CN213465472U - Adjustable-bending interventional instrument conveying system - Google Patents

Abstract

The application discloses but adjustable curved intervention apparatus conveying system has relative distal end and near-end, conveying system is including the operating handle that is in the near-end and the sheath pipe subassembly that links to each other and extend to the far-end with operating handle, sheath pipe subassembly includes sheath pipe and sheath core subassembly, its characterized in that, sheath core subassembly includes the core pipe, is fixed in the core pipe distal end and is used for connecting the latch fitting of intervention apparatus to and the accent return bend pipe of establishing in the core pipe periphery, transfer return bend pipe with the mutual fixed connection of both distal ends of core pipe, but both near-ends relative slip just all extend to be connected to operating handle; the sheath tube is in sliding fit with the periphery of the sheath core assembly, the distal end of the sheath tube is an expanded loading section for accommodating an interventional instrument, and the proximal end of the sheath tube is extended and connected to the operating handle; the loading section adopts a multilayer structure, one layer of the loading section is a metal pipe, the far end side of the metal pipe is provided with a plurality of expansion pieces which are arranged elastically at intervals along the circumferential direction, and each expansion piece is provided with a hollow area.

Description

Adjustable-bending interventional instrument conveying system

Technical Field

The utility model belongs to the technical field of medical instrument, especially, relate to a conveying system of intervention instrument.

Background

The interventional device conveying system generally comprises a sheath core assembly and a sheath tube which is sleeved outside the sheath core assembly in a sliding mode, the sheath tube and the sheath tube form a sheath tube assembly, the far end of the sheath tube assembly can enter a human body vascular system, the near end of the sheath tube assembly is connected with an operating handle, and the direction of the far end needs to be adjusted and controlled to enable the sheath tube assembly to move to a target position based on the tortuous characteristic of the human body vascular system and the consideration of remote operation. Therefore, the double requirements of axial support and flexible compliance are provided for the sheath core assembly and the sheath tube, and the force application part and the force application mode influence the safety and the difficulty of operation and control to a certain extent during bending adjustment.

SUMMERY OF THE UTILITY MODEL

The application provides an adjustable curved interventional instrument conveying system, improves to relevant parts such as sheath pipe, more is favorable to adjusting curved and controlling.

The adjustable-bending interventional instrument conveying system is provided with a far end and a near end which are opposite, the conveying system comprises an operating handle at the near end and a sheath pipe assembly which is connected with the operating handle and extends towards the far end, and the sheath pipe assembly comprises a sheath pipe and a sheath core assembly;

the sheath core assembly comprises a core pipe, a locking piece fixed at the far end of the core pipe and used for connecting an interventional instrument, and an adjusting bent pipe sleeved on the periphery of the core pipe, wherein the far ends of the adjusting bent pipe and the core pipe are fixedly connected with each other, and the near ends of the adjusting bent pipe and the core pipe can slide relatively and are both extended and connected to the operating handle;

the sheath tube is in sliding fit with the periphery of the sheath core assembly, the distal end of the sheath tube is an expanded loading section for accommodating an interventional instrument, and the proximal end of the sheath tube is extended and connected to the operating handle;

the loading section adopts a multilayer structure, one layer of the loading section is a metal pipe, the far end side of the metal pipe is provided with a plurality of expansion pieces which are arranged elastically at intervals along the circumferential direction, and each expansion piece is provided with a hollow area.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

The application also provides a sheath pipe assembly, the sheath pipe assembly comprises a sheath pipe and a sheath core assembly, the sheath core assembly comprises a core pipe, a locking piece fixed at the far end of the core pipe and used for connecting an interventional instrument, and a bending pipe mutually nested with the core pipe, wherein the bending pipe and the far end of the core pipe are fixedly connected with each other, and the near ends of the bending pipe and the core pipe can slide relatively and are all extended and connected to the operating handle;

the sheath tube is in sliding fit with the periphery of the sheath core assembly, the far end of the sheath tube is a diameter-expanded loading section for accommodating interventional instruments, the loading section is of a multilayer structure and sequentially comprises an inner lining tube, a metal tube and an outer wrapping film from inside to outside, and the near end of the sheath tube extends and is connected to the operating handle.

Optionally, the operating handle includes a control assembly, a bending adjustment assembly and a front-end handle;

the control assembly includes:

a first support fixed to the front end handle;

a first connector slidably mounted to the first support, the proximal end of the sheath being secured to the first connector;

the first driving piece is movably arranged on the first supporting body and drives the first connecting piece to slide;

the bend adjustment assembly comprises:

a second support fixed opposite to the first support;

the second connecting piece is slidably mounted on the second support body, and the near end of the bend adjusting pipe penetrates through the sheath pipe and then is fixed on the second connecting piece;

the second driving piece is movably arranged on the second supporting body and drives the second connecting piece to slide;

and the pipe joint is fixedly arranged at the near end of the second support body, and the near end of the core pipe penetrates out of the bend adjusting pipe and then is fixed on the pipe joint.

Optionally, the sheath pipe is divided into loading section, suitable curved section and first extension section by distal end to near-end in proper order in the axial, the sheath pipe adopts multilayer structure, includes:

the inner sheath pipe is distributed on the bending section and the first extending section in the axial direction;

the lining pipe is butted at the far end of the inner sheath pipe and is distributed on the loading section in the axial direction;

the metal pipe wraps the distal end part of the inner sheath pipe and the periphery of the inner lining pipe, and is distributed on the bending section and the loading section in the axial direction;

the outer wrapping film is wrapped on the periphery of the metal pipe and is distributed on the bending section and the loading section in the axial direction.

Optionally, the metal tube comprises a head end tube, a main tube and an extension tube, which are sequentially butted with each other, from a far end to a near end, wherein the head end tube and the main tube are distributed on the loading section and the extension tube is distributed on the bending section in the axial direction;

the expansion tab is on a distal side of the head end tube.

Optionally, the core tube extends out of the locking piece towards the distal end and is fixed with a guide head at the most distal end of the extending part, a loading position of the interventional device is arranged between the guide head and the locking piece, and the interventional device in a compressed state is connected with the locking piece at the loading position.

Optionally, the core tube includes a compliant section adjacent to the locking element, and a third extension section abutting against the compliant section and extending proximally, wherein the compliant section is a hypotube and has a length in a range of 120-18 mm, and the third extension section is a steel cable tube or a hypotube.

Optionally, the bending adjusting pipe sequentially comprises a pulling section and a second extending section from the far end to the near end, wherein the pulling section is of an integral structure and adopts a hypotube.

Optionally, the traction section sequentially comprises a first traction section, a transition section and a second traction section from the far end to the near end, the first traction section has higher flexibility than the second traction section, and the length ratio of the first traction section to the compliant section is 1: 0.7-1.5.

Optionally, the compliant section is cut to form an axially extending first rib.

Optionally, the width of the cutting seam of the compliant section is 0.1-1 mm, and the seam distance is 0.1-1 mm.

Optionally, the more proximal the compliant segment is to the distal end, the smaller the ultimate radius of curvature after being tuned.

Optionally, the compliant segment has a gradually changing cutting slit width, and the closer to the distal end, the larger the cutting slit width.

Optionally, the compliant section has a gradually changing gap spacing, and the closer to the distal end, the smaller the gap spacing.

Optionally, the compliant section has a gradual change in stiffness, with the stiffness being lower the closer to the distal end.

Optionally, the first pulling section is formed with a second reinforcing rib extending axially in a cutting manner, and circumferential positions of the second reinforcing rib and the first reinforcing rib are different by 180 degrees.

Optionally, the width of the cutting seam of the first traction section is 0.03-0.5 mm, and the seam distance is 0.2-0.85 mm.

Optionally, the second pulling section is formed with two axially extending third reinforcing ribs in a cutting manner, and the two third reinforcing ribs are radially opposite and have a 90-degree difference from the circumferential position of the first reinforcing rib.

Optionally, the width of the cutting seam of the second traction section is 0.03-0.5 mm, and the seam distance is 0.2-0.85 mm.

Optionally, the transition section is an uncut structure with a complete circle in the circumferential direction.

Optionally, the bending adjusting pipe is sleeved on the periphery of the core pipe or is positioned inside the core pipe.

Optionally, the head end tube includes a body section, a plurality of elastic expansion pieces spaced apart from each other in a circumferential direction on a distal side of the body section, and a first connector on a proximal side of the body section, and the distal side of the body tube has a second connector, and the first connector and the second connector are engaged with each other and have complementary shapes.

Optionally, each expansion piece is provided with a hollow-out area.

Optionally, the expansion pieces are evenly distributed along the circumferential direction, and the number of the expansion pieces is 3-6.

Optionally, the first connector is T-shaped.

Optionally, the main body section forms a developing area in a hollow manner, and the developing area is used for installing a developing point.

