Delivery devices and medical systems

The delivery device addresses the limitations of current sheaths by using a container, outer, and inner tube system with a balloon for controlled implant release and expansion, enhancing surgical efficiency and safety for diverse implants.

JP2026524222APending Publication Date: 2026-07-21UNITED INNOMED (SHANGHAI) LTD
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
UNITED INNOMED (SHANGHAI) LTD
Filing Date
2024-07-19
Publication Date
2026-07-21

AI Technical Summary

Technical Problem

Current delivery sheaths are inadequate for quickly and conveniently delivering implants such as shunt stents and sensors with anchor structures to predetermined positions in the body, often requiring complex operations and increasing surgical risks.

Method used

A delivery device with a container, outer tube, and inner tube system that allows for detachable connection and controlled release of implants, featuring a balloon for pre- and post-expansion treatments, and an eccentric inner tube design to accommodate various implant sizes and structures.

Benefits of technology

Facilitates rapid, secure, and simple implant placement with reduced surgical complexity and risk by enabling controlled delivery and expansion without repeated manipulation, accommodating diverse implant sizes and structures.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides a delivery device and a medical system, relating to the technical field of interventional medical devices, used to deliver an implant (10) to a target tissue (20) via a body cavity or lumen of the human body, the delivery device comprising a container (100) including a lumen for housing the implant (10) and an outlet (110) for discharging the implant, an outer tube (200) connected to and communicating with the container (100), and a release mechanism (300) including an inner tube (310) and a control mechanism (400) for controlling the axial relative position of the inner tube (310) and the container (100). The present invention enables the delivery and control of the implant (10) by adjusting the relative position of the inner tube (310) and the container (100), significantly improving the ease of operation of the delivery device.
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Description

Related Application

[0001] The present invention claims priority from a Chinese invention patent with patent application number 202310898704.4, filing date July 21, 2023, and invention title "Delivery Device and Medical System".

Technical Field

[0002] The present invention relates to the technical field of interventional medical devices, and particularly to a delivery device and a medical system.

Background Art

[0003] In the field of Class III medical devices, a delivery sheath is an important medical device, mainly used to deliver an implant into a human blood vessel, body cavity or other organs. Here, the most common implants include stent products such as vascular stents, shunt stents, occlusive plugs, artificial valve stents, etc., and other types of implants also include various sensors having an anchor structure. As the structure, form and use of implants become more and more diverse, the current delivery sheath and its delivery form can no longer meet the requirements of some implants. For example, in the prior art, in the case of a shunt stent provided in the atrial septum, first, a puncture needle is used to puncture the atrial septum to create a perforation, and then the perforation is expanded with a balloon catheter or a dilator, and then a shunt stent to be subsequently delivered is often placed. The shunt stent is usually self-expanding and can automatically expand when delivered to the perforated location to engage with the perforated wall. Also, for example, in the case of a sensor having an anchor structure, the anchor structure may also have self-expanding characteristics. For such types of implants, a delivery sheath that can deliver it more quickly and conveniently and release it at a predetermined position is required.

Summary of the Invention

Problems to be Solved by the Invention

[0004] To overcome the aforementioned drawbacks of the prior art, the present invention provides a delivery device and a medical system for solving one or more problems in the prior art. [Means for solving the problem]

[0005] To achieve the above objectives, the technical solutions employed in this invention are specifically as follows:

[0006] The present invention discloses a delivery device for delivering an implant to target tissue via a body cavity or lumen of the human body, comprising: a container including a housing cavity for housing the implant and an outlet for discharging the implant; an outer tube connected to and communicating with the container; an inner tube penetrating the container and the outer tube and detachably connected to the implant; and an end structure provided at the distal end of the inner tube for selectively closing or exposing the outlet.

[0007] The present invention further discloses a medical system comprising an implant and the above-described delivery device for housing and delivering the implant.

[0008] The present invention further discloses a delivery device for delivering an implant to a target position via a body cavity or tubular lumen of the human body, comprising: a container for housing the implant, having an outlet at one end for discharging the implant and provided with a signal transmission window; an outer tube having a tubular body, a first end and a second end, connected to the container via the first end and coaxially communicating with it; and a release mechanism penetrating the outer tube and the container, connected to the implant, and for controlling the axial relative positional relationship between the implant and the container, wherein the implant includes a wireless sensor, and the release mechanism is configured to hold the implant in the container and to align the wireless sensor with the signal transmission window.

[0009] The present invention discloses a medical system comprising an implant including a wireless sensor and a delivery device for housing and delivering the implant, wherein the delivery device is the above-described delivery device. [Effects of the Invention]

[0010] Compared to the conventional technology, the beneficial effects of the present invention are as follows:

[0011] In the embodiment of the present invention, the delivery device has a container connected to and communicating with an outer tube during use, and the container has a receiving cavity for housing the implant and an outlet for discharging the implant. The inner tube penetrates the container and the outer tube, and the implant and the inner tube are detachably connected. An end structure is provided at the distal end of the inner tube and is used to selectively close or expose the outlet. In this invention, by simultaneously installing the end structure and the implant in the inner tube, the outlet can be closed or exposed through the cooperation of the inner tube and the end structure. Furthermore, because the implant and the inner tube are detachably connected, when the outlet is exposed, the implant can be separated from the inner tube so that it is released to the target position on the target tissue. In this invention, the delivery and control of the implant can be achieved by the outer tube and the inner tube, the implant can be delivered to the target tissue, the implant can be released without requiring complex operations, and the operability of the delivery device is significantly improved.

[0012] Furthermore, in one specific embodiment, the balloon can be used as an end structure to perform pre-expansion treatment on the target tissue during the implant delivery route, which is advantageous for implanting the implant into the target tissue. At the same time, after the implant has been delivered and placed in the target tissue, the balloon can also perform post-expansion treatment directly on the implant during the retraction route, allowing the implant to bond more tightly to the target tissue and enabling rapid, simple, and secure implant placement. Throughout the entire process, there is no need to repeatedly move the inner tube, effectively avoiding damage to human tissue that may occur during the movement of the inner tube.

[0013] In another specific embodiment, by arranging the corresponding portion of the inner tube and the container with a certain degree of eccentricity rather than a normal coaxial structure, it is possible not only to effectively mount implants of a specific structure (for example, implants combining a stent and a sensor), but also to avoid the container being too large, which would affect the passage performance of the delivery device. [Brief explanation of the drawing]

[0014] The following drawings are intended solely to provide a schematic explanation and interpretation of the present invention and are not intended to limit the scope of the invention. [Figure 1] This is a schematic diagram of the delivery device in one embodiment of the present invention. [Figure 2] This is a schematic cross-sectional view of a part of the structure of the delivery device in the embodiment shown in Figure 1 of the present invention. [Figure 3] This is a schematic cross-sectional view of a balloon in an inflated state according to one embodiment of the present invention. [Figure 4] This is a schematic cross-sectional view of the balloon in a contracted state according to one embodiment of the present invention. [Figure 5] This is a schematic cross-sectional view of an implant in an intermediate release state according to one embodiment of the present invention. [Figure 6] This is a schematic cross-sectional view of an implant in a fully open state according to one embodiment of the present invention. [Figure 7] This is a schematic cross-sectional view of an inner tube eccentrically positioned in a container according to one embodiment of the present invention. [Figure 8] This is a schematic cross-sectional view of the first and second bent portions in one embodiment of the present invention, in which the implant is omitted. [Figure 9] This is a schematic side view of the balloon structure in one embodiment of the present invention. [Figure 10] This is a schematic side view of the balloon structure in one embodiment of the present invention. [Figure 11]It is a schematic structural side view of a balloon in an embodiment of the present invention. [Figure 12] It is a schematic structural side view of the balloon in an embodiment of the present invention. [Figure 13] It is a schematic structural cross-sectional view of a connection base according to an embodiment of the present invention. [Figure 14] It is a schematic structural side view of the connection base according to an embodiment of the present invention. [Figure 15] It is a schematic structural side view showing a second angle α according to an embodiment of the present invention. [Figure 16] It is a schematic structural side view showing a third angle γ according to an embodiment of the present invention. [Figure 17] It is a schematic structural perspective view of a delivery device in an un-released state in an embodiment of the present invention. [Figure 18] It is a schematic structural perspective view of a delivery device in a state of being in the process of release in an embodiment of the present invention. [Figure 19] It is a schematic structural perspective view of a delivery device in a fully released state in an embodiment of the present invention. [Figure 20] It is a schematic structural perspective view of a delivery device in a post-expansion state in an embodiment of the present invention. [Figure 21] It is a schematic structural perspective view of an implant in an embodiment of the present invention. [Figure 22] It is a schematic structural diagram of a delivery device in another embodiment of the present invention. [Figure 23] It is a partially enlarged cross-sectional view of the distal end of the delivery device in FIG. 22. [Figure 24] It is a view showing a further enlarged container of the delivery device in FIG. 23. [Figure 25] It is a schematic structural diagram of a first metal wire mesh on the surface layer of a container in an alternative embodiment. [Figure 26] It is a schematic distribution diagram of a first metal wire mesh on the surface layer of a container according to another embodiment of the present disclosure. <0​​​​This is a schematic diagram of the internal structure of the distal end of a medical system according to one embodiment of the present disclosure. [Figure 29] Figure 28 is a partial cross-sectional view of the distal end of the medical system. [Figure 30] This is a schematic diagram showing an implant in a compressed state within a medical system. [Modes for carrying out the invention]

[0015] To provide a clearer understanding of the technical features, objectives, and effects of the present invention, specific embodiments of the present invention will be described here with reference to the drawings.

