Medical device connection device

Abstract

The present invention relates to a novel medical connection device and a medical apparatus comprising at least one such medical connection device, as well as its use in medical prostheses.

Description

Technical Field

[0001] The present invention relates to a novel medical connection device and a medical apparatus comprising at least one such medical connection device, as well as the use thereof in a medical prosthesis. Background Art

[0002] Minimally invasive techniques and catheter-based implantation technologies have advanced over the years and are now feasible in many areas of medicine.

[0003] In many areas of medicine, patients can now be treated with catheter-based technologies, making it possible to treat patients who otherwise would not receive adequate care due to medical conditions and the risks associated with surgery. This catheter-based technology is applicable to delivery systems, such as catheters and / or introducer sheaths, that are used to implant medical devices into the patient's body at the desired target site through various pathways.

[0004] In such procedures, the prosthesis used is made of a single component or composed of two or more parts. These parts can be sutured together or connected by fitting two parts together. Alternatively, the different components can be assembled inside the body during deployment. Proper fit and durability are crucial aspects of these medical devices.

[0005] In recent years, in particular, there has been increasing success in the treatment of heart valve diseases and defects. Examples include transapical, transjugular and transfemoral procedures for heart valve replacement therapies, such as aortic or mitral valve treatment.

[0006] In many cases, a stent-based prosthesis with a tissue-based replacement valve is used and implanted to replace a native heart valve using a catheter delivery system.

[0007] A replacement heart valve prosthesis must be crimped and loaded onto a catheter. This prosthesis may consist of a single part, or it may consist of two or more parts. One aspect of this prosthesis is connecting the various parts to form a functional prosthesis, either before or after implantation in the patient.

[0008] More specifically, there is a problem in providing an easy-to-use and reliable connection device for medical devices and / or sized to conform to catheter-based delivery methods, as well as providing a connection device for medical devices that has features that are superior to those of the prior art.

[0009] Therefore, there is a need for an easy-to-use and reliable connection device that can be used to connect two medical device components or multiple medical device components, which preferably meets the needs of catheter-based delivery methods.

[0010] Therefore, it is an object of the present disclosure to provide a reliable connection device that combines medical device components in a simple and / or effective and / or reliable manner and / or is compatible with catheter crimping and / or catheter delivery, or at least to provide a connection device in which the disadvantages of the prior art are substantially avoided or reduced compared to the disadvantages of the prior art. Summary of the Invention

[0011] In one aspect, the present disclosure relates to a medical connection device for connecting two or more medical device components, characterized by two connection features for engaging and locking the two medical device components, wherein the first connection feature forms part of a first medical device and the second connection feature forms part of a second medical device, wherein the medical connection device includes or has at least one spring locking tongue and a spring locking cover.

[0012] On the other hand, the present disclosure relates to a two-part medical device comprising a first part and a second part, wherein each part comprises at least one connecting feature, wherein one connecting feature of the first part and one connecting feature of the second part are aligned in the same direction or in opposite directions, a spring locking cover engages the two connecting features and the two connecting features are locked by at least one spring locking tongue, preferably one or two spring locking tongues, and at least one support tongue stop of each connecting feature, wherein multiple medical device parts can also be connected.

[0013] On the other hand, the present disclosure relates to a two-part stent comprising an inner stent and an outer stent, wherein each stent comprises at least one connecting feature, wherein one connecting feature of the first stent and one connecting feature of the second stent are aligned in the same direction or in opposite directions, a spring locking cover engages the two connecting features and locks the two connecting structural features by at least one spring locking tongue, preferably one or two spring locking tongues, and at least one strut tongue stop for each connecting feature, wherein multiple medical device parts can also be connected.

[0014] In another aspect, the present disclosure relates to a heart valve replacement prosthesis comprising a replacement valve and a two-part stent comprising an inner stent and an outer stent, wherein each stent comprises at least one connection feature, wherein one connection feature of the first stent and one connection feature of the second stent are aligned in the same direction or in opposite directions, and a spring-locking cover engages the two connection features and locks the two connection features via at least one spring-locking tongue and a strut tongue stop for each connection feature.

[0015] In another aspect, the present disclosure relates to a method of assembling two or more medical device parts, such as stent parts, using one or more medical connection devices as described herein to obtain an assembled medical device prosthesis.

[0016] In another aspect, the present disclosure relates to connecting different medical device parts using one or more medical connection devices as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Various embodiments of the present disclosure are illustrated by the accompanying drawings, in which:

[0018] Figure 1 One embodiment of a connection device according to the present disclosure is shown.

[0019] Figure 2 、 2a 2b shows details of various possibilities for connecting two medical components to each other according to the present disclosure.

[0020] Figures 2 to 4 Various spring-lock covers according to the present invention are shown.

[0021] Figure 5 、 5a 5d to 5d depict various possibilities for strut alignment and spring-lock cover connection according to the present disclosure.

[0022] Figures 6 to 8 Various embodiments of spring-lock covers according to the present disclosure are shown.

[0023] Figure 9 、 9a 9c illustrate different embodiments of struts for connecting different medical device components using the spring-locking covers according to the present disclosure.

[0024] Figure 10 、 10a , 10b show different embodiments of a spring-lock cover according to the present disclosure.

[0025] Figures 11 to 16b Different embodiments of a spring-locking cover according to the present disclosure are shown, including different possibilities for stop variations and post alignment according to the present disclosure.

