CN221712126U - Catheter sheath and catheter sheath assembly - Google Patents

Abstract

The application discloses a catheter sheath and a catheter sheath assembly, wherein the catheter sheath comprises: a sheath for establishing a first instrument channel; the far end of the bypass seat is a connecting end used for connecting the near end of the sheath tube, the bypass seat is also provided with an adapting end and a bypass end, a first access channel is formed between the connecting end and the adapting end, a second access channel is formed between the connecting end and the bypass end, and the first access channel and the second access channel are intersected and communicated in the bypass seat; the first sealing device is connected to the adapting end and is used for the first conveying device; and the second sealing device is connected with the bypass end and used for penetrating the second conveying device. According to the application, through the arrangement of the bypass seat and the sealing device, the mutual communication between different instrument channels and the access channels is realized, so that the risk of vascular damage can be reduced on the premise of meeting the use condition, and a structural foundation is provided for richer treatment schemes.

Description

Introducer sheaths and introducer sheath assemblies

Technical Field

The present application relates to the field of medical devices, and in particular to a catheter sheath and a catheter sheath assembly.

Background Art

The catheter sheath is a medical device used for interventional medical operations, usually used to guide medical devices, catheters or drugs into the human body during surgery or diagnosis and treatment. In order to prevent blood loss, a sealing hemostatic valve is usually required in the catheter sheath.

In transcatheter interventional surgery, it is usually necessary to establish a main access route and an auxiliary access route. The transcatheter interventional treatment device reaches the lesion area through the main access vessel, and the auxiliary device used for angiography and other functions often needs to enter the human body through the auxiliary access vessel. In the existing technology, to establish the main access route and the auxiliary access route, a trauma point needs to be formed at each access vessel for inserting a catheter sheath, and a catheter sheath is usually only suitable for a single interventional device to enter, resulting in a catheter sheath being inserted into each of the main access vessel and the auxiliary access vessel to establish the access. This method has high requirements on the patient's vascular conditions and is prone to increase the risk of vascular complications.

Utility Model Content

In order to solve the above technical problems, the present application discloses a catheter sheath, which is characterized by comprising:

A sheath, used for establishing a first instrument channel;

A bypass seat, wherein the distal end of the bypass seat is a connecting end for connecting to the proximal end of the sheath tube, and the bypass seat is further provided with an adapting end and a bypass end, a first access channel is formed between the connecting end and the adapting end, and a second access channel is formed between the connecting end and the bypass end, and the first access channel and the second access channel intersect and communicate with the interior of the bypass seat;

A first sealing device, connected to the adapter end, for passing through a first conveying device;

The second sealing device is connected to the bypass end and is used for passing the second conveying device.

Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

Optionally, the bypass seat includes:

A main body, the main body is cylindrical and has the first access channel inside, and two ends of the main body form the connecting end and the adapting end;

A bypass pipe, connected to the side wall of the main body, the end of the bypass pipe being the bypass end;

An exhaust hole or an exhaust pipe, wherein the exhaust hole or the exhaust pipe is directly connected to the main body or the bypass pipe.

Optionally, from the distal end to the proximal end, the internal cavity diameter and the external radial dimension of the main body have a tendency to expand; the main body is a split structure, which includes a connecting section and a transition section arranged in sequence from the distal end to the proximal end, and the radial expansion trend of the transition section is greater than or equal to the radial expansion trend of the connecting section; on the extension axis of the main body, the bypass end protrudes from the proximal side end face of the connecting section.

Optionally, an extension direction of the exhaust pipe or the exhaust hole is perpendicular to an extension axis of the main body.

Optionally, the bypass seat is provided with two exhaust pipes or two exhaust holes, which are respectively located on both sides of the first inlet channel.

Optionally, one exhaust pipe or exhaust hole is connected to the bypass pipe, and the other exhaust pipe or exhaust hole is connected to the main body.

Optionally, the bypass seat is provided with a suture portion for positioning with surrounding tissue at the access position.

Optionally, the suturing portion is arranged on the body and comprises at least one through hole, wherein the through hole is used to pass a suture thread for suturing with surrounding tissues at the access position. Optionally, the extension axis of the bypass tube intersects with the extension axis of the body and the angle between the two toward the proximal side is an acute angle.

Optionally, the first sealing device includes a first hemostatic valve; the first hemostatic valve may be fluid-driven or elastic-driven;

When the first hemostatic valve is fluid-driven, the first hemostatic valve includes a shell and a sealing membrane with a tubular structure, the inner cavity of the sealing membrane forms a second instrument channel, the first end of the shell is sealedly connected to the first end of the sealing membrane, and the second end of the shell is sealedly connected to the second end of the sealing membrane, so as to form a driving chamber for filling fluid between the shell and the sealing membrane; the shell is an elastic material or a rigid material. When the shell is a rigid material, the first hemostatic valve also includes an energy storage mechanism that can be linked with the fluid, the energy storage mechanism stores or releases energy accordingly when the state of the sealing membrane changes, and drives the sealing membrane to seal the second instrument channel when releasing energy, and the distal end of the second instrument channel is provided with a mounting port; or

When the first hemostatic valve is elastically driven, the first hemostatic valve comprises a shell and a sealing member located inside the shell, and the sealing member is a silicone sealing member.