[0016] The terms “including” and their variations as used in this disclosure should be understood to have an open meaning, i.e., “including but not limited to.” The term “based on” means “based at least in part.” The terms “first” or “second,” etc., may be used in this disclosure to describe various elements, but these elements should be understood not to be limited by these terms, and these terms are used only to distinguish one element from another. The terms “proximal end” and “distal end” refer to the relative orientation, relative position, or direction of movement of parts relative to each other as seen from the operator, and “proximal end” and “distal end” are not restrictive, however, “proximal end” usually refers to the end closer to the physician in the normal operation of the medical instrument, and “distal end” usually refers to the end that first enters the patient’s body. Embodiment 1

[0017] As shown in Figures 1, 2, and 21, embodiments of the present invention provide a delivery device for delivering an implant 10 to a target location on target tissue 20 via a body cavity or lumen of the human body. As shown in Figures 1 and 2, the delivery device includes a container 100 having a housing cavity for housing the implant 10 and an outlet 110 (see Figure 4) for discharging the implant 10; an outer tube 200 connected to and communicating with the container 100, and preferably integrally molded with the container 100; an inner tube 310 penetrating the container 100 and the outer tube 200 and for being detachably connected to the implant 10; and an end structure 600 provided at the distal end of the inner tube 310 for selectively closing or exposing the outlet 110 of the container 100.

[0018] In this embodiment, after the implant 10 is mounted on the inner tube 310, both the end structure 600 and the implant 10 are installed in the inner tube 310, and the implant 10 is located inside the container 100. By changing the relative position of the end structure 600 and the container 100, the outlet 110 can be selectively closed or exposed. Preferably, the implant 10 includes a wireless pressure sensor. When the outlet 110 is exposed, blood enters the container 100 through the outlet 110 and can come into contact with the wireless pressure sensor, thereby enabling pressure measurement during surgery. Because the implant 10 and the inner tube 310 are detachably connected, as the container 100 and the implant 10 are gradually separated, the implant 10 can also be gradually separated from the inner tube 310 so that it is released to a target position on the target tissue 20. Of course, in other embodiments, the implant 10 may be a standalone stent that does not include a wireless pressure sensor.

[0019] The present invention enables the delivery and control of the implant 10 solely by controlling the outer tube 200 and the inner tube 310, allowing the implant 10 to be released without requiring complex operations, and significantly improving the ease of operation of the delivery device.

[0020] In embodiments of the present invention, as shown in the examples in Figures 1 and 2, the outer tube 200 and the container 100 are provided coaxially, and the outer tube 200 and the container 100 are axially movable relative to the end structure 600 such that the end structure 600 closes or exposes the outlet 110.

[0021] In other embodiments, it can be understood that the end structure 600 may be driven and moved along the axial direction of the container 100 so as to close or expose the outlet 110 by the inner tube 310.

[0022] To accommodate both the implant 10 and the passage of the container 100, the container 100 is larger in size than the outer tube 200, and has a circular tube structure with its walls forming a ring-shaped enclosure to create a receiving cavity. This allows the implant 10 to be placed inside the container 100.

[0023] Furthermore, as shown in Figure 21, the implant 10 includes a stent 16 made of shape memory material, which is sleeve-mounted to the inner tube 310 and is suitable for being pressed against the inner tube 310 under the constraint of the container 100. When the container 100 no longer restrains the stent 16, the stent 16 can self-expand to a set width and separate from the inner tube 310.

[0024] By utilizing a stent 16 made of shape memory material, when the stent 16 detaches from the housing cavity of the container 100, the stent 16 can separate from the inner tube 310 and self-expand to a set width, at which point the stent 16 can be fixed or temporarily fixed to the target tissue 20. In this embodiment, the target tissue 20 is the atrial septum in the heart, and the stent 16 is a shunt positioned in the atrial septum to direct blood flow from the left atrium to the right atrium. In other embodiments, the stent 16 may serve as an anchor structure for other devices (e.g., sensors) to anchor to the target tissue 20.

[0025] It can be understood that if the distance between the container 100 and the end structure 600 is smaller than a predetermined value, the distance between the end structure 600 and the implant 10 will not change. The predetermined value is determined by the connection configuration between the implant 10 and the inner tube 310. Specifically, the predetermined value may be greater than or equal to the distance H1 between the end structure 600 and the member connected to the implant 10 in the inner tube 310, or it may be equal to the distance H2 between the end structure 600 and the proximal end face of the implant 10. If H1 is greater than H2, the predetermined value is greater than or equal to H1, and if H1 is less than or equal to H2, the predetermined value is equal to H2. It can be understood that the implant 10 is completely free to the target tissue 20 only when the container 100 no longer restrains the implant 10 and the implant 10 is separated from the connecting member in the inner tube 310. The designer may adjust the specific numerical value of the predetermined value according to the requirements for use (e.g., the length of the implant 10), and therefore, it is not specifically limited. Preferably, the predetermined value is less than or equal to the length of the container 100.

[0026] More preferably, when at least a portion of the implant 10 is inside the container 100, the distance between the container 100 and the end structure 600 is considered to be smaller than a predetermined value. That is, when at least a portion of the implant 10 is inside the container 100 and the implant 10 is connected to the inner tube 310, the end structure 600 and the implant 10 move synchronously with respect to the container 100 and the outer tube 200, and the distance between the end structure 600 and the implant 10 does not change.

[0027] If the distance between the container 100 and the end structure 600 exceeds a predetermined value, the implant 10 separates from the inner tube 310 and self-expands to the set width. As can be seen from the above, if the distance exceeds a predetermined value, the implant 10 is removed from the container 100, and at this time, the implant 10 can be placed on the target tissue 20 to support the target tissue 20.

[0028] In an embodiment of the present invention, the end structure 600 is a plug made of a polymer material. After the implant 10 is released into the target tissue 20, the end structure 600 is removed from inside the implant 10 and the outlet 110 of the container 100 is closed again by moving the outer tube 200 and the inner tube 310 in synchronous motion. Subsequently, the delivery device can be completely removed from the human body by moving the outer tube 200 and the inner tube 310. Embodiment 2

[0029] In Embodiment 1, since the end structure 600 is non-adjustable, if the inner diameter of the stent 16 is less than or equal to the outer diameter of the end structure 600 after the stent 16 has self-expanded, the end structure 600 cannot retract through the inside of the stent 16, and a delivery device of this structure can only be applied to stents 16 of a specific size. The size of the stent 16 is designed to meet the needs of holes in the atrial septum, and the stent 16 will inevitably have different sizes for different people; for example, the size of the stent 16 will be relatively smaller for younger children or adults with smaller physiques. On the other hand, in the prior art, in order to create an opening for implant 10 in the atrial septum, a balloon catheter is used to expand the small hole after puncture, the balloon catheter is removed, and then a delivery device is used to release the implant 10 to the opening. The puncture needle, balloon catheter, and shunt stent 16 all need to be delivered into the human body and manipulated. This not only prolongs the surgical time and increases the difficulty of the procedure, but also introduces more surgical risks to the surgery itself.

[0030] To overcome the above problems, the delivery device according to Embodiment 1 was improved in an embodiment of the present invention. However, the same parts will not be described again here, and the differences will be described in detail below.

[0031] As shown in the embodiments in Figures 3 and 4, the end structure 600 includes a balloon 610 having a first operating mode in an inflated state and a second operating mode in a deflated state. When the balloon 610 is in the first operating mode, it can be used to move relative to the container 100 along the axial direction of the container 100 to occlude or expose the outlet 110. As 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. After the perforation is formed, there is no need to remove the balloon 610, and by continuing to push the delivery device in, the position of the implant 10 can be associated with the perforation, after which the implant 10 can be directly released. In this embodiment, the location of the perforation is a target location on the target tissue (atrial septum).

[0032] Specifically, as shown in the embodiments in Figures 5 and 6, the implant 10 can be released from the constraint of the container 100 by moving the outer tube 200 and the container 100 toward 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. During the process of the implant 10 separating from the inner tube 310, the balloon 610 remains stationary, always closer to the distal end of the implant 10 than to the proximal end, maintaining its relative axial position to the implant 10.

[0033] After the implant 10 has completely separated from the inner canal 310, regardless of whether the expanded size of the implant 10 is larger than the size of the balloon 610 in its inflated state, the balloon 610 can be converted to a deflated state. This allows the balloon 610 to not only retract through the implant 10 (specifically, the stent 16), but also to directly retro-expand the stent 16 in its retraction path so that it can be brought into close contact with the side wall of the perforation on the target tissue 20.

[0034] In other viable embodiments, if the balloon 610 deflates during retraction, the balloon 610 does not need to post-expand the stent 16. It can be understood that the physician can choose whether or not to use the balloon 610 to expand the stent 16, depending on the needs of the procedure.

[0035] In this invention, the balloon 610 and implant 10 are placed together in an inner tube 310, and the state of the balloon 610 is controlled by the inner tube 310. This allows for not only pre-expansion of the target tissue 20 but also post-expansion of the stent 16, and since the balloon 610 can freely form an inflated or deflated state, there is no need to repeatedly deliver or remove the balloon catheter. This makes it possible to apply the delivery device to stents 16 of various sizes, significantly simplifying the surgical steps, reducing patient discomfort, and lowering the physician's learning curve.

[0036] In this embodiment, in order to better exhibit the post-expansion function of the balloon 610 relative to the stent 16, the length of the balloon 610 is made to be greater than or equal to the length of the stent 16. As a result, when the balloon 610 retracts, the balloon 610 enters the interior of the stent 16 and can sufficiently perform an expansion function relative to the stent 16 in the axial direction.

[0037] Furthermore, the nominal width of the balloon 610 after inflation is greater than or equal to the set width of the stent 16. This allows the balloon 610 to adequately expand radially around the stent 16 after it has entered the stent 16, which is advantageous for the stent 16 to be positioned in the target tissue 20. Specifically, because the stent 16 is compressed in the inner tube 310 during delivery, its self-expanded width (i.e., radial size) after being released from the inner tube 310 may be smaller than the set width, or the perforation size may not reach the set width, resulting in the stent 16 being smaller than the set width after release. Post-expanding the stent 16 with the balloon 610 allows the stent 16 to be further expanded to the set width, thereby improving the adhesion and connection strength between the stent 16 and the target tissue 20.

