Patent Application
20250144391
The present invention relates to a system for mounting a medical implant, particularly an aortic heart valve prosthesis, to a delivery catheter configured for delivering the medical implant to an implantation site.
Such a delivery catheter can include a capsule for receiving medical the implant when the latter is in a collapsed state; e.g., a crimped aortic heart valve prosthesis. The capsule is configured to cover the medical implant when the latter is arranged on a support element connected to an inner sheath of the delivery catheter while the capsule is connected to an outer sheath of the delivery catheter. Retraction of the outer sheath with respect to the inner sheath allows displacing the capsule with respect to the inner sheath and the respective support element so as to deploy and release the medical implant. With such a delivery catheter, a medical implant like an aortic heart valve prosthesis can be, e.g., only partially released and can then be retracted into the capsule for the purpose of re-positioning the medical implant so that it can be deployed at a proper implantation site in a next attempt. Reinserting the medical implant into the capsule is commonly termed “resheathing” and is for example achievable by providing a connection of the medical implant to a connector of the delivery catheter connected to the inner sheath of the delivery catheter. However, such a resheathing procedure is only possible up to a certain point of no return. Once this point has been passed upon deploying the medical implant, the latter will be completely deployed and released from the delivery catheter and can no longer be retrieved by the delivery catheter. Delivery catheters of the afore-mentioned kind, particularly for implantation of a self-expanding aortic heart valve prosthesis via a transcatheter aortic valve implantation (TAVI, also denoted as TAVR for transcatheter aortic valve replacement), are challenging in multiple aspects. A typical difficulty is to prepare such delivery catheter for an implantation of the self-expandable medical implant, particularly to mount the medical implant to the delivery catheter.
US 2013/0116770 A1 describes a system and a method for sheathing an implantable device. EP 2 865 355 B1 discloses a system for attaching an implant to a catheter shaft including at least two components which each at least partially enclose a rotationally symmetrical space tapering along the axis of symmetry. Furthermore, U.S. Pat. No. 7,743,918 B2 discloses a package for a catheter that holds the distal part of the catheter in a natural state and the proximal part of the catheter in a curled State. The package is included of two trays that are bridged by the catheter and are held together by a slidable fixing member. Further, US 2012/0305441 A1 describes a tray and packaging system for a prosthetic valve delivery system that permits a conversion from a storage and/or shipping configuration to a set up and preparation configuration. US 2017/0056149 A1 discloses a packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment, wherein the packaging system includes a tray that includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. Further, WO 2018/204455 A1 relates to wet transcatheter prosthetic heart valve packaging and assemblies in which a prosthetic heart valve is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize interior portions of the container as well as provide moisture to prevent the implant from drying out. Finally, US 2015/0305867 A1 discloses a delivery apparatus suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve, wherein the delivery apparatus is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.
Preparing/Loading a delivery catheter of the afore-mentioned kind usually is a multi-step procedure that involves manual handling of the delivery catheter and medical implant (e.g. with forceps) to be mounted thereto and is therefore prone to errors. Therefore, based on the above, the problem to be solved by the present invention is to provide a system for mounting a medical implant, particularly a self-expandable or self-expanding aortic heart valve prosthesis (e.g. a TAVI prosthesis) or stent, to a delivery catheter configured for delivering the medical implant to an implantation site, which system allows a safe mounting of the medical implant to the delivery catheter and can be conducted by a single person.
A preferred embodiment connector for connecting a medical implant to a delivery catheter includes a proximal portion and a distal portion connected to the proximal portion via a central portion. The proximal, distal and central portions extend along a central axis (A). A distal end of the distal portion facing away from the central portion. At least one recess is formed in the central portion and in the distal portion. The at least one recess is configured to receive a connecting element of the medical implant configured to connect the medical implant to the connector. The distal portion tapers towards the distal end. Preferably, the distal portion includes a conical section, and an outer surface of the conical section includes a generatrix that encloses an acute angle (α) with the central axis (A), and the acute angle (α) is in the range of between 20° and 60°.
A preferred system includes a connector as described above and the system is configured for connecting a medical implant to a delivery catheter configured for delivering the medical implant to an implantation site. The system includes the medical implant in the form of a self-expandable or self-expanding scaffold. A delivery catheter is configured to deliver the medical implant to an implantation site. The delivery catheter includes a capsule for covering the medical implant and at least one connector. A loading cone is configured to arrange a proximal end portion of the scaffold in a crimped state by decreasing an outer diameter of the proximal end portion of the scaffold, wherein the loading cone includes a body with a distal opening configured to receive the scaffold and an opposing proximal opening. The distal opening has a diameter that is larger than a diameter of the proximal opening. The body of the loading cone has an inner surface extending from the distal opening to the proximal opening. The inner surface tapers towards the proximal opening. A loading tube is configured to be inserted into the proximal opening of the loading cone and to enclose the capsule of the delivery catheter. The loading cone and the loading tube are pre-mounted on the delivery catheter, and packaging encloses the delivery catheter, the loading cone, and the loading tube pre-mounted on the delivery catheter.
