Piercing instrument

Abstract

The present application discloses a puncture instrument, which comprises a catheter and a puncture assembly; the catheter is provided with a containing cavity in the axial direction, the puncture assembly comprises a puncture needle, the puncture needle is movably arranged in the containing cavity, and the distal end of the puncture needle can extend out of the distal end surface of the catheter during movement; the containing cavity is also provided for a traction wire to pass through, wherein the traction wire arranged in the containing cavity is parallel to the puncture needle, and the two ends of the traction wire can respectively extend out of the proximal end surface and the distal end surface of the catheter, and the operator can adjust the puncture angle of the instrument by pulling the proximal end and the distal end of the traction wire extending out of the proximal end surface and the distal end surface of the catheter. The puncture angle of the puncture needle can be quickly and accurately adjusted by pulling the traction wire, the puncture angle is effectively ensured to adapt to the openings of different blood vessels, the puncture needle can quickly and accurately puncture the aortic covered stent to perform windowing, the operation time is reduced, and the operation difficulty is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical instruments, in particular to a puncture instrument. BACKGROUND

[0002] In recent years, endoluminal repair is perfected by many interventional workers at home and abroad, and its treatment principle and operation method are quite different from the traditional "cut and sew" method. Although the operation is fast and has fewer complications, many technical difficulties may be encountered during the operation process, and many problems need to be solved. The most important one is that the curved blood vessels or the particularly twisted branch blood vessels often cause a lot of trouble to doctors in endoluminal repair.

[0003] At present, for the aortic dissection or aneurysm involving the aortic arch, when the left subclavian artery (LSA) needs to be reconstructed, the in-situ fenestration operation is often used to reconstruct the arch blood vessels and their arch branch blood vessels, that is, a puncture device is used to fenestrate the stent graft under the intraoperative angiography, and a small stent is placed to reconstruct the arch branch blood vessels. The existing auxiliary instruments for adjusting the puncture angle are one-way adjustable curved sheaths or two-way adjustable curved sheaths. The puncture instrument is guided to the puncture site through the adjustable curved sheath, and then the angle of the adjustable curved sheath is adjusted to assist the angle of the puncture instrument. After the required angle is reached, the puncture access is established. This conventional puncture method requires two instruments to complete one operation, and the outer diameter of the instrument is relatively thick, which may cause problems in the access of some thin blood vessels. In addition, the existing auxiliary instruments are suitable for the LSA blood vessels that are emitted from the top of the aortic arch. The in-situ fenestration using the auxiliary instrument will not cause any problems. However, for some LSAs emitted from the side wall or curved / twisted blood vessels, especially when the angle between the LSA and the aortic arch is less than 30°, the adjustable angle space of the auxiliary adjustable curved sheath is very small after passing through the curved blood vessels to the target position. The adjustable angle space can meet the requirements for the flat angle, but it cannot meet the requirements for the twisted angle, which may cause many difficulties in puncture. If not handled properly, the puncture instrument may cause blood vessel injury and even lead to surgical failure. In addition, the supporting force of this type of instrument is weak, and several punctures may be required to pierce the stent, which may cause damage to the blood vessels and surrounding tissues.

[0004] For example, as Figure 1The disease condition shown is Stanford B aortic dissection. The aortic arch 10' includes the ascending aorta 101' and the left subclavian artery 102', and the dissection 103' involves the vicinity of the left subclavian artery 102'. After endovascular isolation of the endovascular dissection by the covered stent 105', the opening of the left subclavian artery 102' is blocked, at which time the covered membrane position where the window hole 104' is located needs to be windowed. When the included angle β between the left subclavian artery 102' and the arch is less than 30 degrees, the existing puncture instrument is difficult to puncture successfully, the membrane breaking opportunity is small, and even the operation fails. Generally, such patients cannot be directly windowed, and the chimney method is directly used to solve the problem, or when the operation fails, other methods are converted for treatment. SUMMARY

[0005] Therefore, the puncture instrument provided by the present application can adapt to different paths to perform in-situ windowing, thereby solving the problem that the existing products cannot perform puncture windowing in curved / twisted blood vessels.

[0006] To achieve the above object, the present application adopts the following technical solutions:

[0007] The present application provides a puncture instrument, which at least includes a catheter and a puncture assembly; the catheter is axially provided with a containing cavity, the puncture assembly includes a puncture needle, the puncture needle is movably arranged in the containing cavity, and the distal end of the puncture needle can extend out of the distal end face of the catheter during movement; the containing cavity is also provided for a traction wire to pass through, wherein the traction wire arranged in the containing cavity is parallel to the puncture needle, and the two ends of the traction wire can respectively extend out of the proximal end face and the distal end face of the catheter, and the operator can adjust the puncture angle of the instrument by pulling the proximal end and the distal end of the traction wire extending out of the proximal end face and the distal end face of the catheter.

[0008] In one of the embodiments, the puncture instrument further includes a traction wire, the traction wire is movably arranged in the containing cavity and the proximal end of the traction wire extends out of the proximal end face of the catheter, and the distal end of the traction wire can extend out of the distal end face of the catheter during movement.

[0009] In one of the embodiments, the distal end of the traction wire is in a self-bending state in a non-constrained state, so that the distal end of the traction wire arranged in the containing cavity is in a monofilament state in a constrained state, and the distal end of the traction wire extending out of the containing cavity is restored to a self-bending state in an unconstrained state.

[0010] In one of the embodiments, the maximum bending radius range of the distal end of the traction wire in the non-constrained state is 2-10 mm.

[0011] In one of the embodiments, the distal end of the catheter is provided with a developing mark.

