CN217489502U

CN217489502U - Catheter sheath and interventional assembly

Info

Publication number: CN217489502U
Application number: CN202123432671.XU
Authority: CN
Inventors: 赵银涛; 王翔; 秦华北; 李美琴; 张晗晖
Original assignee: Hangzhou Qiming Medical Devices Co ltd
Current assignee: Hangzhou Qiming Medical Devices Co ltd
Priority date: 2021-12-29
Filing date: 2021-12-29
Publication date: 2022-09-27
Anticipated expiration: 2031-12-29

Abstract

The application discloses catheter sheath and intervene subassembly, wherein the catheter sheath includes: a sheath for establishing a first instrument channel; the first hemostatic valve is arranged at the near end of the sheath tube and is provided with a second instrument channel, and the far end of the second instrument channel is provided with a mounting port; the connecting sleeve is arranged between the mounting opening and the sheath tube so as to butt the first instrument channel and the second instrument channel; and the second hemostatic valve is arranged in the connecting sleeve and is restrained at the distal end side of the first hemostatic valve by the connecting sleeve, and the second hemostatic valve is used for controlling the connection and disconnection between the second instrument channel and the first instrument channel. According to the technical scheme disclosed by the application, the first hemostatic valve and the second hemostatic valve are matched through structural optimization in the catheter sheath, so that the drawing operation hand feeling of the instrument is guaranteed, and the blood loss is effectively reduced; the whole drawing operation of the intervention assembly is good, the change of the operation force is small, and a structural foundation is provided for adjusting the hand feeling of the drawing instrument.

Description

Catheter sheath and interventional assembly

Technical Field

The present application relates to the field of medical devices, and more particularly to catheter sheaths and interventional assemblies.

Background

Interventional therapy is a leading-edge treatment technique developed in recent years between drug administration and open surgery. The interventional therapy technology usually needs to use medical imaging equipment such as X-ray fluoroscopy, CT positioning, B-type ultrasonic equipment and the like for guiding, and a catheter device loaded with interventional instruments (such as a vascular stent and a prosthetic heart valve) or medicines reaches a lesion area in a human body through arteries and veins of the human body, so that the purposes of diagnosing and treating diseases are achieved.

The sheath provides a passageway for the catheter device to enter the body and also creates an outflow port for blood or other body fluids. To prevent blood loss, it is often necessary to provide a sealing hemostatic valve within the catheter sheath. The problem in the prior art solutions is that a contradiction arises between the sealing function of the haemostatic valve and the passable function for facilitating the passage of an interventional instrument. To prevent blood from escaping, it is often desirable to improve the sealing properties, but the penetrability of the interventional device within the haemostatic valve is correspondingly affected.

Technical improvements directed to catheter sheaths are also disclosed in the related art. For example, in a related art, the hemostatic valve of the catheter sheath includes a housing and a tubular sealing membrane located in the housing, an annular sealed cavity is defined between an outer periphery of the tubular sealing membrane and the housing, and the size of the sealed cavity is adjusted by injecting a filler into the sealed cavity, so as to achieve opening and closing of the hemostatic valve.

The inventor finds that after the sealing membrane is sealed, the existing catheter sheath can generate large friction with an interventional instrument, the position of the interventional instrument relative to the hemostatic valve is convenient to operate, the dense hemostatic valve needs to be frequently adjusted to adjust the sealing state of the sealing membrane, the operation is complex, the precision control difficulty is large, and the treatment process is affected.

SUMMERY OF THE UTILITY MODEL

In order to solve the above-mentioned technical problem, the present application discloses a catheter sheath, including:

a sheath for establishing a first instrument channel;

the first hemostatic valve is arranged at the near end of the sheath tube and is provided with a second instrument channel, and the far end of the second instrument channel is provided with a mounting port;

the connecting sleeve is arranged between the mounting opening and the sheath tube so as to butt the first instrument channel and the second instrument channel;

and the second hemostatic valve is arranged in the connecting sleeve and is restrained at the distal end side of the first hemostatic valve by the connecting sleeve, and the second hemostatic valve is used for controlling the connection and disconnection between the second instrument channel and the first instrument channel.

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.

Optionally, the second hemostatic valve includes a base covering the distal opening of the second device channel and at least two elastic valve plates movably disposed on the base, each valve plate has an open state and a closed state, the open state and the closed state are mutually compact, and the valve plates in the closed state prevent fluid from flowing from the first device channel to the second device channel.

Optionally, the mounting opening is cylindrical, the base includes an inner edge extending into the mounting opening and a fixing edge overlapping on a distal end side surface of the mounting opening, and the connecting sleeve and the mounting opening surround and constrain the fixing edge and/or the inner edge.

Optionally, the connecting sleeve is cylindrical, one end of the connecting sleeve is a pipe joint for inserting the sheath pipe, and the other end of the connecting sleeve is a screw thread connected with the mounting opening in a threaded manner; the two axial ends of the connecting sleeve are smoothly transited with the peripheral surfaces of the corresponding parts.

Optionally, the connecting sleeve gradually reduces from the proximal end to the distal end, the lumen diameter of the pipe joint is matched with the lumen diameter of the sheath pipe, and the lumen diameter of the screw is matched with the size of the second hemostatic valve.

Optionally, the second hemostatic valve includes a base covering the distal opening of the second instrument channel and at least two elastic valve plates movably disposed on the base; the mounting opening is cylindrical, the base comprises an inner edge extending into the mounting opening and a fixing edge arranged on the far-end side face of the mounting opening in a lapping mode, a positioning step matched with the far-end side face of the mounting opening in size is arranged in the connecting sleeve, and the fixing edge is clamped between the positioning step and the far-end side face of the mounting opening;

a movable chamber is arranged between the pipe joint and the positioning step, and the valve plate moves in the movable chamber to control the opening and closing state of the far-end opening of the second instrument channel.

Optionally, a bypass joint communicated with the movable chamber is formed on the side wall of the connecting sleeve.

Optionally, the proximal side of the first hemostatic valve is provided with an anti-drop snap structure, and the snap structure at least provides axial limitation for the binder extending into the second instrument channel.

Optionally, the engagement structure is disposed on a radial skirt of the proximal opening of the second instrument channel.

Optionally, the engaging structure includes a stopper disposed axially of the second instrument channel and an access opening circumferentially open toward the proximal end opening of the second instrument channel.

Optionally, the sheath tube includes a tube wall, the tube wall is a coiled wall structure, the cross section is in a coiled shape, and the tube wall has an expanded state for unfolding the coiled wall structure at a corresponding position and a pre-shaping state for automatically restoring the coiled wall structure.

Optionally, the near-end cover of sheath pipe is equipped with the elastic sleeve, the elastic sleeve certainly the connecting sleeve extends to the distal end and near-end side forms the reducing section, the reducing section with the connecting sleeve cooperation.

Optionally, the elastic sleeve is made of TPU.

Optionally, the starting side and the tail side of the pipe wall winding are connected through a flexible envelope film, and the pipe wall is of a double-layer composite structure.

Optionally, the materials of the layers in the double-layer composite structure are independently set to be HDPE, TPU, or the composition of HDPE and TPU.

Optionally, the sheath pipe includes the pipe wall and the pipe wall has the swell state of expansion corresponding part pipe diameter and restores the presetting state of corresponding part pipe diameter by oneself, the pipe wall includes by interior and the first high score sublayer of establishing of outer cover in proper order, elastic layer and second high score sublayer, the elastic layer is used for driving about the pipe wall keeps the presetting state.

Optionally, the material of the first polymer layer is PTFE.

Optionally, the second polymer layer is made of Pebax.

Optionally, the elastic layer is an elastomer disposed in a wound configuration.

Optionally, the elastic body is a coil spring made of stainless steel or memory metal.

Optionally, the sheath includes from inside to outside in proper order the first high polymer layer of establishing, intermediate level and second high polymer layer, the intermediate level is for weaving the structure.