[0038] In this embodiment, the delivery device further includes a radiopaque marker provided on the end structure 600. By providing a radiopaque marker on the end structure 600, the radiopaque marker can be visualized by X-ray when the end structure 600 enters the human body. This allows the physician to quickly and accurately obtain the real-time position of the end structure 600.

[0039] Specifically, the end structure 600 includes a balloon 610 on which the radiopaque marker is provided. As the balloon 610 passes through the vascular passage, the physician can track the relative position of the balloon 610 in real time via the radiopaque marker.

[0040] Once the balloon 610 is retracted into the stent 16, the physician can determine whether the balloon 610 is aligned with the stent 16 based on the radiopaque marker. If the balloon 610 is inside the stent 16, the balloon 610 is further inflated and the stent 16 is retro-expanded with the balloon 610 to bring the stent 16 more tightly into contact with the target tissue 20.

[0041] Of course, the designer can adjust the specific structure of the opaque marker according to the requirements for use, for example, the opaque marker may be at least one opaque ring or at least one opaque section provided on the end structure 600, and is not specifically limited thereto. Preferably, one opaque ring is provided on each end of the balloon 610.

[0042] If the radiopaque marker is an radiopaque ring, the overall contour state of the balloon 610 cannot be indicated by the radiopaque ring, i.e., the inflated and deflated states of the balloon 610 cannot be determined by the radiopaque ring. Therefore, in another viable embodiment of the present invention, the balloon 610 is manufactured from a radiopaque material. By manufacturing the balloon 610 from a radiopaque material, the inflated or deflated state of the balloon 610 can be indicated. The designer may adjust the specific composition of the radiopaque material according to the requirements of use, and is not specifically limited herein.

[0043] In another feasible embodiment of the present invention, the balloon 610 does not need to be provided with a radiopaque marker, and the balloon 610 is visualized by X-rays by injecting a contrast agent into the balloon 610 to indicate its inflated or deflated state. Here, the designer may adjust the specific components of the contrast agent according to the requirements of use, and is not specifically limited herein.

[0044] Of course, in other viable embodiments, the designer may adjust the specific installation configuration of the opaque markers in the end structure 600 according to the requirements of use, and is not specifically limited herein.

[0045] When using only a contrast agent, the radiopaqueness is lost when the balloon 610 deflates and is removed, making it impossible to determine the effective position of the balloon 610. However, the radiopaque ring can still function at this time. For this reason, it is preferable to use the radiopaque ring and a contrast agent together.

[0046] In embodiments of the present invention, as shown in the examples in Figures 9, 10, 11, and 12, a pre-expansion guide portion 611 and a post-expansion guide portion 612 are formed at both ends of the end structure 600 along the direction from the distal end of the inner tube 310 to the proximal end of the inner tube 310, and the cross-section of the pre-expansion guide portion 611 gradually decreases along the direction from the post-expansion guide portion 612 to the pre-expansion guide portion 611, and / or the cross-section of the post-expansion guide portion 612 gradually decreases along the direction from the pre-expansion guide portion 611 to the post-expansion guide portion 612.

[0047] By providing a front expansion guide portion 611 and a rear expansion guide portion 612 at both ends of the end structure 600, and by providing both the front expansion guide portion 611 and the rear expansion guide portion 612 in a tapered shape, it is advantageous to improve the smooth transition at both ends of the end structure 600. As a result, the end structure 600 can perform front and rear expansion operations more effectively while simultaneously closing the outlet 110 of the container 100.

[0048] Of course, in other viable embodiments, the designer may adjust the specific shape and structure of the front extension guide portion 611 and the rear extension guide portion 612 according to the requirements of use, and is not specifically limited herein. Embodiment 3

[0049] With advancements in various sensing technologies and processing processes, implants 10 also exhibit more structural features, as shown in the embodiment in Figure 21. For example, if implant 10 is a combination of two or more implant components arranged in parallel, its overall radial size will inevitably be larger than that of a single implant component. Consequently, the portion of the delivery sheath that accommodates implant 10 must also be correspondingly larger. This not only reduces the delivery performance of the delivery sheath but also increases the risk of injury to the human body.

[0050] This embodiment is similar to embodiments 1 and 2, and the same parts will not be repeated; the differences will be described in detail below. The implant 10 includes a sensor and a stent 16, and after the sensor and stent 16 are coupled, the overall volume of the implant 10 is significantly larger than that of a single stent 16, and since the sensor itself is an incompressible rigid member, the size of the delivery sheath container 100 needs to be enlarged to provide sufficient housing space for the sensor. To avoid enlarging the container 100 as much as possible, the size of the sensor may be reduced as much as possible by a machining process, but this imposes very high demands on the technical achievement and machining process.

[0051] As shown in Figure 7, the inventor proposes a new inner tube structure in which the inner tube 310 is eccentrically positioned within the container 100, and at least the main body portion of the implant 10 is also eccentrically positioned within the container 100. Specifically, in a typical delivery device, the inner tube 310 and the container 100 are coaxial, and the container 100 is attached to the outside of the inner tube 310 in a sleeve-like manner 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 inside the container 100 (which may also be called the mounting section) is not coaxial with the container 100, but is eccentrically positioned on one side of the housing cavity of the container 100. As a result, the mounting section of the inner tube 310 is closer to one side wall of the container 100, and a relatively large housing space for housing a rigidity sensor is formed between the inner tube 310 and the other side wall of the container 100. The stent 16 is attached to the mounting section in a sleeve-like manner, and since the stent 16 is compressible, it can still be mounted inside the container 100 even if the housing space on one side of the inner tube 310 and the container 100 becomes smaller.

[0052] By positioning the mounting section of the inner tube 310 eccentrically within the housing cavity of the container 100, the existing space of the container 100 can be fully utilized, unnecessary enlargement of the overall size of the container 100 can be avoided, and the requirements for sensor size are also reduced.

[0053] Furthermore, as shown in the embodiment in Figure 7, along the direction from the distal end to the proximal end of the inner tube 310, the inner tube 310 includes a first extended section 311, a second extended section 312, and a third extended section 313, the direction of extension of the first extended section 311 and the third extended section 313 is the same, the direction of extension of the second extended section 312 is different from the direction of extension of the first extended section 311 and the second extended section 312, the first extended section 311 is the mounting section of the inner tube 310 and is used to mount the implant 10. The axis of the first extended section 311 is eccentrically positioned on one side of the axis of the container 100, the implant 10 is provided in the first extended section 311, and the stent 16 is attached to the first extended section 311 in a sleeve-like manner.

[0054] Specifically, the first extended section 311 is provided extending substantially parallel to the axis of the container 100 and may be eccentrically positioned on one side of the axis of the container 100, the third extended section 313 may be provided extending substantially along the axial direction of the container 100, or the third extended section 313 may be provided extending substantially along the axial direction of the outer tube 200, thereby offsetting the first extended section 311 and the third extended section 313 in the axial direction of the container 100.

[0055] By offsetting the first extended section 311 and the third extended section 313 in the axial direction of the container 100, the first extended section 311 is positioned eccentrically to one side of the axis of the container 100. This allows for the formation of a larger cavity for placing the implant 10 between the first extended section 311 and the container 100, improving the mounting performance of the container 100. This allows for better mounting of different types of implants 10, eliminates the need to increase the cavity volume, and significantly improves the applicability of the delivery device.

[0056] In an embodiment of the present invention, a first port portion 613 and a second port portion 614 are formed at both ends of the end structure 600 along the direction from the distal end of the inner tube 310 to the proximal end of the inner tube 310.

[0057] Specifically, the first port portion 613 is roughly columnar, and a passage for inserting the inner pipe 310 is formed inside the first port portion 613. The second port portion 614 is also roughly columnar, and a passage for inserting the inner pipe 310 is also formed inside the second port portion 614.

[0058] The first port portion 613 and the second port portion 614 are advantageous in increasing the connection length between the end structure 600 and the inner tube 310 in the axial direction, thereby improving the mounting stability of the end structure 600 to the inner tube 310. The designer may adjust the specific structure of the end structure 600 according to the requirements of use, and is not specifically limited herein.

[0059] In one feasible embodiment, as shown in the embodiment in Figure 9, the first port portion 613 and the second port portion 614 are provided coaxially with the axis of the container 100. By providing the first port portion 613 and the second port portion 614 coaxially with the axis of the container 100, the end structure 600 is provided substantially symmetrically, and the difficulty of processing and manufacturing the end structure 600 is reduced.

[0060] In another feasible embodiment, as shown in the embodiment in Figure 10, the first port portion 613 is provided coaxially with the axis of the container 100, and the second port portion 614 is provided coaxially with the axis of the first extended section 311.

[0061] Since the first port portion 613 is provided coaxially with the axis of the container 100 and the second port portion 614 is provided coaxially with the axis of the first extended section 311, the first port portion 613 and the second port portion 614 are offset from each other. Therefore, when the inner tube 310 drills through the end structure 600, the portion of the inner tube 310 connecting the first port portion 613 and the second port portion 614 exhibits an inclined shape with respect to the container 100.

[0062] By providing the second port portion 614 coaxially with the axis of the first extension section 311, the first extension section 311 can be smoothly connected to the end structure 600, reducing or eliminating the radial displacement between the first extension section 311 and the end structure 600, thereby allowing the guide wire 500 to pass through the first extension section 311 and the end structure 600 more smoothly.

[0063] In another feasible embodiment, as shown in the embodiment in Figure 11, the first port portion 613 and the second port portion 614 are provided coaxially with the axis of the first extension section 311.

[0064] By arranging the first port section 613 and the second port section 614 coaxially with the axis of the first extended section 311, a straight passage connecting the first port section 613 and the second port section 614 can be provided inside the end structure 600, improving passability.

[0065] In another feasible embodiment, as shown in the embodiment in Figure 12, the first port portion 613 is provided coaxially with the axis of the first extension section 311, and the second port portion 614 is provided coaxially with the axis of the container 100.

