Delivery device for a valve prosthesis and valve prosthesis system
Patent Information
- Application Number
- CN202111056594.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-09-09
- Publication Date
- 2026-10-30
- Estimated Expiration
- 2041-09-09
AI Technical Summary
[0003]二尖瓣反流是最常见的老年心脏瓣膜假体病,随着人口老年化,发病率急剧上升,目前用于治疗二尖瓣反流的方法主要分为外科开胸手术以及二尖瓣置换术,其中,由于外科开胸手术对人体创伤较大,导致75岁以上高龄患者中有50%的患者因顾虑外科开胸手术的风险而拒绝采用外科开胸手术治疗
[0006]本申请实施例的目的在于提供一种瓣膜假体的输送装置以及瓣膜假体系统,可确保在使用瓣膜假体的输送装置进行手术时,能够顺利释放瓣膜假体,从而降低手术时的风险。
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Figure CN115778632B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to a valve prosthesis delivery device and a valve prosthesis system. Background Technology
[0002] The main pathophysiological change in mitral regurgitation is mitral regurgitation, that is, when the left ventricle contracts, blood flows from the left ventricle into the aorta and the left atrium where resistance is lower. The regurgitation flow into the left atrium can reach more than 50% of the left ventricular output, which increases the diastolic load on the left ventricle.
[0003] Mitral regurgitation is the most common prosthetic heart valve disease in the elderly, and its incidence is rising sharply with an aging population. Currently, the main treatments for mitral regurgitation are open-heart surgery and mitral valve replacement. However, due to the greater trauma of open-heart surgery, 50% of patients over 75 years of age refuse this procedure due to concerns about its risks. Therefore, the less invasive mitral valve replacement is becoming increasingly widely used.
[0004] Existing valve prosthesis delivery devices used in mitral valve replacement surgery mostly employ wire-controlled or suture-controlled methods to control the valve prosthesis, aiming for precise positioning and controllable release. However, the inventors discovered that when using existing valve prosthesis delivery devices for mitral valve replacement surgery, during the process of removing sutures or wires to release the valve prosthesis, the sutures or wires often fail to untangle, preventing the valve prosthesis from being released from the delivery device and thus increasing the surgical risk.
[0005] Therefore, there is an urgent need to provide a valve prosthesis delivery device and a valve prosthesis system to ensure that the valve prosthesis can be successfully released during surgery using the valve prosthesis delivery device, thereby reducing the risks during surgery. Summary of the Invention
[0006] The purpose of this application is to provide a valve prosthesis delivery device and a valve prosthesis system, which can ensure that the valve prosthesis can be successfully released when performing surgery using the valve prosthesis delivery device, thereby reducing the risks during surgery.
[0007] To address the aforementioned problems, this application provides a valve prosthesis delivery device, comprising: a clamping assembly; the clamping assembly includes at least two clamps and a control member; the clamps have a first working state and a second working state, wherein in the first working state, the clamps are configured to form closed ends to bind the connecting ends of the valve prosthesis, and in the second working state, the clamps are configured to form open ends to separate from the valve prosthesis; the control member is used to move relative to the clamps to change the clamps from the first working state to the second working state.
[0008] Furthermore, this application embodiment also provides a valve prosthesis system, including: a valve prosthesis and the above-mentioned delivery device, wherein the valve prosthesis includes a connecting end, the connecting end is provided with a slot, and the slot is used for detachable connection with the clamp of the delivery device.
[0009] The valve prosthesis delivery device and valve prosthesis system provided in this application include: a clamping assembly; the clamping assembly includes at least two clamps and a control member; the clamps have a first working state and a second working state, in the first working state the clamps are configured to form a closed end to bind the connecting end of the valve prosthesis, and in the second working state the clamps are configured to form an open end to separate from the valve prosthesis; the control member is used to move relative to the clamps to change the clamps from the first working state to the second working state. Thus, when the delivery device releases the valve prosthesis, it only needs to move the control component relative to the clamp to change the clamp from the first working state to the second working state, and separate the valve prosthesis that was originally bound to the clamp from the clamp. Therefore, it is not necessary to use wire or wire control to control the valve prosthesis. This avoids the valve prosthesis being unable to be released from the delivery device due to the inability to untie the wire or wire during the release of the valve prosthesis. This ensures that the valve prosthesis can be released smoothly when using the valve prosthesis delivery device during surgery, reducing the risks during surgery.
