Delivery device and medical treatment system
By designing a conveyor device including container, external tube, internal tube, and end structure, the problem of difficulty transporting and release of diverse implants in existing technology can be solved. Convenient transportation and release have improved the convenience of handling and reduced damage to human tissues.
Patent Information
- Application Number
- PCT/CN2024/106561
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-07-21
- Filing Date
- 2024-07-19
- Publication Date
- 2025-01-30
AI Technical Summary
Existing delivery sheaths are difficult to quickly and easily transport and release diverse implants such as shunt stents and sensors with anchor structures to the target position of the human body, especially in shunt stents and straps arranged in the atrial septum. In the case of an anchor structure with self-expansion characteristics.
Design a conveyor device including container, external pipe, internal tube, and end structure. The container is used to accommodate implants, connects the outer pipe and container, and the internal tube runs through the container and external tube. The end structure is set at the distal end of the inner tube to selectively block or expose the outlet, thereby achieving the rapid transportation and release of implants.
Through this transportation device, the implant can be transported to the target position quickly and conveniently without complex operations, which significantly improves the convenience of control and reduces damage to human tissue.
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Figure CN2024106561_30012025_PF_FP_ABST
Abstract
Description
Delivery Devices and Medical Systems
[0001] Related applications
[0002] This application claims priority to the Chinese invention patent with patent application number 202310898704.4, application date 2023.07.21, and invention name “Delivery device and medical system”. Technical Field
[0003] The present application relates to the technical field of interventional medical devices, and in particular to a delivery device and a medical system. Background Art
[0004] In the field of Class III medical devices, delivery sheaths are an important medical device, primarily used to deliver implants into blood vessels, cavities, or other organs within the human body. Among these, the most common implants are stents, including vascular stents, shunt stents, occluders, and artificial valve stents. Other types of implants include various sensors with anchoring structures. As the structure, form, and use of implants become increasingly diverse, current delivery sheaths and their delivery methods are no longer able to meet the needs of some implants. For example, in the prior art, for a shunt stent placed in the atrial septum, a puncture needle is often used to first puncture the atrial septum to create a perforation, which is then expanded with a balloon catheter or dilator to allow placement of the subsequent shunt stent. Shunt stents are typically self-expanding in design, automatically expanding upon delivery to the perforation to engage the perforation wall. For another example, sensors with anchoring structures may also have self-expanding properties. For these types of implants, a delivery sheath is needed that can more quickly and conveniently deliver and release them into place.
[0005] Summary of the Invention
[0006] In order to overcome the above-mentioned defects of the prior art, the present application provides a delivery device and a medical system for solving one or more problems in the prior art.
[0007] In order to achieve the above objectives, the technical solutions adopted in this application are as follows:
[0008] The present application discloses a delivery device for delivering an implant to a target tissue via a cavity or channel of the human body, comprising: a container, the container comprising a receiving cavity for accommodating the implant and an outlet for discharging the implant; an outer tube, the outer tube being connected to and in communication with the container; an inner tube, the inner tube passing through the container and the outer tube and being detachably connected to the implant; and an end structure, the end structure being arranged at the distal end of the inner tube, the end structure being used to selectively block or expose the outlet.
[0009] The present application also discloses a medical system, comprising an implant and the aforementioned delivery device, wherein the delivery device is used to accommodate and deliver the implant.
[0010] The present application also discloses a delivery device for delivering an implant to a target location via a human body cavity or duct, comprising: a container for accommodating the implant, one end of the container having an outlet for discharging the implant; the container being provided with a signal transmission window; an outer tube having a tube body, a first end, and a second end, the outer tube being connected to the container through the first end and coaxially connected; and a release mechanism passing through the outer tube and the container, the release mechanism being used to connect the implant and control the axial relative position relationship between the implant and the container; wherein the implant includes a wireless sensor, and the release mechanism is configured to keep the implant in the container and align the wireless sensor with the signal transmission window.
[0011] The present application also discloses a medical system, comprising: an implant including a wireless sensor; and a delivery device, the delivery device being used to accommodate and deliver the implant; wherein the delivery device is the aforementioned delivery device.
[0012] Compared with the prior art, the present invention has the following advantages:
[0013] When the delivery device described in the embodiment of the present application is in use, the container is connected and communicated with the outer tube, and a receiving cavity for accommodating the implant and an outlet for discharging the implant are formed on the container. In addition, the inner tube runs through the container and the outer tube, the implant is detachably connected to the inner tube, and the end structure is arranged at the distal end of the inner tube, and the end structure is used to selectively block or expose the outlet. The present application arranges the end structure and the implant on the inner tube at the same time, and the inner tube and the end structure cooperate to block or expose the outlet, and the implant is detachably connected to the inner tube. When the outlet is exposed, the implant can also be separated from the inner tube to be released to the target position on the target tissue. The present application can achieve the delivery and control of the implant through the outer tube and the inner tube, so that the implant can be delivered to the target tissue and the implant can be released without complicated operations, which significantly improves the ease of operation of the delivery device.
[0014] Furthermore, in one embodiment, a balloon is used as an end structure to pre-expand the target tissue during the implant's delivery path, thereby facilitating placement of the implant within the target tissue. Furthermore, after the implant is delivered and placed within the target tissue, the balloon can also directly post-expand the implant during its withdrawal path, allowing for a tighter fit between the implant and the target tissue, enabling rapid, portable, and secure placement of the implant. Throughout this process, repeated movement of the inner tube is unnecessary, effectively preventing potential damage to human tissue during this process.
[0015] In another specific embodiment, the inner tube and the corresponding part of the container are arranged as an unconventional coaxial structure, but are offset to a certain extent, thereby not only achieving the effective loading of implants of specific structures (such as implants composed of a stent and a sensor), but also avoiding the impact of the container size being too large on the passing performance of the conveying device. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The following figures are intended only to illustrate and explain the present application and are not intended to limit the scope of the present application.
[0017] FIG1 is a schematic structural diagram of a conveying device in one embodiment of the present application;
[0018] FIG2 is a partial cross-sectional structural diagram of the conveying device in the embodiment shown in FIG1 of the present application;
[0019] FIG3 is a schematic cross-sectional view of a balloon in an expanded state according to an embodiment of the present application;
[0020] FIG4 is a schematic cross-sectional view of the balloon in a deflated state according to an embodiment of the present application;
[0021] FIG5 is a schematic cross-sectional view of an implant in a semi-released state according to an embodiment of the present application;
[0022] FIG6 is a schematic cross-sectional view of the implant in a fully released state according to one embodiment of the present application;
[0023] FIG7 is a schematic cross-sectional view of an inner tube offset in a container in one embodiment of the present application;
[0024] FIG8 is a schematic cross-sectional view of a first bending portion and a second bending portion in one embodiment of the present application, wherein the implant is omitted;
[0025] FIG9 is a side view schematic diagram of the structure of a balloon in one embodiment of the present application;
[0026] FIG10 is a schematic side view of the structure of a balloon in one embodiment of the present application;
[0027] FIG11 is a schematic side view of the structure of a balloon in one embodiment of the present application;
[0028] FIG12 is a schematic side view of the balloon in one embodiment of the present application;
[0029] FIG13 is a schematic cross-sectional view of a connecting socket according to an embodiment of the present application;
[0030] FIG14 is a schematic side view of the structure of a connecting socket according to an embodiment of the present application;
[0031] FIG15 is a schematic side view of a structure of an embodiment of the present application showing a second angle α;
[0032] FIG16 is a schematic side view showing a third angle γ of an embodiment of the present application;
[0033] FIG17 is a schematic diagram of the three-dimensional structure of a delivery device in an unreleased state according to an embodiment of the present application;
[0034] FIG18 is a schematic diagram of the three-dimensional structure of a delivery device in a semi-released state according to an embodiment of the present application;
[0035] FIG19 is a schematic diagram of the three-dimensional structure of a delivery device in a fully released state according to an embodiment of the present application;
[0036] FIG20 is a schematic diagram of the three-dimensional structure of a conveying device in a rearwardly expanded state according to an embodiment of the present application;
[0037] FIG21 is a schematic diagram of the three-dimensional structure of an implant according to an embodiment of the present application;
[0038] FIG22 is a schematic structural diagram of a conveying device in another embodiment of the present application;
[0039] FIG23 is a partial enlarged cross-sectional view of the distal end of the delivery device in FIG22;
[0040] FIG24 is a further enlarged view of the container of the delivery device of FIG23;
[0041] FIG25 is a schematic structural diagram of a first metal wire mesh on the surface of a container in an optional embodiment;
[0042] FIG26 is a schematic diagram showing the distribution of the first metal wire mesh on the surface of the container according to another embodiment of the present disclosure;
[0043] FIG27 is a schematic structural diagram of the first metal wire mesh in FIG26;
[0044] FIG28 is a schematic diagram of the internal structure of the distal end of the medical system according to an embodiment of the present disclosure;
[0045] FIG29 is a partial cross-sectional view of the distal end of the medical system of FIG28;
[0046] FIG. 30 is a schematic diagram of a medical system in which an implant is compressed. DETAILED DESCRIPTION
[0047] In order to have a clearer understanding of the technical features, purposes and effects of this application, the specific implementation methods of this application are now described with reference to the accompanying drawings.
[0048] It should be understood that the term "including" and its variations used in the present disclosure are open inclusions, that is, "including but not limited to". The term "based on" means "based at least in part on". It should be understood that although the terms "first" or "second" and the like may be used to describe various elements in the present disclosure, these elements are not limited by these terms, and these terms are only used to distinguish one element from another. The terms "proximal" and "distal" refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the operator's perspective. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device that is close to the doctor during normal operation, and "distal" generally refers to the end that first enters the patient's body.
