CN219207219U - Membrane breaker for endovascular surgery - Google Patents

Abstract

The utility model belongs to the field of medical instruments, and particularly relates to a membrane breaker for endovascular surgery. The utility model provides a membrane breaker system which combines a membrane breaking needle and an adjustable bent sheath in a modularized manner, wherein a sheath tube can realize one-section, two-section and even multi-section bending, and can also realize unidirectional, bidirectional and multidirectional bending to assist in accurate membrane breaking of the membrane breaking needle.

Description

Membrane breaker for endovascular surgery

Technical Field

The utility model belongs to the field of medical instruments, and particularly relates to a membrane breaker for endovascular surgery.

Background

The current preferred treatment for Stanford B aortic dissection is percutaneous stent implantation. The current treatment scheme of aortic aneurysms involving branch blood vessels is to release a covered stent through a conveying system, rupture membranes at the branch blood vessels, expand the holes by using a balloon after rupture of the membranes, and release the branched stent to ensure normal supply of branched blood flow.

(1) After the aortic arch releases the covered stent, the covered stent is punctured from the vascular access of the three-branch brachiocephalic artery, the left common carotid artery and the left subclavian artery, and the whole operation process for releasing the covered stent comprises the rupture needle for rupture of the membrane, so that the balloon reaming and the branch stent release are carried out from the branch vessel, the damage to the branch vessel is large, and the occurrence rate of cerebral infarction complications is high.

(2) After the aortic arch is released and covered by the stent, the curved sheath (or the adjustable curved sheath) is introduced into the branch inlet along the original conveying system passage, the membrane breaking needle is introduced into the branch opening along the sheath to puncture and break the membrane, the membrane breaking needle is retracted after the puncture is completed, and the balloon is used for reaming, so that the damage caused by the operation of the branched vessel part is reduced compared with the reverse puncture and breaking of the branched vessel (1), but the same branch reconstruction time is longer, and the risk of the main body covered stent blocking the branched blood flow is larger as the operation time is longer.

(3) The existing regulating sheath is mostly one-section regulating bending or one-way regulating bending, and due to individual difference of the aortic branch vessels of the patient, when the angle alpha between the branch vessels and the aortic vessels is large, the optimized angle adjustment can not be realized after one-section regulating, the puncture effect is poor, and even the risk of damaging the wall of the branch vessels can be caused, as shown in fig. 1.

When the bow is complex, multi-terminal, multi-directional bending adjustment is required to achieve rupture of the membrane.

Disclosure of Invention

Because the branch vessel is mainly used for supplying blood to the brain, if the branch is damaged or blood volume is blocked for a long time, cerebral infarction complications can be caused, and the risk is high, so that the damage of the apparatus to the branch in the operation is reduced, and the time for positioning the branch vessel stent is especially important. Due to individual differences of patients, the aortic branch structure is slightly different, the bending adjustment of the sheath is particularly important in the process of reconstructing the branch blood vessel, and proper angle puncture needs to be adjusted, otherwise, the risk that the wall of the branch blood vessel is damaged by a membrane rupture needle is caused.

In order to solve the above-mentioned existing technical problems, the present utility model provides a membrane breaker for endovascular surgery, comprising:

a membrane rupture needle handle;

the bending sheath structure comprises a bending sheath tube, a handle main body and a plurality of bending sheath handles; the handle main body is detachably connected with the membrane breaking needle handle, and an opening is formed in one end, far away from the membrane breaking needle handle, of the handle main body; the bending sheath tube comprises a plurality of traction wires and a plurality of traction rings, wherein the distal ends of the traction wires are connected with the traction rings, and the proximal ends of the traction wires penetrate through the opening of the handle main body to be connected with the bending sheath handle for adjusting the angle of the bending sheath tube;

the membrane rupture needle sequentially comprises a proximal tube, a membrane rupture needle flexible tube and a needle head, wherein the tail end of the proximal tube is connected with a membrane rupture needle handle, and the position of the needle head and the depth of the puncture membrane rupture are adjusted through the membrane rupture needle handle; the membrane rupture needle flexible tube and the needle head axially extend out of the inner part of the bending sheath tube so as to perform membrane rupture operation.

The utility model relates to a membrane-breaking needle and a bent sheath tube adjusting tube combining type interventional membrane breaking, wherein the membrane-breaking needle is matched with a bent sheath tube for use, so that after bending, the membrane-breaking needle must ensure enough flexibility to perform membrane breaking action through a sheath tube with a bent tip.