[0026] Reference Signs List

[0027] 001–First Pillar

[0028] 002–Second Pillar

[0029] 003–Spring lock cover

[0030] 004 / 004' / 004" / 004"'–spring latch

[0031] 005–First Bracket

[0032] 006–Second bracket

[0033] 007 / 007'–Strut Hard Stop

[0034] 008 / 008' / 008" / 008"'-Spring Lock Hard Stop

[0035] 009 / 009' / 009" / 009"'–Staple tongue stop

[0036] 010 / 010'–Pillar Alignment Device

[0037] 011 / 011'–Spring lock cover skirt. DETAILED DESCRIPTION

[0038] Certain terms of the present disclosure are defined below. Otherwise, the technical terms in the present disclosure should be understood to have the same meaning as understood by a skilled person.

[0039] In the sense of the present disclosure, the terms "prosthesis" or "medical device" or "implant" are to be understood as any medical device that can be delivered in a minimally invasive manner or by a catheter-based procedure. These terms can be used interchangeably. A prosthesis in the sense of the present disclosure can be, for example, a stent or a stent-based prosthesis or a stent-based replacement heart valve prosthesis, such as an aortic replacement heart valve, a mitral replacement heart valve, or a tricuspid replacement heart valve.

[0040] In the sense of the present disclosure, the term "catheter" or "delivery device" is understood as a device for deploying a prosthesis at a defined site in a patient's body to replace a heart valve, such as a native aortic valve, mitral valve or tricuspid valve.

[0041] In the sense of the present disclosure, a "mesh stent" or "braided mesh stent" or "braided stent" is a stent composed of metal wires, as contrasted with, for example, laser-cut Nitinol tubes.

[0042] In the sense of the present disclosure, a "cut stent" or "laser cut stent" is a stent obtained by laser cutting, for example, a nickel titanium alloy tube. Due to its tubular origin, the outer radius is larger than the inner radius, and therefore, when cut into a stent, it gradually tapers from the outside to the inside (the original tube).

[0043] In the sense of the present disclosure, a "stent region" or multiple "stent regions" are defined areas of an outer stent, mesh stent or replacement heart valve prosthesis, particularly specifying the longitudinal portion or outer portion, which is defined as the proximal, middle or distal region or the atrium, valve annulus or ventricle.

[0044] In the sense of the present disclosure, "proximal region", "middle region", "distal region" refer to regions of a stent or prosthesis that are relevant to an operator performing an implantation by using a catheter, wherein the proximal end is close to the operator and the distal end is away from the operator. In the sense of the present disclosure, "middle region" refers to the region between the distal region and the proximal region in a stent or prosthesis. "Proximal region" may also refer to the in-situ, i.e., in vivo, in an individual (human or patient) in terms of the inflow end or inflow region relative to the natural blood flow, and "distal region" may also refer to the in-situ, i.e., in vivo, in an individual (human or patient) in terms of the outflow end or outflow region relative to the natural blood flow; the proximal end may also refer to the atrium, the middle may refer to the valve annulus, and the distal end may refer to the ventricle.

[0045] In the sense of the present disclosure, the "annulus area" or "annulus region" is the corresponding area of ​​the native heart valve, or it defines the corresponding area in a replacement heart valve or stent to be positioned at the implantation site and which is intended to be aligned with the native annulus.

[0046] In the sense of the present disclosure, the "subannular region" is the prosthesis region in the distal direction (or inflow direction or ventricular direction) of the annulus of the native heart valve. The prosthesis can cover the "subannular region" with a U or V groove region and a distal region.

[0047] In the sense of the present disclosure, a "groove" describes an area of ​​a stent or prosthesis that exhibits a smaller diameter than other areas and wherein other areas of the stent or prosthesis having a larger diameter are adjacent to the groove distally and proximally; the groove may have a V-shape or a U-shape or a combination thereof or any other curved and useful geometric shape or be characterized by only a smaller diameter compared to the atrial and ventricular stent areas.

[0048] In the sense of the present disclosure, a "multi-part stent" may refer to a "two-part stent" or a "three-part stent," wherein the inner stent is connected by a medical connection device according to the present disclosure. The medical connection device according to the present disclosure may be placed at the atrial end or in the region of the inner stent or in the annulus region of the native valve.

[0049] In the sense of the present disclosure, a "target site" is the location or place where a replacement heart valve prosthesis is to be implanted and where a dysfunction or malfunction should be treated, for example, the tricuspid or mitral valve annulus.

[0050] In the sense of the present disclosure, "connection" of a stent is the fixing of two medical device components to a medical connection device according to the disclosure, wherein multiple medical device components can be assembled in this manner to form a final multi-component medical device that is ready for implantation or assembled during implantation in a patient.

[0051] In the sense of the present disclosure, a "fixation device" or "anchoring device" is a component connected to the internal stent and essentially serves to anchor the prosthesis at the target site, optionally in conjunction with additional devices. In a particular aspect, the fixation device consists of or includes an anchoring ring, an anchoring arm, a connecting arch, and an internal stent anchor, preferably a connecting device connecting the internal stent anchor of the fixation device to the internal stent.

[0052] An "anchoring ring" in the sense of the present disclosure is a part of a stent that can be used to secure the stent or prosthesis and help prevent the stent or prosthesis from moving at the target site. Generally, an anchoring ring in the sense of the present disclosure is a device for improving the fixation of a stent or prosthesis, wherein the ring is fixed to or connected to an internal stent, forms part of an internal stent, or is an integral part of an internal stent. A "ring" or multiple "rings" in the sense of the present disclosure can have different shapes, such as circular, square, etc., and be located in a defined area in a defined pattern. A "ring" in the sense of the present disclosure will present a defined angle to the surface of the internal stent and it can be designed to be retracted into the catheter after the stent or prosthesis has completed initial and possible partial deployment.