[0049] Implementation Method 1
[0050] 1 , 2 , and 21 , an embodiment of the present application provides a delivery device for delivering an implant 10 to a target location on a target tissue 20 via a human body cavity or duct. As shown in FIG1 and FIG2 , the delivery device comprises a container 100, an outer tube 200, an inner tube 310, and an end structure 600. The container 100 comprises a cavity for accommodating the implant 10 and an outlet 110 (see FIG4 ) for discharging the implant 10. The outer tube 200 is connected to and communicates with the container 100, and preferably, the outer tube 200 and the container 100 are integrally formed. The inner tube 310 passes through the container 100 and the outer tube 200 and is configured to be detachably connected to the implant 10. The end structure 600 is disposed at the distal end of the inner tube 310 and is configured to selectively block or expose the outlet 110 of the container 100.
[0051] In this embodiment, after the implant 10 is loaded onto the inner tube 310, the end structure 600 and the implant 10 are both disposed on the inner tube 310 and the implant 10 is located within the container 100. By changing the relative position of the end structure 600 and the container 100, the outlet 110 can be selectively blocked or exposed. Preferably, the implant 10 includes a wireless pressure sensor. When the outlet 110 is exposed, blood can enter the container 100 through the outlet 110 and contact the wireless pressure sensor, thereby enabling intraoperative pressure measurement. The implant 10 is detachably connected to the inner tube 310. Therefore, when the container 100 and the implant 10 are gradually separated, the implant 10 can also be gradually separated from the inner tube 310 to be released to the target location on the target tissue 20. Of course, in other embodiments, the implant 10 can also be an independent stent without including a wireless pressure sensor.
[0052] The present application can achieve delivery and control of the implant 10 by controlling the outer tube 200 and the inner tube 310 , and can release the implant 10 without complicated operations, thereby significantly improving the ease of operation of the delivery device.
[0053] In an embodiment of the present application, as shown in FIG. 1 and FIG. 2 , the outer tube 200 is coaxially arranged with the container 100 , and the outer tube 200 and the container 100 can move axially relative to the end structure 600 so that the end structure 600 blocks or exposes the outlet 110 .
[0054] It is understandable that in other embodiments, the end structure 600 may be driven by the inner tube 310 to move along the axial direction of the container 100 to block or expose the outlet 110 .
[0055] In order to take into account the loading requirements of the implant 10 and the passability of the container 100, the size of the container 100 is larger than that of the outer tube 200. The container 100 is a circular tube structure, and the tube wall encloses a receiving cavity so that the implant 10 can be placed in the container 100.
[0056] Furthermore, as shown in Figure 21, the implant 10 includes a stent 16 made of shape memory material. The stent 16 is suitable for being sleeved on the inner tube 310 and being pressed onto the inner tube 310 under the constraint of the container 100. When the container 100 no longer constrains the stent 16, the stent 16 can self-expand to a set width and separate from the inner tube 310.
[0057] By utilizing stent 16 made of a shape-memory material, when stent 16 is removed from the container 100's accommodating cavity, it can separate from inner tube 310 and self-expand to a predetermined width, allowing stent 16 to be secured or preliminarily secured to target tissue 20. In this embodiment, target tissue 20 is the atrial septum within the heart, and stent 16 is a shunt, positioned within the atrial septum to direct blood flow from the left atrium to the right atrium. In other embodiments, stent 16 can also serve as an anchoring structure for other devices, such as sensors, to anchor them to target tissue 20.
[0058] It will be appreciated that when the distance between the container 100 and the end structure 600 is less than a preset value, the distance between the end structure 600 and the implant 10 remains unchanged. This preset value depends on the connection method between the implant 10 and the inner tube 310. Specifically, the preset value can be greater than or equal to the distance H1 between the end structure 600 and the component on the inner tube 310 that connects the implant 10, or the preset value can be equal to the distance H2 between the end structure 600 and the proximal end face of the implant 10. When H1 is greater than H2, the preset value is greater than or equal to H1; when H1 is less than or equal to H2, the preset value is equal to H2. It will be appreciated that the implant 10 is fully released into the target tissue 20 only when the container 100 no longer constrains the implant 10 and the connection component on the inner tube 310 is separated. The designer can adjust the specific numerical value of the preset value according to the actual use requirements (e.g., the length of the implant 10), and this is not specifically limited here. Preferably, the preset value is no greater than the length of the container 100.
[0059] More preferably, when at least a portion of the implant 10 is within the container 100, the distance between the container 100 and the end structure 600 is considered to be less than a predetermined value. That is, when at least a portion of the implant 10 is within the container 100 and the implant 10 is connected to the inner tube 310, the end structure 600 and the implant 10 move synchronously relative to the container 100 and the outer tube 200, and the distance between the end structure 600 and the implant 10 remains unchanged.
[0060] When the distance between the container 100 and the end structure 600 is greater than or equal to a predetermined value, the implant 10 separates from the inner tube 310 and self-expands to a predetermined width. As can be seen from the foregoing, when the distance is greater than or equal to the predetermined value, the implant 10 is removed from the container 100 and can be placed on the target tissue 20 to provide support thereto.
[0061] In an embodiment of the present application, the end structure 600 is a plug made of a polymer material. After the implant 10 is released into the target tissue 20, the outer tube 200 and the inner tube 310 are synchronously moved, causing the end structure 600 to be withdrawn from the interior of the implant 10 and re-block the outlet 110 of the container 100. Subsequently, by moving the outer tube 200 and the inner tube 310, the delivery device is completely withdrawn from the human body.
[0062] Implementation Method 2
[0063] In the first embodiment, since the end structure 600 is non-adjustable, after the stent 16 self-expands, if the inner diameter of the stent 16 is less than or equal to the outer diameter of the end structure 600, the end structure 600 will not be able to be withdrawn through the interior of the stent 16, so that this type of structural delivery device can only be suitable for stents 16 of a specific size. The size of the stent 16 is designed according to the needs of the hole on the atrial septum. For different groups of people, the stent 16 must have different sizes. For example, for younger children or smaller adults, the size of the stent 16 will be relatively small. On the other hand, in order to create a stoma on the atrial septum for setting the implant 10, the prior art uses a balloon catheter to expand the small hole after puncture, then withdraws the balloon catheter, and then uses a delivery device to release the implant 10 into the stoma. The puncture needle, balloon catheter and shunt stent 16 all need to be delivered into the human body separately for operation, which not only prolongs the operation time and increases the difficulty of operation, but also brings more operational risks to the operation itself.
[0064] In order to overcome the above problems, the conveying device of embodiment 1 is improved in the embodiments of the present application. The similarities are not repeated here, and the differences are described in detail as follows.
[0065] As shown in the embodiment of Figures 3 and 4, the end structure 600 includes a balloon 610, which has a first working state in which it is inflated and a second working state in which it is in deflated. When the balloon 610 is in the first working state, the balloon 610 can be used to move relative to the container 100 along the axial direction of the container 100 to block or expose the outlet 110. When the distal end of the delivery device enters the human body and approaches the target tissue 20, the balloon 610 can be used to expand the puncture hole to form an ideal perforation. After the perforation is formed, there is no need to withdraw the balloon 610, and the delivery device continues to be pushed so that the position of the implant 10 corresponds to the perforation, and then the implant 10 can be directly released. In this embodiment, the location of the perforation is the target position on the target tissue (atrial septum).
[0066] 5 and 6 , the outer tube 200 and the container 100 can be moved toward the proximal end to free the implant 10 from the container 100. Once the implant 10 is free from the container 100, it can be separated from the inner tube 310. During the separation process of the implant 10 from the inner tube 310, the balloon 610 remains stationary, always closer to the distal end of the implant 10 than the proximal end of the implant 10, and maintains an unchanged relative axial position with the implant 10.
[0067] When the implant 10 is completely separated from the inner tube 310, regardless of whether the size of the implant 10 after expansion is larger than the size of the balloon 610 in the inflated state, the balloon 610 can be transformed into a contracted state, so that the balloon 610 can not only be withdrawn through the implant 10 (specifically, the stent 16), but can also directly expand the stent 16 on the withdrawal path, so that the stent 16 can fully and tightly fit the side wall of the perforation on the target tissue 20.
[0068] In other feasible embodiments, when the balloon 610 is in a deflated state during withdrawal, the balloon 610 may not be used to post-expand the stent 16. It is understood that the doctor may choose whether to expand the stent 16 using the balloon 610 according to the needs of the surgical procedure.
[0069] The present application arranges the balloon 610 and the implant 10 together on the inner tube 310, and uses the inner tube 310 to control the state of the balloon 610, so that the balloon 610 can achieve both the front expansion of the target tissue 20 and the back expansion of the stent 16, and the balloon 610 can freely form an expanded state or a contracted state, thereby eliminating the need for repeated delivery and withdrawal of the balloon catheter, and also making the delivery device applicable to stents 16 of various sizes, greatly simplifying the surgical steps, reducing the pain suffered by patients, and lowering the learning curve of doctors.
[0070] In this embodiment, in order to better exert the post-expansion function of the balloon 610 on the stent 16, the length of the balloon 610 is greater than or equal to the length of the stent 16, so that when the balloon 610 is retracted, the balloon 610 can enter the interior of the stent 16 and fully expand the stent 16 in the axial direction of the stent 16.
[0071] Furthermore, the nominal width of the balloon 610 after expansion is greater than or equal to the set width of the stent 16, so that after the balloon 610 enters the interior of the stent 16, it can fully expand the stent 16 in the radial direction of the stent 16, which is conducive to the installation of the stent 16 in the target tissue 20. Specifically, because the stent 16 is compressed on the inner tube 310 during transportation, when it is released from the inner tube 310, its width after expansion (i.e., radial dimension) may be less than the set width, or the width of the stent 16 after release may be less than the set width because the perforation size does not reach the set width. Post-expansion of the stent 16 by the balloon 610 can further expand the stent 16 to the set width, thereby improving the fit and connection firmness between the stent 16 and the target tissue 20.