In the following, further features, advantages and embodiments of the present invention are explained with reference to the Figures, wherein
A system for mounting a medical implant to a delivery catheter configured for delivering the medical implant to an implantation site, wherein the system includes:
Also disclosed is a system for mounting a medical implant to a delivery catheter configured for delivering the medical implant to an implantation site is disclosed, wherein the system includes:
Preferably, the inner surface includes a conical shape or cone shape. The cone shape or conical shape enables a sliding of the medical implant along the inner surface of the loading cone towards the proximal opening. Particularly, the fact that the loading tube and the loading cone are pre-mounted on the delivery catheter means that the delivery catheter extends through the loading tube and through the proximal and distal opening of the loading cone.
Furthermore, the loading tube is configured to support a distal end of the capsule, wherein an inner diameter of the loading tube prevents the capsule from flaring and gives it radial support.
Further, particularly, the loading cone's main purposes are to crimp the outflow end portion of the scaffold and help guide it into the loading tube or capsule.
In the framework of the present invention, the notion “distal” refers to a portion or component of the system or the implant that is remote from the handle or from the physician that operates the delivery catheter as seen along the course of the delivery catheter while the notion “proximal” refers to those portions or components that are closer to the handle of the delivery catheter or closer to the physician along the course of the delivery catheter.
According to a preferred embodiment of the system, the latter includes a carrier, wherein the medical implant is pre-mounted to the carrier.
Furthermore, according to an embodiment, the system includes a jar for storing the medical implant being pre-mounted to the carrier. Particularly, the jar can include a lid for closing the jar.
According to a further embodiment of the system, the proximal end portion of the scaffold includes connecting elements, wherein the delivery catheter includes a connector, wherein each connecting element is configured to engage with a corresponding recess of the connector. Particularly, the scaffold can be formed by a plurality of interconnected struts, wherein each connecting element is connected to at least one strut of the scaffold. The scaffold can be made out of a suitable alloy, such as a nickel titanium alloy (e.g. Nitinol), so that the scaffold includes a self-expanding property, i.e., the scaffold will automatically self-expand from a crimped state to an expanded state when an outer diameter of the scaffold is no longer limited (e.g. by a capsule surrounding the crimped scaffold).
Furthermore, according to an embodiment, the loading cone is configured for receiving the medical implant pre-mounted to the carrier through the distal opening of the loading cone with the proximal end portion of the scaffold ahead so that the proximal end portion of the scaffold transitions to the crimped state upon sliding along the inner surface of the loading cone and eventually protrudes out of the proximal opening of the body of the loading cone.
Further, according to a preferred embodiment, the carrier includes a plurality of posts protruding from a base plate of the carrier, wherein the posts are configured to secure the medical implant to the carrier, and wherein the respective post is configured to be inserted into an associated slot formed in the body of the loading cone for guiding the carrier when the medical implant is being received by the loading cone.
According to a further embodiment, the medical implant is configured to be released from the posts upon sliding along the inner surface of the loading cone to protrude out of the proximal opening with the proximal end portion of the scaffold.
Preferably, in an embodiment, the carrier is configured to be connected to the body of the loading cone by latching noses configured to engage with a groove formed in the body of the loading cone.
Furthermore, according to a preferred embodiment, the system includes a splay tube device that is configured to spread the connecting elements apart from one another when the proximal end portion of the scaffold is in the crimped state and protrudes out of the proximal opening of the body of the loading cone so that each connecting element is able to engage with the corresponding recess of the connector.
According to a preferred embodiment, the splay tube device further includes a splay tube that is movably arranged with respect to a spring retainer, wherein the splay tube can be moved from a retracted position into an advanced position when the spring retainer is connected to the carrier, wherein in the advanced position the splay tube extends through the loading cone and protrudes out of the proximal opening of body the loading cone to spread the connecting elements apart from one another, wherein the spring retainer holds a spring element that is configured to be pretensioned against the splay tube when the latter is moved into the advanced position so that the spring element generates a restoring force that tries to move the splay tube back to the retracted position.
Furthermore, in an embodiment, the splay tube device forms a handle when connected to the carrier for removing the carrier and the medical implant pre-mounted thereon from the jar.
According to yet another embodiment, the connector includes a proximal portion and a distal portion connected to the proximal portion via a central portion of the connector, wherein the distal portion includes a distal end, and wherein the respective recess is formed in the central portion and in the distal portion, and wherein the distal portion tapers towards the distal end, so that the connecting elements are spread apart from one another upon sliding along the sloped distal portion of the connector towards the respective recess of the connector. Particularly, in case the system includes such a sloped connector, the splay tube device may be omitted since the connecting elements can be spread apart by the tapering distal portion of the connector.
Furthermore, according to an embodiment, the carrier includes latching noses configured to engage with a groove formed in the spring retainer or the splay tube.
According to a further embodiment of the present invention, the loading cone includes a loading tube guide connected via spacer bridges to the body of the loading cone, wherein the loading tube guide forms a guiding opening for receiving the loading tube, which guiding opening is aligned with the proximal opening of the body of the loading cone.
Preferably, the proximal opening of the body of the loading cone includes a ledge according to an embodiment, which ledge forms a stop for the loading tube.