[0053] In the sense of the present disclosure, an "angle structure" or "angle" is the angle between two auxiliary lines drawn at a specific area or layer of a stent in order to define a specific geometry of said stent portion or arch or layer relative to other stent structures, such as an internal stent, etc.

[0054] For the purposes of the present disclosure, "radial force" is the force exerted in the radially outward direction by a stent or prosthesis, more particularly by the prosthesis's outer stent, which may be a mesh or laser-cut stent, such as a nitinol stent. The radial force depends on the specific mesh or cut stent design and is related to material density, such as the density of wires per square meter in a mesh stent, or the number of cells and the size of said cells circumferentially at a specific laser-cut stent level or region, such as the proximal / atrial, mid-annular, or distal / ventricular regions. The magnitude of the radial force in a replacement heart valve prosthesis according to the present disclosure is selected for the outer stent, or the combination of inner and outer stents and fixation devices, to provide good contact with the surrounding tissue and support the fixation function of the stent or prosthesis, and is also optionally minimized to avoid interfering with the endogenous environment and biology of the target site. Thus, the magnitude of the radial force is selected to avoid interfering with the implant site and endogenous tissue and function. The radial force can be used to support the fixation function by other means, such as by the use of a fixation loop.

[0055] In the sense of the present disclosure, a "target region" is a three-dimensional space surrounding or located within a native organ, such as a native heart valve, such as the tricuspid valve or the mitral valve.

[0056] In the sense of the present disclosure, an "atraumatic design" of a ring is one in which a ring or other device or component of a stent or prosthesis is designed to avoid causing any or substantially any damage to surrounding tissue or tissue in contact with the component or at least the component is made so as to minimize damage and / or injury to the tissue it contacts.

[0057] "Compliance" of a stent or replacement heart valve prosthesis, in the sense of the present disclosure, such as comprising an inner laser-cut stent within an outer mesh stent or a laser-cut inner stent within a laser-cut outer stent, relates to positive interference with target tissue. "Compliance" relates to a design that exhibits good geometrical adaptation of the stent or prosthesis to the implantation site, and wherein the stent or prosthesis exhibits favorable fixation characteristics, good functionality with respect to valve function, and simultaneously minimal interference with intrinsic cardiac structure and cardiac function.

[0058] In the sense of the present disclosure, a "medical device" may refer to any component or assembly of components that can be used in a medical setting or application. It may relate to a surgical instrument or minimally invasive tool or medical device designed for implantation into a patient by surgery or by minimally invasive techniques using a delivery system such as a catheter. A "medical device" may particularly relate to a stent, a replacement heart valve prosthesis, a repair device or a replacement device, such as an aortic, pulmonary, mitral or tricuspid replacement heart valve prosthesis.

[0059] For the purposes of the present disclosure, a "medical connection device" refers to a device that can minimally connect two parts of a medical device using two connecting devices (e.g., struts) and a cover, such as a snap-lock cover, wherein the snap-lock cover includes means for releasably or non-releasably connecting the two connecting devices. The medical connection device according to the present disclosure can be used to connect multiple medical device components to form a final medical device ready for use in a patient, or all or part of a medical device can be connected during delivery via a catheter.

[0060] Thus, one, two, three, four, five, six or more medical connection devices according to the present disclosure may be used to provide a multi-component medical device, the components being produced separately and then connected in this manner.

[0061] A "snap lock cap" as used herein refers to a component that releasably or non-releasably connects two connection devices, such as a stent or a replacement heart valve prosthesis. It may include one or more springs, one or more snap lock hard stops, and one or more snap lock cap skirts.

[0062] In the sense of the present disclosure, a "snap latch" refers to a component forming part of a snap latch cover that is used to engage a connecting device such as a strut and hold, for example, two struts in a predetermined position, thereby connecting two medical components. The snap latch has a counterpart in each strut and can therefore hold and secure the two struts together.

[0063] In the sense of this disclosure, a "snap lock hard stop" refers to a predetermined stop within the snap lock cover for engaging the post.

[0064] In the sense of the disclosed devices, a "pillar tongue stop" is a counterpart included in a pillar or any connecting device, which can engage with a spring latch to form a connection and connect two medical components and their connecting devices, respectively.

[0065] In the sense of the disclosed apparatus, a "connection feature" is a portion of a medical device component that is intended to engage in a snap-lock cover.

[0066] In the sense of the disclosed arrangement, a "snap-lock cover skirt" is a portion of the snap-lock cover which serves to support the alignment of eg two struts and which adds to the connection supporting the correct positioning of the connection arrangement in the snap-lock cover.

[0067] In the sense of this disclosure, "distal" means away from an operator when the catheter device is in use.

[0068] In the sense of the present disclosure, "proximal" refers to the area close to the operator when the catheter device is in use.

[0069] In the sense of the present disclosure, "longitudinal" or "longitudinal direction" refers to the longitudinal direction of a medical device, such as a heart valve replacement prosthesis.

[0070] In the sense of the present disclosure, "angled inwardly" refers to, for example, in a valve or replacement heart valve, toward a middle or inner portion of the device or a region of the device as opposed to an outer portion or region.

[0071] In the context of the present disclosure, "round," "square," or "angled" refers to the design of the snap-lock cap. A square cut or angled shape may be advantageous because it uses less space and is therefore preferred in medical devices that are implanted via catheter delivery and in small environments where crimped devices are required, such as replacement heart valve prostheses.

