Medical system

Abstract

The utility model provides a medical system, which relates to the technical field of interventional medical instruments, and comprises a conveying device and an implant, the conveying device is used for conveying the implant to a target tissue through a human body chamber or a pipeline, and the conveying device comprises a container, an outer tube, an inner tube and an end structure, the container comprises an inner cavity for accommodating the implant and an outlet for discharging the implant; the outer pipe is connected and communicated with the container; the inner tube penetrates through the container and the outer tube and is used for being separably connected with an implant; the end structure is arranged at the far end of the inner tube and used for selectively blocking or exposing the outlet. According to the utility model, the delivery and control of the implant can be realized by adjusting the relative position of the inner tube and the container, and the control convenience of the conveying device is obviously improved. Moreover, the end structure can be used for pre-expanding the target tissue, and the implant can be directly post-expanded on the withdrawing path, so that the implant can be quickly and stably mounted in place.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of interventional medical instruments, in particular to a medical system. BACKGROUND

[0002] In the field of three types of medical instruments, the delivery sheath is an important medical instrument, which is mainly used to send the implant into the blood vessels, cavities or other organs of the human body. Among them, the most common implant is the stent product, including vascular stent, shunt stent, occluder, artificial valve stent, etc., and other types of implants also include various sensors with anchoring structure, etc. With the increasing diversification of the structure, form and purpose of the implant, the current delivery sheath and its delivery method cannot meet the needs of some implants. For example, in the prior art, for the shunt stent arranged on the atrial septum, a puncture needle is usually used to puncture the atrial septum to create a perforation, and then a balloon catheter or dilator is used to expand the perforation to place the subsequent delivery shunt stent. The shunt stent is usually self-expanding, which can automatically expand when delivered to the perforation to be engaged with the hole wall of the perforation, and for example, the sensor with anchoring structure can also have the self-expanding property. For such implants, a delivery sheath is needed to deliver and release them to the target position more quickly and conveniently. SUMMARY

[0003] In order to overcome the above-mentioned defects of the prior art, the utility model provides a delivery device and a medical system for solving one or more problems in the prior art.

[0004] The above-mentioned purpose of the utility model can be realized by the following technical scheme, the utility model provides a delivery device for delivering an implant to a target tissue through a human body cavity or duct, comprising:

[0005] A container, the container comprises a containing cavity for containing the implant and an outlet for discharging the implant;

[0006] An outer tube connected with and communicating with the container;

[0007] An inner tube penetrating through the container and the outer tube and used for being detachably connected with the implant;

[0008] An end structure arranged at the distal end of the inner tube, the end structure being used for selectively blocking or exposing the outlet.

[0009] In a preferred embodiment of the utility model, the outer tube is coaxially arranged with the container, the container can be axially moved relative to the end structure to block or expose the outlet; when the distance between the container and the end structure is less than a preset value, the distance between the end structure and the implant is unchanged, when the distance between the container and the end structure is greater than or equal to the preset value, the implant is released to the target tissue; the implant comprises a stent made of a shape memory material, the stent is adapted to be sleeved on the inner tube, and the stent can be self-expanded to a set width after being separated from the inner tube.

[0010] In a preferred embodiment of the utility model, the end structure comprises a balloon, the balloon has a first working condition in an inflated state and a second working condition in a contracted state, when the balloon is in the first working condition, the balloon can be axially moved relative to the container to block or expose the outlet; during the process that the implant is separated from the inner tube, the balloon is always closer to the distal end of the implant than the proximal end of the implant and keeps the relative axial position unchanged with the implant; after the implant is separated from the inner tube, the balloon can directly expand the stent on the withdrawal path.

[0011] In a preferred embodiment of the utility model, the length of the balloon is greater than or equal to the length of the stent; and / or, the nominal width of the balloon after inflation is greater than or equal to the set width of the stent.

[0012] In a preferred embodiment of the utility model, the delivery device further comprises a developing mark arranged on the end structure; and / or, the end structure is made of a material with developing function.

[0013] In a preferred embodiment of the utility model, along the direction from the distal end of the inner tube to the proximal end of the inner tube, the two ends of the end structure form a front expansion guide part and a rear expansion guide part respectively; along the direction from the rear expansion guide part to the front expansion guide part, the cross section of the front expansion guide part gradually decreases; and / or, along the direction from the front expansion guide part to the rear expansion guide part, the cross section of the rear expansion guide part gradually decreases.

[0014] In a preferred embodiment of the utility model, along the direction from the distal end to the proximal end of the inner tube, the inner tube comprises a first extension section, a second extension section and a third extension section, the extension direction of the second extension section is different from the extension direction of the first extension section and the second extension section, the axis of the first extension section is offset on one side of the axis of the container; the main body of the implant is arranged on the first extension section, and the stent is sleeved on the first extension section.

[0015] In a preferred embodiment of the utility model, two ends of the end structure form a first port part and a second port part along the direction from the distal end of the inner tube to the proximal end of the inner tube; the first port part and the second port part are coaxially arranged with the axis of the container; or, the first port part is coaxially arranged with the axis of the container, and the second port part is coaxially arranged with the axis of the first extension section; or, the first port part and the second port part are coaxially arranged with the axis of the first extension section; or, the first port part is coaxially arranged with the axis of the first extension section, and the second port part is coaxially arranged with the axis of the container.

[0016] In a preferred embodiment of the utility model, the end structure comprises a balloon, and the first port part and the second port part of the balloon are respectively sleeved on the inner tube, and the main body of the balloon is coaxially arranged with the container;

[0017] The length of the balloon is greater than or equal to the length of the stent; and / or, the nominal width of the balloon after inflation is greater than or equal to the set width of the stent, so that the balloon can directly expand the stent on the withdrawal path after the implant is separated from the inner tube.

[0018] In a preferred embodiment of the utility model, the conveying device further comprises a first connecting structure arranged on the inner tube, and the implant is provided with a second connecting structure;

[0019] When the implant is in the container, the implant is connected with the first connecting structure through the second connecting structure to maintain the axial relative position of the implant and the inner tube;

[0020] When the implant is separated from the container, the second connecting structure and the first connecting structure can be automatically separated to release the implant.

[0021] In a preferred embodiment of the utility model, a connecting piece is arranged on the inner tube, the connecting piece can be accommodated in the container, the first connecting structure is arranged on the connecting piece; the connecting piece comprises a connecting seat, and an eccentric channel for the inner tube to pass through is formed on the connecting seat; the connecting seat is arranged in extension along a first preset direction, a first included angle β is formed between the first preset direction and the axis of the eccentric channel, and the range of the first included angle β is 0° to 60°.

[0022] In a preferred embodiment of the utility model, the outer tube has a first bending part, the inner tube has a second bending part, and when the end structure blocks the outlet, the first bending part and the second bending part are correspondingly arranged;

[0023] The connecting seat comprises a first seat body and a second seat body connected with each other along a direction from a distal end of the inner tube to a proximal end of the inner tube, the first seat body is in a columnar shape, and the first connecting structure is arranged on the first seat body;

[0024] The second seat body is in a frustoconical shape, the eccentric channel penetrates through the first seat body and the second seat body, the second seat body has a first end and a second end, a radial dimension of the first end is greater than a radial dimension of the second end, and the first end of the second seat body is connected with the first seat body.

[0025] In a preferred embodiment of the utility model, the second end of the second seat body is formed with an orifice end face, the orifice end face is perpendicular to an axis of the eccentric channel, and the eccentric channel penetrates through the orifice end face; the second seat body is further provided with a clearance end face, at least part of the clearance end face is connected with the orifice end face, the rest part of the clearance end face is arranged away from the proximal end of the inner tube, a second included angle alpha is formed between the clearance end face and a vertical direction, and the second included angle alpha ranges from 0 to 60 degrees.

[0026] In a preferred embodiment of the utility model, the inner tube further comprises a fourth extension section, the fourth extension section is located between the second extension section and the third extension section, the fourth extension section is used for penetrating through the eccentric channel, and an included angle between the fourth extension section and the axis of the container is smaller than an included angle between the second extension section and the axis of the container.

[0027] In a preferred embodiment of the utility model, the end structure is formed with an end channel, the inner tube further comprises a fifth extension section, the fifth extension section is arranged on the other side of the first extension section relative to the second extension section, and the fifth extension section penetrates through the end channel; the inner tube has an inner cavity and can be used for arranging a guide wire.