[0012] In one of the embodiments, the distance between the radiopaque marker and the distal end of the catheter is 1-5 mm.

[0013] In one of the embodiments, the catheter further comprises a sheath sleeved on the pull wire, the sheath is movably arranged in the accommodating cavity and the proximal end of the sheath extends out of the proximal end of the catheter, and the distal end of the sheath can extend out of the distal end of the catheter during the movement of the sheath.

[0014] In one of the embodiments, the catheter comprises a main tube body, wherein,

[0015] the accommodating cavity comprises a main cavity axially arranged in the main tube body, and the puncture needle and the pull wire are arranged in the main cavity; or,

[0016] the accommodating cavity comprises a first sub-cavity and a second sub-cavity arranged in parallel in the main tube body and not penetrating each other, and the puncture needle and the pull wire are arranged in the first sub-cavity and the second sub-cavity, respectively; or,

[0017] the accommodating cavity comprises a first sub-cavity and a second sub-cavity arranged in parallel in the main tube body and penetrating each other, and the puncture needle and the pull wire are arranged in the first sub-cavity and the second sub-cavity, respectively.

[0018] In one of the embodiments, a through hole for the pull wire to pass through is arranged on the proximal end side wall of the main tube body and penetrates the main cavity or the second sub-cavity.

[0019] In one of the embodiments, the catheter further comprises a branch tube arranged at the through hole of the main tube body, the branch tube is arranged obliquely relative to the main tube body, the distal end of the branch tube is connected to the main tube body and the proximal end of the branch tube is away from the main tube body, and a branch cavity in the branch tube is in communication with the through hole and the main cavity or the second sub-cavity.

[0020] In one of the embodiments, the angle between the axis of the main tube body and the axis of the branch tube is α, wherein 0°<α≤30°.

[0021] In one of the embodiments, when the accommodating cavity comprises the first sub-cavity and the second sub-cavity, the main tube body comprises a first part provided with the first sub-cavity and a second part provided with the second sub-cavity, the distal end of the first part extends out of the distal end of the second part by 0-30 mm or the distal end of the second part extends out of the distal end of the first part by 0-30 mm; and when the distal end of the catheter is provided with a radiopaque marker, the radiopaque marker is arranged at the distal end of the first part.

[0022] In one of the embodiments, the second part has a stiffness of 0-30mm at the distal end of the second part relative to the distal end of the first part.

[0023] In one of the embodiments, the puncture assembly further comprises a first connecting seat and a second connecting seat, the distal end of the first connecting seat is detachably connected with the proximal end of the catheter, the first connecting seat is provided with a through hole in communication with the accommodating cavity, and the second connecting seat is connected with the puncture needle.

[0024] In one of the embodiments, the first connecting seat comprises a first connecting pipe and annular handles arranged on both sides of the connecting pipe, and the distal end of the first connecting pipe is detachably connected with the proximal end of the catheter; and the second connecting seat comprises a second connecting pipe and an annular handle arranged on one side of the second connecting pipe, and the distal end of the second connecting seat is connected with the puncture needle.

[0025] When the puncture instrument is used for puncture, the puncture angle of the puncture needle can be quickly and accurately adjusted by pulling the traction wire, so that the puncture angle is adapted to the openings of different blood vessels, the puncture needle can quickly and accurately pierce the aortic covered stent to perform windowing, the operation time is reduced, and the operation difficulty is reduced. It can adapt to the curved or uncurved path to perform in-situ windowing, can effectively assist the in-situ windowing of the twisted blood vessel position, and meet the windowing reconstruction of the twisted angle blood vessel. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 It is a schematic diagram of the existing in-situ windowing treatment of aortic dissection; wherein the included angle β formed by the left subclavian artery 102' and the arch is less than 30 degrees;

[0027] Figure 2 It is a schematic diagram of the puncture instrument of the present application;

[0028] Figure 3 It is Figure 2 It is an enlarged schematic diagram of part A;

[0029] Figure 4 It is a front view schematic diagram of the puncture instrument of the present application;

[0030] Figure 5 It is a half sectional view of one structure of the catheter in the puncture instrument of the present application;

[0031] Figure 6 It is a half sectional view of another structure of the catheter in the puncture instrument of the present application;

[0032] Fig. 7(a), Fig. 7(b) and Fig. 8(a), Fig. 8(b) are respectively Figure 6 schematic diagrams of different cross sections of the catheter;

[0033] Figure 9 Fig. 9 is a schematic diagram of another structure of the catheter of the puncture apparatus of the present application;

[0034] Fig. 10(a), Fig. 10(b) are respectively Figure 9 schematic diagrams of different cross sections of the catheter;

[0035] Fig. 11(a), Fig. 11(b) are respectively schematic diagrams of different embodiments of the catheter with the first sub-cavity and the second sub-cavity respectively arranged in the first part and the second part;

[0036] Figure 12 Fig. 12 is a schematic diagram of the implantation of the catheter of the puncture apparatus of the present application after the first sub-cavity and the second sub-cavity are respectively arranged in the first part and the second part;

[0037] Figure 13 Fig. 13 is a schematic diagram of the use of the puncture apparatus of the present application;

[0038] Figure 14 Fig. 14 is a schematic diagram of the implantation of the puncture apparatus of the present application;

[0039] Figure 15 Fig. 15 is a schematic diagram of the adjustment of the angle after the implantation of the puncture apparatus of the present application. DETAILED DESCRIPTION

[0040] In order to make the objects, technical solutions and advantages of the present application clearer, the exemplary embodiments of the present disclosure will be described in more detail below with reference to the drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be completely conveyed to those skilled in the art.

