Artificial valve delivery device and delivery locating method

Abstract

Disclosed are an artificial valve delivery device and a delivery locating method. The artificial valve delivery device comprises: an outer tube; a catheter arranged in the outer tube, wherein a space capable of accommodating an artificial valve is formed between the outer tube and the catheter, and the outer tube and the catheter can move relative to each other in an axis direction thereof; and a marking piece, wherein the marking piece is arranged on the catheter and located at a position corresponding to a position where the artificial valve is located, and is configured to be capable of being detected by an ultrasonic detection device when the artificial valve is unfolded in an implantation process of the artificial valve. By arranging the marking piece at the position where the artificial valve is loaded on the delivery device, the position and the angle of the artificial valve in the unfolded state can be accurately located through the ultrasonic detection device according to the characteristics of the marking piece on an ultrasonic image, thereby solving the problem that it is difficult to accurately locate the position of the artificial valve after being unfolded.

Description

Artificial valve delivery device and delivery positioning method Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an artificial valve delivery device and a delivery positioning method. Background Art

[0002] During the implantation of a prosthetic valve using a transcatheter valve replacement system, the angle and depth of the valve release position must be adjusted to match the patient's physiological characteristics. Therefore, it is often necessary to accurately locate the implantation site of the prosthetic valve. This requires the ability to clearly determine the position and angle of the prosthetic valve within the human body, especially for asymmetric prosthetic valve prostheses. Currently, conventional implantation procedures rely on X-ray imaging to visualize and locate the position and angle of the prosthetic valve. However, this method not only places high demands on the surgical site and equipment, but also increases the risk of X-ray radiation causing harm to the surgeon and patient.

[0003] Summary of the Invention

[0004] The purpose of the present invention is to provide an artificial valve delivery device and a delivery positioning method to solve the problems existing in the prior art of using X-ray imaging to achieve positioning of artificial valves.

[0005] The present invention is achieved through the following technical solutions:

[0006] An artificial valve delivery device comprising:

[0007] External control;

[0008] a catheter, the catheter being disposed within the outer tube, the outer tube and the catheter forming a space capable of accommodating an artificial valve, the outer tube and the catheter being capable of relative movement along their axial directions;

[0009] The marker is provided on the catheter and is located at a position corresponding to the position of the artificial valve. The marker is configured to be detected by an ultrasonic detection device when the artificial valve is deployed during the implantation of the artificial valve.

[0010] In some embodiments, the marker is configured to form a tight fit with the catheter under the action of an external force, and to be deformed to a state detectable by an ultrasonic detection device after the external force is released.

[0011] In some embodiments, the marker is configured to have a fixed end connected to the catheter and a deformable segment connected to the fixed end, and the deformable segment can separate from the catheter and move toward a side away from the catheter after the external force is released.

[0012] In some embodiments, after the external force is released, the marking part has an identification portion, and the identification portion has a shape or structure different from other parts of the marking part in the current state, so that when the marking part is detected by an ultrasonic detection device, the detection characteristics presented by the identification portion are different from those of other parts of the marking part.

[0013] In some embodiments, the marker and the catheter are located in the same plane after the external force is released.

[0014] In some embodiments, the marker has a fixed end fixedly connected to the catheter and a deformation segment connected to the fixed end, and the other end of the deformation segment is configured to be slidably connected to the catheter so that the deformation segment can arch toward the side away from the catheter after the external force is released.

[0015] In some embodiments, after the external force is released, the position of the most deformed part of the deformation segment corresponds to the position of the valve ring on the artificial valve in the current state.

[0016] In some embodiments, the marker has a fixed end fixedly connected to the catheter and a deformation segment connected to the fixed end, and the other end of the deformation segment is a free end, so that the deformation segment can move toward a side away from the catheter after the external force is released.

[0017] In some embodiments, after the external force is released, the position of the free end of the deformed segment corresponds to the position of the valve ring on the artificial valve in the current state.

[0018] In some embodiments, the free end of the deformation segment is configured to have a shape different from that of other portions of the deformation segment.

[0019] In some embodiments, the marker has a fixed end fixedly connected to the catheter and a deformation segment connected to the fixed end. The deformation segment is coiled and the other end is a free end, so that the deformation segment can move toward the side away from the catheter after the external force is released.