[0072] In this embodiment, the delivery device further includes a radiographic marker provided on the end structure 600. By providing the radiographic marker on the end structure 600, when the end structure 600 enters the human body, the radiographic marker can be visualized under X-rays, allowing the doctor to promptly and accurately obtain the real-time position of the end structure 600.
[0073] Specifically, the end structure 600 includes a balloon 610, and the imaging mark is provided on the balloon 610. When the balloon 610 passes through the vascular passage, the doctor can track the relative position of the balloon 610 in real time through the imaging mark.
[0074] When the balloon 610 is withdrawn into the stent 16, the doctor can determine whether the balloon 610 is aligned with the stent 16 based on the imaging mark. When the balloon 610 is in the stent 16, the balloon 610 is further inflated and the stent 16 is expanded by the balloon 610, so that the stent 16 and the target tissue 20 are more closely attached.
[0075] Of course, designers can adjust the specific structure of the imaging mark according to the needs of use, for example, the imaging mark can be at least one imaging ring or at least one imaging portion provided on the end structure 600, and there is no specific limitation here. Preferably, a imaging ring is provided at each end of the balloon 610.
[0076] When the developing mark is a developing ring, the developing ring cannot display the overall outline of balloon 610. That is, the expansion and contraction states of balloon 610 cannot be determined by the developing ring. Therefore, in another feasible embodiment of the present application, balloon 610 is made of a material with a developing function. By using a material with a developing function to make balloon 610, the expansion and contraction states of balloon 610 can be displayed. Designers can adjust the specific composition of the material with a developing function according to the needs of use, and no specific restrictions are imposed here.
[0077] In another possible embodiment of the present application, the balloon 610 may not be provided with a developing mark. Instead, a developing agent may be injected into the balloon 610 so that the balloon 610 is developed under X-rays to show the expanded or deflated state of the balloon 610. The specific composition of the developing agent may be adjusted by the designer according to the actual use, and is not specifically limited here.
[0078] Of course, in other feasible embodiments, designers can adjust the specific setting method of the development mark on the end structure 600 according to usage needs, and no specific limitation is made here.
[0079] When only the developer is used, the developer loses its developer property when the balloon 610 is contracted and removed, thereby making it impossible to determine the effective position of the balloon 610, while the developer ring can still work. Therefore, the preferred method is to use the developer ring and the developer in combination.
[0080] In an embodiment of the present application, as shown in Figures 9, 10, 11 and 12, a front expansion guide portion 611 and a rear expansion guide portion 612 are respectively 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; the cross-section of the front expansion guide portion 611 gradually decreases along the direction from the rear expansion guide portion 612 to the front expansion guide portion 611; and / or, the cross-section of the rear expansion guide portion 612 gradually decreases along the direction from the front expansion guide portion 611 to the rear expansion guide portion 612.
[0081] By respectively arranging a front expansion guide portion 611 and a rear expansion guide portion 612 at both ends of the end structure 600, and by setting both the front expansion guide portion 611 and the rear expansion guide portion 612 to be conical, it is beneficial to improve the transition smoothness at both ends of the end structure 600, so that the end structure 600 can better perform forward expansion and rear expansion operations, and at the same time block the outlet 110 of the container 100.
[0082] Of course, in other feasible embodiments, designers can adjust the specific shape and structure of the front expansion guide portion 611 and the rear expansion guide portion 612 according to usage requirements, and no specific restrictions are made here.
[0083] Implementation Method 3
[0084] With the advancement of various sensing technologies and processing techniques, the implant 10 also presents more structural features, such as the embodiment shown in Figure 21. For example, when the implant 10 is composed of two or more implant components combined side by side, its overall radial size will inevitably be larger than the size of a single implant component, so that the part of the delivery sheath used to load the implant 10 has to be increased accordingly, which will not only reduce the delivery performance of the delivery sheath, but also increase the risk of damage to the human body.
[0085] This embodiment is similar to Embodiments 1 and 2, and the similarities are omitted. The differences are detailed below. Implant 10 includes a sensor and a stent 16. When the sensor and stent 16 are combined, the overall volume of implant 10 is significantly larger than that of stent 16 alone. Furthermore, since the sensor itself is an incompressible, rigid component, the size of the container 100 of the delivery sheath needs to be increased to provide sufficient space for the sensor. To minimize the need for container 100, the sensor can also be minimized through processing. However, this places very high demands on both technical implementation and processing technology.
[0086] As shown in FIG7 , the inventors have proposed a new inner tube structure, whereby the inner tube 310 is offset within the container 100, thereby offsetting at least the main portion of the implant 10 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 sleeved outside the inner tube 310 and moves relative to the inner tube 310 to achieve delivery of the implant 10. However, in this embodiment, the portion of the inner tube 310 located within the container 100 (referred to as the loading section) is no longer coaxial with the container 100, but is offset to one side of the container 100's receiving cavity. This places the loading section of the inner tube 310 closer to one side wall of the container 100, creating a larger receiving space between the inner tube 310 and the other side wall of the container 100 for accommodating a rigid sensor. The bracket 16 is sleeved on the loading section. Since the bracket 16 is compressible, even if the receiving space between the inner tube 310 and one side of the container 100 is small, the sensor can still be loaded into the container 100.
[0087] By offsetting the loading section of the inner tube 310 into the accommodating cavity of the container 100 , the existing space of the container 100 can be fully utilized, thus avoiding unnecessary expansion of the overall size of the container 100 and reducing the requirement on the size of the sensor.
[0088] Furthermore, as shown in the embodiment of FIG7 , along the distal-to-proximal direction of the inner tube 310, the inner tube 310 includes a first extension section 311, a second extension section 312, and a third extension section 313. The first extension section 311 and the third extension section 313 extend in the same direction, while the second extension section 312 extends in a different direction from the first and second extension sections 311 and 312. The first extension section 311 serves as the loading section of the inner tube 310 and is used to load the implant 10. The axis of the first extension section 311 is offset to one side of the axis of the container 100; the implant 10 is disposed in the first extension section 311, and the stent 16 is sleeved within the first extension section 311.
[0089] Specifically, the first extension section 311 can be extended roughly parallel to the axis of the container 100 and offset to one side of the axis of the container 100, and the third extension section 313 can be extended roughly along the axial direction of the container 100, or the third extension section 313 can be extended roughly along the axial direction of the outer tube 200, so that the first extension section 311 and the third extension section 313 are staggered in the axial direction of the container 100.
[0090] By staggering the first extension section 311 and the third extension section 313 in the axial direction of the container 100, the first extension section 311 is offset to one side of the axis of the container 100, so that a larger cavity can be formed between the first extension section 311 and the container 100 to place the implant 10, thereby increasing the loading performance of the container 100, so that different types of implants 10 can be better loaded without increasing the volume of the cavity, thereby significantly improving the applicability of the delivery device.
[0091] In the embodiment of the present application, along the direction from the distal end to the proximal end of the inner tube 310 , a first port portion 613 and a second port portion 614 are formed at both ends of the end structure 600 .
[0092] Specifically, the first port portion 613 is substantially cylindrical and has a passage formed therein for sleeved on the inner tube 310. Furthermore, the second port portion 614 is substantially cylindrical and has a passage formed therein for sleeved on the inner tube 310.
[0093] The first and second end portions 613 and 614 facilitate increasing the axial connection length between the end structure 600 and the inner tube 310, thereby improving the installation stability of the end structure 600 on the inner tube 310. Designers can adjust the specific structure of the end structure 600 according to actual needs and are not specifically limited here.
[0094] In one feasible embodiment, as shown in FIG9 , the first port portion 613 and the second port portion 614 are coaxially arranged with the axis of the container 100. By coaxially arranging the first port portion 613 and the second port portion 614 with the axis of the container 100, the end structure 600 is substantially symmetrically arranged, thereby reducing the difficulty of manufacturing the end structure 600.
[0095] In another feasible embodiment, as shown in FIG. 10 , the first port portion 613 is coaxially disposed with the axis of the container 100 , and the second port portion 614 is coaxially disposed with the axis of the first extension section 311 .
[0096] Since the first port portion 613 is coaxially arranged with the axis of the container 100, and the second port portion 614 is coaxially arranged with the axis of the first extension section 311, the first port portion 613 and the second port portion 614 are staggered. Therefore, when the inner tube 310 is passed through the end structure 600, the part of the inner tube 310 connecting the first port portion 613 and the second port portion 614 is inclined relative to the container 100.
[0097] By arranging 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, thereby reducing or eliminating the radial misalignment between the first extension section 311 and the end structure 600, so that the guide wire 500 can pass through the first extension section 311 and the end structure 600 more smoothly.
[0098] In yet another feasible embodiment, as shown in FIG. 11 , the first port portion 613 and the second port portion 614 are coaxially disposed with the axis of the first extension section 311 .
[0099] By arranging the first port portion 613 and the second port portion 614 coaxially with the axis of the first extension section 311 , a straight channel connecting the first port portion 613 and the second port portion 614 can be provided inside the end structure 600 , which has better passability.
[0100] In yet another feasible embodiment, as shown in FIG. 12 , the first port portion 613 is coaxially disposed with the axis of the first extension section 311 , and the second port portion 614 is coaxially disposed with the axis of the container 100 .
[0101] As can be seen from the above, in order to increase the loading performance of the container 100, the axis of the first extension section 311 is offset and set on one side of the axis of the container 100, so that the first extension section 311 is misaligned with the axis of the container 100. On the one hand, it affects the passability of the guide wire 500 between the first extension section 311 and the third extension section 313; on the other hand, since the guide wire 500 needs to pass through the inner tube 310 and the end structure 600, when the first extension section 311 is offset and set, it is also easy to affect the passability of the guide wire 500 between the first extension section 311 and the end structure 600.
[0102] Therefore, in order to improve the passability between the first extension section 311 and the end structure 600 , preferably, the second end portion 614 is coaxially arranged with the axis of the first extension section 311 .