Furthermore, the loading tube preferably includes a head and an end portion connected to the head according to an embodiment, wherein the end portion includes a ledge on an inner surface of the tube, which ledge is configured to prevent the capsule from traveling into the loading cone. Particularly, the head of the loading tube facilitates the handling of the loading tube and may form a stop for limiting a movement of the loading tube into the proximal opening of the body of the loading cone.
According to yet another embodiment, the loading tube includes (four) slots formed into an end of the loading tube, which slots allow the end to spread for letting a nose cone of the delivery catheter pass through the loading tube. When the loading tube is fully inserted into the proximal opening of the loading cone, this radial expansion is limited by the proximal opening in the loading cone, so the nose cone can only pass through the loading tube if the loading tube is not fully inserted into the loading cone.
According to yet another aspect of the present invention, a method for mounting a medical implant to a delivery catheter according to the present invention is disclosed, wherein the method includes the steps of:
Furthermore, yet another aspect of the present invention relates to a connector for connecting a medical implant, particularly a self-expandable prosthesis, to a delivery catheter.
As already described above, reinserting the medical implant into the capsule is commonly termed re-sheathing and is for example achievable by providing a connection of the self-expandable prosthesis to a connector connected to a distal portion of the inner sheath of the delivery catheter.
When the medical implant/prosthesis is in its collapsed state, it has to be partially spread to be connectable to the connector. In the state of the art, tools such as tubes are known that spread the prosthesis device, particularly the stent, such that it can be connected to the connector. Hence, according to state of the art, the loading process requires an additional tool, e.g. the splay tube, and involves an additional process step. This increases the number of parts needed for loading. Further, the time needed for loading is increased due to the additional process steps. Therefore, a device is of interest that simplifies the loading process, i.e. the connection of the prosthesis to the connector, in particular to the delivery catheter or to the connector of the delivery catheter.
This problem is solved by a connector having the features of claim 15. Embodiments of this aspect of the present invention are described below.
According to claim 15 a connector for connecting a self-expanding prosthesis to a delivery catheter is disclosed. The self-expandable prosthesis includes at least one connecting element, particularly a plurality of connecting elements such as two or three connecting elements. The connector extends along a central axis, wherein the connector includes a proximal portion and a distal portion connected to the proximal portion through a central portion of the connector. Alternatively, the connector can include a proximal portion and a distal portion being integrally formed. The distal portion includes a distal end facing away from the central portion. The connector includes at least one recess formed in the central portion and in the distal portion, wherein the at least one recess is configured to receive the at least one connecting element of the self-expandable prosthesis. According to the invention, the distal portion of the connector tapers towards the distal end. Particularly, the notion “distal” means, that a distal component (e.g. a portion, section etc.) of the connector is further away along the delivery catheter from a handle or a user of the delivery catheter than a corresponding “proximal” component, when the connector is connected to the delivery catheter as intended.
According to an embodiment, the connector includes a lumen that extends along the central axis. When the connector is mounted to a delivery catheter, a guide wire can extend in this lumen through the connector and towards an outlet formed in a catheter tip of the delivery catheter.
Particularly, as described above, the prosthesis (e.g. an aortic heart valve prosthesis) can include a self-expandable tubular stent that includes a plurality of interconnected struts that form a tubular cell structure surrounding an interior space of the stent in which interior space a valve member may be arranged. Blood can flow into and out of this interior space through axial openings of the stent thereby passing a valve member of the prosthesis that is arranged in said interior space and connected to the stent. Particularly, the at least one connecting element is arranged at an end of the stent and is connected to at least one strut of the stent. The connecting element can include an eyelet.
Perpendicular to the central axis, the distal portion of the connector can have a circular cross-sectional contour. A diameter of the contour can decrease towards the distal end due to said tapering. The diameter can decrease continuously.
The distal portion and the central portion can be integrally joined together (e.g. can be formed out of a metal or another suitable material, e.g. a plastic material such as a polymer). Furthermore, also the proximal portion and the central portion are preferably integrally joined together. According to an embodiment, the distal portion, the central portion and the proximal portion are integrally joined together to form a single continuous body.
According to an embodiment, the distal end of the connector is configured to be inserted into a proximal axial opening of the prosthesis, particularly of its stent, when the prosthesis, particularly the stent, is in a collapsed state such that the at least one connecting element slides on the distal portion of the connector and engages with the associated at least one recess of the connector. Particularly, the proximal axial opening is arranged between a plurality of connecting elements of the stent that are each connected to at least one strut of the stent at a proximal end of the stent.
Particularly, the notion “collapsed state” means, that the stent, particularly the prosthesis as a whole, is radially compressed to assume a smaller diameter compared to a fully expanded state of the stent/prosthesis. Since the stent is self-expandable or self-expanding, the diameter of the stent has to be delimited so as to keep the stent in the collapsed state (when loaded into the delivery catheter, the capsule of the delivery catheter can cover the stent/prosthesis and keeps it in this collapsed state). Once the delimiting feature (e.g. the capsule) is taken away, the stent expands in the radial direction (i.e. perpendicular to the central axis) and the prosthesis is deployed. Partial deployment is possible by keeping the at least one connecting element covered with the capsule when the at least one connecting element is engaged with the at least one recess, which allows re-sheathing of the prosthesis/stent.
