of the delivery sheath 11 .

In this embodiment, the spacer 113 separates the tractor 12 from the covering part 2103, and the part of the traction part 12 in the inner cavity of the spacer 113 can move relative to the spacer 113, thereby preventing the traction part 12 from being covered by the covering part 2103. Part of the covering part 2103 is resisted and limited so that it cannot slide relative to the spacer 113 , so that the support part 2102 cannot bend.

In this embodiment, the covering part 2103 is made of the same material as that of the main body part 2101 , which is a polymer material. The covering part 2103 can be fused with the main body part 2101 in a molten state. In other embodiments, the material of the covering part 2103 may be different from that of the main body part 2101 .

In this embodiment, the covering part 2103 has a melting point lower than that of the spacer 113 . When the covering part 2103 is fused with the main body part 2102 in the molten state, the spacer 113 will not be melted, thereby preventing the molten covering part 2103 from completely affixing the drawing part 12 and the spacer 113 in the spacer 113 into one body. Preferably, in this embodiment, the proximal end of the spacer 113 is farther away from the distal end of the delivery sheath 11 than the proximal end of the bending member 111, so as to prevent the covering part 2103 from covering the proximal end port of the spacer 113 and prevent melting more effectively. The covering part 2103 of the isolating member 113 completely affixes the traction member 12 and the isolating member 113 as a whole.

In this embodiment, the distal end of the pulling member 12 passes through the distal end of the isolation member 113 and is covered and fixed by the covering portion 2013 . When the traction member 12 is pulled, the traction member 12 can slide towards the proximal end of the delivery sheath 11 in the spacer 113, and the distal end of the traction member 12 pulls the covering part 2103, so that the bending adjustment part 111 and the support part 2102 face toward the handle assembly. The proximal end is curved. In other embodiments, the distal end of the pulling member 12 is fixedly connected to the bending member 111 after passing through the spacer 113 . When the traction member 12 is pulled, the distal end of the traction member 12 pulls the bend adjustment member 111 , so that the bend adjustment member 111 and the support portion 2102 bend toward the proximal end of the delivery sheath 11 . In the operation process of puncturing with a traditional puncture piece, the doctor generally holds the joint of the puncture piece with his hand, and applies a pushing force to the joint of the puncture piece, so that the needle point of the puncture piece penetrates the interatrial septum. Due to the structural differences of the heart and the in vivo operation invisible to the naked eye, when the atrial septal puncture needle passes through the atrial septum and enters the left atrium, due to inertia, the doctor's hand continues to push the joint of the puncture piece, so that the needle tip of the puncture piece continues to advance, resulting in a stroke is too big. It is easy to puncture the wall of the left atrium, cause cardiac tamponade, or easily puncture the aorta and cause serious complications and other situations that endanger the patient. Moreover, the pushing force applied by the doctor to the joint of the puncture member is uneven, which affects the sliding of the puncture member in the sheath tube.

In order to solve the above hidden dangers, this embodiment optimizes the operation process based on the delivery and puncture device 100 . As shown in FIG. 3 , the second adjusting member 15 and the first adjusting member 35 are spaced apart in this embodiment. The second adjustment member 15 is connected with the delivery sheath 11 , and the second adjustment member 15 controls the delivery sheath 11 to slide relative to the puncture needle 31 . The movable axial stroke of the delivery sheath 11 is the same as the movable axial stroke of the second adjusting member 15 . The first regulating member 35 is connected with the puncture needle 31 , and the first regulating member 35 controls the sliding of the puncture needle 31 . The movable axial stroke of the puncture needle 31 is the same as the movable axial stroke of the first adjusting member 35 . The movable axial stroke of the delivery sheath 11 is greater than or equal to the movable axial stroke of the puncture needle 31 , so that the delivery sheath 11 can cover the puncture needle 31 again after the puncture needle 31 extends out of the delivery sheath 11 .

The brief operation process of the present embodiment is:

Firstly, after the delivery sheath 11 of the delivery and puncture device 100 is delivered to the right atrium through the guide wire, the second adjustment member 15 on the sheath assembly 1 is rotated. After receiving the external force, the second adjusting member 15 transmits the force to the sliding block 17 to make the sliding block 17 slide axially. In this embodiment, the slider 17 moves along the proximal direction of the sheath assembly 1 . The slider 17 pulls the traction member 12 to bend the distal end of the delivery sheath 11 to a desired angle and find the position of the interatrial septum. At this time, the puncture needle 31 is in a state of not being pushed out.

Next, push the first adjustment member 35 on the piercing assembly 3 . After receiving the force from the outside, the first adjusting member 35 transmits the force to the sliding member 39 to make the sliding member 39 slide axially. The sliding member 39 is connected with the puncture needle 31 , and the sliding member 39 drives the puncture needle 31 to slide relative to the sheath tube assembly 1 . In this embodiment, the first regulating member 35 is pushed toward the distal end of the puncture assembly 3 , and the puncture needle 31 passes through the delivery sheath 11 and abuts against the atrial septal tissue.