[0041] It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order in which they are described, unless specifically identified as an order dependent step. It is also to be understood that additional or alternative steps can be employed.

[0042] Although the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first", "second", and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

[0043] Spatially relative terms, such as "inner", "outer", "inward", "outward", "lower", "bottom", "top", "upper", and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Such spatially relative terms can encompass different orientations of the device in use or operation, depending on the particular context in which it is used. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0044] In addition, it should be noted that in the field of interventional medical devices, the end of a medical device or a delivery system for delivering the medical device that is closer to an operator is generally referred to as a "proximal end", and the end that is farther away from the operator is generally referred to as a "distal end", and the "proximal end" and "distal end" of any component of the medical device or the delivery system are defined according to this principle. The "axial direction" generally refers to the length direction of the medical device when it is being delivered, and the "radial direction" generally refers to the direction perpendicular to the "axial direction" of the medical device, and the "axial direction" and "radial direction" of any component of the medical device are defined according to this principle.

[0045] With reference to Figure 2 The present application exemplarily provides a puncture device 100, which can adapt to different paths for in-situ fenestration, especially effectively assisting in-situ fenestration of curved / twisted blood vessel positions, meeting the fenestration reconstruction of twisted angle blood vessels, reducing the risk of damage to blood vessels and complications, and improving the efficiency and success rate of surgery.

[0046] With reference to Figure 2 and Figure 4 The puncture device 100 at least includes a catheter 10 and a puncture assembly 20. The catheter 10 is axially provided with a receiving cavity, and the arrangement of the receiving cavity on the catheter 10 is described below. The puncture assembly 20 includes a puncture needle 21, which is movably arranged in the receiving cavity, and the distal end of the puncture needle 21 can extend out of the distal end face of the catheter 10 during movement. In addition, the proximal end of the puncture needle 21 generally extends out of the proximal end face of the catheter 10. In the puncture device of the present application, the receiving cavity can also be used for a pull wire to pass through. The middle of the pull wire passing through the receiving cavity is arranged in the receiving cavity, and both ends extend out of the proximal end face and the distal end face of the catheter. The pull wire arranged in the receiving cavity is parallel to the puncture needle. When the puncture device 100 of the present application is punctured, the operator can pull the proximal end and the distal end of the pull wire extending out of the proximal end face and the distal end face of the catheter 10. The puncture angle of the puncture needle 21 can be quickly and accurately adjusted by pulling the pull wire, so that the needle of the puncture needle 21 in the puncture device 100 can be adjusted to a suitable puncture position, enabling the puncture needle 21 to quickly and accurately pierce the aortic covered stent, and then perform puncture fenestration operation, thereby reducing the operation time and reducing the difficulty of the operation. The puncture device is provided with a receiving cavity for the pull wire to pass through, thereby providing a new bending adjustment mode, so that the puncture device 100 can adapt to curved or uncurved paths for in-situ fenestration, solving the problem that the existing products cannot perform puncture fenestration in curved / twisted blood vessels, and greatly improving the applicability of the product. At the same time, when the guide wire path is established, the pull wire can be used as a guide wire, without the need for additional preparation of a guide wire, and can achieve one wire multiple uses. In the puncture device of the present embodiment, the external pull wire can be used in cooperation with the puncture device. Preferably, the outer diameter of the catheter of the present embodiment is 5F-10F.

[0047] In other embodiments, referring to Figure 2 and Figure 4 , based on the structure of the puncture instrument described above, the puncture instrument of the present embodiment further comprises a traction wire 30 movably disposed in the accommodation cavity and having its proximal end extending out of the proximal end face of the catheter 10, and during movement, the distal end of the traction wire 30 can extend out of the distal end face of the catheter 10, and the operator can adjust the puncture angle of the instrument by pulling the proximal end and distal end of the traction wire 30 extending out of the proximal end and distal end face of the catheter 10. The diameter of the traction wire is preferably 0.018 inch to 0.038 inch. The surface friction of the traction wire is 180 gf to 330 gf, which on the one hand reduces the process difficulty, and on the other hand, makes the friction between the traction wire and the lumen as small as possible, facilitating the passage of the instrument; at the same time, when passing through the blood vessel, the stimulation to the blood vessel is small, and the frictional resistance is also small. The traction wire has a two-layer structure, which comprises a nickel-titanium core wire in the inner layer and a polyurethane layer covering the surface of the inner layer.

[0048] Referring to Figure 3 , preferably, when the puncture needle 21 and the traction wire 30 are disposed in the accommodation cavity, the direction of the needle tip of the puncture needle 21 is against the side of the traction wire 30, that is, the wedge-shaped opening of the needle head of the puncture needle 21 is away from the traction wire 30, which can avoid damaging the blood vessel when the puncture needle 21 punctures.

[0049] Continuing to refer to Figures 2 to 4 , in a further preferred embodiment, the distal end of the traction wire 30 is self-curved in a non-constrained state, so that the distal end of the traction wire 30 constrained in the accommodation cavity is in a monofilament state, and the distal end of the traction wire 30 extending out of the accommodation cavity is restored to its natural curved state. The curved state is provided so that the distal end of the traction wire 30 can be captured by other instruments (such as a catcher) when it extends into the blood vessel, and then is pulled out of the body, achieving the effect of traction. Preferably, the maximum bending radius of the distal end of the traction wire 30 in the non-constrained state is in the range of 2-10 mm, as shown in Figure 4 , the maximum bending radius is D1 / 2. The bending radius facilitates the movement of the traction wire 30 in the blood vessel and facilitates the capture of other instruments. The length of the traction wire 30 is preferably 150 cm to 300 cm, and the coiled length of the distal end is 2 cm to 5 cm. It should be noted that the length of the traction wire 30 and the coiled length of the distal end can be set according to actual needs, and are not limited thereto.