[0010] In addition, the clamp includes a main body and an elastic part. When the clamp is in the first working state, the elastic part deforms at least partially under the action of the control member to form the closed end. When the clamp is in the second working state, the closed end of the elastic part returns to the open end in its natural state.
[0011] Additionally, the control element includes a control channel, the size of which is configured to allow the main body portion to pass through while preventing the elastic portion from passing through; when the clamp is in a first working state, the elastic portion abuts against the control channel and forms the closed end under the action of the control channel; when the clamp is in a second working state, the elastic portion maintains a radial gap with the control channel.
[0012] In addition, when the clamp is in the first working state, the maximum diameter of the elastic part is greater than the diameter of the control channel.
[0013] In addition, the control component is a cylindrical component or a frustum-shaped component; the control channel is arranged on the control component in a direction parallel to the axis of the control component.
[0014] Additionally, the control element includes a sleeve located at the distal end, and the control channel includes the inner cavity of the sleeve.
[0015] Additionally, the clip includes two opposing single pieces, each single piece including a main body portion and an elastic portion; in any of the clips, the main body portions of the two single pieces form the main body portion, and the elastic portions of the two single pieces form the elastic portion.
[0016] Additionally, in any of the aforementioned single pieces, the elastic portion includes a first extension connected at an angle to the main body portion and a second extension connected to the first extension; the two first extensions of each clip extend in a direction that is opposite to each other and away from the two main body portions, and the two second extensions of each clip extend in a direction that is close to each other and away from the two first extensions.
[0017] In addition, the conveying device also includes a handle for driving the control member to move relative to the clamp.
[0018] Additionally, the delivery device further includes: an inner tube assembly; the clamping assembly further includes a control tube; the handle includes a first drive assembly and a housing; the proximal end of the inner tube assembly is configured to be fixedly connected to the housing, and the distal end of the inner tube assembly is configured to carry the valve prosthesis; the control tube is sleeved on the inner tube assembly, and the proximal end of the control tube is connected to the first drive assembly, the distal end of the control tube is connected to the clamp, the control element is fixed to the inner tube assembly and away from the control tube, and the first drive assembly is used to drive the control tube to move so that the control tube moves relative to the inner tube assembly.
[0019] In addition, the clamping assembly also includes a connecting tube, which is sleeved on the distal end of the control tube; the clamps are circumferentially distributed outside the connecting tube.
[0020] Additionally, the delivery device further includes: an inner tube assembly; the clamping assembly further includes a control tube; the handle includes a first drive assembly and a housing; the proximal end of the inner tube assembly is configured to be fixedly connected to the housing, and the distal end of the inner tube assembly is configured to carry the valve prosthesis; the control tube is sleeved on the inner tube assembly, and the proximal end of the control tube is connected to the first drive assembly, the distal end of the control tube is connected to the control element, and the distal end of the control tube is provided with a travel groove, the clamp is fixed to the inner tube assembly through the travel groove, and the first drive assembly is used to drive the control tube to move so that the control tube moves relative to the inner tube assembly.
[0021] Additionally, the first drive assembly includes a screw and a nut. The screw is located within the housing and is configured to prevent axial rotation. The screw is fixed to the proximal end of the control tube. The nut is sleeved on the screw and threadedly connected to the screw. The housing has an opening through which at least a portion of the nut protrudes from the housing.
[0022] In addition, the first drive assembly also includes a first guide and a second guide. The first guide is disposed on the housing, and the second guide is disposed on the screw. The extension direction of the first guide is in the same direction as the axial direction of the screw. The second guide is slidably disposed on the first guide along the extension direction of the first guide to prevent the screw from rotating axially.
[0023] In addition, the first guide is a track disposed on the housing; the second guide is a groove disposed on the screw and fitted with the first guide.