[0072] In the sense of the present disclosure, the term "position" or "positioning" generally refers to the broader orientation of two medical device components that should be connected according to the present disclosure. The term can also refer to the spatial orientation of an operator operating a delivery or deployment device in the sense of proximal (close to the operator / catheter handle) and distal (away from the operator / catheter handle). In the context of heart valve replacement prostheses, it refers to the longitudinal shape of the prosthesis when implanted in the native heart valve site via a catheter procedure.

[0073] In the sense of the present disclosure, "alignment" or "alignment" of components refers to the micro-positioning of the two connecting devices adjacent to each other and the micro-positioning of the two connecting devices to fit into the snap-lock cover. Thus, with the snap-lock cover and its connection thereto, the struts of the two medical device components are oriented at a very close distance. Preferably, the alignment of the two struts (connecting devices) can be supported by a strut alignment device to very precisely align the two struts before or during connection with the snap-lock cover.

[0074] The alignment of the struts and spring-lock caps can be described relative to an original tube from which the medical device components have been cut (via a laser cutting process), or relative to the orientation in space in which they are placed during catheter delivery and deployment, where such deployment is relative to the operator, i.e., close to the operator (relative to the catheter handle) or away from the operator (relative to the catheter handle).

[0075] In the sense of the present disclosure, "top-to-bottom" alignment or "bottom-to-top" alignment (both terms are related to the viewer's perspective) or "superposition" refers to placing two connecting means such as Figure 2 The struts (connecting means) are superimposed in the proximal-distal direction relative to the prosthesis, as Figure 2 As shown in .

[0076] In the sense of the present disclosure, reference is also made to the production and laser cutting method of the medical component in question, wherein a tube (e.g., a nitinol tube) has an inner and outer tube surface and an edge from which the tube is cut, in order to align a connection feature of an internal component or stent "tube cut edge to tube cut edge." With reference to the original tube from which the medical component, e.g., a stent, is obtained by cutting the original tube, one can define the alignment of the interior and exterior of the tube and the interior and exterior of the medical component (e.g., a stent) according to the present disclosure, and on the other hand, can also define cutting levels and cutting sides and areas.

[0077] Thus, one can define the alignment of two parts from outside to inside, where inside and outside depends on the perspective, which may mean from inside to outside or from outside to inside (which means the same thing just different because of a different viewpoint), or from outside to outside or from inside to inside; side by side may mean cut side by side.

[0078] Another way of defining the orientation of a medical device component may be in relation to an operator using the catheter, ie relative to the operator and the proximal and distal ends of the catheter handle, respectively.

[0079] In the sense of the present disclosure, aligning one or more connection features of the inner portion or stent "side by side" means that the two struts of a two-part stent (or two-part heart valve replacement prosthesis) are positioned adjacent to each other with respect to the longitudinal direction of the device, where the longitudinal direction can be denoted as the proximal-distal direction, where the proximal-distal direction is from the perspective of the operator in a catheter-based delivery procedure. Thus, the struts of the prosthesis are at the same level with respect to the proximal-to-distal orientation and with respect to the operator.

[0080] In the sense of the present disclosure, a "directly inward" direction refers to a component, such as a spring latch, whose outermost edge is not 100% directed in the longitudinal direction, but is angled in the inward direction relative to the longitudinal direction of the device (003). This angle can vary as required and can therefore have a value between 5° and 75°.

[0081] In the sense of the present disclosure, "engage" or "engage" means that two means for connecting and / or locking come into close contact to connect two medical device components.

[0082] In the sense of this disclosure, "locking" means that two medical device components are connected by a feature designed to engage a spring-lock cover.

[0083] In the sense of the present invention, a "snap-lock cover" is understood to mean a component which is able to functionally connect two components of two medical device components and which contributes to their connection in a stable and secure manner.

[0084] For the purposes of this disclosure, a "snap lock cover skirt" refers to a feature that supports secure locking by extending the snap lock cover to increase stability on both sides. Furthermore, the combination of the snap lock cover skirt and the strut hard stop advantageously reduces or substantially eliminates tilting of the strut within the snap lock cover, thereby preventing undesirable separation of the strut and snap lock cover.

[0085] like Figure 11 As shown, a "strut alignment device" within the meaning of the disclosed device is used to facilitate alignment of two connecting devices (e.g., struts) of two medical device components. The strut alignment device not only facilitates proper assembly of the struts, thereby ensuring proper positioning and locking of the struts into the snap-lock caps, but also prevents the struts from sliding relative to each other, thereby preventing wear and / or material fatigue. This can be particularly advantageous in embodiments requiring side-by-side strut alignment, as well as in the case of heart valve replacement prostheses, where very high forces are present in the patient and during heart beats.

[0086] In the context of the present invention, "two strut alignment devices of a connection feature pair" or "connection feature pair" refers to the pair being used to connect two medical device components via the medical connection device according to the present disclosure. This can facilitate alignment of the devices and improve device durability.

[0087] In the sense of the present disclosure, "two parts" or "two-part medical device" means in each case two parts connected with a medical connection device according to the present disclosure, wherein multiple parts (2, 3, 4, 5, 6 or more parts) can be connected to form a functional multi-part medical device.

[0088] Various aspects of the disclosure are described below.

[0089] In one aspect of the present disclosure, a problem of the present application is solved by a medical connecting device for connecting two or more medical device components, characterized in that two connecting features of two medical device components are engaged and locked, wherein the first connecting feature forms part of a first medical device and the second connecting feature forms part of a second medical device, wherein the medical connecting device includes or has at least one spring locking tongue and a spring locking cover.

[0090] The medical connection device advantageously provides a quick, simple and reliable device for connecting two or more parts of a medical device.In addition, the medical device parts can be connected before or during implantation or during a delivery process or a deployment process.