[0020] In some embodiments, the fixing end is coiled, has a coiling density different from that of the deformed segment, and is located at a position corresponding to the position of the valve ring on the artificial valve in the current state.

[0021] In some embodiments, the marking element is made of elastic alloy, memory alloy or other polymer materials with corresponding properties.

[0022] In some embodiments, a guide head is provided at one end of the catheter, and the guide head is configured to be detectable by an ultrasonic detection device.

[0023] In some embodiments, the guide head is provided with a first ultrasonic imaging structure, and the first ultrasonic imaging structure is a reflection rib or a reflection groove provided along the axial direction of the guide head.

[0024] In some embodiments, a second ultrasonic development structure is provided on the guide head at a position opposite to the first ultrasonic development structure, and the second ultrasonic development structure is a weakened groove provided along the axial direction of the guide head.

[0025] In some embodiments, a delivery handle is further included, on which a positioning identification structure capable of indicating the circumferential position of the artificial valve is provided.

[0026] In another aspect, the present invention further provides a method for delivering and positioning an artificial valve, comprising:

[0027] loading the artificial valve onto the artificial valve delivery device;

[0028] Ultrasonic detection equipment is used to detect the position and angle of the guide head, and the artificial valve is adjusted axially and circumferentially according to the position and angle of the guide head;

[0029] Operate the artificial valve delivery device to release the artificial valve, use ultrasonic detection equipment to detect the position and angle of the marker, and adjust the artificial valve axially and circumferentially according to the position and angle of the marker;

[0030] The artificial valve delivery device is operated to release the connection with the artificial valve.

[0031] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0032] 1) By setting a marker at the position where the artificial valve is loaded on the delivery device, based on the characteristics of the marker in ultrasound imaging, the position and angle of the artificial valve in the deployed state can be accurately located by ultrasound detection equipment, thereby solving the problem of difficulty in accurately locating the position of the artificial valve after deployment.

[0033] 2) By setting the marker as a structural part that can undergo elastic deformation, while achieving accurate positioning of the artificial valve, the setting of the marker on the delivery device will not affect the normal performance of the original delivery device and the loading of the artificial valve, making it have better practical performance.

[0034] 3) By using the positioning identification structure, the guide head and the marker to position the artificial valve at different stages of the delivery process, the accurate positioning of the artificial valve implantation operation can be achieved with the help of ultrasonic detection equipment. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0036] FIG1 is a schematic structural diagram of the artificial valve delivery device of the present invention in an initial state.

[0037] FIG2 is a schematic structural diagram of an embodiment of a marking member on an artificial valve delivery device of the present invention.

[0038] FIG3 is a partial schematic diagram of point A in FIG2 .

[0039] FIG4 is a structural schematic diagram of the artificial valve delivery device in FIG2 in a released state during delivery.

[0040] FIG5 is a schematic structural diagram of the marking member shown in FIG2 .

[0041] FIG6 is a schematic structural diagram of another embodiment of a marking member on the artificial valve delivery device of the present invention.

[0042] FIG7 is a partial schematic diagram of point B in FIG6 .

[0043] FIG8 is a structural schematic diagram of the artificial valve delivery device in FIG6 in the released state during the delivery process.

[0044] FIG9 is a schematic structural diagram of the marking member shown in FIG6 .

[0045] FIG10 is a schematic structural diagram of another embodiment of a marking member on the artificial valve delivery device of the present invention.

[0046] FIG11 is a partial schematic diagram of point C in FIG10 .

[0047] FIG12 is a structural schematic diagram of the artificial valve delivery device in FIG10 in the released state during the delivery process.

[0048] FIG13 is a schematic structural diagram of the marking member shown in FIG10.

[0049] FIG14 is a schematic structural diagram of an embodiment of a guide head in an artificial valve delivery device of the present invention.

[0050] FIG15 is a schematic structural diagram of another embodiment of the guide head in the artificial valve delivery device of the present invention.

