阅读说明：本技术 一种破膜装置 (Membrane rupture device ) 是由 陆栋梁 葛书晨 阳明 卢俊杰 于 2021-07-01 设计创作，主要内容包括：本发明公开一种破膜装置,该破膜装置包括锚定组件；调弯组件,套装于所述锚定组件内；穿刺组件,套装于所述调弯组件内；以及手柄组件,所述手柄组件分别与所述锚定组件、所述调弯组件及所述手柄组件连接。本发明的破膜装置可依靠内置调弯组件来调整角度,在分支血管与宿主血管成角小时,能使破膜装置对中,无需其他器械辅助破膜器械对中。(The invention discloses a membrane rupturing device, which comprises an anchoring component; the bending adjusting component is sleeved in the anchoring component; the puncture assembly is sleeved in the bending adjusting assembly; and the handle assembly is respectively connected with the anchoring assembly, the bending adjusting assembly and the handle assembly. The membrane rupturing device can adjust the angle by means of the built-in bending adjusting assembly, and can be centered when the angle between the branch blood vessel and the host blood vessel is small, and other instruments are not needed for assisting the centering of the membrane rupturing instrument.)

1. A membrane rupturing device, comprising:

an anchor assembly;

the bending adjusting component is sleeved in the anchoring component;

the puncture assembly is sleeved in the bending adjusting assembly; and

and the handle assembly is respectively connected with the anchoring assembly, the bending adjusting assembly and the handle assembly.

2. The rupture device of claim 1, wherein the anchor assembly comprises a first catheter, a balloon disposed at a distal end of the first catheter, and a connection valve disposed at a proximal end of the first catheter.

3. The rupture device of claim 2, wherein the first catheter has a first lumen through which the bend adjustment assembly passes and a balloon inflation lumen in communication with the balloon.

4. The rupture device of claim 3, wherein the first catheter is a double tube, the space between the double tubes serves as the balloon inflation lumen, and the central hole of the inner tube of the double tube serves as the first lumen.

5. The rupture device of claim 3, wherein the first catheter is a single-layer tube having at least two lumens, one of which serves as the first lumen and the remaining lumens serve as the balloon inflation lumen.

6. The rupture device of claim 5, wherein the balloon inflation lumen comprises a plurality of lumens disposed about the first lumen.

7. The membrane rupturing device according to claim 1, wherein the bend adjustment assembly comprises a long straight section, at least one transition section and at least one short straight section, the long straight section and the short straight section are connected through the transition section, and a preset angle is formed between the long straight section and the short straight section.

8. The membrane rupturing device according to claim 7, wherein the transition section is an arc section, and the long straight section and the short straight section are respectively arranged in a tangent manner at two ends of the transition section.

9. The membrane rupturing device according to claim 7, wherein the bending adjustment assembly comprises a plurality of short straight sections which are arranged in sequence, and two adjacent short straight sections are connected through the transition section.

10. The membrane rupturing device according to claim 1, wherein the bend adjustment assembly comprises a tube body and a traction wire, the traction wire is arranged along the tube body, two ends of the traction wire are respectively connected with the tube body and the handle assembly, and the traction wire is driven by the handle assembly to change the curvature of one end of the tube body.

11. The membrane rupturing device according to claim 1, wherein the puncture assembly comprises a puncture needle, a threaded tube and a second conduit which are connected in sequence.

12. The rupture device of claim 11, wherein, in use, the piercing needle and the threaded tube extend from a head end of the distal end of the bend adjustment assembly.

13. The membrane rupturing device of claim 11, wherein the external thread of the threaded tube is a male thread or a female thread.

14. The membrane rupturing device of claim 11, wherein the puncture needle has an outer diameter less than or equal to the outer diameter of the threaded tube.

15. The membrane rupturing device of claim 11, wherein the wall of the second conduit has a plurality of rectangular openings spaced axially apart.

16. The membrane rupturing device of claim 1, wherein the handle assembly comprises an outer tube holder, a middle tube holder, and an inner tube assembly, wherein the middle tube holder is threaded into the outer tube holder, and the inner tube holder is threaded into the middle tube holder; the outer tube seat is connected with the anchoring assembly, the middle tube seat is connected with the bending adjusting assembly, and the inner tube seat is connected with the puncture assembly.

17. The membrane rupturing device of claim 16, wherein the middle tube holder is provided with a limit switch for limiting the maximum moving distance of the inner tube holder to the outer tube holder.

18. The membrane rupturing device according to claim 1, wherein the inner tube base is provided with a speed adjusting device for adjusting the movement mode of the puncture assembly.

19. The membrane rupturing device of claim 18, wherein the movement of the puncture assembly comprises a linear movement and a rotational movement.

Technical Field

The invention relates to the technical field of biomedical engineering, in particular to a membrane breaking device.

Background

The in-situ windowing of the covered stent of the thoracic aorta is an intracavitary technique with super indications. The operation steps of the in-situ windowing technology are as follows: after a conventional covered stent is implanted into an aortic aneurysm part, a puncture device (a rigid guide wire, a puncture needle, a laser fiber, a high-frequency probe and the like) and a balloon (a non-compliant balloon, a cutting balloon and the like) are placed into the aortic aneurysm part, a covered membrane is punctured at an opening position of an important branch and is further expanded, one or more window holes are formed, and finally a bare stent or a covered stent is implanted to ensure the normal perfusion of the important branch artery.

The existing needling instrument in-situ windowing has the following disadvantages

1. When the included angle between the branch and the host is small, the membrane breaking device is difficult to center by only relying on the membrane breaking device, and other devices are needed to assist the membrane breaking device to center.

2. The existing puncture mode is that a needle tool punctures a tectorial membrane by pushing force, and for a stent with a thicker or harder tectorial membrane, the needle tool is difficult to puncture once and can slide on the tectorial membrane, so that the risk of puncturing the vascular wall exists.