[0091] The different medical device components only need to be connected, and a correct and secure connection of the different components is automatically formed. Due to its structure, it is also a reliable and safe connection that does not cause tissue damage due to the non-invasiveness and favorable shape of the spring-locking cover, which avoids harm to surrounding tissue.

[0092] Furthermore, an additional advantage is that the connection does not imply additional assembly steps or materials, such as welding, sewing or gluing.

[0093] Furthermore, with the advantageous medical connection device according to the present disclosure, the material of the medical component and its materials are not subjected to mechanical, thermal, chemical or other stresses that could negatively impact the material and durability of the device when used in a patient.

[0094] Finally, the advantageous medical connection device according to the present disclosure means faster production and assembly, reduced material usage, shorter processing time, and lower costs. Therefore, the medical connection device according to the present disclosure is economically advantageous.

[0095] Using the medical connection device according to the present disclosure, it can also be reopened by means of special tools, which is not possible with known mechanochemical connection methods.

[0096] Medical connection devices according to the present disclosure may exhibit variation in their design and may be adapted for specific applications, such as stents, replacement heart valve prostheses.

[0097] In certain aspects, it is preferred if the medical connection device according to the present disclosure is modified so that the snap-lock cover further comprises at least one snap-lock hard stop, preferably 2, 3, 4, 5, 6, 7, or 8 snap-lock hard stops, and / or at least one snap-lock cover skirt, preferably 2, 3, or 4 snap-lock cover skirts. Advantageously, the position of the connection struts can thus be adjusted more precisely, and the connection of two or more different medical device components can be aligned very precisely as desired.

[0098] The snap lock hard stop or multiple snap lock hard stops in the medical connection device according to the present disclosure can be positioned as useful and consistent with its other design features. The medical connection device according to the present disclosure can be designed so that the one or more snap lock hard stops are positioned at the proximal end, or at the distal end, or / and in the area between the distal and proximal ends of the snap lock cover.

[0099] The spring-lock cover of the medical connection device according to the present disclosure is not limited by its geometric size or design and can be adjusted according to the needs of other features and functional and technical considerations. The spring-lock cover according to the present disclosure can be, for example, a medical connection device, wherein the spring-lock cover has a circular shape, a saw-cut shape, an angular shape, or / and a longitudinal shape.

[0100] In another aspect of the present disclosure, a problem of the present application is solved by a two-part medical device comprising a first part and a second part, wherein each part comprises at least one connecting feature, wherein one connecting feature of the first part and one connecting feature of the second part are aligned in the same direction or in opposite directions, and a spring locking cover engages with the two connecting features, and the two connecting features are locked by at least one spring locking tongue, preferably one or two spring locking tongues, and at least one support tongue stop of each connecting feature, wherein multiple medical device components can also be connected.

[0101] In another aspect of the present disclosure, a problem of the present application is solved by a two-part bracket comprising an inner bracket and an outer bracket, wherein each bracket comprises at least one connecting feature, wherein one connecting feature of the first bracket and one connecting feature of the second bracket are aligned in the same direction or in opposite directions, a spring locking cover engages the two connecting features and locks the two connecting features by at least one spring locking tongue, preferably one or two spring locking tongues, and at least one support tongue stop of each connecting feature, wherein multiple medical device components can also be connected.

[0102] In another aspect of the present disclosure, a problem of the present application is solved by a heart valve replacement prosthesis, the heart valve replacement prosthesis comprising a replacement valve and a two-part stent comprising an inner stent and an outer stent, wherein each stent comprises at least one connection feature, wherein one connection feature of the first stent and one connection feature of the second stent are aligned in the same direction or in opposite directions, and a spring-lock cover engages the two connection features and locks the two connection features by at least one spring-lock tongue and one strut tongue stop for each connection feature. The number of spring-lock tongues and corresponding strut tongue stops, strut hard stops, and spring-lock hard stops can be adjusted to suit the respective application and can be 1, 2, 3, 4, 5, or 6 for each device.

[0103] Advantageously, if the struts are aligned in a manner such that the cut edge of the tube (due to the tube origin) tapers from the outside-inward direction relative to the original tube, thereby tapering in the opposite direction to improve alignment of adjacent regions, this could mean less micromotion and wear during heart valve movement in the cardiac environment and when the heart is active.

[0104] The heart valve replacement prosthesis according to the present disclosure and as described above has the advantage that its material is not subjected to mechanical, thermal, chemical, or other stresses that could negatively impact the material and durability of the device when used in a patient. This is especially true in the case of implantation in a patient's heart, where significant forces are present and excellent durability is required.

[0105] Generally, the following feature variations are equally applicable to a two-part medical device or a two-part stent or heart valve replacement prosthesis that may be composed of two or more parts.

[0106] In one embodiment of a two-part medical device or a two-part stent or a heart valve replacement prosthesis according to the present disclosure, it may be advantageous if one or more connection features of the inner portion or stent are angled inwardly at an angle of about 3° to 60°, preferably 5° to 30°, and more preferably 25°, relative to the longitudinal direction of the inner stent or stent.

[0107] The parts to be connected can have special struts or other devices for connecting the two parts via a spring-locking cover, and they are suitable for being connected and fixed thereby via the spring-locking cover. Thus, the two parts are correctly aligned and reliably connected to form the desired final medical device. For example, the two parts can be positioned relative to each other to form the final medical device. In a preferred embodiment, a two-part medical device or a two-part stent or a heart valve replacement prosthesis according to the present disclosure can be advantageously designed, wherein one or more connection features of the outer part or stent are overlapping (aligned up and down) relative to the distal or proximal direction or aligned from inside to outside or from inside to inside or from outside to outside relative to the original tube, wherein the part or stent is obtained by cutting the original tube, or aligning the tube cut edge to the cut edge with one or more connection features of the inner part or stent.