According to an embodiment, the connector is configured to bend the at least one connecting element radially outwards when it is moved into the proximal axial opening of the stent with the distal end ahead when the stent/prosthesis assumes its collapsed state. In case of several connecting elements, the connecting elements are spread apart in the radial direction by the distal portion of the connector while sliding on the tapered distal portion, so that eventually the connecting elements fall into the respective recess of the connector which connects the prosthesis to the connector. This connection can be maintained by covering the connecting elements with the capsule so that the latter covers the connecting elements and the prosthesis/stent.
Particularly, according to an embodiment, the connector, in particular the distal portion, is configured to guide the at least one connecting element of the prosthesis towards the at least one recess of the connector, when the connector is coaxially aligned with the stent and moved towards the proximal axial opening of the stent. Particularly due to said guiding, the at least one connecting element can slide up the distal portion of the connector to fall into the at least one recess.
An advantage of the connector according to the present invention is that it fulfils two tasks, the bending of the respective connecting element of the self-expandable stent/prosthesis and the fastening of the prosthesis to the connector. This simplifies the process of loading the prosthesis to the delivery catheter that is used for delivering the prosthesis (e.g. via TAVI). No additional tools are needed for deforming the stent/prosthesis such that it can be connected to the connector. Hence, less equipment is needed to perform the loading operation, such that costs are advantageously reduced. Moreover, the time needed to load the prosthesis to the delivery catheter is decreased because the connector is configured such that bending of the connecting element(s) and anchoring occur in one combined loading step.
Furthermore, in an embodiment, the proximal portion of the connector includes a proximal end facing away from the central portion, wherein the proximal portion tapers towards the proximal end, too. Particularly, the proximal end faces away from the distal end of the connector.
Further, according to an embodiment, perpendicular to the central axis, the proximal portion of the connector includes a circular cross-sectional contour. The proximal portion can be conical or can include a proximal conical section. The proximal conical section can form the proximal end of the proximal portion of the connector.
According to an embodiment, an outer surface of the distal portion of the connector (or of the conical section of the distal portion) includes a generatrix that encloses an acute angle with the central axis of the connector, wherein in an embodiment, the acute angle may be in the range of between 20° and 60°, preferably of between 25° and 45°, more preferably of between 3° and 40°. The generatrix is a straight or curved line that, when moved along a given path, here rotated about the central axis along the circumferential direction of the connector, generates a surface corresponding to the outer surface of the distal portion (or of the conical section of the distal portion) of the connector.
Furthermore, according to an embodiment, an outer surface of the proximal portion or of the proximal conical section of the proximal portion of the connector includes a generatrix that encloses an acute angle with the central axis, wherein this acute angle is preferably in the range the range of between 20° and 60°, preferably of between 25° and 45°, more preferably of between 3° and 40°. The acute angle of the proximal portion may be the same as or different from the acute angle of the distal portion.
In a further embodiment, the at least one recess of the connector includes a groove and a pocket connected with the groove via a narrow section of the at least one recess, wherein the groove is preferably formed in the distal portion of the connector and the pocket is preferably formed in the central portion of the connector. The narrow section can be formed in an intermediate portion connecting the distal portion to the central portion. The narrow section can also be formed in the central portion and or in the distal portion. Particularly, the groove is formed in the conical section of the distal portion of the connector. Particularly, the intermediate portion can integrally connect the distal portion to the central portion and may provide a rounded transition between the distal portion and the central portion of the connector.
According to a preferred embodiment, the pocket may be configured to receive the at least one connecting element of the prosthesis. Furthermore, particularly, the groove can be configured to receive a strut of the stent to which the at least one connecting element is connected. According to an embodiment, particularly due to the narrow section, the pocket forms an undercut, so that the at least one connecting element can engage behind the undercut formed by the pocket. In case the pocket is now covered with a capsule, the at least one connecting element being engaged with the pocket/undercut cannot be released from the connector unless the capsule is pulled away from the pocket to release the connecting element. Particularly, the groove tapers towards the pocket to form said narrow section of the at least one recess.
Furthermore, according to an embodiment, the narrow section of the at least one recess includes a width extending in a circumferential direction of the connector and the pocket includes a pocket width extending in the circumferential direction of the connector, wherein the width of the narrow section is smaller than the pocket width.
In an embodiment, the at least one recess of the connector is configured such that when the prosthesis is connected to the connector, the at least one connecting element resides in the pocket, wherein the undercut is configured to anchor the connecting element to the connector. This is particularly achieved by letting the connecting element engage behind the undercut when it resides in said pocket.
Such a configuration allows an easy connection between the respective connecting element of the stent and the connector. Further, the prosthesis can be easily released from the connector, when necessary, by allowing the respective connecting element to jump out of the associated pocket (e.g. by removing a capsule holding the respective connecting element in the associated pocket).
According to a further embodiment, the distal portion of the connector includes a distal first section and a proximal second section, wherein particularly, with respect to the central axis, an outer surface of the first section include a first slope and an outer surface of the second section includes a second slope, wherein preferably the first slope is smaller than the second slope.
The force acting on the respective connecting element in the radial direction due to the distal portion of the connector can be influenced by the slope of the tapering of the distal portion. Particularly, by corresponding selection of the slope of the first section of the distal portion, the connector can be configured such that the first section can be easily inserted in the proximal axial opening of the prosthesis. Furthermore, the slope of the second section of the distal portion of the connector can be configured so as to allow bending of the connecting element(s) with a desired force.