[0103] By offsetting the second port portion 614 at one side of the container 100 , the second port portion 614 can reserve more installation space for the implant 10 in the container 100 , while not affecting the various functions of the balloon 610 .
[0104] In an embodiment of the present application, such as the embodiment shown in Figures 3 and 4 , the end structure 600 includes a balloon 610, wherein a first end portion 613 and a second end portion 614 of the balloon 610 are respectively disposed on the inner tube 310; the length of the balloon 610 is greater than or equal to the length of the stent 16; and / or the nominal width of the balloon 610 after expansion is greater than or equal to the set width of the stent 16, so that when the implant 10 is separated from the inner tube 310, the balloon 610 can directly expand the stent 16 during the withdrawal path. Regardless of which configuration of the balloon 610 is shown in Figures 9 to 12 , the main body of the balloon 610 (i.e., the portion between the first end portion 613 and the second end portion 614) is always coaxially disposed with the cavity of the container 100, thereby enabling the balloon 610 to effectively block the outlet 110 of the container 100.
[0105] Specifically, by respectively 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 modes with the inner tube 310. Different from the balloon structure on the existing catheter, the balloon 610 can be an irregular balloon 610 (that is, at least one port portion of the balloon 610 is not coaxial with the main structure), thereby enabling selective blocking and exposure of the outlet 110 of the container 100. At the same time, by controlling the specific setting positions of the first port portion 613 and the second port portion 614, the first extension section 311 and the balloon 610 can have better passability, facilitating the passage of the guide wire 500.
[0106] In the embodiment shown in Figures 17 to 20 , the balloon 610 is disposed at the distal end of the inner tube 310 and enters the human body earlier than the implant 10. Once the balloon 610 reaches the target tissue 20, it can pre-dilate the target tissue 20, for example, pre-dilate the puncture hole in the atrial septum. Furthermore, by controlling the proximal withdrawal of the container 100 relative to the inner tube 310, the implant 10 can be released, allowing it to be placed in the atrial septum.
[0107] After the implant 10 is fully released, the inner tube 310 can be retracted to allow the balloon 610 to retract to the position of the stent 16 of the implant 10. When the implant 10 reaches the position of the stent 16 as determined by the imaging mark, the balloon 610 is further inflated and used to further expand the stent 16 to ensure a closer fit between the stent 16 and the target tissue 20. It is understood that in other embodiments, the end structure 600 can also be a conventional polymer plug.
[0108] In an embodiment of the present application, as shown in Figures 5, 6, 14, 16 and 21, the delivery device also includes a first connecting structure 740 arranged on the inner tube 310, and the implant 10 includes an implant body and a second connecting structure 17 (please refer to Figure 21, which is not shown in Figures 5, 6, 14, 16, etc. for indirect purposes); when the implant 10 is in the container 100, the implant 10 is connected to the first connecting structure 740 through the second connecting structure 17 to maintain the axial relative position of the implant 10 and the inner tube 310; when the implant 10 is out of the container 100, the second connecting structure 17 and the first connecting structure 740 can be automatically separated to release the implant 10.
[0109] Specifically, the implant 10 includes a bracket 16 made of a shape memory material. The bracket 16 is provided with a second connection structure 17 , and the inner tube 310 is provided with a first connection structure 740 .
[0110] In one embodiment, the second connecting structure 17 comprises a clamping arm disposed on the bracket 16, and the first connecting structure 740 comprises a protruding connecting block. Furthermore, multiple clamping arms may be provided, with the connecting blocks corresponding to the clamping arms. This, combined with multiple sets of clamping arms and connecting blocks, improves the stability of the connection between the implant 10 and the inner tube 310. Since the clamping arms of the bracket 16 are intended to clamp onto the atrial septum, employing the clamping arms as the second connecting structure 17, coupled to the first connecting structure 740, effectively simplifies the connection between the implant 10 and the inner tube 310 and conserves space within the container 100.
[0111] In this embodiment, the preset value corresponding to the spacing between the container 100 and the end structure 600 is equal to the distance between the end structure 600 and the proximal end surface of the first connecting structure 740 and the width of the clamping arm. After the container 100 moves to the proximal end surface of the first connecting structure 740, the container 100 abuts against the end of the clamping arm. After the container 100 continues to move toward the proximal end and leaves the clamping arm, the bracket 16 is completely released.
[0112] Of course, in other feasible embodiments, designers can adjust the specific structures of the first connecting structure 740 and the second connecting structure 17 according to usage requirements, and no specific limitations are imposed herein.
[0113] When the bracket 16 is in the container 100, the container 100 can restrict the state of the bracket 16, and the bracket 16 cannot be unfolded. Then the bracket 16 is connected to the first connecting structure 740 through the second connecting structure 17 to maintain the axial relative position of the bracket 16 and the inner tube 310.
[0114] Generally speaking, when stent 16 is deployed, the clamping arms and the main body of stent 16 are substantially perpendicular to each other. Therefore, when stent 16 is released from container 100, stent 16 automatically deploys, simultaneously driving the clamping arms to return to a predetermined position, separating second connecting structure 17 from first connecting structure 740, thereby releasing the axial relative position of stent 16 and inner tube 310. Furthermore, after separation from inner tube 310, stent 16 can self-expand to a predetermined width, thereby enabling stent 16 to be placed in the perforation of target tissue 20.
[0115] The present application significantly improves the structural stability between the implant 10 and the inner tube 310 by setting the first connecting structure 740 and the second connecting structure 17, so that the implant 10 can be accurately and quickly released in the target tissue 20, thereby improving the implantation accuracy and portability of the implant 10, effectively simplifying the connection method between the implant 10 and the inner tube 310, and saving the internal space of the container 100.
[0116] Implementation Method 4
[0117] This embodiment is similar to the third embodiment, and the similarities are not repeated here. The differences are described in detail below.
[0118] For embodiment three, when the second extension section 312 is shorter, the first extension section 311 and the third extension section 313 may undergo a sudden change in the radial direction of the container 100, which may easily affect the passability of the guide wire 500 channel of the inner tube 310, making it impossible for the guide wire 500 to smoothly pass through the inner tube 310, thereby affecting the subsequent surgical positioning.
[0119] In this embodiment, as shown in Figures 14 to 16 , the inner tube 310 is provided with a connector that can be received within the container 100. The connector includes a connector seat 700 having a first connecting structure 740 disposed thereon. The connector seat 700 is formed with an eccentric passage 730 through which the inner tube 310 passes. The connector seat 700 extends along a first predetermined direction F. A first angle β is formed between the first predetermined direction F and the axis of the eccentric passage 730. The first angle β ranges from 0° to 60°, preferably from 15° to 30°. The first predetermined direction F can be aligned with the axis of the container 100.
[0120] Specifically, the connecting base 700 can be received in the container 100 and positioned between the first extension section 311 and the third extension section 313. Furthermore, since the first extension section 311 and the third extension section 313 are offset from each other, an eccentric channel 730 for the inner tube 310 to pass through is formed on the connecting base 700 to prevent the connecting base 700 from affecting the passability of the inner tube 310 and to further ensure a smoother transition between the first extension section 311 and the third extension section 313.
[0121] Preferably, as shown in the embodiments of Figures 8 and 13 , the eccentric channel 730 has a tendency to tilt from the third extension section 313 toward the first extension section 311. Furthermore, the inner wall of the eccentric channel 730 may be provided with a threaded structure for installation. The provision of the eccentric channel 730 ensures a smooth transition length of the inner tube 310 within the eccentric channel 730, thereby improving the passability of the guidewire 500.
[0122] The outer contour of the connecting base 700 and the container 100 can be coaxially matched, and the first connecting structure 740 on the connecting base 700 can be tightly matched with the inner wall of the container 100, with no gap between the two. This prevents the second connecting structure 17 on the bracket 16 from falling through the gap between the first connecting structure 740 and the container 100, thereby improving the installation stability between the bracket 16 and the connecting base 700. It will be understood that the container 100 can be made of a polymer material, and the inner wall of the container 100 can be smooth. When the first connecting structure 740 and the inner wall of the container 100 are tightly matched, or even have a certain interference fit, the first connecting structure 740 and the container 100 can still maintain relative movement.
[0123] In other embodiments, the first connecting structure 740 on the connecting seat 700 may also be loosely fitted with the inner wall of the container 100 to improve the passing ability of the connecting seat 700 in the container 100 and avoid interference between the connecting seat 700 and the inner wall of the container 100, thereby affecting the release of the implant.
[0124] Designers can adjust the size of the first angle β according to usage requirements. For example, the first angle β can be 10°, 20°, 30°, etc., and no specific numerical value is limited here.
[0125] By arranging the connection seat 700 on the inner tube 310 and arranging the first connection structure 740 on the connection seat 700 , the structure of the inner tube 310 is avoided from being affected, and the difficulty of processing and installing the inner tube 310 is reduced.
[0126] Of course, in other feasible embodiments, designers can adjust the specific structure of the connector according to usage requirements, and no specific restrictions are imposed here.
[0127] Furthermore, as shown in the embodiment of Figure 16, the first preset direction F is parallel to the axial direction of the container 100 or the first preset direction F has a third angle γ with the axial direction of the container 100, and the range of the third angle γ is 0° to 60°, preferably, 15° to 30°.
[0128] Designers can adjust the specific size of the third angle γ according to usage needs. For example, the third angle γ can be 5°, 10°, 15°, 20° or 25°, etc., and no specific limitation is made here.
[0129] In an embodiment of the present application, as shown in FIG8 , the outer tube 200 has a first bending portion 201 , and the inner tube 310 has a second bending portion 316 . When the end structure 600 blocks the outlet 110 , the first bending portion 201 and the second bending portion 316 are correspondingly arranged.
[0130] Specifically, the first bend 201 is disposed near the container 100, and the second bend 316 is disposed near the connector. By providing the first bend 201 on the outer tube 200 and the second bend 316 on the inner tube 310, the first bend 201 and the second bend 316 cooperate to achieve a predetermined bending angle at the distal end of the delivery device, thereby making it easier to position the container 100 when facing tissue at a specific location or structure (e.g., the atrial septum).