Optionally, the outer wall of the distal end portion of the sheath tube is provided with scale marks.

Optionally, a bionic coating for improving biocompatibility is arranged on the outer circumferential surface of the sheath tube.

Optionally, first hemostasis valve includes the casing and installs in the casing and be the sealing membrane of tubular structure, the inner chamber of tubular structure is regarded as second apparatus passageway, be equipped with in the casing and be in the peripheral driver chamber that is used for filling fluid of sealing membrane, first hemostasis valve still include can with energy storage mechanism that the fluid linked mutually, energy storage mechanism is in corresponding energy storage or energy release when sealing membrane state changes, and drive when energy release the sealing membrane is sealed the second apparatus passageway.

The application also discloses intervene subassembly, including catheter sheath and the puncture sheath among the above-mentioned technical scheme, the puncture sheath includes body and connection handle, the catheter sheath with the puncture sheath is under the combined state, the body via the second apparatus passageway with first apparatus passageway extends to the distal end of sheath pipe, the connection handle with first hemostasis valve block location each other.

Optionally, the proximal side of the first hemostatic valve is provided with an anti-drop clamping structure, the connecting handle is provided with a positioning clamping block matched with the clamping structure, and the positioning clamping block and the clamping structure are clamped with each other to realize axial limiting of the puncture sheath.

According to the technical scheme disclosed by the application, the first hemostatic valve and the second hemostatic valve are matched through structural optimization in the catheter sheath, so that the drawing operation hand feeling of the instrument is guaranteed, and the blood loss is effectively reduced; the whole drawing operation of the intervention assembly is good, the change of the operation force is small, and a structural foundation is provided for adjusting the hand feeling of the drawing instrument.

Specific advantageous technical effects will be further explained in conjunction with specific structures or steps in the detailed description.

Drawings

FIG. 1 is a schematic view of an embodiment of a catheter sheath;

FIG. 2a is a schematic view of the proximal end of the catheter sheath of FIG. 1;

FIG. 2b is an exploded proximal end view of the catheter sheath of FIG. 2 a;

FIG. 3a is a proximal end view of the catheter sheath of FIG. 1 from another perspective;

FIG. 3b is an exploded view of the proximal end of the catheter sheath of FIG. 3 a;

FIG. 4a is a schematic view of an assembly of the first hemostatic valve, the second hemostatic valve, and the connection sleeve according to an embodiment;

FIG. 4b is a schematic view of the assembly of the first and second hemostatic valves of FIG. 4 a;

FIG. 5 is a sectional view of the assembly of the first hemostatic valve, the second hemostatic valve, and the connection sleeve of FIG. 4 a;

FIGS. 6 and 7 are schematic views of a second hemostasis valve from different perspectives, respectively;

FIGS. 8a to 8c are schematic views of the snap-fit structure at the proximal side of the first hemostatic valve;

FIG. 9a is a schematic view of the internal structure of the first hemostatic valve according to one embodiment;

FIG. 9b is an enlarged view of the internal structure of the first hemostatic valve of FIG. 9 a;

FIG. 10 is a schematic view of the internal structure of the first hemostatic valve from another perspective;

FIGS. 11-13 are schematic views of the housing of the first hemostatic valve according to one embodiment;

FIG. 14 is a schematic view of a puncture sheath in one embodiment;

FIGS. 15a and 15b are schematic views of the stem from different perspectives, respectively;

FIG. 15c is an enlarged view of the positioning latch of FIG. 15 b;

FIGS. 16 a-16 b are schematic views illustrating a multi-chamber first hemostatic valve according to one embodiment;

FIGS. 17a to 19d are schematic views of a multi-chamber first hemostatic valve according to further embodiments;

fig. 20a to 21f are schematic views of a sheath according to an embodiment.

The reference numerals in the figures are illustrated as follows:

1. a housing; 11. a second instrument channel; 12. a drive chamber; 14. a first end cap; 15. a second end cap; 16. an exhaust hole;

2. sealing the film; 21. an inner cavity;

3. an energy storage mechanism; 31. a balancing chamber; 311. a balance hole; 32. a first pressure regulating hole; 33. an energy storage chamber; 331. a second pressure regulating hole; 332. a third end cap; 34. a piston; 341. an elastic member; 342. a support member;

9. an interventional instrument;

204. a tube wall; 205. a joint; 206. an elastic sleeve; 207. a tail side boundary; 208. a pressed region; 209. a start side; 210. The tail side; 211. an excess portion; 212. a non-excess portion; 213. overlapping the overlapping area; 214. a flexible envelope film; 215. A circuitous portion; 216. a turning point; 217. a turning point;

500. a catheter sheath;

510. a sheath tube; 511. a first instrument channel;

520. a first hemostasis valve; 521. a second instrument channel; 522. an installation port;

530. connecting sleeves; 531. positioning a step; 532. a pipe joint; 533. screwing; 534. an activity room; 535. a bypass connection; 536. assembling;

540. a second hemostatic valve; 541. a base; 5411. an inner edge; 5412. a fixed flange; 542. a valve plate;

550. a snap-fit structure; 551. a stopper; 552. opening;

600. puncturing the sheath; 610. a tube body; 620. a connecting handle; 621. positioning a fixture block; 622. positioning blocks; 623. a positioning ring; 624. A holding part.

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 some embodiments of the present application, and not all 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. 1-15 c, the present application discloses a catheter sheath 500 comprising:

a sheath 510 for establishing a first instrument channel 511;

a first hemostatic valve 520, which is disposed at the proximal end of the sheath tube 510 and is provided with a second instrument channel 521, wherein the distal end of the second instrument channel 521 is provided with an installation opening 522;

a connection sleeve 530, which is disposed between the installation port 522 and the sheath 510 to connect the first instrument channel 511 and the second instrument channel 521;

a second hemostatic valve 540 disposed within the connection sleeve 530 and constrained by the connection sleeve 530 on a distal side of the first hemostatic valve 520, the second hemostatic valve 540 for controlling the connection and disconnection between the second instrument channel 521 and the first instrument channel 511.

The catheter sheath 500 is used to establish a first instrument channel 511 for the passage of instruments into and out of the target site, where the instruments may be the penetrating sheath 600 as described below, or other therapeutic instruments of suitable outer diameter. After the device has entered the first device channel 511 via the second device channel 521 and the second hemostasis valve 540, a buffer space is formed between the second hemostasis valve 540 and the first hemostasis valve 520, which buffer space is able to further reduce blood loss when the device enters or exits the first device channel 511 and/or the second device channel 521. Independently of the above effects, the second hemostatic valve 540 can also be configured differently from the first hemostatic valve 520 to provide a structural basis for other functions. For example, the second hemostatic valve 540 can achieve a sealing effect of the guidewire. When the guide wire is arranged in a penetrating way, the valve plate of the second hemostatic valve 540 is sealed and attached to the periphery of the guide wire, so that the hemostatic effect is achieved.

The first hemostatic valve 520 and the second hemostatic valve 540 are matched through structural optimization in the catheter sheath 500, so that the blood loss is effectively reduced while the drawing operation hand feeling of the instrument is ensured; the whole drawing operation of the intervention assembly is good, the change of the operation force is small, and a structural foundation is provided for adjusting the hand feeling of the drawing instrument.