[0051] Among them: 11. Outer tube; 12. Catheter; 13. Marking member, 131. Fixed end, 132. Movable end, 133. Deformation section, 134. Free end, 135. Extension section; 14. Guide head, 141. Reflection rib, 142. Reflection groove, 143. Weakened groove; 15. Delivery handle, 151. Positioning identification structure; 20. Artificial valve. DETAILED DESCRIPTION

[0052] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0053] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. used to indicate the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they should not be understood as limiting the present invention.

[0054] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this invention does not necessarily imply that a component must be absolutely horizontal or vertical; rather, it may be slightly tilted. For example, "horizontal" simply refers to a more horizontal orientation relative to "vertical" and does not imply that the structure must be perfectly horizontal; rather, it may be slightly tilted. The terms "distal" and "proximal" are primarily used with reference to the operator. The end closer to the operator or farther from the patient is considered the "proximal end," while the end farther from the operator or closer to the patient is considered the "distal end."

[0055] It should also be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific contexts.

[0056] Accurate positioning of artificial valves during delivery is an important step in artificial valve implantation surgery. In view of the problems existing in the currently commonly used X-ray imaging technology in assisting the positioning of artificial valves, the present invention provides a device and method that can realize the positioning of artificial valves based on ultrasonic detection technology.

[0057] This artificial valve delivery device is capable of delivering a self-expanding valve. This self-expanding valve typically utilizes a self-expanding valve stent that can be curled and shrunk outside the body and then expanded and deployed after being delivered to the implantation site in the human body via the delivery device. Currently, there are many artificial valve delivery devices capable of this delivery operation, such as the structures disclosed in patent documents CN114886616A, CN114767336A, CN116509601A, or other similar structures. The basic process for delivering an artificial valve using this type of delivery device is as follows: loading the artificial valve in a contracted state onto the delivery device, delivering it to the implantation site via the delivery device, then operating the delivery device to release the artificial valve at the implantation site, causing the artificial valve to expand and deploy, and then operating the delivery device to disconnect the delivery device from the artificial valve, completing the implantation of the artificial valve. The present invention is an improvement on existing delivery devices of this type, enabling the use of ultrasonic detection equipment to locate the position and angle of the artificial valve during delivery and implantation.

[0058] 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , and 13 , in some embodiments, an artificial valve delivery device includes:

[0059] outer tube 11;

[0060] The catheter 12 is disposed within the outer tube 11, with a space formed between the outer tube 11 and the catheter 12 capable of accommodating an artificial valve 20, enabling the artificial valve to be loaded onto the delivery device. The outer tube is used to restrict expansion and deployment of the artificial valve. The outer tube and the catheter are capable of relative movement along their axial directions, so that when the outer tube moves, the artificial valve is exposed and the restriction on the artificial valve is released, allowing the artificial valve to be released and expand.

[0061] Marker 13 is provided on the catheter at a position corresponding to the location of prosthetic valve 20. The marker is configured to be detected by ultrasound detection equipment during the implantation process when the prosthetic valve is deployed. By detecting the marker, the position and angle of the prosthetic valve in the deployed state can be determined.

[0062] In some embodiments, the marker is configured to form a tight fit with the catheter under the action of an external force, and to deform to a position detectable by ultrasound detection equipment after the external force is released. One purpose of this arrangement is to avoid or minimize the impact that the marker's placement at this location may have on the prosthetic valve when the prosthetic valve is loaded onto the delivery device, thereby eliminating the need for other structural improvements to the delivery device. For example, the marker can have certain elasticity and flexibility properties so that when the prosthetic valve is loaded, the marker can deform under the action of an external force and form a good fit with the catheter's outer shape.

[0063] Here, when the artificial valve is loaded on the delivery device, the catheter and the artificial valve exert a force on the marker to cause it to deform. When the artificial valve is released, as the artificial valve unfolds, the force exerted on the marker is released. At this time, the marker can be restored to its original form or free form based on its elasticity and other properties. The marker is usually set in its original form or free form to be better detected by ultrasonic detection equipment, so that the position, angle and other characteristics of the marker can be more clearly displayed on the ultrasonic detection equipment. In this way, in the process of the artificial valve being gradually released, as the artificial valve changes in different forms at different release levels, the position and angle of the marker can be detected by ultrasonic detection equipment, so that the position and angle of the artificial valve can be located, thereby achieving precise adjustment of the implantation position and angle of the artificial valve during the delivery process.