Optionally, the sealing film material is a multi-layer porous material with draping properties.

Optionally, a second hemostatic valve is provided at a distal end of the first hemostatic valve, and the second hemostatic valve is used to control the connection and disconnection between the second instrument channel and the first instrument channel.

Optionally, the second hemostatic valve is located proximal to the bypass seat.

Optionally, the main body is an integrated structure or a split structure, and the split structure includes a connecting section and a transition section arranged in sequence from the distal end to the proximal end;

A first limiting shoulder abutting against the proximal end of the sheath is disposed inside the connecting section, wherein the first limiting shoulder has a stop surface on one side facing the distal end and a guide slope on the other side facing the proximal end.

Optionally, the main body is a split structure, a second limiting shoulder is provided inside the connecting section, and the transition section is cylindrical, inserted into the connecting section and abutted against the second limiting shoulder.

Optionally, the inner circumference of the joint between the connecting section and the transition section has a smooth transition.

Optionally, the sheath is an expandable sheath having a compressed state when not expanded, and an expanded state when an instrument is passed through.

Optionally, the sheath tube includes a tube wall, the tube wall is a rolled wall structure, the cross section is a coiled shape, and the tube wall has an expanded state of unfolding the rolled wall structure at a corresponding part and a predetermined state of self-restoring the rolled wall structure.

Optionally, a metal layer is provided in the tube wall of the sheath tube, and the metal layer is a spiral spring or a braided mesh or a cut metal tube.

Optionally, the length of the sheath is 300 to 420 mm.

Optionally, the second sealing device is a third hemostatic valve, and the third hemostatic valve is connected to the bypass end to form a third instrument channel.

Optionally, the first delivery device is a catheter device for delivering implants or repairing intracavitary tissues;

The second delivery device is an auxiliary measuring catheter or a guide wire. The present application also discloses a catheter sheath assembly, including:

The catheter sheath is the catheter sheath in the above technical solution;

The dilator is used for pre-dilatation of the sheath tube, and comprises: a tube body, which is constructed to have an internal channel for the guide wire to pass through; and a hand-held part fixedly connected to the tube body.

Optionally, a radially protruding protrusion is provided at the distal end of the dilator tube body; when the dilator is fully assembled in the catheter sheath, the protrusion is located inside the catheter sheath.

The technical solution disclosed in the present application realizes that during transcatheter heart valve intervention surgery, auxiliary instruments and interventional instruments enter the human body through the same access route through the provision of a bypass seat and a hemostatic valve, thereby reducing the risk of vascular damage while meeting the conditions of use, and also provides a structural basis for more abundant treatment options.

The specific beneficial technical effects will be further explained in the specific implementation methods in combination with specific structures or steps.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic diagram of a catheter sheath in one embodiment;

Fig. 2 is a schematic diagram of the proximal portion of the catheter sheath in Fig. 1;

FIG3 is a schematic diagram of an explosion of the catheter sheath in FIG2 ;

FIG4 is a schematic diagram of an explosion of a bypass seat in one embodiment;

FIG5 is a schematic diagram of the internal structure of a bypass seat in one embodiment;

6 to 7 are schematic diagrams of the bypass seat structure in one embodiment;

8 to 9 are schematic diagrams of the bypass seat structure in another embodiment;

10 to 18 are schematic diagrams of different states of the sheath tube in different embodiments;

19 to 23 are schematic diagrams of a first hemostatic valve in one embodiment;

FIG24 is a schematic diagram of an expander in one embodiment;

FIG25 is a schematic diagram of a catheter sheath assembly in one embodiment;

26 to 28 are schematic diagrams of a catheter sheath in another embodiment;

29 to 31 are schematic diagrams of a catheter sheath in another embodiment.

The reference numerals in the figures are described as follows:

1. Shell; 12. Drive chamber; 14. First end cover; 15. Second end cover;

2. Sealing membrane; 21. Inner cavity;

3. Energy storage mechanism; 31. Balance chamber; 32. First pressure regulating hole; 33. Energy storage chamber; 34. Piston; 341. Elastic member; 342. Support member;

4. dilator; 41. protrusion;

9. Interventional devices;

204, pipe wall; 206, elastic sleeve; 207, end side boundary; 208, pressure-bearing part; 209, starting side; 210, end side; 211, exceeding part; 212, not exceeding part; 213, overlapping area; 214, flexible envelope;

401, a first sealing device; 402, a second sealing device;

500, catheter sheath;

510, sheath;

520, first hemostatic valve; 521, second instrument channel; 522, installation port;

530, transition section; 532, pipe joint; 533, screw mouth;

540, second hemostatic valve;

700, bypass seat; 701, connecting end; 702, adapter end; 703, bypass end; 704, connecting cavity; 705, main body; 706, bypass pipe; 707, first limiting shoulder; 708, second limiting shoulder; 709, exhaust pipe; 710, connecting section; 711, suture part.