Optionally, through holes are distributed on the body section and the first connector, and the lining pipe and the outer coating film are mutually fused at the through holes.

Optionally, the hollow-out area is a plurality of through holes arranged at intervals along the axial direction of the sheath, and the total area of the through holes on each expansion piece is smaller than 50% of the area of the expansion piece.

Alternatively, the area of the through hole is larger the closer to the distal end on the same expansion sheet.

Optionally, the through holes are circular or oval, and the number of the through holes on the same expansion piece is 2-5.

Optionally, the hollowed-out area is a strip-shaped hole, and the strip-shaped hole axially extends along the head end pipe.

Optionally, on the same expansion piece, two strip-shaped holes are provided.

Optionally, the strip-shaped holes extend with equal width.

Optionally, the two ends of the strip-shaped hole in the length direction are arc-shaped inner edges.

Optionally, a gap is formed between two adjacent expansion pieces, each expansion piece is provided with a narrowing portion at a proximal end portion, and the gap is provided with a widening portion corresponding to the narrowing portion at the proximal end portion.

Optionally, the inner edge of the widened portion is a smooth curve.

Optionally, the central region in the length direction of the spaced opening extends with equal width.

Optionally, the width of the equal-width extending part of the spaced opening is substantially the same as the width of the strip-shaped hole.

Optionally, the proximal side of the strip-shaped hole crosses over the narrowed part of the expansion sheet.

Optionally, the narrow part of the expansion piece is crossed by the near end side of the strip-shaped hole by 1-5 mm.

Optionally, the distal end of the expansion piece has a smooth outer edge.

Optionally, the head end pipe is formed by cutting a nickel-titanium alloy pipe, and the main body pipe and the extension pipe are formed by cutting stainless steel pipes.

Optionally, the head-end tube is made of nickel-titanium alloy, and each expansion piece has a closed state extending along the axial direction of the sheath tube and an everted state away from each other.

Optionally, the extension tube is a hypotube.

Optionally, the inner sheath tube has a multilayer structure, and fourth reinforcing ribs extending in the axial direction are arranged in the interlayer, two of the fourth reinforcing ribs are provided, one of the fourth reinforcing ribs and the first reinforcing rib are located at the same circumferential position, and the other fourth reinforcing rib and the first reinforcing rib are located at a 180-degree difference in circumferential position.

Optionally, the distal end of the fourth reinforcing bead extends to the proximal end of the extension tube or the distal end of the extension tube.

Optionally, a fifth reinforcing rib extending axially is arranged in the extension pipe, and the fifth reinforcing rib is one and is located at the same circumferential position as the first reinforcing rib; or two fifth reinforcing ribs are arranged, wherein one fifth reinforcing rib is located at the same circumferential position as the first reinforcing rib, and the other fifth reinforcing rib is 180 degrees different from the first reinforcing rib in circumferential position.

Optionally, the head pipe and the main pipe are connected by mutual embedding of connectors with complementary shapes, and the main pipe and the extension pipe are connected by a hook.

Optionally, two hollow areas are distributed on the tube wall of the main tube, and two guide ribs which extend axially and are arranged oppositely along the radial direction are distributed between the two hollow areas.

Optionally, along the axial direction of the sheath tube, the outer envelope comprises a plurality of sections, and each section is made of different materials, or at least two sections are made of the same material.

Optionally, the strength of the outer covering film corresponding to the main tube is greater than the strength of the outer covering film corresponding to the distal end of the head tube.

Optionally, the main body pipe and the head end pipe are formed by cutting metal pipes made of different materials.

Optionally, the operating handle includes a control assembly, a bending adjustment assembly and a front-end handle; the control assembly includes:

a first support fixed to the front end handle;

the first connecting piece is slidably mounted on the first support body, and the proximal end of the sheath tube is fixed to the first connecting piece;

the first driving piece is movably arranged on the first supporting body and drives the first connecting piece to slide;

the bend adjustment assembly comprises:

a second support fixed opposite to the first support;

the second connecting piece is slidably arranged on the second support body, and the near end of the bend adjusting pipe penetrates through the sheath pipe and then is fixed on the second connecting piece;

the second driving piece is movably arranged on the second supporting body and drives the second connecting piece to slide;

and the pipe joint is fixedly arranged at the near end of the second support body, and the near end of the core pipe penetrates out of the bend adjusting pipe and then is fixed on the pipe joint.

Optionally, the front end handle is connected with a catheter sleeved outside the sheath tube.

Optionally, the first driving part is rotatably sleeved on the periphery of the first supporting body, and a limiting mechanism for limiting the rotation angle of the first driving part is arranged between the front-end handle and the first driving part.

Optionally, the limiting mechanism includes:

a slide key mounted to one of the front end handle and the first driver;

the lockhole is formed in the other one of the front end handle and the first driving piece.

Optionally, a sliding groove is formed in the outer wall of the front-end handle, the sliding key is installed in the sliding groove, and the locking hole is formed in the axial end face of the first driving piece.

Optionally, the limiting mechanism includes a locking pin which is installed on the first driving member in a threaded manner and abuts against the first supporting body.

Optionally, the first supporting body is a cylindrical shape, a guide strip hole extending along the axial direction is formed in the side wall of the first supporting body, the first connecting piece is slidably mounted inside the first supporting body, a guide key extending out of the guide strip hole along the radial direction is arranged on the first connecting piece, and a threaded structure matched with the guide key is arranged on the inner wall of the first driving piece.

Optionally, the second support body is cylindrical and is arranged coaxially with the first support body, and the second support body and the first support body are fixed by adopting an integral structure or a split structure.

Optionally, the second driving element is rotatably mounted with respect to the second supporting body, the second supporting body is provided with an operation opening, a part of the second driving element is disposed inside the second supporting body, and at least a part of the second driving element is exposed to the operation opening as a force application portion, and the second connecting element is located inside the second supporting body and is linked with the second driving element.

Optionally, the second driving member has an internal thread, at least a portion of the second connecting member has an external thread and extends into the second driving member, and the second driving member drives the second connecting member to slide in a threaded manner.

Optionally, the inner wall of the second supporting body is provided with a guide bar extending along the axial direction, at least one part of the second connecting piece is located in the second supporting body, and the outer wall of the part is provided with a guide groove matched with the guide bar.

The application also provides a method for processing the sheath tube, which comprises the following steps:

step S100, providing an inner sheath tube and processing the distal end of the inner sheath tube to form a flaring part;

step S200, fixedly sleeving a lining pipe on the periphery of the flaring part;

step S300, sleeving a metal pipe on the periphery of the distal end part of the inner sheath pipe and the periphery of the lining pipe;

and S400, coating the outer surface of the metal pipe by sections by using an outer coating material, and forming an outer coating film integrally after the outer coating material of each section is hot-melted.

The sheath can be the sheath of this application, this application still provides a processing method of the sheath promptly, includes:

step S100, processing the distal end of the inner sheath tube to form a flaring part;

step S200, fixedly sleeving the inner lining pipe on the periphery of the flaring part;

step S300, sleeving the metal pipe on the outer peripheries of the inner sheath pipe and the lining pipe;

and S400, coating the outer surface of the metal pipe by sections by using an outer coating material, and integrally forming the outer coating film after the outer coating material of each section is hot-melted.

Optionally, in step S200, the proximal end of the inner liner tube has a plurality of lugs arranged at intervals along the circumferential direction, the plurality of lugs are overlapped and wrapped around the periphery of the flared portion, and then the plurality of lugs are wrapped by the fixing sleeve and then fixed by hot melting.

Optionally, the lugs are uniformly arranged in the circumferential direction by 3-6.

Optionally, the lining pipe is made of PTFE.

Optionally, the fixing sleeve is made of Pebax.

Optionally, step S400 specifically includes:

step S410, wrapping a first connecting sleeve at the butt joint part of the main body pipe and the head end pipe, wrapping a head end outer sleeve at the head end pipe, and fixing the first connecting sleeve and the head end outer sleeve in a hot melting way;

step S420, wrapping the main body outer sleeve on the periphery of the main body pipe and fixing the main body outer sleeve in a hot melting mode;

step S430, wrapping a second connecting sleeve at the proximal end of the extension tube and the inner sheath tube at the adjacent position, and fixing the second connecting sleeve in a hot melting manner;

and step S440, wrapping the connecting sleeve on the periphery of the extension pipe and performing hot melting and fixing.

Optionally, the main tube has hollow areas at intervals, guide ribs are formed between adjacent hollow areas, and in step S420, before the main tube is wrapped by the main jacket, a gasket is placed in each hollow area and is fixed by hot melting.

Optionally, the liner is made of Pebax.

Optionally, the head end outer sleeve and the connecting sleeve are made of TPU.

Optionally, the first connecting sleeve, the second connecting sleeve and the main body casing are all made of Pebax material.