[0050] In combination with Figures 2 to 4In other embodiments, the puncture instrument 100 further comprises a sleeve 40 sleeved on the traction wire 30, the sleeve 40 is movably arranged in the accommodating cavity along with the traction wire 30 and the proximal end of the sleeve 40 extends out of the proximal end surface of the catheter 10, and the distal end of the sleeve 40 can extend out of the distal end surface of the catheter 10 during movement. It can be understood that the sleeve 40 is always in the same cavity as the traction wire 30. The sleeve 40 is sleeved on the outside of the traction guide wire, which can protect the blood vessel from being damaged by the traction wire 30 when the traction guide wire is pulled, and also provide a certain tension for puncture.

[0051] With reference to the drawings again, Figures 2 to 4 The puncture assembly 20 further comprises a first connecting seat and a second connecting seat, the distal end of the first connecting seat is detachably connected with the proximal end of the catheter 10, the first connecting seat is provided with a through hole in communication with the accommodating cavity, and the second connecting seat is connected with the puncture needle 21. After the puncture needle 21 penetrates into the through hole, the second connecting seat is movably connected with the proximal end of the first connecting seat, so that the first connecting seat can carry the puncture needle 21 to move axially relative to the second connecting seat. For example, the first connecting seat comprises a first connecting pipe 22 and annular handles 24 arranged on both sides of the connecting pipe 22, and the distal end of the first connecting pipe 22 is detachably connected with the proximal end of the catheter 10. For example, the detachable connection can be achieved by a bolt which connects the catheter 10 and the first connecting pipe 22 at the same time. The second connecting seat comprises a second connecting pipe 23 and annular handles 24 arranged on one side of the second connecting pipe 23, and the distal end of the second connecting seat is connected with the puncture needle 21. The first connecting seat and the second connecting seat can enable the operator to stably push the puncture needle connected with the second connecting seat.

[0052] With reference to the drawings again, Figure 2 and Figure 4 The catheter 10 comprises a main pipe body 11 having opposite proximal and distal end surfaces 11a and 11b, the accommodating cavity is arranged in the main pipe body 11, the puncture needle 21 and the traction wire 30 are movably arranged in the accommodating cavity of the main pipe body 11, and the proximal ends of the puncture needle 21 and the traction wire 30 extend out of the proximal end surface 11a of the main pipe body 11, and the distal ends of the puncture needle 21 and the traction wire 30 can extend out of the distal end surface 11b of the main pipe body 11 during movement. In other embodiments, in order to facilitate the operation of the puncture needle 21 and the traction wire 30 which extend out of the proximal end surface of the main pipe body 11 at the same time, and to avoid misoperation, a through hole for the traction wire to pass through is arranged on the proximal side wall of the main pipe body 11 in communication with the accommodating cavity, so that the traction wire can pass into / out of the through hole on one side of the main pipe body 11, and the puncture needle 21 and the traction wire 30 can be independently operated, avoiding mutual influence.

[0053] In other embodiments, the catheter 10 further comprises a branch pipe 12 arranged at the perforation of the main pipe body 11, the branch pipe 12 is arranged obliquely relative to the main pipe body 11, the distal end of the branch pipe 12 is connected with the main pipe body 11 and the proximal end is away from the main pipe body 11, so that the branch pipe 12 has a free proximal inclined surface 12a. Wherein, the branch pipe 12 is provided with a branch cavity 121, the branch cavity 121 is communicated with the perforation in the main pipe body 11 and the accommodation cavity. The puncture needle 21 and the traction wire 30 are movably arranged in the accommodation cavity of the main pipe body 11, the proximal end of the puncture needle 21 extends out of the proximal end surface 11a of the main pipe body 11, and the proximal end of the traction wire 30 extends out of the proximal inclined surface 12a of the branch pipe 12 through the perforation. The arrangement of the inclined branch makes the puncture needle 21 and the traction wire 30 close to the proximal end of the catheter 10 separate in the radial direction, which facilitates independent operation of the puncture needle 21 and the traction wire 30, avoids mutual influence and also avoids misoperation. Meanwhile, the branch pipe 12 can be further connected with the hemostatic valve. Preferably, in order to ensure the puncture angle of the puncture needle 21 and the force exerted on the puncture needle 21 as directly as possible during puncture, the central axis of the loaded puncture needle 21 is coaxially arranged with the central axis of the main pipe body 11, and the branch pipe 12 is arranged obliquely relative to the axis. Further, in order to ensure the smoothness of pushing the traction wire 30 and avoid the traction wire 30 being pushed blocked due to excessive angle deviation during movement, the included angle between the axis a of the main pipe body 11 and the axis b of the branch pipe 12 is α, wherein 0°<α≤30°.