[0066] As can be seen from the above, in order to improve the mounting performance of the container 100, the axis of the first extended section 311 is set eccentrically to one side of the axis of the container 100. This results in a misalignment between the first extended section 311 and the axis of the container 100, which affects the passage of the guide wire 500 between the first extended section 311 and the third extended section 313. Furthermore, since the guide wire 500 needs to penetrate the inner tube 310 and the end structure 600, if the first extended section 311 is set eccentrically, it is more likely to affect the passage of the guide wire 500 between the first extended section 311 and the end structure 600.

[0067] Therefore, in order to improve passability between the first extended section 311 and the end structure 600, the second port section 614 is preferably provided coaxially with the axis of the first extended section 311.

[0068] By positioning the second port portion 614 eccentrically on one side of the container 100, the second port portion 614 secures more space in the container 100 for installing the implant 10, while also not affecting the functions of the balloon 610.

[0069] In embodiments of the present invention, as shown in the embodiments in Figures 3 and 4, the end structure 600 includes a balloon 610, the first port portion 613 and the second port portion 614 of the balloon 610 being sleeve-likely attached to the inner tube 310, the length of the balloon 610 being greater than or equal to the length of the stent 16, and / or the nominal width of the balloon 610 after inflation being greater than or equal to the set width of the stent 16. This allows the balloon 610 to directly expand the stent 16 in the retraction path after the implant 10 has separated from the inner tube 310. Regardless of which form the balloon 610 takes in Figures 9 to 12, the body of the balloon 610 (i.e., the portion between the first port portion 613 and the second port portion 614) is always provided coaxially with the cavity of the container 100, so that the balloon 610 can effectively close the outlet 110 of the container 100.

[0070] Specifically, by providing a first port portion 613 and a second port portion 614 at both ends of the balloon 610, the balloon 610 can have more connection configurations with the inner tube 310, and unlike the balloon structure in conventional catheters, the balloon 610 may be an irregularly shaped balloon 610 (i.e., at least one port portion of the balloon 610 is not coaxial with the main body structure). This allows for selective occlusion or exposure of the outlet 110 of the container 100, and at the same time, by controlling the specific installation positions of the first port portion 613 and the second port portion 614, better passability is provided between the first extended section 311 and the balloon 610, facilitating the passage of the guidewire 500.

[0071] Here, as shown in the embodiments in Figures 17 to 20, the balloon 610 is positioned at the distal end of the inner tube 310 and enters the human body earlier than the implant 10. After the balloon 610 reaches the target tissue 20, it can pre-expand the tissue of the target tissue 20, for example, by pre-expanding the puncture hole in the atrial septum. Furthermore, by controlling the container 100 to retract to the proximal end relative to the inner tube 310, the implant 10 can be released and placed in the atrial septum.

[0072] After the implant 10 is fully released, the inner tube 310 may be retracted to retract the balloon 610 to the position of the stent 16 on the implant 10. If it is determined that the implant 10 has reached the position of the stent 16 based on the radiopaque marker, the balloon 610 is further inflated to post-expand the stent 16 and bring it into closer contact with the target tissue 20. In other embodiments, the end structure 600 may be a conventional polymer plug.

[0073] In embodiments of the present invention, as shown in the examples in Figures 5, 6, 14, 16 and 21, the delivery device further includes a first connection structure 740 provided on the inner tube 310, and the implant 10 includes an implant body and a second connection structure 17 (see Figure 21, not shown in Figures 5, 6, 14, 16, etc. for simplification of illustration), and when the implant 10 is inside the container 100, the implant 10 is connected to the first connection structure 740 via the second connection structure 17 to maintain an axial relative position with respect to the inner tube 310, and when the implant 10 is removed from the container 100, the second connection structure 17 and the first connection structure 740 can be automatically separated to release the implant 10.

[0074] Specifically, the implant 10 includes a stent 16 made of shape memory material, the stent 16 is provided with a second connection structure 17, and the inner tube 310 is provided with a first connection structure 740.

[0075] In one feasible embodiment, the second connection structure 17 includes a grip arm provided on the stent 16, and the first connection structure 740 includes a protruding connection block. Furthermore, there may be multiple grip arms, and by providing the connection block in correspondence with the grip arms, the connection stability between the implant 10 and the inner tube 310 is improved by multiple sets of grip arms and connection blocks. Since the grip arm of the stent 16 is intended to grip the atrial septum, by employing the grip arm as the second connection structure 17 and connecting it to the first connection structure 740, the connection configuration between the implant 10 and the inner tube 310 can be effectively simplified, and the internal space of the container 100 can be saved.

[0076] In this embodiment, a predetermined 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 face of the first connecting structure 740 and the width of the grip arm. After the container 100 moves to the proximal end face of the first connecting structure 740, the container 100 comes into contact with the end of the grip arm. After the container 100 continues to move toward the proximal end and moves away from the grip arm, the stent 16 is fully released.

[0077] Of course, in other viable embodiments, the designer may adjust the specific structures of the first connection structure 740 and the second connection structure 17 according to the requirements of use, and is not specifically limited herein.

[0078] When the stent 16 is located inside the container 100, the container 100 can exert a restrictive effect on the state of the stent 16, preventing it from deploying, and is further connected to the first connecting structure 740 via the second connecting structure 17, maintaining the axial relative position of the stent 16 and the inner tube 310.

[0079] Generally, after the stent 16 is deployed, the grip arm and the main body of the stent 16 are in a basically vertical position. Therefore, when the stent 16 is detached from the container 100, the stent 16 can automatically deploy, and by returning the grip arm to its predetermined position, the second connecting structure 17 is separated from the first connecting structure 740. This releases the axial relative position between the stent 16 and the inner tube 310. Furthermore, after being separated from the inner tube 310, the stent 16 can self-expand to a set width, thereby allowing the stent 16 to be placed in the perforation of the target tissue 20.

[0080] The present invention significantly improves the structural stability between the implant 10 and the inner tube 310 by providing a first connection structure 740 and a second connection structure 17, enabling accurate and rapid release of the implant 10 into the target tissue 20, improving the implantation accuracy and portability of the implant 10, effectively simplifying the connection configuration between the implant 10 and the inner tube 310, and saving internal space in the container 100. Embodiment 4

[0081] This embodiment is similar to Embodiment 3, and the same parts will not be described repeatedly. The differences will be described in detail below.

[0082] In Embodiment 3, if the second extended section 312 is short, the first extended section 311 and the third extended section 313 may change abruptly in the radial direction of the container 100, which can easily affect the passability of the guide wire 500 through the inner tube 310. As a result, the guide wire 500 may not be able to pass through the inner tube 310 smoothly, which can affect the positioning of subsequent surgeries.

[0083] In this embodiment, as shown in Figures 14 to 16, the inner tube 310 is provided with a connecting member that can be housed in the container 100. The connecting member includes a connecting base 700 on which a first connecting structure 740 is provided. The connecting base 700 has an eccentric passage 730 through which the inner tube 310 passes. The connecting base 700 extends along a first predetermined direction F, and a first angle β is formed between the first predetermined direction F and the axis of the eccentric passage 730, with a range of 0° to 60°, preferably 15° to 30°. The first predetermined direction F may be the same as the axial direction of the container 100.

[0084] Specifically, the connecting base 700 can be housed within the container 100 and is placed between the first extended section 311 and the third extended section 313. Furthermore, since the first extended section 311 and the third extended section 313 are offset from each other, an eccentric passage 730 for the inner pipe 310 is formed in the connecting base 700 to avoid the connecting base 700 affecting the passability of the inner pipe 310, and at the same time to make the transition between the first extended section 311 and the third extended section 313 smoother.

[0085] Preferably, as shown in the embodiments in Figures 8 and 13, the eccentric passage 730 tends to slope from the third extended section 313 to the first extended section 311. Furthermore, a screw structure can be provided on the inner wall of the eccentric passage 730 for mounting. By providing the eccentric passage 730, a smooth transition length of the inner tube 310 within the eccentric passage 730 is ensured, further improving the passage of the guide wire 500.

[0086] Here, the connecting base 700 may have an outer contour that is fitted coaxially with the container 100, and the first connecting structure 740 on the connecting base 700 may be tightly fitted with the inner wall of the container 100, so that there is no gap between them, which prevents the second connecting structure 17 on the stent 16 from falling out of the gap between the first connecting structure 740 and the container 100, and improves the mounting stability between the stent 16 and the connecting base 700. The container 100 may be made of a polymer material, and if the inner wall of the container 100 is smooth, and the first connecting structure 740 and the inner wall of the container 100 are tightly fitted, and a certain level of interference fit is achieved, it can be understood that the first connecting structure 740 and the container 100 can still maintain relative movement.

[0087] In other embodiments, the first connection structure 740 in the connection base 700 may be gap-fitted with the inner wall of the container 100, thereby improving the passage capacity of the connection base 700 in the container 100 and avoiding interference between the connection base 700 and the inner wall of the container 100 that could affect the release of the implant.

[0088] The designer can adjust the magnitude of the first angle β according to the usage requirements, for example, the first angle β may be 10°, 20°, 30°, etc., without specifying a concrete numerical value.

[0089] By providing a connection base 700 on the inner pipe 310 and providing the first connection structure 740 on the connection base 700, the structure of the inner pipe 310 is not affected, and the difficulty of processing and installing the inner pipe 310 is reduced.

[0090] Of course, in other viable embodiments, the designer may adjust the specific structure of the connecting member according to the requirements of use, and is not specifically limited here.

[0091] Furthermore, as shown in the embodiment in Figure 16, the first predetermined direction F is parallel to the axial direction of the container 100, or the first predetermined direction F has a third angle γ with respect to the axial direction of the container 100, and the range of the third angle γ is 0° to 60°, preferably 15° to 30°.

[0092] The designer can adjust the specific magnitude of the third angle γ according to the usage requirements, for example, the third angle γ may be 5°, 10°, 15°, 20°, or 25°, and is not specifically limited thereto.

[0093] In an embodiment of the present invention, as shown in the example in Figure 8, the outer tube 200 has a first bent portion 201, and the inner tube 310 has a second bent portion 316, and when the end structure 600 closes the outlet 110, the first bent portion 201 and the second bent portion 316 are provided in correspondence.