In the specific structure of the second hemostatic valve 540, referring to the embodiment shown in fig. 4b to fig. 7, the second hemostatic valve 540 includes a base 541 covering the distal opening of the second instrument channel 521 and at least two elastic valve plates 542 movably disposed on the base 541, each valve plate 542 has an open state away from each other and a closed state (referring to fig. 4b), and each valve plate 542 in the closed state prevents the fluid from flowing from the first instrument channel 511 to the second instrument channel 521. In different schemes, the materials of the valve plate 542 and the base 541 may be the same or different. The valve plate 542 is mounted on the base 541 through a movable structure, or the valve plate 542 is fixed on the base 541 and realizes switching between different states through self deformation. In the top view of the central axis of the second hemostatic valve 540, the valve sheets 542 are V-shaped and the bottom (sharp corner) of the V-shape is close to the central axis of the second hemostatic valve 540, and the V-shaped bottoms of the valve sheets 542 are compact and the V-shaped edges are compact to achieve the closed state. The number of the valve plates 542 is preferably 3 or more, and the number of the valve plates 542 is 4 in the figure. The valve plates 542 can be arranged differently, for example, one large valve plate 542 is matched with a plurality of small valve plates 542, or one small valve plate 542 is matched with a plurality of large valve plates 542, or the sizes of the valve plates 542 are different. The valve plates 542 can be arranged in the same way, and in the figure, the valve plates 542 are uniformly distributed on the circumference of the base 541. The included angle range of the center of each valve plate 542 relative to the central axis of the base 541 is 90 degrees plus or minus 30 degrees. The valve plates 542 can be arranged at intervals or can be partially overlapped. When the interventional device passes through the second hemostasis valve 540, the valve plates 542 are forced away from each other by the interventional device, but the valve plates 542 can abut against the surface of the interventional device, thereby still maintaining a certain sealing effect. Thanks to the elastic arrangement of the valve plates 542, when the valve plates 542 receive an acting force (in the drawing, the acting force from the near end to the far end actually represents that an instrument or a guide wire passes through the valve plates) conforming to the deformation direction of the valve plates 542, the valve plates 542 are far away from each other to realize opening; when the valve plates 542 receive an acting force (in the drawing, the acting force from the far end to the near end actually shows the tendency of blood or other body fluid to be lost to the outside) in the direction opposite to the deformation direction, the valve plates 542 are compacted with each other to realize the sealing. The different states of valve block 542 switch over in order to realize the one-way function of switching on. In the embodiment shown in the drawings, the second hemostatic valve 540 is made of rubber or silicone material.

In the mounting structure of the second hemostatic valve 540, referring to the embodiment shown in fig. 4a to 5, the mounting opening 522 is cylindrical, the base 541 includes an inner edge 5411 extending into the mounting opening 522 and a fixing edge 5412 overlapping the distal side surface of the mounting opening 522, and the connection sleeve 530 surrounds the fixing edge 5412 and/or the inner edge 5411 with the mounting opening 522. In a preferred connection manner, the connection sleeve 530 is provided with a positioning step 531 matching with the size of the distal side of the mounting opening 522, and the positioning step 531 and the distal side of the mounting opening 522 clamp the fixing rim 5412. The inner diameter of the mounting opening 522 is sized to fit the outer diameter of the retaining rim 5412, either in a clearance fit or an interference fit. The outer diameter of the retaining rim 5412 is larger than the inner diameter of the mounting opening 522 to achieve overlap. In the drawings, the outer diameter of the fixing rim 5412 is adapted to the outer diameter of the mounting opening 522, and further, the outer surfaces of the fixing rim and the mounting opening 522 are flush and avoid the assembling position of the connecting sleeve 530. In the drawing, the connection sleeve 530 and the mounting opening 522 are connected by a screw, and the outer diameter of the fixing rim 5412 is equal to or less than the smooth portion of the outer peripheral surface of the mounting opening 522, or the screw on the mounting opening 522 is protruded from the outer peripheral surface of the fixing rim 5412. In particular components, the mounting opening 522 is provided in the second end cap 15.

In the specific structure of the connection sleeve 530, referring to the embodiment shown in fig. 4a to 5, the connection sleeve 530 is cylindrical, one end is a pipe joint 532 for inserting the sheath pipe 510, and the other end is a screw 533 screwed with the mounting hole 522; the two axial ends of the connecting sleeve 530 are smoothly transited to the outer peripheral surfaces of the corresponding parts. Specifically, the diameter of the connection sleeve 530 gradually decreases from the proximal end to the distal end, the lumen diameter of the tube joint 532 is matched with the lumen diameter of the sheath tube 510, and the lumen diameter of the screw 533 is matched with the size of the second hemostatic valve 540.

In the matching relationship between the connection sleeve 530 and the second hemostatic valve 540, a movable chamber 534 is formed between the pipe joint 532 and the positioning step 531, and the valve plate 542 moves in the movable chamber 534 to control the open/close state of the distal opening of the second instrument channel 521. In the embodiment shown in the figures, the connector sleeve 530 further includes a fitting sleeve 536 disposed between the connector sleeve 530 and the first hemostasis valve 520. In the drawings, the fitting sleeve 536 is constrained to the first hemostatic valve 520 by the connecting sleeve 530, and the distal side of the fitting sleeve 536 is a smooth end surface that can rotate relative to the connecting sleeve 530, and the proximal side of the fitting sleeve 536 is a snap-fit end surface that can be mutually locked to the first hemostatic valve 520. The outer peripheral surface of the fitting sleeve 536 smoothly transits to the outer peripheral surfaces of the connecting sleeve 530 and the first hemostatic valve 520.

The connection sleeve 530 may also be provided with auxiliary functions. Referring to fig. 5, the connection sleeve 530 has a bypass connector 535 formed on a sidewall thereof to communicate with the movable chamber 534.

In the specific structure of the first hemostatic valve 520, referring to the embodiment shown in fig. 9a to 13, the present application discloses a first hemostatic valve for a catheter sheath, and referring to the embodiment shown in fig. 16a to 18d, the present application also discloses another first hemostatic valve for a catheter sheath, which has the same basic principle and slightly different detail arrangement, and therefore will be described together hereinafter, and for convenience of reading, the first hemostatic valve in the embodiment shown in fig. 16a to 18d will be described with emphasis.

The first hemostatic valve 520 comprises a shell 1 and a sealing membrane 2 which is arranged in the shell 1 and has a tubular structure, wherein an inner cavity 21 of the tubular structure is used as a second instrument channel 11, a driving chamber 12 which is positioned at the periphery of the sealing membrane 2 and is used for filling fluid and a balance chamber 31 which is positioned outside the driving chamber 12 are arranged in the shell 1 along the radial direction of the second instrument channel 11, the driving chamber 12 is communicated with the balance chamber 31, and the balance chamber 31 surrounds the periphery of the driving chamber 12;

the first hemostatic valve further comprises an energy storage mechanism 3 which can be linked with fluid, and the fluid in the driving chamber 12 is linked with the energy storage mechanism 3 through a balance chamber 31; the energy storing mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes, and drives the sealing membrane 2 to seal the second instrument channel 11 when releasing the energy.

According to the application, the first hemostatic valve 520 stores the deformation energy of the sealing membrane through the design of the energy storage mechanism, and the posture and the form of the sealing membrane can be adjusted in a self-adaptive manner in the process that the instrument and the first hemostatic valve 520 generate relative displacement, so that good compatibility and good sealing effect are achieved when different instruments pass through; through the setting of the self parameters of the sealing film, the setting of the parameters of the energy storage structure and the matching between the self parameters and the energy storage structure, the advantages of good drawing operation feeling and small change of the operation force of the instrument are realized, and a structural basis is provided for adjusting the hand feeling of the drawing instrument.

Structurally, the balance chamber 31 surrounds the periphery of the drive chamber 12 and is capable of supplying fluid to the drive chamber 12 for driving the sealing membrane 2 in a plurality of directions, thereby closing the second instrument channel 11. The power of the fluid in the balancing chamber 31 is provided by the energy storing means 3, so that during assembly, energy can be pre-supplied to the energy storing means 3 to improve the adaptability of the first haemostatic valve to interventional instruments 9 of different outer diameters. The energy input mode can be realized by pre-pressing an elastic part or filling fluid with preset conditions (pressure, temperature and other physical and chemical indexes capable of changing energy) and the like.