[0028] In a preferred embodiment of the utility model, the connecting piece is provided with a flow guide structure, the flow guide structure communicates the accommodating cavities of the container located on both sides of the connecting piece; the first preset direction is parallel to an axial direction of the container or the first preset direction has a third included angle gamma with the axial direction of the container, and the third included angle gamma ranges from 0 to 60 degrees.

[0029] In a preferred embodiment of the utility model, the end structure comprises a balloon, the inner tube is further provided with a flow passing structure, the flow passing structure has an injection channel, and the injection channel communicates an inner cavity of the balloon.

[0030] In a preferred embodiment of the utility model, the conveying device further comprises a releasing mechanism, the releasing mechanism comprises the inner tube and a control mechanism, and the control mechanism is used for adjusting an axial relative position between the inner tube and the container.

[0031] The utility model also provides a kind of medical system, including implant, and the transport device of preceding, the transport device is used to accommodate and transport the implant.

[0032] In a preferred embodiment of the utility model, the medical system further comprises a guide wire arranged in the inner tube, and the implant comprises a wireless sensor and a stent, and the wireless sensor and the stent are arranged side by side.

[0033] The technical scheme of the utility model has the following remarkable beneficial effects:

[0034] In use, the container is connected to and communicates with the outer tube, and the container has a receiving cavity for receiving the implant and an outlet for discharging the implant. Moreover, the inner tube penetrates the container and the outer tube, the implant is detachably connected to the inner tube, and the end structure is arranged at the distal end of the inner tube. The end structure is used to selectively block or expose the outlet. By arranging the end structure and the implant on the inner tube simultaneously, the outlet can be blocked or exposed by cooperation between the inner tube and the end structure. Moreover, the implant is detachably connected to the inner tube. When the outlet is exposed, the implant can be separated from the inner tube to be released to the target position on the target tissue. The delivery and control of the implant can be realized by the outer tube and the inner tube, so that the implant can be delivered to the target tissue. The implant can be released without complex operation, and the convenience of the transport device is significantly improved.

[0035] Further, in a specific embodiment, the balloon is used as the end structure, which can be used to pre-expand the target tissue on the delivery path of the implant, thereby facilitating the implant to be arranged on the target tissue. After the implant is delivered and placed on the target tissue, the balloon can also be used to post-expand the implant on the withdrawal path, so that the implant can be combined with the target tissue more closely, and the implant can be quickly, conveniently and firmly arranged. In the whole process, the inner tube does not need to be moved repeatedly, and the damage to the human tissue caused by the movement of the inner tube can be effectively avoided.

[0036] In another specific embodiment, the corresponding part of the inner tube and the container is arranged in a non-conventional coaxial structure, but presents a certain bias, so that not only the effective loading of the implant with a specific structure (for example, the implant combined by the stent and the sensor) is realized, but also the through performance of the transport device is affected due to the oversize of the container. BRIEF DESCRIPTION OF DRAWINGS

[0037] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced as follows. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort on the basis of these drawings.

[0038] The drawings described herein are for illustrative purposes only, and are not intended to limit the scope of the present application in any way. In addition, the shapes and scale sizes of the components in the drawings are only illustrative, and are used to help understand the present application, and are not specifically limited to the shapes and scale sizes of the components of the present application. Those skilled in the art can select various possible shapes and scale sizes to implement the present application according to the specific circumstances under the guidance of the present application.

[0039] Figure 1 The structure of the conveying device in an embodiment of the present application is shown in the figure.

[0040] Figure 2 The structure of the conveying device in an embodiment of the present application is shown in the figure. Figure 1

[0041] Figure 3 The cross-sectional structure of the balloon in an embodiment of the present application is shown in the figure.

[0042] Figure 4 The cross-sectional structure of the balloon in an embodiment of the present application is shown in the figure.

[0043] Figure 5 The cross-sectional structure of the implant in a semi-released state in an embodiment of the present application is shown in the figure.

[0044] Figure 6 The cross-sectional structure of the implant in a fully released state in an embodiment of the present application is shown in the figure.

[0045] Figure 7 The cross-sectional structure of the inner tube biased in the container in an embodiment of the present application is shown in the figure.

[0046] Figure 8 The cross-sectional structure of the first and second bending portions in an embodiment of the present application is shown in the figure, and the implant is omitted.

[0047] Figure 9 The side view structure of the balloon in an embodiment of the present application is shown in the figure.

[0048] Figure 10 ​A side view structure schematic diagram of the balloon in an embodiment of the utility model;

[0049] Figure 11 A side view structure schematic diagram of the balloon in an embodiment of the utility model;

[0050] Figure 12 A side view structure schematic diagram of the balloon in an embodiment of the utility model;

[0051] Figure 13 A side view structure schematic diagram of the connecting seat in an embodiment of the utility model;

[0052] Figure 14 A side view structure schematic diagram of the connecting seat in an embodiment of the utility model;

[0053] Figure 15 A side view structure schematic diagram of the second included angle alpha in an embodiment of the utility model shows;

[0054] Figure 16 A side view structure schematic diagram of the third included angle gamma in an embodiment of the utility model shows;

[0055] Figure 17 A three-dimensional structure schematic diagram of the conveying device in an embodiment of the utility model in unreleased state shows;

[0056] Figure 18 A three-dimensional structure schematic diagram of the conveying device in an embodiment of the utility model in half released state shows;

[0057] Figure 19 A three-dimensional structure schematic diagram of the conveying device in an embodiment of the utility model in full released state shows;

[0058] Figure 20 A three-dimensional structure schematic diagram of the conveying device in an embodiment of the utility model in rear expansion state shows;

[0059] Figure 21 A three-dimensional structure schematic diagram of the implant in an embodiment of the utility model shows.

[0060] The reference signs of the above drawing:

[0061] 10, implant; 16, stent; 17, second connecting structure;

[0062] F, first preset direction;

[0063] 20, target tissue;

[0064] 100, container; 110, outlet;

[0065] 200 outer tube; 201 first bend;

[0066] 300 release mechanism; 310 inner tube; 311 first extension; 312 second extension; 313 third extension; 314 fourth extension; 315 fifth extension; 316 second bend;

[0067] 400 control mechanism; 410 actuator; 420 auxiliary;

[0068] 500 guidewire;

[0069] 600 end structure; 610 balloon; 611 anterior expansion guide; 612 posterior expansion guide; 613 first port portion; 614 second port portion;

[0070] 700 connection seat; 710 first seat body; 720 second seat body; 730 eccentric passage; 740 first connection structure; 750 orifice end face; 760 avoidance end face; 770 flow guide structure. DETAILED DESCRIPTION

[0071] 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. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0072] It should be understood that the term "comprising" and its variants used in the present disclosure are open and inclusive, i.e. "including but not limited to". The term "according to" is "at least partially according to".

[0073] It should be understood that although the terms "first" or "second" and the like can be used in the present disclosure to describe various elements, these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

[0074] The terms "proximal" and "distal" are relative positions, directions of elements or actions relative to each other from the perspective of the operator,

[0075] Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device that is closest to the physician during normal operation, and "distal" generally refers to the end that enters the patient's body first.

[0076] Embodiment one

[0077] Please refer to Figure 1 ,Figure 2 and Figure 21 As shown in the embodiments of the utility model, a delivery device is provided for delivering an implant 10 to a target location on a target tissue 20 through a human body cavity or duct. As shown in Figure 1 and Figure 2 The delivery device comprises a container 100, an outer tube 200, an inner tube 310 and an end structure 600. The container 100 comprises a receiving cavity for receiving the implant 10 and an outlet 110 for discharging the implant 10 (see Figure 4 ). The outer tube 200 is connected to and communicates with the container 100, and preferably, the outer tube 200 is integrally formed with the container 100. The inner tube 310 penetrates the container 100 and the outer tube 200 and is used for detachably connecting with the implant 10. The end structure 600 is arranged at the distal end of the inner tube 310, and the end structure 600 is used for selectively blocking or exposing the outlet 110 of the container 100.