[0024] Additionally, the first drive assembly includes a rack and a gear, the rack being located within the housing and configured to move only along its extension direction, the rack being fixed to the proximal end of the control tube, and the gear meshing with the rack; the housing has an opening through which at least a portion of the gear protrudes from the housing. Attached Figure Description
[0025] Figure 1 A schematic diagram of the clamping assembly and inner tube assembly of the conveying device provided in Embodiment 1 of this application;
[0026] Figure 2 A schematic diagram showing the clamp in the clamping assembly of the conveying device provided in Embodiment 1 of this application engaging with the connecting pipe sleeved on the control pipe;
[0027] Figure 3 A schematic diagram showing the cooperation between the control component of the conveying device provided in Embodiment 1 of this application and the central steel pipe;
[0028] Figure 4 This is a schematic diagram of the structure of a single piece of the conveying device provided in Embodiment 1 of this application;
[0029] Figure 5 A schematic diagram of the sheath assembly of the conveying device provided in Embodiment 1 of this application when it is engaged with the second drive assembly;
[0030] Figure 6 A schematic diagram of the inner tube assembly and control components of the conveying device provided in Embodiment 1 of this application;
[0031] Figure 7 This is a schematic diagram of the conveying device provided in Embodiment 1 of this application;
[0032] Figure 8 A schematic diagram of the clamping component of the conveying device provided in Embodiment 1 of this application when it is engaged with the first driving component;
[0033] Figure 9This is a schematic diagram of the handle of the conveying device provided in Embodiment 1 of this application. Detailed Implementation
[0034] As can be seen from the background art, existing valve prostheses used in mitral valve replacement surgery are mostly delivered using wire-controlled or wire-controlled methods to control the valve prosthesis in order to achieve precise positioning and controllable release.
[0035] The inventors of this application have discovered through analysis that when performing mitral valve replacement surgery using existing valve prosthesis delivery devices, during the process of removing sutures or wires to release the valve prosthesis, the sutures or wires often fail to untangle, resulting in the valve prosthesis being unable to be released from the delivery device, thereby increasing the risk of the surgery.
[0036] To address the aforementioned problems, Embodiment 1 of this application provides a valve prosthesis delivery device, comprising: a clamping assembly; the clamping assembly includes at least two clamps and a control member; the clamps have a first working state and a second working state, wherein in the first working state, the clamps are configured to form a closed end to bind the connecting end of the valve prosthesis, and in the second working state, the clamps are configured to form an open end to separate from the valve prosthesis; the control member is used to move relative to the clamps to change the clamps from the first working state to the second working state. Thus, when the delivery device releases the valve prosthesis, it only needs to move the control component relative to the clamp to change the clamp from the first working state to the second working state, and separate the valve prosthesis that was originally bound to the clamp from the clamp. Therefore, it is not necessary to use wire or wire control to control the valve prosthesis. This avoids the valve prosthesis being unable to be released from the delivery device due to the inability to untie the wire or wire during the release of the valve prosthesis. This ensures that the valve prosthesis can be released smoothly when using the valve prosthesis delivery device during surgery, reducing the risks during surgery.
[0037] This application does not impose any particular limitations on the specific application scenarios of the valve prosthesis, such as valve prostheses for aortic, mitral, tricuspid, or pulmonary valves. The valve prosthesis includes a compressed state and a released state; in the compressed state, the radial dimension of the valve prosthesis is smaller than that in the released state. When the valve prosthesis needs to be delivered to the target location in the body, it must be set to the compressed state. After delivery to the target location, the valve prosthesis must be changed from the compressed state to the released state using a balloon or self-inflation method.
[0038] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the various embodiments of this application will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details have been presented in the various embodiments of this application to enable readers to better understand this application. However, the technical solutions claimed in this application can also be implemented based on various changes and modifications to the following embodiments.
[0039] See Figures 1 to 3 This application provides a valve prosthesis delivery device, including: a clamping assembly 110; the clamping assembly 110 includes at least two clamps 111 and a control member 112; the clamps 111 have a first working state and a second working state, in the first working state, the clamps 111 are configured to form a closed end to bind the connecting end of the valve prosthesis, and in the second working state, the clamps 111 are configured to form an open end to separate from the valve prosthesis; the control member 112 is used to move relative to the clamps 111 to change the clamps 111 from the first working state to the second working state.
[0040] Specifically, in this embodiment, when the clip 111 is in the first working state, the clip 111 is acted upon by the control member 112 to form a closed end, thereby allowing the clip 111 to be configured to restrain the connecting end of the valve prosthesis; when the clip 111 is in the second working state, the control member 112 moves away from the clip 111, and the clip 111 is no longer subject to the force of the control member 112, forming an open end, thereby allowing the clip 111 to separate from the valve prosthesis that was originally restrained on the clip 111.