3. The existing puncture mode is that a needle tool punctures a tectorial membrane by pushing force, and when the tectorial membrane is thick, the pushing force is completely applied to the tectorial membrane, so that the tectorial membrane stent is displaced.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, it is an object of the present invention to provide an endoluminal stent rupture device having a greater rupture adaptability range, a more flexible and safer operation than the prior art products.

To achieve the above and other related objects, the present invention provides a membrane rupturing device, comprising:

an anchor assembly;

the bending adjusting component is sleeved in the anchoring component;

the puncture assembly is sleeved in the bending adjusting assembly; and

and the handle assembly is respectively connected with the anchoring assembly, the bending adjusting assembly and the handle assembly.

In an alternative embodiment of the invention, the anchor assembly includes a first catheter, a balloon disposed at a distal end of the first catheter, and a connection valve disposed at a proximal end of the first catheter.

In an alternative embodiment of the invention, the first catheter has a first lumen through which the bend adjustment assembly passes and a balloon inflation lumen in communication with the balloon.

In an optional embodiment of the invention, the first catheter is a double-layer tube, a gap between the double-layer tubes serves as an inflation cavity of the balloon, and a central hole of an inner tube of the double-layer tube serves as the first cavity.

In an alternative embodiment of the present invention, the first catheter is a single-layer tube having at least two lumens, one of which serves as the first lumen and the remaining lumens serve as the balloon inflation lumen.

In an alternative embodiment of the present invention, the balloon inflation lumen comprises a plurality of inflation lumens disposed around the first lumen.

In an optional embodiment of the present invention, the bend adjustment assembly includes a long straight section, at least one transition section and at least one short straight section, the long straight section and the short straight section are connected through the transition section, and a predetermined angle is formed between the long straight section and the short straight section.

In an optional embodiment of the present invention, the transition section is an arc section, and the long straight section and the short straight section are respectively tangent to two ends of the transition section.

In an optional embodiment of the present invention, the bend adjusting assembly includes a plurality of short straight sections sequentially arranged, and two adjacent short straight sections are connected by the transition section.

In an optional embodiment of the invention, the bend adjusting assembly comprises a tube body and a traction wire, the traction wire is arranged along the tube body, two ends of the traction wire are respectively connected with the tube body and the handle assembly, and the traction wire is driven by the handle assembly to change the curvature of one end of the tube body.

In an optional embodiment of the invention, the puncture assembly comprises a puncture needle head, a threaded pipe and a second guide pipe which are connected in sequence.

In an alternative embodiment of the present invention, in use, the piercing needle and the threaded tube extend from a distal tip of the bend adjustment assembly.

In an alternative embodiment of the invention, the external thread of the threaded pipe is a male thread or a female thread.

In an alternative embodiment of the invention, the outer diameter of the puncture needle is smaller than or equal to the outer diameter of the threaded tube.

In an optional embodiment of the present invention, the tube wall of the second conduit has a plurality of rectangular openings spaced apart from each other in the axial direction.

In an optional embodiment of the invention, the handle assembly comprises an outer tube seat, a middle tube seat and an inner tube group, wherein the middle tube seat is arranged in the outer tube seat in a penetrating manner, and the inner tube seat is arranged in the middle tube seat in a penetrating manner; the outer tube seat is connected with the anchoring assembly, the middle tube seat is connected with the bending adjusting assembly, and the inner tube seat is connected with the puncture assembly.

In an optional embodiment of the present invention, the middle tube base is provided with a limit switch for limiting a maximum moving distance of the inner tube base to the outer tube base.

In an optional embodiment of the invention, the inner tube seat is provided with a speed adjusting device for adjusting the moving mode of the puncture assembly.

In an alternative embodiment of the invention, the movement of the spike assembly comprises a linear movement and a rotational movement.

The membrane rupturing device can adjust the angle by means of the built-in bending adjusting assembly, and can be centered when the angle between the branch blood vessel and the host blood vessel is small, and other instruments are not needed for assisting the centering of the membrane rupturing instrument.

The membrane breaking device provided by the invention has the advantages that the membrane breaking component breaks the membrane by virtue of the pushing force, the membrane can be broken by virtue of the rotation of the puncture component, the pushing force on the puncture component can be reduced, and the displacement of the membrane covered stent can be reduced.

When the membrane breaking device breaks the membrane of the stent with thicker or harder covered membrane, the covered membrane can be punctured by the rotation of the puncture assembly, and the puncture assembly cannot slide on the covered membrane, so that the risk of puncturing the blood vessel wall can be avoided.

The membrane rupturing device has the characteristics of wider application range, more flexibility and more safety. The membrane rupturing device can reduce the whole pushing force, can slowly lift the membrane by virtue of the external thread of the threaded pipe of the puncture assembly when the puncture assembly partially punctures the membrane, can completely rupture the membrane without giving the pushing force, and reduces the displacement of the membrane covered stent.

Drawings

Fig. 1 shows a schematic structural diagram of a membrane rupturing device according to an embodiment of the present invention.

Fig. 2 shows a perspective view of an anchor assembly of an embodiment of the present invention.

Fig. 3 shows a schematic plan view of an anchor assembly of an embodiment of the present invention.

Fig. 4 shows a cross-sectional view a-a in fig. 3.

Fig. 5 shows a schematic perspective view of a balloon having a spherical shape.

Fig. 6a and 6b show the cross section of the balloon with two and three lobes respectively.

Fig. 7 shows a schematic representation of the balloon when an expanding stent is used.

Fig. 8a and 8b show two further schematic views of the section a-a in fig. 3, respectively.

Fig. 9 is a schematic perspective view of a bend adjustment assembly according to an embodiment of the present invention.

Fig. 10a and 10b show schematic plan views of a bend adjusting assembly according to an embodiment of the present invention before and after sizing, respectively.

Fig. 11 shows a schematic cross-sectional view B-B in fig. 10B.

Fig. 12a-12c respectively show schematic views of alternative configurations of bend adjustment assemblies.