[0131] When the outer tube 200 has a first bending portion 201 and the inner tube 310 has a second bending portion 316, if the connecting seat 700 is set at the bending portion, the connecting seat 700 may cause structural interference with the bent portion of the container 100, thereby causing problems such as damage to the container 100.
[0132] In order to solve the above problems, in an embodiment of the present application, such as the embodiment shown in Figures 13 and 14, along the distal end of the inner tube 310 to the proximal end of the inner tube 310, the connecting seat 700 includes a first seat body 710 and a second seat body 720 connected to each other, the first seat body 710 is cylindrical, and the first connecting structure 740 is arranged on the first seat body 710; the second seat body 720 is frustum-shaped, the second seat body 720 is connected to the first seat body 710, and the eccentric channel 730 passes through the first seat body 710 and the second seat body 720, the second seat body 720 has a first end and a second end, and the radial dimension of the first end is larger than the radial dimension of the second end.
[0133] By forming an eccentric channel 730 on the first seat body 710 and the second seat body 720, the eccentric channel 730 is longer than the straight channel, and the eccentric channel 730 is tilted, so that the eccentric channel 730 can provide a better smooth transition for the inner tube 310, and can extend and drive the inner tube 310 to achieve synchronous unidirectional offset with the implant 10 in advance, which is beneficial to reduce the sudden change in the extension direction of the inner tube 310 at the connecting seat 700, prevent the guide wire 500 channel in the inner tube 310 from being lost, and ensure the passability of the guide wire 500 in the inner tube 310.
[0134] In the embodiment shown in Figure 15, the second end of the second seat body 720 is formed with an orifice end face 750, the orifice end face 750 is perpendicular to the axis of the eccentric channel 730, and the eccentric channel 730 passes through the orifice end face 750; the second seat body 720 is also provided with an avoidance end face 760, at least a portion of the avoidance end face 760 is connected to the orifice end face 750, and the remaining portion of the avoidance end face 760 is set away from the proximal end of the inner tube 310, and a second angle α is formed between the avoidance end face 760 and the vertical direction, and the range of the second angle α is 0° to 60°, preferably, 15° to 30°. That is, the avoidance end face 760 is tilted from the second seat body 720 toward the first seat body 710. The connecting seat 700 can reserve more space in the container 100 through the avoidance end face 760 to play an avoidance role, thereby helping to improve the adaptability between the connecting seat 700 and the container 100, reduce or eliminate the interference problem between the two, and prevent the connecting seat 700 from causing damage to the container 100.
[0135] Designers can adjust the size of the second angle α according to usage requirements. For example, the second angle α can be 10°, 20°, 30°, 40° or 50°, etc., and there is no specific limitation here.
[0136] Furthermore, as shown in the embodiment of Figure 7, the inner tube 310 also includes a fourth extension section 314, which is located between the second extension section 312 and the third extension section 313. The fourth extension section 314 is used to pass through the eccentric channel 730, and the angle between the fourth extension section 314 and the axis of the container 100 is smaller than the angle between the second extension section 312 and the axis of the container 100.
[0137] By controlling the angle between the fourth extension section 314 and the axis of the container 100, the inclination amplitude between the fourth extension section 314 and the second extension section 312 is gradually increased, which is beneficial to improving the transition smoothness between the fourth extension section 314 and the second extension section 312, thereby improving the passability of the inner tube 310.
[0138] Designers can adjust the angle between the fourth extension section 314 and the axis of the container 100 and the angle between the second extension section 312 and the axis of the container 100 according to usage needs, and no specific numerical value is imposed here.
[0139] In addition, an end channel is formed on the end structure 600. In the embodiment shown in Figure 7, the inner tube 310 also includes a fifth extension segment 315, which is arranged on the other side of the first extension segment 311 relative to the second extension segment 312, and the fifth extension segment 315 runs through the end channel; the inner tube 310 has an inner cavity, which can be used to set the guide wire 500.
[0140] Specifically, the end channel passes through the first port portion 613 , the body of the end structure 600 , and the second port portion 614 , and the fifth extension section 315 passes through the end channel.
[0141] Since the connecting seat 700 is arranged in 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 in the container 100 needs to pass through the gap between the connecting seat 700 and the inner wall of the container 100. However, due to the size of the gap, it is difficult for the liquid and / or gas to pass through the connecting seat 700 efficiently, thereby generating a damping effect and reducing the movement efficiency between the inner tube 310 and the container 100.
[0142] In order to solve the above problems, in an embodiment of the present application, as shown in the embodiment of FIG14 , a flow guiding structure 770 is provided on the connecting piece, and the flow guiding structure 770 communicates with the accommodating cavities of the container 100 located on both sides of the connecting piece.
[0143] Specifically, the connector includes a connector base 700, and the flow-guiding structure 770 includes flow-guiding grooves disposed on the connector base 700. The flow-guiding grooves communicate with the inner cavities of the containers 100 located on both sides of the connector base 700. The flow-guiding grooves can improve the flow capacity of liquid and / or gas, thereby reducing or eliminating damping during relative motion between the connector base 700 and the container 100, thereby improving motion efficiency. More preferably, the flow-guiding grooves are disposed on the second base body 720.
[0144] In an embodiment of the present application, the end structure 600 includes a balloon 610 , and an overflow structure is further provided on the inner tube 310 . The overflow structure has an injection channel, and the injection channel is connected to the inner cavity of the balloon 610 .
[0145] Specifically, the overflow structure includes at least one overflow port arranged on the inner tube 310, which connects the injection channel and the inner cavity of the balloon 610, so that the filling liquid can be injected into the balloon 610 or discharged from the balloon 610 through the injection channel, thereby facilitating the control of the expansion and contraction state of the balloon 610.
[0146] Furthermore, the inner tube 310 includes a first tube body and a second tube body inserted in the first tube body. The inner cavity of the second tube body forms a guide wire 500 channel, and the gap between the first tube body and the second tube body forms an injection channel.
[0147] Of course, in other feasible embodiments, designers can adjust the molding method of the injection channel according to usage requirements, and no specific limitation is made here.
[0148] In an embodiment of the present application, such as the embodiment shown in FIG1 , the delivery device further comprises a release mechanism 300, which comprises an inner tube 310 and a control mechanism 400, wherein the control mechanism 400 is configured to adjust the axial relative position between the inner tube 310 and the container 100. The control mechanism 400 is configured to enable the container 100 to move axially relative to the inner tube 310 between a first position and a second position. When the container 100 is in the first position, the implant 10 is located within the container 100. When the container 100 moves from the first position to the second position, the implant 10 is axially released from the outlet 110 of the container 100.
[0149] Specifically, the control mechanism 400 can be a handle. In this embodiment, the control mechanism 400 includes an actuator 410 and an auxiliary member 420. The axial position of the auxiliary member 420 is fixed, and the actuator 410 can move axially on the auxiliary member 420. The actuator 410 is also connected to the outer tube 200, so that the actuator 410 can drive the outer tube 200 to move axially when moving axially. The proximal end of the inner tube 310 is fixed in the auxiliary member 420 of the control mechanism 400, and the axial relative position between the inner tube 310 and the auxiliary member 420 remains unchanged. In this way, the inner tube 310 and the outer tube 200 can be moved axially relative to each other by moving the outer tube 200 axially forward or backward. In this embodiment, the control mechanism 400 can control the movement of the outer tube 200 to cause the relative position of the inner tube 310 and the outer tube 200 to change (relative motion). In other embodiments, the control mechanism 400 can also control the movement of the inner tube 310 to cause the relative position of the inner tube 310 and the outer tube 200 to change (relative motion).
[0150] In the embodiment of the present application, please refer to the embodiments shown in Figures 17 to 20, which also provide a specific use step of the delivery device. The implant 10 includes a stent and a wireless pressure sensor:
[0151] Operate the release mechanism 300 to expose the first extension section 311 at the distal end of the inner tube 310, so that the balloon 610 is in a contracted state; load and fix the implant 10 on the first extension section 311, and connect the first connecting structure 740 with the second connecting structure 17, and then operate the release mechanism 300 until the implant 10 is completely recovered into the container 100; use the pressure filling device to empty the handle, implant 10 and inner tube 310 through the standard Luer seat of the handle; use the pressure filling device with a readable pressure value to fill the balloon 610 to the nominal pressure with a 1:1 contrast agent and saline solution; under the guidance of the image device, through the prepared vascular access guide wire 500, the delivery system is sent along the guide wire 500 to the release position of the implant 10; based on the operator's assessment of the lesion location and the lesion location, if the lesion access or perforation needs to be expanded, pre-expansion treatment can be directly performed through the balloon 610 until the ideal implantation requirements of the implant 10 are achieved; the position of the implant 10 and the container After the position of the device 100 is confirmed to be correct by the image guidance device and the surgeon, the pressure of the balloon 610 is quickly relieved through the pressure filling device, the pressure is detected in real time, the pressure value is read, and then the pressure is gradually released until it reaches a safe and retrievable point, and the accuracy of the implantation position is confirmed again; if the release position is not ideal, the implant 10 is quickly recovered in situ and then withdrawn to a safe position; then the balloon 610 is inflated to the nominal pressure through the pressure filling device again, and the above steps are repeated to perform the re-implantation and release work; after confirming that the release position is correct, the implant 10 is completely released; after the image guidance device confirms that the release position of the implant 10 is correct, under the image guidance device, the balloon 610 is first withdrawn to the corresponding position of the implant 10, and then the balloon 610 is inflated and expanded by the balloon 610 pressure filling device to achieve post-expansion treatment of the implant 10 and the lesion position; after the post-expansion treatment is completed, the pressure of the balloon 610 is completely relieved, and then the inner tube 310 is withdrawn from the body along the guide wire 500.