The application also provides a conveying method of the interventional instrument, which comprises the steps of loading the interventional instrument on a conveying system and conveying the interventional instrument to a far end;

the conveying system comprises an operating handle at the near end and a sheath tube assembly which is connected with the operating handle and extends towards the far end, the sheath tube assembly comprises a sheath tube and a sheath tube core assembly, the interventional device is connected with the sheath tube core assembly and is wrapped by the sheath tube, the sheath tube core assembly comprises a core tube, a locking piece which is fixed at the far end of the core tube and is used for connecting the interventional device, and an adjusting tube, the far ends of the adjusting tube and the core tube are fixedly connected with each other, and the near ends of the adjusting tube and the core tube can slide relatively and extend and are connected to the operating;

in the conveying process, the proximal end of the adjusting pipe is pulled, so that the proximal ends of the adjusting pipe and the core pipe slide relatively, and the distal end of the core pipe is driven to change the direction to adapt to the intervention path.

The conveying system is more convenient for bending operation and meets the performance requirements of all parts.

Drawings

FIG. 1 is a schematic diagram of the construction of a conveyor system according to the present application;

FIG. 2 is an exploded view of the delivery system of FIG. 1;

FIG. 3a is an internal structural schematic of the operating handle of FIG. 1;

FIG. 3b is an internal structural schematic view of the operating handle of FIG. 1 from another perspective;

FIG. 3c is an enlarged partial schematic view of FIG. 3 b;

FIG. 4 is an exploded view of the operating handle of FIG. 1;

FIG. 5a is a schematic view of a core tube assembly according to an embodiment of the present invention in which the locking element is in a line-by-wire configuration;

FIG. 5b is a schematic illustration of the locking element of FIG. 5a engaged with the access device;

FIG. 5c is a schematic view of a core tube assembly according to an embodiment of the present invention;

FIG. 6 is a schematic structural diagram of an elbow adjustment pipe according to an embodiment of the present application;

FIG. 7 is a schematic view of the core tube (compliant section) according to an embodiment of the present invention;

FIG. 8 is a schematic view of the core tube (compliant section) of FIG. 7 at another angle;

FIG. 9 is a schematic structural diagram of an elbow adjustment pipe according to an embodiment of the present application;

FIG. 10 is a schematic view of the bend adjusting pipe of FIG. 9 at another angle;

FIG. 11 is an expanded view of the elbow of FIG. 9;

FIG. 12 is a schematic structural view of a sheath according to an embodiment of the present application;

FIG. 13 is an assembled structural schematic view of the components of FIGS. 5c, 6 and 12;

FIG. 14 is a cross-sectional view of a sheath assembly according to an embodiment of the present application;

figure 15a is a schematic view of the interventional instrument of figure 14 after loading thereof;

FIG. 15b is a schematic view of the interventional instrument of FIG. 15a in a semi-released configuration;

FIG. 15c is a schematic illustration of the interventional instrument of FIG. 15a after complete release;

FIG. 15d is a schematic view of the axial segment-to-segment relationship of the pipe elements in one embodiment of the present application;

FIG. 16 is a cross-sectional view of a sheath and core assembly according to an embodiment of the present application;

fig. 17a is a schematic view of the interventional instrument of fig. 16 after loading;

FIG. 17b is a schematic view of the interventional instrument of FIG. 17a in a semi-released configuration;

FIG. 17c is a schematic illustration of the interventional instrument of FIG. 17a after complete release;

FIG. 17d is a schematic view of the axial segment-to-segment relationship of the pipe elements in one embodiment of the present application;

FIG. 18 is an illustration of components in the sheath;

FIG. 19a is a schematic view of the structure of a head-end tube;

FIG. 19b is a schematic view of a head end tube in an alternative embodiment in an expanded configuration;

FIG. 20 is a schematic view of a distal portion of the delivery system of the present application;

FIG. 21 is a cross-sectional view of the inner sheath of FIG. 20 at C-C;

FIG. 22 is an enlarged view of portion A of FIG. 21;

FIG. 23 is a cross-sectional view taken at B-B of FIG. 20;

FIG. 24 is a cross-sectional view of the alternate embodiment of FIG. 20 at B-B;

FIGS. 25-34 are schematic views of components involved in the assembly process of the sheath and related variations in an embodiment of the present application;

FIG. 35 is a schematic view of a distal end variation of the delivery system of the present application during bend adjustment;

fig. 36 to 40 are schematic diagrams illustrating state changes of different processes in a use scenario of the conveying system.

The reference numerals in the figures are illustrated as follows:

100. an operating handle;

110. a bending adjusting component; 111. a second support; 112. a second driving member; 113. a second connecting member; 114. a guide strip; 115. A guide groove; 116. an operation port; 117. a force application part; 118. a luer fitting;

120. a control component; 121. a first support; 122. a first driving member; 123. a first connecting member; 124. a guide key; 125. A guide bar hole; 126. a lock hole;

130. a front end handle; 131. a sliding key; 132. a chute;

200. a conduit;

300. a sheath tube; 310. a loading section; 320. a bending section; 330. a first extension section;

340. a head end tube; 341. spaced openings; 342. a developing area; 343. a first connector; 344. an expansion sheet; 345. a hollow-out area; 346. a body section; 347. a through hole; 348. a narrowed portion; 349. the proximal side of the strip-shaped hole;

350. a main body tube; 351. a second connector; 352. a closing-in part; 353. a hollow-out area; 354. a hollow-out area; 355. a guide rib;

360. an extension tube; 3601. reinforcing ribs (fifth reinforcing ribs); 3602. reinforcing ribs (fifth reinforcing ribs);

370. an inner sheath tube; 370A, a distal portion; 370B, a proximal portion; 3701. an inner layer of PTFE; 3702. weaving layer; 3703. A reinforcing rib (fourth reinforcing rib); 3704. weaving layer; 3705. an outer layer; 371. a distal end; 372. a core rod; 373. a circular table section; 374. a flared part; 375. a liner tube; 376. a cutting area; 377. fixing a sleeve;

380. wrapping a film; 381. a first connecting sleeve; 382. a head end outer sleeve; 383. a first liner sheet; 384. a second liner sheet; 385. a main body coat; 386. a second connecting sleeve; 387. connecting a sleeve;

400. a sheath-core assembly;

410. adjusting a bent pipe; 411. a first pulling section; 4111. a reinforcing rib (second reinforcing rib); 412. a second pulling section; 4121. a reinforcing rib (third reinforcing rib); 4122. a reinforcing rib (third reinforcing rib); 413. a second extension section; 414. a transition section;

420. a core tube assembly; 421. a guide head; 422. a lock; 4221. a lock hole; 4222. a distributing board; 4223. a pull wire; 4224. A lock lever; 4225. threading a sleeve; 423. layering; 424. an inner core; 425. a core tube; 4251. a compliant section; 4252. a third extension section; 4253. a rib (first rib);

500. an interventional instrument; 501. connecting lugs;

600. the aortic valve.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1-4, in one embodiment of the present application, a delivery system is provided having opposite distal and proximal ends, the delivery system including a proximal operating handle 100 and a sheath 300 and sheath core assembly 400 connected to the operating handle 100 and extending distally, the sheath 300 being a sliding fit to the outer circumference of the sheath core assembly 400.

Wherein sheath core subassembly includes the core pipe, is fixed in the core pipe distal end and is used for connecting the latch fitting of intervention apparatus, and the latch fitting can have the structure of multiple different forms, for example, adopts the engaging lug on recess form and the support to be connected, or adopts radial outside convex plush copper form, or adopts the drive-by-wire mode, adopts long line or wire loop and support connection, no matter what kind of form of adoption, its purpose all is in order to realize being connected with the support engaging lug.

In some embodiments, the sheath core assembly further comprises an adjusting pipe sleeved on the periphery of the core pipe, the distal ends of the adjusting pipe and the core pipe are fixedly connected with each other, and the proximal ends of the adjusting pipe and the core pipe are both extended and connected to the operating handle and can slide relatively.

In some embodiments, the sheath core assembly further comprises an adjustable bending tube inside the core tube, wherein the adjustable bending tube and the core tube are fixedly connected with each other at the distal ends and can slide relative to each other at the proximal ends.

The relative movement between the core tube and the bend-adjusting tube at the proximal end is required no matter how the inside-outside relationship is, generally, during bend adjustment, the proximal end of the core tube is kept unchanged, or the proximal end of the bend-adjusting tube is pulled by taking the proximal end of the core tube as a reference, and the difference of the inside-outside relationship between the core tube and the bend-adjusting tube can cause the difference of the contact position between the core tube and the bend-adjusting tube at the turning position. The following embodiments and the accompanying drawings mainly take the outside of the bend-adjusting pipe as an example. The structure of the operating handle can be correspondingly adjusted according to the internal and external relations of the core tube and the bending adjusting tube, so that the proximal ends of the core tube and the bending adjusting tube can move relatively.