The balancing chamber 31 surrounds the periphery of the drive chamber 12 and is able to supply the drive chamber 12 with fluid for driving the sealing membrane 2 in a movement from a plurality of directions, so that a closure of the second instrument channel 11 is achieved. In the actual surround form, there are a number of implementations. For example, in one embodiment, the balance chambers 31 are plural and arranged at intervals on the outer periphery of the drive chamber 12, and the energy storage mechanism 3 is provided for each balance chamber 31; further, the respective balance chambers 31 are disposed at the outer periphery of the driving chamber 12 at uniform or non-uniform intervals. For another example, in an embodiment, each balance chamber 31 communicates with the driving chamber 12 through a separate balance hole 311 or at least two balance chambers 31 share the same balance hole 311 to communicate with the driving chamber 12, and further, each balance chamber 31 communicates with the driving chamber 12 through the same balance hole 311. For another example, in one embodiment, the number of balance chambers 31 is 2 to 8.

The different arrangements and the assortment of the various arrangements of the energy storage means 3 also have an influence. For example, in one embodiment, the energy storage mechanism 3 includes: an energy storage chamber 33; a balance chamber 31 is also arranged in the shell 1, and the driving chamber 12 is communicated with the balance chamber 31; a piston 34 sealingly sliding between the balance chamber 31 and the energy storage chamber 33; an energy storage element, which is a compressible gas and/or elastic member 341 in the energy storage chamber 33 and interacting with the piston 34; the housing 1 is provided with at least two cylindrical spaces in which the pistons 34 slide, and the cylindrical spaces are divided by the pistons 34 into the balance chamber 31 and the energy storage chamber 33. For another example, in one embodiment, each piston 34 is sealingly engaged with the inner wall of the corresponding cylindrical space by a sealing edge on its outer edge, and the sealing edge and the inner wall of the cylindrical space are provided with at least two seals in the sliding direction of the piston 34.

In one embodiment, the housing 1 has at least two cylindrical spaces for the piston 34 to slide, and each cylindrical space has an independent energy storage element therein, and the energy storage performance of each energy storage element is consistent or inconsistent.

The specific combinations and technical effects that can be brought about can be referred to in the following exemplary embodiments.

In the embodiment shown in fig. 9b and 10, the piston 34 is provided with three seals at the periphery, and the connection is realized by a support 342 and an elastic member 341, and the hardness of the support 342 is higher than that of the piston 34. In this embodiment, the piston 34 may be sealed by its own material.

In the embodiment referring to fig. 17a to 17d, the number of the balance chambers 31 is preferably three, each balance chamber 31 is disposed at the periphery of the driving chamber 12 at regular intervals and communicates with the driving chamber 12 with the independent balance hole 311, each balance chamber 31 is provided with the energy storage mechanism 3, and the energy storage mechanism 3 includes: an energy storage chamber 33; a balance chamber 31 is also arranged in the shell 1, and the driving chamber 12 is communicated with the balance chamber 31; a piston 34 sealingly sliding between the balance chamber 31 and the energy storage chamber 33; an energy storage element, which is a compressible gas and/or elastic member 341 in the energy storage chamber 33 and interacting with the piston 34; each piston 34 is in sealing fit with the inner wall of the corresponding cylindrical space through the sealing edge of the outer edge of the piston 34, at least two seals are arranged between the sealing edge and the inner wall of the cylindrical space in the sliding direction of the piston 34, and a sealing gap is arranged between the two seals at the sealing edge.

From the design principle of each part, the increase in the number of the balance chambers 31 can provide a more uniform and detailed driving effect of the sealing film 2, but if the number is too large, the difficulty in processing the housing 1 is increased; also, under the same volume of the housing 1, the side walls between the adjacent balance chambers 31 may become thin with a corresponding risk, and therefore the number of the balance chambers 31 is preferably 2 to 8. The balance chambers 31 are uniformly spaced at the periphery of the driving chamber 12 to provide a good visual effect, and at the same time, can provide stable acting force for all directions of the second instrument channel 11, and accordingly, in some special cases, the balance chambers 31 can also be non-uniformly spaced at the periphery of the driving chamber 12 to provide non-uniform driving force to achieve a special effect. In this embodiment, the balance chambers 31 are respectively communicated with the driving chamber 12 through the independent balance holes 311, which provides the advantages of avoiding the mutual interference between the balance chambers 31 and providing a finer adjustment effect. Accordingly, in some special cases, the balance chambers 31 can also communicate with the driving chamber 12 through the common balance hole 311, which is advantageous in that the working processes of different balance chambers 31 can be synchronized, and the specific design can be adjusted according to different working conditions and design requirements. In the arrangement of the energy storage mechanism 3, the piston 34 is a main working component, the energy storage element is an elastic element 341 in this embodiment, and two ends of the energy storage element respectively press against the piston 34 and the third end cap 332 to store and release energy. The piston 34 therefore needs to be able to guarantee a good seal with the cylindrical space to avoid pressure leakage of the fluid, in this embodiment by means of two sealing edges of the piston 34 itself. Meanwhile, in order to avoid resistance brought by an overlarge sealing contact area, a sealing gap is also arranged between the sealing edges, and the sealing gap can release deformation of the sealing edges, so that the sealing effect is improved.

In a specific product, in addition to whether the balancing chambers 31 are uniformly arranged on the outer periphery of the driving chamber 12, different effects can be achieved by the differentiated arrangement between different balancing chambers 31. For example, in the present embodiment, the diameter and length of each cylindrical space are the same, and the elastic coefficient of the elastic member 341 is the same, so as to obtain a more uniform fluid driving effect. In other embodiments, the diameter and length of each cylindrical space may be different, and the elastic coefficient of the elastic member 341 may also be different, so as to flexibly adjust according to different working conditions and design requirements. Correspondingly, when the energy storage element is compressible gas, the physical and chemical indexes of the compressible gas can be adjusted, for example, the parameters of the compressible gas, such as the preset working pressure, the preset working temperature and the like, can be changed correspondingly.

The product of this embodiment may operate in the following manner during assembly: injecting a certain amount of liquid from the first pressure regulating hole 32 to make the piston 34 slightly move leftwards and keep stable, wherein the balance chamber 31 and the energy storage chamber 33 are in pressure balance, and the sealing membrane 2 is pressed and clings by the liquid in the driving chamber 12 to seal the second instrument channel 11;

the gas entering the inside of the body of the second instrument channel 11 is exhausted through the vent hole 16 and then inserted into the blood vessel which is now in communication with the catheter sheath to form a window for the entry of the instrument, while the blood is sealed inside the body by the sealing membrane 2. The vent 16 may be implemented by the bypass connector 535 described above.

When the product of the embodiment is used for interventional operation, instruments enter the body from the middle of the sealing film 2 and are tightly wrapped by the sealing film 2, and blood is always blocked in the body by the sealing film 2. When the instrument passes through the channel, the driving chamber 12 is pressurized due to the reduction of volume, so that the elastic member 341 is compressed and stored with energy by pushing the piston 34 to the left by the liquid, and the internal pressure reaches a new equilibrium and is still sealed. When the instrument is withdrawn, the resilient member 341 is de-energized, pushing the piston 34 to the right. And returning to the initial state. During the process of the in-out of the instrument, the sealing membrane 2 is always squeezed to continuously seal.

With reference to fig. 18a to 18d, the present application further discloses a multi-chamber first hemostatic valve, which includes a housing 1 and a sealing membrane 2 installed in the housing 1 and having a tubular structure, wherein a lumen 21 of the tubular structure is used as a second instrument channel 11, a driving chamber 12 for filling fluid is disposed in the housing 1 at the periphery of the sealing membrane 2 along a radial direction of the second instrument channel 11, and a balance chamber 31 is disposed outside the driving chamber 12, the driving chamber 12 and the balance chamber 31 are communicated with each other, and the balance chamber 31 surrounds the periphery of the driving chamber 12.