Then, turn the first regulating member 35 on the piercing assembly 3 . The first regulating member 35 moves along the axis of the sheath tube housing 13 after receiving an external force. The first regulating member 35 drives the sliding member 39 to move synchronously. In this embodiment, the first regulating member 35 moves toward the direction close to the distal end of the puncture assembly 3, so that the puncture needle 31 punctures the interatrial septum and enters the left atrium. Of course, according to the actual situation, if the atrial septum is thicker, the first adjustment member 35 can be rotated multiple times to move the puncture needle 31 forward and retreat the puncture needle 31, so as to improve the safety and efficiency of puncture.

Afterwards, push the second adjustment member 15 of the sheath tube assembly 1 . After receiving the force from the outside, the second adjusting part 15 transmits the force to the mounting part 19 to make the mounting part 19 slide axially. The installation part 19 is connected with the delivery sheath 11 , and the installation part 19 drives the delivery sheath 11 to slide. In this embodiment, the second adjustment member 15 is pushed toward the direction close to the distal end of the sheath assembly 1 , so that the delivery sheath 11 enters the left atrium along the puncture needle 31 . At this time, the position of the puncture needle 31 does not move, the puncture needle 31 moves backward relative to the delivery sheath 11 , and the needle head 311 of the puncture needle 31 is completely retracted into the delivery sheath 11 . The needle head 311 of the puncture needle 31 will not be in contact with the heart wall, which prevents the puncture needle 31 from further stabbing the heart wall, and improves the safety of the puncture operation using the puncture needle 31 .

Finally, the connecting piece 5 is removed, the sheath tube casing 13 and the needle casing 33 are separated, and the entire puncture assembly 3 is pulled out from the adjustable bendable sheath tube assembly 1 . The sheath tube assembly 1 at this time can be used as an independent delivery sheath. Instruments that need to be implanted enter through the hole 193 of the mounting part 19, so as to realize the integrated and multi-purpose function of the delivery and puncturing device 100 .

The above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention. Any modification, equivalent replacement or improvement made within the spirit and principles of the present invention shall be included in the protection of the present invention. within range.

Claims (11)

1. A delivery and puncture device, characterized in that it comprises a sheath tube assembly and a puncture assembly detachably connected to the sheath tube assembly, the puncture assembly is connected to the proximal end of the sheath tube assembly, and the sheath tube assembly The assembly includes a delivery sheath for the delivery instrument, the puncture assembly includes a puncture needle movably inserted in the delivery sheath, at least part of the delivery sheath is sleeved outside the puncture needle, the puncture The distal end of the needle can be exposed from or received in the distal end of the delivery sheath, and the proximal end of the puncture needle passes through the proximal end of the delivery sheath. 2. The delivery and puncture device according to claim 1, wherein the sheath assembly includes a sheath casing, the delivery sheath is pierced through the sheath casing, and the puncture assembly further includes A needle casing, the puncture needle can be movably passed through the needle casing, and the needle casing is detachably connected to the sheath casing. 3. The delivery and puncture device according to claim 2, wherein the puncture assembly further comprises a first adjustment member connected to the needle housing, the first adjustment member is connected to the puncture needle , for controlling the sliding of the puncture needle. 4. The conveying and puncturing device according to claim 3, wherein the needle insertion housing is provided with a first limit hole, and the first limit hole limits the axial stroke of the first adjustment member . 5 . The delivery and puncturing device according to claim 3 , wherein the puncturing assembly includes a sliding part for fixing the puncture needle, and the first adjusting part drives the sliding part to slide. 6 . 6. The delivery and puncturing device of claim 3, wherein the delivery sheath is slidable relative to the sheath housing. 7. The delivery and puncture device according to claim 6, wherein the sheath assembly further comprises a second adjustment member, the second adjustment member is spaced apart from the first adjustment member, and the second adjustment member is spaced from the first adjustment member. The regulating part is connected with the delivery sheath, and the second regulating part controls the sliding of the delivery sheath relative to the puncture needle. 8 . The delivery and puncture device according to claim 7 , wherein the sheath tube assembly is provided with a second limiting hole, and the second limiting hole limits the axial stroke of the second adjusting member. 9. The delivery and puncture device according to claim 7, wherein the movable axial stroke of the delivery sheath is greater than or equal to the movable axial stroke of the puncture needle. 10. The conveying and puncturing device according to claim 2, characterized in that, the conveying and puncturing device further comprises a connecting part, and the connecting part comprises two first connecting parts and a second connecting part matched with each other, so The first connecting part is arranged on the sheath casing, and the second connecting part is arranged on the needle casing. 11. The delivery and puncture device of claim 1, wherein the delivery sheath is bendable and deformable.

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