In other embodiments, the delivery system may further comprise a catheter 200 fixed relative to the operating handle 100, the catheter 200 being used to establish a channel to prevent injury to body tissue as the sheath 300 reciprocates. The interventional device is loaded into the sheath core assembly 400 and is carried along with the catheter 200 into the body under the sheath 300. the sheath 300 is then axially movable relative to the other two to effect release and, if necessary, retrieval of the interventional device.

The bending is mainly achieved by operating the handle 100. Referring to fig. 3a and 4, in one embodiment, the operating handle 100 is used for connecting the proximal ends of three tubes nested inside and outside in sequence, and driving the proximal ends of the three tubes to move relative to each other, the three tubes are a core tube, a bend-adjusting tube and a sheath tube from inside to outside, and the operating handle 100 comprises a control assembly 120, a bend-adjusting assembly 110 and a front-end handle 130;

the control assembly 120 includes:

a first support 121 fixed to the front end handle 130;

a first connector 123 slidably mounted on the first support 121, wherein the proximal end of the sheath is fixed to the first connector 123;

a first driving member 122 movably mounted on the first supporting body 121 and driving the first connecting member 123 to slide;

the bend adjustment assembly 110 includes:

a second support 111 fixed to the first support 121;

the second connecting piece 113 is slidably mounted on the second support 111, and the proximal end of the bend-adjusting pipe penetrates through the sheath pipe and then is fixed on the second connecting piece 113;

a second driving member 112 movably mounted on the second supporting body 111 and driving the second connecting member 113 to slide;

and the pipe joint is fixedly arranged at the near end of the second support body 111, and the near end of the core pipe penetrates through the bend adjusting pipe and then is fixed on the pipe joint.

Specifically, the control assembly 120 includes a first supporting body 121, the first driving member 122 is rotatably sleeved on the periphery of the first supporting body 121, a guide bar hole 125 extending along the axial direction is formed in the side wall of the first supporting body 121, a first connecting member 123 is slidably mounted inside the first supporting body 121, a guide key 124 extending from the guide bar hole 125 is arranged on the first connecting member 123, and a threaded structure matched with the guide key 124 is arranged on the inner wall of the first driving member 122.

In the configuration of the first supporting body 121, referring to an embodiment, the first supporting body 121 is cylindrical, a hole of the guide bar 114 extending along the axial direction is formed in a side wall of the first supporting body 121, the first connecting member 123 is slidably installed inside the first supporting body 121, a guide key 124 extending out of the hole of the guide bar 114 along the radial direction is arranged on the first connecting member 123, and a threaded structure matching with the guide key 124 is arranged on an inner wall of the first driving member 122.

Specifically, the first supporting body 121 is substantially cylindrical, and may adopt an integral or radial snap-fit split structure (as shown in fig. 4), when the first driving member 122 rotates, the guide key 124 drives the first connecting member 123 to slide in the first supporting body 121, and due to the limitation of the guide bar hole 125, the first connecting member 123 does not rotate, i.e., only moves axially.

The front handle 130 is fixedly connected to the first support 121, the proximal end of the catheter 200 is fixedly inserted into the front handle 130, the proximal end of the sheath 300 is fixedly mounted to the first connector 123, and the sheath 300 extends distally through the catheter 200.

In the matching relationship between the first supporting body 121 and the second supporting body 111, referring to an embodiment, the second supporting body 111 is cylindrical and is coaxially arranged with the first supporting body 121, and the second supporting body 111 and the first supporting body 121 are fixed together by an integral structure or a separate structure.

In the matching relationship between the second driving member 112 and the second supporting body 111, referring to an embodiment, the second driving member 112 is rotatably mounted with respect to the second supporting body 111, the second supporting body 111 is provided with an operation opening 116, a portion of the second driving member 112 is disposed inside the second supporting body 111, and at least a portion of the second driving member is exposed to the operation opening 116 as a force application portion 117, and the second connecting member 113 is disposed inside the second supporting body 111 and is linked with the second driving member 112.

Specifically, the bending adjustment assembly 110 includes a second supporting body 111, the second supporting body 111 is also substantially cylindrical and is fixed relative to the first supporting body 121, the second supporting body 111 itself may adopt a split structure (as shown in fig. 4) that is integrally or radially fastened, and the second supporting body 111 and the first supporting body 121 are coaxially arranged and adopt a split fixed butt joint manner.

Correspondingly, the bend adjustment assembly 110 further includes a second driving member 112, and in the specific configuration of the second driving member 112, referring to an embodiment, the second driving member 112 is provided with an internal thread, at least a portion of the second connecting member 113 is provided with an external thread and extends into the second driving member 112, and the second driving member 112 drives the second connecting member 113 to slide in a threaded manner.

Specifically, the second driving member 112 is rotatably mounted relative to the second supporting body 111, an operation opening 116 is partially formed in the second supporting body 111, a part of the second driving member 112 is disposed inside the second supporting body 111, and at least a part of the second driving member is exposed to the operation opening 116 as a force application portion 117, the second driving member 112 is integrally cylindrical and has an internal thread, and the second connecting member 113 is slidably mounted inside the second driving member 112.

In order to limit the movement of the second connecting member 113, referring to an embodiment, the inner wall of the second supporting body 111 is provided with a guide bar 114 extending along the axial direction, at least a portion of the second connecting member 113 is located in the second supporting body 111 and the outer wall of the portion is provided with a guide groove 115 cooperating with the guide bar 114. In this embodiment, the cooperation of the guide groove 115 and the guide bar 114 enables the second connector 113 to slide only in the axial direction with respect to the second support body 111.

As can be readily understood from the above description, the bending adjustment function of the operating handle 100 is mainly realized by the rotation of the components, and a corresponding limiting mechanism can be provided to prevent the unstable bending adjustment state caused by the mutual movement of the components in the operating process. In an embodiment, the first driving member 122 is rotatably sleeved on the outer periphery of the first supporting body 121, and a limiting mechanism for limiting a rotation angle of the first driving member 122 is disposed between the front handle 130 and the first driving member 122.

Accordingly, the present embodiment exemplarily provides an arrangement manner of the limiting mechanism. In reference to an embodiment, the limiting mechanism includes:

a slide key 131 mounted to one of the front end handle 130 and the first driving member 122;

a lock hole 126 opened in the other of the front handle 130 and the first driving member 122.

When the sliding key 131 is engaged with the lock hole 126, the position of the front end knob 130 and the first driving member 122 in the circumferential direction is determined, and therefore the axial position of the first connecting member 123 with respect to the front end knob 130 is determined, and the function of the operating handle 100 for bending is limited, ensuring stability during use. In practical products, as for a specific arrangement, in an embodiment, the outer wall of the front end handle 130 is provided with a sliding slot 132, the sliding key 131 is installed in the sliding slot 132, and the locking hole 126 is provided on an axial end surface of the first driving member 122.

The locking holes 126 can achieve locking of the first driving member 122 in multiple positions by increasing the number of the locking holes. Referring to fig. 3c, the locking holes are provided in plurality on an axial end surface of the first driver 122, and are sequentially arranged along a circumferential surface of the first driver 122. The increase in the number of the locking holes 126 may increase the locking positions of the first driving member 122, but correspondingly, the increase in the number of the locking holes 126 may increase the manufacturing difficulty of the first driving member 122 and may decrease the gap between adjacent locking holes 126, thereby decreasing the strength of a single locking hole 126, and thus the specific number may be adjusted according to design requirements, practical conditions, and practical product sizes.

In the embodiment shown in fig. 3b and 3c, since the first driving member 122 is a split structure that is fastened up and down, the locking hole 126 near the separation point has two arrangements, one is an arrangement that is open toward the separation point, and the other is an arrangement that is closed to avoid the separation point. In a particular product, only one of the two arrangements may be present.

Accordingly, a limiting mechanism may be disposed between the first driving member 122 and the first supporting member 121 to achieve the above-mentioned functions. In one embodiment, the limiting mechanism includes a locking pin (not shown) threadedly mounted on the first driving member 122 and abutting against the first supporting body 121. The bolt joint of the locking pin and the first driving member 122 can realize the relative position of the locking pin and the first driving member 122, thereby realizing the positioning of the first supporting body 121. When the relative position between the first driving member 122 and the first supporting member 121 is determined, the function of the limiting mechanism can be achieved, and therefore the locking principle is not described in detail.