Furthermore, in an embodiment, the first section includes a first length and the second section includes a second length along the central axis, wherein preferably the first length equals the second length.
Furthermore, particularly, the groove of the at least one recess can be formed in the second section of the distal portion of the connector. In an embodiment, the groove is formed in the first section and in the second section of the distal portion. The groove can span the entire second section or the entire first and second section.
Particularly, in an embodiment, the first section of the distal portion adjoins the second section of the distal portion of the connector. Furthermore, the second section is connected to the central portion, particularly via the intermediate portion of the connector (see also above). Further, in an embodiment, the first section forms the distal end of the distal portion of the connector. Preferably, the first section is integrally formed with the second section of the distal portion of the connector.
In a further embodiment, the first section of the distal portion of the connector is a conical section including an outer surface and the second section of the distal portion is a conical section including an outer surface, wherein the outer surface of the first section includes a generatrix that encloses a first acute angle with the central axis and the outer surface of the second section of the distal portion includes a generatrix that encloses a second acute angle with the central axis, wherein the first acute angle is smaller than the second acute angle. The two generatrixes enclose an obtuse angle. The first angle may be between 20° and 25°, preferably 21°. The second angle may be between 31° and 40°, preferably 32°.
According to an embodiment, the first section and the second section of the distal portion of the connector enclose an obtuse angle, wherein the obtuse angle is greater than 90°, particularly greater than 120°, particularly greater than 135° and preferably less than 180°.
According to a further embodiment of the present invention, the groove of the at least one recess of the connector includes a groove bottom including a first groove bottom section arranged in the first section of the distal portion and a second groove bottom section arranged in the second section of the distal portion of the connector, wherein—with respect to the central axis—a slope of the first groove bottom section is larger than a slope of the second groove bottom section.
Furthermore, according to an embodiment, the pocket of the at least one recess of the connector includes a pocket bottom. The pocket bottom can include a slope with respect to the central axis of the connector. In an embodiment, this pocket bottom slope equals the slope of the second groove bottom section. Particularly, the pocket bottom and the second groove bottom section can extend in a common plane.
Further, in an embodiment, the slope of the first groove bottom section is larger than the slope of the first section of the distal portion of the connector. According to a further embodiment, the slope of the second groove bottom section is smaller than the slope of the second section of the distal portion of the connector.
In a further embodiment, the connector includes a plurality of recesses, preferably at least two or three recesses, wherein each of these recesses can be configured like the at least one recess described above, i.e., according to at least one of the embodiments described herein with respect to the at least one recess. Particularly, each of the recesses of the plurality of recesses is configured to receive an associated connecting element of the self-expandable prosthesis, particularly an associated connecting element of the stent of the prosthesis.
According to an embodiment, the recesses are equidistantly spaced in the circumferential direction of the connector.
A further aspect of the present invention relates to a delivery catheter for implanting an implantable prosthesis such as an aortic heart valve prosthesis (see e.g. above), wherein the delivery catheter includes an inner sheath and a connector according to the present invention, wherein the connector is connected to a distal end portion of the inner sheath of the delivery catheter. According to an embodiment, the delivery catheter further includes an outer sheath and a capsule that is connected to a distal end of the outer sheath, wherein the outer sheath surrounds the inner sheath. Particularly, the outer sheath is configured to cover the prosthesis when the latter is connected to the connector, wherein the outer sheath and therewith the capsule is movable with respect to the inner sheath to withdraw the capsule from the prosthesis and to thereby release the prosthesis from the connector.
According to an embodiment of the delivery catheter, the delivery catheter can include a prosthesis that is connectable to the connector or that is connected to the connector, wherein preferably the prosthesis is an aortic heart valve prosthesis. According to an embodiment, the prosthesis includes a self-expandable tubular stent that includes a plurality of interconnected struts that form a tubular cell structure surrounding an interior space of the stent, in which interior space a valve member of the prosthesis is arranged and connected to the stent. The stent includes a proximal axial opening (through which blood can exit the prosthesis in the implanted state). Particularly, the at least one connecting element is arranged at a proximal end of the stent and is connected to at least one strut of the stent. The connecting element can include an eyelet. Preferably, the stent includes a plurality of connecting elements, wherein each connecting element is connected to at least one strut at the proximal end of the stent. The proximal axial opening is arranged between the connecting elements.
A further aspect of the invention relates to a method for connecting a self-expandable prosthesis (for example an aortic heart valve prosthesis as described herein) to a connector according to the present invention, including the steps of:
The self-expandable stent can be maintained in the collapsed state by any suitable means, e.g. by a circumferential member that encloses the prosthesis, particularly the stent, so as to prevent it from expanding in the radial direction.
As described above, the connector can include a plurality of recesses (e.g. three such recesses). In this case, the prosthesis, particularly the stent, includes a corresponding number of connecting elements. Here the connecting elements are caused to slide on the connector such that the respective connecting element engages with the associated recess of the connector.