[0041] More specifically, in this embodiment, when the delivery device releases the valve prosthesis, the control member 112 remains fixed while the clamp 111 moves, thereby causing relative movement between the control member 112 and the clamp 111, and thus changing the clamp 111 from a first working state to a second working state. In an alternative embodiment, when the delivery device releases the valve prosthesis, the clamp remains fixed while the control member moves, thereby causing relative movement between the control member and the clamp, and thus changing the clamp from a first working state to a second working state. In yet another alternative embodiment, when the delivery device releases the valve prosthesis, both the clamp and the control member move, but the displacement of the clamp is different from the displacement of the control member. This also allows relative movement between the control member and the clamp, thereby changing the clamp from a first working state to a second working state.
[0042] For the preferred option, please continue reading. Figures 1 to 3The clip 111 includes a main body 113 and an elastic part 114. When the clip 111 is in a first working state, the elastic part 114 deforms at least partially under the action of the control member 112 to form the aforementioned closed end, thereby locking the valve prosthesis. When the clip 111 is in a second working state, the closed end of the elastic part 114 returns to an open end in its natural state, thereby separating from the valve prosthesis. In this embodiment, when the clip 111 is in the first working state, the elastic part 114 deforms partially under the action of the control member 112 to form the aforementioned closed end, thereby locking the valve prosthesis.
[0043] Specifically, the process of the clip 111 changing from the first working state to the second working state is the process from the control member 112 acting on the elastic part 114 of the clip 111 to the control member 112 no longer acting on the elastic part 114 of the clip 111. During this process, the elastic part 114 of each clip 111 gradually opens from the closed end to form an open end.
[0044] It should be noted that the elastic part 114 in its natural state is the state in which the elastic part 114 is when it is not subjected to external force. In this embodiment, the elastic part 114 forms an open end in its natural state. In an alternative embodiment, the elastic part may also form a closed end in its natural state. In this case, the clamp is in a first working state, and when the clamp forms an open end under the action of the control member, the clamp is in a second working state.
[0045] More specifically, when the clip 111 is in the first working state, the control member 112 contacts the elastic part 114 and applies a force to the elastic part 114, causing the elastic part 114 to undergo elastic deformation and form a closed end to lock the valve prosthesis; when the clip 111 is in the second working state, the control member 112 no longer contacts the elastic part 114, and the elastic part is in its natural state after the force of the control member 112 is removed, the deformed part recovers, the closed end returns to the open end, and the valve prosthesis can be separated from the open end; when the control member 112 and the elastic part 114 are relatively far apart, the clip 111 changes from the first working state to the second working state.
[0046] Preferably, the control member 112 includes a control channel 115, the size of which is configured to allow the main body portion 113 to pass through while the elastic portion 114 cannot pass through; when the clamp 111 is in a first working state, the elastic portion 114 of the clamp 111 abuts against the control channel 115 and forms a closed end under the action of the control channel 115; when the clamp 111 is in a second working state, the elastic portion 114 of the clamp 111 maintains a radial gap with the control channel 115 and forms an open end.
[0047] Thus, since the size of the control channel 115 is configured to allow the main body 113 to pass through while preventing the elastic part 114 from passing through, the entire clamp 111 is prevented from passing through the control channel 115 when the control member 112 moves relative to the clamp 111. Furthermore, by moving relative to the control member 112 and the clamp 111, in the first working state, the clamp 111 abuts against the control channel 115 to form a closed end, and in the second working state, the clamp 111 and the control channel 115 maintain a radial gap, that is, the clamp 111 and the control channel 115 no longer contact each other to form an open end.
[0048] In this embodiment, when the clamp 111 is in the first working state, the maximum diameter of the elastic portion 114 is greater than the diameter of the control channel 115. This allows the size of the control channel 115 to be configured such that the elastic portion 114 cannot pass through. In this embodiment, the maximum diameter of the elastic portion 114 refers to the diameter of its largest circumscribed circle.
[0049] Specifically, the control element 112 is a cylindrical element or a frustum-shaped element; the control channel 115 is disposed on the control element 112 along a direction parallel to the axis of the control element 112. In this embodiment, the control element 112 is a cylindrical element. In an alternative embodiment, the control element 112 is a frustum-shaped element.
[0050] Furthermore, the control element 112 also includes a sleeve 116 located at the distal end, and the control channel 115 also includes the inner cavity of the sleeve 116. This improves the passability of the clamp 111.