Preferably, the membrane breaking needle handle comprises a knob piece, a luer connector, a cylindrical tube and a moving block arranged in the cylindrical tube, the moving block is screwed with the luer connector through threads, and the membrane breaking needle sequentially penetrates through the cylinder and the knob piece to be connected with the moving block.

Specifically, the bending sheath structure and the handle structure of the membrane breaking needle have the same principle, and are not repeated here. The sheath tube is internally provided with a pre-buried traction wire which is fixed with a traction wire connecting block of the bending-adjusting sheath handle assembly. The angle adjustment of the sheath tip is realized by stretching or dilating the traction wire through the rotation of a knob on the bending sheath handle assembly. The traction wire limiting groove is used for guaranteeing the horizontal traction position, improving bending adjustment precision and simultaneously avoiding stress concentration of the traction wire at the outlet of the end part of the sheath tube.

Specifically, the bending sheath tube in the bending sheath structure mainly comprises an inner layer wall, a middle protective layer, an outer layer wall, traction wires and traction rings, wherein the number of the traction rings and the number of the traction wires are determined according to the number of bending sections, and if three sections of bending are realized, 3 traction rings are needed. The traction wire is connected with the traction ring to realize the bending adjustment of the front end of the sheath tube. The traction wire is connected with the traction ring through the cavity. The sheath tube is axially divided into a main body section and a bending section, wherein the bending section can be one section, two sections, multiple sections and the like. The bending adjustment can be one-way, two-way, four-way or even multi-way, and is realized by adjusting the traction wire cavity. The body end needs to provide sufficient rigidity to avoid bending deformation of the body section, and the bending section needs to have certain flexibility to ensure the bending angle.

Further, the membrane breaking needle and the moving block are connected in a glue bonding or welding mode.

Further, the inside of cylinder pipe is equipped with spiral track, is equipped with spacing post on the movable block, is equipped with the spacing groove on the knob spare, spacing post can insert in the spacing groove, makes the movable block carry out spiral rectilinear motion in the inside of cylinder pipe along with spiral track.

Specifically, the inside of the rupture needle handle is in spiral-to-linear motion, and the position of the rupture needle in the sheath tube and the depth of puncture rupture are adjusted through the rupture needle handle. The operator rotates the knob piece clockwise, and the spacing post on the movable block receives the effect of spacing groove, can carry out spiral ascending rectilinear motion, and the movable block can take the rupture of membranes needle to do spiral rectilinear motion to reach the purpose of puncture. Meanwhile, the stroke design of the spiral groove has a safety margin, so that the membrane breaking needle is ensured not to go deep to cause damage after penetrating to the expected depth.

Preferably, the bending sheath handle is in a screw feeding structure.

Preferably, a traction wire limiting groove is further formed in the handle body.

Preferably, the membrane breaking needle handle and the handle body are screwed together through threads.

Preferably, a stress diffusion tube is arranged on the opening of the handle body.

Preferably, the bending sheath handle and the handle body are detachably connected.

Further, the bending sheath handle and the handle main body are connected through a buckle.

Preferably, the bending-adjusting sheath adjusts the compliance of the different tube sections by selecting the hardness as metal braided tube, reed pipe or PEBAX (polyether block polyamide).

The membrane breaker for the endovascular surgery comprises the following specific application steps: the method comprises the steps of adjusting the bending sheath tube to reach the aortic arch part, adjusting the angle of the sheath tube to align with a branch vessel (adjusting the bending of the tip of the sheath tube through a handle mechanism), breaking a membrane by a membrane breaking needle (rotating a knob at the tail end handle), retracting the membrane breaking needle (the membrane breaking needle handle can be disassembled in a modularized and integrally withdrawn mode), and matching an upper saccule reaming-conveying system to enter a branch release branch bracket.

The utility model provides a membrane breaker system which combines a membrane breaking needle and an adjustable bent sheath in a modularized manner, wherein a sheath tube can realize one-section, two-section and even multi-end bending, and can also realize unidirectional, bidirectional and multidirectional bending to assist accurate membrane breaking of the membrane breaking needle, the matched membrane breaking needle ensures flexibility through a structure in a subsequent scheme, the matched membrane breaking needle is specifically operated to puncture in the direction of an aortic approach, the bending sheath enters a branch inlet, the angle of the bending sheath is adjusted to be aligned with a branch port, the axial extension of the membrane breaking needle is realized through a knob on the membrane breaker, the membrane breaking needle is retracted, a balloon is introduced for reaming, and a branch stent is released, so that reconstruction of a branch vessel is realized.

