A delivery system for a pulmonary valve stent

Abstract

The application relates to a delivery system of a pulmonary valve stent, which comprises an inner core in a thin strip structure extending from a proximal end to a distal end, an inner tube fixedly sleeved outside the inner core, a connecting piece arranged at the distal end of the inner tube, a sheath tube movably sleeved outside the inner tube, a loading cavity arranged at the distal end of the sheath tube, and a driving handle arranged at the proximal end of the sheath tube and fixedly connected with the inner tube, used for driving the axial movement of the sheath tube, so that the pulmonary valve stent connected with the connecting piece enters the loading cavity; wherein the two ends of the loading cavity are provided with circumferentially-arranged structural reinforcing pieces; the structural reinforcing pieces at the two ends of the loading cavity can effectively increase the tension bearing capacity of the two ends, and only the two ends are provided with the structural reinforcing pieces, so that the middle part of the loading cavity has certain flexibility and can realize certain bending adjustment; through the arrangement of the structural reinforcing pieces, the technical problem of difficulty in loading and releasing caused by tension is effectively solved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a pulmonary valve stent delivery system. Background Technology

[0002] In recent years, due to the continuous increase in life expectancy, the number of elderly and high-risk patients with valvular heart disease has been steadily increasing. In the field of interventional cardiology, percutaneous heart valve surgery has developed rapidly due to its minimally invasive nature, low risk, and high patient acceptance. Currently, techniques applied clinically include percutaneous aortic valve replacement, percutaneous pulmonary valve replacement, and percutaneous mitral valve repair. Among these three techniques, percutaneous pulmonary valve replacement was the first to be applied clinically because the pulmonary valve region has a relatively simple anatomical structure and lower circulatory pressure. This technique involves delivering an artificial pulmonary valve stent via a catheter through a peripheral vein to the patient's own pulmonary valve to replace the dysfunctional pulmonary valve, thereby treating pulmonary valve disease.

[0003] Because the pulmonary valve stent in pulmonary artery replacement surgery is much larger than the main valve stent, but the outer diameter of the sheath cannot be increased, the pulmonary valve stent will generate a lot of tension when loaded into the sheath, making loading and release difficult. If this tension is not addressed effectively, it may directly affect the success of release or even lead to surgical failure. Therefore, it is necessary to provide a pulmonary valve stent delivery system. Summary of the Invention

[0004] Based on the above description, the present invention provides a pulmonary valve stent delivery system to solve the technical problem in the prior art where the loading and release of pulmonary valve stents into the sheath is difficult due to high tension.

[0005] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A pulmonary valve stent delivery system comprising: The inner core has a thin strip-shaped structure that extends from the proximal end to the distal end. An inner tube is fixedly sleeved on the outside of the inner core, and the distal end of the inner tube is provided with a connector for detachable connection with a pulmonary valve stent. A sheath, which is axially movable and sleeved on the outside of the inner tube, has a loading cavity at the distal end of the sheath for loading the pulmonary valve stent. A drive handle is disposed at the proximal end of the sheath and fixedly connected to the inner tube, for driving the sheath to move axially, so that the pulmonary valve stent connected to the connector enters the loading chamber. Both ends of the loading cavity are provided with circumferentially arranged structural reinforcements.

[0006] Compared with the prior art, the technical solution of this application has the following beneficial technical effects: The delivery system provided in this application has a loading chamber at the distal end of the sheath. The pulmonary valve stent to be loaded is connected to the connector at the distal end of the inner tube. The sheath is driven to slide on the surface of the inner tube by the drive handle, so that the pulmonary valve stent enters the loading chamber for loading. The structural reinforcements at both ends of the loading chamber can effectively increase its ability to withstand tension. At the same time, the presence of structural reinforcements at only the two ends gives the middle of the loading chamber a certain degree of flexibility, allowing for some bending adjustment. The inclusion of structural reinforcements effectively solves the technical problem of loading and releasing difficulties caused by tension.

[0007] Based on the above technical solution, the present invention can be further improved as follows.

[0008] Furthermore, the inner diameter of the loading cavity is larger than the inner diameter of the sheath.

[0009] Furthermore, the outer side of the inner tube is attached to the inner wall of the sheath and can slide relative to each other axially. Furthermore, the connector is a columnar structure arranged along the axial direction of the inner tube, and the outer wall of the connector can fit against the inner wall of the loading cavity and can slide relative to it axially.

[0010] Furthermore, multiple grooves are formed on the outer curved surface of the connector for connecting with the protrusions reserved on the pulmonary valve stent.