DETAILED DESCRIPTION

The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be a central component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be a central component at the same time.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and/or" used herein includes any and all combinations of one or more of the related listed items.

With reference to FIG. 1 , the present application discloses a catheter sheath 500, comprising:

A sheath 510 is used to establish a first instrument channel;

Bypass seat 700, referring to FIG. 4 , the distal end of bypass seat 700 is a connection end 701 for connecting the proximal end of sheath tube 510, bypass seat 700 is further provided with an adapter end 702 and a bypass end 703, a first access channel is formed between connection end 701 and adapter end 702, a second access channel is formed between connection end 701 and bypass end 703, the first access channel and the second access channel intersect and are connected to the inside of bypass seat 700;

The first sealing device 401 is connected to the adapter end 702 and is used to pass through the first conveying device;

The second sealing device 402 is connected to the bypass end 703 and is used to pass the second conveying device.

In interventional surgery, the first delivery device may be a catheter device for delivering implants or repairing intracavitary tissues; the second delivery device may be an auxiliary measurement catheter or a guidewire. In an artificial heart valve implantation or repair system, the auxiliary measurement catheter may be, for example, a pigtail catheter for delivering contrast agents or measuring transvalvular pressure gradients.

The technical solution disclosed in the present application realizes that during transcatheter interventional surgery, auxiliary instruments and interventional instruments enter the human body through the same access route through the arrangement of the bypass seat 700, the first sealing device 401 and the second sealing device 402, thereby reducing the number of access routes required during the interventional surgery while meeting the use conditions, avoiding human body damage caused by multiple access routes, and also providing a structural basis for richer treatment options.

In the specific configuration of the bypass seat 700, referring to the embodiments shown in Figures 2 to 9, the bypass seat 700 includes a main body 705 for forming a first access channel and a bypass pipe 706 for forming a second access channel. The main body 705 is cylindrical and the two ends of the main body 705 form a connecting end 701 and an adapting end 702. A connecting cavity 704 is formed between the connecting end 701 and the adapting end 702. The bypass pipe 706 penetrates the side wall of the main body 705 and is connected to the connecting cavity 704. The proximal end of the bypass pipe 706 forms a bypass end 703. In the specific configuration, the configuration of the main body 705 can refer to Figure 3 or Figure 27 or Figure 30. The main body 705 is configured as an integral structure.

As shown in FIG. 4 , the main body 705 is a split structure, including a connecting section 710 and a transition section 530 arranged in sequence from the distal end to the proximal end, the transition section 530 connects the first access channel and the second instrument channel 521 described below, and the first instrument channel is connected to the second instrument channel 521 via the first access channel;

5 to 9 , the main body 705 is an integrated structure in another manner. Different configurations of the main body 705 expand the adaptability of the bypass seat 700 .

In the above-mentioned setting scheme, the internal cavity diameter of the main body and the radial dimension of the outside both have an expansion tendency. Among them, in the split structure, the radial expansion tendency of the transition section is greater than or equal to the radial expansion tendency of the connecting section; on the extension axis of the main body, the bypass end protrudes from the proximal side end face of the connecting section. In the accompanying drawings, the first access channel, the first instrument channel and the second instrument channel below are coaxially arranged to facilitate the passage of interventional instruments. In this embodiment, the proximal ends of the main body 705 and the bypass tube 706 are independent of each other, thereby providing a basis for the extension of multiple instruments in the same sheath 510. In order to better achieve the intervention of the instrument, the inner diameter of the sheath 510 and the bypass seat 700 can be enlarged, and the inner diameter of the bypass seat 700 can also be optimized with reference to the following embodiments. For example, in one embodiment, the inner diameter of the main body 705 is extended from the proximal end to the distal end. The setting of the reduced diameter provides more ample proximal space on the premise of ensuring that the distal size meets the requirements, especially in the scene of multiple instrument access. For another example, in one embodiment, the interior of the main body 705 is extended with equal diameter in the direction from the proximal end to the distal end. The equal diameter extension can avoid interference with the inner wall of the main body 705 during the instrument access process, especially at the transition position of each part. In order to ensure the accuracy of assembly, the connection part of the pipe is often designed with a limit shoulder or a limit step, which may cause the problem of poor passage of the instrument. In order to avoid this problem, referring to Figure 7, the interior of the connecting section 710 is provided with a first limit shoulder 707 that abuts against the proximal end of the sheath 510, and the side of the first limit shoulder 707 facing the distal end is a stop surface, and the side facing the proximal end is a guide slope. This setting can control the overall size of the bypass seat 700 as much as possible while ensuring that the instrument passes smoothly in the main body 705. Similarly, as shown in FIG4 , the interior of the connecting section 710 is provided with a second limiting shoulder 708, and the transition section 530 is cylindrical, with one end being the proximal end of the connecting section 710 for inserting a pipe joint 532, and the other end being a screw port 533 screwed to the mounting port 522 (refer to FIG22 ); the axial ends of the transition section 530 and the outer peripheral surface of the corresponding component are smoothly transitioned; the pipe joint 532 abuts against the second limiting shoulder 708; in the installed position, the inner peripheral surface of the connecting section 710 and the transition section 530 at the joint position is smoothly transitioned, for example, the inner peripheral surfaces of the joint position of the two are flush. In the overall form of the bypass seat 700, referring to the embodiment shown in FIG6 , the extension axis of the bypass pipe 706 intersects with the extension axis of the main body 705, and the angle between the two toward the proximal side is an acute angle. In this embodiment, the extension axis of the main body 705 is parallel to the extension axis of the second instrument channel 521, so it can also be understood that the extension axis of the bypass tube 706 intersects with the extension axis of the second instrument channel 521 and the angle between the two toward the proximal side is an acute angle.