[0078] In the present embodiment, after the implant 10 is loaded on the inner tube 310, the end structure 600 and the implant 10 are both arranged on the inner tube 310 and the implant 10 is located in the container 100. By changing the relative position of the end structure 600 and the container 100, the outlet 110 can be selectively blocked or exposed. Preferably, the implant 10 comprises a wireless pressure sensor. When the outlet 110 is exposed, blood can enter the container 100 through the outlet 110 and contact the wireless pressure sensor, thereby realizing intraoperative pressure measurement. The implant 10 is detachably connected with the inner tube 310, so that when the container 100 is gradually separated from the implant 10, the implant 10 can also be gradually separated from the inner tube 310 to be released to the target location on the target tissue 20. Of course, in other embodiments, the implant 10 can also be a separate stent without a wireless pressure sensor.

[0079] The utility model discloses through the control to outer tube 200 and inner tube 310, can realize the delivery and control of implant 10, need not complicated operation to release implant 10, the control convenience of delivery device is improved significantly.

[0080] In the embodiments of the utility model, as shown in Figure 1 and Figure 2 The outer tube 200 is coaxially arranged with the container 100, and the outer tube 200 and the container 100 can axially move relative to the end structure 600 to block or expose the outlet 110.

[0081] It can be understood that in other embodiments, the end structure 600 can also be driven by the inner tube 310 to axially move along the container 100 to block or expose the outlet 110.

[0082] In order to meet the loading requirement of the implant 10 and the passability of the container 100, the size of the container 100 is larger than that of the outer tube 200, and the container 100 is in a circular tube structure, and the tube wall encloses a receiving cavity, so that the implant 10 can be placed in the container 100.

[0083] Further, as shown in Figure 21 The implant 10 includes a stent 16 made of a shape memory material, the stent 16 is adapted to be sleeved on the inner tube 310 and is compressed on the inner tube 310 under the constraint of the container 100, and when the container 100 no longer constrains the stent 16, the stent 16 can be self-expanded to a set width and separated from the inner tube 310.

[0084] By using the stent 16 made of a shape memory material, when the stent 16 is separated from the receiving cavity of the container 100, the stent 16 can be separated from the inner tube 310 and self-expanded to a set width, at this time, the stent 16 can be fixed or preliminarily fixed in the target tissue 20. In the present embodiment, the target tissue 20 is the atrial septum in the heart, and the stent 16 is a shunt for being arranged in the atrial septum to guide the blood flow of the left atrium to the right atrium. In other embodiments, the stent 16 can also be used as an anchoring structure of other instruments for anchoring other instruments (such as sensors) to the target tissue 20.

[0085] It can be understood that when the distance between the container 100 and the end structure 600 is less than a preset value, the distance between the end structure 600 and the implant 10 is unchanged. The preset value depends on the connection mode of the implant 10 and the inner tube 310. Specifically, the preset value can be greater than or equal to the distance H1 between the end structure 600 and the connecting component of the implant 10 on the inner tube 310, or the preset value can be equal to the distance H2 between the end structure 600 and the proximal end surface of the implant 10, and when H1 is greater than H2, the preset value is greater than or equal to H1; when H1 is less than or equal to H2, the preset value is equal to H2. It can be understood that only when the container 100 no longer constrains the implant 10 and the connecting component of the implant 10 on the inner tube 310 is separated, the implant 10 is completely released into the target tissue 20. The designer can adjust the specific value of the preset value according to the use requirement (such as the length of the implant 10), which is not specifically limited here. Preferably, the preset value is not greater than the length of the container 100.

[0086] More preferably, when at least a part of the implant 10 is in the container 100, the distance between the container 100 and the end structure 600 can be considered to be less than the preset value. That is, when at least a part of the implant 10 is in the container 100, and the implant 10 is in a connected state with the inner tube 310, the end structure 600 and the implant 10 move synchronously relative to the container 100 and the outer tube 200, and the distance between the end structure 600 and the implant 10 is unchanged.

[0087] When the distance between the container 100 and the end structure 600 is greater than or equal to the preset value, the implant 10 is separated from the inner tube 310 and self-expands to a set width. As known from the foregoing, when greater than or equal to the preset value, the implant 10 is removed from the container 100, at which time the implant 10 can be placed on the target tissue 20 to support the target tissue 20.

[0088] In the embodiment of the present application, the end structure 600 is a plug head made of a high polymer material. After the implant 10 is released to the target tissue 20, the outer tube 200 and the inner tube 310 can be moved synchronously, so that the end structure 600 is withdrawn from the inside of the implant 10 and blocks the outlet 110 of the container 100 again, and then the delivery device is completely removed from the human body by moving the outer tube 200 and the inner tube 310.

[0089] Embodiment two

[0090] In the first embodiment, because the end structure 600 is in a non-adjustable arrangement, after the stent 16 self-expands, if the inner diameter of the stent 16 is less than or equal to the outer diameter of the end structure 600, the end structure 600 cannot be withdrawn through the inside of the stent 16, so that such a structure delivery device can only be applied to a stent 16 of a specific size. The size of the stent 16 is designed according to the hole on the atrial septum, and for different people, the stent 16 must have different sizes. For example, for younger children or smaller adults, the size of the stent 16 will be relatively small. On the other hand, in order to make an ostomy on the atrial septum for setting the implant 10, a balloon catheter is used in the prior art to expand a small hole after puncture, and then the balloon catheter is withdrawn, and then the implant 10 is released to the ostomy by using the delivery device. The puncture needle, the balloon catheter and the shunt stent 16 all need to be delivered into the human body for operation, which not only prolongs the operation time and increases the operation difficulty, but also brings more operation risks to the operation itself.

[0091] In order to overcome the above problems, the delivery device of the first embodiment is improved in the embodiment of the present application. For the same parts, this will not be described again, and for the different parts, the details are described as follows.

[0092] As Figure 3 and Figure 4In the shown embodiment, the end structure 600 comprises a balloon 610, which has a first working condition in an inflated state and a second working condition in a deflated state, and when the balloon 610 is in the first working condition, the balloon 610 can be used to move along the axial direction of the container 100 relative to the container 100 to block or expose the outlet 110. When the distal end of the delivery device enters the human body and approaches the target tissue 20, the balloon 610 can be used to expand the puncture hole to form an ideal perforation, and after the perforation is formed, the balloon 610 does not need to be withdrawn, and the delivery device continues to be pushed, so that the position of the implant 10 corresponds to the perforation, and then the implant 10 can be directly released. In this embodiment, the position of the perforation is the target position on the target tissue (the atrial septum).

[0093] Specifically, as shown in the embodiment shown in Figure 5 and Figure 6 The implant 10 can be released from the constraint of the container 100 by moving the outer tube 200 and the container 100 towards the proximal end. Once the implant 10 is released from the constraint of the container 100, it can be separated from the inner tube 310, and in the process of separating the implant 10 from the inner tube 310, the balloon 610 remains stationary, always closer to the distal end of the implant 10 than the proximal end of the implant 10 and maintains the relative axial position of the implant 10 unchanged.

[0094] When the implant 10 is completely separated from the inner tube 310, whether the size of the implant 10 after expansion is greater than the size of the balloon 610 in the inflated state or not, the balloon 610 can be converted to the deflated state, so that the balloon 610 can not only be withdrawn through the implant 10 (specifically, the stent 16), but also can directly post-expand the stent 16 on the withdrawal path, so that the stent 16 can be tightly fitted with the side wall of the perforation on the target tissue 20.

[0095] In other possible embodiments, when the balloon 610 is in the deflated state during withdrawal, the balloon 610 can not post-expand the stent 16. It can be understood that the doctor can choose whether to use the balloon 610 to expand the stent 16 according to the needs of the operation.

[0096] The utility model discloses a balloon 610 and implant 10 are arranged on the inner tube 310 together, the state of balloon 610 is controlled by using the inner tube 310, so that the balloon 610 can realize the pre-expansion of the target tissue 20 and the post-expansion of the stent 16, and the balloon 610 can freely form the inflated state or the deflated state, so that the balloon catheter does not need to be repeatedly delivered and withdrawn, and the delivery device can be suitable for various sizes of stents 16, greatly simplifying the operation steps, reducing the pain suffered by the patient, and reducing the learning curve of the doctor.

[0097] In the embodiment, the length of the balloon 610 is greater than or equal to the length of the stent 16, so that the balloon 610 can enter the stent 16 when the balloon 610 is retracted, and the balloon 610 can sufficiently expand the stent 16 in the axial direction of the stent 16.