Particularly, the step of letting the connecting elements slide on the connector (e.g. on the distal end portion of the connector) includes inserting the distal end of the connector into a proximal axial opening of the prosthesis in an insertion direction, thereby spreading the connecting elements apart by the distal portion of the connector, wherein the connector is inserted such into the proximal axial opening of the prosthesis that each connecting element engages with its associated recess of the connector. Particularly, said proximal axial opening of the prosthesis is formed by the stent of the prosthesis and is arranged between the connecting elements. The connecting elements are preferably formed as eyelets (see also above).
When the respective connecting element engages with its associated recess it engages behind the undercut of the pocket of the associated recess of the connector which connects the respective connecting element to the connector.
According to an embodiment of the method, the method can include the further step of aligning the respective connecting element with an associated recess of the connector by rotating the connector about the central axis.
Furthermore, according to an embodiment of the method, the method can include the further step of moving the connector in a direction opposite the insertion direction so as to achieve engagement of the respective connecting element with an associated recess, particularly in case the respective connecting element has been moved past its associated recess during initial insertion of the connector in the axial opening. This opposite movement is facilitated by the slope of the proximal portion of the connector.
In the method according to the present invention, insertion of the connector into the axial opening of the prosthesis/stent can be achieved by moving the connector and/or the prosthesis.
Due to the method according to the present invention, the prosthesis can be easily connected to the connector, particularly to the delivery catheter, without the need of additional tools to spread the prosthesis in order to connect it to the connector. This reduces the complexity of the equipment needed as well as the time needed for loading the prosthesis to the connector.
Further examples are described below:
A connector for connecting a medical implant, preferably an implantable self-expandable or self-expanding prosthesis, to a delivery catheter, wherein the connector extends along a central axis and includes a proximal portion and a distal portion connected to the proximal portion via a central portion of the connector, wherein the distal portion includes a distal end facing away from the central portion, and wherein the connector includes at least one recess formed in the central portion and in the distal portion, wherein the at least one recess is configured to receive a connecting element of the medical implant, preferably the self-expandable or self-expanding prosthesis, for connecting the medical implant, preferably the self-expandable or self-expanding prosthesis, to the connector, wherein the distal portion tapers (continuously) towards the distal end.
The proximal portion can include a proximal end facing away from the central portion, wherein the proximal portion tapers towards the proximal end.
The distal portion can include a conical section, wherein an outer surface of the conical section includes a generatrix that encloses an acute angle with the central axis, wherein the acute angle is in the range of between 20° and 60°, preferably of between 25° and 45°, more preferably of between 3° and 40°.
The at least one recess can include a groove and a pocket connected to the groove via a narrow section of the at least one recess, wherein the groove is formed in the distal portion and the pocket is formed in the central portion.
The groove can taper towards the pocket.
The narrow section can include a width extending in a circumferential direction of the connector, and the pocket can include a pocket width extending in the circumferential direction of the connector, wherein the width is smaller than the pocket width.
7The at least one recess can be configured such that the pocket forms an undercut.
The distal portion can include a distal first section and a proximal second section.
The first section can adjoin the second section.
The first section can be a conical section including an outer surface and the second section is a conical section including an outer surface, wherein the outer surface of the first section includes a generatrix that encloses a first acute angle with the central axis and the outer surface of the second section includes a generatrix that encloses a second acute angle with the central axis, wherein the first acute angle is smaller than the second acute angle.
The generatrixes of the first section and of the second section can enclose an obtuse angle, wherein the obtuse angle is larger than 100°, particularly larger than 120°, more particularly larger than 135° or larger than 150°.
The groove can include a groove bottom including a first groove bottom section arranged in the first section of the distal portion and a second groove bottom section arranged in the second section of the distal portion, wherein a slope of the first groove bottom section is larger than a slope of the second groove bottom section.
The connector can include at least two, preferably three, recesses, wherein each recess is formed in the central portion and in the distal portion, wherein each recess is configured to receive a connecting element of the medical implant, preferably the self-expandable or self-expanding prosthesis.
A delivery catheter includes a connector according to one of the preceding examples and an inner sheath including a distal end portion wherein the connector is connected to the distal end portion of the inner sheath.
A method for connecting a medical implant, preferably a self-expandable or self-expanding prosthesis, to a connector of a delivery catheter, includes the steps of:
A system for mounting a medical implant, preferably a self-expandable or self-expanding prosthesis, to a delivery catheter configured for delivering the self-expandable or self-expanding prosthesis to an implantation site, wherein the system includes:
The system can include a carrier, wherein the medical implant, preferably the self-expandable or self-expanding prosthesis, is pre-mounted to the carrier.
The system can include a jar for storing the medical implant, preferably the self-expandable or self-expanding prosthesis, being pre-mounted to the carrier.
The medical implant, can be a self-expandable or self-expanding prosthesis, which includes at least one connecting element.
The delivery catheter can include more than one connector and the medical implant, preferably the self-expandable or self-expanding prosthesis, includes more than one connecting element.
The proximal end portion of the scaffold can include one connecting element, which is configured to engage with the corresponding recess of the connector to connect the medical implant, preferably the self-expandable or self-expanding prosthesis, to the delivery catheter.
The proximal end portion of the scaffold can include several connecting elements, and wherein the delivery catheter includes a connector, wherein each connecting element is configured to engage with a corresponding recess of the connector to connect the medical implant, preferably the self-expandable or self-expanding prosthesis, to the delivery catheter.
