Implant device delivery system capable of controlling the opening angle of positioning parts

Abstract

The present application relates to the field of medical devices, and in particular to an implant device delivery system capable of controlling the opening angle of a positioning member, comprising an implant device and a delivery system, wherein the implant device is provided with a positioning member, one end of the positioning member is connected to the implant device, and the other end is a free end, the delivery system comprises an outer sheath tube, an inner core tube, a middle cavity tube and a control component, a withdrawal sheath and a control wire, the control component is arranged at the distal end of the middle cavity tube, the control component comprises a first control member, an elastic member and a second control member, when pre-installed, the proximal end of the implant device is connected to the first control member, the distal end of the implant device is connected to the second control member and is arranged inside the withdrawal sheath, the inner core tube is pulled toward the proximal end to compress the elastic member and expand the free end of the positioning member outward; the delivery system of the present application scheme can realize controllable adjustment of the opening angle of the positioning member, thereby adapting to the physiological and anatomical structures of different patients, has a wide range of indications, and is very convenient to operate.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an implant device delivery system capable of controlling the opening angle of a positioning member. Background Art

[0002] Aortic valve stenosis is mainly caused by the sequelae of rheumatic fever, congenital aortic valve structural abnormalities or senile aortic valve calcification. Patients are asymptomatic during the compensatory period, while patients with severe aortic valve stenosis often experience fatigue, dyspnea (exertional or paroxysmal), angina pectoris, dizziness or syncope, and may even die suddenly.

[0003] Aortic regurgitation means that the aortic valve opens when the ventricle contracts, and the blood in the left ventricle enters the aorta and is ejected to the whole body. It closes when the ventricle relaxes, preventing the blood in the aorta from flowing back to the left ventricle. If aortic valve insufficiency occurs, the aortic valve cannot close tightly during diastole, causing blood to flow back from the aorta into the left ventricle.

[0004] At present, native aortic valve regurgitation is still listed as a contraindication for TAVR. The main reason is that there are many problems with the existing valve positioning parts during loading and release. For example: when the valve is loaded, its loading structure and process are relatively complicated, which may cause interference with other components when it is released, and the complex process will also increase the difficulty of loading; in addition, after the valve enters the aorta, the opening angle between its positioning part and the valve stent is difficult to control, which makes it more difficult for the positioning part to enter the sinus, or because the opening angle is too large, the positioning part will scratch the blood vessel wall, causing the thrombus to peel off, causing a stroke, etc.

[0005] Patent CN202211084554.5 discloses an implant device delivery system with an elastic release device, comprising: an implant device, an elastic release device and a delivery catheter; the elastic release device comprises a connecting structure, an elastic member, a rigid member and a releasing member, the connecting structure is connected to the delivery catheter, one end of the elastic member is fixed to the connecting structure, and the other end is connected to the rigid member; and the distal end of the releasing member is fixedly connected to the elastic member; during pre-installation, the connecting structure and the implant device are circumferentially compressed, the proximal end of the implant device passes through the connecting structure, and the rigid member passes through the proximal end of the implant device to form a detachable connection; when releasing the implant device, the releasing member is pulled so that the elastic member undergoes elastic deformation and moves toward the proximal end under the pulling of the releasing member, and the elastic member simultaneously drives the rigid member to move toward the proximal end, and the rigid member gradually separates from the implant device to complete the release of the implant device. In this solution, although the controlled release between the implant device and the delivery system can be guaranteed, the connection structure between the implant device and the delivery system is relatively complex, which not only increases the difficulty of processing, but also makes the implant device more complicated to assemble. In addition, the delivery system cannot control the opening angle of the positioning part, resulting in greater difficulty in inserting the positioning part into the sinus after release, fewer indications, and extremely high requirements on the operator's operation.