[0152] Implementation Method Five
[0153] The present application also provides a medical system, which includes an implant 10 and a delivery device as described in any one of embodiments one to four, wherein the delivery device is used to accommodate and deliver the implant 10.
[0154] The specific structure, operating principle, and beneficial effects of the delivery device are the same as those of any of Embodiments 1 to 4 and are not further described herein. The medical system utilizes the delivery device of Embodiment 1 to perform forward expansion of the target tissue 20 and, on the retraction path, further perform post-expansion of the implant 10, thereby enabling the implant 10 to be more securely positioned.
[0155] In an embodiment of the present application, implant 10 includes a stent 16 and a wireless sensor disposed in parallel with stent 16. Furthermore, stent 16 includes a stent body and a covering, and the stent body has a second connecting structure 17. In one embodiment, second connecting structure 17 includes a clamping arm disposed on the stent body. The clamping arm can be engaged with first connecting structure 740 on connector 700 to secure implant 10 to inner tube 310 and release it from inner tube 310.
[0156] In an embodiment of the present application, the medical system further includes a guide wire 500, which is used to be arranged in the inner tube 310. Specifically, the diameter of the guide wire 500 is smaller than that of the inner tube 310. Designers can adjust the specific structure of the guide wire 500 according to the needs of use. For example, the guide wire 500 is a slender metal wire, which is not specifically limited here. In addition, the guide wire 500 has a larger support strength and a smaller diameter, so that the guide wire 500 is easier to bend in the human body tube. The guide wire 500 can play a guiding role, so that when the inner tube 310 is sleeved on the guide wire 500, the inner tube 310 can move along the guide wire 500 to the target tissue 20.
[0157] Although in the above embodiments, the implants are atrial septal shunt stents and sensors as examples, those skilled in the art will appreciate that the delivery device disclosed in this application can be applied to various implants, including but not limited to cardiovascular stents.
[0158] Implementation Method 6
[0159] In many situations, doctors need to monitor physiological parameters to assess patients' physical condition. If these parameters are abnormal, prompt action is required. For example, if a patient's left ventricular pressure is too high, prompt intervention and treatment are needed to reduce the pressure. In in-hospital settings, such as hospitals, surgeons can achieve this by inserting an interventional catheter equipped with a sensor into the body. Alternatively, surgeons can implant a wireless sensor to allow patients to move freely.
[0160] However, the inventors discovered that during the entire implantation process of wireless sensors or other implants being implanted into the human body via a delivery device, it is sometimes necessary to monitor certain physiological parameters within the patient's body. In these cases, a common approach is to use another set of invasive sensing catheters to place the corresponding sensors at specific locations elsewhere in the body. However, this approach not only increases the incision and pain for the patient, but also increases surgical time and consumable costs. Furthermore, due to differences in the implantation process and target location between the invasive sensing catheters and the delivery device, data deviations are inevitable, resulting in time lags and low accuracy.
[0161] Embodiments of the present disclosure provide a delivery device for delivering an implant to a target location via a human body cavity or duct. The implant can be a wireless sensor for measuring physiological parameters within a human body cavity or duct, or it can be a combination of another implantable component and a wireless sensor, such as a combination of a shunt for atrial bypass surgery and a wireless pressure sensor. The delivery device includes a container, an outer tube, and a release mechanism. The container is used to hold 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 body, a first end, and a second end. The outer tube is coaxially connected to the container through the first end. The release mechanism extends through the outer tube and the container. The release mechanism is used to connect the implant and control the axial relative position of the implant and the container. The release mechanism is configured to retain the implant in the container and align the wireless sensor with the signal transmission window. When performing an interventional procedure using the delivery device provided by embodiments of the present disclosure, the implant can be held in the container and the release mechanism configured to align the implant with the signal transmission window. In this way, during the implantation process, the implant can also collect information and send the information to the outside of the human body through the signal transmission window, so that real-time and accurate physiological parameters can be obtained during the intervention process. The alignment or alignment of the wireless sensor and the signal transmission window referred to in this application means that the wireless sensor corresponds to the signal transmission window in the axial direction. Furthermore, the wireless sensor may include a signal acquisition unit and a wireless signal transmitting unit. Therefore, it is also sufficient that only the wireless signal transmitting unit in the wireless sensor corresponds to the signal transmission window in the axial direction, that is, the signal of the wireless signal transmitting unit can be transmitted to the receiving device outside the body through the signal transmission window without hindrance, and this application does not impose any restrictions on comparison.
[0162] The delivery device provided by the present disclosure is used to deliver an implant including a wireless sensor to a target location. It not only enables the wireless sensor to perform monitoring and diagnostic functions after being implanted, but also, by setting a signal transmission window in the container that holds the implant, the wireless sensor can also play a role in the entire delivery process, transmitting the sensed information to the outside of the human body through wireless signals, thereby realizing real-time and accurate monitoring of human physiological parameters during the intervention process. There is no need to implant other interventional sensing catheters during the operation, which not only reduces the patient's trauma and pain, but also realizes a change in the entire surgical procedure, effectively reducing the operation time, reducing the difficulty of the operation, and reducing the cost of the operation.
[0163] Refer to Figures 22 to 24. Figure 22 is a schematic structural diagram of a delivery device according to an 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.
[0164] The delivery device includes a container 100, an outer tube 200, a release mechanism 300, a control mechanism 400, and a guidewire 500. The container 100 and the control mechanism 400 are located at both ends of the outer tube 200. The release mechanism 300 extends through the container 100 and the outer tube 200 and is connected to the control mechanism 400. The control mechanism 400 allows the user to grasp and manipulate the release mechanism 300. The guidewire 500 guides the outer tube 200.
[0165] The container 100 is a circular tube with a conical outer wall forming a receiving cavity. One end of the container 100 has a tapered outlet 110, and the other end is connected to the outer tube 200. In this embodiment, the outer diameter of the container 100 is larger than that of the outer tube 200 to maximize the capacity of the implant 10 while minimizing the overall diameter, improving its flowability and minimizing damage to human tissue during implantation. Of course, in other embodiments, the outer diameter of the container 100 can also be equal to that of the outer tube 200. In this embodiment, a first wire mesh 150 is also provided within the wall of the container 100 to increase strength. The first wire mesh 150 is woven from a plurality of front-end wires 159. The front-end wires 159 can be elastic wires such as stainless steel, nickel-titanium, or copper. The first wire mesh 150 surrounds the sidewalls of the container 100 but does not completely cover them. This is because the first wire mesh 150 is not a complete cylindrical structure, but rather has an open area 155 in the middle. The opening area 155 is the entire cylindrical area between position a and position b. No metal wire passes through the opening area 155, forming a signal transmission window 140. The signal transmission window 140 is not a physical opening formed by the lack of material in the container 100, but an invisible opening that does not hinder the transmission of wireless signals. The first metal mesh 150 itself is used to increase the strength of the container 100, but from an electrical perspective, its mesh structure forms an electromagnetic shield that shields electromagnetic signals. Since there are no metal wires or other shielding structures in the opening area 155, it does not hinder the transmission of electromagnetic signals, and therefore can be called a signal transmission window 140. In other words, the signal transmission window is not provided with any shielding structure that would hinder signal transmission.
[0166] In this embodiment, the first metal mesh 150 comprises two independent mesh cylinders on either side of the signal transmission window 140. Specifically, the two mesh cylinders are woven from two groups of metal wires. At position a, these metal wires are connected and fixed to each other. From position b, the weaving continues using the same or different numbers of metal wires.
[0167] In an optional embodiment shown in Figure 25, the first wire mesh 150 is woven from a single set of wires, comprising a first wire 151, a second wire 152, a third wire 153, and a fourth wire 154. The first wire 151 and the second wire 152 are spirally wound counterclockwise around the tube body, while the third wire 153 and the fourth wire 154 are wound clockwise around the tube body. At position a, the wires are no longer spirally wound but continue to extend parallel to the axial direction. After extending a predetermined distance, the wires continue to spirally wind at position b. Furthermore, when the four wires extend in parallel, the circumferential spacing is smaller, thus occupying a smaller area. This arrangement eliminates the need to cut the wires at position a to terminate the weaving process; the same set of wires can be used to continue weaving at position b, simplifying the weaving process without significantly reducing the strength of the tube section where the signal transmission window 140 is located. Between positions a and b, the wires extend in parallel, thus not forming a woven structure and having a minimal impact on wireless signal transmission. Furthermore, the metal wire is not disconnected between position a and position b, so that the strength of the container 100 is not significantly weakened at this position.
[0168] In other alternative embodiments, the metal wires extend parallel to each other between positions a and b and are evenly distributed circumferentially, forming a non-woven area, rather than being concentrated in a narrow area. As long as the metal wires do not cross and are appropriately spaced, the non-woven area will not significantly affect signal transmission, thereby forming a signal transmission window.
[0169] In other optional embodiments, between position a and position b, the metal wires are arranged more densely when extending in the axial direction or are woven into a mesh belt on one side. At this time, the metal wires may have a certain impact on signal transmission, but one or more larger opening areas without metal mesh or metal wire distribution can still be made, and the opening areas form signal transmission windows.
[0170] In other embodiments, the metal wire before position b may be completely omitted; or, no metal wire may be provided in the tube wall of the container 100. In this case, the tube wall of the entire container forms a signal transmission window, which is not limited in this application.
[0171] Preferably, the wall of the container 100 is further provided with a side hole 120, and the side hole 120 is located distal to the signal transmission window 140. There may be one or more side holes 120. During a transarterial interventional procedure, blood can enter the container 100 through the side holes 120, allowing the sensor in the container 100 to measure physiological parameters such as blood pressure.