[0051] See further Figure 2 and Figure 4 In this embodiment, the clip 111 includes two opposing single pieces 117, each single piece 117 including a main body portion 101 and an elastic portion 102. In any clip 111, the main body portions 101 of all single pieces 117 form a main body portion 113, and the elastic portions 102 of all single pieces 117 form an elastic portion 114. More specifically, the main body portions 101 constituting the main body portion 113 are fixed to each other.
[0052] Specifically, in this embodiment, in any single piece 117, the elastic portion 102 includes a first extension 103 connected at an angle to the main body portion 101 and a second extension 104 connected to the first extension 103; the two first extensions 103 of each clip 111 extend in directions that are opposite to each other and away from the two main body portions 101, and the two second extensions 104 of each clip 111 extend in directions that are close to each other and away from the two first extensions 103.
[0053] More specifically, in this embodiment, when the clip 111 is in the first working state, the ends of the two second extensions 104 of the clip 111 that are away from the main body 113 abut against each other to form a closed end to lock the valve prosthesis. When the clip 111 is in the second working state, the ends of the two second extensions 104 of the clip 111 that are away from the main body 113 separate from each other to form an open end, so as to separate the clip from the valve prosthesis.
[0054] In addition, see Figures 5 to 7 The delivery device also includes a sheath assembly 120 and an inner tube assembly 130. The sheath assembly 120 is movably sleeved on the inner tube assembly 130 for restraining the valve prosthesis in a compressed state; the inner tube assembly 130 is used to load the valve prosthesis in a compressed state.
[0055] Preferably, the inner tube assembly 130 includes a guide head 131, an inner core 132, and a central steel tube 133. The guide head 131 is located at the distal end of the inner tube assembly 130, the distal end of the inner core 132 is connected to the guide head 131, and the proximal end of the inner core 132 is fixed to the distal end of the central steel tube 133.
[0056] The guide head 131 is used to support the inner cavity of the sheath assembly 120.
[0057] Specifically, in this embodiment, the guide head 131 is spindle-shaped. It should be noted that in other embodiments, the guide head may not be spindle-shaped. In an alternative embodiment, the guide head is conical.
[0058] More specifically, in this embodiment, the guide head 131 is made of PEBAX (PEBAX: polyether amide block copolymer) to avoid puncturing the heart or blood vessels in human tissue. It should be noted that in other alternative embodiments, the guide head may also be made of other materials, such as TPU (Turboplastic polyurethane elastomer).
[0059] See also Figure 6 In this embodiment, the inner core 132 supports the valve prosthesis loaded in the delivery device; that is, the inner core 132 supports the valve prosthesis restrained by the clamp 111, and the central steel tube 133 supports the sheath assembly 120. Furthermore, in this embodiment, the bending resistance of the inner core 132 is weaker than that of the central steel tube 133. Thus, when the sheath assembly 120 retracts to release the valve prosthesis, the guide head 131 has a certain degree of compliance within the atrium and will not puncture the atrium.
[0060] For the preferred option, please continue reading. Figure 1 and Figure 7 The conveying device also includes a handle 140, which is used to drive the control member 112 to move relative to the clamp 111.
[0061] Furthermore, see also Figure 2 , Figure 6 and Figure 8 The clamping assembly 110 also includes a control tube 118; the handle 140 includes a first drive assembly 141 and a housing 142; the proximal end of the inner tube assembly 130 is configured to be fixedly connected to the housing 142, and the distal end of the inner tube assembly 130 is configured to carry the valve prosthesis; the control tube 118 is sleeved on the inner tube assembly 130.
[0062] Specifically, in this embodiment, the proximal end of the middle steel tube 133 of the inner tube assembly 130 is fixed to the housing 142 of the handle 140 to fix the inner tube assembly 130 to the handle 140.
[0063] In this embodiment, the proximal end of the control tube 118 is connected to the first drive assembly 141, the distal end of the control tube 118 is connected to the clip 111, the control member 112 is fixed to the inner tube assembly 130 and away from the control tube 118, and the first drive assembly 141 is used to drive the control tube 118 to move so that the control tube 118 moves relative to the inner tube assembly 130.