Fig. 13 shows a perspective view of a spike assembly in accordance with an embodiment of the present invention.

Fig. 14 shows a schematic plan view of a puncture assembly according to an embodiment of the invention.

Fig. 15 shows a schematic plan view of the puncture needle head of the puncture assembly according to the embodiment of the present invention.

Fig. 16 shows a perspective view of a puncture needle having two needle points.

Fig. 17 shows a perspective view of a puncture needle with a bent tip.

FIG. 18 shows a schematic plan view of the threaded tube of the spike assembly in an embodiment of the present invention.

Figure 19 shows a perspective view of an alternative construction of the threaded pipe.

Fig. 20 shows a perspective view of an alternative construction of a threaded pipe.

FIG. 21 shows a schematic plan view of a second catheter of the spike assembly in accordance with an embodiment of the present invention.

FIG. 22 is a perspective view of an alternative configuration of the secondary catheter of the spike assembly in accordance with an embodiment of the present invention.

FIG. 23 shows a perspective view of a handle assembly according to an embodiment of the present invention.

FIG. 24 shows a cross-sectional view of a handle assembly of an embodiment of the present invention.

FIG. 25 is a perspective view of the outer tube base of the handle assembly of an embodiment of the present invention.

FIG. 26 shows a cross-sectional view of the outer tube base of the handle assembly of an embodiment of the present invention.

FIG. 27 shows a perspective view of the middle tube seat of the handle assembly of an embodiment of the present invention.

FIG. 28 shows a cross-sectional view of the mid-tube seat of the handle assembly of an embodiment of the present invention.

FIG. 29 is a perspective view of the inner hub of the handle assembly of an embodiment of the present invention.

FIG. 30 shows a cross-sectional view of the inner hub of the handle assembly of an embodiment of the present invention.

FIG. 31 is a schematic view showing the engagement of the adjusting nut and the peristaltic disk of the inner tube base of the handle assembly according to the embodiment of the present invention.

FIG. 32 shows a schematic plan view of an aortic vessel with a stent graft placed therein.

Fig. 33 shows a schematic diagram of the rupture of the membrane of the left subclavian artery in the LAO position.

FIG. 34 shows a schematic view of a projection of a branch vessel onto a stent graft.

Fig. 35 shows a schematic representation of the contrast at the RAO position.

Fig. 36 shows a schematic view of the angular change adjustment of the bend adjustment assembly at a predetermined angle.

FIG. 37 shows a schematic of stripping with the external threads of the threaded tube of the spike assembly.

Description of the reference symbols

The membrane rupture device 1, the anchoring component 10, the balloon 101, the first catheter 102, the first cavity 1021, the balloon filling cavity 1022, the connection valve 103, the bend adjusting component 20, the short straight section 201, the transition section 202, the long straight section 203, the second cavity 204, the puncture component 30, the puncture needle 301, the threaded tube 302, the second catheter 303, the rectangular opening 3031, the third cavity 304, the handle component 40, the outer tube seat 41, the first small inner cavity 411, the first large inner cavity 412, the first hand-held part 413, the rotation angle indicator 414, the middle tube seat 42, the second small inner cavity 421, the angle indicator 422, the second large inner cavity 423, the guide installation groove 424, the limit switch 425, the inner tube seat 43, the fast and slow adjusting device 431, the tube seat body 432, the inner cavity 4321, the threaded section 4322, the second hand-held part 433, the connection joint 434, the peristaltic sheet 435, the connection block 4351, the local arc-shaped bump 4352, the adjusting nut 436, the groove 4361, the limit ring 437, the membrane-covered stent 50, a covering film 51, an aortic blood vessel 60, a brachiocephalic trunk 61, a left common carotid artery 62, a left subclavian artery 63 and a guide wire 70.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Please refer to fig. 1-21. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.

The present embodiment introduces an intraluminal membrane rupturing device 1, wherein fig. 1 shows a schematic structural diagram of the membrane rupturing device 1 of the present embodiment. As shown in fig. 1, the membrane rupturing device 1 is an assembly formed by combining the components such as the anchor component 10, the bend adjusting component 20, the puncture component 30, the handle component 40 and the like through a certain process. For convenience of explanation, the end of each component and device near the operator is defined as a proximal end, and the end far from the operator is defined as a distal end.

Fig. 2 shows a perspective view of the anchor assembly 10, fig. 3 shows a plan view of the anchor assembly 10, and fig. 4 is a cross-sectional view taken along line a-a of fig. 3. As shown in fig. 2-4, the anchor assembly 10 is one of the components constituting the membrane rupturing device 1, and has a first cavity 1021 therein for providing a track for the bending adjustment assembly 20. Anchor assembly 10 is a balloon catheter comprised of a balloon 101, a first catheter 102, and a connection valve 103.

As shown in fig. 2-4, in the present embodiment, the balloon 101 is attached to the distal end of the first catheter tube 102, and the distal end of the first catheter tube 102 has a tip located outside the balloon 101, so that the bending adjustment assembly 20 can extend from the distal tip of the first catheter tube 102.

As shown in fig. 2-4, in this embodiment, the overall shape of balloon 101 is a cylinder with a circular or near-circular cross-section. Balloon 101 has an overall length H1 in the range of 5-20mm, such as 5mm, 10mm, 15mm, or 20 mm. After inflation of balloon 101, which has an overall diameter D1 in the range of 16-20mm, such as 16mm, 17mm, 18mm, 19mm or 20mm, the diameter D1 of balloon 101 needs to be slightly larger than the diameter of the branch vessel to be anchored by the radial pressure of the vessel after it has been attached to the wall. The wall thickness of balloon 101 may range from 0.2-1mm, such as 0.2mm, 0.4mm, 0.6mm, 0.8mm, or 1 mm. The distance L1 between the balloon 100 and the distal end of the first catheter 102 is in the range of 5-10mm, such as 5mm, 6mm, 7mm, 8mm, 9mm, or 10 mm. The balloon 101 may be made of or mixed with a polymer material, such as polyether block amide, thermoplastic polyurethane elastomer rubber, nylon or silicone.