[0094] Specifically, the first bent portion 201 is provided close to the container 100, and the second bent portion 316 is provided close to the connecting member. By providing the first bent portion 201 on the outer tube 200 and the second bent portion 316 on the inner tube 310, the second bent portion 316 fits into the first bent portion 201 to achieve a predetermined curvature angle at the distal end of the delivery device. This allows the container 100 to reach a predetermined location more easily in the case of tissues at a specific location or structure (e.g., the atrial septum).

[0095] If the outer tube 200 has a first bent portion 201 and the inner tube 310 has a second bent portion 316, for example, if a connecting base 700 is provided at the bent portion, the connecting base 700 may structurally interfere with the bent portion of the container 100, potentially causing problems such as damage to the container 100.

[0096] To solve the above problems, in an embodiment of the present invention, as shown in the embodiment in Figures 13 and 14, the connecting base 700 extends from the distal end to the proximal end of the inner tube 310, and includes a first base 710 and a second base 720 connected to each other, wherein the first base 710 is columnar, a first connecting structure 740 is provided on the first base 710, the second base 720 is frustoconical and connected to the first base 710, an eccentric passage 730 penetrates the first base 710 and the second base 720, and the second base 720 has a first end and a second end, the radial size of the first end is larger than the radial size of the second end.

[0097] By forming eccentric passages 730 in the first base 710 and the second base 720, the length of the eccentric passages 730 is longer than that of the straight passages, and the eccentric passages 730 are provided at an incline. This allows the eccentric passages 730 to provide a smoother transition to the inner tube 310, extending the path length of the inner tube 310 and guiding it to achieve synchronized unidirectional eccentricity with the implant 10 earlier. This is advantageous in reducing abrupt changes in the direction of extension of the inner tube 310 at the connecting base 700, preventing the guide wire 500 from losing its passage within the inner tube 310, and ensuring the passage of the guide wire 500 within the inner tube 310.

[0098] As shown in the embodiment in Figure 15, the second end of the second base 720 has a hole end face 750 formed perpendicular to the axis of the eccentric passage 730, through which the eccentric passage 730 passes. The second base 720 is further provided with a retractable end face 760, at least a portion of which is connected to the hole end face 750, and the remaining portion is provided separated from the proximal end of the inner tube 310, forming a second angle α with a range of 0° to 60°, preferably 15° to 30°, between it and the vertical. That is, the retractable end face 760 is provided at an angle from the second base 720 toward the first base 710, and the connecting base 700 can perform a retraction function by securing more space within the container 100 via the retractable end face 760. This is advantageous in improving the fit between the connecting base 700 and the container 100, reducing or eliminating interference problems between them, and preventing damage to the container 100 by the connecting base 700.

[0099] The designer can adjust the magnitude of the second angle α according to the usage requirements, for example, the second angle α may be 10°, 20°, 30°, 40°, or 50°, and is not specifically limited thereto.

[0100] Furthermore, as shown in the embodiment in Figure 7, the inner tube 310 further includes a fourth extending section 314 located between the second extending section 312 and the third extending section 313, used to penetrate the eccentric passage 730, and having an angle with respect to the axis of the container 100 that is smaller than the angle between the second extending section 312 and the axis of the container 100.

[0101] By controlling the angle between the fourth extended section 314 and the axis of the container 100 so as to gradually increase the slope width between the fourth extended section 314 and the second extended section 312, it is advantageous to improve the smooth transition between the fourth extended section 314 and the second extended section 312, and further improve the passability of the inner pipe 310.

[0102] The designer may adjust the magnitude of the angle between the fourth extension section 314 and the axis of the container 100, and the magnitude of the angle between the second extension section 312 and the axis of the container 100, without specifying any particular numerical values, as required by the user.

[0103] Furthermore, an end passage is formed in the end structure 600, and as shown in the embodiment in Figure 7, the inner tube 310 further includes a fifth extension section 315 provided on the other side of the first extension section 311 relative to the second extension section 312, with the fifth extension section 315 penetrating the end passage. The inner tube 310 has a lumen for accommodating the guide wire 500.

[0104] Specifically, the end passage penetrates the first port section 613, the main body of the end structure 600, and the second port section 614, and the fifth extended section 315 penetrates the end passage.

[0105] Because the connecting base 700 is provided inside the container 100, when the inner tube 310 and the container 100 move relative to each other in the axial direction, the liquid and / or gas inside the container 100 needs to pass through the gap between the connecting base 700 and the inner wall of the container 100. However, the size of the gap restricts the liquid and / or gas from efficiently passing through the connecting base 700, causing a damping effect and reducing the efficiency of the movement between the inner tube 310 and the container 100.

[0106] To solve the above problem, in an embodiment of the present invention, as shown in the example in Figure 14, the connecting member is provided with a flow guide structure 770 that connects the housing cavities of the containers 100 located on both sides of the connecting member.

[0107] Specifically, the connecting member includes a connecting base 700, and the flow guide structure 770 includes flow guide grooves provided in the connecting base 700 that communicate the internal lumens of the containers 100 located on both sides of the connecting base 700. The flow guide grooves can improve the flow capacity of liquids and / or gases, thereby reducing or eliminating damping during relative motion between the connecting base 700 and the containers 100, and improving motion efficiency. More preferably, the flow guide grooves are provided in a second base 720.

[0108] In an embodiment of the present invention, the end structure 600 includes a balloon 610, and the inner tube 310 is further provided with a flow structure having an injection passage that communicates with the lumen of the balloon 610.

[0109] Specifically, the flow structure includes at least one flow port provided in the inner tube 310, and the flow port connects the injection passage to the lumen of the balloon 610, so that the filling liquid can be injected into the balloon 610 via the injection passage or discharged from the balloon 610, thereby making it easier to control the inflation and deflation state of the balloon 610.

[0110] Furthermore, the inner tube 310 includes a first tube body and a second tube body inserted into the first tube body, with a passage for the guide wire 500 formed in the lumen of the second tube body, and an injection passage formed by the gap between the first tube body and the second tube body.

[0111] Of course, in other viable embodiments, the designer may adjust the molding form of the injection channel according to the requirements of use, and is not specifically limited herein.

[0112] In an embodiment of the present invention, as shown in the embodiment in Figure 1, the delivery device further includes 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 axially movable between a first position and a second position relative to the inner tube 310, positions the implant 10 inside the container 100 when the container 100 is in the first position, and releases the implant 10 axially from the outlet 110 of the container 100 as the container 100 moves from the first position to the second position.

[0113] Specifically, the control mechanism 400 may be a handle. In this embodiment, the control mechanism 400 includes an actuator 410 and an auxiliary member 420. The auxiliary member 420 has a fixed axial position, and the actuator 410 is movable axially on the auxiliary member 420. The actuator 410 is also connected to the outer tube 200, so that when the actuator 410 moves axially, the outer tube 200 is driven to move axially. The proximal end of the inner tube 310 is fixed to the auxiliary member 420 of the control mechanism 400, and its relative axial position with respect to the auxiliary member 420 does not change. In this way, by moving the outer tube 200 forward or backward along the axial direction, the inner tube 310 and the outer tube 200 can be moved relative to each other in the axial direction. In this embodiment, the control mechanism 400 can change the relative position (relative motion) between the inner tube 310 and the outer tube 200 by controlling the movement of the outer tube 200, and in other embodiments, the control mechanism 400 may change the relative position (relative motion) between the inner tube 310 and the outer tube 200 by controlling the movement of the inner tube 310.

[0114] In embodiments of the present invention, referring to the examples shown in Figures 17 to 20, specific steps for using the delivery device are further provided, and the implant 10 includes a stent and a wireless pressure sensor.

[0115] The steps include: operating the release mechanism 300 to expose the first extended section 311 at the distal end of the inner tube 310 and deflate the balloon 610; mounting and fixing the implant 10 on the first extended section 311 and connecting the first connecting structure 740 to the second connecting structure 17, and then operating the release mechanism 300 until the implant 10 is completely recovered into the container 100; using a pressure filling device to evacuate the handle, implant 10 and inner tube 310 via the standard Luer connector of the handle; and using a pressure filling device having a readable pressure value. The steps include: filling the balloon 610 to nominal pressure with a 1:1 solution of contrast agent and saline solution; under the guidance of an imaging device, guiding the delivery system along the already prepared vascular passage guidewire 500 to the release position of the implant 10; evaluating the operator and the position of the lesion, and if it is necessary to widen the passage or perforation to the lesion, pre-expansion can be performed directly by the balloon 610 until the ideal implant placement requirement is reached; and positioning the implant 10 and container 100. After confirming the correct position using an image guidance device and the operator, the procedure involves first rapidly removing the balloon 610 using a pressure filling device, detecting the pressure in real time, reading the pressure value, then gradually releasing it to a point where safe retrieval is possible, and reconfirming the accuracy of the implantation position; if the release position is not ideal, rapidly retrieving the implant 10 to its original position, then retracting it to a safe position, then reinflating the balloon 610 to the nominal pressure using the pressure filling device, repeating the above steps, and performing the implantation and release procedure again; after confirming that the release position is correct, completely releasing the implant 10; after confirming that the release position of the implant 10 is correct using an image guidance device, first retracting the balloon 610 to the position corresponding to the implant 10 under the image guidance device, then inflating and expanding the balloon 610 using a pressure filling device for the balloon 610 to perform post-expansion treatment for the implant 10 and the lesion position; and after the post-expansion treatment is completed, completely releasing the pressure of the balloon 610, and then,This includes the step of removing the inner tube 310 from the body along the guide wire 500. Embodiment 5,

[0116] The present invention further provides a medical system comprising an implant 10 and a delivery device according to any one of embodiments 1 to 4 for housing and delivering the implant 10. The specific structure, operating principle, and beneficial effects of the delivery device are the same as those of any one of Embodiments 1 to 4 and will not be repeated here. The medical system, by using the delivery device in Embodiment 1, can perform pre-expansion treatment on the target tissue 20 and post-expansion treatment on the implant 10 in the retraction path, thereby allowing the implant 10 to be better positioned.