[0064] Specifically, in this embodiment, the clamp 111 is arranged at the distal end of the control tube 118, and the control member 112 is fixed to the inner tube assembly 130, with the control member 112 fixed to the inner tube assembly 130 at a position away from the control tube 118. When the first drive assembly 141 drives the control tube 118 to move relative to the inner tube assembly 130, the clamp 111 moves distally relative to the control member 112 fixed on the inner tube assembly 130 under the drive of the control tube 118, causing the clamp 111 to change from a first working state to a second working state.
[0065] For more details, please see [link / reference]. Figure 6 The control element 112 is located between the inner core 132 and the middle steel tube 133, and is connected to the proximal end of the inner core 132 and the distal end of the middle steel tube 133 respectively, so as to fix the proximal end of the inner core 132 and the distal end of the middle steel tube 133, and fix the control element 112 to the inner tube assembly 130.
[0066] Further details can be found by referring to [link / reference]. Figure 2 and Figure 8 The clamping assembly 110 also includes a connecting tube 119, which is sleeved on the distal end of the control tube 118; clamps 111 are circumferentially distributed outside the connecting tube 119. Specifically, in this embodiment, there are two clamps 111, which are arranged opposite to each other and distributed outside the connecting tube 119; more specifically, the main body 113 of the clamp 111 is fixed to the connecting tube 119.
[0067] It should be noted that, in an alternative embodiment, the connecting tube may not be provided. In this case, the clips can be directly distributed circumferentially outside the control tube and fixed to the control tube.
[0068] Additionally, see also Figure 1 and Figure 3 The number of control channels 115 is the same as the number of clips 111, and each control channel 115 is correspondingly set to one of the multiple clips 111. In this embodiment, since there are two clips 111, there are also two control channels 115.
[0069] It should be noted that this embodiment does not limit the number of clips 111. In an exemplary embodiment, the number of clips is four, and in this case, the number of control channels is also four.
[0070] In an alternative embodiment, the proximal end of the control tube is connected to a first drive assembly, and the distal end of the control tube is connected to a control element. The distal end of the control tube has a travel groove, through which a clamp is fixed to an inner tube assembly located inside the control tube. The first drive assembly drives the control tube to move relative to the inner tube assembly. Thus, since the proximal end of the control tube is connected to the first drive assembly, the distal end is connected to the control element, and the distal end of the control tube has a travel groove, the clamp is fixed to the inner tube assembly via the travel groove. When the drive assembly drives the control tube to move proximally relative to the inner tube assembly, the control element moves away from the clamp fixed to the inner tube assembly under the influence of the control tube, causing the clamp to change from a first working state to a second working state.
[0071] Preferably, in this embodiment, see further... Figure 8 The first drive assembly 141 includes a screw 143 and a nut 144. The screw 143 is located within the housing 142 and is configured to prevent axial rotation. The screw 143 is fixed to the proximal end of the control tube 118. The nut 144 is sleeved on the screw 143 and threadedly connected to it. The housing 142 has a first opening through which at least a portion of the nut 144 protrudes from the housing 142. Thus, an operator of the conveying device can operate the portion of the nut 144 protruding from the housing through the first opening to drive the control tube 118 to move via the screw 143.
[0072] For details, see Figure 9 In this embodiment, the first drive assembly 141 further includes a first guide 105 and a second guide 106. The first guide 105 is disposed on the housing 142, and the second guide 106 is disposed on the screw 143. The extending direction of the first guide 105 is in the same direction as the axial direction of the screw 143. The second guide 106 is slidably disposed on the first guide 105 along the extending direction of the first guide 105 to prevent the screw 143 from rotating axially.
[0073] More specifically, in this embodiment, the first guide 105 is a track disposed on the housing 142; the second guide 106 is a groove disposed on the screw 143 and fitted with the first guide 105.
[0074] It should be noted that in other alternative embodiments, the technical solution for preventing axial rotation of the screw may differ from the above-described technical solution. In an alternative embodiment, the first guide member may be slidably disposed on the second guide member along the extending direction of the second guide member to prevent axial rotation of the screw.
[0075] It should also be noted that in other alternative embodiments, the first drive assembly may not include the screw and nut, as long as the first drive assembly can be used to drive the control tube to move relative to the inner tube assembly. In an alternative embodiment, the first drive assembly includes a rack and a gear, the rack being located within the housing and configured to move only along its extension direction, the rack being fixed to the proximal end of the control tube, and the gear meshing with the rack; the housing has an opening through which at least a portion of the gear protrudes from the housing. Thus, an operator of the conveying device can operate the at least portion of the gear protruding from the housing through the opening to drive the control tube to move via the rack.