[0064] That is to say, in order to reduce the impact on the artificial valve implantation operation, the marker 13 is usually set to have the ability to elastically deform. Before the artificial valve is loaded into the delivery device and is released, the marker is deformed under the restraining force of the artificial valve and the outer tube so that it can fit well with the catheter or be confined in the space between the outer tube and the catheter; in the process of the artificial valve being released, the restraining force on the marker is released, so that the marker can undergo elastic deformation, so that it can be detected by the ultrasonic detection equipment to locate and mark the current position of the artificial valve.

[0065] In some embodiments, the marker 13 is configured to have a fixed end connected to the catheter and a deformable segment connected to the fixed end. When the external force is released, the deformable segment can separate from the catheter and move away from the catheter. In this case, when the external force is released, the marker remains stably connected to the catheter, allowing the deformable segment to be better detected by ultrasound detection equipment. The directional characteristics of the deformable segment can also be used to determine the circumferential angle of the prosthetic valve in its current state.

[0066] In some embodiments, when the external force is released, the marker 13 is provided with an identification portion, which has a shape or structure different from other parts of the marker in the current state, so that when the marker is detected by an ultrasonic detection device, the detection characteristics presented by the identification portion are different from those of other parts of the marker. Through the function and principle of the marker, it is easy to understand that when the above-mentioned identification portion is provided on the marker, the position of the identification portion can be used to determine a certain position on the marker. In this way, we can preset the position of the identification portion on the marker in this state to achieve the direction or positioning of a specific characteristic position on the artificial valve. For example, the position of the identification portion on the marker in this state is set to correspond to the position of the valve ring of the current artificial valve in the expanded state. In this way, the position of the valve ring of the artificial valve can be determined by visually identifying the identification portion on the marker on the ultrasonic detection device.

[0067] In some embodiments, the marker 13 is configured to be in the same plane as the catheter after the external force is released. One purpose of this configuration is that when the marker is detected, the position of the current artificial valve in the circumferential direction, that is, the setting angle of the current artificial valve, can be determined based on the extension direction of the marker. Usually, when loading the artificial valve, since one end of the artificial valve is fixed on the conveying device, by setting the relative position of the artificial valve and the marker, when the artificial valve is unfolded, the current installation angle of the artificial valve can be located by detecting the position of the marker. At this time, the purpose of simultaneously positioning the axial position and circumferential angle of the artificial valve in the human body can be achieved by detecting the marker.

[0068] Typically, the marking member can be made of elastic alloy, memory alloy, other polymer materials with corresponding properties, or similar materials, so that it can have the above-mentioned elastic deformation and the function of being detected by ultrasonic detection equipment.

[0069] In some embodiments, as shown in Figures 2, 3, and 4, as an embodiment, one end of the marker 13 is fixedly connected to the catheter, and the other end is configured to be slidably connected to the catheter. When the artificial valve is released, the external force constraint on the marker is released, and the movable end 132 of the marker 13 can move toward the fixed end. At this time, the portion of the marker between its two ends arches toward the side away from the catheter to form a special-shaped structure. At this time, because the marker is located at the position where the artificial valve is located, it can be more easily detected by ultrasonic detection equipment and can be clearly displayed on the ultrasonic detection equipment. Based on the detection of the position and angle of the marker, the position and angle of the current artificial valve can be accurately located.

[0070] As shown in Figure 5, the marker 13 has a movable end 132 and a fixed end 131 with tubular ends, as well as a deformable section 133 located between the movable and fixed ends. Both the movable end 132 and the fixed end 131 are sleeved onto the catheter 12. The fixed end 131 can be fixed to the catheter by welding or other connection methods, while the movable end 132 can slide freely on the catheter. The deformable section 133 can generally adopt a sheet-like structure to facilitate its free deformation. This type of marker can be cut and formed from a pipe made of materials such as stainless steel and memory alloy, so that the deformable section can be directly formed into an arc-shaped cross-section structure that can form a good fit with the catheter, thereby reducing the impact on the loading of the artificial valve on the delivery device.

[0071] It is easy to imagine that this marking part can also have two movable ends 132, which are respectively arranged on both sides of the fixed end 131. After the external force is released, the two movable ends 132 move toward the fixed end at the same time, and the two deformation sections of the marking part are deformed. At this time, it can also achieve its intended function.