In one embodiment, the second sealing device 402 is a third hemostatic valve, which is connected to the bypass end 703 and forms a third instrument channel. The third hemostatic valve can refer to the form of the first hemostatic valve or the second hemostatic valve described below. For example, the third hemostatic valve is a silicone seal.

In the embodiment shown in FIG. 4 , the exhaust channel can be provided on the side of the transition section 530 , and the bypass seat 700 and the sheath tube as a whole can be exhausted by injecting exhaust liquid into the transition section 530 . Referring to the embodiments shown in FIGS. 8 and 9 , the exhaust pipe 709 is provided on the bypass tube 706 , and extends from the side wall of the bypass tube 706 back to the sheath tube 510 . The exhaust pipe 709 can also be provided in the form of an exhaust hole. In the accompanying drawings, the extension direction of the exhaust pipe or the exhaust hole is perpendicular to the extension axis of the main body. Referring to the embodiments shown in FIGS. 26 to 28 , two exhaust pipes 709 are provided on the bypass seat 700 . The setting of the double exhaust pipes can improve the exhaust efficiency while ensuring the exhaust effect, and avoid the problem of poor exhaust caused by the spatial posture of the catheter sheath 500 . In detail, the two exhaust pipes 709 are respectively located on both sides of the first access channel. One exhaust pipe 709 is connected to the bypass pipe 706 , and the other exhaust pipe is connected to the main body 705 . Similarly, the exhaust pipe mentioned above can also be provided as an exhaust hole.

In addition to the change in the exhaust method, in the embodiments shown in Figures 26 to 28, the bypass seat 700 is provided with a suture portion 711 for mutual positioning with the surrounding tissue at the entry position. The suture portion 711 is provided on the body 705 and includes at least one through hole, and the through hole is used to pass a suture thread for suturing with the surrounding tissue at the entry position. Similarly, the suture portion 711 can also be provided in other embodiments, such as those shown in Figures 29 to 31.

Different access channels converge at the bypass seat and eventually extend to the distal end through the sheath tube. In the setting details of the sheath tube 510, the sheath tube is an expandable sheath. The sheath tube has a compressed state when it is not expanded, and an expanded state when the instrument passes through. Referring to the embodiments shown in Figures 10 to 18, the sheath tube 510 includes a tube wall 204, the tube wall 204 is a rolled wall structure, and the cross section is a coiled shape. The tube wall 204 has an expanded state of unfolding the rolled wall structure of the corresponding part and a pre-set state of self-recovering the rolled wall structure. The tube wall 204 is an elastic material that can switch autonomously between the expanded state and the pre-set state. The outer diameter of the tube wall 204 in the pre-set state is 4-9mm. The tube wall 204 in the pre-set state is wound more than a circumference, and the part beyond 360 degrees of the circumference overlaps with the part within 360 degrees. The overlapping parts have a smooth contact surface. The tube wall 204 in the pre-set state is wound less than 720 degrees. The starting side 209 and the end side 210 of the rolled wall structure wound in the circumferential direction are connected by a flexible envelope membrane. A crease line is provided at the turning point of the flexible envelope membrane. The wall thickness of the flexible envelope membrane is 0.1-1mm. The flexible envelope membrane is a circumferentially closed tubular structure, the circumference of the cross section of the flexible envelope membrane tubular structure is greater than the wall length of the cross 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 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 handle, and the connecting part is wrapped by the elastic sleeve 206. The axial length of the elastic sleeve 206 is 5 to 50cm. In the accompanying drawings, the axial length of the elastic sleeve 206 is preferably 5 to 20cm. The outside of the tube wall 204 is wrapped with a bundle sleeve for limiting the tube wall 204 to a predetermined state, and the bundle sleeve bursts when the tube wall 204 is inflated. The sleeve extends axially along the tube wall 204 out of the distal end of the tube wall 204, and the extended part is a closing structure. On the tail side 210 of the circumferentially wound wall structure, it is a cut-angle structure near the distal end of the tube wall 204. In the circumferential direction, the wall rolling structure spirally extends from the starting side to the tail side. The tail side boundary of the starting side can extend axially along the sheath tube or spirally extend around the axis of the sheath tube. As shown in Figure 11, the tail side boundary 207 is a straight line and extends axially along the sheath tube. When a spiral line is used, the force distribution of the sheath tube when it is bent can be made more uniform. In terms of size, in the pre-formed state, the outer diameter of the sheath tube is 5mm (15Fr) and the inner diameter is 4mm. In the expanded state, the inner diameter can reach 8mm (24Fr), and the sheath tube can be transported through the corresponding diameter.