[0011] Furthermore, the structural reinforcement is a metal ring structure disposed in the inner wall, outer wall, or interlayer of the loading cavity. Furthermore, the pulmonary valve stent is configured with an upper part, a waist part, and a lower part distributed sequentially, and two structural reinforcements are configured to correspond to the upper part and the lower part respectively, and the axial width of the structural reinforcements matches the width of the corresponding upper part or the lower part.

[0012] Furthermore, the drive handle includes a threaded control assembly that causes the sheath to move axially by rotating the thread.

[0013] Furthermore, the thread control assembly includes: The skeleton is generally rod-shaped and is fixedly connected to the proximal end of the inner tube. The middle part of the outer side is concave and has an external thread. The skeleton is hollow along the axial direction and has a sliding cavity. The side wall of the skeleton has a strip-shaped hole groove arranged along the axial direction. A sliding block is threadedly connected to the middle of the skeleton; A drive block is slidably disposed in the sliding cavity and fixed to the proximal end of the sheath. The drive block has an extension that passes through the strip-shaped groove and is movably connected to the sliding block.

[0014] Furthermore, the distal end of the inner core is connected to a TIP head, and the proximal end of the TIP head can be relatively moved and loaded into the loading cavity. Attached Figure Description

[0015] Figure 1 A three-dimensional structural schematic diagram of a pulmonary valve stent delivery system provided in an embodiment of the present invention; Figure 2 This is a schematic diagram of the structure of the distal portion in an embodiment of the present invention; Figure 3 This is a schematic diagram of the planar structure of the distal portion in an embodiment of the present invention; Figure 4 This is a schematic diagram illustrating the use of an embodiment of the present invention; Figure 5 This is a cross-sectional schematic diagram of the proximal portion in an embodiment of the present invention. Detailed Implementation

[0016] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate embodiments of the present application. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0017] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0018] It is understood that spatial relation terms such as "below," "under," "below," "below," "above," "above," etc., can be used here to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, the element or feature described as "below" or "below" of the other element or feature will be oriented "above" the other element or feature. Therefore, the exemplary terms "below" and "below" can include both upper and lower orientations. Furthermore, the device may also include other orientations (e.g., rotated 90° or other orientations), and the spatial descriptive terms used herein will be interpreted accordingly.

[0019] It should be noted that when one element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediary element. In the following embodiments, "connection" should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have the transmission of electrical signals or data between them.

[0020] When used here, the singular forms of “a,” “an,” and “ / the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “including / contains” or “having” specify the presence of the stated feature, whole, step, operation, component, part, or combination thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof.

[0021] like Figure 1-5 As shown, this application discloses a pulmonary valve stent delivery system, which includes an inner core 10, an inner tube 20, a sheath 30, and a drive handle 40.

[0022] The inner core 10 has a thin strip structure that extends from the proximal end to the distal end.

[0023] It is understood that, in the embodiments of this application, the proximal end refers to the end that is closer to the operator when the delivery system is in use, and the distal end refers to the end that is closer to the patient's body.

[0024] The inner tube 20 is fixedly sleeved on the outside of the inner core 10, and the distal end of the inner tube 20 is provided with a connector 21 for detachable connection with the pulmonary valve stent 200.

[0025] The sheath 30 is axially movable and sleeved on the outside of the inner tube 20. The distal end of the sheath 30 is provided with a loading cavity 31 for loading the pulmonary valve stent 200.

[0026] The end of the pulmonary valve stent 200 is connected by a connector 21. The movement of the sheath 30 causes relative movement between the loading chamber 31 and the pulmonary valve stent 200 connected to the connector 21, and the stent enters from the end of the loading chamber 31 to complete the loading process.

[0027] In a preferred embodiment of this application, the connector 21 is a columnar structure arranged along the axial direction of the inner tube, preferably made of metal. The outer wall of the connector 21 can fit against the inner wall of the loading cavity 31 and can slide relative to it axially. Multiple grooves 21a are formed on the outer curved surface of the connector 21 for connecting with the protrusions 201 reserved on the pulmonary valve stent 200. With the above structure, when the protrusions 201 are located in the loading cavity, the inner wall of the loading cavity 31 forms a fitting relationship with the protrusions 201 and limits them, which can effectively prevent the protrusions 201 from falling off.