The utility model provides an embodiment provides a sheath core subassembly for carrying intervene apparatus, including the core pipe, be fixed in the core pipe distal end and be used for connecting the latch fitting of intervene apparatus, sheath core subassembly still including the cover establish the accent return bend in the core pipe periphery, transfer the mutual fixed connection of both distal ends of return bend and core pipe, but both near-ends relative slip. The sheath core assembly 400 comprises an inner and outer nested bend adjusting pipe 410 and a core pipe 425, the bend adjusting pipe 410 is wrapped outside the core pipe 425, the distal ends of the two are fixedly connected with each other, the proximal end can slide relatively, the proximal end of the bend adjusting pipe 410 is fixed on the second connecting piece 113, the proximal end of the core pipe 425 extends out of the second connecting piece 113 and then is fixed on the tail end, namely the proximal end side, of the second support body 111, and in order to facilitate butt joint with external pipe fittings, a pipe joint is installed at the proximal end of the core pipe 425, for example, a.

When the interventional device needs to be released or retracted, the first driving member 122 is rotated to axially move the first connecting member 123, i.e., to drive the sheath 300 to move relative to the sheath core assembly 400. When bending needs to be adjusted, the second driving member 112 is rotated to axially move the second connecting member 113, i.e. to drive the proximal end of the bending tube 410 to move relative to the proximal end of the core tube 425.

Referring to fig. 5a to 11, the sheath core assembly 400 includes an adjustable bending tube 410 and a core tube assembly 420, wherein the core tube assembly 420 includes a core tube 425, a locking member 422 is installed at a distal end portion of the core tube 425 for connecting an interventional instrument, the adjustable bending tube 410 is sleeved on an outer periphery of the core tube 425, distal ends of the adjustable bending tube 410 and the core tube 425 are fixedly connected with each other, and proximal ends of the adjustable bending tube 410 and the core tube 425 can slide relatively.

The distal side of the tuning tube 410 extends adjacent to the proximal side of the locking element 422, the tuning tube 410 may be directly secured to the core tube 425, or to the proximal locking element 422, or both, and both the tuning tube 410 and the core tube 425 may be made of metal material such as hypotube, and may be secured by welding, bonding, or fasteners.

The distal end of core tube 425 further extends out of locking element 422 and is secured with guide head 421. The distal end of the guide head 421 has a rounded head structure with a convergent shape to facilitate the passing and advancing in the body, and the position between the guide head 421 and the locking element 422 is used as the loading position of the interventional device, and the interventional device in a compressed state is in the position and is in limit fit with the locking element 422.

In one embodiment, inner core 424 is threaded into barrel 425, the distal end of inner core 424 extends out of locking element 422 and is fixed with guide head 421, the extension length of the proximal end of inner core 424 is not limited strictly, the position at the periphery of inner core and between guide head and locking element is used as the loading position of the interventional device, the interventional device in the compressed state is in the position and is in limit fit with locking element 422, and the radial space of the loading position is expanded because inner core 424 has a smaller outer diameter relative to barrel 425 because barrel 425 does not extend to the loading position.

Referring to fig. 5a and 5b, in some embodiments, the locking element is a wire-controlled locking element, the interventional instrument 500 has a coupling lug 501 at a proximal end thereof, the coupling lug 501 generally has a hole or hook for threading a pull wire 4223, the locking element 422 has a locking hole 4221, the locking rod 4224 has a distal end engaged with the locking hole 4221, and a proximal end thereof extends to the operating handle.

In a loading state, the pull wire 4223 passes through the connecting lug 501 and then is sleeved on the lock rod 4224, the far end of the lock rod 4224 is inserted into the lock hole 4221, so that the pull wire 4223 can limit the connecting lug 501 from coming out of the lock piece 422, when release is needed, the lock rod 4224 is pulled towards the near end and comes out of the lock hole 4221, the pull wire 4223 is also released, and the connecting lug 501 is allowed to come out of the lock piece 422.

The number of the connecting lugs 501 is multiple, and a plurality of pull wires 4223 are arranged, each pull wire 4223 extends towards the far end through a wire distributing disc 4222, and a wire threading sleeve 4225 is sleeved on the periphery of the core tube 425 for arranging the wire harness so as to form an extending channel of the pull wire 4223.

The locking rods 4224 and the locking holes 4221 are used as a set of locking mechanism, and multiple sets of locking mechanisms can be arranged as required and are sequentially arranged along the circumferential direction of the locking piece 422.

Referring to fig. 5c, in some embodiments, the locking member 422 may be provided with 1 or more retaining grooves around its periphery, and the interventional device may have engaging lugs disposed in the retaining grooves, which may serve as axial retainers for the interventional device, allowing only radial expansion of the interventional device before release. In order to prevent the connecting lug from accidentally disengaging or suddenly tilting outwards to stab tissues when the connecting lug is released, pressing strips 423 matched with all limiting grooves are further fixed at the locking piece 422, the connecting lug is limited in the limiting grooves by the constraint of the sheath tube after the connecting lug is loaded, the safety is further improved, and the flexible pressing strips 423 are outwards turned outwards to allow the connecting lug to disengage from the locking piece 422 when the connecting lug is released.

Inner core 424 and core tube 425, both of tubular construction, do not require axial relative movement between core tube 425 and inner core 424, and therefore are nested and welded to one another, and may be provided with one or more weld attachment points. If necessary, a bush may be added to the welding portion to fill the radial gap between the core tube 425 and the inner core 424, and the inner core tube 425 and the bush may be welded to each other.

The plunger 425 is secured directly or indirectly to the proximal side of the locking element 422 at one end and extends toward the operating handle at the other end.

In one embodiment, to facilitate bending, the barrel 425 includes a compliant segment 4251 adjacent the locking element 422 and a third extension segment 4252 abutting and extending proximally from the compliant segment 4251. The compliant section has less improved stiffness than the third extension, i.e. better compliance and easier bending.

In one embodiment, compliant segment 4251 is a hypotube or a spring tube (i.e., a tube wall sandwich with helically extending ribs) having a length in the range of 120mm to 180mm, such as 150 mm.

The third extension 4252 is made of a hypotube or a steel cable tube (woven or twisted by metal wires); the steel cable pipe can be wrapped with a PTFE film to play a role in lubrication.

In other embodiments, core tube 425 is a full piece of hypotube. The hypotube can ensure axial supporting force and can be bent radially, in order to control the bending direction of the compliant section 4251, the compliant section 4251 can be provided with an axially extending reinforcing rib, and the reinforcing rib is obtained by cutting the corresponding part of the hypotube (the region which is not cut or has relatively sparse cutting marks is the reinforcing rib). The reinforcing ribs may extend to the proximal end of core tube 425 accordingly, but may also extend to the middle of core tube 425 or slightly proximal to the proximal end because core tube 425 does not have a significant bending requirement near the proximal end.

Referring to fig. 7, fig. 8, when compliant segment 4251 is cut, the cutting slit width (i.e., laser spot diameter): 0.1-1 mm, seam spacing (i.e. the uncut portion between adjacent cut seams): 0.1-1 mm; wherein an uncut portion extends in the axial direction to form a rib 4253.

In some embodiments, the core tube is the subject of the bend, and the compliant segment is configured to have a smaller extreme radius of curvature after the bend is made, the closer to the distal end. The distal end of the core tube may be made more adaptable to complex paths, particularly in terms of compliant segments, in at least one of the following ways, for example:

the slot width in the compliant segment varies gradually and the closer to the distal end, the larger the slot width.

The slot spacing varies gradually in the compliant section, and the closer to the distal end, the smaller the slot spacing.

In the compliant section, the stiffness (degree of flexibility) changes gradually, and the closer to the distal end, the lower the stiffness.

Referring to fig. 9 to 11, the bending adjusting tube 410 is sleeved outside the core tube 425, and the bending adjusting tube 410 sequentially includes a pulling section and a second extending section 413 from a distal end to a proximal end, wherein the pulling section is an integral structure and adopts a hypotube.

The distal side of the pulling member extends adjacent the proximal side of locking element 422 and is secured to core tube 425. In order to prevent the pulling section from being reversed during processing, different marks can be made at the two ends of the pulling section in a punching mode and the like so as to identify the assembly orientation of the far end and the near end.

The pulling section comprises a first pulling section 411, a transition section 414 and a second pulling section 412 in sequence from the distal end to the proximal end.

In the present application, the bending adjustment tube 410 is located outside the core tube 425, i.e. the active person applying force during bending adjustment is located outside, and the passive person under traction is located inside, so that the arrangement is relative to the active person, and the passive person can be allowed to obtain a larger bending angle outside.

The first pulling section 411 is formed with a rib 4111 by cutting, and the circumferential position of the rib 4111 is 180 degrees different from that of a rib 4253 of the compliant section 4251.

The second drawing segment 412 is also cut, and when the first drawing segment 411 and the second drawing segment 412 are cut, the width of the cutting seam is: 0.03-0.5 mm, seam spacing: 0.2 mm-0.85 mm; the first pulling section 411 is located at an expected bending position and is relatively soft and easy to bend, the second pulling section 412 is relatively hard, but in order to ensure certain flexibility, the first pulling section can be bent during transportation and packaging, and can be bent according to blood vessels after an operation enters a human body, so that a cutting mode is adopted, and the seam width and the seam interval can be correspondingly adjusted according to the hardness requirements of different sections during actual operation.