It should be noted that in some embodiments, the shape of balloon 101 may also be a ball as shown in fig. 5. In other embodiments, balloon 101 may also be a structure with a cross-section in the shape of multiple shapes such as two (see fig. 6a), three petals (see fig. 6b), and the like. In still other embodiments, balloon 101 may also be an expandable stent as shown in fig. 7, which is woven from shape memory alloy or cut from elastic polymer material.

As shown in fig. 2-4, in the present embodiment, the first conduit 102 is a double-layer pipe, and each layer of material may be the same or different. The gap between the double-layer tubes serves as a balloon filling cavity 1022, the balloon filling cavity 1022 is communicated with the balloon 101, and the central hole of the inner tube of the double-layer tube serves as a first cavity 1021 of the anchoring assembly 10 to provide a track for the bending adjustment assembly 20. The first conduit 102 has an overall shape of an elongated cylinder having a cross-section in the shape of a multi-layered circular ring. The overall length H2 of the first conduit 102 ranges from 350 to 1000mm, such as 350mm, 500mm, 650mm, 800mm, 950mm or 1000 mm; the overall diameter D2 of the first conduit 102 ranges from 2-3mm, such as 2mm, 2.2mm, 2.4mm, 2.6mm, 2.8mm, or 3 mm; the lumen diameter of the first catheter 102 ranges from 1.2-2.0mm, such as 1.2mm, 1.4mm, 1.6mm, 1.8mm, or 2.0 mm. The first conduit 102 may be made of a polymer material or a material mixed with a polymer, such as polyether block amide, nylon, or a metal tube with a teflon coating.

It should be noted that, in some embodiments, referring to fig. 8, the first catheter 102 may be a single-layer tube with a plurality of lumens, one lumen is used as the first lumen 1021 to provide a track for the bending module 20, and the other lumens are used as balloon inflation lumens 1022, one or more balloon inflation lumens 1022 may be provided, and may be provided at one side of the first lumen 1021 or around the first lumen 1021, and the cross-sectional shape of the balloon inflation lumens 1022 may be circular or any shape arranged according to the cross-sectional shape around the first lumen 1021, where fig. 8a shows that 2 balloon inflation lumens 1022 are provided around the first lumen 1021, and fig. 8b shows that 3 balloon inflation lumens 1022 are provided around the first lumen 1021 respectively.

As shown in fig. 2 and 3, in the present embodiment, the connection valve 103 has a Y-shaped structure. The distal end of the connecting valve 103 is connected with the proximal end of the first conduit 102, and the distal end of the connecting valve 103 is communicated with the first cavity 1021; the proximal end of the connection valve 103 is threadedly connected to the distal end of the outer tube base 41 of the handle assembly 40, thereby enabling assembly of the anchor assembly 10 to the handle assembly 40; one end of the connection valve 103 between the distal end and the proximal end is a filling end, the filling end is communicated with the balloon filling cavity 1022, and the filling end is connected with the pressure pump for filling the balloon 101 through the balloon filling cavity 1022. Of course, the second end of the connection valve 103 and the distal end of the outer tube seat 41 may be connected by interference fit or other suitable means.

Fig. 9 is a schematic perspective view of the bend-adjusting assembly 20, fig. 10a and 10B are schematic plan views of the bend-adjusting assembly 20 before and after sizing, respectively, and fig. 11 is a schematic sectional view taken along line B-B in fig. 10B. As shown in fig. 9-11, the bend-adjusting assembly 20 is one of the components constituting the membrane rupturing device 1, the bend-adjusting assembly 20 is coaxially sleeved in the anchor assembly 10, the bend-adjusting assembly 20 can extend from the distal end of the anchor assembly 10, and the bend-adjusting assembly 20 is provided with a second cavity 204 therein, which can provide a track for the puncture assembly 30.

As shown in fig. 10a and 10b, in the present embodiment, the bending adjustment assembly 20 is a preset angle bending adjustment assembly, and is formed by bending and heat-treating a pipe with a circular cross section. The bend-adjusting assembly 20 comprises a short straight section 201, a transition section 202 and a long straight section 203 which are connected in sequence, wherein the short straight section 201 and the long straight section 203 are connected through the transition section 202, and inner holes of the short straight section 201, the transition section 202 and the long straight section 203 are communicated in sequence to form a second cavity 204. The short straight section 101 and the long straight section 203 have a predetermined angle α, which is in the range of 0 ° to 360 °, preferably 90 ° to 180 °. The bending adjusting component 20 is made of a polymer material, a material mixed with a polymer, or a metal material. When the short straight section 201 and the transition section 202 of the bend-adjusting component 20 extend out from the anchoring component 10, when the puncture needle device is used, the included angle between the short straight section 101 and the long straight section 203 can be adjusted by adjusting the length of the bend-adjusting component 20 for withdrawing the anchoring component 10, so that the angle of the puncture needle head 301 of the puncture component 30 is changed, and the centering of the rupture device 1 is realized.

As shown in fig. 10b, in the present embodiment, the transition section 202 may be a circular arc section (or may be another suitable curved section), and the short straight section 201 and the long straight section 203 are respectively disposed tangentially to the transition section 202. The short straight section 201 has a length in the range of 1-20mm, such as 1mm, 5mm, 10mm, 15mm or 20 mm; the radius R1 of the transition section 202 is in the range of 2-20mm, such as 2mm, 6mm, 10mm, 14mm, 18mm or 20mm, and the length of the long straight section 203 is in the range of 350mm and 1000mm, such as 350mm, 500mm, 650mm, 800mm, 950mm or 1000 mm. The bending adjustment assembly 20 has an overall length L2 in the range of 365 and 1050mm, such as 365mm, 550mm, 750mm, 950mm or 1050mm, wherein the overall length is defined as the length of the pipe before being bent and heat-treated. The outside diameter D3 of bend adjustment assembly 20 ranges from 1.2mm to 1.8mm, such as 1.2mm, 1.4mm, 1.6mm, or 1.8 mm; the wall thickness of bend adjustment assembly 20 may range from 0.1mm to 0.5mm, such as 0.1mm, 0.2mm, 0.3mm, 0.4mm, or 0.5 mm.