[0028] The inner diameter of the loading cavity 31 is larger than that of the sheath 30, which gives the loading cavity 31 a larger internal space and can effectively reduce the tension of the sheath 30 after compression. Preferably, the outer side of the inner tube 20 is attached to the inner wall of the sheath 30 and can slide relative to each other axially, ensuring that the inner tube 20 does not shake inside the sheath 30, ensuring that the connector 21 is accurately aligned with the loading cavity 31, and preventing the connector 21 from not being able to enter the loading cavity due to misalignment.

[0029] Both ends of the loading cavity 31 are provided with circumferentially arranged structural reinforcement members 311. The main function of the structural reinforcement members is to strengthen the structural strength at both ends of the loading cavity 31, so that it can not expand under large internal tension or expand within a controllable small range. In a preferred embodiment of this application, the structural reinforcement member 311 is a metal ring structure provided on the inner or outer side wall of the loading cavity 31. In a preferred embodiment, the metal ring structure is provided in the interlayer of the loading cavity 31.

[0030] The metal ring-shaped structural reinforcement 311 serves two purposes. First, the position of the loading cavity 31 can be directly observed during surgery through metal imaging, facilitating a smooth procedure. Second, since the pulmonary valve stent 200 is much larger and longer than the aortic valve stent, when the pulmonary valve stent 200 is compressed and loaded into the loading cavity 31, the loading cavity 31 must not only have a certain degree of flexibility but also be able to withstand significant tension. Currently, commonly used pulmonary valve stents 200 generally have a structure that is wider at both ends and narrower in the middle. Therefore, the tension at both ends will be very high during compression. The metal ring-shaped structural reinforcement 311 can increase the tension-bearing capacity of the loading cavity 31 at both ends. Furthermore, by only setting the structural reinforcement 311 at both ends, the loading cavity 31 still retains a certain degree of flexibility in the middle after the pulmonary valve stent 200 is loaded.

[0031] Secondly, since the pulmonary valve stent 200 and the connector 21 are detachably connected through the cooperation of the groove 21a and the protrusion 201, the connector 21 is fitted to the inner wall of the loading cavity 31. The fitting size design allows the protrusion 201 to be confined within the groove 21a, thus fixing the pulmonary valve stent 200 inside the loading cavity 31, allowing the protrusion 201 to be released last. However, when the pulmonary valve stent 200 is compressed into the loading cavity 31, the tension at both ends of the pulmonary valve stent 200 is relatively large. This tension will act on the distal end of the loading cavity 31. If the distal end of the loading cavity 31 is expanded, the advantage of its size design will no longer exist. The groove 21a and the protrusion 201 may be pulled apart by the distal end before the stent is properly positioned, resulting in a flyaway valve. It should also be noted that during the release of the pulmonary valve stent 200… The distal end of the pulmonary valve stent 200 is released and expanded first, while the proximal part is still in the loading cavity 31. At this time, in order to ensure better surgical results, the doctor needs to find the most suitable release position, which may take a certain amount of time. As a result, the pulmonary valve stent 200 is in a distally expanded flared state for a relatively long period of time. In this state, the proximal end of the pulmonary valve stent 200 is large in size and compressed, creating a lot of tension. Due to the flared state of the pulmonary valve stent 200, the proximal end of the loading cavity 31 is also subjected to very large tension, which can easily expand the proximal part of the loading cavity. This can increase the gap between the inner wall of the loading cavity 31 and the side wall of the connector 21, making it easy for the protrusion 201 to fall out of the groove 21a, forming a flap and causing surgical accidents. Therefore, setting a structural reinforcement at the proximal end of the loading cavity 31 can also effectively prevent the occurrence of flap separation.

[0032] Preferably, the pulmonary valve stent 200 is wider at both ends and narrower in the middle. Specifically, it may include an upper part 210, a waist part 220 and a lower part 230 distributed sequentially. The upper part 210 and the lower part 230 are wider, and the waist part 220 is narrower. Two structural reinforcement members 311 are configured to correspond to the upper part 210 and the lower part 230 respectively, and the axial width of the structural reinforcement member 311 matches the width of the corresponding upper part 210 or lower part 230 to better distribute the tension of the upper part 210 or lower part 230.

[0033] The drive handle 40 is located at the proximal end of the sheath 30 and is fixedly connected to the inner tube 20. It is used to drive the sheath 30 to move axially, so that the pulmonary valve stent 200 connected to the connector 21 enters the loading chamber 31. Specifically, the drive handle 40 includes a threaded control assembly 41, which causes the sheath 30 to move axially by rotating the thread.

[0034] In embodiments of this application, the thread control assembly 41 includes a generally rod-shaped skeleton 411, a sliding block 412, and a drive block 413.