The second pulling section 412 has ribs 4121 and 4122 cut out and diametrically opposed to each other, i.e., 180 degrees apart in circumferential position and 90 degrees apart from the ribs 4111 of the first pulling section 411 in circumferential position.

The transition section 414 is not cut, and the transition section 414 connects the first pulling section 411 and the second pulling section 412, and shares the pulling stress at different positions in the circumferential direction.

The second extension 413 has no special bending requirement and is mainly responsible for transmitting the pulling force, for example, by extending it proximally and connecting it to the operating handle, such as by using a hypotube that is not cut additionally.

The bending degree of the first drawing section 411 and the bending degree of the compliance section 4251 are large in the bending adjusting process, so that the bending adjusting angle is generally required to be larger than 270 degrees when the hypotube is cut, the single reinforcing rib structures arranged on the first drawing section 411 and the compliance section 4251 respectively ensure that the bending adjusting section and the compliance section are not stretched when the hypotube is subjected to bending stress, the softness is moderate after the first drawing section 411 and the compliance section 4251 are overlapped inside and outside, and the bending adjusting and the force transmission are easy to realize. Overall, the bend adjusting pipe 410 is 5mm to 10mm longer than the core pipe 425 to match the axial deviation after bend adjustment, the core pipe 425 and the sheath pipe 300 are both passive during bend adjustment, and the bend adjusting pipe 410 applies force actively.

Referring to fig. 12 to 13, in order to adapt to bending or to adaptively change the distal direction during passing through the body, the sheath 300 at the outermost layer has correspondingly different stiffness distributions at different axial positions, and the sheath 300 sequentially includes a loading section 310, a bending section 320 and a first extending section 330 from the distal end to the proximal end. In use, primarily bends proximal to the loading region that receives the interventional instrument 500, i.e., where the bending section 320 is located.

Referring to fig. 14 to 15d, in an embodiment, a nesting relationship among the sheath 300, the core tube assembly 420 and the adjusting tube 410 and a releasing process of the interventional instrument are illustrated, and in fig. 15d, a general axial position relationship among the sections of the sheath 300, the core tube assembly 420 and the adjusting tube 410 is also illustrated, for each section, the sheath 300 adopts a multi-layer composite structure, that is, for a certain section, the multi-layer structure and different parts are included in processing, and the structure and the process of the sheath 300 are also an improvement of the present application.

Referring to fig. 16 to 17d, in an embodiment, the nesting relationship of the sheath 300 and the core tube assembly 420 and the releasing process of the interventional instrument are illustrated, and in fig. 15d, the sheath 300 is also illustrated, and the approximate axial position relationship of the segments in the core tube assembly 420 is also illustrated, for each segment, the sheath 300 adopts a multi-layer composite structure, that is, for a certain segment, the multi-layer structure is adopted and different components are included in the processing, and the structure and the process of the sheath 300 are also one of the improvements of the present application. In this embodiment, core tube assembly 420 includes a core tube 425 having a locking element 422 secured to core tube 425, and a distal end of core tube 425 further extends beyond locking element 422 and has a guide head 421 secured at a distal end. The distal end of the guide head 421 has a rounded head structure with a convergent shape to facilitate the passing and advancing in the body, and the position between the guide head 421 and the locking element 422 is used as the loading position of the interventional device, and the interventional device in a compressed state is in the position and is in limit fit with the locking element 422.

In one embodiment, core tube 425 has core 424 threaded therein, the distal end of core 424 extends out of locking element 422 and is fixed with guide head 421, the distal end of core tube 425 extends only to locking element 422, the proximal extension of core 424 is not limited, and core 424 has a smaller outer diameter relative to core tube 425 because core tube 425 does not extend to the loading position, so that the radial space of the loading position can be expanded.

In an embodiment of the present application, a sheath for delivering an interventional device is provided, a loading section 310 is provided at a distal end of the sheath for receiving the interventional device, the loading section 310 adopts a multilayer structure and sequentially includes an inner lining tube 375, a metal tube and an outer covering film 380 from inside to outside, wherein the metal tube includes a main tube 350 and a head tube 340, which are butted with each other, from a proximal end to a distal end;

the head tube 340 includes a body section 346, a plurality of expansion tabs 344 spaced circumferentially apart on a distal side of the body section, a first connector 343 on a proximal side of the body section, the distal side of the body tube 350 carrying a second connector 351, the first connector 343 and the second connector 351 being interfitting and complementary in shape.

An embodiment of the present application provides a sheath for delivering an interventional device, the sheath is divided into a loading section 310, a bending section 320 and a first extending section 330 from a distal end to a proximal end in sequence in an axial direction, wherein the loading section 310 is used for accommodating the interventional device 500, the sheath adopts a multilayer structure, including: the inner sheath tubes 370, the inner sheath tubes 370 are distributed on the bending section and the first extending section in the axial direction;

an inner lining tube 375, wherein the inner lining tube 375 is butted against the distal end of the inner sheath tube 370, and the inner lining tube 375 is distributed on the loading section in the axial direction;

the metal pipe wraps the distal end part of the inner sheath pipe and the periphery of the inner lining pipe, and is distributed on the bending section and the loading section in the axial direction;

and the outer wrapping film 380 wraps the periphery of the metal pipe, and the outer wrapping film 380 is distributed on the bending section and the loading section in the axial direction.

Loading section 310 has a larger diameter at the proximal portion of loading section 310 (i.e., compliant section 320 and first extension section 330) relative to the sheath, due to the need to wrap the interventional instrument.

Fig. 18 illustrates a part of the visible components of the sheath 300, the distal portion of the sheath 300 generally has at least three layers, the inner layer and the outer layer are made of polymer materials, the middle layer is made of metal tube, the middle layer adopts three-segment butt joint structure, and comprises a head end tube 340, a main tube 350 and an extension tube 360 which are butt jointed in sequence from the distal end to the proximal end, wherein the head end tube and the main tube are distributed on the loading section, and the extension tube is distributed on the bending section in the axial direction.

The bending section can be bent to change the pointing direction of the distal end of the sheath tube during the delivery process, and the first extension section mainly provides enough axial pushing force and pulling force and has enough length to be connected with an operating handle.

The head-end tube 340 is formed by cutting a nickel-titanium alloy tube, and the main tube 350 and the extension tube 360 are respectively formed by cutting stainless steel tubes. The head end tube 340 and the main tube 350 have larger tube diameters relative to the extension tube 360 due to the fact that the interventional device is wrapped, and the joint position of the main tube 350 and the extension tube 360 is correspondingly flared and tapered by combining the axial position relation of fig. 18.

Referring to fig. 19a, in an embodiment, a plurality of spaced openings 341 are formed at a distal end side of the head end tube 340 along a circumferential direction, an expansion piece 344 is disposed between two adjacent spaced openings, and each expansion piece 344 is provided with a hollow area 345. In a preferred embodiment, the expansion pieces 344 are uniformly arranged along the circumferential direction, and the number of the expansion pieces is 3-6, for example 5.

In general, the head pipe 340 preferably adopts an integral structure, the body section 346 forms a developing area 342 in a hollow manner for installing a developing point, and the first connector 343 is T-shaped for abutting against the main pipe 350 and axially limiting. The through holes 347 are distributed in both the main body segment 346 and the first connecting member 343, so that the polymer materials as the inner and outer layers of the sheath tube can be fused better.

The spacing opening 341 is a strip-shaped gap, the distal end is open and the proximal end is closed, because the head-end tube 340 is made of elastic metal material such as nickel-titanium alloy, the expansion pieces 344 can be radially outwards turned, the interventional device can adapt to gradual deformation when the interventional device is released, the interventional device is prevented from suddenly collapsing at the final stage of release, and when the interventional device needs to be retracted, the expansion pieces 344 are radially outwards turned to form a horn mouth, so that the interventional device can be guided to be gradually radially compressed and accommodated in the sheath tube 300. For better elasticity, the tip tube 340 may be made of nitinol, and each of the expansion pieces has a closed state extending along the axial direction of the sheath and an everted state away from each other.

The hollow-out areas 345 of the expansion pieces 344 facilitate deformation of the expansion pieces and reduce eversion resistance, and in one embodiment, the hollow-out areas 345 are strip-shaped holes extending in the axial direction of the head end pipe 340, and one, two or more strip-shaped holes are formed in the same expansion piece.

In a preferred embodiment, the strip-shaped apertures extend equally wide. The two ends of the strip-shaped hole in the length direction are arc-shaped inner edges. Can avoid the cracking caused by over concentration of stress during deformation.