The loading cone can be configured for receiving the medical implant, preferably the self-expandable or self-expanding prosthesis, pre-mounted to the carrier through the distal opening of the loading cone with the proximal end portion of the scaffold ahead so that the proximal end portion of the scaffold transitions to the crimped state upon sliding along the inner surface of the loading cone and protrudes out of the proximal opening of the body of the loading cone.
The carrier can include a plurality of posts protruding from a base plate of the carrier, wherein the posts are configured to secure the medical implant, preferably the self-expandable or self-expanding prosthesis, to the carrier, and wherein the respective post is configured to be inserted into an associated slot formed in the body of the loading cone for guiding the carrier when the medical implant, preferably the self-expandable or self-expanding prosthesis, is being received by the loading cone.
The medical implant, preferably the self-expandable or self-expanding prosthesis, can be configured to be released from the posts upon sliding along the inner surface of the loading cone to protrude out of the proximal opening of the loading cone with the proximal end portion of the scaffold.
The system can include a splay tube device that is configured to spread the connecting elements apart from one another when the proximal end portion of the scaffold is in the crimped state and protrudes out of the proximal opening of the body of the loading cone so that each connecting element is able to engage with the corresponding recess of the connector.
The splay tube device can include a spring retainer configured to be connected to the carrier, wherein the splay tube device further includes a splay tube that is movably arranged with respect to the spring retainer, wherein the splay tube can be moved from a retracted position into an advanced position when the spring retainer is connected to the carrier, wherein in the advanced position the splay tube extends through the loading cone and protrudes out of the proximal opening of body of the loading cone to spread the connecting elements apart from one another, wherein the spring retainer holds a spring element that is configured to be pretensioned against the splay tube when the latter is moved into the advanced position so that the spring element generates a restoring force that tries to move the splay tube back to the retracted position.
The splay tube device can form a handle when connected to the carrier for removing the carrier and the medical implant, preferably the self-expandable or self-expanding prosthesis, pre-mounted thereon from the jar.
The loading cone can include a loading tube guide connected via at least one spacer bridge to the body of the loading cone, wherein the loading tube guide forms a guiding opening for receiving the loading tube, which guiding opening is aligned with the proximal opening of the body of the loading cone.
The proximal opening of the body of the loading cone can include a ledge that forms a stop for the loading tube.
The loading tube can include a head and an end portion connected to the head, wherein the end portion includes a ledge on an inner surface of the loading tube, which ledge is configured to prevent the capsule from traveling into the loading cone, and wherein optionally the loading tube includes slots formed into an end of the loading tube, which slots allow the end to spread for letting a nose cone of the delivery catheter pass through the loading tube.
The inner surface can taper continuously from the distal opening to the proximal opening.
The inner surface can have a cone shape or conical shape.
A method for connecting a medical implant, preferably a self-expandable or self-expanding prosthesis, to a delivery catheter using a system according to one of the above examples, wherein the method includes the steps of:
The loading cone 4 is configured to arrange a proximal end portion 20a of the scaffold 20 in a crimped state by decreasing an outer diameter of the proximal end portion 20a of the scaffold 20. The loading cone 4 includes a body 40 including a distal opening 41 for receiving the scaffold 20 and an opposing proximal opening 42, wherein the distal opening 41 includes a diameter that is larger than a diameter of the proximal opening 42. The body 40 of the loading cone 4 further includes an inner surface 40a extending from the distal opening 41 to the proximal opening 42, wherein the inner surface 40 tapers towards the proximal opening 42. The loading tube 5 is configured to be inserted into the proximal opening 42 of the loading cone 4 and to enclose the capsule 226 of the delivery catheter 3. The loading cone 4 and the loading tube 5 are pre-mounted on the delivery catheter 3.
The system 1 further includes a packaging 6 enclosing the delivery catheter 3 as well as the loading cone 4 and the loading tube 5 pre-mounted on the delivery catheter 3. The packaging 6 includes a first packaging part 61, including a loading basin 61a, and a second packaging part 63, including a handle compartment and a splay tube device compartment. The first packaging part 61 and the second packaging part 63 are connectable to each other by a detachable connecting rinsing tray 62.
The implant 2 preferably includes a self-expandable scaffold 20 (also denoted as stent) formed out of interconnected struts 21 that are connected to connecting elements 22 at a proximal end portion 20a of the scaffold. The scaffold can carry valve leaflets that can be formed out of a biological tissue (cf. e.g.
Furthermore, the delivery catheter 3 is configured to deliver the medical implant 2 to an implantation site (preferably via TAVI), wherein the delivery catheter 3 includes a capsule 226 for covering the medical implant 2. The catheter 3 can include a flush port 39a for flushing the catheter 3, and a guidewire lumen flush port 39b for flushing a guidewire lumen of the catheter 3. A stiletto 360 can protects the guidewire lumen from kinking.