[0098] Further, the nominal width of the balloon 610 after inflation is greater than or equal to the set width of the stent 16, so that the balloon 610 can sufficiently expand the stent 16 in the radial direction of the stent 16 after the balloon 610 enters the stent 16, which is beneficial to the installation of the stent 16 to the target tissue 20. Specifically, since the stent 16 is compressed on the inner tube 310 during delivery, the width (i.e., the radial dimension) of the stent 16 after self-expansion may be less than the set width, or the width of the stent 16 after release is less than the set width due to the perforated size not reaching the set width. By post-expanding the stent 16 by the balloon 610, the stent 16 can be further expanded to the set width, thereby improving the fit and connection firmness of the stent 16 and the target tissue 20.

[0099] In the embodiment, the delivery device further comprises a visualization marker arranged on the end structure 600. By arranging the visualization marker on the end structure 600, the visualization marker can be visualized under X-ray when the end structure 600 enters the human body, and the doctor can timely and accurately obtain the real-time position of the end structure 600.

[0100] Specifically, the end structure 600 comprises the balloon 610, and the balloon 610 is provided with the visualization marker. When the balloon 610 passes through the blood vessel passage, the doctor can track the relative position of the balloon 610 in real time through the visualization marker.

[0101] When the balloon 610 is retracted into the stent 16, the doctor can determine whether the balloon 610 is aligned with the stent 16 according to the visualization marker. When the balloon 610 is in the stent 16, the balloon 610 is further inflated, and the balloon 610 is used to post-expand the stent 16, so that the stent 16 is more closely attached to the target tissue 20.

[0102] Of course, the designer can adjust the specific structure of the visualization marker according to the needs of use, for example, the visualization marker is at least one visualization ring or at least one visualization part arranged on the end structure 600, which is not specifically limited herein. Preferably, each end of the balloon 610 is provided with a visualization ring.

[0103] When the developing mark is a developing ring, the developing ring cannot show the overall profile state of the balloon 610, that is, the inflation state and the contraction state of the balloon 610 cannot be determined by the developing ring, therefore, in another feasible implementation mode of the utility model, the balloon 610 is made of a material with developing function. By adopting the material with developing function to make the balloon 610, the inflation state or the contraction state of the balloon 610 can be shown. The designer can adjust the specific components of the material with developing function according to the use requirement, which is not specifically limited here.

[0104] In still another feasible implementation mode of the utility model, the developing mark can also not be arranged on the balloon 610, but the developing agent is injected into the balloon 610 to make the balloon 610 develop under X-ray to show the inflation state or the contraction state of the balloon 610. Wherein, the designer can adjust the specific components of the developing agent according to the use requirement, which is not specifically limited here.

[0105] Of course, in other feasible embodiments, the designer can adjust the specific setting mode of the developing mark on the end structure 600 according to the use requirement, which is not specifically limited here.

[0106] When only the developing agent is used, the developing property will be lost when the balloon 610 is contracted and removed, so that the effective position of the balloon 610 cannot be determined, while the developing ring can still work at this time. Therefore, the preferred mode is to combine the developing ring and the developing agent.

[0107] In the implementation mode of the utility model, as shown in the embodiments of Figure 9 , Figure 10 , Figure 11 and Figure 12 , along the direction from the distal end of the inner tube 310 to the proximal end of the inner tube 310, the two ends of the end structure 600 form the front expansion guide part 611 and the rear expansion guide part 612 respectively; along the direction from the rear expansion guide part 612 to the front expansion guide part 611, the cross section of the front expansion guide part 611 gradually decreases; and / or, along the direction from the front expansion guide part 611 to the rear expansion guide part 612, the cross section of the rear expansion guide part 612 gradually decreases.

[0108] By arranging the front expansion guide part 611 and the rear expansion guide part 612 at the two ends of the end structure 600 respectively, and by setting the front expansion guide part 611 and the rear expansion guide part 612 as taper shapes, the transition smoothness of the two ends of the end structure 600 is improved, so that the end structure 600 can better perform the front expansion and rear expansion operations, and at the same time, the outlet 110 of the container 100 is blocked.

[0109] Of course, in other feasible embodiments, the designer can adjust the specific shape structure of the front expansion guide part 611 and the rear expansion guide part 612 according to the use requirement, which is not specifically limited here.

[0110] Implementation Method 3

[0111] With the advancement of various sensing technologies and processing techniques, such as Figure 21 In the illustrated embodiment, the implant 10 also exhibits more structural features. For example, when the implant 10 is composed of two or more implants arranged side by side, its overall radial dimension will inevitably be larger than that of a single implant. As a result, the portion of the delivery sheath used to load the implant 10 must also be increased accordingly. This not only reduces the delivery performance of the delivery sheath but also increases the risk of injury to the human body.

[0112] This embodiment is similar to Embodiments 1 and 2, and the similarities will not be repeated. The differences are detailed below. The implant 10 includes a sensor and a support 16. After the sensor and the support 16 are combined, the overall volume of the implant 10 is significantly larger than that of the support 16 alone. Since the sensor itself is an incompressible rigid component, the size of the delivery sheath container 100 needs to be increased to provide sufficient space for the sensor. In order to avoid increasing the size of the container 100 as much as possible, the size of the sensor can also be reduced as much as possible through the processing technology. However, this places very high demands on the technical implementation and processing technology.

[0113] like Figure 7 As shown, the inventors have proposed a new inner tube structure in which the inner tube 310 is biased within the container 100, thereby biasing at least the main body of the implant 10 within the container 100. Specifically, for a typical delivery device, the inner tube 310 and the container 100 are coaxial, and the container 100 is fitted over the inner tube 310 and moves relative to the inner tube 310 to deliver the implant 10. However, in this embodiment, the portion of the inner tube 310 located within the container 100 (which may be referred to as the loading section) is no longer coaxial with the container 100, but is biased to one side of the receiving cavity of the container 100. This makes the loading section of the inner tube 310 closer to one side wall of the container 100, forming a larger receiving space between the inner tube 310 and the other side wall of the container 100 for accommodating a rigid sensor. The support 16 is fitted onto the loading section. Since the support 16 is compressible, even if the receiving space between the inner tube 310 and one side of the container 100 is small, it can still be loaded into the container 100.

[0114] By offsetting the loading section of the inner tube 310 within the receiving cavity of the container 100, the existing space of the container 100 can be fully utilized, avoiding unnecessary expansion of the overall size of the container 100 and reducing the requirements for sensor size.

[0115] Furthermore, such as Figure 7In the shown embodiment, along the direction from the distal end of the inner tube 310 to the proximal end of the inner tube 310, the inner tube 310 comprises a first extension section 311, a second extension section 312 and a third extension section 313, the first extension section 311 and the third extension section 313 have the same extension direction, the extension direction of the second extension section 312 is different from the extension direction of the first extension section 311 and the second extension section 312, the first extension section 311 is a loading section of the inner tube 310 and is used for loading the implant 10. The axis of the first extension section 311 is offset to one side of the axis of the container 100; the implant 10 is arranged on the first extension section 311 and the stent 16 is sleeved on the first extension section 311.

[0116] Specifically, the first extension section 311 can be arranged in parallel to the axis of the container 100 and offset to one side of the axis of the container 100, and the third extension section 313 can be arranged in parallel to the axis of the container 100 or the third extension section 313 can be arranged in parallel to the axis of the outer tube 200, so that the first extension section 311 and the third extension section 313 are arranged in a staggered manner in the axial direction of the container 100.

[0117] By arranging the first extension section 311 and the third extension section 313 in a staggered manner in the axial direction of the container 100, the first extension section 311 is offset to one side of the axis of the container 100, so that a larger cavity can be formed between the first extension section 311 and the container 100 to place the implant 10, the loading performance of the container 100 is improved, so that different types of implants 10 can be better loaded without increasing the volume of the cavity, and the applicability of the delivery device is significantly improved.

[0118] In the embodiment of the utility model, along the direction from the distal end of the inner tube 310 to the proximal end of the inner tube 310, the two ends of the end structure 600 form a first port portion 613 and a second port portion 614.

[0119] Specifically, the first port portion 613 is substantially columnar, and a channel is formed in the first port portion 613 to be sleeved on the inner tube 310. Moreover, the second port portion 614 is substantially columnar, and a channel is also formed in the second port portion 614 to be sleeved on the inner tube 310.