In one embodiment, each expansion tab 344 has a narrowed portion 348 at a proximal portion and the spaced openings have corresponding widened portions at a proximal portion that correspond to the narrowed portion 348.

To distribute the stress, the inner edge of the widened portion adopts a smooth curve, such as a large head portion in the shape of a drop.

In one embodiment, the spacer openings themselves extend generally of equal width except for the distal side chamfered to accommodate the expansion tabs, and the widened portion of the proximal side.

The width of the equally wide extending portion of the slit is substantially the same as the width of the slit, and for example, the width of the slit is ± 20% of the reference width, based on the width of the slit.

To facilitate eversion of each expansion tab 344 at the constriction 348 and reduce resistance to deformation at the proximal side of the constriction, in one embodiment, the proximal side 349 of the slot passes over the constriction of the expansion tab. In a preferred embodiment, the proximal side 349 of the strip-shaped hole crosses over the narrowed portion of the expansion piece by 1-5 mm, for example, 1.5-3 mm.

To avoid safety concerns, in one embodiment, the distal end of the expansion tab has a smooth outer edge, for example, rounded or generally rounded in shape projecting distally.

Referring to fig. 19b, in an embodiment, each expansion piece 344 is provided with a hollow area 345, the hollow area 345 is a plurality of through holes arranged at intervals along the axial direction of the sheath, and the total area of the through holes on each expansion piece is less than 50% of the area of the expansion piece. It can be seen that the area of the through hole is larger the closer to the distal end on the same expansion sheet. The through holes are circular or oval, and the number of the through holes on the same expansion piece is 2-5.

Similar to the embodiment shown in fig. 19a, the body section 346 of the head-end tube forms a developing area 342 in a hollow manner for installing a developing point, and the first connector 343 is T-shaped for abutting against the main tube and axially limiting. Through holes 347 are distributed on the body section 346 and the first connecting head 343, so that the high polymer materials of the inner layer and the outer layer of the sheath tube can be fused better. The spacing openings 341 are formed between the adjacent expansion pieces 344, the spacing openings 341 are strip-shaped gaps, the far ends of the spacing openings are open, the near ends of the spacing openings are closed, the expansion pieces 344 are more narrow towards the far ends, and the arc-shaped edges are arranged at the farthest end parts to improve the safety.

For preventing the metal material scratch vascular wall in intermediate level, outmost parcel head end pipe 340 at least, main part pipe 350 and extension pipe 360, outmost outer involucrum 380 can adopt macromolecular material, because the metal material part is the multistage structure, involucrum 380 also adopts multistage mosaic structure and then melts as an organic whole man when processing.

For example, along the axial direction of the sheath, the outer covering film 380 comprises multiple sections, each section being made of a different material, or at least two sections being made of the same material.

In one embodiment, the strength of the outer coating corresponding to the main tube 350 is greater than the strength of the outer coating corresponding to the distal end of the head tube 340.

The inner layer comprises an inner sheath tube 370 and an inner lining tube 375, wherein the inner sheath tube 370 extends proximally from one side and extends to the joint of the main tube 350 and the extension tube 360, the inner sheath tube 370 extends distally from the joint of the main tube 350 and the extension tube 360 through the inner lining tube 375 to the distal side of the head tube 340, and the inner lining tube 375 may be made of PTFE.

The axial position of the distal portion of the extension tube 360 corresponds to the compliant section 4251 and the first puller section 411, and the extension tube 360 may also be cut to form reinforcing ribs.

Referring to fig. 20 to 24, the inner sheath 370 itself has a multi-layer structure including, from the inside to the outside, an inner layer 3701 of PTFE, a woven layer 3702, a woven layer 3704, and an outer layer 3705, in which two reinforcing ribs 3704 extending in the axial direction are fixedly wrapped between the woven layer 3702 and the woven layer 3704.

One of the two beads 3704 is located at the same circumferential position as the bead 4253, and the other is located 180 degrees different from the bead 4253.

Braided layers 3702 and 3704 do not require significant layering, can be integrally braided and hold the reinforcing ribs, and outer layer 3705 can be made of Pebax.

The compliant section 4251 is provided with reinforcing ribs 4253, the first pulling section 411 is provided with reinforcing ribs 4111, and the circumferential positions of the reinforcing ribs 4253 and the reinforcing ribs 4111 are staggered by 180 degrees.

The sheath tube in the cross section only shows the extension tube 360, the extension tube 360 can be provided with a reinforcing rib 3601, and the reinforcing rib 3601 and the reinforcing rib 4253 are positioned on the same radial side, namely at the same circumferential position;

or in other embodiments, two reinforcing ribs are arranged in the extension tube 360, which are a reinforcing rib 3601 and a reinforcing rib 3602, wherein the reinforcing rib 3601 and the reinforcing rib 4253 are located on the same radial side, that is, at the same circumferential position, and the reinforcing rib 3602 and the reinforcing rib 4111 are located on the same radial side, that is, at a position 180 degrees different from the circumferential position of the reinforcing rib 4253.

The inner sheath 370 is both in the bending section 320 and the first extension section 330, and because the bending section 320 has a larger bending angle during bending, the strength of the inner sheath 370 is different between the bending section 320 and the first extension section 330, and the inner sheath 370 is softer in the bending section 320, for example, the inner sheath 370 adopts 30-59D Pebax for the outer layer 3705 of the bending section 320, 60-90D Pebax for the outer layer 3705 of the first extension section 330, and the same arrangement can be adopted for the braided layer and the inner PTFE layer 3701 at different positions of the inner sheath 370. Referring to fig. 25 to 34, in an embodiment of the present application, there is provided a method for processing a sheath 300, including:

step S100, processing the distal end of the inner sheath tube to form a flaring part;

the end portion of the inner sheath, i.e., the distal end 371, may be heat softened and the distal end 371 may be expanded to form an expanded portion 374 in conjunction with an inserted core rod 372, and a portion of the outer circumference of the core rod 372 may be formed into a round land 373 in accordance with the desired shape of the expanded portion 374.

Step S200, fixedly sleeving a lining pipe on the periphery of the flaring part;

taking an inner lining pipe 375 made of PTFE material, wherein the end part of the inner lining pipe 375 is provided with lugs arranged at intervals along the circumferential direction, a cutting area 376 is arranged between the lugs, the end is wrapped at an expanding part 374, and then the end is wrapped by a fixing sleeve 377 to be hot-melted, namely the inner lining pipe 375 is connected to the far end 371 of an inner sheath pipe.

The fixing sleeve 377 and the flared portion 374 are made of the same material, such as Pebax, and the cutting area 376 facilitates the fusion of the fixing sleeve 377 and the flared portion 374, so that the connection strength of the lining tube 375 is guaranteed.

Step S300, sleeving a metal pipe on the peripheries of the inner sheath pipe and the inner lining pipe;

the extension pipe 360, the main body pipe 350 and the head end pipe 340 are sequentially butted, the adjacent two are axially limited by adopting modes such as hooks, buckles and the like, wherein the head end pipe 340 adopts a nickel-titanium alloy pipe, and the extension pipe 360 and the main body pipe 350 can adopt stainless steel pipe materials.

The proximal side of the head tube 340 is provided with a first connector 343 in the shape of a T, the distal side of the main tube 350 is provided with a second connector 351 in the shape of a T, and the first connector 343 and the second connector 351 are mutually matched in a complementary manner for axial limitation.

The proximal side of the main tube 350 has a mouth portion 352 and is adapted to engage the extension tube 360 through the mouth portion 352, which may be in the form of a conventional hook or snap. The main tube 350 has hollow areas 353 and 354 distributed on the wall thereof, and guide ribs 355 extending axially are distributed between the hollow areas 353 and 354, the guide ribs 355 can limit the bending direction of the sheath tube 300, and the two guide ribs 355 are arranged oppositely in the radial direction.

The extension tube 360, the main tube 350 and the head end tube 340 are sequentially butted and then sleeved outside the inner sheath tube 370 and the inner lining tube 375, the position of the flared part 374 corresponds to the axial position of the closed part 352, the inner lining tube 375 is slightly longer than the head end tube 340, and the part of the inner lining tube 375 corresponding to the spaced opening 341 is correspondingly cut to adapt to the deformation of the expansion piece.

And S400, coating the outer surface of the metal pipe by sections by using an outer coating material, and forming an outer coating film integrally after the outer coating material of each section is hot-melted. The method specifically comprises the following steps:

step S410, wrapping a first connecting sleeve 381 at the butt joint part of the main body pipe 350 and the head end pipe 340, wrapping a head end outer sleeve 382 at the periphery of the head end pipe 340, and fixing the first connecting sleeve 381 and the head end outer sleeve 382 in a hot melting mode;

the head end outer sleeve 382 is slightly longer than the head end pipe 340 to be approximately aligned with the inner lining pipe 375, and then the first connecting sleeve 381 and the head end outer sleeve 382 are hot-melted together with the corresponding position of the inner lining pipe 375 to wrap and fix the butt joint part of the main body pipe 350 and the head end pipe 340 and the inside and outside of the head end pipe 340.