In conjunction with Figures 12 to 15, the interventional instrument passes from right to left, squeezing the inner side of the tube wall wherever it passes, causing the rolled wall structure of the tube wall to unfold accordingly, and the compressed portion 208 is turned into an expanded state. After the interventional instrument 9 passes through, the tube wall 204 will recover by itself due to its own elasticity and return to the initial predetermined state. In this embodiment, the material of the tube wall is selected from polymer materials such as HDPE or TPU. In order to ensure that the tube wall can recover autonomously and maintain a certain strength and compliance, the thickness of the tube wall is 0.5mm. In a specific implementation method, the tube wall can be set to a double-layer composite structure, and the material of each layer in the double-layer composite structure is independently set to HDPE, TPU, or a composite of HDPE and TPU.

Referring to FIG. 16 , it is a schematic cross-sectional view of the sheath in a predetermined state (initial state) when the device is not implanted. In order to cover and form a channel for the delivery sheath, the tube wall in the predetermined state is wound more than 360 degrees, that is, it extends more than 360 degrees in the circumferential direction from the starting side 209 to the end side 210 of the winding, and the part exceeding 360 degrees overlaps the part not exceeding 360 degrees. The exceeding part 211 and the part not exceeding 212 overlap each other, and the exceeding part 211 is wrapped around the outer periphery of the part not exceeding 212, and a complete channel is formed inside the tube wall.

Fig. 18 is a cross-sectional view of the sheath tube when it is expanded when implanting the interventional device 9. In order to prevent the delivery sheath tube and the implanted device from being exposed, especially in the expanded state, the tube wall in the expanded state is wound more than or equal to 360 degrees, that is, there is still an overlapping area 213.

In FIG. 17 , the starting side 209 and the ending side 210 of the tube wall winding are connected by a flexible envelope 214. The flexible envelope can provide radial support force, restrain the implanted device, prevent it from being exposed, and prevent blood or body fluids from overflowing the tube wall. The flexible envelope 214 of this embodiment is made of PTFE material with a wall thickness of 0.25-0.5 mm. Regardless of the state of the tube wall, the flexible envelope 214 can keep the sheath closed, and the flexible envelope 214 can be fixed to the tube wall by welding or the like. In order to accommodate the flexible envelope 214, the flexible envelope 214 is located in the middle layer of the overlapping part of the tube wall. The flexible envelope 214 can extend for a certain length in the circumferential direction, that is, it does not envelop the entire inner cavity of the tube wall at 360 degrees. In the pre-formed state, the flexible envelope 214 is stretched between the starting side 209 and the ending side 210 of the tube wall winding. The function of the flexible envelope 214 is to close the gap formed between the starting side 209 and the ending side 210 to prevent blood or body fluid from entering or leaving the tube wall. Therefore, the fixing points of the flexible envelope 214 and the tube wall are not strictly required to be at the starting side 209 and the ending side 210, and can also be adjusted appropriately.

In addition to the sheath tube with the rolled wall structure mentioned above, the sheath tube can also refer to an embodiment in which the sheath tube includes a tube wall and the tube wall has a swollen state of expanding the tube diameter of the corresponding part and a predetermined state of self-restoring the tube diameter of the corresponding part, and the tube wall includes a first polymer layer, an elastic layer and a second polymer layer which are sequentially sleeved from the inside to the outside, and the elastic layer is used to drive the tube wall to maintain the predetermined state.

In a specific configuration, the material of the first polymer layer is PTFE. The material of the second polymer layer is Pebax. The elastic layer is a wound elastomer. The elastomer is a spiral spring or a braided mesh made of stainless steel or memory metal. In another embodiment, a metal layer is provided in the tube wall of the sheath tube, and the metal layer is a spiral spring or a braided mesh or a cut metal tube. The metal layer can be provided in a form that allows radial deformation, or can be provided in a form that does not allow radial deformation.