[0120] Through the first port portion 613 and the second port portion 614, the connection length between the end structure 600 and the inner tube 310 in the axial direction is increased, so that the mounting stability of the end structure 600 on the inner tube 310 is improved. The specific structure of the end structure 600 can be adjusted according to the use requirement, which is not specifically limited here.

[0121] In a feasible embodiment, as Figure 9In the illustrated embodiment, the first port portion 613 and the second port portion 614 are coaxially arranged with the axis of the container 100. By arranging the first port portion 613 and the second port portion 614 coaxially with the axis of the container 100, the end structure 600 is arranged approximately symmetrically, reducing the processing and manufacturing difficulty of the end structure 600.

[0122] In another feasible embodiment, such as Figure 10 In the embodiment shown, the first port portion 613 is coaxially arranged with the axis of the container 100, and the second port portion 614 is coaxially arranged with the axis of the first extension 311.

[0123] Since the first port portion 613 is coaxial with the axis of the container 100, and the second port portion 614 is coaxial with the axis of the first extension 311, the first port portion 613 and the second port portion 614 are misaligned. Therefore, when the inner tube 310 passes through the end structure 600, the portion of the inner tube 310 connecting the first port portion 613 and the second port portion 614 is inclined relative to the container 100.

[0124] By coaxially arranging the second port portion 614 with the axis of the first extension 311, the first extension 311 can smoothly connect with the end structure 600, reducing or eliminating the radial misalignment between the first extension 311 and the end structure 600, so that the guide wire 500 can pass through the first extension 311 and the end structure 600 more smoothly.

[0125] In another feasible embodiment, such as Figure 11 In the embodiment shown, the first port portion 613, the second port portion 614 and the first extension 311 are coaxially arranged.

[0126] By coaxially arranging the first port portion 613, the second port portion 614, and the first extension 311, a straight channel connecting the first port portion 613 and the second port portion 614 can be provided inside the end structure 600, resulting in better passability.

[0127] In another feasible embodiment, such as Figure 12 In the embodiment shown, the first port portion 613 is coaxially arranged with the axis of the first extension 311, and the second port portion 614 is coaxially arranged with the axis of the container 100.

[0128] As can be seen from the above, in order to increase the loading performance of the container 100, the axis of the first extension section 311 is offset and arranged on one side of the axis of the container 100, so that the first extension section 311 is misaligned with the axis of the container 100, which on the one hand affects the passability of the guide wire 500 between the first extension section 311 and the third extension section 313; on the other hand, since the guide wire 500 needs to pass through the inner tube 310 and the end structure 600, when the first extension section 311 is offset and arranged, it is also easy to affect the passability of the guide wire 500 between the first extension section 311 and the end structure 600.

[0129] Therefore, in order to improve the passability between the first extension section 311 and the end structure 600, preferably, the second port portion 614 is coaxially arranged with the axis of the first extension section 311.

[0130] By offsetting and arranging the second port portion 614 on one side of the container 100, the second port portion 614 can reserve more installation space for the implant 10 in the container 100, and at the same time, will not affect the functions of the balloon 610.

[0131] In the embodiments of the present application, as shown in the embodiments shown in Figure 3 and Figure 4 The end structure 600 includes the balloon 610, the first port portion 613 and the second port portion 614 of the balloon 610 are respectively sleeved on the inner tube 310; the length of the balloon 610 is greater than or equal to the length of the stent 16; and / or, the nominal width dimension of the balloon 610 after expansion is greater than or equal to the set width of the stent 16, so that when the implant 10 is separated from the inner tube 310, the balloon 610 can directly expand the stent 16 on the withdrawal path. No matter which one of the Figure 9 to Figure 12 The main body of the balloon 610 (i.e. the part between the first port portion 613 and the second port portion 614) is always coaxially arranged with the cavity of the container 100, so that the balloon 610 can effectively block the outlet 110 of the container 100.

[0132] Specifically, by arranging the first port portion 613 and the second port portion 614 at both ends of the balloon 610, the balloon 610 can have more connection modes with the inner tube 310, unlike the existing balloon structure on the catheter, the balloon 610 can be a special-shaped balloon 610 (i.e. at least one port portion of the balloon 610 is differentially coaxial with the main body structure), so as to realize selective blocking and exposure of the outlet 110 of the container 100, and at the same time, by controlling the specific arrangement position of the first port portion 613 and the second port portion 614, the first extension section 311 and the balloon 610 can have better passability, so as to facilitate the guide wire 500 to pass through.

[0133] Among them, as shown in Figure 17 to Figure 20In the embodiment shown, the balloon 610 is arranged at the distal end of the inner tube 310 and enters the human body earlier than the implant 10. When the balloon 610 reaches the target tissue 20, the tissue of the target tissue 20 can be pre-expanded, for example, a puncture hole on the atrial septum is pre-expanded, and by controlling the container 100 to retreat proximally relative to the inner tube 310, the implant 10 can be released so that the implant 10 can be placed on the atrial septum.

[0134] When the implant 10 is completely released, the inner tube 310 can also be retreated to retreat the balloon 610 to the position of the stent 16 of the implant 10. When it is determined according to the imaging mark that the implant 10 reaches the position of the stent 16, the balloon 610 is further inflated to post-expand the stent 16 by the balloon 610, so that the stent 16 is more closely attached to the target tissue 20. It can be understood that in other embodiments, the end structure 600 can also be a common polymer plug.

[0135] In the embodiment of the present application, Figure 5 , Figure 6 , Figure 14 , Figure 16 and Figure 21 The delivery device further comprises a first connecting structure 740 arranged on the inner tube 310, and the implant 10 comprises an implant body and a second connecting structure 17 (see Figure 21 , for the purpose of indirectness, not shown in Figure 5 , Figure 6 , Figure 14 , Figure 16 and the like); when the implant 10 is in the container 100, the implant 10 is connected to the first connecting structure 740 through the second connecting structure 17 to maintain the axial relative position of the implant 10 and the inner tube 310; when the implant 10 is separated from the container 100, the second connecting structure 17 and the first connecting structure 740 can be automatically separated to release the implant 10.

[0136] Specifically, the implant 10 comprises a stent 16 made of a shape memory material, and the stent 16 is provided with a second connecting structure 17, and the inner tube 310 is provided with a first connecting structure 740.

[0137] In an embodiment, the second connecting structure 17 comprises a clamping arm arranged on the stent 16, and the first connecting structure 740 comprises a protruding connecting block. Further, a plurality of clamping arms can be arranged, and the connecting block is arranged correspondingly to the clamping arm, so that the connection stability between the implant 10 and the inner tube 310 is improved by the plurality of clamping arms and connecting blocks. Since the clamping arm of the stent 16 is used to clamp the atrial septum, the clamping arm is used as the second connecting structure 17, and the first connecting structure 740 is connected, so that the connection mode of the implant 10 and the inner tube 310 can be effectively simplified, and the internal space of the container 100 is saved.

[0138] In the embodiment, the preset value corresponding to the distance between the container 100 and the end structure 600 is equal to the distance between the end structure 600 and the proximal end surface of the first connecting structure 740 and the width of the clamping arm. After the container 100 moves to the proximal end surface of the first connecting structure 740, the container 100 and the end of the clamping arm abut, and after the container 100 continues to move towards the proximal end and leaves the clamping arm, the stent 16 is completely released.

[0139] Of course, in other embodiments, the designer can adjust the specific structure of the first connecting structure 740 and the second connecting structure 17 according to the use requirement, which is not limited specifically herein.

[0140] When the stent 16 is in the container 100, the container 100 can limit the state of the stent 16, the stent 16 cannot be expanded, and the stent 16 is connected to the first connecting structure 740 through the second connecting structure 17 to maintain the axial relative position of the stent 16 and the inner tube 310.

[0141] Generally, when the stent 16 is expanded, the clamping arm and the main part of the stent 16 present a substantially perpendicular shape; therefore, when the stent 16 is separated from the container 100, the stent 16 can be automatically expanded, and the clamping arm is restored to the predetermined position, so that the second connecting structure 17 and the first connecting structure 740 are separated, thereby releasing the axial relative position of the stent 16 and the inner tube 310. Moreover, the stent 16 can be self-expanded to a set width after being separated from the inner tube 310, so that the stent 16 can be placed in the perforation of the target tissue 20.