[0076] Further reading, please continue. Figure 5 The handle 140 also includes a second drive assembly 145, to which the sheath assembly 120 is connected. The second drive assembly 145 drives the sheath assembly 120 to move relative to the inner tube assembly 130. Thus, the sheath assembly 120 can be moved by the second drive assembly 145 to control the release or retrieval of the valve prosthesis by moving the sheath assembly 120 away from or towards the guide head 131. After the sheath assembly 120 completes the release of the valve prosthesis, if the valve prosthesis is positioned correctly, the control member 112 is operated to move relative to the clamp 111, causing the clamp 111 to change from a first working state to a second working state, achieving complete release of the valve prosthesis.
[0077] See also Figure 7 Preferably, in this embodiment, the second drive assembly 145 includes: a sheath assembly connector 146, a screw 147, and a nut 148. The sheath assembly connector 146 is connected to the proximal end of the sheath assembly 120 and the distal end of the screw 147. The screw 147 is located within the housing 142 and is configured to prevent axial rotation. The nut 148 is sleeved on the screw 147 and threadedly connected to the screw 147. The housing 142 also has a second opening through which at least a portion of the nut 148 protrudes from the housing 142. Thus, the operator of the conveying device can operate the portion of the nut 148 protruding from the housing through the second opening to drive the sheath assembly 120 to move via the screw 147.
[0078] Specifically, in this embodiment, the second drive assembly 145 further includes a connector 149, which is configured to remain relatively fixed to the housing 142. The screw 147 is provided with a boss extending along its extension direction. The boss is installed in a groove on the connector 149 so that the screw 147 is prevented from rotating axially.
[0079] It should be noted that in other alternative embodiments, the second drive assembly may not include the screw and nut, as long as the second drive assembly can be used to drive the sheath assembly to move. In an alternative embodiment, the second drive assembly includes a rack and a gear, the rack being located within the housing and configured to move only along its extension direction, the rack being fixed to the proximal end of the sheath assembly via a sheath assembly connector, and the gear meshing with the rack; the housing has an opening through which at least a portion of the gear protrudes from the housing, so that an operator of the conveying device can operate the portion of the gear protruding from the housing through the opening to drive the sheath assembly to move via the rack.
[0080] Furthermore, it should be noted that this embodiment does not limit the fixing method between any two components. In one exemplary embodiment, the two components are fixed by welding. In an alternative embodiment, the two components are fixed by snap-fitting. In another alternative embodiment, the two components are fixed by screwing.
[0081] Embodiment 2 of this application provides a valve prosthesis system, including: a valve prosthesis and a delivery device. The valve prosthesis includes a connecting end, and the connecting end is provided with a slot for detachable connection with the clamp of the delivery device.
[0082] Specifically, the delivery device includes: a clamping assembly; the clamping assembly includes at least two clamps and a control element; the clamps have a first working state and a second working state, in the first working state the clamps are configured to restrain the connecting end of the valve prosthesis, and in the second working state the clamps are configured to separate from the valve prosthesis; the control element is used to move relative to the clamps to change the clamps from the first working state to the second working state.
[0083] In fact, the valve prosthesis system provided in Embodiment 2 of this application includes the same delivery device as the delivery device provided in Embodiment 1 above. Therefore, the valve prosthesis system provided in Embodiment 2 of this application includes the same technical effect as the delivery device provided in Embodiment 1 above, and will not be described again here.
[0084] Those skilled in the art will understand that the above-described embodiments are specific examples of implementing this application, and in practical applications, various changes in form and detail may be made without departing from the spirit and scope of this application. Any person skilled in the art can make their own modifications and alterations without departing from the spirit and scope of this application; therefore, the scope of protection of this application should be determined by the scope defined in the claims.