In addition to optimizing the internal structure of the sheath, the present application also provides optimization of the outer peripheral surface of the sheath. Referring to one embodiment, the outer wall of the distal end of the sheath is marked with scale. The scale marking is used to facilitate confirmation of the length entering the human body. In actual use, the actual size of the sheath entering may vary according to different case conditions. The scale marking can also be set in the axial direction of the sheath to meet different needs, such as extending to the middle or even the proximal end of the sheath. A bionic coating for improving biocompatibility is provided on the outer peripheral surface of the sheath. In this embodiment, the sheath length is 300 to 420 mm, preferably 340 to 350 mm.

After the intervention channel is established, the internal pressure of the channel needs to be maintained to prevent the outflow of blood and body fluids. For the details of the setting of the first sealing device 401 in the present application, reference can be made to Figures 19 to 23. The first sealing device 401 is arranged at the proximal end of the bypass seat 700 and includes a first hemostatic valve 520. In the accompanying drawings, the first hemostatic valve is fluid-driven. Specifically, the first hemostatic valve 520 includes a housing 1 and a sealing film 2 with a tubular structure installed in the housing 1. The inner cavity 21 of the sealing film 2 with a tubular structure forms a second instrument channel 521. In this embodiment, the sealing film 2 material is a multi-layer porous material with a dangling property. The porous material specifically refers to the porous structure on its microstructure. When the number of layers is small, the material allows part of the fluid to pass through itself; when the number of layers is large, the material prevents the fluid from passing through itself. The dangling performance is specifically manifested in the property that the material is soft and easy to adhere to the outer peripheral surface of the interventional instrument. Thanks to the dangling performance, the sealing film 2 can cover the interventional instrument and achieve a sealing effect. In driving the sealing membrane 2, the first end of the housing 1 is sealedly connected to the first end of the sealing membrane 2, and the second end of the housing 1 is sealedly connected to the second end of the sealing membrane 2, so as to form a driving chamber 12 for filling the fluid between the housing and the sealing membrane. The housing 1 is provided with a driving chamber 12 for filling the fluid at the periphery of the sealing membrane 2 and a balancing chamber 31 located outside the driving chamber 12. The driving chamber 12 and the balancing chamber 31 are interconnected and the balancing chamber 31 surrounds the outer periphery of the driving chamber 12. The first sealing device 401 also includes an energy storage mechanism 3 that can be linked with the fluid. The energy storage mechanism 3 stores or releases energy accordingly when the state of the sealing membrane 2 changes, and drives the sealing membrane 2 to seal the second instrument channel 521 when releasing energy. The far end of the second instrument channel 521 is provided with an installation port 522. The number of balancing chambers 31 is preferably six. Without considering other conditions such as product volume and production process, in theory, the more balancing chambers 31 are set, the better. According to the volume of the drive chamber 12 and the balance chamber 31 of the current product, as well as considering the function and cost from structural design, spring selection to mass production, the current optimal number of cavities is 5 to 6.

The housing 1 is a solid body with multiple cylindrical spaces, the middle of which is the second instrument channel. The cylindrical spaces around the second instrument channel are used to install multiple pistons 34 to form an energy storage chamber 33 and a balance chamber 31, wherein the balance chamber 31 is connected to the drive chamber 12, and each energy storage chamber 33 has a built-in spring. The piston 34 is provided with three seals on the periphery, and is connected to the elastic member 341 through a support member 342, and the hardness of the support member 342 is higher than that of the piston 34. The housing 1 is connected to the second end cover 15, and a sealing component is built in for sealing, wherein the second end cover 15 is provided with a first pressure regulating hole 32; the second end cover 15 and the first end cover 14 fix and seal the sealing membrane 2 on the housing 1.

In addition to the separate elastic member 341, the energy storage element can also use gas as the compression medium to facilitate the adjustment of the resistance of instruments with different diameters, which is more flexible. However, correspondingly, the sealing requirements for the energy storage chamber 33, the balance chamber 31 and the related components are relatively high, and the process is relatively complicated.

It is not difficult to see from the accompanying drawings that in this embodiment, each balancing chamber 31 can actually be interconnected through the drive chamber 12, that is, the sealing membrane 2 is a whole, and the drive chamber 12 is arranged around the sealing membrane 2 and is connected to each balancing chamber 31. In other embodiments, the sealing membrane 2 may not be a whole, and a plurality of sealing membranes 2 are combined to achieve the closure of the second instrument channel; in this implementation, the drive chambers 12 between different sealing membranes 2 may not be connected, and accordingly, the balancing chambers 31 between different drive chambers 12 are also not connected.

In some embodiments, the housing 1 may also be made of an elastic material, and when the drive chamber is filled with fluid, the housing 1 expands outward accordingly, providing a visual indication that the drive chamber is pressurized.