The first hemostatic valve further comprises an energy storage mechanism 3 which can be linked with fluid, and the fluid in the driving chamber 12 is linked with the energy storage mechanism 3 through a balance chamber 31; the energy storing mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes, and drives the sealing membrane 2 to seal the second instrument channel 11 when releasing the energy. The number of balancing chambers 31 is preferably six. The more the number of the balance chambers 31 is set, the better, theoretically, irrespective of the volume of the product and the production process, and the like. According to the volume of the driving chamber 12 and the balance chamber 31 of the current product, and from structural design, spring type selection to mass production, considering function and cost, the number of the current optimal cavities is 5-6.

The main difference in this embodiment is the number of balancing chambers 31, 6 balancing chambers 31 enabling better compatibility of the instrument, the resistance of the instrument when passing through is better than in the embodiment with fewer balancing chambers 31.

In addition to the different arrangement of the balancing chamber 31, the energy storage element can also be varied and adjusted accordingly. Referring to fig. 19a to 19d, the present application further discloses a multi-chamber first hemostatic valve, which includes a housing 1 and a sealing membrane 2 installed in the housing 1 and having a tubular structure, wherein a lumen 21 of the tubular structure is used as a second instrument channel 11, a driving chamber 12 for filling fluid is arranged in the housing 1 at the periphery of the sealing membrane 2 along the radial direction of the second instrument channel 11, and a balance chamber 31 is arranged outside the driving chamber 12, the driving chamber 12 and the balance chamber 31 are communicated with each other, and the balance chamber 31 surrounds the periphery of the driving chamber 12;

the first hemostatic valve further comprises an energy storage mechanism 3 which can be linked with fluid, and the fluid in the driving chamber 12 is linked with the energy storage mechanism 3 through a balance chamber 31; the energy storing mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes, and drives the sealing membrane 2 to seal the second instrument channel 11 when releasing the energy. The energy storage element includes an elastic member 341 (refer to fig. 19a to 19c) and/or a compressible gas (refer to fig. 19 d).

The housing 1 is a solid body with a plurality of cylindrical spaces, a second apparatus passage 11 is arranged in the middle, the cylindrical spaces around the second apparatus passage 11 are used for installing a plurality of pistons 34 to form an energy storage chamber 33 and a balance chamber 31, wherein the balance chamber 31 is connected with the driving chamber 12, a spring is arranged in each energy storage chamber 33, and the energy storage chamber 33 is provided with a second pressure adjusting hole 331, and the second pressure adjusting hole 331 is used for realizing the function of injecting gas in the embodiment. The housing 1 is connected with a second end cap 15, a sealing member is arranged in the housing for sealing, and a first pressure adjusting hole 32 is formed in the second end cap 15; the second end cap 15 and the first end cap 14 fixedly seal the sealing membrane 2 to the housing 1. The vent hole 16 is in communication with the blood for venting gas from within the second instrument channel 11.

Compared with the arrangement mode that the energy storage element is a single elastic element 341, the embodiment adds the compressed medium of gas, so that the resistance for passing instruments with different diameters can be adjusted more flexibly, but correspondingly, the requirements on the tightness of the energy storage chamber 33, the balance chamber 31 and related components are higher, and the process is relatively complex.

As can be seen from the figures, in the present embodiment, each balancing chamber 31 is in fact able to communicate with each other through the driving chamber 12, i.e. the sealing membrane 2 is integral, the driving chamber 12 being arranged around the sealing membrane 2 and communicating with the respective balancing chamber 31. In other embodiments, the sealing membrane 2 may not be a single piece, and a plurality of sealing membranes 2 in combination together effect closure of the second instrument channel 11; in this implementation, the drive chambers 12 between the different sealing membranes 2 may not communicate, and correspondingly, the balancing chambers 31 between the different drive chambers 12 do not communicate.

The product of this embodiment may operate as follows during assembly:

a certain volume of gas is first injected from the second pressure regulating hole 331. Then, a certain amount of liquid is injected from the first pressure regulating hole 32, so that the piston 34 slightly moves leftwards and is kept stable, the pressure of the energy storage chamber 33 is balanced with that of the driving chamber 12, and the sealing membrane 2 is pressed and attached by the liquid in the driving chamber 12 to seal the second instrument channel 11.

The product of the embodiment can be operated as follows in the using process: the second instrument passage 11 is exhausted to the inside of the body through the first pressure regulating hole 32, and then inserted into a blood vessel which is communicated with the introducer sheath to form the second instrument passage 11 into which an instrument is introduced, and the blood is sealed in the body by the sealing film 2. When an interventional operation is performed, the instrument enters the body from the middle of the sealing membrane 2 and is tightly wrapped by the sealing membrane 2, and blood is always blocked in the body by the sealing membrane 2. When the instrument passes through the channel, the pressure of the driving chamber 12 rises due to the reduction of the volume, so that the piston 34 is pushed to move leftwards, the compressible gas is compressed to store energy, the internal pressure reaches a new balance and is still sealed. When the instrument is withdrawn, the compressible gas releases energy, pushing the piston 34 to the right. And returning to the initial state. During the process of the device in and out, the sealing membrane 2 is always extruded and sealed continuously.

Compared with the arrangement mode that the energy storage element is a combination of the elastic member 341 and the compressible gas, in the embodiment, the resistance of the instruments with different diameters passing through the energy storage element further tends to be gentle when the purely compressible gas is used as the elastic medium; the resistance of instruments with different diameters can be conveniently adjusted, and the adjustment is more flexible. Accordingly, the requirements on the tightness of the energy storage chamber 33, the balancing chamber 31 and the components involved are high, and the process is relatively complex.

In combination with the above embodiments, the multi-cavity structure formed by the plurality of balance chambers 31 has the following advantages and design starting points compared with the single-cavity structure of other embodiments:

1. the structure is simple and reliable, the requirement on the elastic performance of the spring is low, and the mass production is convenient;

2. the multi-cavity structure has stronger compatibility with different instruments, can be stabilized in a smaller range through resistance, and can be summarized that the instruments passing through the diameter have basically the same resistance;

3. the optimum number of cavities is calculated from the volume of the driving chamber 12 and the volume of the balance chamber 31, and the maximum volume of the instrument entering the second instrument channel 11 enables the driving chamber 12 to discharge liquid so that the pistons 34 in the balance chambers 31 move less than 5mm at the same time, and the smaller the movement stroke is, the better the movement stroke is.

In the embodiment, the plurality of balance chambers 31 increase the number of the third end caps 332, the installation process is complicated, and unnecessary stability is caused, so that the function of the third end caps 332 is realized by the first end cap 14 in the embodiment.

In this embodiment, the second end cap 15 also has a variation in detail, and in order to facilitate assembly and to achieve a compact fit between the parts, the second end cap 15 actually has two parts for achieving the fit with the housing 1 and the mounting of the sheath, respectively, on which the first pressure adjusting hole 32 and the exhaust hole 16 mentioned above are provided, respectively.

From the point of view of the overall product, the first hemostatic valve also includes a pressure regulating structure (not shown) for delivering fluid. In an embodiment, the first hemostatic valve further comprises a pressure regulating structure, the pressure regulating structure is provided with a fluid line for providing fluid, and the fluid line is directly or indirectly communicated with the balance chamber or the driving chamber or the balance hole.

The fluid pipeline can be directly communicated with any one of the balance chamber, the driving chamber or the balance hole, can also be directly communicated with the balance chamber, the driving chamber or the balance hole, and can also be indirectly communicated through the mutual communication among the balance chamber, the driving chamber and the balance hole. In actual products, there are many variations, but in principle, the fluid of the fluid line needs to be able to perform the function of filling the drive chamber. The fluid in the fluid pipeline is provided by a pressure adjusting structure, the pressure adjusting structure can be selected from a plunger pump or a peristaltic pump which is commonly used clinically, the design can be simplified, and the production cost can be reduced, for example, the pressure adjusting structure can be a syringe type conveying cylinder which is commonly used clinically, and can also be a separate conveying device. The method can be flexibly adjusted according to actual needs.