The utility model realizes one-section, two-section or even multi-section bending and unidirectional, bidirectional and multidirectional bending of the sheath, provides a design of the flexible section of the membrane breaking needle, enables the flexible section to smoothly pass through the inner hole of the sheath and break membranes, and also realizes spiral forward puncture action of the membrane breaking needle, so that compared with the existing linear forward puncture effect, the structure has better effect, and ensures accurate positioning of branch membrane breaking. The utility model simplifies the operation steps of the instruments of doctors and the operation time of branch reconstruction in the branch reconstruction process, and reduces the risk of long-time blockage of branch blood flow to the brain.

Compared with the prior art, the technical scheme of the utility model has the following advantages:

the release operation time of the branch stent in the prior art is longer, and the time for reconstructing the branch vessel is shortened through the modularized design of the instrument, so that the blood flow blocking time of the branch vessel in the operation is reduced, and the probability of cerebral infarction risk caused by long-time unsmooth blood flow of the branch vessel is greatly reduced.

The sheath tube structure with the bending adjusted by multiple sections is matched with the membrane rupture needle with the flexible design structure, so that the positioning of the sheath tube is more accurate, and the membrane rupture of the membrane rupture needle is safer and more effective in the process of branch vessel reconstruction.

Drawings

FIG. 1 is a schematic diagram of a prior art membrane breaker.

Fig. 2 is a schematic structural view of the present utility model.

Fig. 3 is a schematic view of a bending sheath structure.

Fig. 4 is a cross-sectional view of the handle of the rupture needle.

Fig. 5 is a schematic view of a disassembled structure of the handle of the membrane-breaking needle.

Fig. 6 is a schematic structural view of a membrane-rupturing needle which is a hypotube.

Fig. 7 is a schematic structural view of a membrane-breaking needle which is a metal wound spring.

Fig. 8 is a cross-sectional view of the internal structure of the buckle-regulating sheath.

Fig. 9 is a schematic structural view of a buckle-regulating sheath.

Fig. 10 is an enlarged schematic view of the present utility model.

Fig. 11 is an enlarged schematic view of the traction wire limiting groove.

Fig. 12 is an enlarged schematic view of the handle body.

Fig. 13 is a schematic structural view of a traction wire and a traction ring.

Fig. 14 is a schematic view of a structure in which the bending sheath is in the form of a wrap spring.

Fig. 15 is a schematic view of a structure in which the bending sheath is braided wire.

Fig. 16 is a schematic diagram showing a structure of a bending adjustment sheath tube for carving a metal tube body.

Reference numerals illustrate: the device comprises a 10-membrane-breaking needle handle, a 11-knob piece, a 12-luer connector, a 13-cylindrical tube, a 14-moving block, a 15-spiral track, a 16-limit column, a 17-limit groove, a 20-bending sheath structure, a 21-bending sheath tube, a 22-handle main body, a 23-bending sheath handle, a 24-traction wire, a 25-traction ring, a 26-traction wire limit groove, a 27-stress diffusion tube, a 30-membrane-breaking needle, a 31-proximal tube, a 32-membrane-breaking needle flexible tube, a 33-needle head, a 41-outer wall, a 42-inner wall, a 43-intermediate protective layer, a 44-first bending section, a 45-second bending section, a 46-traction wire cavity and a 47-main body section.

Detailed Description

The present utility model will be further described with reference to the accompanying drawings and specific examples, which are not intended to be limiting, so that those skilled in the art will better understand the utility model and practice it.

A membrane breaker for endovascular surgery, comprising: a membrane rupture needle handle 10; the bending sheath structure 20 comprises a bending sheath tube 21, a handle main body 22 and a plurality of bending sheath handles 23; the handle body 22 is detachably connected with the membrane breaking needle handle 10, after the membrane breaking is completed, the screw is loosened by anticlockwise rotation through the screw connection mode, and the membrane breaking needle handle 10 and the membrane breaking needle 30 are integrally withdrawn, as shown in fig. 10.

An opening is arranged at one end of the handle main body 22 away from the membrane breaking needle handle 10; the bending sheath tube 21 comprises a plurality of traction wires 24 and a plurality of traction rings 25, wherein the distal ends of the traction wires 24 are connected with the traction rings 25, and the proximal ends of the traction wires penetrate through the opening of the handle main body 22 and are connected with the bending sheath handle 23 for performing angle adjustment of the bending sheath tube 21;

the membrane rupture needle 30 sequentially comprises a proximal tube 31, a membrane rupture needle flexible tube 32 and a needle head 33, wherein the tail end of the proximal tube 31 is connected with a membrane rupture needle handle 10, and the position of the needle head 33 and the depth of puncture membrane rupture are adjusted through the membrane rupture needle handle 10; a membrane-rupturing needle flexible tube 32 and a needle head 33 axially protrude from the inside of the bending sheath tube 21 to perform a membrane-rupturing operation.