[0142] The utility model discloses by setting first connecting structure 740 and second connecting structure 17, the structural stability between implant 10 and inner tube 310 is improved significantly, makes implant 10 can be released accurately and quickly in target tissue 20, improves the implant precision and portability of implant 10, effectively simplifies the connection mode of implant 10 and inner tube 310, saves the internal space of container 100.

[0143] Embodiment four

[0144] The present embodiment is similar to Embodiment Three, and the same parts will not be described again. The differences will be described in detail below.

[0145] For Embodiment Three, when the second extension section 312 is short, the first extension section 311 and the third extension section 313 can have a sudden change in the radial direction of the container 100, which can easily affect the passability of the guide wire 500 channel of the inner tube 310, so that the guide wire 500 cannot smoothly pass through the inner tube 310, and the subsequent surgical positioning is affected.

[0146] In the present embodiment, as shown in Figure 14 to Figure 16 , a connecting piece is arranged on the inner tube 310, the connecting piece can be accommodated in the container 100, the connecting piece includes a connecting seat 700, the connecting seat 700 is provided with a first connecting structure 740; the connecting seat 700 is formed with an eccentric channel 730 for the inner tube 310 to pass through; the connecting seat 700 is arranged in extension along a first preset direction F, a first included angle β is formed between the first preset direction F and the axis of the eccentric channel 730, the range of the first included angle β is 0° to 60°, preferably 15° to 30°. The first preset direction F can be the same as the axis direction of the container 100.

[0147] Specifically, the connecting seat 700 can be accommodated in the container 100 and placed between the first extension section 311 and the third extension section 313. Moreover, since the first extension section 311 and the third extension section 313 are arranged in a staggered manner, in order to avoid the connecting seat 700 affecting the passability of the inner tube 310, and further make the transition between the first extension section 311 and the third extension section 313 smoother, the eccentric channel 730 is formed on the connecting seat 700 for the inner tube 310 to pass through.

[0148] Preferably, as shown in the embodiments of Figure 8 and Figure 13 , the eccentric channel 730 has a tendency to tilt from the third extension section 313 to the first extension section 311. Moreover, the inner wall of the eccentric channel 730 can be provided with a threaded structure for installation. By arranging the eccentric channel 730, the smooth transition length of the inner tube 310 in the eccentric channel 730 is ensured, and the passability of the guide wire 500 is improved.

[0149] The outer contour of the connecting seat 700 can be coaxially fitted with the container 100. The first connecting structure 740 on the connecting seat 700 can be tightly fitted with the inner wall of the container 100, with no gap between them. This prevents the second connecting structure 17 on the bracket 16 from falling off through the gap between the first connecting structure 740 and the container 100, thus improving the installation stability between the bracket 16 and the connecting seat 700. It is understood that the container 100 can be made of polymer material, and the inner wall of the container 100 is smooth. When the first connecting structure 740 and the inner wall of the container 100 are tightly fitted, or even have a certain interference fit, the first connecting structure 740 and the container 100 can still maintain relative movement.

[0150] In other embodiments, the first connecting structure 740 on the connector 700 may also be in clearance fit with the inner wall of the container 100 to improve the passage capability of the connector 700 in the container 100 and avoid interference between the connector 700 and the inner wall of the container 100, which would affect the release of the implant.

[0151] Designers can adjust the size of the first included angle β according to the needs of use, such as 10°, 20°, 30°, etc., without making specific numerical restrictions here.

[0152] By setting a connecting seat 700 on the inner tube 310 and setting the first connecting structure 740 on the connecting seat 700, the structure of the inner tube 310 is not affected, and the processing and installation difficulty of the inner tube 310 is reduced.

[0153] Of course, in other feasible embodiments, designers may adjust the specific structure of the connector according to the needs of use, and no specific restrictions are imposed here.

[0154] Furthermore, such as Figure 16 In the embodiment shown, the first preset direction F is parallel to the axial direction of the container 100 or the first preset direction F has a third included angle γ with the axial direction of the container 100. The range of the third included angle γ is 0° to 60°, preferably 15° to 30°.

[0155] Designers can adjust the specific size of the third included angle γ according to the needs of use. For example, the third included angle γ can be 5°, 10°, 15°, 20° or 25°, etc. There are no specific restrictions here.

[0156] In the embodiments of this utility model, such as Figure 8 In the embodiment shown, the outer tube 200 has a first bend 201 and the inner tube 310 has a second bend 316. When the end structure 600 blocks the outlet 110, the first bend 201 and the second bend 316 are correspondingly arranged.

[0157] Specifically, the first bending part 201 is arranged close to the container 100, and the second bending part 316 is arranged close to the connecting piece. By arranging the first bending part 201 on the outer tube 200 and the second bending part 316 on the inner tube 310, the first bending part 201 and the second bending part 316 cooperate to achieve a predetermined bending angle of the distal end of the delivery device, so that the container 100 is more easily positioned when facing a specific location or structure of the tissue (for example, the atrial septum).

[0158] When the outer tube 200 has the first bending part 201 and the inner tube 310 has the second bending part 316, if the connecting seat 700 is arranged at the bending part, the connecting seat 700 can be structurally interfered with the bent part of the container 100, thereby causing damage to the container 100 and other problems.

[0159] To solve the above problems, in the embodiments of the utility model, as shown in the embodiments of the utility model Figure 13 and Figure 14 , the connecting seat 700 comprises a first seat body 710 and a second seat body 720 connected in sequence along the distal end of the inner tube 310 to the proximal end of the inner tube 310, the first seat body 710 is in a columnar shape, and the first connecting structure 740 is arranged on the first seat body 710; the second seat body 720 is in a frustoconical shape, the second seat body 720 is connected with the first seat body 710, the eccentric channel 730 penetrates through the first seat body 710 and the second seat body 720, and the second seat body 720 has a first end and a second end, and the radial dimension of the first end is greater than that of the second end.

[0160] By forming the eccentric channel 730 on the first seat body 710 and the second seat body 720, compared with a straight channel, the length of the eccentric channel 730 is longer, and the eccentric channel 730 is arranged obliquely, so that the eccentric channel 730 can provide a better smooth transition effect for the inner tube 310, and can prolong and drive the inner tube 310 to realize synchronous one-way deviation with the implant 10 in advance, which is beneficial to reduce the mutation of the extension direction of the inner tube 310 at the connecting seat 700, prevent the loss of the guide wire 500 channel in the inner tube 310, and ensure the passability of the guide wire 500 in the inner tube 310.

[0161] As shown in Figure 15In the embodiment shown, the second end of the second seat 720 is formed with an orifice end face 750, which is perpendicular to the axis of the eccentric channel 730 and passes through the orifice end face 750. The second seat 720 is also provided with a clearance end face 760, at least a portion of which is in contact with the orifice end face 750, and the remaining portion of which is disposed away from the proximal end of the inner tube 310. A second included angle α is formed between the clearance end face 760 and the vertical direction, and the range of the second included angle α is 0° to 60°, preferably 15° to 30°. That is, the clearance end face 760 is inclined from the second seat body 720 toward the first seat body 710. The connecting seat 700 can reserve more space in the container 100 through the clearance end face 760 to play a clearance role, thereby improving the compatibility between the connecting seat 700 and the container 100, reducing or eliminating the interference problem between the two, and preventing the connecting seat 700 from damaging the container 100.

[0162] Designers can adjust the size of the second included angle α according to the needs of use. For example, the second included angle α can be 10°, 20°, 30°, 40° or 50°, etc. There are no specific restrictions here.

[0163] Furthermore, such as Figure 7 In the embodiment shown, the inner tube 310 further includes a fourth extension 314 located between the second extension 312 and the third extension 313. The fourth extension 314 is used to pass through the eccentric channel 730. The angle between the fourth extension 314 and the axis of the container 100 is smaller than the angle between the second extension 312 and the axis of the container 100.

[0164] By controlling the angle between the fourth extension section 314 and the axis of the container 100, the inclination between the fourth extension section 314 and the second extension section 312 gradually increases, which helps to improve the smoothness of the transition between the fourth extension section 314 and the second extension section 312, thereby improving the passability of the inner tube 310.