[0054] Wherein, based on the structure of the catheter 10 described above, referring to Figure 5 As a kind of arrangement of accommodation cavity, the accommodation cavity includes a main cavity 111 axially arranged in the main pipe body 11, and the puncture needle 21 and the traction wire 30 are arranged in the main cavity 111. It can be understood that if the main pipe body 11 of the catheter 10 is not provided with a perforation and the catheter 10 does not include a branch pipe 12, the main cavity 111 axially penetrates the proximal end surface 11a and the distal end surface 11b of the main pipe body 11, and the puncture needle 21 and the traction wire 30 are movably arranged in the main cavity 111 of the main pipe body 11, and the proximal ends of the puncture needle 21 and the traction wire 30 extend out of the proximal end surface 11a of the main pipe body 11, and the distal ends of the puncture needle 21 and the traction wire 30 can extend out of the distal end surface 11b of the main pipe body 11 during movement. If the main pipe body 11 of the catheter 10 is provided with a perforation or is provided with a perforation on the basis of further including a branch pipe 12, the main cavity 111 axially penetrates the proximal end surface 11a and the distal end surface 11b of the main pipe body 11, the perforation is communicated with the main cavity 111, further, the branch cavity 121 of the branch pipe 12 is communicated with the perforation and the main cavity 111, and the puncture needle 21 and the traction wire 30 are movably arranged in the main cavity 111 of the main pipe body 11, and the proximal end of the puncture needle 21 extends out of the proximal end surface 11a of the main pipe body 11, and the proximal end of the traction wire 30 extends out of the proximal inclined surface 12a of the branch pipe 12 through the perforation.

[0055] Referring to Figure 6 , as another arrangement of the accommodation cavity, the accommodation cavity comprises a first sub-cavity 112 and a second sub-cavity 113 arranged in parallel in the main pipe body 11 and not through each other, at this time, the first sub-cavity 112 and the second sub-cavity 113 are arranged relatively independently, and the puncture needle 21 and the traction wire 30 are respectively arranged in the relatively independent first sub-cavity 112 and the second sub-cavity 113. The arrangement of the relatively independent cavities avoids the problem of difficulty in pushing and failure caused by the entanglement of the puncture needle 21 and the traction wire 30 with each other. Preferably, the cavity diameter of the first sub-cavity 112 and / or the second sub-cavity 113 is 0.5-1mm, and the wall thickness is 0.1mm-0.15mm. Similarly, it can be understood that if the main pipe body 11 of the catheter 10 is not provided with a puncture hole and the catheter 10 does not comprise a branch pipe 12, the first sub-cavity 112 and the second sub-cavity 113 both axially penetrate the proximal end face 11a and the distal end face 11b of the main pipe body 11, and the puncture needle 21 and the traction wire 30 are respectively movably arranged in the first sub-cavity 112 and the second sub-cavity 113 of the main pipe body 11, and the proximal ends of the puncture needle 21 and the traction wire 30 respectively extend out of the proximal end face of the first sub-cavity 112 and the second sub-cavity 113, and the distal ends of the puncture needle 21 and the traction wire 30 respectively extend out of the distal end face of the first sub-cavity 112 and the second sub-cavity 113 during movement. If the main pipe body 11 of the catheter 10 is provided with a puncture hole or is provided with a puncture hole on the basis of further comprising a branch pipe 12, the first sub-cavity 112 axially penetrates the proximal end face 11a and the distal end face 11b of the main pipe body 11, and the second sub-cavity 113 penetrates the distal end face 11b of the main pipe body 11, at this time, the puncture hole is through the second sub-cavity 112, and the second sub-cavity 113, the puncture hole and the branch cavity 121 on the branch pipe 12 are communicated, the puncture needle 21 and the traction wire 30 are respectively movably arranged in the first sub-cavity 112 and the second sub-cavity 113 of the main pipe body 11, and the proximal end of the puncture needle 21 extends out of the proximal end face 11a of the main pipe body 11, and the proximal end of the traction wire 30 extends out through the puncture hole or the proximal inclined face 12a of the branch pipe 12.

[0056] In the present embodiment, the arrangement of the first sub-cavity 112 and the second sub-cavity 113 which are not through each other includes but is not limited to the following, referring to FIG. 7(a), the first sub-cavity 112 and the second sub-cavity 113 are both semicircular cavities, and a blocking part 114 is arranged between the two semicircular cavities, and the puncture needle 21 and the traction wire 30 are respectively accommodated in the two semicircular cavities which are independent of each other. In other embodiments, referring to FIG. 7(b), since the diameter of the puncture needle 21 is often larger than the diameter of the traction wire 30, in view of this, the cross-sectional area of the first sub-cavity 112 and the second sub-cavity 113 can be unevenly arranged, for example, the blocking part 114 can be eccentrically arranged, so that the cross-sectional area of the first sub-cavity 112 accommodating the puncture needle 21 is larger than the cross-sectional area of the second sub-cavity 113 accommodating the traction wire 30. This arrangement reasonably arranges the accommodation cavities of the puncture needle 21 with a larger diameter and the traction wire 30 with a smaller diameter, and can further realize small-diameter design, thereby reducing damage to the puncture port. It is further preferred that, as shown in FIG. 7(b), when the blocking part 114 is eccentrically arranged, the center of the puncture needle 21 accommodated in the first sub-cavity 112 can be concentrically arranged with the center of the main pipe body 11 of the catheter 10, so that the needle tip of the puncture needle 21 is located at the center position of the main pipe body 11, thereby protecting the surrounding blood vessels and improving the accuracy of puncture. Of course, when the cross-sectional area can be unevenly arranged, the cross-sectional area of the first sub-cavity 112 can also be smaller than the cross-sectional area of the second sub-cavity 113 according to other needs.