[0072] In some embodiments, the marker is configured, for example, by designing the original shape of the marker so that it can return to its original shape and a predetermined shape after deformation. For example, during the process of deformation and return to its original shape, the position of the most deformed portion of the marker corresponds to the position of the annulus on the artificial valve in the current deployed state. By detecting this position on the marker, the position of the artificial valve can be more accurately located. Taking the structure of the marker shown in FIG5 as an example, after the marker returns to its original shape, the deformation is most obvious at the position farthest from the catheter on the deformed segment 133. The aforementioned identification area is formed at this position, making it distinguishable from other parts of the deformed segment, making this position more easily detectable by ultrasound equipment. By developing and indicating this position, the position of the annulus on the artificial valve can be accurately indicated and located.

[0073] In some embodiments, as shown in Figures 6, 7 and 8, as another feasible method, one end of the marker 13 is fixedly connected to the catheter 12, and the other end is set as a free end 134. After the external force applied to the marker is released, the free end 134 of the marker can move toward the side away from the catheter, so that it can be better detected by the ultrasonic detection equipment after it returns to its original state.

[0074] Specifically, referring to Figure 9 , the marker 13 includes a fixed end 131 and a deformable section 133. The fixed end 131 is configured as a tubular structure, allowing it to be easily sheathed on a catheter and fixedly connected thereto. An extension section 135 can be provided on the fixed end 131, positioned opposite the deformable section. The extension section 135 is configured to form a fit with the catheter and be fixedly connected thereto, thereby more stably connecting the marker to the catheter. The marker can also be cut and formed from a tube made of a material such as stainless steel or a memory alloy. The free end 134 of the marker 13 can be cut and configured into a different shape, making it structurally different from the rest of the deformable section 133 of the marker. This allows the position of the free end to be more clearly displayed during ultrasonic testing, facilitating accurate positioning.

[0075] Similarly, the marker can be set so that after the external force on the marker is released, the position of the free end 134 of the marker 13 corresponds to the position of the valve ring on the artificial valve in the current state, so that the position of the valve ring on the artificial valve can be indicated and located by the marker.

[0076] In some embodiments, referring to Figures 10, 11, 12 and 13, as another feasible manner, the marker 13 has a fixed end 131 fixedly connected to the catheter 12 and a deformation segment 133 connected to the fixed end, the deformation segment 133 is coiled and the other end of the deformation segment is a free end, so that when the artificial valve is loaded, the deformation segment of the marker can be coiled onto the catheter, and when the artificial valve is unfolded, the deformation segment can move toward the side away from the catheter based on its elasticity and structural characteristics, so that it can be easily detected by the ultrasonic detection equipment.

[0077] Similarly, the marking part can be set, as shown in Figure 13, the fixed end 131 is set to a winding structure, so that the fixed end 131 can be detected by the ultrasonic detection equipment, and the fixed end 131 is set to have a winding density different from that of the deformed section. For example, the fixed end is set to have a larger winding density to facilitate the identification and positioning of the fixed end position; at the same time, the position of the fixed end is set to correspond to the position of the valve ring on the artificial valve in the current state, so that the position of the valve ring on the artificial valve can be positioned by detecting the position of the fixed end.

[0078] In some embodiments, referring to FIG1 , a guide head 14 is provided at the end of the catheter 12 extending into the human body. The guide head 14 is configured to be detectable by ultrasound detection equipment. Thus, during delivery, the position of the guide head can be detected to preliminarily locate the delivery position of the artificial valve.

[0079] We know that after the artificial valve is delivered to the predetermined position, the artificial valve device is usually operated to move the outer tube in the proximal direction, so that the artificial valve is exposed from the outer tube and the restraint on the artificial valve is gradually released, and the artificial valve expands and unfolds. At this time, due to the position of the guide head, its imaging function in ultrasound detection is weakened, and it may be difficult to accurately locate the position and angle of the artificial valve in the current state. Therefore, it is necessary to use the above-mentioned marking parts to further locate the artificial valve at this stage; that is, the guide head is set here mainly to achieve preliminary positioning of the delivery position and angle of the artificial valve.