The first lining 383 and the second lining 384 are placed in the hollowed-out areas 353 and 354, and then the first lining 383 and the second lining 384 are hot-melted with the corresponding positions of the lining tube 375, and the first lining 383 and the second lining 384 penetrate into and fill the corresponding hollowed-out areas.

Step S420, wrapping the main body outer sleeve 385 on the periphery of the main body pipe 350 and performing hot melting and fixing;

the distal side of the body sleeve 385 is generally aligned with the proximal side of the first coupling sleeve 381, and the proximal side of the body sleeve 385 surrounds the interface of the elongated tube 360 and the body tube 350.

The head end outer cover 382 is required to be more flexible, the material can be TPU, etc., and the first connecting cover 381, the first lining 383, the second lining 384 and the main body outer cover 385 can be Pebax, etc., which has better strength, wherein the first lining 383 and the second lining 384 can be thinner than the main body outer cover 385, for example, the thickness of the first lining 383 and the second lining 384 is about 0.15mm, and the thickness of the main body outer cover 385 can be increased to 0.35 mm.

In addition, the first connecting sleeve 381 requires a greater strength, so that a relatively hard material can be selected, for example, the hardness is 60-72D, and the main body cover 385 mainly covers the protection function, and the hardness can be reduced by a suitable amount, for example, 40-55D. Step S430, wrapping a second connecting sleeve 386 at the proximal end of the extension tube 360 and the inner sheath tube 370 at the adjacent position, and fixing the second connecting sleeve 386 by hot melting;

step S440, the extension tube 360 is wrapped with the connection sleeve 387 and fixed by heat fusion.

The axial position of the connecting sleeve 387 is such that the proximal end abuts the second connecting sleeve 386 and the distal end abuts the body sleeve 385.

The second connecting sleeve 386 is made of Pebax and the like with better strength, the connecting sleeve 387 is made of TPU and the like due to the fact that the connecting sleeve 387 is located at the bending position and is required to be smooth and flexible, and in addition, the connecting sleeve 387 can prevent an inner metal pipe from directly contacting and scratching a blood vessel and also has a sealing effect.

The material of each section of parcel in extension pipe 360, main part pipe 350, head end pipe 340 three periphery finally melts and forms outer envelope 380 as an organic whole, and the part hot melt binding off that surpasss at the head end pipe 340 distal end is finally handled, and wherein also can corresponding cutting with the position that the interval opening 341 corresponds to the adaptation is possibly out of shape at interval opening 341, or utilizes the material elasticity adaptation of head end overcoat 382 self.

Referring to fig. 35-40, the bending adjustment system of the present application can actively change the orientation of the distal portion by pulling the bending adjustment tube at the operation handle, and can be adapted to the complex path transportation, for example, when the interventional device 500 is disposed in the aortic valve 600, the distal end of the sheath assembly is directed and located at the aortic valve 600 by bending adjustment when passing through the aortic arch, and the bending adjustment tube pulls the core tube assembly, so that the interventional device loaded on the core tube assembly does not change the orientation when the sheath is retracted to release the interventional device, and the potential for dislocation during the release process can be avoided.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims (16)

1. The adjustable-bending interventional instrument conveying system is provided with a far end and a near end which are opposite, the conveying system comprises an operating handle at the near end and a sheath pipe assembly which is connected with the operating handle and extends towards the far end, the sheath pipe assembly comprises a sheath pipe and a sheath core assembly, and the adjustable-bending interventional instrument conveying system is characterized in that the sheath core assembly comprises a core pipe, a locking piece which is fixed at the far end of the core pipe and used for connecting an interventional instrument, and an adjustable bending pipe which is mutually nested with the core pipe, the far ends of the adjustable bending pipe and the core pipe are mutually and fixedly connected, and the near ends of the adjustable bending pipe and the core pipe can relatively slide;

the sheath tube is in sliding fit with the periphery of the sheath core assembly, the distal end of the sheath tube is an expanded loading section for accommodating an interventional instrument, and the proximal end of the sheath tube is extended and connected to the operating handle;

the loading section adopts a multilayer structure, one layer of the loading section is a metal pipe, the far end side of the metal pipe is provided with a plurality of expansion pieces which are arranged elastically at intervals along the circumferential direction, and each expansion piece is provided with a hollow area.

2. The adjustable bend interventional instrument delivery system of claim 1, wherein the operating handle comprises a control assembly, a bend adjustment assembly, and a front end grip;

the control assembly includes:

a first support fixed to the front end handle;

a first connector slidably mounted to the first support, the proximal end of the sheath being secured to the first connector;

the first driving piece is movably arranged on the first supporting body and drives the first connecting piece to slide;

the bend adjustment assembly comprises:

a second support fixed opposite to the first support;

the second connecting piece is slidably mounted on the second support body, and the near end of the bend adjusting pipe penetrates through the sheath pipe and then is fixed on the second connecting piece;

the second driving piece is movably arranged on the second supporting body and drives the second connecting piece to slide;

and the pipe joint is fixedly arranged at the near end of the second support body, and the near end of the core pipe penetrates out of the bend adjusting pipe and then is fixed on the pipe joint.

3. The adjustable-bend interventional instrument delivery system of claim 1, wherein the sheath is axially divided into a loading section, a bending section and a first extension section from a distal end to a proximal end, and the sheath has a multi-layer structure comprising:

the inner sheath pipe is distributed on the bending section and the first extending section in the axial direction;

the lining pipe is butted at the far end of the inner sheath pipe and is distributed on the loading section in the axial direction;

the metal pipe wraps the distal end part of the inner sheath pipe and the periphery of the inner lining pipe, and is distributed on the bending section and the loading section in the axial direction;

the outer wrapping film is wrapped on the periphery of the metal pipe and is distributed on the bending section and the loading section in the axial direction.

4. The adjustable bend interventional instrument delivery system of claim 3, wherein the metal tube comprises, from distal end to proximal end, a head tube, a main tube and an extension tube, which are sequentially abutted, wherein in the axial direction, the head tube and the main tube are distributed in the loading section, and the extension tube is distributed in the bending section;

the expansion tab is on a distal side of the head end tube.

5. The bendable interventional instrument delivery system of claim 1, wherein the core tube includes a compliant segment adjacent the lock and a third extension segment abutting the compliant segment and extending proximally, wherein the compliant segment is less rigid relative to the third extension segment.

6. The adjustable bend interventional instrument delivery system of claim 5, wherein the compliant section has a length in the range of 120-18 mm, and the third extension is a steel cable or hypotube.

7. The adjustable bend interventional instrument delivery system of claim 5, wherein the compliant segment is a hypotube or a spring tube.

8. The adjustable bend interventional instrument delivery system of claim 7, wherein the compliant segment is cut to form an axially extending first stiffening rib; the width of a cutting seam of the compliant section is 0.1-1 mm, and the seam interval is 0.1-1 mm.

9. The adjustable bend interventional instrument delivery system of claim 8, wherein the radius of ultimate curvature after being adjusted is smaller in the compliant segment as the distal end is closer.

10. The adjustable-bend interventional instrument delivery system of claim 8, wherein the adjustable-bend tube comprises a pulling section and a second extension section in sequence from a distal end to a proximal end, wherein the pulling section is of an integral structure and adopts a hypotube; the traction section sequentially comprises a first traction section, a transition section and a second traction section from a far end to a near end, the first traction section has higher flexibility than the second traction section, and the length ratio of the first traction section to the compliant section is 1: 0.7-1.5.

11. The adjustable bend interventional instrument delivery system of claim 10, wherein the first pulling section is cut to form a strip of axially extending second reinforcing ribs having circumferential positions 180 degrees different from the circumferential positions of the first reinforcing ribs.

12. The adjustable bend interventional instrument delivery system of claim 11, wherein the first pulling section has a cutting slit width of 0.03-0.5 mm and a slit spacing of 0.2-0.85 mm.

13. The adjustable bend interventional instrument delivery system of claim 10, wherein the second pulling section is cut to form two axially extending third reinforcing ribs, the two third reinforcing ribs being diametrically opposed and each being 90 degrees different from the circumferential position of the first reinforcing rib.

14. The adjustable bend interventional instrument delivery system of claim 13, wherein the second pulling section has a cutting slit width of 0.03-0.5 mm and a slit spacing of 0.2-0.85 mm.

15. The adjustable bend interventional instrument delivery system of claim 10, wherein the transition segment is a full circle of uncut structure in the circumferential direction.

16. The adjustable bend interventional instrument delivery system of claim 1, wherein the adjustable bend sheath is disposed about an outer periphery of the core tube or within the core tube.

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