[0057] In other embodiments, referring to FIG. 8(a), since the puncture needle 21 and the traction wire 30 are both columnar structures, in order to limit the puncture needle 21 and the traction wire 30 in the radial direction and at the same time achieve small-diameter design as much as possible, thereby reducing damage to the puncture port, the cross section of the first sub-cavity 112 and the second sub-cavity 113 can be a circular hole. Also, since the diameter of the puncture needle 21 is often larger than the diameter of the traction wire 30, in the preferred embodiment, referring to FIG. 8(b), the diameter of the circular hole of the first sub-cavity 112 accommodating the puncture needle 21 is larger than the diameter of the circular hole of the second sub-cavity 113 accommodating the traction wire 30. It is further preferred that, as shown in FIG. 8(b), the center of the circular hole of the first sub-cavity 112 is concentrically arranged with the center of the main pipe body 11 of the catheter 10, so that the needle tip of the puncture needle 21 is located at the center position of the catheter 10, thereby protecting the surrounding blood vessels and improving the accuracy of puncture. Of course, when the diameters of the circular holes are different sizes, the diameter of the circular hole of the first sub-cavity 112 can also be smaller than the diameter of the circular hole of the second sub-cavity 113 according to other needs.

[0058] Referring to Figure 9As another arrangement of the accommodation cavity, the accommodation cavity comprises a first sub-cavity 112 and a second sub-cavity 113 arranged in parallel in the main pipe body 11 and penetrating each other, at this time, the first sub-cavity 112 and the second sub-cavity 113 are penetrated, but this penetration cannot cause the puncture needle 21 and the traction wire 30 placed in the first sub-cavity and the second sub-cavity 113, respectively, to move radially, that is, they still constitute two relatively independent channels. This arrangement can reduce the diameter of the catheter 10 as much as possible while ensuring independence to avoid entanglement and failure, which is beneficial to the design of small pipe diameter, thereby improving the applicability of the instrument. Similarly, it can be understood that if the main pipe body 11 of the catheter 10 is not provided with a perforation and the catheter 10 does not comprise a branch pipe 12, the first sub-cavity 112 and the second sub-cavity 113 axially penetrate the proximal end face 11a and the distal end face 11b of the main pipe body 11, the puncture needle 21 and the traction wire 30 are movably placed in the first sub-cavity 112 and the second sub-cavity 113 of the main pipe body 11, respectively, and the proximal end of the puncture needle 21 and the traction wire 30 respectively extends out of the proximal end face of the first sub-cavity 112 and the second sub-cavity 113, and the distal end of the puncture needle 21 and the traction wire 30 respectively extends out of the distal end face of the first sub-cavity 112 and the second sub-cavity 113 during movement. If the main pipe body 11 of the catheter 10 is provided with a perforation or is provided with a perforation on the basis of further comprising a branch pipe 12, the first sub-cavity 112 axially penetrates the proximal end face 11a and the distal end face 11b of the main pipe body 11, and the second sub-cavity 113 penetrates the distal end face 11b of the main pipe body 11, at this time, the perforation and the second sub-cavity 112 are penetrated, and the second sub-cavity 113, the perforation and the branch cavity 121 on the branch pipe 12 are communicated, the puncture needle 21 and the traction wire 30 are movably placed in the first sub-cavity 112 and the second sub-cavity 113 of the main pipe body 11, respectively, and the proximal end of the puncture needle 21 extends out of the proximal end face 11a of the main pipe body 11, and the proximal end of the traction wire 30 extends out of the proximal inclined face 12a of the branch pipe 12 through the perforation.

[0059] In this embodiment, the arrangement of the first sub-cavity 112 and the second sub-cavity 113, which are interconnected, includes, but is not limited to, the following: Referring to Figure 10(a), the first sub-cavity 112 and the second sub-cavity 113 intersect each other at opposite locations, forming a through opening at the intersection. The radial distance of this through opening is smaller than the smaller diameter of the puncture needle 21 and the traction wire 30, thereby preventing the puncture needle 21 and the traction wire 30 from moving radially. Preferably, referring to Figure 10(b), since both the puncture needle 21 and the traction wire 30 are columnar structures, in order to provide a certain radial limit for the puncture needle 21 and the traction wire 30, and to achieve the smallest possible diameter design, the cross-sections of the first sub-cavity 112 and the second sub-cavity 113 are both open circular holes. The two circular holes intersect each other at opposite locations, forming an open through opening at the intersection, so that the cross-sections of the outer contours of the first sub-cavity 112 and the second sub-cavity 113 both form a superior arc. Similarly, since the diameter of the puncture needle 21 is often larger than the diameter of the traction wire 30, in a preferred embodiment, as shown in FIG10(b), the diameter of the unclosed circular hole of the first sub-cavity 112 accommodating the puncture needle 21 is larger than the diameter of the unclosed circular hole of the second sub-cavity 113 accommodating the traction wire 30. More preferably, the center of the unclosed circular hole of the first sub-cavity 112 is concentrically located with the center of the main body 11 of the catheter 10. This allows the tip of the puncture needle 21 to be positioned at the center of the catheter 10, thereby protecting surrounding blood vessels and improving puncture accuracy. Of course, when different sizes of the unclosed circular hole are used, the diameter of the unclosed circular hole of the first sub-cavity 112 can be smaller than the diameter of the unclosed circular hole of the second sub-cavity 113, depending on other needs.

[0060] Further, see Figure 5 , Figure 6 and Figure 9 As shown, a contrast indicator 50 is provided at the distal end of the catheter 10. This contrast indicator 50 not only indicates the proximal position of the catheter 10 component 201 during surgery, but also indicates the position of the needle tip of the puncture needle 21. Preferably, the distance L1 between the contrast indicator 50 and the distal end of the catheter 10 is 1-5 mm. This distance avoids the puncture needle 21 being too far from the distal end of the catheter 10, which would affect the efficiency of its advancement, and also avoids the puncture needle 21 being too close to the distal end of the catheter 10, which could lead to contact with the blood vessel wall and puncture the vessel wall when the catheter 10 bends. In other words, this distance ensures both the timeliness of advancing the puncture needle 21 and safety. One possible configuration of the contrast indicator 50 is a contrast ring fitted onto the distal end of the catheter 10. The specific fixing method of the contrast ring can refer to existing technology and will not be elaborated here. It should be noted that the configuration of the contrast ring is only one implementation of the contrast indicator 50 and is not limited thereto.