[0165] Designers can adjust the angle between the fourth extension 314 and the axis of the container 100, as well as the angle between the second extension 312 and the axis of the container 100, according to the needs of use, without making specific numerical restrictions here.

[0166] Furthermore, an end channel is formed on the end structure 600, such as... Figure 7 In the embodiment shown, the inner tube 310 further includes a fifth extension 315, which is disposed on the other side of the first extension 311 relative to the second extension 312, and the fifth extension 315 extends through the end channel; the inner tube 310 has an inner cavity that can be used to install the guide wire 500.

[0167] Specifically, the end channel penetrates the first port portion 613, the body of the end structure 600, and the second port portion 614, and the fifth extension section 315 penetrates the end channel.

[0168] Since the connecting seat 700 is arranged in the container 100, when the inner tube 310 moves relative to the container 100 in the axial direction, the liquid and / or gas in the container 100 needs to pass through the gap between the connecting seat 700 and the inner wall of the container 100, but the liquid and / or gas is difficult to pass through the connecting seat 700 efficiently due to the size of the gap, thereby generating a damping effect and reducing the movement efficiency between the inner tube 310 and the container 100.

[0169] To solve the above problems, in the embodiment of the utility model, as shown in the example, Figure 14 The connecting piece is provided with a flow guide structure 770, and the flow guide structure 770 communicates the accommodation cavities of the containers 100 on both sides of the connecting piece.

[0170] Specifically, the connecting piece includes a connecting seat 700, and the flow guide structure 770 includes a flow guide groove arranged on the connecting seat 700, and the flow guide groove communicates the inner cavities of the containers 100 on both sides of the connecting seat 700. The flow guide groove can improve the flow capacity of the liquid and / or gas, thereby reducing or eliminating the damping when the connecting seat 700 moves relative to the container 100, and improving the movement efficiency. More preferably, the flow guide groove is arranged on the second seat body 720.

[0171] In the embodiment of the utility model, the end structure 600 includes a balloon 610, and the inner tube 310 is further provided with a flow structure, and the flow structure has an injection channel, and the injection channel communicates the inner cavity of the balloon 610.

[0172] Specifically, the flow structure includes at least one flow port arranged on the inner tube 310, and the flow port communicates the injection channel and the inner cavity of the balloon 610, so that the filling liquid can be injected into the balloon 610 or discharged from the balloon 610 through the injection channel, thereby facilitating the control of the expansion and contraction state of the balloon 610.

[0173] Further, the inner tube 310 includes a first tube body and a second tube body inserted into the first tube body, the inner cavity of the second tube body forms a guide wire 500 channel, and the gap between the first tube body and the second tube body forms an injection channel.

[0174] Of course, in other feasible embodiments, the designer can adjust the forming mode of the injection channel according to the use needs, which is not specifically limited here.

[0175] In the embodiment of the utility model, as shown in the example, Figure 1In the illustrated embodiment, the delivery device further comprises a release mechanism 300, which includes an inner tube 310 and a control mechanism 400 for adjusting the axial relative position between the inner tube 310 and the container 100. The control mechanism 400 is configured such that the container 100 is movable relative to the inner tube 310 between a first position and a second position, the container 100 holding the implant 10 in the first position, and the implant 10 being caused to exit the outlet 110 of the container 100 in an axial direction during movement of the container 100 from the first position to the second position.

[0176] In particular, the control mechanism 400 can be a handle. In the present embodiment, the control mechanism 400 includes an actuating member 410 and an auxiliary member 420. The axial position of the auxiliary member 420 is fixed, and the actuating member 410 is axially movable on the auxiliary member 420. The actuating member 410 is further connected to the outer tube 200, such that axial movement of the actuating member 410 causes axial movement of the outer tube 200. The proximal end of the inner tube 310 is fixed in the auxiliary member 420 of the control mechanism 400, and the axial relative position between the inner tube 310 and the auxiliary member 420 is fixed. Thus, axial movement of the outer tube 200 in a forward or backward direction causes axial relative movement between the inner tube 310 and the outer tube 200. In the present embodiment, the control mechanism 400 controls the movement of the outer tube 200 to cause relative position change (relative movement) between the inner tube 310 and the outer tube 200, and in other embodiments, the control mechanism 400 can control the movement of the inner tube 310 to cause relative position change (relative movement) between the inner tube 310 and the outer tube 200.

[0177] In the embodiments of the present application, please refer to Figure 17 to Figure 20 In the illustrated embodiment, the delivery device further comprises a release mechanism 300, which includes an inner tube 310 and a control mechanism 400 for adjusting the axial relative position between the inner tube 310 and the container 100. The control mechanism 400 is configured such that the container 100 is movable relative to the inner tube 310 between a first position and a second position, the container 100 holding the implant 10 in the first position, and the implant 10 being caused to exit the outlet 110 of the container 100 in an axial direction during movement of the container 100 from the first position to the second position.

[0178] The releasing mechanism 300 is operated to expose the first extension section 311 at the distal end of the inner tube 310, so that the balloon 610 is in a contracted state; the implant 10 is loaded and fixed on the first extension section 311, and the first connecting structure 740 is connected with the second connecting structure 17, and then the releasing mechanism 300 is operated until the implant 10 is completely recovered into the container 100; the handle, the implant 10 and the inner tube 310 are exhausted through the standard luer seat of the handle of the pressure filling device; the balloon 610 is filled with a 1:1 developer and normal saline solution to a nominal pressure through the pressure filling device with a readable pressure value; under the image guiding device, the delivery system is sent to the implant 10 releasing position along the guide wire 500 through the prepared vascular access guide wire 500; according to the operator and the lesion position condition evaluation, if the lesion access or perforation needs to be expanded, the balloon 610 can be directly used for pre-expansion until the ideal implant 10 implanting requirement is achieved; after the implant 10 position and the container 100 position are confirmed by the image guiding device and the operator, the balloon 610 is quickly depressurized through the pressure filling device, the pressure is detected in real time, the pressure value is read, and then the implant 10 is gradually released until the safe recoverable point, and the accuracy of the implant position is confirmed again; if the releasing position does not meet the ideal requirement, the implant 10 is quickly recovered in the original position, and then is withdrawn to a safe position; then the balloon 610 is filled to the nominal pressure through the pressure filling device, and the above steps are repeated to perform the implant releasing work again; after the releasing position is confirmed to be accurate, the implant 10 is completely released; after the implant 10 releasing position is confirmed to be accurate by the image guiding device, the balloon 610 is first withdrawn to the position corresponding to the implant 10 under the image guiding device, and then the balloon 610 is inflated and expanded through the balloon 610 pressure filling device, so that the post-expansion treatment of the implant 10 and the lesion position is realized; after the post-expansion treatment is completed, the balloon 610 pressure is completely unloaded, and then the inner tube 310 is withdrawn out of the body along the guide wire 500.

[0179] Embodiment five

[0180] The utility model further provides a medical system, the medical system includes implant 10, and the delivery device as any one of the preceding embodiments, the delivery device is used to contain and deliver implant 10.

[0181] The specific structure, working principle and beneficial effects of the delivery device are the same as any one of the preceding embodiments, and will not be repeated here. The medical system can perform pre-expansion treatment on the target tissue 20 by using the delivery device in embodiment one, and can also perform post-expansion treatment on the implant 10 in the withdrawal path, so that the implant 10 can be better installed in place.

[0182] In the embodiment of the utility model, implant 10 includes support 16 and wireless sensor which is arranged in parallel with support 16. Further, support 16 includes support main body and film, and support main body has second connecting structure 17. In a feasible embodiment, second connecting structure 17 includes clamping arm arranged on support main body, and clamping arm can be sleeved with first connecting structure 740 on connecting seat 700 to realize that implant 10 is fixed to inner tube 310 and can be released from inner tube 310.

[0183] In the embodiment of the utility model, the medical system further includes guide wire 500 arranged in inner tube 310. Specifically, the diameter of guide wire 500 is smaller than that of inner tube 310. The designer can adjust the specific structure of guide wire 500 according to the use requirement, for example, guide wire 500 is an elongated metal wire, which is not limited specifically herein. Moreover, guide wire 500 has relatively large supporting strength and relatively small diameter, so that guide wire 500 is more easily bent in the human body pipeline. Guide wire 500 can play a guiding role, so that when inner tube 310 is sleeved on guide wire 500, inner tube 310 can move to target tissue 20 along guide wire 500.