[0080] Specifically, a first ultrasonic imaging structure is provided on the guide head 14, forming an ultrasonic sound intensity strong reflection area on the guide head 14 to realize the imaging function of the guide head; referring to FIG10, the first ultrasonic imaging structure can be a reflective rib 141 provided along the axial direction of the guide head; or, referring to FIG11, the first ultrasonic imaging structure can be a reflective groove 142 provided along the axial direction of the guide head. By detecting the position of the reflective rib and the reflective groove, the delivery position of the artificial valve can be determined. Similarly, when loading the artificial valve, by presetting the relative position relationship between the artificial valve and the pointing direction of the reflective rib or the reflective groove, and by determining the pointing direction of the reflective rib or the reflective groove, the circumferential angle of the artificial valve can be positioned.

[0081] In some embodiments, a second ultrasonic imaging structure is provided on the seeker 14, opposite the first ultrasonic imaging structure. This second ultrasonic imaging structure is used to form a region of weak ultrasonic reflection on the seeker, working in conjunction with the first ultrasonic imaging structure to further improve the ultrasonic imaging positioning accuracy of the seeker. Referring to Figures 10 and 11 , this second ultrasonic imaging structure can be a weakened groove 143 provided along the axial direction of the seeker.

[0082] Here, the guide head 14 can be made of metal, polymer or other materials.

[0083] In some embodiments, referring to FIG1 , the artificial valve delivery device includes a delivery handle 15. The delivery handle 15 can generally be used to facilitate the operator's operation of the artificial valve delivery device to deliver the artificial valve into the human body. In some artificial valve delivery devices, the delivery handle can also drive the release component on the delivery device to release the connection between the artificial valve and the delivery device by driving it in a linear motion toward the proximal direction. In general, the delivery handle is a component of the delivery device that remains outside the human body during the implantation process, and the component generally does not rotate relative to the catheter. In this way, when a positioning identification structure 151 is provided on the delivery handle, by setting the relative position between the artificial valve and the positioning identification structure 151 in advance, the current circumferential position of the artificial valve, i.e., the angle of the artificial valve, can be determined based on the positioning identification structure.

[0084] The positioning identification structure 151 on the delivery handle 15 can be a positioning surface or a marking line set on the delivery handle, both of which can assist in determining the implantation angle of the artificial valve.

[0085] Usually, the positioning identification structure on the delivery handle, the first ultrasonic imaging structure / second ultrasonic imaging structure on the guide head and the marking part can be set to be located in the same plane, that is, the corresponding circumferential positions represented are at the same angle, so as to further facilitate the delivery positioning operation of the artificial valve.

[0086] On the other hand, a method for positioning an artificial valve for delivery of an artificial valve using the artificial valve delivery device includes:

[0087] loading the artificial valve onto an artificial valve delivery device, and performing an implantation operation using the artificial valve delivery device;

[0088] Ultrasonic detection equipment is used to detect the position and angle of the guide head, and the position of the artificial valve in the axial and circumferential directions is adjusted according to the position and angle of the guide head to achieve preliminary positioning of the implantation position;

[0089] The artificial valve delivery device is operated to move the outer tube toward the proximal end, thereby gradually releasing the artificial valve. During this process, the artificial valve gradually expands. At this time, an ultrasonic detection device is used to detect the position and angle of the marker. The position of the artificial valve in the axial and circumferential directions is adjusted according to the position and angle of the marker to achieve accurate positioning of the implantation position of the artificial valve in the expanded state.

[0090] Operate the artificial valve delivery device to release the connection with the artificial valve and complete the implantation of the artificial valve.

[0091] It can be understood that the artificial valve delivery device and delivery positioning method provided above can be applied to the delivery and positioning of products such as artificial valves or stents through vascular catheters.

[0092] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any simple modification or equivalent change made to the above embodiment based on the technical essence of the present invention shall fall within the scope of protection of the present invention.

Claims

1. An artificial valve delivery device, characterized in that, Comprising: An outer tube; A catheter disposed within the outer tube, a space capable of accommodating an artificial valve being formed between the outer tube and the catheter, and relative movement being capable of occurring between the outer tube and the catheter along their axial directions; A marker disposed on the catheter and at a position corresponding to the position where the artificial valve is located, and the marker being configured to be detectable by an ultrasonic detection device when the artificial valve is deployed during the implantation process of the artificial valve.