As shown in fig. 11, in the present embodiment, the inner cross-sectional contour and the outer cross-sectional contour of the bend adjustment assembly 20 are circular. It is understood that, in some embodiments, the inner cross-sectional profile of the bend adjustment assembly 20 may also be square, regular polygon, or other suitable shapes, and the outer cross-sectional profile of the bend adjustment assembly 20 may also be square, regular polygon, or other suitable shapes.

Fig. 10b shows only one short straight segment 201 and one long straight segment 203 of the bend-adjusting assembly 20, and the preset included angle between the short straight segment 201 and the long straight segment 203 is 120 °. It is understood that, in some embodiments, as shown in fig. 12a to 12c, the bending adjustment assembly 20 may also include one long straight section 203, a plurality of short straight sections 201, and a plurality of transition sections 202, the long straight section 203 and the short straight section 201 are connected by the transition section 202 (which may be an arc section), the short straight section 201 and the short straight section 201 are connected by the transition section 202 (which may be an arc section), and the included angles between two adjacent straight sections may be the same or different, where fig. 12a to 12c sequentially show that the bending adjustment assembly 20 includes 2, 3, and 4 short straight sections 201.

Of course, in some embodiments, the bend adjustment assembly 20 may also be an adjustable bend, and includes a tube body and a traction wire, the traction wire is disposed along the tube body, the traction wire can slide in the tube body, one end of the traction wire is fixed to the distal end of the tube body, the other end of the traction wire is connected to the handle assembly 40, the distal end of the tube body has a certain elasticity, and the curvature of the distal end of the tube body can be changed by controlling the traction wire through the handle assembly 40.

Fig. 13 is a perspective view of the spike assembly 30 and fig. 14 is a plan view of the spike assembly 30. As shown in fig. 13 and 14, the puncture assembly 30 is one of the components constituting the membrane rupturing device 1, and is coaxially sleeved in the bending adjustment assembly 20, the puncture assembly 30 can extend from the distal end of the bending adjustment assembly 20, and a third cavity 304 is formed in the puncture assembly 30 and can provide a track for the guide wire 70 (see fig. 37).

In this embodiment, as shown in fig. 13 and 14, the puncture assembly 30 is a long needle that can be threaded through a wire, and has a cylindrical overall shape. The puncture needle consists of a puncture needle head 301, a threaded pipe 302 and a second guide pipe 303 which are connected in sequence, the three parts can be connected together through a certain process or processed on a pipe, and inner holes of the puncture needle head 301, the threaded pipe 302 and the second guide pipe 303 are communicated in sequence to form a third cavity 304. The length L4 of the spike assembly 30 ranges from 380mm to 1100mm, such as 380mm, 500mm, 650mm, 800mm, 950mm or 1100 mm; the overall outer diameter D4 of spike assembly 30 ranges from 0.5mm to 1.0mm, such as 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, or 1.0 mm. In use, the piercing needle 301 and threaded tube 302 extend from the distal tip of bend adjustment assembly 20, see fig. 37.

Fig. 15 shows a schematic plan view of the puncture needle tip 301 of the present embodiment. The puncture needle 301 has a needle tip, and the needle tip is a straight needle tip. The overall length L5 of the piercing needle 301 ranges from 1 to 10mm, such as 1mm, 3mm, 5mm, 7mm, 9mm or 10 mm; the puncture needle 301 has an overall outer diameter D5 in the range of 0.5-1.0mm, such as 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1.0 mm. The puncture needle 301 is made of a single metal material or a material mixed with metal, and may be made of stainless steel, nickel titanium, or the like.

In this embodiment, the maximum outer diameter D5 of the puncture needle 301 does not exceed the minimum outer diameter of the threaded tube 302, so that the diameter of the opening formed by the puncture needle 301 for puncturing the membrane does not exceed the minimum outer diameter of the threaded tube 302, so as to enable slow membrane lifting by rotation of the external thread of the threaded tube 302 of the puncture assembly 30 (see fig. 37).

In this embodiment, the inner bore of the piercing needle 301 is circular. Of course, the inner bore of the puncture needle 301 may have other suitable shapes such as a square shape, a regular polygon shape, and the like. In the present embodiment, as shown in fig. 15, the puncture needle 301 has a needle tip, and the center line of the needle tip of the puncture needle 301 is parallel to the axis of the puncture needle 301. Of course, the number of the puncture needle 301 may be two or three or more, for example, the puncture needle 301 having two needle points as shown in fig. 16. The tip centerline of the piercing needle 301 may not be parallel to the axis of the piercing needle 301 as shown in fig. 17.

Fig. 18 shows a schematic plan view of the threaded pipe 302 of the present embodiment. The threaded pipe 302 is a pipe manufactured by machining a pipe material to have an external thread, and the cross section of the pipe is circular, the external thread of the threaded pipe 302 is a female thread, but the external thread of the threaded pipe 302 may be a male thread as shown in fig. 20. The overall length L6 of threaded tube 302 ranges from 4-15mm, such as 4mm, 7mm, 10mm, 13mm, or 15 mm; the overall outside diameter D6 of threaded tube 302 is in the range of 0.5-1.0mm, such as 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, or 1.0 mm. The material of the threaded tube 302 is a single metal material or a material mixed with metal, and may be stainless steel or nickel titanium.

In this embodiment, the inner bore of threaded tube 302 is circular. Alternatively, the inner bore of threaded tube 302 may have other suitable shapes such as square, regular polygon, etc.

In this embodiment, the threaded pipes 302 have the same outer diameter in the axial direction. Alternatively, the threaded tube 302 may be tapered so that the maximum outer diameter of the piercing needle 301 does not exceed the minimum outer diameter of the second catheter 303.