[0117] In embodiments of the present invention, the implant 10 includes a stent 16 and a wireless sensor provided in parallel with the stent 16. Furthermore, the stent 16 includes a stent body having a second connection structure 17 and a coating. In one executable embodiment, the second connection structure 17 includes a grip arm provided on the stent body, the grip arm can be placed over and connected to the first connection structure 740 on the connection base 700, thereby allowing the implant 10 to be fixed to or released from the inner tube 310.

[0118] In embodiments of the present invention, the medical system further includes a guide wire 500 provided within the inner tube 310. Specifically, the guide wire 500 has a diameter smaller than that of the inner tube 310. The designer may adjust the specific structure of the guide wire 500 according to the requirements of use; for example, the guide wire 500 is an elongated metal wire, but is not specifically limited thereto. The guide wire 500 also has high support strength and a small diameter, making it more easily bendable within the tubular structure of the human body. Because the guide wire 500 can perform a guiding action, when the inner tube 310 is sleeved to the guide wire 500, the inner tube 310 can move along the guide wire 500 to the target tissue 20.

[0119] In the above embodiments, the implant was given as an example of an atrial septal shunt stent and sensor, but those skilled in the art will understand that the delivery device disclosed in the present invention can be applied to a variety of implants, including but not limited to cardiovascular stents. Embodiment 6

[0120] In many cases, physicians need to monitor the subject's physiological parameters to assess the patient's condition and take timely action if abnormalities occur in the relevant parameters. For example, if a patient's left ventricular pressure is too high, rapid intervention and treatment are needed to lower the pressure. In a hospital setting, the operator can achieve this by implanting a sensor-equipped intervention catheter into the body, or they can meet the patient's need for free movement by implanting a wireless sensor into the body.

[0121] However, the inventors discovered that sometimes it is necessary to know certain physiological parameters within the patient's body during the entire process of the surgeon implanting a wireless sensor or other implant into the human body via a delivery device. In this case, a common practice is to place the corresponding sensor at a specific location from another part of the body using a separate intervention sensing catheter, but this method not only increases the number of incisions and causes pain to the patient, but also increases surgical time and consumable costs. On the other hand, because the intervention sensing catheter inserted from another site and the delivery device differ in their implantation process and target placement location, data deviations are unavoidable, leading to problems such as hysteresis and low accuracy.

[0122] Embodiments of this disclosure provide a delivery device for delivering an implant to a target location via a body cavity or lumen of the human body. The implant may be a wireless sensor for measuring physiological parameters within a body cavity or lumen of the human body, or a combination of a wireless sensor and another implantable element, such as a combination of a shunt for atrial shunt surgery and a wireless pressure sensor. The delivery device includes a container, an outer tube, and a release mechanism. The container is used to house the implant. One end of the container has an outlet for discharging the implant. The container is provided with a signal transmission window. The outer tube has a tubular body, a first end, and a second end. The outer tube is coaxially connected to the container via the first end. The release mechanism penetrates the outer tube and the container. The release mechanism is connected to the implant and is used to control the axial relative position of the implant and the container. Here, the release mechanism is configured to hold the implant in the container and to align the wireless sensor with the signal transmission window. When performing an interventional surgery using the delivery device provided in the embodiments of this disclosure, the implant can be housed in a container and aligned with the signal transmission window by arranging a release mechanism. In this way, while in place, the implant can collect information and transmit it to the outside of the human body via the signal transmission window, allowing accurate physiological parameters to be obtained in real time during the intervention process. In this invention, the alignment of the wireless sensor and the signal transmission window means that the wireless sensor must correspond to the signal transmission window in the axial direction. Furthermore, since the wireless sensor may include a signal acquisition unit and a wireless signal transmission unit, only the wireless signal transmission unit in the wireless sensor needs to correspond to the signal transmission window in the axial direction; that is, the signal from the wireless signal transmission unit only needs to be transmitted to an external receiving device via the signal transmission window without interference, and this invention is not limited to this.

[0123] The delivery device provided in this disclosure is used to deliver an implant including a wireless sensor to a target location. Not only can the wireless sensor perform monitoring and diagnostic functions after placement, but by providing a signal transmission window in the container housing the implant, the wireless sensor also functions throughout the entire delivery process, transmitting sensed information to the outside of the human body via wireless signals. This allows for accurate real-time monitoring of the body's physiological parameters during intervention. This eliminates the need to separately place other intervention sensing catheters during surgery, reducing patient wounds and pain, and further enabling modifications to the entire surgical procedure, effectively reducing surgical time, decreasing the difficulty of the surgery, and lowering surgical costs.

[0124] Refer to Figures 22 to 24. Figure 22 is a schematic structural diagram of a delivery device according to one embodiment of the present disclosure. Figure 23 is a partially enlarged cross-sectional view of the distal end of the delivery device in Figure 22. Figure 24 is a further enlarged view of the container of the delivery device in Figure 23.

[0125] The delivery device includes a container 100, an outer tube 200, a release mechanism 300, a control mechanism 400, and a guide wire 500. The container 100 and the control mechanism 400 are located at opposite ends of the outer tube 200, respectively. The release mechanism 300 is connected to the control mechanism 400 from the inside, passing through the container 100 and the outer tube 200. The control mechanism 400 is used to be grasped by a user and to operate the release mechanism 300. The guide wire 500 is used to guide the outer tube 200.

[0126] The container 100 has a cylindrical structure, and its wall forms a cavity by enclosing it in an annular shape. The container 100 has a tapered outlet 110 at one end and communicates with the outer tube 200 at the other end. In this embodiment, the outer diameter of the container 100 is larger than the outer diameter of the outer tube 200, thereby meeting the accommodation requirements for the implant 10 as much as possible, while keeping the overall tube diameter as small as possible, improving its passage performance, and reducing damage to human tissue during implantation. Of course, in other embodiments, the outer diameter of the container 100 may be equal to the outer diameter of the outer tube 200. In this embodiment, the tube wall of the container 100 is further provided with a first metal wire mesh 150 to reinforce its strength. The first metal wire mesh 150 is formed by weaving together a plurality of pre-metal wires 159. The pre-metal wires 159 may be elastic metal wires such as stainless steel, nickel-titanium, or copper. The entire first metal wire mesh 150 is provided so as to surround the side wall of the container 100, but it does not completely cover the side wall of the container 100. This is because the first metal wire mesh 150 is not a complete cylindrical structure, and an opening region 155 is provided in the middle section. The opening region 155 is a cylindrical surface region spanning between position a and position b. No metal wires pass through the opening region 155, and a signal transmission window 140 is formed. The signal transmission window 140 is not a physical opening formed due to a lack of material in the container 100, but an intangible opening that does not hinder the transmission of wireless signals. The first metal wire mesh 150 itself is intended to reinforce the strength of the container 100, but from an electrical standpoint, its mesh structure forms an electromagnetic shielding cover that shields electromagnetic signals. Since there are no metal wires in the opening region 155 and no other shielding structure is provided, it does not hinder the transmission of electromagnetic signals and can therefore be called a signal transmission window 140. In other words, the signal transmission window is not provided with any shielding structure that would interfere with signal transmission.

[0127] In this embodiment, the first metal mesh 150 includes two independent mesh tubes located on either side of the signal transmission window 140, namely, each of the two mesh tubes being formed by weaving together two sets of metal wires, which are connected and fixed together at position a. From position b, weaving continues using the same or a different number of metal wires.

[0128] In the selectable embodiment shown in Figure 25, the first metal wire mesh 150 was formed by weaving together identical sets of metal wires, including a first metal wire 151, a second metal wire 152, a third metal wire 153, and a fourth metal wire 154. The first metal wire 151 and the second metal wire 152 were wound spirally around the tube counterclockwise, while the third metal wire 153 and the fourth metal wire 154 were wound clockwise around the tube. The metal wires were wound spirally up to position a, and from there continued to extend parallel to the axial direction. After the metal wires extended a predetermined distance, they continued to be wound spirally at position b. Furthermore, because the circumferential spacing between the four metal wires when they extend parallel to each other is small, the area they occupy is also small. With this installation configuration, there is no need to cut the metal wire at position a to complete the braiding, and the same set of metal wires can be used to continue braiding at position b, simplifying the braiding process and not significantly reducing the strength of the pipe section where the signal transmission window 140 is provided. Between position a and position b, the metal wires extend parallel to each other, so no braided structure is formed, resulting in minimal impact on wireless signal transmission. Furthermore, the metal wires are not cut between position a and position b, so the strength of this part of the container 100 is not significantly weakened.

[0129] In other optional embodiments, the metal wires extend parallel to each other between positions a and b and are uniformly distributed circumferentially, forming unbraided regions that do not need to be concentrated in a narrow area. If the metal wires do not intersect and are appropriately spaced, the unbraided regions do not significantly affect signal transmission, thereby forming a signal transmission window.

[0130] In other selectable embodiments, between positions a and b, the metal wires are densely arranged as they extend axially, or woven into a mesh belt on one side, in which case one or more large openings can be left where the metal mesh or metal wires are not placed, although the metal wires may affect signal transmission to some extent, and these openings form signal transmission windows.

[0131] In other embodiments, the metal wire in front of position b may be completely omitted, or the metal wire may not be provided at all on the tube wall of container 100, in which case the entire tube wall of the container forms a signal transmission window, and the present invention is not limited thereto.

[0132] Preferably, the tube wall of the container 100 is further provided with a side hole 120 located at the distal end of the signal transmission window 140. There may be one or more side holes 120. In surgery via an artery, blood can enter the container 100 through the side holes 120 so that physiological parameters such as blood pressure can be measured by a sensor inside the container 100.