The membrane rupture needle handle 10 comprises a knob piece 11, a luer connector 12, a cylindrical tube 13 and a moving block 14 arranged in the cylindrical tube 13, wherein the moving block 14 is screwed with the luer connector 12 through threads, and the membrane rupture needle 30 sequentially penetrates through the cylindrical tube 13 and the knob piece 11 to be connected with the moving block 14.

The membrane breaking needle 30 and the moving block 14 are connected by glue bonding or welding.

The inside of the cylindrical tube 13 is provided with a spiral track 15, the movable block 14 is provided with a limit column 16, the knob piece 11 is provided with a limit groove 17, the limit column 16 can be inserted into the limit groove 17, the movable block 14 can perform spiral linear motion along with the spiral track 15 in the inside of the cylindrical tube 13, and the position of the rupture needle 30 in the bending sheath 21 and the depth of puncture rupture are adjusted through the rupture needle handle 10. As shown in fig. 4 and 5, when the operator rotates the knob member 11 clockwise, the limiting post 16 on the moving block 14 receives the force of the limiting groove and performs spiral ascending linear motion, and the moving block 14 carries the membrane breaking needle 30 to perform spiral linear motion, so as to achieve the purpose of puncture. Meanwhile, the stroke design of the spiral track 15 has a safety margin, so that the membrane rupture needle is ensured not to go deep to cause damage after puncturing to the expected depth.

Similarly, the structure of the bending sheath handle 23 is the same as that of the rupture needle handle 10.

The bending sheath adjusting handle 23 is of a spiral feeding structure, a traction wire limiting groove 26 is further formed in the handle main body 22, the traction wire limiting groove 26 is designed in the handle main body 22, as shown in fig. 11 and 12, the traction wire 24 is always kept at an axial horizontal position in the traction process, bending reliability is improved, and stress concentration at a traction wire outlet of the bending sheath adjusting tube 21 is avoided after transition of the traction wire limiting groove 26 is increased.

The membrane breaking needle handle 10 and the handle main body 22 are connected in a screwed mode through threads, a stress diffusion tube 27 is arranged on an opening of the handle main body 22, and the membrane breaking needle flexible tube 32 is a hypotube or a metal reed pipe; the bending sheath handle 23 and the handle main body 22 are connected through a buckle.

In fig. 8, only the structural design between the bending sheath handle 23 and the bending sheath tube 21 is illustrated, and the bending sheath tube is not limited to bidirectional bending, and may be unidirectional (i.e. one bending sheath handle 23), multidirectional (a plurality of bending sheath handles 23), and similarly, may be single-section bending, or double-end or multiple-end bending.

The bending sheath 21 in the bending sheath structure 20 mainly comprises an inner layer wall 42, an intermediate protective layer 43, an outer layer wall 41, traction wires 24 and traction rings 25, wherein the number of the traction rings 25 and the number of the traction wires 24 are determined according to the number of bending sections, and if three sections of bending are realized, 3 traction rings 25 are needed. The traction wire 24 is connected with the traction ring 25 to realize the bending adjustment of the front end of the bending adjustment sheath tube 21. As shown in fig. 9, the pull wire 24 is connected to the pull ring 25 through a pull wire lumen 46. The bending sheath 21 is axially divided into a main body section 47 and a bending section, and the bending section may be one section, two sections (including a first bending section 44 and a second bending section 45), multiple sections, and the like. The bending may be unidirectional, bi-directional, tetra-directional or even multi-directional by adjusting the pulling wire lumen 46. The body end needs to provide sufficient rigidity to avoid bending deformation of the body section 47, and the bending section needs to have a certain flexibility to ensure a bending angle.

Alternatively, the bending sheath 21 can be wound in a spring form, and the flexibility of the sheath tip and the transition of the main pipe section can be realized by changing the screw pitch of the bending sheath, so that the proximal end is compact, the enough strength is ensured, and the bending sheath cannot deform in the process of finishing the bending. The distal end is properly increased in pitch transition to provide flexibility, and meanwhile, a certain supporting force needs to be provided for the bending part of the sheath tube bending adjustment, so that the puncture of the membrane breaking needle is smooth. As shown in fig. 14.