In an alternative embodiment, threaded tube 302 may also be printed by a 3D metal printer.

In an alternative embodiment, as shown in fig. 19, the thread of the threaded pipe 302 may be made of round wire or flat wire, etc. through a certain process, and then the thread is connected to the conduit pipe through a welding, gluing or hot melting process, etc., the conduit pipe may be a metal pipe or a braided pipe, and the thread of the threaded pipe 302 may be made of metal, metal-mixed material or polymer material, etc.

Fig. 21 shows a schematic plan view of the second conduit 303 of the present embodiment. The second conduit 303 is a tube having a certain flexibility, a strong transmission of pushing force, and a good transmission of torque, and has a circular cross section. To increase the flexibility of the second conduit 303, rectangular openings 3031 spaced apart in the axial direction may be formed in the wall of the second conduit 303 by a laser cutting process. The second conduit 303 is made of a metal material, a material mixed with metal, or a polymer material, and may be stainless steel, nickel titanium, or polyetheretherketone.

As shown in FIG. 21, in the present embodiment, the overall length L7 of the second conduit 303 ranges from 365 and 1005mm, such as 365mm, 500mm, 650mm, 800mm, 950mm, or 1005 mm; the overall outer diameter D7 of the second conduit 303 ranges from 0.5 to 1.0mm, such as 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1.0 mm.

In this embodiment, the inner bore of the second conduit 303 is circular. Alternatively, the inner bore of the second conduit 303 may be square, regular polygon, or other suitable shape.

In an alternative embodiment, as shown in fig. 22, the second conduit 303 may be formed into a tube form by a certain process from a plurality of round wires or flat wires, and the number of the wires may be 9 or 12.

Fig. 24 and 25 show a perspective view and a cross-sectional view, respectively, of the handle assembly 40 of the present embodiment. The handle assembly 40 is one of the components constituting the membrane rupturing device 1. The handle assembly 40 is coupled to the anchor assembly 10, the bend adjustment assembly 20 and the spike assembly 30, respectively, by a process that controls the manner in which they move. The handle assembly 40 is a two-handed handle. The handle assembly 40 is composed of an outer tube base 41, a middle tube base 42 and an inner tube base 43, wherein the outer tube base 41 is connected with the anchoring assembly 10, the middle tube base 42 is connected with the bending adjusting assembly 20, and the inner tube base 43 is connected with the puncture assembly 30.

Fig. 26 and 27 show a perspective view and a cross-sectional view of the outer tube base 41 of the present embodiment, respectively. As shown in fig. 1, 26 and 27, the distal end of the outer tube holder 41 is threadably connected to the proximal end of the connection valve 103 of the anchor assembly 10. The overall shape of the outer tube holder 41 is a cylinder having a hollow inner cavity; the length L9 of the outer tube base 41 ranges from 120mm to 150mm, such as 120mm, 130mm, 140mm or 150 mm; the outer tube base 41 has an overall outer diameter D9 of 30-40mm, such as 30mm, 32mm, 34mm, 36mm, 38mm, 40 mm.

As shown in fig. 26 and 27, in the present embodiment, the outer tube base 41 includes a first small inner cavity 411, a first large inner cavity 412, a first hand-held portion 413, and a rotation angle indicator 414. The first small inner cavity 411 is communicated with the first large inner cavity 412, the first handheld part 413 is positioned in the middle of the outer tube base 41, the rotation angle indicator 414 is positioned at the proximal end of the outer tube base 41, and the rotation angle indicator 414 is fixedly connected with the first handheld part 413. The first small inner cavity 411 is positioned at the distal end of the outer tube seat 41, and the first small inner cavity 411 is used as a catheter cavity for the bending adjustment assembly 20 to move back and forth and rotate in; the first large lumen 412 is located at the proximal end of the outer tube support 41 for the distal end of the middle tube support 42 to move back and forth and rotate therein. The first hand-held portion 413 is for an operator to hold, and is ergonomic. The rotation angle indicator 414 is an angle indicator for allowing an operator to know how much the bending adjustment assembly 20 rotates when rotating the middle tube seat 42. It should be noted that the first large inner cavity 412 may be a screw thread, a smooth surface, a gear, a worm gear, or other suitable shapes.

Fig. 28 and 29 show a perspective view and a cross-sectional view of the middle stem 42 of the present embodiment, respectively. As shown in fig. 1, 28 and 29, a central hub 42 is connected to the proximal end of bend adjustment assembly 20. The overall shape of the middle tube holder 42 is a cylinder with a hollow inner cavity; the length L10 of the middle stem 42 ranges from 110mm to 150mm, such as 110mm, 120mm, 130mm, 140mm or 150 mm; the overall outer diameter D10 of the middle tube base 42 is 20-40mm, such as 20mm, 25mm, 30mm, 35mm or 40 mm.

As shown in fig. 28 and 29, in the present embodiment, the middle tube seat 42 includes a second small inner cavity 421, an angle mark 422, a second large inner cavity 423, and a limit switch 425. The distal end of the middle tube seat 42 is inserted into the first large inner cavity 412 of the outer tube seat 41 and can move back and forth and rotate in the first large inner cavity 412.

The second small inner cavity 421 is communicated with the second large inner cavity 423, the second small inner cavity 421 is positioned at the distal end of the middle tube seat 42, and the second small inner cavity 421 serves as a catheter cavity for the puncture assembly 30 to move back and forth and rotate in the catheter cavity; the second large lumen 423 is provided at the proximal end of the middle tube holder 42 for the inner tube holder 43 to move forward and backward and rotate therein.

The limit switch 425 is tubular and is sleeved at the near end of the middle tube seat 42, a limit bump (not marked) is arranged on the inner wall of the limit switch 425 and can be matched with a limit clamping groove (not marked) on the outer wall of the near end of the middle tube seat 42, so that the limit switch 425 can move axially and be locked relative to the middle tube seat 42, and the maximum moving distance of the inner tube seat 43 to the outer tube seat 41 can be limited by adjusting the length of the limit switch 425 protruding out of the near end of the middle tube seat 42. Alternatively, the limit switch 425 may be a screw locking structure or a snap locking structure.