[0184] Although in the above embodiment, the implant is taken as an atrial septum shunt support and sensor as an example, those skilled in the art can understand that the disclosed delivery device can be applied to various implants, including but not limited to cardiovascular stents.

[0185] All articles and references disclosed, including patent applications and publications, are incorporated herein by reference for all purposes. The term "consisting essentially of to describe combinations shall include the elements, ingredients, components or steps identified, and such other elements, ingredients, components or steps that do not materially affect the basic and novel characteristics of the combinations. The use of the term "comprising" or "including" to describe combinations herein is also taken to mean that embodiments consisting essentially of the recited elements, ingredients, components or steps can also be covered. By use of the term "can" herein, it is intended that any property described can or can not be present. Multiple elements, ingredients, components or steps can be provided by a single integrated element, ingredient, component or step. Alternatively, a single integrated element, ingredient, component or step might be divided into separate multiple elements, ingredients, components or steps. To "comprise" or "include" an element or list of elements means that the element or list of elements can be present, but is not exclusive of other elements that might be present as well.

[0186] The various embodiments in the specification are described in a progressive manner, and each embodiment focuses on the difference from other embodiments, and the same and similar parts between various embodiments can be referred to each other. The above embodiments are only for illustrating the technical concept and characteristics of the utility model, and the purpose is to enable persons skilled in the art to understand the content of the utility model and implement it, and cannot limit the protection scope of the utility model. Any equivalent changes or modifications made according to the spirit and essence of the utility model shall be covered within the protection scope of the utility model.

Claims

1. A medical system comprising a delivery device for delivering an implant through a body lumen or duct to a target tissue, the implant comprising a stent made of a shape memory material, characterized in that, The delivery device comprises: a container comprising a receiving cavity for receiving the implant and an outlet for discharging the implant; an outer tube connected with the container and in communication with the container; an inner tube penetrating through the container and the outer tube and used for detachably connecting with the implant; an end structure comprising a balloon arranged at a distal end of the inner tube, the end structure being used for selectively blocking or exposing the outlet; wherein the stent is adapted to be sleeved on the inner tube, and the stent is capable of self-expanding to a set width after being separated from the inner tube, the nominal width of the balloon after inflation is greater than or equal to the set width of the stent, and the balloon is capable of expanding the stent on a retraction path after the implant is separated from the inner tube.

2. The medical system of claim 1, wherein, The outer tube is coaxially arranged with the container, the container is capable of moving axially relative to the end structure to make the end structure block or expose the outlet; when the distance between the container and the end structure is less than a preset value, the distance between the end structure and the implant remains unchanged, and when the distance between the container and the end structure is greater than or equal to the preset value, the implant is released to the target tissue.

3. The medical system of claim 2, wherein, The balloon has a first working condition in an inflated state and a second working condition in a contracted state, the balloon is capable of moving axially relative to the container to block or expose the outlet when the balloon is in the first working condition; during the process of separating the implant from the inner tube, the balloon is always closer to the distal end of the implant than the proximal end of the implant and keeps the relative axial position unchanged.

4. The medical system of claim 3, wherein, The length of the balloon is greater than or equal to the length of the stent.

5. The medical system of claim 2 or 3, wherein, The delivery device further comprises a developing mark arranged on the end structure; and / or, the end structure is made of a material having developing function.

6. The medical system of claim 2 or 3, wherein, Two ends of the end structure form a front expansion guide part and a rear expansion guide part respectively in a direction from the distal end of the inner tube to the proximal end of the inner tube; the cross section of the front expansion guide part gradually decreases in a direction from the rear expansion guide part to the front expansion guide part; and / or, the cross section of the rear expansion guide part gradually decreases in a direction from the front expansion guide part to the rear expansion guide part.

7. The medical system of claim 2 or 3, wherein, The inner tube comprises a first extension section, a second extension section and a third extension section in a direction from the distal end to the proximal end of the inner tube, the extension direction of the second extension section is different from the extension direction of the first extension section and the second extension section, and the axis of the first extension section is offset on one side of the axis of the container; the main body of the implant is arranged in the first extension section, and the stent is sleeved on the first extension section.

8. The medical system of claim 7, wherein, Two ends of the end structure are formed with a first port portion and a second port portion in a direction from a distal end of the inner tube to a proximal end of the inner tube; the first port portion and the second port portion are coaxially arranged with the axis of the container; or, the first port portion is coaxially arranged with the axis of the container, and the second port portion is coaxially arranged with the axis of the first extension section; or, the first port portion and the second port portion are coaxially arranged with the axis of the first extension section; or, the first port portion is coaxially arranged with the axis of the first extension section, and the second port portion is coaxially arranged with the axis of the container.

9. The medical system of claim 8, wherein, The end structure comprises a balloon, the first port portion and the second port portion of the balloon are sleeved on the inner tube, and a main body of the balloon is coaxially arranged with the container; The length of the balloon is greater than or equal to the length of the stent.

10. The medical system of claim 7, wherein, The delivery device further comprises a first connecting structure arranged on the inner tube, and the implant is provided with a second connecting structure; When the implant is in the container, the implant is connected with the first connecting structure through the second connecting structure to maintain the axial relative position of the implant and the inner tube; When the implant is separated from the container, the second connecting structure and the first connecting structure can be automatically separated to release the implant.

11. The medical system of claim 10, wherein, The inner tube is provided with a connecting piece which can be accommodated in the container, the connecting piece is provided with the first connecting structure; the connecting piece comprises a connecting seat, the connecting seat is formed with an eccentric channel for the inner tube to pass through; the connecting seat is arranged in extension in a first preset direction, a first included angle β is formed between the first preset direction and the axis of the eccentric channel, and the range of the first included angle β is 0° to 60°.

12. The medical system of claim 11, wherein, The outer tube has a first bending portion, and the inner tube has a second bending portion, the first bending portion and the second bending portion are correspondingly arranged when the end structure blocks the outlet; In a direction from a distal end of the inner tube to a proximal end of the inner tube, the connecting seat comprises a first seat body and a second seat body connected with each other, the first seat body is in a columnar shape, and the first connecting structure is arranged on the first seat body; The second seat body is in a frustoconical shape, the eccentric channel penetrates through the first seat body and the second seat body, the second seat body has a first end and a second end, the radial dimension of the first end is greater than that of the second end, and the first end of the second seat body is connected with the first seat body.

13. The medical system of claim 12, wherein, The second end of the second seat body is formed with a hole end face which is perpendicular to the axis of the eccentric channel, and the eccentric channel penetrates through the hole end face; the second seat body is further provided with a relief end face, at least part of the relief end face is connected with the hole end face, the remaining part of the relief end face is arranged away from the proximal end of the inner tube, a second included angle α is formed between the relief end face and the vertical direction, and the range of the second included angle α is 0° to 60°.

14. The medical system of claim 11, wherein, The inner tube further comprises a fourth extending section, which is located between the second extending section and the third extending section, and is used to penetrate the eccentric passage, and the included angle between the fourth extending section and the axis of the container is smaller than the included angle between the second extending section and the axis of the container.

15. The medical system of claim 14, wherein, The end structure is formed with an end passage, the inner tube further comprises a fifth extending section, which is arranged on the other side of the first extending section relative to the second extending section, and penetrates the end passage; the inner tube has an inner cavity for arranging a guide wire.

16. The medical system of claim 11, wherein, The connecting piece is provided with a flow guide structure, which communicates the accommodating cavities of the containers located on both sides of the connecting piece; the first preset direction is parallel to the axial direction of the container or the first preset direction has a third included angle γ with the axial direction of the container, and the third included angle γ ranges from 0° to 60°.

17. The medical system of claim 2, wherein, The end structure comprises a balloon, and the inner tube is further provided with a flow-through structure, which has an injection passage communicating the inner cavity of the balloon.

18. The medical system of claim 1, wherein, The delivery device further comprises a release mechanism, which comprises the inner tube and a control mechanism for adjusting the axial relative position between the inner tube and the container.

19. The medical system of claim 1, wherein, The medical system further comprises a guide wire arranged in the inner tube, and the implant comprises a wireless sensor and a stent, and the wireless sensor and the stent are arranged side by side.

Images