[0006] Patent CN202211084554.5 discloses a valve prosthesis that is convenient for capturing leaflets, including an expandable stent for supporting and anchoring, a positioning member for positioning and clamping autologous leaflets, and a delivery system for delivering the valve prosthesis, wherein the expandable stent has an inflow end and an outflow end, the positioning member includes a connecting portion arranged at the distal end and a positioning portion at the proximal end, the expandable stent is provided with a plurality of connecting structures at the outflow end, a strut is provided on the connecting structure, and one end of the strut is connected to the connecting portion of the positioning member, and the other end of the strut is connected to the connecting structure; when the valve prosthesis reaches the target position, the positioning portion of the positioning member extends out of the delivery system, and the two ends of the expandable stent are restricted by the delivery system, so that the proximal end of the strut is propped up toward the outside of the expandable stent relative to the distal end of the strut, and drives the positioning portion of the positioning member to prop up toward the outside of the expandable stent. Although this patented solution can expand the opening angle of the positioning member to a certain extent, due to the large differences in physiological and anatomical structures between different patients, the required opening angles of different patients are different, and the prefabricated mechanical structure cannot adjust the opening angle of the positioning member in real time, resulting in many difficulties during the operation. For example, if the opening angle of the positioning member is too small, it is difficult for the positioning member to enter the sinus and difficult to position; if the opening angle is too large, it is easy to scratch the blood vessel wall, causing thrombus detachment, stroke, etc. Summary of the invention

[0007] This application is proposed in view of the above and other more concepts.

[0008] One of the purposes of the present application is to overcome the deficiencies of the prior art and to provide an implant device delivery system with controllable positioning member angle for patients with cardiovascular diseases such as aortic stenosis who require interventional treatment.

[0009] The technical solution adopted to solve the technical problem of the present invention is to provide an implant device delivery system with a controllable positioning member angle, including an implant device and a delivery system for delivering the implant device to a target position, wherein the implant device is provided with a positioning member, one end of the positioning member is connected to the implant device, and the other end is a free end, the delivery system includes an outer sheath tube, an inner core tube arranged in the outer sheath tube, a middle cavity tube arranged in the outer sheath tube and sleeved on the inner core tube, and a control component, a withdrawal sheath fixed at the distal end of the inner core tube, and a control wire matched with the control component, the control component is arranged at the distal end of the middle cavity tube, wherein the control component includes a first control member, an elastic member and a second control member, when pre-installed, the proximal end of the implant device is connected to the first control member, the distal end of the implant device is connected to the second control member and is arranged inside the withdrawal sheath, and the inner core tube is pulled toward the proximal end to compress the elastic member and expand the free end of the positioning member outward.

[0010] As a further improvement of the present invention, the distal end of the middle cavity tube is connected to the first control component, and when the inner core tube is pushed or pulled back, the inner core tube can undergo axial displacement relative to the control component.

[0011] As a further improvement of the present invention, when the elastic member is compressed, the proximal end portion of the implant instrument is squeezed toward the distal end by force, so that the free end of the positioning member expands outward.

[0012] As a further improvement of the present invention, the operator can control the length of the elastic member by pulling back the inner core tube, thereby controlling the outward expansion angle of the positioning member.

[0013] As a further improvement of the present invention, the second control member cooperates with the distal end of the implant instrument and is preinstalled in the withdrawal sheath. When the withdrawal sheath moves toward the distal end relative to the second control member, the implant instrument is separated from the second control member.

[0014] As a further improvement of the present invention, a connector is provided at the distal end of the implant device, wherein the second control member is provided with a connecting structure corresponding to the connecting structure, and when pre-installed, the connector is buckled on the connecting structure, and the connector and the connecting structure are located in the withdrawal sheath; specifically, when pre-installed, the elastic member is in a pre-tightened state, the withdrawal sheath limits the expansion of the distal end portion of the implant device, and the connector is embedded in the connecting structure and pre-installed in the withdrawal sheath.

[0015] As a further improvement of the present invention, in the natural state, the length of the elastic member is greater than or equal to the axial length of the implant device.

[0016] As a further improvement of the present invention, the elastic member is a helical spring.