Alternatively, the bending sheath 21 may be formed by a braided wire structure, the proximal ends of which are braided densely to ensure sufficient strength, and the distal ends of which are braided at a reasonable distance to provide flexibility, and the braided wires may be flat wires (a of fig. 15) or round wires (b of fig. 15).

Alternatively, the bending sheath 21 may be subjected to different hardness transitions by engraving the metal tube body, as shown in fig. 16, and the hardness of the bending sheath main body section and the bending section is adjusted according to the different hardness transitions of the PEBAX (polyether block polyamide) outer layer of the bending sheath 21.

When in use, the bending sheath tube 21 reaches the aortic arch part, the angle of the sheath is adjusted to align with the branch vessel (the tip of the bending sheath tube 21 is adjusted to bend through the bending sheath handle 23), the membrane breaking needle breaks the membrane (the membrane breaking needle handle 10 rotates), the membrane breaking needle 30 is retracted (the membrane breaking needle handle 10 can be disassembled in a modularized and integrally withdrawn), and the upper saccule reaming-conveying system is matched into the branch release branch stent.

It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations and modifications of the present utility model will be apparent to those of ordinary skill in the art in light of the foregoing description. It is not necessary here nor is it exhaustive of all embodiments. And obvious variations or modifications thereof are contemplated as falling within the scope of the present utility model.

Claims (10)

1. A membrane breaker for endovascular surgery, comprising:

a membrane rupture needle handle (10);

the bending sheath adjusting structure (20) comprises a bending sheath adjusting tube (21), a handle main body (22) and a plurality of bending sheath adjusting handles (23); the handle main body (22) is detachably connected with the membrane breaking needle handle (10), and an opening is formed in one end, far away from the membrane breaking needle handle (10), of the handle main body (22); the bending sheath tube (21) comprises a plurality of traction wires (24) and a plurality of traction rings (25), wherein the distal ends of the traction wires (24) are connected with the traction rings (25), and the proximal ends of the traction wires penetrate through the opening of the handle main body (22) to be connected with the bending sheath handle (23) for adjusting the angle of the bending sheath tube (21);

the membrane rupture needle (30) sequentially comprises a proximal tube (31), a membrane rupture needle flexible tube (32) and a needle head (33), wherein the tail end of the proximal tube (31) is connected with a membrane rupture needle handle (10), and the position of the needle head (33) and the depth of a puncture membrane rupture are adjusted through the membrane rupture needle handle (10); the membrane rupture needle flexible tube (32) and the needle head (33) axially extend out of the inner part of the bending sheath tube (21) so as to perform membrane rupture operation.

2. The membrane breaker for endovascular surgery according to claim 1, wherein the membrane breaking needle handle (10) comprises a knob member (11), a luer connector (12), a cylindrical tube (13) and a moving block (14) arranged inside the cylindrical tube (13), the moving block (14) is screwed with the luer connector (12), and the membrane breaking needle (30) sequentially penetrates through the cylindrical tube (13) and the knob member (11) to be connected with the moving block (14).

3. A device according to claim 2, wherein the connection between the needle (30) and the block (14) is by gluing or welding.

4. The membrane breaker for endovascular surgery according to claim 2, wherein a spiral track (15) is provided inside the cylindrical tube (13), a limit post (16) is provided on the moving block (14), a limit groove (17) is provided on the knob member (11), and the limit post (16) can be inserted into the limit groove (17) to enable the moving block (14) to perform spiral linear motion inside the cylindrical tube (13) along with the spiral track (15).

5. A membrane breaker for endovascular procedures as claimed in claim 1, wherein the bending sheath handle (23) is of a screw-fed configuration.

6. The membrane breaker for endovascular surgery of claim 1, wherein the handle body (22) is further provided with a pull wire limiting groove (26) inside.

7. A rupture disc for endovascular surgery as claimed in claim 1, wherein the handle body (22) is provided with a stress diffuser (27) over the opening.

8. The membrane breaker for endovascular surgery of claim 1, wherein the membrane-breaking needle flexible tube (32) is a hypotube, a metal sculptured tube, or a reed tube.

9. A rupture disc for endovascular surgery as claimed in claim 1, wherein the bending sheath handle (23) and the handle body (22) are connected by a snap-fit.

10. A membrane breaker for endovascular procedures as claimed in claim 1, wherein the bending sheath (21) adjusts the compliance of the different tube segments by selecting the hardness as metal braided tube, reed switch or PEBAX.

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