In a specific connection relation, in reference to one embodiment, a plurality of balance chambers are arranged and circumferentially distributed outside the driving chamber, and each balance chamber is communicated with the driving chamber through an independent balance hole; one side of each balance hole is linked with the driving chamber, the other side of each balance hole radially extends to the outer peripheral wall of the shell, and each balance hole is closed on the outer peripheral wall or is in butt joint with the fluid pipeline. The balance hole extends to form a channel which can communicate the driving chamber and the balance chamber. The end of the balance hole extending to the peripheral wall of the shell can be closed or opened by plugging materials to be in butt joint with the fluid pipeline for receiving fluid. The number of specific closures and openings can be adjusted as desired.

The invention also discloses a catheter sheath assembly, which comprises an axially extending sheath tube, wherein the sheath tube is provided with an axially through cavity, the sheath tube is provided with a near end and a far end, and the near end of the sheath tube is connected with the first hemostatic valve.

In one embodiment, the distal end of the sheath is provided with a visualization ring.

The invention also discloses an interventional instrument sealing method based on the first hemostatic valve, the first hemostatic valve comprises a shell and a sealing membrane which is arranged in the shell and is of a tubular structure, an inner cavity of the tubular structure is used as a second instrument channel and penetrates through the shell, a driving chamber which is positioned at the periphery of the sealing membrane and can be filled with fluid and an energy storage mechanism which can be linked with the fluid are arranged in the shell, and the interventional instrument sealing method comprises the following steps:

injecting fluid into the driving chamber, wherein the fluid drives the sealing membrane to close the second instrument channel, and the fluid also acts on the energy storage mechanism to pre-store energy in the energy storage mechanism so as to keep the state of the sealing membrane;

when an interventional instrument is inserted into the second instrument channel, the sealing membrane is extruded and deformed by the interventional instrument and drives the energy storage mechanism to store energy through fluid;

when the interventional device is withdrawn from the second device channel, the energy storage mechanism releases energy, and the sealing membrane is driven by the fluid to deform so as to close the second device channel.

Viewed from the first hemostatic valve, the first hemostatic valve comprises:

the sealing membrane is arranged in the shell and is of a tubular structure;

the sealing membrane has an inner surface and an outer surface, the sealing membrane inner surface defining a second instrument channel for inserting an instrument;

the shell is provided with an inner wall, the inner wall of the shell and the outer surface of the sealing film form a driving chamber, and the driving chamber is filled with fluid;

the first hemostatic valve further comprises an energy storage mechanism which can be linked with the fluid;

the drive chamber and/or a fluid line connected thereto.

In view of the sealing method of the first hemostatic valve:

injecting a preset fluid into the driving chamber through the fluid pipeline, wherein the fluid in the driving chamber is linked with the energy storage mechanism, the energy storage mechanism stores energy, the sealing membrane is closed, and the second instrument channel is sealed;

and inserting an instrument into the second instrument channel, and driving the fluid in the chamber to be linked with the energy storage mechanism, so that the energy storage mechanism further stores energy.

In the embodiment, the variation range of the first hemostatic valve is widened through the design of the energy storage mechanism, instruments with different outer diameters can be allowed to pass through the second instrument channel, the sealing effect is guaranteed, and the contradiction between the passing hand feeling of the interventional instrument and the size range of the interventional instrument in the related technology is overcome. Thereby automatically adjusting the pressure in the driving chamber and improving the penetrability of the instrument.

In one embodiment, the drive chamber is further in communication with a fluid line and is connected to an external fluid source via the fluid line. In a specific arrangement of the fluid pipeline, referring to an embodiment, a control valve is configured on the fluid pipeline. The control valve can realize the flow regulation and other functions of the fluid pipeline. In the communication arrangement of the fluid pipe, in reference to an embodiment, the driving chamber is further communicated with a balance chamber, and the fluid in the driving chamber is linked with the energy storage mechanism through the balance chamber; the fluid pipeline is communicated with the driving chamber in at least one of the following modes:

directly communicated to the driving chamber; or

Directly communicated to the balance chamber; or

Directly communicated between the driving chamber and the balance chamber.

The fluid line requires a fluid source to provide powered support while providing fluid. In one embodiment, the external fluid source is provided by a pressure regulating structure. The pressure adjusting mechanism has a plurality of setting modes, and in one embodiment, the driving mode of the pressure adjusting mechanism is manual, electric or pneumatic. In the specific selection, the pressure regulating mechanism can select the clinically common plunger pump or peristaltic pump and other forms, and can be flexibly adjusted according to actual needs. In principle, the pressure regulating structure has at least one storage chamber, and the fluid pipeline is communicated with the storage chamber.

In a specific arrangement of the balance chamber and the driving chamber, referring to an embodiment, a cylindrical space is formed in the housing, and the energy storage mechanism includes:

the piston is arranged in the cylindrical space in a sliding mode and divides the cylindrical space into a balance chamber and an energy storage chamber;

and the energy storage element is positioned in the energy storage chamber and is a gas and/or elastic element which interacts with the piston.

In terms of the manner in which the cylindrical space and the housing cooperate, with reference to one embodiment, the housing is annular and has an annular wall within which the cylindrical space is located.

The cylindrical space has various design forms, for example, the axis is a curved form, and the section of the cylindrical space changes in the special-shaped cylinder, and in order to ensure the stable operation and the processing difficulty of the energy storage mechanism, in reference to an embodiment, the cylindrical space is a straight cylinder structure, and the axis of the straight cylinder structure is parallel to the axis of the housing. In a specific selection of the cylindrical structure, in reference to an embodiment, the cylindrical space is one or more. Correspondingly, the number of the cylindrical spaces is 2-8. Correspondingly, the cylindrical spaces are distributed in sequence along the circumferential direction of the shell.

The barrel provides physical space for the balance chamber and the drive chamber, and in an integral mating relationship, with reference to one embodiment, the second instrument channel extends through the housing along the axis of the housing.

In cooperation with the interventional instrument, the embodiment shown with reference to fig. 8a to 8c, the proximal side of the first haemostatic valve 520 is provided with a snap-off prevention catch 550, the catch 550 providing an axial stop for at least a coupling extending into the second instrument channel 521. The coupling member may be the interventional instrument mentioned above, or may be another component suitable for coupling with the catheter sheath 500 of the present application. Further, a snap feature 550 is provided on a radial skirt of the proximal opening of the second instrument channel 521. In the drawing, the engaging structure 550 is a stopper 551 disposed on the proximal side of the first hemostatic valve 520, and the stopper 551 opens a slit 552 into which the coupler is engaged in the circumferential direction of the first hemostatic valve 520. That is, the snap-fit feature 550 includes a stop 551 disposed axially of the second instrument channel 521 and a notch 552 that opens circumferentially toward the proximal opening of the second instrument channel 521. The snap feature 550 may be provided at a suitable location on the proximal side of the first hemostasis valve 520, in the figures, the snap feature 550 is provided on the first end cap 14.

Similarly, the corresponding engaging component is also required to be arranged on the combining piece. Referring to the embodiment shown in fig. 14 to fig. 15c, the coupling member is a puncture sheath 600, a positioning latch 621 cooperating with the engaging structure 550 is disposed on the connection handle 620 of the puncture sheath 600, and the positioning latch 621 and the latch 551 of the engaging structure 550 are engaged with each other to realize axial position limitation of the puncture sheath 600. Further, a positioning block 622 is disposed on one side of the positioning block 621, and is used for abutting against the stop 551 to align the relative positions of the positioning block 621 and the stop 551. Further, a positioning ring 623 matched with the proximal side surface of the first hemostatic valve 520 is arranged on the connecting handle 620 of the puncture sheath 600, and the positioning ring 623, the positioning block 621 and the positioning block 622 surround to form a semi-closed constraint space which is used for being matched with the block 551. In a specific structure, the positioning ring 623, the positioning latch 621, and the positioning block 622 are disposed on a distal side of the stem 620, and a proximal side of the stem 620 is provided with a grip 624 for gripping, the grip 624 extending in a radial direction from a surface of the stem 620 so as to drive the stem 620 to rotate circumferentially. In the drawings, the proximal side of the grip 624 is smoothly arranged and the distal side is curved.