[0172] The outer tube 200 is an elongated tube comprising a body 230, a first end 210, and a second end 220. The outer tube 200 is a slender flexible tube formed of a polymer material. A second wire mesh 250 formed of a rear section of wires 259 is disposed within the body 230. The second wire mesh 250 serves to enhance the outer tube 200's torsional resistance. The rear section of wires 259 may be an elastic wire, such as stainless steel. The outer tube 200 is coaxially connected to the container 100 via the first end 210 and is connected to the control mechanism 400 via the second end 220. Preferably, the front section of wires 159 and the rear section of wires 259 are a single set of wires. That is, the wires forming the second wire mesh 250 extend into the container 100 and are woven together to form the first wire mesh 150.
[0173] 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 passes through the outer tube 200 and the container 100 from within the outer tube 200. The plug 320 has a shuttle-shaped structure with a central through-hole along its length. The plug 320 is inserted into the inner tube 310 through the central through-hole and positioned at the outlet 110 of the container 100. One end of the plug 320 can be partially inserted into the outlet 110 to block it. The portion of the inner tube 310 located within the container 100 is used to connect to the implant 10. When the inner tube 310 moves axially relative to the container 100, it can drive the implant 10 to move axially relative to the container 100. The plug 320 can also move axially with the inner tube 310, thereby blocking the outlet 110 or partially disengaging from the outlet 110 to form an annular top gap 130. The top gap 130 provides communication between the interior and exterior of the container 100. During transarterial intervention, blood can enter the container 100 through the headspace 130, allowing sensors within the container 100 to measure physiological parameters such as blood pressure. Of course, the side holes 120 provided in the wall of the container 100 allow blood to enter the container 100 without moving the inner tube 310. Therefore, the provision of the side holes 120 can simplify surgical procedures and prevent damage to body tissues caused by movement of the inner tube 310 during delivery.
[0174] The release mechanism 300 is configured to allow the inner tube 310 to move axially relative to the container 100 between a first position and a second position. When the inner tube 310 is in the first position, the implant 10 is positioned within the container 100 and corresponds to the signal transmission window. As the inner tube 310 moves from the first position to the second position, the implant 10 is axially released from the outlet 110 of the container 100 and placed at the target position. Furthermore, the release mechanism 300 is configured such that when the implant 10 is positioned within the container 100 and corresponds to the signal transmission window, the side hole 120 is located at the sensing end (e.g., distal end) of the wireless sensor of the implant 10, thereby allowing blood flowing through the side hole 120 to directly contact the implant 10, thereby enabling the sensor in the implant 10 to directly measure physiological parameters.
[0175] The control mechanism 400 can be a handle. It is used to control the axial relative position of 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 is fixed in axial position, while the actuator 410 is axially movable on the auxiliary member 420. The actuator 410 is also connected to the outer tube 200, so that when the actuator 410 moves axially, it can drive the outer tube 200 to move axially. The proximal end of the inner tube 310 is fixed in the control mechanism and maintains a constant axial relative position with the auxiliary member 420. Thus, axially moving the outer tube forward or backward causes axial movement between the inner tube 310 and the outer tube 200, allowing the implant secured to the inner tube 310 to move axially relative to the container at the end of the outer tube. This allows the implant to be positioned on the inner tube 310 before implantation and to be removed axially from the opening of the container once the implant reaches its target location. Those skilled in the art will understand that in other embodiments, the control mechanism 400 may also include an actuator connected to the inner tube, which actuates the inner tube and relatively fixes the outer tube to achieve axial relative movement between the inner tube and the outer tube. Since various known catheter handle structures can achieve relative position control between the outer tube and the inner tube, this application will not elaborate on this.
[0176] 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 sleeved on the guide wire 500. The guide wire 500 has greater support strength and a smaller diameter, making it easier to bend and provide guiding support in the human body.
[0177] Refer to Figures 26 and 27. Figure 26 is a schematic diagram of the distribution 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 diagram of the structure of the first metal wire mesh in Figure 26. In this embodiment, the first metal wire mesh includes a first opening area 155a and a second opening area 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 parallel to the axial direction at position a from the first side of the container 100 (the second channel 170 in Figure 26, or the upper side in Figure 27), and the second metal wire 152 and the fourth metal wire 154 extend parallel to the axial direction at position a from the second side of the container 100 (the first channel 160 in Figure 26, or the lower side in Figure 27). In this way, the first opening area 155a and the second opening area 155b are formed.
[0178] Refer to Figures 28 to 30. Figure 28 is a schematic diagram of the internal structure of the distal end of a medical system according to an 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 implant in the medical system in a compressed state.
[0179] The medical system includes an implant 10 and a delivery device. Implant 10 has a sensor 11. Sensor 11 is used to measure one or more parameters including temperature, flow, pressure, acceleration, vibration, pH value, conductivity, dielectric constant, component composition, component content, and sound waves. The delivery device is used to accommodate and deliver the implant. The delivery device can be any of the aforementioned embodiments.
[0180] In one possible embodiment, implant 10 is a combination of a shunt and a wireless sensor, wherein the wireless sensor is a pressure sensor. The shunt is compressed within a container and can be released outside the container by a release mechanism. Specifically, implant 10 includes a wireless sensor 11 and an expandable shunt 12. Wireless sensor 11 is used to measure blood pressure. Sensor 11 includes a pressure detection element 14 and a wireless signal transmission element 15. The wireless signal transmission element is aligned with a signal transmission window 140. Shunt 12 is positioned in the atrial septum to direct blood flow from the left atrium to the right atrium. An axial stopper 330 is also provided on the inner tube 310. Implant 10 includes a hook 13 connected to the axial stopper 330 to maintain its relative position relative to the inner tube 310 during implantation. Upon reaching the target position, as implant 10 is released from the constraints of container 100, hook 13 expands along with shunt 12 and returns to its original shape. During radial expansion, the hook 13 separates from the axial stopper 330. Specifically, the axial stopper 330 has a stopper groove, while the hook 13 has a stopper plate. When the hook 13 is compressed, the stopper plate is radially and detachably engaged with the stopper groove. During the restoration of the hook 13, the stopper plate disengages from the stopper groove, thereby also separating axially from the axial stopper 330.
[0181] In one possible embodiment, the hook 13 may be a rod-shaped element that does not expand itself, but can follow the compression and expansion of the diverter 12 to move closer to or further away from the axial stop 330, thereby achieving engagement or separation. It should be understood that the distance between the diverter 12 and / or the hook 13 and the inner wall of the container is exaggerated in FIG. 29 to clearly illustrate the various components.
[0182] The implant 10 can be pre-placed in the container 100 after compression, or can be temporarily placed in the container 100 when in use. When the diverter 12 is compressed, it is radially compressed into a C-shaped concave structure in cross section, which can partially surround the sensor 11.
[0183] During cardiovascular interventional surgery, accurate and continuous measurement of physiological parameters and index curve changes in various parts of the heart chambers and blood vessels throughout the implantation process helps the surgeon to judge the patient's cardiac function, cardiac load, and pulmonary hemodynamic load, etc., while providing a reference for guiding surgical strategies and real-time evaluation of postoperative efficacy.
[0184] During an atrial shunt implantation procedure, for example, a shunt with a wireless pressure sensor can be implanted in the atrial septum using the aforementioned delivery device. This delivery device ensures the strength of the interventional catheter while allowing the pressure sensor to transmit wireless signals outside the body in real time, enabling accurate, real-time monitoring.
[0185] Interventional surgery using the above-mentioned delivery devices or medical systems also has the following clinical advantages:
[0186] 1. In emergency situations during surgery, the hemodynamic indicators of various parts of the cardiac chambers and blood vessels can be directly measured without the need for additional catheterization, thus reducing surgical risks and alleviating patient pain;
[0187] 2. When 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 veins, right atrium, pulmonary artery, and pulmonary arterioles, thus reducing patient trauma. This can also reduce surgical complexity and the impact of intracardiac catheterization on intraoperative procedures, ultimately reducing operative time and costs.
[0188] 3. When the wireless sensor is a pressure sensor, the average pressure value and change curve of different cardiac chambers can be used to assist in determining the position of the implant delivery device in the cardiac chamber. This can assist the surgeon in determining the position of the delivery system in the cardiac chamber (right atrium, left atrium, superior and inferior vena cava) without image guidance, thereby simplifying the specific operation of device release during surgery and reducing radiation exposure to the patient.
[0189] 4. When the wireless sensor is a pressure sensor, the cardiac chamber pressure data obtained by the delivery device of this application is more accurate and real-time than data measured by traditional right cardiac catheterization (such as left atrial pressure). This avoids interference from factors such as deviations and time differences caused by pressure transmission. Immediate postoperative cardiac chamber pressure can be measured, directly assessing the effectiveness of postoperative treatment and providing a basis for treatment strategies.
[0190] The above description is only an illustrative embodiment of the present application and is not intended to limit the scope of the present application. Any equivalent changes and modifications made by any person skilled in the art without departing from the concept and principle of the present application shall fall within the scope of protection of the present application.
Claims
1. A delivery device for delivering an implant to a target tissue via a human cavity or channel, wherein: include: a container, the container comprising a receiving cavity for receiving the implant and an outlet for discharging the implant; an outer tube, the outer tube being connected to and in communication with the container; The release mechanism comprises an inner tube and a control mechanism, wherein the inner tube passes through the container and the outer tube and is used to be connected with the implant, and the control mechanism is used to control the axial relative position relationship between the inner tube and the outer tube.
2. The conveying device according to claim 1, wherein: The delivery device includes an end structure, which is arranged at the distal end of the inner tube, and is used to selectively block or expose the outlet; the outer tube is coaxially arranged with the container, and the container can move axially relative to the end structure so that the end structure blocks or exposes the outlet; when the distance between the container and the end structure is less than a preset value, the distance between the end structure and the implant remains unchanged, and when the distance between the container and the end structure is greater than or equal to the preset value, the implant is released to the target tissue; the implant includes a stent made of shape memory material, the stent is suitable for being sleeved on the inner tube, and the stent can self-expand to a set width after being separated from the inner tube.