[0108] Thus, depending on the design of the individual components of the medical device and / or the relative positioning of these components with respect to each other, the connecting means, e.g. two struts (each strut or connecting means from one medical device component) can be positioned and aligned with each other as it best suits the final design of the assembled medical device.

[0109] According to the present disclosure, the medical connection device or / and the specific components and devices in a two-part medical device or a two-part stent or a heart valve replacement prosthesis can be varied according to technical advantages and / or needs. Therefore, the individual feature spring lock covers, spring lock tongues, spring lock hard stops, strut hard stops, strut tongue stops, strut alignment devices, spring lock cover skirts and / or struts (connecting struts or devices) can have different designs and quantities according to specific application requirements. The medical connection device or / and in a two-part medical device or a two-part stent or a heart valve replacement prosthesis according to the present disclosure can preferably include a spring lock cover and 2, 3 or 4 spring lock tongues and a corresponding number of strut tongue stops of the connection feature.

[0110] In another preferred embodiment according to the present disclosure, a two-part medical device or a two-part stent or a heart valve replacement prosthesis may include 1 spring lock hard stop and one strut hard stop for each connecting feature, or 2, 3 or 4 spring lock hard stops and 1 or 2 strut hard stops for each connecting feature.

[0111] In another preferred embodiment according to the present disclosure, the two-part medical device or the two-part stent or the heart valve replacement prosthesis is characterized in that the one or more spring locking tongues are placed in the longitudinal direction of the medical device, stent or prosthesis or are substantially at an angle of 90° to the longitudinal direction or at an angle of 5° to 90°, or 10° to 45° or 45° to the longitudinal direction.

[0112] In another preferred embodiment according to the present disclosure, a two-part medical device or a two-part stent or a heart valve replacement prosthesis is characterized in that the connection features are placed at the distal region or distal ends of the struts extending from each part of the medical device, struts or prosthesis.

[0113] In another preferred embodiment according to the present disclosure, the two-part medical device or the two-part stent or the heart valve replacement prosthesis is characterized in that the or each connecting feature comprises at least one strut alignment means, preferably wherein both strut alignment means of a pair of connecting features.

[0114] In another preferred embodiment according to the present disclosure, a two-part medical device or a two-part stent or a heart valve replacement prosthesis is characterized in that it comprises at least one medical connection device according to the present disclosure.

[0115] In another aspect of the present disclosure, a problem of the present application is solved by a method of assembling two or more medical device components, such as strut components, using one or more medical connection devices according to the present disclosure to obtain an assembled medical device prosthesis.

[0116] Particularly for assembling a medical connection device and a corresponding method for assembling medical components according to the present disclosure, it is advantageous that the connection does not imply additional assembly steps that consume time and / or material, such as welding, sewing or gluing.

[0117] In another aspect of the present disclosure, a problem of the present application is solved by connecting different medical device components using one or more medical connection devices according to the present disclosure.

[0118] Compared to known methods of the prior art, the use of the medical connection device according to the present disclosure provides a simple, reliable and cost-effective method, thus offering advantages over the prior art.

[0119] Example

[0120] The following examples are provided to illustrate various embodiments of the present disclosure. These examples are not intended to be construed as limiting in any way.

[0121] Figure 1An embodiment of a connection device according to the present disclosure is shown, wherein a first pillar (001) and a second pillar (002) are placed within a spring lock cover (003) and wherein the first pillar (001) and the second pillar (002) are locked by a spring lock tongue (004). Optional features of the spring lock hard stop (008) and the pillar hard stop (007, 007') facilitate better positioning and locking of the pillars (001, 002) within the spring lock cover (003). Optional features of the spring lock cover skirt (011, 011') can further provide for better retention of the pillars (001, 002) within the spring lock cover (003). The spring lock hard stop (008) and the pillar hard stop (007, 007') can avoid or prevent the pillars (001, 002) from continuing to slide within the spring lock cover (003). The spring lock cover skirt (011, 011') helps avoid or at least reduce the twisting of the pillars (001, 002), thereby preventing unlocking of the pillars.

[0122] Figure 2 A longitudinal section of a two-part heart valve replacement prosthesis is shown in the main figure, along with an enlarged view of struts (001, 002) from different parts of the prosthesis that have not yet been assembled and are connected by a snap-lock cover (003). An outer first stent (005) and an inner second stent (006) are depicted, with the enlarged view showing the corresponding struts (001, 002), which are aligned (see arrows) and introduced into the snap-lock cover (003) in the next step. The second stent (006) is pushed inward and upward into the first stent (005), so that the position of the struts (001, 002) is from bottom to top or from top to bottom (strut 002 of the second stent 006 is the "lower strut" and strut 001 of the first stent 005 is the "upper strut"). It can also be represented by the longitudinal stent / prosthesis orientation and relationship to the operator operating the catheter device for implantation and deployment, i.e., the distal end is the "downward direction", thus the "lower strut", and the proximal end is the "upward direction", thus the "upper strut". When aligned, the spring lock cover (003) is pushed over the two pillars (001, 002) and locked by the spring lock tongue (004), wherein the optional feature spring lock hard stop (008) will stop the two pillars (001, 002) in the correct position through the pillar hard stop (007, 007') to provide optimal locking of the pillars (001, 002) by the spring lock tongue (004); and the optional feature spring lock cover skirt (0011, 0011') helps to provide additional locking force in the proximal and distal directions (up and down directions). In addition, they avoid or help prevent the connection from opening, thereby helping to achieve a secure connection of the pillars.