[0133] The outer tube 200 is an elongated tube and includes a tubular body 230, a first end 210, and a second end 220. The outer tube 200 is an elongated hose made of a polymer material, and the tubular body 230 is provided with a second metal wire mesh 250 made of downstream metal wire 259. The second metal wire mesh 250 is used to improve the twist resistance of the outer tube 200. The downstream metal wire 259 may be an elastic wire such as stainless steel wire. The outer tube 200 is coaxially connected to the container 100 via the first end 210 and connected to the control mechanism 400 via the second end 220. Preferably, the upstream metal wire 159 and the downstream metal wire 259 are the same set of metal wires. That is, the metal wires forming the second metal wire mesh 250 extend to the container 100 and are woven together to form the first metal wire mesh 150.

[0134] The release mechanism 300 includes an inner tube 310 and a plug 320. The inner tube 310 is an elongated tube with a smaller diameter than the outer tube 200. The inner tube 310 penetrates the outer tube 200 and the container 100 from the inside of the outer tube 200. The plug 320 is a spindle-shaped structure with a central through-hole along its longitudinal direction. The plug 320 is attached to the inner tube 310 in a sleeve-like manner via the central through-hole and is located at the outlet 110 of the container 100. One end of the plug 320 can be partially inserted into the outlet 110 to close the outlet 110. The portion of the inner tube 310 located in the container 100 is used to connect to the implant 10. As the inner tube 310 moves axially relative to the container 100, the implant 10 can be moved axially relative to the container 100. The plug 320 may move axially with the inner tube 310, thereby closing the outlet 110 or partially detaching from the outlet 110 to form an annular top clearance 130. The top clearance 130 is used to communicate the inside and outside of the container 100. In arterial surgery, blood can enter the container 100 through the top clearance 130 so that physiological parameters such as blood pressure can be measured by a sensor inside the container 100. Of course, the side holes 120 provided in the tube wall of the container 100 allow blood to enter the container 100 without the need to move the inner tube 310. Therefore, the installation of the side holes 120 simplifies surgical procedures and prevents damage to internal tissues due to movement of the inner tube 310 during delivery.

[0135] The release mechanism 300 is configured such that the inner tube 310 is movable relative to the container 100 between a first and second axial position, and when the inner tube 310 is in the first position, it positions the implant 10 inside the container 100 and corresponds to the signal transmission window, and as the inner tube 310 moves from the first position to the second position, it releases the implant 10 axially from the outlet 110 of the container 100 and places it in the target position. Furthermore, when the implant 10 is positioned inside the container 100 and corresponds to the signal transmission window, the release mechanism 300 is configured such that the side hole 120 is positioned at the sensing end (e.g., distal end) of the wireless sensor of the implant 10, so that blood flowing in from the side hole 120 can directly contact the implant 10, and the sensor in the implant 10 can directly measure physiological parameters.

[0136] The control mechanism 400 may be a handle. The control mechanism 400 is used to control the axial relative positional relationship between the outer tube and the inner tube in the release mechanism 300. In this embodiment, the control mechanism 400 includes an actuator 410 and an auxiliary member 420. The auxiliary member 420 has a fixed axial position, and the actuator 410 is movable axially on the auxiliary member 420. The actuator 410 is also connected to the outer tube 200 so that when the actuator 410 moves axially, the outer tube 200 is driven to move axially. The proximal end of the inner tube 310 is fixed to the control mechanism and its axial relative position with respect to the auxiliary member 420 does not change. Thus, by moving the outer tube forward or backward along the axial direction, the inner tube 310 and the outer tube 200 can be moved relative to each other in the axial direction, and the implant fixed to the inner tube 310 can be moved axially relative to the container at the tip of the outer tube, thereby allowing the implant to be placed in the inner tube 310 before placement and to be released axially from the opening of the container when the implant reaches the target position. As those skilled in the art will understand, in other embodiments, the control mechanism 400 may include one actuator connected to the inner tube that drives the inner tube and fixes the outer tube relatively, thereby achieving relative axial movement between the inner tube and the outer tube, and relative position control between the outer tube and the inner tube can be achieved by various known catheter handle structures, so the present invention will not be described again.

[0137] The guide wire 500 has a smaller diameter than the inner tube 310. The guide wire 500 is a slender metal wire. The inner tube 310 is attached to the guide wire 500 in a sleeve-like manner. The guide wire 500 has high support strength and a small diameter, making it more flexible within the tubular structure of the human body and providing guide support.

[0138] Refer to Figures 26 and 27. Figure 26 is a schematic distribution diagram of the first metal wire mesh on the surface of the container according to another embodiment of the present disclosure. Figure 27 is a schematic structural diagram of the first metal wire mesh in Figure 26. In this embodiment, the first metal wire mesh includes a first opening region 155a and a second opening region 155b, thereby forming a first signal transmission window 140a and a second signal transmission window 140b. Specifically, the first metal wire 151 and the third metal wire 153 extend axially parallel from the first side of the container 100 (the second passage 170 in Figure 26, or the upper side in Figure 27) at position a, and the second metal wire 152 and the fourth metal wire 154 extend axially parallel from the second side of the container 100 (the first passage 160 in Figure 26, or the lower side in Figure 27) at position a. This formed the first opening region 155a and the second opening region 155b.

[0139] Refer to Figures 28 to 30. Figure 28 is a schematic internal structure diagram of the distal end of a medical system according to one embodiment of the present disclosure. Figure 29 is a partial cross-sectional view of the distal end of the medical system in Figure 28. Figure 30 is a schematic diagram of the medical system in a compressed state.

[0140] The medical system includes an implant 10 and a delivery device. The implant 10 has a sensor 11. The sensor 11 is used to measure one or more parameters from among temperature, flow rate, pressure, acceleration, vibration, pH value, conductivity, dielectric constant, component composition, component content, and sound waves. The delivery device is used to house and deliver the implant. Here, the delivery device may be the delivery device in any one of the embodiments described above.

[0141] In one possible embodiment, the implant 10 is a combination of a shunt and a wireless sensor, the wireless sensor being a pressure sensor, and the shunt being able to be compressed inside a container and released outside the container by a release mechanism. Specifically, the implant 10 includes a wireless sensor 11 and an inflatable shunt 12. The wireless sensor 11 is used to measure blood pressure. The sensor 11 includes a pressure sensing element 14 and a wireless signal transmission element 15. The wireless signal transmission element is aligned with a signal transmission window 140. The shunt 12 is placed in the atrial septum and directs blood flow from the left atrium to the right atrium. The inner tube 310 is further provided with an axial position regulating member 330, and to maintain relative position with respect to the inner tube 310 during implantation, the implant 10 includes a hanging member 13 connected to the axial position regulating member 330, and after reaching the target position, as the implant 10 is released from the constraint of the container 100, the hanging member 13 unfolds together with the shunt 12 and returns to its original shape. The hooking member 13 separates from the axial position restricting member 330 during the process of radial expansion. Specifically, the axial position restricting member 330 has a position restricting groove, and the hooking member 13 has a position restricting piece. In the compressed state, the hooking member 13 has a position restricting piece that is hooked into the position restricting groove so as to be detachable in the radial direction. During the process of the hooking member 13 returning to its original position, the position restricting piece escapes from the position restricting groove, thereby separating from the axial position restricting member 330 in the axial direction as well.

[0142] In one possible embodiment, the hooking member 13 may be a bar-shaped member that does not expand itself, but can achieve hooking or detachment by moving closer to or further away from the axial position regulating member 330 in response to the compression and expansion of the shunt 12. To clearly show each member, it can be seen that the distance between the shunt 12 and / or hooking member 13 and the inner wall of the container has been enlarged in Figure 29.

[0143] Here, the implant 10 may be pre-placed in the container 100 after being compressed, or it may be temporarily placed in the container 100 when in use. When the shunt 12 is compressed, it is compressed radially so that its cross-section has a C-shaped recessed structure, and this recessed structure can partially surround the sensor 11.

[0144] In cardiovascular interventional surgery, accurately and continuously measuring changes in physiological parameters and indicator curves of each part of the cardiac chamber and blood vessel throughout the entire implantation process allows the surgeon to assess the patient's cardiac function, cardiac load, and pulmonary hemodynamic load, as well as to guide the surgical strategy and evaluate the postoperative treatment effect in real time.

[0145] For example, in atrial shunt placement surgery, the above-described delivery device allows for the placement of a shunt with a wireless pressure sensor in the atrial septum. The above-described delivery device not only ensures the strength of the intervention catheter but also allows for the real-time transmission of wireless signals outside the human body via the pressure sensor, achieving the effect of accurate real-time monitoring.

[0146] The interventional surgery using the above-mentioned delivery device or medical system also has the following clinical advantages:

[0147] 1. In emergency situations during surgery, hemodynamic indicators of each part of the cardiac chamber and blood vessel can be measured directly without the need for inserting a separate catheter, reducing surgical risks and patient discomfort.

[0148] 2. If the wireless sensor is a pressure sensor, there is no need to insert a separate right cardiac catheter to measure pressure changes in the superior and inferior vena cava, right atrium, pulmonary artery, and pulmonary arterioles, thus reducing patient trauma. Furthermore, it can reduce the complexity of the surgery and the impact of catheter insertion into the cardiac chambers on the intraoperative procedure, thereby reducing surgical time and costs.

[0149] 3. If the wireless sensor is a pressure sensor, the average pressure values ​​and change curves of different cardiac chambers can be used to assist in determining the position of the implant delivery device in the cardiac chamber. This can help the surgeon determine the position of the delivery system within the cardiac chamber (right atrium, left atrium, superior and inferior vena cava) without image guidance, thereby simplifying the specific procedure of releasing the device during surgery and reducing radiation exposure to the patient.

[0150] 4. When the wireless sensor is a pressure sensor, the cardiac chamber pressure data acquired by the delivery device of the present invention is more accurate and real-time compared to data measured by conventional right heart catheterization methods (e.g., left atrial pressure). Interference due to factors such as variability and time lag caused by pressure transmission is avoided. Cardiac chamber pressure can be measured immediately after surgery, allowing for direct evaluation of the postoperative treatment effect and providing the surgeon with a basis for treatment strategies.