[0017] As a further improvement of the present invention, the proximal end of the implant instrument is provided with a connecting hole, the first control component is provided with a fixing hole corresponding to the connecting hole, and the control wire connects the fixing hole and the connecting hole. When the control wire is pulled out of the connecting hole, the proximal end of the implant instrument is separated from the second control component.

[0018] As a further improvement of the present invention, when used for aortic valve treatment, the implant device is a valve stent, and the number of the positioning members is 3.

[0019] Compared with the prior art, the advantages of the technical solution of the present application include at least the following:

[0020] The existing delivery system cannot control the size of the opening angle of the positioning piece after it is released, resulting in the positioning piece of the valve prosthesis being excessively fitted to the stent body after release, making it difficult to position, or the positioning piece having too large an opening angle, causing scratches on the blood vessel wall, etc.; according to an idea of ​​the present application, the two ends of the implant device (i.e., the valve stent) are respectively connected to the first control piece and the second control piece, one end of the positioning piece is fixed to the proximal end of the valve stent, and the other end is in a free state. When the positioning piece is released from the outer sheath tube, the elastic piece can be compressed by pulling the inner core tube, and the proximal end of the valve stent and the end where the positioning piece is fixed are subjected to a force squeezing toward the distal end, thereby causing the free end of the positioning piece to be tilted. The operator can control the size of the outward expansion angle of the positioning piece by pulling back the amplitude of the inner core tube, thereby adapting to the physiological and anatomical structures of different patients. It has a wide range of indications and is very convenient to operate.

[0021] According to one concept of the present application, when the distal end of the implant device is pre-installed, it is only necessary to embed the connector into the connecting structure, and then pull back the inner core tube so that the distal end of the implant device is placed in the withdrawal sheath. When separation is required, it is only necessary to push the inner core tube toward the distal end, and the second control part is detached from the withdrawal sheath to achieve disassembly and separation. The operation is simple and the stability is high.

[0022] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below and are predictable and understandable to those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The above-mentioned features and advantages and other features and advantages of these embodiments and the manner in which they are achieved will become more apparent, and the embodiments of the present application can be better understood by referring to the following description together with the accompanying drawings, in which:

[0024] Figure 1 and Figure 2 It is a schematic diagram of the structure of the conveying system of the present invention.

[0025] Figure 3 and Figure 4 It is a schematic diagram of the structure of the positioning member after being released and adjusting the opening angle of the positioning member according to the present invention.

[0026] Figure 5 This is a schematic diagram of the control component structure.

[0027] Figure 6 Schematic diagram of the delivery catheter structure.

[0028] Figure 7 Schematic diagram of the implanted device structure.

[0029] Figures 8 to 11 It is a schematic diagram of the process of the conveying system of the present invention entering the target position.

[0030] The features indicated by the numbers in the accompanying drawings are as follows:

[0031] 1-implantation device, 11-positioning piece, 111-free end, 12-connector, 13-connecting hole, 2-delivery catheter, 21-outer sheath tube, 22-inner core tube, 23-middle cavity tube, 24-withdrawal sheath, 25-control wire, 3-control assembly, 31-first control piece, 311-fixing hole, 32-elastic piece, 33-second control piece, 331-connection structure. Implementation

[0032] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.

[0033] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and may be implemented or executed in various ways. Each example is provided by explaining the disclosed embodiments rather than limiting them. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence disclosed in the present application. For example, a feature illustrated or described as part of an embodiment may be used together with another embodiment to still produce another embodiment. Therefore, the present application discloses and covers such modifications and variations within the scope of the appended claims and their equivalent elements.

[0034] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents and additional items.

[0035] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0036] In the present application, the term “proximal end” or “proximal side” refers to an end or a side closer to a surgical operator, and the term “distal end” or “distal side” refers to an end or a side farther from a surgical operator.