[0123] Figure 2a Depicts Figure 2Continuation of the assembly process (locking process). The pillars (001, 002) of the two brackets (005, 006) are now completely aligned. The two pillars (001, 002) are aligned and the spring-lock cover (003) is now pushed over them / the pillars (001, 002) are introduced into the spring-lock cover (003).

[0124] Figure 2b The enlarged view shows the connected brackets (005, 006), with the pillars (001, 002) introduced into the spring-locking cover (003) and locked by the spring-locking tongue (004). All other optional devices for correct, safe and reliable locking are in the correct position (007, 007', 008, 011, 011').

[0125] Figure 3 、 3a 3b shows different views (side view and top view) of a snap lock cover according to the present disclosure, wherein the snap lock cover (003) comprises two snap lock tongues (004, 004') and two snap lock hard stops (008, 008').

[0126] Figure 3c A longitudinal section through the spring lock cover (003) is shown, with the cutting line (AA) indicated. The spring lock tongues (004, 004') are inwardly directed, with their flexibility allowing the posts (001, 002 - not shown here) to be introduced and pushed as far as possible into the spring lock cover, whereupon the corresponding parts on the posts (001, 002) will be locked using the spring lock tongues (004, 004'). Optional features, the spring lock hard stop (008, 008') and the spring lock cover skirt (011), are also depicted.

[0127] Figure 4 Depicted is a variation of a snap lock cover (003) according to the present disclosure, wherein only one snap lock tongue (004) is used. The figure shows a top view and cutouts (BB) and optional features (008, 008', 011).

[0128] Figure 5 Detail of the alignment (see arrows) of two struts (001, 002) is shown, depicting the strut tongue stops (009, 009') and strut hard stops (007, 007' - optional) of the struts (001, 002).

[0129] Figure 5a 、 5b The assembly of components (001, 002, 003) is described for safely and easily connecting two medical device components. Figure 5a In the figure, the arrows indicate that the spring lock cover (003) is pushed onto the pillars (001, 002). Figure 5bIn the figure, the components (001, 002, 003) have been assembled and the two medical components are securely connected to each other.

[0130] Figure 5c The alignment of two struts (001, 002) within a snap lock cover (003) is shown, wherein the struts are aligned from left to right from outside to inside, or from right to left from inside to outside, wherein the struts are tapered due to the origin of the medical component, which is cut from a tube, such as a Nitinol tube, where the tapering refers to the outside of the tube being larger than the inside of the tube. With respect to the distal / proximal orientation of the instrument, the two struts can either be stacked in a distal to proximal direction or can be placed side by side in a distal to proximal direction. The different orientations and alignments mean that the strut hard stops (007, 007'), strut tongue stops (009, 009', 009", 009'") are correctly placed on the struts for proper alignment and introduction of the snap lock cover (003).

[0131] Figure 5d 5s is a side view depicting a snap lock cover (003) with a snap lock tongue (004), a snap lock hard stop (008), two snap lock cover skirts (011, 011') and two posts (001, 002) carrying post hard stops (007, 007'). 004' and 008' are not visible.

[0132] Figures 6 to 8 Various embodiments of a spring-lock cover (003) according to the present disclosure are shown.

[0133] Figure 6 、 6a 6b shows a circular spring lock cover (003) which includes two spring lock tongues (004, 004', 004", 004'" on each side (in Figure 6a ,exist Figure 6b The spring lock cover (003) includes a spring lock hard stop (008) and two spring lock cover skirts (011, 011') on one side of the spring lock cover (003) and is visible. Thus, a connecting device (e.g., a support of two medical device components) will be engaged into the spring lock cover (003) from one side for connecting the two medical device components. Certain details are not visible because they are on the reverse side of the figure.

[0134] Figure 6In particular, a circular snap lock cover (003) is shown, which includes four snap lock tongues (004, 004', 004", 004'", two snap lock hard stops (008, 008') and two snap lock cover skirts (011, 011' not visible). Thus, a connecting device (e.g., a post of two medical device components) will engage into the snap lock cover (003) from one side for connecting the two medical device components.

[0135] Figure 6a Especially shown Figure 6 A side view of the device wherein features such as the two spring latches (004', 004'') and one spring lock hard stop (008') are not visible.

[0136] Figure 6b Especially shown Figure 6 An isometric view of the embodiment of the invention wherein features such as two spring lock tongues (004', 004"') and a spring lock hard stop (008') and a spring lock cover skirt (011') are not visible.

[0137] Figures 7 to 9c A spring-lock cover (003) according to the present disclosure is shown, wherein connecting means (e.g., struts 001, 002) are introduced and engaged into the spring-lock cover (003) from different sides. Each strut (001, 002) includes two strut tongue stops (009, 009', 009", 009'") and two strut hard stops (007, 007'). The arrows indicate the direction in which the struts (001, 002) are introduced into the spring-lock cover (003).

[0138] Figure 8 Shown Figure 7 Cutout (CC) of FIG, illustrating details of the inwardly pointing spring lock tongues (004, 004', 004", 004'). Also shown are optional features spring lock hard stops (008, 008', 008", 008') and spring lock cover skirts (011, 011').