[0151] The foregoing are merely specific embodiments illustrated by the present invention and do not limit the scope of the present invention. Equivalent changes and modifications made by those skilled in the art without departing from the concept and principles of the present invention shall all fall within the scope of protection of the present invention.

Claims

1. A delivery device for delivering implants to target tissue via a body cavity or tubular lumen of the human body, A container including a housing cavity for housing the implant and an outlet for discharging the implant, An outer tube connected to and communicating with the aforementioned container, The release mechanism includes an inner tube that penetrates the container and the outer tube and is connected to the implant, and a control mechanism for controlling the relative axial positional relationship between the inner tube and the outer tube. Delivery device.

2. The end structure provided at the distal end of the inner tube includes a structure for selectively closing or exposing the outlet, The outer tube is provided coaxially with the container, which is movable axially relative to the end structure such that the end structure closes or exposes the outlet. If the distance between the container and the end structure is less than a predetermined value, the distance between the end structure and the implant remains unchanged; if the distance between the container and the end structure is greater than or equal to the predetermined value, the implant is released into the target tissue. The implant includes a stent made of shape memory material, the stent is suitable for sleeve-like attachment to the inner tube, and the stent is self-expandable to a set width after being separated from the inner tube. The delivery device according to claim 1.

3. The end structure includes a balloon having a first operating mode in an inflated state and a second operating mode in a deflated state, wherein when the balloon is in the first operating mode, the balloon is movable in the axial direction of the container so as to close or expose the outlet. During the process of the implant separating from the inner tube, the balloon is always closer to the distal end of the implant than to the proximal end of the implant, maintaining a relative axial position with respect to the implant. After the implant separates from the inner tube, the balloon directly expands the stent in its retraction path. The delivery device according to claim 2.

4. 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. The delivery device according to claim 3.

5. The end structure further includes a radiopaque marker provided on the end structure, and / or the end structure is made of a radiopaque material. The delivery device according to claim 2 or 3.

6. Along the direction from the distal end to the proximal end of the inner tube, a pre-expansion guide portion and a post-expansion guide portion are formed at both ends of the end structure, and along the direction from the post-expansion guide portion to the pre-expansion guide portion, the cross-section of the pre-expansion guide portion gradually decreases, and / or along the direction from the pre-expansion guide portion to the post-expansion guide portion, the cross-section of the post-expansion guide portion gradually decreases. The delivery device according to claim 2 or 3.

7. Along the direction from the distal end to the proximal end of the inner tube, the inner tube includes a first extension section, a second extension section, and a third extension section, wherein the extension direction of the second extension section differs from the extension directions of the first and second extension sections, the axis of the first extension section is eccentrically positioned to one side of the axis of the container, the body of the implant is provided in the first extension section, and the stent is attached to the first extension section in a sleeve-like manner. The delivery device according to claim 2 or 3.

8. Along the direction from the distal end to the proximal end of the inner tube, a first port portion and a second port portion are formed at both ends of the end structure. The first port portion and the second port portion are provided coaxially with the axis of the container, or The first port portion is provided coaxially with the axis of the container, and the second port portion is provided coaxially with the axis of the first extended section, or The first port portion and the second port portion are provided coaxially with the axis of the first extended section, or The first port portion is provided coaxially with the axis of the first extension section, and the second port portion is provided coaxially with the axis of the container. The delivery device according to claim 7.

9. The end structure includes a balloon, the first port portion and the second port portion of the balloon are each attached to the inner tube in a sleeve-like manner, and the body of the balloon is provided coaxially with the container. 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, thereby allowing the balloon to directly expand the stent in its retraction path after the implant has separated from the inner tube. The delivery device according to claim 8.

10. The implant further includes a first connection structure provided in the inner tube, and the implant is provided with a second connection structure. When the implant is inside the container, the implant is connected to the first connecting structure via the second connecting structure so as to maintain its axial relative position with respect to the inner tube. If the implant detaches from the container, the second connection structure and the first connection structure automatically separate to release the implant. The delivery device according to claim 7.

11. The inner tube is provided with a connecting member that can be housed in the container and is equipped with the first connecting structure. The connecting member includes a connecting base through which the inner pipe passes, and The connecting base extends along a first predetermined direction, and a first angle β with a range of 0° to 60° is formed between the first predetermined direction and the axis of the eccentric passage. The delivery device according to claim 10.

12. The outer tube has a first bent portion, and the inner tube has a second bent portion, and when the end structure closes the outlet, the first bent portion and the second bent portion are provided in correspondence. From the distal end to the proximal end of the inner tube, the connecting base includes a connected first base and a second base, the first base being columnar, and the first connecting structure being provided on the first base. The second base is frustoconical, the eccentric passage penetrates the first base and the second base, the second base has a first end and a second end, the radial size of the first end is greater than the radial size of the second end, and the first end of the second base is connected to the first base. The delivery device according to claim 11.

13. The second end of the second base has an opening face formed perpendicular to the axis of the eccentric passage, through which the eccentric passage passes. The second base is further provided with a retracted end face, at least a portion of which is connected to the hole end face, and the remaining portion is provided separated from the proximal end of the inner tube, forming a second angle α with respect to the vertical, ranging from 0° to 60°. The delivery device according to claim 12.

14. The inner pipe further includes a fourth extending section located between the second extending section and the third extending section, for penetrating the eccentric passage. The angle between the fourth extension section and the axis of the container is smaller than the angle between the second extension section and the axis of the container. The delivery device according to claim 11.

15. The end structure has an end passage formed therein, and the inner pipe further includes a fifth extension that is provided on the other side of the first extension with respect to the second extension and penetrates the end passage. The inner tube has a lumen for providing a guide wire. The delivery device according to claim 14.

16. The connecting member is provided with a flow guide structure that connects the containment cavities of the container located on both sides of the connecting member. The first predetermined direction is parallel to the axial direction of the container, or the first predetermined direction has a third angle γ with respect to the axial direction of the container, and the range of the third angle γ is 0° to 60°. The delivery device according to claim 11.

17. The end structure includes a balloon, and the inner tube is further provided with a flow structure having an injection passage that communicates with the lumen of the balloon. The delivery device according to claim 2.

18. The container is provided with a signal transmission window. The outer tube has a tubular body, a first end, and a second end, and is connected to the container via the first end and is coaxially connected. The release mechanism penetrates the outer tube and the container, is connected to the implant, and is used to control the axial relative positional relationship between the implant and the container. The implant includes a wireless sensor, and the release mechanism is configured to hold the implant in the container and to align the wireless sensor with the signal transmission window. The delivery device according to claim 1.

19. The signal transmission window is not provided with any shielding structure that would obstruct signal transmission, and the outer diameter of the container is larger than the outer diameter of the outer tube. The delivery device according to claim 18.

20. The container includes a front metal wire provided on the side wall of the container, which forms a first metal wire mesh. The first metal wire network is provided with an opening region through which the preceding metal wire does not pass, and the opening region forms the signal transmission window, or The first metal wire network is provided with an unbraided region, the preceding metal wires do not cross in the unbraided region, and the unbraided region forms the signal transmission window. The delivery device according to claim 18.

21. When the opening region is provided in the first metal wire mesh, the opening region is formed by leaving an area through which the preceding metal wire does not pass. The delivery device according to claim 20.

22. The aforementioned preceding metal wires change their extension direction and extend axially for a predetermined distance without intersecting each other, thereby creating the opening region. The delivery device according to claim 21.

23. The outer tube includes a downstream metal wire provided on the side wall of the outer tube and extending to the container to form the first metal wire mesh, forming a second metal wire mesh. The delivery device according to claim 22.

24. The number of signal transmission windows is one or more. A delivery device according to any one of claims 18 to 23.

25. The container is provided with a side hole located at the distal end of the signal transmission window, and when the wireless sensor and the signal transmission window are aligned, the side hole corresponds to the sensing end of the wireless sensor. The delivery device according to claim 18.

26. A plug connected to the release mechanism is provided at the outlet of the container. The plug can be driven by the release mechanism and displaced axially, thereby forming a top clearance between itself and the outlet. The delivery device according to claim 18.

27. The release mechanism includes an inner tube and an axial position regulating member, the inner tube passing through the container and outer tube and used to connect to the implant, and the axial position regulating member used to maintain the axial relative position of the implant with respect to the inner tube. The delivery device according to claim 18.

28. The release mechanism is configured such that the inner tube is movable relative to the container between a first and second axial position, and when the inner tube is in the first position, the implant is positioned inside the container, and the wireless sensor corresponds to the signal transmission window, and as the inner tube moves from the first position to the second position, the implant is released from the opening of the container along the axial direction. The delivery device according to claim 27.

29. The wireless sensor is used to measure one or more parameters from among temperature, flow rate, pressure, acceleration, vibration, pH value, conductivity, dielectric constant, component composition, component content, and sound waves. The delivery device according to claim 18.

30. Includes an implant and a delivery device according to any one of claims 1 to 17 for housing and delivering the implant. Healthcare system.

31. The implant further includes a guide wire provided within the inner tube, and the implant includes a wireless sensor and a stent provided in parallel. The medical system according to claim 30.

32. An implant including a wireless sensor, A delivery device according to any one of claims 18 to 29 for housing and delivering the implant, including Healthcare system.

33. The implant includes an inflatable shunt, the wireless sensor is a pressure sensor connected to the shunt, and the shunt can be compressed inside the container and released outside the container by the release mechanism. The medical system according to claim 32.

34. The pressure sensors are positioned outside the shunt, and are compressed by the container along the radial direction of the shunt, so as to be partially enclosed by the shunt. The medical system according to claim 33.

35. If the release mechanism includes an inner tube and an axial position restricting member, the implant further includes a hooking member, wherein when the implant is compressed, the hooking member is connected to the axial position restricting member, and when the implant expands, the hooking member is disconnected from the axial position restricting member. The medical system according to claim 33.

36. The implant further includes a signal receiving device for receiving signals from the wireless sensor. The medical system according to claim 33.