[0035] The skeleton 411 is fixedly connected to the proximal end of the inner tube 20. The middle part of its outer side is concave and has an external thread. The skeleton 411 has a hollow structure along the axial direction and forms a sliding cavity. The side wall of the skeleton 411 forms a strip-shaped groove 411a arranged along the axial direction. The sliding block 412 is threadedly connected to the middle part of the skeleton 411. The driving block 413 is slidably disposed in the sliding cavity and fixed to the proximal end of the sheath 30. The driving block 413 has an extension 4131 that passes through the strip-shaped groove 411a and is movably connected to the sliding block 412. As an optional embodiment, an annular groove is formed on the inner side of the sliding block 412. The part of the extension 4131 that extends out of the strip-shaped groove 411a is located in the annular groove. The rotation of the sliding block 412 drives the driving block 413 to move axially inside the sliding cavity, thereby causing the sheath 30 to move axially.

[0036] The delivery system described above uses a transapical implantation method. Transapical implantation has low or no requirements for bending adjustment, but it is very invasive. Therefore, it can be implanted via a catheter. Thus, the system needs to have a certain bending adjustment capability. Therefore, in the preferred embodiment of this application, at least one bending adjustment device can be provided at the proximal end of the delivery system for bending the sheath or inner tube. It is understood that bending the distal end of the tubular component by means of a bending wire is a mature technology in the field. Generally, a bending wire is connected to the distal end of the tube, and the bending wire is pulled at the proximal end. In the prior art, a threaded handle is usually used to pull the bending wire, which is similar to the structure of the threaded control component 41, and will not be described in detail here.

[0037] The distal end of the inner core 10 is connected to a TIP head 11. The proximal end of the TIP head 11 can be moved and loaded into the loading cavity 31. The TIP head 11 can effectively prevent the distal end of the inner core 10 from puncturing human tissue.

[0038] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A pulmonary valve stent delivery system, characterized in that, include: The inner core has a thin strip-shaped structure that extends from the proximal end to the distal end. An inner tube is fixedly sleeved on the outside of the inner core, and the distal end of the inner tube is provided with a connector for detachable connection with a pulmonary valve stent. A sheath, which is axially movable and sleeved on the outside of the inner tube, has a loading cavity at the distal end of the sheath for loading the pulmonary valve stent. A drive handle is disposed at the proximal end of the sheath and fixedly connected to the inner tube, for driving the sheath to move axially, so that the pulmonary valve stent connected to the connector enters the loading chamber. Both ends of the loading cavity are provided with circumferentially arranged structural reinforcements; The pulmonary valve stent is configured with an upper part, a waist part and a lower part distributed sequentially, and two structural reinforcements are configured to correspond to the upper part and the lower part respectively, and the axial width of the structural reinforcements matches the width of the corresponding upper part or the lower part. The drive handle includes a threaded control assembly, which causes the sheath to move axially via threaded rotation; the threaded control assembly includes: A generally rod-shaped skeleton is fixedly connected to the proximal end of the inner tube. The middle part of the outer side of the skeleton is concave and has an external thread. The skeleton is hollow along the axial direction and has a sliding cavity. The sidewall of the skeleton has a strip-shaped hole groove arranged along the axial direction. A sliding block is threadedly connected to the middle of the skeleton; A drive block is slidably disposed in the sliding cavity and fixed to the proximal end of the sheath. The drive block has an extension that passes through the strip-shaped groove and is movably connected to the sliding block.

2. The pulmonary valve stent delivery system according to claim 1, characterized in that, The inner diameter of the loading cavity is larger than the inner diameter of the sheath.

3. The pulmonary valve stent delivery system according to claim 2, characterized in that, The outer side of the inner tube is in contact with the inner wall of the sheath and can slide relative to each other axially.

4. The pulmonary valve stent delivery system according to claim 1, characterized in that, The connector is a columnar structure arranged along the axial direction of the inner tube. The outer wall of the connector can fit against the inner wall of the loading cavity and can slide relative to it axially.

5. The pulmonary valve stent delivery system according to claim 4, characterized in that, Multiple grooves are formed on the outer curved surface of the connector for connecting with the protrusions reserved on the pulmonary valve stent.

6. The pulmonary valve stent delivery system according to claim 1, characterized in that, The structural reinforcement is a metal ring structure disposed in the inner wall, outer wall, or interlayer of the loading cavity.

7. The pulmonary valve stent delivery system according to claim 1, characterized in that, The distal end of the inner core is connected to a TIP head, and the proximal end of the TIP head can be relatively moved and loaded into the loading cavity.

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