[0037] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems. Example

[0038] like Figure 1 and Figure 2As shown, an implant device 1 delivery system that can be used for aortic valve surgery and can be automatically centered according to an embodiment of the present application is illustrated, comprising an implant device 1 and a delivery system for delivering the implant device 1 to a target position, wherein the implant device 1 is provided with a positioning member 11, one end of the positioning member 11 is connected to the implant device 1, and the other end is a free end 111, and the number of the positioning members 11 is 3, as shown in FIG. Figure 7 As shown, the delivery system includes an outer sheath tube 21, an inner core tube 22 arranged in the outer sheath tube 21, a middle cavity tube 23 arranged in the outer sheath tube 21 and sleeved on the inner core tube 22, a control component 3, a retraction sheath 24 fixed to the distal end of the inner core tube 22, and a control wire 25 cooperating with the control component 3, the proximal end of the control component 3 is fixedly connected to the distal end of the middle cavity tube 23 (so that the inner core tube 22 can move axially relative to the control component 3), wherein the control component 3 includes a first control member 31, an elastic member 32 and a second control member 33, and the first control member 31, the elastic member 32 and the second control member 33 are an integrated structure, as shown in FIG. Figure 5 As shown, during pre-installation, the proximal end of the implant device 1 is detachably connected to the first control member 31 through the control wire 25, and the distal end of the implant device 1 is connected to the second control member 33 and is disposed inside the retractable sheath 24. Figure 2 As shown, the inner core tube 22 is pulled toward the proximal end to compress the elastic member 32, and the free end 111 of the positioning member 11 expands outward, as shown in FIG. Figure 4 As shown; during pre-installation, the proximal end of the implant device 1 is first connected to the first control member 31 through the control wire 25, and then the distal end of the implant device 1 is matched with the second control member 33, and then the distal end of the implant device 1 is located in the withdrawal sheath 24 by pulling back the inner core tube 22, and then the outer sheath tube 21 is moved toward the distal end, thereby completing the loading of the implant device 1; wherein, after the implant device 1 reaches the predetermined position of the predetermined aortic valve, the outer sheath tube 21 is first moved toward the proximal end, and then the inner core tube 22 is pulled back to compress the elastic member 32, and the opening angle of the positioning member 11 is observed through the image, and after the positioning member 11 is inserted into the sinus, the inner core tube 22 is pushed toward the distal end so that the distal end portion of the implant device 1 is released, and the control wire 25 is further operated to release the proximal end portion of the implant device 1, thereby completing the release of the implant device 1.

[0039] In this embodiment, the distal end of the middle cavity tube 23 is connected to the first control component 31 , and when the inner core tube 22 is pushed or pulled back, the inner core tube 22 can undergo axial displacement relative to the control component 3 .

[0040] In this embodiment, a connector 12 is provided at the distal end of the implant device 1, wherein the second control member 33 is provided with a connecting structure 331 corresponding to the connecting structure, and when pre-installed, the connector 12 is buckled on the connecting structure 331, and the connector 12 and the connecting structure 331 are located in the withdrawal sheath 24; specifically, when pre-installed, the elastic member 32 is in a pre-tightened state, the withdrawal sheath 24 limits the expansion of the distal end portion of the implant device 1, and the connector 12 is embedded in the connecting structure 331 and pre-installed in the withdrawal sheath 24, as shown in FIG. Figure 2 shown.

[0041] In this embodiment, in the natural state, the length of the elastic member 32 is greater than or equal to the axial length of the implant device 1 .

[0042] In this embodiment, the elastic member 32 is a helical spring.

[0043] In this embodiment, the proximal end of the implant instrument 1 is provided with a connecting hole 13, the first control component 31 is provided with a fixing hole 311 corresponding to the connecting hole 13, and the control wire 25 connects the fixing hole 311 and the connecting hole 13. When the control wire 25 is pulled out of the connecting hole 13, the proximal end of the implant instrument 1 is separated from the second control component 33.

[0044] The operation process of the conveying system capable of controlling the angle of the positioning member 11 includes the following steps: Figures 8 to 11 shown.