Claims
1. A valve prosthesis delivery device, characterized in that, include: A clamping assembly, comprising at least two clamps, a control element, a control tube, and a connecting tube, wherein the connecting tube is sleeved on the distal end of the control tube, and the clamps are circumferentially distributed around the outer periphery of the connecting tube; The clip has a first working state and a second working state. The clip includes a main body and an elastic part. When the clip is in the first working state, the elastic part deforms at least partially under the action of the control member to form a closed end to restrain the joint end of the valve prosthesis. When the clip is in the second working state, the closed end of the elastic part returns to the open end in the natural state to separate from the valve prosthesis; The control element is a cylindrical or frustum-shaped component, and has a control channel parallel to its axis. The control element also includes a sleeve at its distal end. The control channel includes the inner cavity of the sleeve. The size of the control channel is configured to allow passage of the main body portion but not the elastic portion. When the clamp is in a first working state, the elastic portion abuts against the control channel and forms the closed end under the action of the control channel. When the clamp is in a second working state, the elastic portion does not contact the control channel to form the open end. The control element is used to move relative to the clamp, so that the clamp changes from a first working state to a second working state; Inner tube assembly, wherein the control tube is sleeved within the inner tube assembly.
2. The conveying device according to claim 1, characterized in that, When the clamp is in its first working state, the maximum diameter of the elastic part is greater than the diameter of the control channel.
3. The conveying device according to claim 1, characterized in that, The clip includes two opposing single pieces, each single piece including a main body portion and an elastic portion; in any one of the clips, the main body portions of the two single pieces form the main body portion, and the elastic portions of the two single pieces form the elastic portion.
4. The conveying device according to claim 3, characterized in that, In any of the aforementioned single pieces, the elastic portion includes a first extension that is angularly connected to the main body portion and a second extension that is connected to the first extension; The two first extensions of each clamp extend in a direction that is opposite to each other and away from the two main body portions, and the two second extensions of each clamp extend in a direction that is close to each other and away from the two first extensions.
5. The conveying device according to claim 1, characterized in that, Also includes: A handle for driving the control relative to the clamp.
6. The conveying device according to claim 5, characterized in that, The handle includes a first drive assembly and a housing; The proximal end of the inner tube assembly is configured to be fixedly connected to the housing, and the distal end of the inner tube assembly is configured to support the valve prosthesis. The proximal end of the control tube is connected to the first drive assembly, and the distal end of the control tube is connected to the clamp. The control element is fixed to the inner tube assembly and located away from the control tube. The first drive component is used to drive the control tube to move so that the control tube moves relative to the inner tube assembly.
7. The conveying device according to claim 5, characterized in that, The handle includes a first drive assembly and a housing; The proximal end of the inner tube assembly is configured to be fixedly connected to the housing, and the distal end of the inner tube assembly is configured to support the valve prosthesis. The proximal end of the control tube is connected to the first drive assembly, and the distal end of the control tube is connected to the control element. The distal end of the control tube has a travel groove, and the clamp is fixed to the inner tube assembly via the travel groove. The first drive component is used to drive the control tube to move so that the control tube moves relative to the inner tube assembly.
8. The conveying device according to claim 6 or 7, characterized in that, The first drive assembly includes a screw and a nut. The screw is located inside the housing and is configured to prevent axial rotation. The screw is fixed to the proximal end of the control tube. The nut is sleeved on the screw and threadedly connected to the screw. The housing has an opening through which at least a portion of the nut protrudes from the housing.
9. The conveying device according to claim 8, characterized in that, The first drive assembly further includes a first guide and a second guide. The first guide member is disposed on the housing, and the second guide member is disposed on the screw. The extension direction of the first guide member is in the same direction as the axial direction of the screw. The second guide member is slidably disposed on the first guide member along the extension direction of the first guide member to prevent the screw from rotating axially.
10. The conveying device according to claim 9, characterized in that, The first guide is a track disposed on the housing; The second guide is a groove disposed on the screw and fitted with the first guide.
11. The conveying device according to claim 6 or 7, characterized in that, The first drive assembly includes a rack and a gear, the rack being located within the housing and configured to move only along its extension direction, the rack being fixed to the proximal end of the control tube, and the gear meshing with the rack; the housing has an opening through which at least a portion of the gear protrudes from the housing.
12. A valve prosthesis system, characterized in that, include: A valve prosthesis and a delivery device as described in any one of claims 1-11, wherein the valve prosthesis includes a connecting end, the connecting end having a slot for detachably connecting with a clamp of the delivery device.
Citation Information
Patent Citations
Delivery systems and methods of implantation for prosthetic heart valves
CN102858275A
Valve prosthesis conveying device and valve prosthesis system
CN216148288U