2. The artificial valve delivery device according to claim 1, wherein The marker is configured to be capable of forming a tight fit with the catheter under an external force, and being capable of deforming to a state where it can be detected by an ultrasonic detection device after the external force is removed.

3. The artificial valve delivery device according to claim 2, wherein, The marker is configured to have a fixed end connected to the catheter and a deformation section connected to the fixed end, and the deformation section being capable of separating from the catheter and moving away from the catheter side after the external force is removed.

4. The artificial valve delivery device according to claim 3, wherein, After the external force is removed, an identification portion is provided on the marker, and the identification portion has a shape or structure different from other portions of the marker in the current state, so that when the marker is detected by an ultrasonic detection device, the detection characteristics presented by the identification portion are different from those of other portions of the marker.

5. The artificial valve delivery device according to claim 2, wherein, After the external force is removed, the marker and the catheter are located in the same plane.

6. The artificial valve delivery device according to claim 2, characterized in that, The marker has a fixed end fixedly connected to the catheter and a deformation section connected to the fixed end, and the other end of the deformation section is arranged to be slidably and cooperatively connected to the catheter, so that the deformation section can arch away from the catheter side after the external force is removed.

7. The artificial valve delivery device according to claim 6, wherein After the external force is removed, the position where the portion with the largest deformation on the deformation section is located corresponds to the position of the valve annulus on the artificial valve in the current state.

8. The artificial valve delivery device according to claim 2, wherein, The marker has a fixed end fixedly connected to the catheter and a deformation section connected to the fixed end, and the other end of the deformation section is a free end, so that the deformation section can move away from the catheter side after the external force is removed.

9. The artificial valve delivery device according to claim 8, wherein, After the external force is removed, the position where the free end of the deformation section is located corresponds to the position of the valve annulus on the artificial valve in the current state.

10. The artificial valve delivery device according to claim 9, wherein, The free end of the deformation section is arranged to have a shape different from other portions of the deformation section.

11. The artificial valve delivery device according to claim 2, wherein, The marker has a fixed end fixedly connected to the catheter and a deformation section connected to the fixed end, the deformation section being wound and the other end being a free end, so that the deformation section can move away from the catheter side after the external force is removed.

12. The artificial valve delivery device according to claim 11, wherein, The fixed end is wound, and the fixed end has a winding density different from that of the deformation section and is located at a position corresponding to the position of the valve annulus on the artificial valve in the current state.

13. The artificial valve delivery device according to claim 6, 8 or 11, characterized in that, The marker is made of an elastic alloy, a shape memory alloy or a polymer material.

14. The artificial valve delivery device according to any one of claims 1-12, characterized in that, A guiding head is provided at one end of the catheter, and the guiding head is configured to be detectable by an ultrasonic detection device.

15. The artificial valve delivery device according to claim 14, wherein, A first ultrasonic imaging structure is provided on the guiding head, and the first ultrasonic imaging structure is a reflecting rib or a reflecting groove arranged along the axial direction of the guiding head.

16. The artificial valve delivery device according to claim 15, wherein, A second ultrasonic imaging structure is provided on the guiding head at a position opposite to the first ultrasonic imaging structure, and the second ultrasonic imaging structure is a weakening groove arranged along the axial direction of the guiding head.

17. The artificial valve delivery device according to any one of claims 1-12, characterized in that, It further includes a delivery handle, and a positioning identification structure capable of indicating the circumferential position of the artificial valve is provided on the delivery handle.

18. Method for delivering and positioning an artificial valve, characterized in that, Comprising: Load the artificial valve onto the artificial valve delivery device according to any one of claims 1-17; Use an ultrasonic detection device to detect the position and angle of the guide head, and adjust the artificial valve axially and circumferentially according to the position and angle of the guide head; Operate the artificial valve delivery device to release the artificial valve, use an ultrasonic detection device to detect the position and angle of the marker, and adjust the artificial valve axially and circumferentially according to the position and angle of the marker; Operate the artificial valve delivery device to disconnect from the artificial valve.

Images