Independent of the above description, the first hemostatic valve can also be configured to be elastically driven. For example, in other embodiments, the first hemostatic valve includes a housing and a sealing member located in the housing, and the sealing member is a silicone sealing member. The sealing form can be a disc seal and/or a cross-seam seal.

Referring to the embodiment shown in FIG. 3 , the first sealing device 401 further includes a second hemostatic valve 540 installed in the housing 1 , and the second hemostatic valve 540 is arranged at the distal end side of the first hemostatic valve 520 , and the second hemostatic valve 540 is used to control the on-off between the second instrument channel 521 and the first instrument channel. In the accompanying drawings, the second hemostatic valve 540 is located on the proximal side of the bypass seat. In the specific structure of the second hemostatic valve 540 , the second hemostatic valve 540 includes a base covering the distal end opening of the second instrument channel 521 and at least two elastic valve plates movably arranged on the base, each valve plate has an open state away from each other and a closed state close to each other, and each valve plate in the closed state prevents the fluid from flowing from the first instrument channel to the second instrument channel 521. In different schemes, the materials of the valve plate and the base can be set the same or different. The valve plate is installed on the base through a movable structure, or the valve plate is fixed on the base and realizes the switching of different states through its own deformation. In the top view of the central axis of the second hemostatic valve 540, the shape (edge) of each valve sheet is V-shaped and the bottom (pointed corner) of the V-shape is close to the central axis of the second hemostatic valve 540. The bottoms of the V-shapes of multiple valve sheets are close to each other and the edges of the V-shapes are close to each other to achieve a closed state. The number of valve sheets is preferably greater than or equal to 3, and the number of valve sheets in the figure is 4. The valve sheets can be set differently, for example, a large valve sheet is matched with multiple small valve sheets, or a small valve sheet is matched with multiple large valve sheets, or the sizes of the valve sheets are different. The valve sheets can also be set the same, and the valve sheets in the figure are evenly distributed in the circumferential direction of the base. The center angle range of each valve sheet relative to the central axis of the base is 90 degrees ± 30 degrees. The valve sheets can be set at intervals or partially overlapped. When the interventional instrument passes through the second hemostatic valve 540, the valve sheets are moved away from each other by the force of the interventional instrument, but the valve sheets can be attached to the surface of the interventional instrument, thereby still maintaining a certain sealing effect. Thanks to the elastic setting of the valve sheet, when the valve sheet receives a force in the direction of its deformation (the force from the proximal end to the distal end in the attached figure, which is actually manifested by the passage of an instrument or a guide wire), the valve sheets move away from each other to achieve opening; when the valve sheet receives a force in the opposite direction of its deformation (the force from the distal end to the proximal end in the attached figure, which actually represents the tendency of blood or other body fluids to flow out of the body), the valve sheets are pressed together to achieve closure. The different states of the valve sheet are switched to achieve a one-way conduction function. In the embodiment shown in the attached figure, the second hemostatic valve 540 is made of rubber or silicone as a whole.

In combination with the above description, it is not difficult to understand that the present application also discloses a catheter sheath assembly, as shown in FIGS. 24 to 25 , comprising:

The catheter sheath 500 is the catheter sheath described in the above technical solution;

The dilator 4 is used for pre-dilatation of the sheath tube 510 , and comprises: a tube body, which is constructed to have an internal channel for the guide wire to pass through; and a hand-held part fixedly connected to the tube body.

The distal end of the dilator 4 is provided with a radially protruding protrusion 41; when the dilator is fully assembled in the catheter sheath, the protrusion 41 is located inside the catheter sheath. In other words, the length of the portion of the dilator that can be inserted into the catheter sheath 500 does not exceed the length of the catheter sheath 500 (see FIG. 25).

The catheter sheath in the catheter sheath assembly can also refer to Figures 26 to 28 and Figures 29 to 31.

Compared with the catheter sheath in Figure 25, the main difference between the catheter sheaths shown in Figures 26 to 28 is that the bypass seat 700 is shorter in the axial direction of the sheath tube 510, the connecting position of the bypass tube 706 is closer to the first sealing device 401, and two exhaust pipes 709 are provided on the bypass seat 700. The connecting positions of each exhaust pipe 709 and the bypass tube 706 are close to each other in the axial direction of the sheath tube 510, and the bypass seat 700 is provided with the suture portion 711 mentioned above.

Compared with the catheter sheaths in Figures 26 to 28, the main difference between the catheter sheaths shown in Figures 29 to 31 is that the bypass seat 700 is provided with an exhaust pipe 709, and the exhaust pipe 709 and the bypass pipe 706 are located on the same side, and the suture part 711, the exhaust pipe 709 and the bypass pipe 706 are in contact with each other.

For the specific description, please refer to the corresponding description above, which will not be repeated here.