In the specific configuration of the sheath 510, referring to the embodiment shown in fig. 20a to 21f, the sheath 510 includes a tube wall 204, the tube wall 204 is a coiled wall structure, and the cross section of the coiled wall structure is a coiled wall structure, and the tube wall 204 has an expanded state for unfolding the corresponding part of the coiled wall structure and a predetermined shape for self-restoring the coiled wall structure. The tube wall 204 is an elastic material that can be autonomously switched between an expanded state and a pre-shaped state. The outer diameter of the pipe wall 204 in the pre-shaped state is 4-9 mm. The pipe wall 204 in the pre-set condition is wrapped more than one circumference, overlapping 360 degrees beyond the circumference and within 360 degrees. The overlapped parts have smooth contact surfaces. The pipe wall 204 in the pre-set condition is wound less than 720 degrees. The starting side 209 and the end side 210 of the circumferential winding of the wall-winding structure are connected by a flexible envelope film. The turning part of the flexible envelope film is provided with a crease line. The wall thickness of the flexible envelope film is 0.1-1 mm. The flexible envelope membrane is a tubular structure with a closed circumferential direction, the circumferential length of the section of the tubular structure of the flexible envelope membrane is larger than the wall length of the section of the tube wall 204, and the tube wall 204 is fixedly attached to the outer wall of the flexible envelope membrane. In one embodiment, the proximal outer periphery of the tube wall 204 is wrapped with an elastic sleeve 206. The proximal end of the tube wall 204 is connected to the sheath shaft and the connection is surrounded by an elastic sleeve 206. The axial length of the elastic sleeve 206 is 5-50 cm. In the drawings, the axial length of the elastic sleeve 206 is preferably 5 to 20 cm. The proximal side of the elastic sleeve 206 forms a reducer section which fits the connection sleeve. The exterior of the wall 204 is wrapped with a collar for restraining the wall 204 in a pre-shaped state, and the collar is burst in an expanded state of the wall 204. The collar extends axially along the tube wall 204 beyond the distal end of the tube wall 204, where the extension is in a closed-off configuration. The rolled wall structure is a chamfered structure on the trailing side 210 of the circumferential roll, adjacent the distal end of the tube wall 204.

Referring specifically to fig. 20a to 21f, in the present embodiment, the tube wall 204 of the sheath is a coiled wall structure, and the cross section of the sheath is a coil shape, and the tube wall 204 has an expanded state for unfolding the coiled wall structure at the corresponding position and a predetermined shape for restoring the coiled wall structure.

In the pre-shaped state, the outer diameter of the sheath is 5mm (15Fr), and the inner diameter is 4 mm. The inner diameter can reach 8mm (24Fr) in the expanded state, and the sheath can be conveyed through the corresponding diameter.

Referring to fig. 20b, the proximal end of the sheath is fitted with a fitting 205 for engagement with a delivery device, and the junction of the sheath and the fitting 205 is covered by an elastic sheath 206. Blood (or body fluid) can be prevented from escaping from the gap at the overlapping portion of the tube wall. The elastic sleeve is made of elastic nylon and has a thickness of 0.1-0.2 mm.

In the circumferential direction, the wall-winding structure extends spirally from the starting side to the end side, and the end side boundary of the starting side may extend axially along the sheath or spirally around the sheath axis, and fig. 20b shows that the end side boundary 207 is straight and extends axially along the sheath. When the spiral line is adopted, the stress distribution of the sheath tube during bending is more uniform.

With reference to fig. 20 c-20 f, when the interventional device is passed from right to left, the inner side of the tube wall is pressed at the passing position, so that the wall-rolling structure of the tube wall is correspondingly unfolded, and the pressed portion 208 is converted into an expanded state.

After the interventional device 9 is passed through, the vessel wall 204 will self-restore due to its own elasticity and return to the initial, pre-shaped state.

In this embodiment, the pipe wall is made of a polymer material such as HDPE or TPU, and the thickness of the pipe wall is 0.5mm in order to ensure that the pipe wall can recover independently and maintain certain strength and compliance. In a specific embodiment, the pipe wall may be configured as a double-layer composite structure, and the material of each layer in the double-layer composite structure is independently configured as HDPE, TPU, or a composite of HDPE and TPU.

Referring to fig. 21a, a cross-sectional view of the sheath in the pre-set state (initial state) without the device implanted, the wall of the pre-set state is wrapped more than 360 degrees, i.e. extends more than 360 degrees in the circumferential direction from the beginning 209 to the end 210 of the wrap, the portion of the wrap that exceeds 360 degrees overlapping the portion that does not exceed 360 degrees, in order to cover and form the channel for delivering the sheath.

As can be seen in fig. 21a, the excess part 211 and the non-excess part 212 overlap each other, the excess part 211 is wrapped around the periphery of the non-excess part 212, and a complete channel is formed inside the tube wall.

Figure 21c is a cross-sectional view of the sheath inflated with the interventional instrument 9 implanted. In order to avoid that the delivery sheath and the implantation instrument are not exposed in the expanded state, fig. 21c shows that the tube wall is rolled up by 360 degrees or more in the expanded state, i.e. there is still an overlap region 213.

In fig. 21e, where the overlap area 213 is enlarged, the degree of wall wrap, i.e. the corresponding central angle, is increased to 540 degrees, which after deployment will achieve a larger inner diameter, allowing for a thicker interventional device 9.

Although the excess part 211 and the non-excess part 212 overlap each other but are not fixed relative to each other as shown in fig. 21a, they can slide relative to each other to form a gap, so that blood or body fluid can enter and exit the vessel wall, and in order to form a closed channel of the interventional device in different states, the invention provides another embodiment, in which the vessel wall is closed by providing flexible envelope films at the beginning side and the end side of the vessel wall.

In fig. 21b, the starting side 209 and the ending side 210 of the winding of the tube wall are connected by a flexible envelope film 214. The flexible envelope mainly acts as a radial supporting force to restrain the implanted device and prevent the implanted device from being exposed, and simultaneously, the flexible envelope can prevent blood or body fluid from overflowing the tube wall.

The flexible envelope 214 has a lower wall thickness and stiffness than the tube wall itself, since it is subject to kinking or twisting when the tube wall switches state. The flexible enveloping film 214 of the embodiment is made of PTFE material, and the wall thickness is 0.25-0.5 mm.

No matter what state the tube wall is, the flexible envelope 214 can keep the sheath closed, and the flexible envelope 214 can be fixed with the tube wall by welding or the like.

To receive the flexible envelope 214, the flexible envelope 214 is in the middle layer of the overlapping portion of the tube wall. The flexible envelope 214 may extend in the circumferential direction for a period of time, i.e. there is no lumen enveloping the entire wall of the vessel for 360 degrees, and in the pre-set state, the flexible envelope 214 is stretched between the starting side 209 and the ending side 210 of the winding of the vessel wall, and the flexible envelope 214 acts to close the gap formed between the starting side 209 and the ending side 210, thereby preventing blood or body fluid from entering and exiting the vessel wall. The fixing points of the flexible envelope 214 to the tube wall are not strictly required at the beginning side 209 and the end side 210, and can be adjusted appropriately.

In fig. 21d, as another embodiment, the flexible enveloping film 214 is a circumferentially closed tubular structure, the tube wall is fixedly attached to the outer wall of the flexible enveloping film 214, one part of the flexible enveloping film 214 is a winding part 215, and the winding part 215 is located between the beginning side 209 and the end side 210 of the tube wall.