As shown in fig. 28 and 29, in the present embodiment, the middle stem 42 further includes a guide installation groove 424 penetrating the middle stem 42, the guide installation groove 424 penetrates the second large inner cavity 423, and the guide installation groove 424 is used for installing the inner stem 43 in the second large inner cavity 423.

Fig. 30 and 31 show a perspective view and a cross-sectional view of the inner tube base 43 of the present embodiment, respectively. As shown in FIGS. 1, 30 and 31, the inner hub 43 is connected to the proximal end of the spike assembly 30. The length L11 of the inner tube seat 43 ranges from 100mm to 150mm, such as 100mm, 110mm, 120mm, 130mm, 140mm or 150 mm; the overall outer diameter D11 is 20-40mm, 20mm, 25mm, 30mm, 35mm or 40 mm.

As shown in fig. 30 and 31, in the present embodiment, the inner tube base 43 includes a quick/slow adjustment device 431, a tube base body 432 having an inner cavity 4321, a second hand-held portion 433, and a connection joint 434. A second hand grip 433 is located at the proximal end of the inner hub 43, the hand grip 433 being for an operator to hold, which is ergonomic. The fourth lumen 432 is a guide wire evacuation lumen for the guide wire 70 to move forward and backward and rotate therein, and also for evacuation of the rupture device 1.

The connecting joint 434 is located at the proximal end of the inner tube seat 43 and is used for connecting medical instruments such as a needle tube and the like with the membrane rupturing device 1, the connecting joint 434 is of a tubular structure, and an inner hole of the connecting joint 434 is communicated with the fourth inner cavity 432. As an example, the connection joint 434 may be a tubular structure having connection threads, and the membrane rupturing device 1 may be screwed with a medical instrument such as a needle tube through the connection joint 434.

The fast-slow adjusting device 431 is sleeved on the distal end of the tube seat body 432 for adjusting the moving manner of the puncture assembly 30, and the moving manner may be linear movement (corresponding to fast gear) or rotational movement (corresponding to slow gear). The slow gear position causes the spike assembly 30 to rotate (left or right) proximally or distally and the fast gear position causes the spike assembly 30 to rotate linearly proximally or distally.

As shown in fig. 23, 24, 30 and 31, the speed adjustment device 431 includes an adjustment nut 436, a creep plate 435 and a limiting ring 437, the adjustment nut 436 is ring-shaped, the adjustment nut 436 is sleeved on the middle tube seat 42 and limited by the limiting ring 437, the adjustment nut 436 corresponds to the guiding installation groove 424 of the middle tube seat 42, and the adjustment nut 436 can rotate around the middle tube seat 42. The inner wall of the adjusting nut 436 is inwardly grooved 4361. The peristaltic motion piece 435 is annular, a local arc-shaped bump 4352 is arranged on the inner wall of the peristaltic motion piece 435 along the circumferential direction, and the local arc-shaped bump 4352 is matched with the external thread of the threaded section 4322 of the tube seat body 432; the outer side wall of the peristaltic motion piece 435 is symmetrically provided with a pair of connecting blocks 4351 outwards, one connecting block 4351 corresponds to the partial arc-shaped convex block 4352, the peristaltic motion piece 435 is installed in the middle tube seat 42 through the connecting block 4351, the two connecting blocks 4351 extend into the guide installation groove 424 of the middle tube seat 42, and the connecting block 4351 extends out of the guide installation groove 424 and is matched with a groove 4361 arranged on the inner wall of the adjusting nut 436 to realize gear adjustment.

The distal end of the tube holder body 432 is provided with a threaded section 4322, and when the distal end of the tube holder body 432 of the inner tube holder 43 is inserted into the second large inner cavity 423 of the middle tube holder 42, the peristaltic blades 435 are sleeved on the threaded section 4322. When the gear is adjusted, by rotating the adjusting nut 436, when the connecting block 4351 corresponding to the partial arc-shaped projection 4352 abuts against the inner wall of the adjusting nut 436 and the other connecting block 4351 abuts against the bottom of the groove 4361 of the adjusting nut 436, the partial arc-shaped projection 4352 of the peristaltic slice 435 is engaged with the external thread of the threaded section 4322 of the tube seat body 432, and the inner tube seat 43 can only move rotationally (corresponding to a slow gear); when the connection block 4351 corresponding to the partial arc-shaped projection 4352 abuts against the bottom of the groove 4361 of the adjusting nut 436 and the other connection block 4351 abuts against the inner wall of the adjusting nut 436, the partial arc-shaped projection 4352 of the peristaltic sheet 435 is separated from the external thread of the threaded section 4322 of the tube seat body 432, and the inner tube seat 43 can move back and forth along a straight line under the pushing force (corresponding to a fast gear).

It should be noted that, in some embodiments, the fast and slow adjusting device 431 may also be a screw structure, a worm gear structure, a gear structure or other structures capable of achieving the functions thereof.

FIG. 32 is a schematic plan view of an aortic blood vessel 60 with a stent graft 50 placed therein. The branch vessels are, from left to right, the brachiocephalic trunk 61, the left common carotid artery 62 and the left subclavian artery 63. The blood vessels of the approach are respectively a right common carotid artery, a left common carotid artery and a left brachial artery. There are LAO views and RAO views under DSA.

As shown in fig. 33, the following description will be made of the method for rupture of the left subclavian artery to illustrate the use of the rupture device 1 of the present invention, including the following steps:

in the first step, the rupture device 1 is evacuated, and then the rupture device 1 is introduced along the left brachial artery vessel until the distal end of the anchor assembly 10 of the rupture device 1 abuts against the covering membrane.