The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims (15)

1. A catheter sheath, comprising: A sheath, used for establishing a first instrument channel; A bypass seat, wherein the distal end of the bypass seat is a connecting end for connecting to the proximal end of the sheath tube, and the bypass seat is further provided with an adapting end and a bypass end, a first access channel is formed between the connecting end and the adapting end, and a second access channel is formed between the connecting end and the bypass end, and the first access channel and the second access channel intersect and communicate with the interior of the bypass seat; A first sealing device, connected to the adapter end, for passing through a first conveying device; The second sealing device is connected to the bypass end and is used for passing the second conveying device. 2. The catheter sheath according to claim 1, characterized in that the bypass seat comprises: A main body, the main body is cylindrical and has the first access channel inside, and two ends of the main body form the connecting end and the adapting end; A bypass pipe, connected to the side wall of the main body, the end of the bypass pipe being the bypass end; An exhaust hole or an exhaust pipe, wherein the exhaust hole or the exhaust pipe is directly connected to the main body or the bypass pipe. 3 . The catheter sheath according to claim 2 , wherein the extension axis of the bypass tube intersects with the extension axis of the main body and an angle between the two toward the proximal end is an acute angle. 4. The catheter sheath according to claim 2 is characterized in that a first limiting shoulder is provided inside the main body to abut against the proximal end of the sheath tube, the first limiting shoulder has a stop surface on the side facing the distal end and a guide slope on the side facing the proximal end. 5. The catheter sheath according to claim 1, characterized in that the first sealing device comprises a first hemostatic valve; the first hemostatic valve can be fluid-driven or elastically driven; When the first hemostatic valve is fluid-driven, the first hemostatic valve includes a shell and a sealing membrane with a tubular structure, the inner cavity of the sealing membrane forms a second instrument channel, the first end of the shell is sealedly connected to the first end of the sealing membrane, and the second end of the shell is sealedly connected to the second end of the sealing membrane, so as to form a driving chamber for filling fluid between the shell and the sealing membrane; the shell is an elastic material or a rigid material. When the shell is a rigid material, the first hemostatic valve also includes an energy storage mechanism that can be linked with the fluid, the energy storage mechanism stores or releases energy accordingly when the state of the sealing membrane changes, and drives the sealing membrane to seal the second instrument channel when releasing energy, and the distal end of the second instrument channel is provided with a mounting port; or When the first hemostatic valve is elastically driven, the first hemostatic valve comprises a shell and a sealing member located inside the shell, and the sealing member is a silicone sealing member. 6 . The catheter sheath according to claim 5 , further comprising a second hemostatic valve disposed on the distal end side of the first hemostatic valve, wherein the second hemostatic valve is used to control the opening and closing between the second instrument channel and the first instrument channel. 7. The catheter sheath according to claim 1 is characterized in that the sheath tube is an expandable sheath; the sheath tube has a compressed state when not expanded, and an expanded state when an instrument passes through. 8. The catheter sheath according to claim 7 is characterized in that the sheath tube includes a tube wall, the tube wall is a rolled wall structure, the cross-section is coiled, and the tube wall has an expanded state of unfolding the rolled wall structure at a corresponding part and a predetermined state of self-recovering the rolled wall structure. 9 . The catheter sheath according to claim 1 , wherein a metal layer is provided in the tube wall of the sheath tube, and the metal layer is a spiral spring or a braided mesh or a cut metal tube. 10 . The catheter sheath according to claim 1 , wherein the length of the sheath tube is 300 to 420 mm. 11. The catheter sheath according to claim 1, characterized in that the second sealing device is a third hemostatic valve, and the third hemostatic valve is connected to the bypass end and forms a third instrument channel. 12. The catheter sheath according to claim 1, characterized in that the first delivery device is a catheter device for delivering an implant or repairing intracavitary tissue; The second delivery device is an auxiliary measuring catheter or a guide wire. 13. The catheter sheath according to claim 2, characterized in that, from the distal end to the proximal end, the internal cavity diameter and the external radial size of the main body have an expansion tendency; the main body is a split structure, and the split structure includes a connecting section and a transition section arranged in sequence from the distal end to the proximal end, and the radial expansion tendency of the transition section is greater than or equal to the radial expansion tendency of the connecting section; on the extension axis of the main body, the bypass end protrudes from the proximal side end face of the connecting section; An extension direction of the exhaust pipe or the exhaust hole is perpendicular to an extension axis of the main body. 14. A catheter sheath assembly, characterized in that it comprises: A catheter sheath, which is the catheter sheath according to any one of claims 1 to 13; The dilator is used for pre-dilatation of the sheath tube, and comprises: a tube body, which is constructed to have an internal channel for the guide wire to pass through; and a hand-held part fixedly connected to the tube body. 15 . The catheter sheath assembly according to claim 14 , wherein a radially protruding protrusion is provided at the distal end of the dilator tube body; when the dilator is fully assembled in the catheter sheath, the protrusion is located inside the catheter sheath.