[0061] Referring to FIG. 11(a) and FIG. 11(b), based on the aforementioned first sub-cavity 112 and second sub-cavity 113, in other embodiments, the main tube 11 comprises a first portion 11A provided with the first sub-cavity 112 and a second portion 11B provided with the second sub-cavity 113, the first portion 11A is radially connected to the second portion 11B. Preferably, the first portion 11A and the second portion 11B are integrally formed. The difference is that, as shown in FIG. 11(a), the distal end of the first portion 11A provided with the first sub-cavity 112 protrudes 0-30mm from the distal end of the second portion 11B provided with the second sub-cavity 113, i.e. the distance L2 in FIG. 11(a) is 0-30mm. When adjusting the second portion 11B, the movement of the distal end of the second portion 11B will rotate with the traction force, and the rotation response of the first portion 11A is faster, which can quickly adjust the angle of the distal end of the first portion 11A, and vertically align the windowing component.

[0062] Alternatively, as shown in FIG. 11(b), the distal end of the second portion 11B provided with the second sub-cavity 113 protrudes 0-30mm from the distal end of the first portion 11A provided with the first sub-cavity 112, i.e. the distance L3 in FIG. 11(b) is 0-30mm. Among them, when the distal end of the second portion 11B protrudes 0-30mm from the distal end of the first portion 11A, i.e. the distance L3 is 0-30mm, the hardness of the protruding segment of the second portion 11B is less than that of the non-protruding segment of the second portion 11B. And when adjusting the second portion 11B, the movement of the distal end of the second portion 11B will rotate with the traction force, and the rotation response of the first portion 11A will be slower, which can fine-tune the angle of the distal end of the first portion 11A, and also can ensure the vertical split of the windowing component. Among them, when the distal end of the catheter 10 is provided with a developing mark 50 for indicating the position of the needle tip of the puncture needle 21, the developing mark 50 is arranged at the distal end of the first portion 11A.

[0063] As Figure 12As shown, taking the example where the distal end of the first part 11A with the first sub-cavity 112 extends 20mm beyond the distal end of the second part 11B with the second sub-cavity 113 (i.e., the first part 11A is longer than the second part 11B), under X-ray fluoroscopy with the vascular fluoroscopy showing the left anterior oblique arch at its maximum expansion, when the covered stent 200 is successfully implanted, the catheter 10 of the puncture instrument also reaches the vicinity of the left subclavian artery 301 along the traction wire 30. At this time, force is applied to fix the traction wire 30, and then force is applied to the distal end 30b of the traction wire 30 to adjust the angle of the instrument. At this time, because the outer diameter of the first part 11A is small, the tip is easy to deform, and the required tension is small. When the opening of the catheter 10 is adjusted to be perpendicular to the surface of the covered stent 200 by appropriate force, a perpendicular X-ray projection can also be taken to determine the relationship between the puncture needle 21 and the surface of the covered stent 200, thus the puncture is successful. Furthermore, when adjusting the traction wire 30 in the second part 11B, the distal end of the second part 11B will rotate with the traction wire 30, and the rotation response of the first part 11A is faster, so that the distal end angle of the first part 11A can be quickly adjusted to be vertically aligned with the surface of the film-coated support 200.

[0064] like Figure 13 As shown in the figure, the usage process of the exemplary puncture instrument of the present invention is described in detail, taking the left subclavian artery 301 with in-situ fenestration as an example. During the operation, preparation is required according to the human puncture path 300. First, the brachial artery 304 is punctured or cut, and a passage is established using guide wire m or traction wire 30; at the same time, the left femoral artery 302 and the right femoral artery 303 are cut. Taking the release of the covered stent in the right femoral artery 303 as an example, the guide wire m or traction wire 30 is pulled out from the left femoral artery 302. This is mainly achieved by utilizing the self-bending structure of the distal end of the guide wire m or traction wire 30. When the end moves to the vicinity of the left femoral artery 302, the end is pulled out of the blood vessel using surgical forceps or a grabber, and finally fixed outside the body, always keeping the traction wire 30 in the blood vessel.

[0065] like Figure 14 As shown, under X-ray fluoroscopy with the left anterior oblique arch at its maximum expansion, when the covered stent 200 is successfully implanted, the catheter 10 of the puncture instrument 100 also reaches the vicinity of the left subclavian artery 301 along the guide wire m or traction wire 30. At this time, if force is applied to the puncture needle 21 in the catheter 10 for puncture, it is easy to damage the blood vessel. Figure 15As shown, the proximal end 30a of the traction wire 30 is fixed by applying force, and then the distal end 30b of the traction wire 30 is applied to adjust the angle of the instrument, and by applying appropriate force, the opening of the catheter 10 can be adjusted to be perpendicular to the surface of the covered stent 200, and also a vertical X-ray projection can be used to determine the relationship between the puncture needle 21 and the surface of the covered stent 200, so as to successfully puncture. In the embodiment, after the adjustable puncture instrument is placed in the curved blood vessel, the position of the needle of the puncture needle can be adjusted to be relatively perpendicular to the surface of the covered stent by adjusting the traction wire, so as to successfully puncture. At the same time, the risk of repeated adjustment and switching to other surgical methods can be reduced. At the same time, the learning curve of the doctor can be reduced, and the treatment or cure effect can be achieved.