3. The conveying device according to claim 2, wherein: The end structure comprises a balloon, and the balloon has a first working state of being in an expanded state and a second working state of being in a contracted state. When the balloon is in the first working state, the balloon can move axially relative to the container to block or expose the outlet; during the process of separating the implant from the inner tube, the balloon is always closer to the distal end of the implant than the proximal end of the implant and maintains a constant relative axial position with the implant; When the implant is separated from the inner tube, the balloon can directly expand the stent on the withdrawal path.
4. The conveying device according to claim 3, wherein: 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 expansion is greater than or equal to the set width of the stent.
5. The conveying device according to claim 2 or 3, wherein: The conveying device further comprises a developing mark arranged on the end structure; and / or the end structure is made of a material having a developing function.
6. The conveying device according to claim 2 or 3, wherein: Along the direction from the distal end of the inner tube to the proximal end of the inner tube, the two ends of the end structure respectively form a front expansion guide part and a rear expansion guide part; along the direction from the rear expansion guide part to the front expansion guide part, the cross-section of the front expansion guide part gradually decreases; and / or, along the direction from the front expansion guide part to the rear expansion guide part, the cross-section of the rear expansion guide part gradually decreases.
7. The conveying device according to claim 2 or 3, wherein: Along the distal to proximal direction of the inner tube, the inner tube includes a first extension segment, a second extension segment and a third extension segment, the extension direction of the second extension segment is different from the extension directions of the first extension segment and the second extension segment, and the axis of the first extension segment is offset to one side of the axis of the container; the main body of the implant is arranged in the first extension segment, and the bracket is sleeved on the first extension segment.
8. The conveying device according to claim 7, wherein: A first port portion and a second port portion are formed at both ends of the end structure along the direction from the distal end of the inner tube to the proximal end of the inner tube; the first port portion and the second port portion are coaxially arranged with the axis of the container; or, the first port portion and the axis of the container are coaxially arranged, and the second port portion and the axis of the first extension section are coaxially arranged; or, the first port portion and the second port portion and the axis of the first extension section are coaxially arranged; or, the first port portion and the axis of the first extension section are coaxially arranged, and the second port portion and the axis of the container are coaxially arranged.
9. The conveying device according to claim 8, wherein: The end structure comprises a balloon, the first end portion and the second end portion of the balloon are respectively sleeved on the inner tube, and the main body of the balloon is coaxially arranged with the container; The length of the balloon is greater than or equal to the length of the stent; and / or the nominal width of the balloon after expansion is greater than or equal to the set width of the stent, so that when the implant is separated from the inner tube, the balloon can directly expand the stent on a withdrawal path.
10. The conveying device according to claim 7, wherein: The delivery device further comprises a first connection structure disposed on the inner tube, and a second connection structure is disposed on the implant; When the implant is in the container, the implant is connected to the first connection structure through the second connection structure to maintain the axial relative position of the implant and the inner tube; When the implant is separated from the container, the second connection structure and the first connection structure can be automatically separated to release the implant.
11. The delivery device according to claim 10, wherein: A connecting piece is provided on the inner tube, and the connecting piece can be accommodated in the container, and the first connecting structure is provided on the connecting piece; the connecting piece includes a connecting seat, and an eccentric channel for the inner tube to pass through is formed on the connecting seat; the connecting seat is extended along a first preset direction, and a first angle β is formed between the first preset direction and the axis of the eccentric channel, and the range of the first angle β is 0° to 60°.
12. The delivery device according to claim 11, wherein: The outer tube has a first bending portion, and the inner tube has a second bending portion. When the end structure blocks the outlet, the first bending portion and the second bending portion are arranged correspondingly; Along the distal end of the inner tube to the proximal end of the inner tube, the connecting seat includes a first seat body and a second seat body connected to each other, the first seat body is columnar, and the first connecting structure is arranged on the first seat body; The second seat body is in a frustum shape, the eccentric channel runs through the first seat body and the second seat body, the second seat body has a first end and a second end, the radial dimension of the first end is larger than the radial dimension of the second end, and the first end of the second seat body is connected to the first seat body.
13. The delivery device according to claim 12, wherein: An orifice end face is formed at the second end of the second seat body, and the orifice end face is perpendicular to the axis of the eccentric channel, and the eccentric channel passes through the orifice end face; an avoidance end face is also provided on the second seat body, at least a portion of the avoidance end face is connected to the orifice end face, and the remaining portion of the avoidance end face is arranged away from the proximal end of the inner tube, and a second angle α is formed between the avoidance end face and the vertical direction, and the range of the second angle α is 0° to 60°.
14. The delivery device according to claim 11, wherein: The inner tube also includes a fourth extension segment, which is located between the second extension segment and the third extension segment. The fourth extension segment is used to penetrate the eccentric channel, and the angle between the fourth extension segment and the axis of the container is smaller than the angle between the second extension segment and the axis of the container.
15. The delivery device according to claim 14, wherein: An end channel is formed on the end structure, and the inner tube also includes a fifth extension segment, which is arranged on the other side of the first extension segment relative to the second extension segment and runs through the end channel; the inner tube has an inner cavity for setting a guide wire.
16. The delivery device according to claim 11, wherein: A flow guiding structure is provided on the connecting piece, and the flow guiding structure is connected to the accommodating cavity of the container located on both sides of the connecting piece; the first preset direction is parallel to the axial direction of the container or the first preset direction has a third angle γ with the axial direction of the container, and the range of the third angle γ is 0° to 60°.
17. The delivery device according to claim 2, wherein: The end structure includes a balloon. The inner tube is also provided with a flow-through structure. The flow-through structure has an injection channel. The injection channel is connected to the inner cavity of the balloon.
18. The delivery device according to claim 1, wherein: The container is provided with a signal transmission window; The outer tube has a tube body, a first end and a second end, and the outer tube is connected to the container through the first end and is coaxially communicated with the container; and The release mechanism penetrates the outer tube and the container, and is used to connect the implant and control the axial relative position relationship between the implant and the container; The implant includes a wireless sensor, and the release mechanism is configured to keep the implant in the container. The wireless sensor is placed in the device and aligned with the signal transmission window.
19. The delivery device according to claim 18, wherein: The signal transmission window is not provided with a shielding structure that would hinder signal transmission, and the outer diameter of the container is greater than the outer diameter of the outer tube.
20. The delivery device according to claim 18, wherein: The container comprises a front section of metal wire, the front section of metal wire is arranged in the side wall of the container and forms a first metal wire mesh; The first metal mesh is provided with an opening area, through which the front-section metal wires do not pass, and the opening area forms the signal transmission window; or, the first metal mesh is provided with a non-woven area, through which the front-section metal wires do not cross, and the non-woven area forms the signal transmission window.
21. The delivery device according to claim 20, wherein: When the first metal wire mesh is provided with the opening area, the opening area is formed by the front section of the metal wire giving way.
22. The delivery device according to claim 21, wherein: The front section of the metal wire changes its extension direction and extends a predetermined distance in the axial direction without intersecting each other to give way to form the opening area.
23. The delivery device according to claim 22, wherein: The outer tube includes a rear section of metal wires, which are arranged in the side wall of the outer tube and form a second metal wire mesh, and the second metal wire mesh extends to the container to form the first metal wire mesh.
24. The delivery device according to any one of claims 18 to 23, wherein: The number of the signal transmission windows is one or more.
25. The delivery device according to claim 18, wherein: The container is provided with a side hole, the side hole is located at the distal end of the signal transmission window, and when the wireless sensor is aligned with the signal transmission window, the side hole corresponds to the sensing end of the wireless sensor.
26. The delivery device according to claim 18, wherein: A plug is provided at the outlet of the container, the plug is connected to the release mechanism, and the plug can be driven by the release mechanism to axially displace to form a top gap with the outlet.
27. The delivery device according to claim 18, wherein: The release mechanism comprises an inner tube and an axial stopper, wherein the inner tube passes through the container and the outer tube and is used to connect the implant, and the axial stopper is used to keep the implant in an axial relative position relationship with the inner tube.
28. The delivery device according to claim 27, wherein: The release mechanism is configured so that the inner tube can move relative to the container between a first axial position and a second axial position, and when the inner tube is in the first position, the implant is located in the container and the wireless sensor corresponds to the signal transmission window, and when the inner tube reaches the second position from the first position, the implant is axially disengaged from the opening of the container.
29. The delivery device according to claim 18, wherein: The wireless sensor is used to measure one or more parameters of temperature, flow, pressure, acceleration, vibration, pH value, conductivity, dielectric constant, component composition, component content and sound wave.
30. A medical system, wherein: The invention comprises an implant and a delivery device according to any one of claims 1 to 17, wherein the delivery device is used for accommodating and delivering the implant.
31. The medical system of claim 30, wherein: The medical system further comprises a guide wire for being arranged in the inner tube, and the implant comprises a wireless sensor and a stent, wherein the wireless sensor and the stent are arranged side by side.
32. A medical system, wherein: include: implants, including wireless sensors; as well as a delivery device, the delivery device being used to contain and deliver the implant; Wherein, the conveying device is the conveying device described in any one of claims 18 to 29.
33. The medical system of claim 32, wherein: The implant comprises an expandable shunt, the wireless sensor is a pressure sensor connected to the shunt, the shunt is compressed in the container and can be released to the outside of the container by the release mechanism.
34. The medical system of claim 33, wherein: The pressure sensors are arranged side by side outside the diverter, and the pressure sensors are compressed by the container along the radial direction of the diverter and are partially surrounded by the diverter.
35. The medical system of claim 33, wherein: When the release mechanism includes an inner tube and an axial limiter, the implant further includes a hanging member, which is connected to the axial limiter when the implant is compressed, and which is disconnected from the axial limiter when the implant expands.
36. The medical system of claim 33, wherein: It also includes a signal receiving device, which is used to receive the signal of the wireless sensor in the implant.
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