[0045] 1) The delivery system is operated to enter the heart through a transvascular approach, and the outer sheath 21 follows the curvature of the aortic arch and enters the ascending aorta until the implant device 1 reaches the aortic valve position.

[0046] 2) The outer sheath 21 is operated to move toward the proximal end. At this time, the free end 111 of the positioning member 11 is released first. Figure 8 As shown, pull back the inner core tube 22 and observe the opening angle of the positioning member 11 through the image, as shown in FIG. Fig. 9 As shown, when the appropriate position is reached, the delivery system is operated to allow the positioning member 11 to enter the sinus.

[0047] 3) The inner core tube 22 is further operated to move distally, and the distal end of the implant device 1 is released, and then the control wire 25 is withdrawn to separate the proximal end of the implant device 1 from the first control member 31, and the implantation is completed. Fig.10 and Fig.11 shown.

[0048] The foregoing description of several embodiments of the present application is presented for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, constructions and / or steps disclosed, and it is apparent that many modifications and variations may be made in light of the teachings above. The scope of the present invention and all equivalents are intended to be defined by the appended claims.

Claims

1. An implant device delivery system capable of controlling the opening angle of a positioning member, comprising an implant device and a delivery system for delivering the implant device to a target position, wherein the implant device is provided with a positioning member, one end of the positioning member is connected to the implant device, and the other end is a free end, and is characterized in that: The delivery system includes an outer sheath tube, an inner core tube arranged in the outer sheath tube, a middle cavity tube arranged in the outer sheath tube and sleeved on the inner core tube, a control component, a withdrawal sheath fixed at the distal end of the inner core tube, and a control wire matched with the control component, wherein the control component is arranged at the distal end of the middle cavity tube, wherein the control component includes a first control member, an elastic member and a second control member, wherein the first control member, the elastic member and the second control member are an integrated structure, and when pre-installed, the proximal end of the implant device is connected to the first control member, the distal end of the implant device is connected to the second control member and is arranged inside the withdrawal sheath, and the inner core tube Pulling the tube toward the proximal end can cause the elastic member to be compressed and the free end of the positioning member to expand outward; in the natural form, the length of the elastic member is greater than or equal to the axial length of the implant device; the distal end of the middle cavity tube is connected to the first control member, the second control member cooperates with the distal end of the implant device and is pre-installed in the withdrawal sheath, the distal end of the implant device is provided with a connector, the second control member is provided with a connecting structure corresponding to the connector, the proximal end of the implant device is provided with a connecting hole, the first control member is provided with a fixing hole corresponding to the connecting hole, and the control wire connects the fixing hole and the connecting hole.

2. The implant device delivery system according to claim 1, characterized in that: When the inner core tube is pushed or pulled back, the inner core tube can be axially displaced relative to the control component.

3. The implant device delivery system according to claim 1, characterized in that: When the elastic member is compressed, the proximal end portion of the implant instrument is pressed toward the distal end, causing the free end of the positioning member to expand outward.

4. The implant device delivery system according to claim 1, characterized in that: When the withdrawal sheath moves distally relative to the second control member, the implantation instrument is separated from the second control member.

5. The implant device delivery system according to claim 4, characterized in that: During pre-installation, the connector is buckled on the engagement structure, and the connector and the engagement structure are located in the withdrawal sheath.

6. The implant device delivery system according to claim 5, characterized in that: During pre-installation, the elastic member is in a pre-tightened state, and the withdrawal sheath limits the expansion of the distal end portion of the implant instrument.

7. The implant device delivery system according to claim 1, characterized in that: The elastic member is a helical spring.

8. The implant device delivery system according to claim 1, characterized in that: When the control wire is pulled out of the connecting hole, the proximal end of the implantation instrument is separated from the second control member.

9. The implant device delivery system according to claim 1, characterized in that: The implant device is a valve stent, and the number of the positioning elements is three.

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