[0066] The present application is an example of an adjustable angle puncture instrument, which can effectively overcome the problem of difficult positioning, and can also provide a certain tension for the puncture instrument. The instrument can also be used for other branches of the aorta with severe distortion or special shape. The embodiments shown are within the scope of the instrument, and will not be demonstrated one by one.

[0067] The technical features of the above-mentioned embodiments can be combined arbitrarily, and in order to make the description simple, all possible combinations of the technical features in the above-mentioned embodiments are not described, however, as long as the combination of the technical features does not exist contradictory, it should be considered as the scope of the present application.

[0068] The above-mentioned embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application. Therefore, the protection scope of the present application patent should be subject to the appended claims.

Claims

1. A puncturing instrument, characterized by, The device comprises a catheter and a puncture assembly; the catheter is provided with a receiving cavity in the axial direction, and the puncture assembly comprises a puncture needle which is movably arranged in the receiving cavity and has a distal end capable of extending out of the distal end face of the catheter during movement; the receiving cavity is also provided with a pull wire which is arranged in parallel with the puncture needle and has two ends capable of extending out of the proximal end face and the distal end face of the catheter respectively, and the operator can adjust the puncture angle of the device by pulling the proximal end and the distal end of the pull wire extending out of the proximal end face and the distal end face of the catheter.

2. The puncturing instrument according to claim 1, characterized in that The device further comprises a pull wire which is movably arranged in the receiving cavity and has a proximal end extending out of the proximal end face of the catheter, and the distal end of the pull wire is capable of extending out of the distal end face of the catheter during movement.

3. The puncturing instrument according to claim 2, wherein The distal end of the pull wire is in a self-bending state in the non-constrained state, so that the distal end of the pull wire arranged in the receiving cavity is in a monofilament state in the constrained state, and the distal end of the pull wire extending out of the receiving cavity is restored to the self-bending state in the unconstrained state.

4. The puncturing instrument according to claim 3, wherein The maximum bending radius of the distal end of the pull wire in the non-constrained state ranges from 2 mm to 10 mm.

5. The puncturing instrument according to claim 1, wherein The distal end of the catheter is provided with a developing mark.

6. The puncturing instrument according to claim 5, wherein The distance between the developing mark and the distal end face of the catheter ranges from 1 mm to 5 mm.

7. The puncturing instrument according to claim 2, wherein The device further comprises a sleeve arranged outside the pull wire, the sleeve is movably arranged in the receiving cavity and has a proximal end extending out of the proximal end face of the catheter, and the distal end of the sleeve is capable of extending out of the distal end face of the catheter during movement.

8. The puncturing instrument according to any one of claims 1 to 7, wherein The catheter comprises a main pipe body; wherein The receiving cavity comprises a main cavity arranged in the main pipe body in the axial direction, and the puncture needle and the pull wire are arranged in the main cavity; or The receiving cavity comprises a first sub-cavity and a second sub-cavity arranged in parallel in the main pipe body and not penetrating each other, and the puncture needle and the pull wire are arranged in the first sub-cavity and the second sub-cavity respectively; or The receiving cavity comprises a first sub-cavity and a second sub-cavity arranged in parallel in the main pipe body and penetrating each other, and the puncture needle and the pull wire are arranged in the first sub-cavity and the second sub-cavity respectively.

9. The puncturing instrument according to claim 8, characterized in that The proximal side wall of the main pipe body is provided with a through hole penetrating the main cavity or the second sub-cavity and capable of allowing the pull wire to pass through.

10. The puncturing instrument according to claim 9, characterized in that The catheter further comprises a branch pipe arranged at the through hole of the main pipe body, the branch pipe is arranged obliquely relative to the main pipe body, the distal end of the branch pipe is connected to the main pipe body, and the proximal end of the branch pipe is away from the main pipe body, and the branch cavity in the branch pipe is in communication with the through hole and the main cavity or the second sub-cavity.

11. The puncturing instrument according to claim 10, wherein The angle between the axis of the main pipe body and the axis of the branch pipe is α, wherein 0°<α≤30°.

12. The puncturing instrument according to claim 8, wherein When the accommodation cavity comprises the first sub-cavity and the second sub-cavity, the main pipe body comprises a first part provided with the first sub-cavity and a second part provided with the second sub-cavity, the distal end of the first part extends 0-30mm relative to the distal end of the second part or the distal end of the second part extends 0-30mm relative to the distal end of the first part; wherein when the catheter is provided with a developing mark at the distal end, the developing mark is arranged at the distal end of the first part.

13. The puncturing instrument according to claim 12, characterized in that When the distal end of the second part extends 0-30mm relative to the distal end of the first part, the hardness of the extended section of the second part is less than the hardness of the non-extended section of the second part.

14. The puncturing instrument according to claim 1, wherein The puncture assembly further comprises a first connecting seat and a second connecting seat, the distal end of the first connecting seat is detachably connected with the proximal end of the catheter, the first connecting seat is provided with a through hole in communication with the accommodation cavity, the second connecting seat is connected with the puncture needle, and the second connecting seat is movably connected with the proximal end of the first connecting seat after the puncture needle penetrates into the through hole, so that the first connecting seat can carry the puncture needle to move axially relative to the second connecting seat.

15. The puncturing instrument according to claim 14, characterized in that The first connecting seat comprises a first connecting pipe and annular handles arranged on both sides of the first connecting pipe, and the distal end of the first connecting pipe is detachably connected with the proximal end of the catheter; the second connecting seat comprises a second connecting pipe and an annular handle arranged on one side of the second connecting pipe, and the distal end of the second connecting seat is connected with the puncture needle.

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