And secondly, observing the positions of the membrane rupturing device 1, the branch blood vessel and the host blood vessel under DSA (digital radiography). When the stent is pressed against the covering film, the filled balloon 101 can be anchored to the blood vessel and the membrane breaking device 1 can pierce the blood vessel wall or break the membrane to the position of the left common carotid artery 62. The rupture device 1 therefore needs to be withdrawn proximally behind the bend of the branch vessel to ensure that the surface of the balloon 101 is fully anchored to the branch vessel.

And thirdly, filling liquid (which can be medical saline, contrast liquid and the like) into the balloon 101 through the balloon filling cavity 1022 to expand the balloon 101 until the rupture device 1 is completely anchored on the central axis of the branch vessel.

Fourthly, under the observation of DSA radiography, the branch vessel wall is punctured to avoid the puncture assembly 30 of the membrane rupturing device 1 extending directly to perform membrane rupturing. Therefore, the bending adjustment component 20 of the rupture device 1 needs to be pushed distally to allow the bending adjustment component 20 to extend from the distal end of the anchoring component 10.

In a fifth step, as shown in FIG. 34, the bending adjustment assembly 20 is rotated to the LAO position, and the distal end of the catheter of the bending adjustment assembly 20 is located near the center of the projected contour of the branch vessel on the stent graft 50.

Sixthly, as shown in fig. 35, under the RAO contrast of switching the view angle to DSA, the distal end of the catheter of the bending adjustment assembly 20 is observed to be located near the central axis of the branch vessel, so as to ensure that the puncture assembly 30 does not puncture the vessel wall.

And seventhly, switching the visual angle to the LAO contrast of the DSA to break the membrane. When a relatively thick and hard stent graft 50 is used, membrane rupture is required at a slow speed, and the puncture assembly 30 can be operated at a slow speed by the speed adjustment device 431 of the handle assembly 40 and rotated to rupture the membrane. When the stent graft 50 with a thin and easily punctured membrane is used, the puncture assembly 30 works at a fast gear by using the fast and slow adjusting device 431 on the handle assembly 40 to directly rupture the membrane.

The membrane rupturing device 1 of the embodiment can adjust the angle by means of the built-in bending adjusting component 20, and when the angle between the branch blood vessel and the host blood vessel is small, the membrane rupturing device 1 can be centered without other devices for assisting in centering membrane rupturing devices. Taking the bending adjustment assembly 20 with the predetermined angle α shown in fig. 10 as an example, the different angle β can be adjusted by adjusting the length of the bending adjustment assembly 20 for retracting the anchor assembly 10, as shown in fig. 36a and 36b, and the centering of the rupture device 1 can be achieved by changing the angle β to synchronously change the angle of the puncture needle 301.

The membrane rupturing device 1 of the embodiment punctures the membrane by means of the rotation of the needle tip part of the puncture needle head 301 of the puncture assembly 30, reduces the pushing force to the puncture assembly 30, and thus can reduce the displacement of the covered stent. The membrane rupture device 1 of this embodiment can rely on puncture subassembly's rotation to puncture the tectorial membrane when carrying out the rupture of membranes to the tectorial membrane is thick or harder support, and puncture subassembly can not be on sliding on the tectorial membrane to can avoid pricking the risk of vascular wall. The membrane rupturing device 1 of the embodiment has the characteristics of wider application range, more flexibility and more safety.

As shown in fig. 37, the membrane rupturing device 1 of the present embodiment can reduce the entire pushing force, and when the puncture set 30 partially punctures the membrane 51, the membrane can be slowly lifted by the external thread of the threaded tube 302 of the puncture set 30, and the membrane can be completely ruptured without applying the pushing force, thereby reducing the displacement of the stent graft.

In the description herein, numerous specific details are provided, such as examples of components and/or methods, to provide a thorough understanding of embodiments of the invention. One skilled in the relevant art will recognize, however, that an embodiment of the invention can be practiced without one or more of the specific details, or with other apparatus, systems, assemblies, methods, components, materials, parts, and/or the like. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of embodiments of the invention.

It will also be appreciated that one or more of the elements shown in the figures can also be implemented in a more separated or integrated manner, or even removed for inoperability in some circumstances or provided for usefulness in accordance with a particular application.

Additionally, any reference arrows in the drawings/figures should be considered only as exemplary, and not limiting, unless otherwise expressly specified. Further, as used herein, the term "or" is generally intended to mean "and/or" unless otherwise indicated. Combinations of components or steps will also be considered as being noted where terminology is foreseen as rendering the ability to separate or combine is unclear.

The above description of illustrated embodiments of the invention, including what is described in the abstract of the specification, is not intended to be exhaustive or to limit the invention to the precise forms disclosed herein. While specific embodiments of, and examples for, the invention are described herein for illustrative purposes only, various equivalent modifications are possible within the spirit and scope of the present invention, as those skilled in the relevant art will recognize and appreciate. As indicated, these modifications may be made to the present invention in light of the foregoing description of illustrated embodiments of the present invention and are to be included within the spirit and scope of the present invention.

The systems and methods have been described herein in general terms as the details aid in understanding the invention. Furthermore, various specific details have been given to provide a general understanding of the embodiments of the invention. One skilled in the relevant art will recognize, however, that an embodiment of the invention can be practiced without one or more of the specific details, or with other apparatus, systems, assemblies, methods, components, materials, parts, and/or the like. In other instances, well-known structures, materials, and/or operations are not specifically shown or described in detail to avoid obscuring aspects of embodiments of the invention.

Thus, although the present invention has been described herein with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosures, and it will be appreciated that in some instances some features of the invention will be employed without a corresponding use of other features without departing from the scope and spirit of the invention as set forth. Thus, many modifications may be made to adapt a particular situation or material to the essential scope and spirit of the present invention. It is intended that the invention not be limited to the particular terms used in following claims and/or to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include any and all embodiments and equivalents falling within the scope of the appended claims. Accordingly, the scope of the invention is to be determined solely by the appended claims.