[0139] Figure 9 、 9a 9c to 9c show different embodiments of the struts of different medical device components connected using the spring-locking cover according to the present disclosure. Thus, the strut tongue stops (009, 009', 009", 009'") are positioned distally of the respective struts (001, 002) and locked in a position away from this side by the spring-locking tongue, wherein the respective struts (001, 002) are introduced into the spring-locking cover (003). It is also possible to include only two spring-locking tongues (004) on the same side of the spring-locking cover (003) or on different sides, for example, 180° opposite each other. Other degrees of rotation of the position of the spring-locking tongues are conceivable.

[0140] exist Figure 9b The fully assembled device is shown in . Figure 9c Includes a cross-sectional view of the connection device (DD) wherein the pillar is shown locked with the spring locking tongue, pillar tongue stop (004, 004', 004", 004'"; 009, 009', 009", 009'").

[0141] Figure 10 、 10a 10b shows a different embodiment of a snap lock cover according to the present disclosure, wherein the snap lock cover is rectangular. This can have the advantage that the pillars (001, 002) can be very tightly connected to the snap lock cover (003) without hollow areas. The snap lock tongue (004), the snap lock cover skirt (011, 011') and the snap lock hard stop (008, 008') are depicted.

[0142] Figure 11 An embodiment of a pillar alignment device (010, 010') placed on two pillars (001, 002) is shown, which facilitates the precise alignment of the two pillars and the correct positioning within the spring-lock cover (003). The arrows indicate the steps in assembling and connecting the pillars to the spring-lock cover (003- Figure 11 The movement of the struts (001, 002) during the assembly (not shown). Here, the struts are oriented upward or downward, either outside or inside the laser-cut original tube (e.g., Nitinol). Thus, the two struts are aligned on the curved side, aligned with the original tube, and aligned with the cut side, with the outer and inner tube sides facing upward and downward, respectively, and vice versa. With respect to tube cutting, assembly can also be represented as occurring side-by-side relative to the cutting.

[0143] Figure 11a The connection process of the pillars (001, 002) is shown, the pillars (001, 002) including the pillar alignment devices (010, 010'), and the spring-locking cover (003), which is pushed over the pillars (001, 002) and connects the two medical device parts in an easy and safe manner. Figure 11b The fully assembled components (001, 002, 003) are depicted.

[0144] Figure 12 yes Figure 11b A cross-sectional view (EE) of the embodiment of the present invention shows the struts (001, 002) connected by a spring-lock cover (003).

[0145] Figure 13A variation of the snap lock hard stop (008, 008') is shown, which is located at the distal end of the snap lock cover (003). Thus, the snap lock hard stop can be placed at the proximal or distal end of the snap lock cover, wherein the proximal position represents the side where the strut is introduced into the snap lock cover (003) and the distal position of the snap lock hard stop represents the side opposite to the side where the strut is introduced into the snap lock cover (003). The snap lock hard stop can be one or more, and in the opposite place where it is positioned to the side where the strut is introduced, it can be one or more snap lock hard stops (see e.g. Figure 13 、 13a , 13b, 13c).

[0146] Figure 14 Depicts Figure 13c The spring lock cover (003) is connected with the pillars (001, 002) and the components ( Figure 14a 、 14b ) indicates the alignment of pillars (001, 002).

[0147] Figure 15 、 15a , 5b and 15c (FF cross-section) show variations according to the present disclosure wherein the snap lock hard stops (008, 008') are located inside the snap lock cover (003) and find their counterparts (pillar hard stops 007, 007') in the pillars (001, 002) as special design features within the pillars, e.g. Figure 16 The cutouts or cutouts shown.

[0148] Figures 16a to 16b The assembly (see arrows) and connection of the struts (001, 002) with the snap lock cover (003) and the specially designed snap lock hard stop (008) are shown.

Claims

1. A two-part bracket, characterized in that: include: An inner stent and an outer stent, the distal end region of each stent extending from the strut includes a connecting feature, wherein the struts of the inner stent and the struts of the outer stent overlap in the distal to proximal direction, a connecting feature of the inner stent is aligned in the same direction as a connecting feature of the outer stent, and a spring lock cover is engaged with the two connecting features, the two connecting features are locked by two spring lock tongues (004, 004') of the spring lock cover and two strut tongue stops (009, 009') of each connecting feature, or the spring lock cover includes three or four spring lock tongues , each connection feature includes a corresponding number of pillar tongue stops, wherein the pillar tongue stops are corresponding parts in the pillar, and the pillar tongue stops can be engaged with a spring lock tongue to form a connection, and the spring lock cover also includes two spring lock hard stops (008, 008'), each connection feature includes two pillar hard stops (007, 007'), the spring lock hard stops (008, 008') and the pillar hard stops (007, 007') allow better positioning and locking of the pillar in the spring lock cover, and prevent the pillar from continuing to slide in the spring lock cover.

2. The two-part bracket according to claim 1, characterized in that The distal end of each stent-extending strut includes a connection feature.

3. The two-part bracket according to claim 1 or 2, characterized in that The spring locking tongue is arranged along the longitudinal direction of the two-part bracket or at an angle of 5° to 90° to the longitudinal direction.

4. The two-part bracket according to claim 3, characterized in that The spring locking tongue is at an angle of 10° to 45° to the longitudinal direction of the two-part bracket.

5. A heart valve replacement prosthesis, characterized in that: include: A replacement valve and a two-part stent according to any one of claims 1-2.

6. The heart valve replacement prosthesis according to claim 5, characterized in that: The spring locking tongue is arranged along the longitudinal direction of the heart valve replacement prosthesis, or forms an angle of 5° to 90° with the longitudinal direction.

7. The heart valve replacement prosthesis according to claim 6, characterized in that: The spring locking tongue forms an angle of 10° to 45° with respect to the longitudinal direction of the heart valve replacement prosthesis.

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