The turns 216 and 217 of the detour portion 215 are provided with crease lines which can be processed by a heat setting process, and in a predetermined state, the crease lines can make the turns of the detour portion more flat.

Referring to fig. 21f, the detour 215 is deployed in the expanded state of the vessel wall, allowing a larger deformation range of the vessel wall.

In addition to the sheath tube with the wall-rolling structure, in an embodiment, the sheath tube includes a tube wall, the tube wall has a swelling state for expanding the tube diameter of the corresponding portion and a pre-shaping state for automatically restoring the tube diameter of the corresponding portion, the tube wall includes a first polymer layer, an elastic layer and a second polymer layer, the first polymer layer, the elastic layer and the second polymer layer are sequentially sleeved from inside to outside, and the elastic layer is used for driving the tube wall to be kept in the pre-shaping state.

In a specific embodiment, the first polymer layer is made of PTFE. The second polymer layer is made of Pebax. The elastic layer is an elastomer which is arranged in a winding way. The elastic body is a spiral spring made of stainless steel or memory metal.

In an embodiment of the sheath, the sheath includes a first polymer layer, a middle layer and a second polymer layer, which are sequentially sleeved from inside to outside, and the middle layer is a woven structure. Compared with the above embodiments, the intermediate layer of the braided structure in this embodiment can maintain the radial dimension of the sheath, and accordingly, the catheter sheath with the sheath cannot be expanded. Wherein the first polymer layer and the second polymer layer may be as described above, and are not described herein again.

In addition to the optimization of the internal structure of the sheath, the present application also provides the optimization of the outer circumference of the sheath, and in one embodiment, the outer wall of the distal portion of the sheath is marked with scale marks. The scale marks are used for conveniently confirming the length of the human body, in actual use, the actual size of the sheath tube entering according to different case conditions can be changed, and the scale marks can be further arranged in the axial direction of the sheath tube to meet different requirements, such as extending to the middle part or even the near end of the sheath tube. The outer peripheral surface of the sheath tube is provided with a bionic coating for improving biocompatibility.

With reference to the above, it will be understood that the present application also discloses an interventional assembly, which includes the catheter sheath 500 and the puncture sheath 600 of the above-mentioned technical solutions, the puncture sheath 600 includes a tube body 610 and a connection handle 620, the catheter sheath 500 and the puncture sheath 600 in a combined state, the tube body 610 extends to the distal end of the sheath tube 510 via the second instrument channel 521 and the first instrument channel 511, and the connection handle 620 and the first hemostatic valve 520 are mutually clamped and positioned.

The process of advancing the puncture sheath 600 is described above with reference to the first hemostatic valve 520 and the sheath 510, and is not described herein again, and the engagement between the connection handle 620 of the puncture sheath 600 and the first hemostatic valve 520 can be realized with reference to the engagement structure 550 mentioned above, or can be provided separately.

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 implementation modes of the present application, and the description thereof is specific and detailed, but not construed as limiting the scope of 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, and these are all within the scope of protection of the present application.

Claims

1. A catheter sheath, comprising:

a sheath for establishing a first instrument channel;

the second hemostatic valve is arranged in the connecting sleeve and is restrained at the distal end side of the first hemostatic valve by the connecting sleeve, and the second hemostatic valve is used for controlling the connection and disconnection between the second instrument channel and the first instrument channel.

2. The catheter sheath of claim 1, wherein the second hemostatic valve includes a base covering the distal opening of the second device channel and at least two resilient flaps disposed on the base, each flap having an open position away from each other and a closed position in which each flap is closed against fluid flow from the first device channel to the second device channel.

3. The catheter sheath of claim 2, wherein the mounting opening is cylindrical, the base comprises an inner edge extending into the mounting opening and a fixing rim overlapping the distal side of the mounting opening, and the connecting sleeve and the mounting opening enclose and constrain the fixing rim and/or the inner edge.

4. The catheter sheath according to claim 1, wherein the connecting sleeve is cylindrical, one end is a pipe joint for inserting the sheath pipe, and the other end is a screw port screwed with the mounting port; the two axial ends of the connecting sleeve are smoothly transited with the peripheral surfaces of the corresponding parts.

5. The catheter sheath of claim 4, wherein the second hemostasis valve includes a base covering the distal opening of the second instrument channel and at least two resilient flaps disposed on the base; the mounting opening is cylindrical, the base comprises an inner edge extending into the mounting opening and a fixing edge arranged on the far-end side face of the mounting opening in a lapping mode, a positioning step matched with the far-end side face of the mounting opening in size is arranged in the connecting sleeve, and the fixing edge is clamped between the positioning step and the far-end side face of the mounting opening;

a movable chamber is arranged between the pipe joint and the positioning step, and the valve plate moves in the movable chamber to control the opening and closing state of the distal end opening of the second instrument channel.

6. The catheter sheath of claim 5, wherein the side wall of the connecting sleeve is provided with a bypass joint communicated with the movable chamber.

7. The catheter sheath of claim 1, wherein the proximal side of the first hemostatic valve carries a retaining snap feature that provides an axial stop for at least a coupling member extending into the second instrument channel.

8. The catheter sheath of claim 7, wherein the snap-fit feature is disposed on a radial skirt of the proximal opening of the second instrument channel.

9. The catheter sheath of claim 7, wherein the snap-fit structure includes a stop disposed axially of the second instrument channel and an access opening circumferentially open to the proximal opening of the second instrument channel.

10. The introducer sheath of claim 1, wherein the sheath includes a wall having a rolled wall configuration and a coiled cross-section, the wall having an expanded configuration for unrolling the rolled wall configuration at a corresponding location and a pre-shaped configuration for self-righting the rolled wall configuration.

11. The catheter sheath according to claim 10, wherein the sheath tube is sleeved at a proximal end with an elastic sleeve extending distally from the connection sleeve and forming a tapered section at a proximal side, the tapered section being engaged with the connection sleeve.

12. The catheter sheath of claim 10, wherein the starting side and the ending side of the winding of the tube wall are connected by a flexible envelope film, and the tube wall has a double-layer composite structure.

13. The introducer sheath according to claim 1, wherein the sheath comprises a tubular wall, the tubular wall has an expanded state for expanding the caliber of the corresponding portion and a pre-shaped state for self-restoring the caliber of the corresponding portion, the tubular wall comprises a first polymer layer, an elastic layer and a second polymer layer, the first polymer layer, the elastic layer and the second polymer layer are sequentially sleeved from inside to outside, and the elastic layer is used for driving the tubular wall to keep the pre-shaped state.

14. The catheter sheath of claim 1, wherein the sheath comprises a first polymer layer, a middle layer and a second polymer layer, which are sequentially sleeved from inside to outside, and the middle layer is of a braided structure.

15. The catheter sheath of claim 1, wherein the first hemostatic valve includes a housing and a sealing membrane mounted in the housing and having a tubular structure, the lumen of the tubular structure being the second instrument channel, the housing having a driving chamber disposed therein at a periphery of the sealing membrane for filling with a fluid, the first hemostatic valve further including an energy storage mechanism operatively associated with the fluid, the energy storage mechanism being configured to store or release energy when the state of the sealing membrane changes and to urge the sealing membrane to sealingly close the second instrument channel when the energy is released.

16. An access assembly comprising an introducer sheath according to any one of claims 1 to 15 and a puncture sheath, the puncture sheath comprising a tubular body and a stem, the introducer sheath and the puncture sheath in an engaged state, the tubular body extending distally of the sheath tube via the second instrument channel and the first instrument channel, the stem and the first hemostasis valve being snap-fit into position with one another.

17. The access assembly of claim 16, wherein the proximal side of the first hemostatic valve includes an anti-release latch structure, and the stem includes a detent latch cooperating with the latch structure, the detent latch and the latch structure being configured to engage with each other to axially restrain the puncture sheath.