The system 1 further includes a loading cone 4 for arranging the proximal end portion 20a of the scaffold 20 in a crimped state by decreasing an outer diameter of the proximal end portion 20a of the scaffold 20, wherein the loading cone 4 includes a body 40 including a distal opening 41 for receiving the scaffold 20 and an opposing proximal opening 42, wherein the distal opening 41 includes a diameter that is larger than a diameter of the proximal opening 42, and wherein the body 40 of the loading cone 4 further includes an inner surface 40a extending from the distal opening 41 to the proximal opening 42, wherein the inner surface 40a tapers towards the proximal opening 42.
Furthermore, the system 1 includes a loading tube 5 configured to be inserted into the proximal opening 42 of the loading cone 4 and to enclose the capsule 226 of the delivery catheter 3, wherein the loading cone 4 and the loading tube 5 are pre-mounted on the delivery catheter 3, and wherein the system 1 includes a packaging 6 enclosing the delivery catheter 3 as well as the loading cone 4 and the loading tube 5 pre-mounted on the delivery catheter 3.
Furthermore, for handling of the medical implant 2, the system preferably further includes an implant storage jar 7 for storing the implant 2 that is preferably pre-mounted to a carrier 8. For removing the carrier 8 and implant 2 from the implant storage jar 7 and for aligning the connecting elements 22 of the scaffold 20, the system 1 can further include a splay tube device 9 (cf. e.g.
Particularly, as indicated in
The following sections describe a particular example of the mounting procedure of the medical implant 2 step by step. In a first step, the tray is arranged starting from the initial elongated configuration shown in
As shown in
Particularly, according to an alternative embodiment, the connector 33 could be attached to the connecting elements 22 before submerging it in (physiological) saline having a temperature of between 0° C. and 8° C. to prevent staying deformation of the connecting elements 22. Furthermore, instead of pulling the medical implant (e.g. prosthesis) 2 directly into the capsule 226, an intermediate step could be introduced, where the medical implant (e.g. prosthesis) 2 is pulled back into the loading tube 5 and is encapsulated from there.
The medical implant (e.g. prosthesis) 2 would have to be secured by slightly moving forward the capsule 226 and securing the medical implant (e.g. prosthesis) 2, then pulling it into the loading tube 5 by pulling on the outer sheath 202 of the delivery catheter 3. Furthermore, instead of extracting the loading tube 5 and the loading cone 4 from the delivery catheter 3 one could also pull the delivery catheter 3 out of the (loading) system 1. Furthermore, the duration of the rinsing steps could potentially be reduced to save time during the loading process. Further, the mounting of the implant 2 could also be performed in saline at room temperature.
In the following, the components of the system and embodiments relating thereto will be described in more detail.
Furthermore, the spring retainer 91 includes a lip 91a that prevents the splay tube 90 from escaping. The splay tube 90 includes a corresponding lip 90b which overlaps with the lip 91a of the spring retainer 91. These parts are connected by pressure, extending the radius of the spring retainer lip 91a. The force for disassembling the splay tube 90 is high enough so it does not detach during transport and use. The spring retainer 91 further includes a tube passage 91c that allows the splay tube 90 to reach trough the spring retainer 91 and also acts as a guide to keep the spring retainer 91 and the splay tube 90 axially aligned. The larger the height of this passage 91c, the better the alignment of splay tube 90 and retainer 91. Furthermore, the retainer 91 can include a circumferential groove 91d to connect the splay tube device 9 to the carrier 8, e.g. via latching noses of the carrier 8 that engage with the groove to establish a snap-fit connection. This connection and possible alternatives will be described in more detail below.
Furthermore, the retainer 91 can include a finger flange 91e, that allows the spring retainer 91 to be secured while pushing forward the splay tube 90. Particularly, this mechanism functions similar to one seen in a syringe. As indicated in
A preferred embodiment of the loading cone 4 is shown in
When inserting the prosthesis carrier 8 into loading cone 4 through its distal opening 41, the tapered shape, preferably cone shape, of the inner surface 40a of the body 40 of the loading cone 4, guides the outflow/proximal end portion 20a of the scaffold 20 and the diameter of the outflow/proximal end portion 20a is reduced as shown in
In the following, an embodiment of the carrier 8 and its functionality with regard to holding the implant 2 will be described in more detail.
As indicated in
As further shown in
For storing the implant 2 before mounting it to the delivery catheter 3, the system 1 preferably includes an implant storage jar 7. An embodiment of the implant storage jar 7 is shown in
According to an alternative embodiment, the carrier 8 could also be combined with the implant storage jar lid 7a of the implant storage jar 7 (either as separate parts or as one part). The splay tube device 9 would have to be left away or could be integrated. The ring 81a in the center of the carrier base plate 81 is used to center the medical implant (e.g. prosthesis) 2. As an alternative, centering ring 81a (or any other centering possibility or shapes) could also be on the inside of the medical implant (e.g. prosthesis) 2 (instead of on the outside) or both on the inside and outside for extra stability.
Preferably, as shown in
Furthermore,
As particularly shown in
As an alternative, it is also conceivable to interchange the positions of the latching noses 81b and the wings 81h. Another option for connecting the carrier 8 to the loading cone could be a press fit, magnetic-, screwed-, or wedged-connector. The length of the end portion 81i of the respective wing 81h that serves as a release handle, which end portion 81i is arranged opposite the latching nose 81b, can be further increased to reach the implant jar lid 7a. This would allow for less movement of the implant 2 within the prosthesis jar 7 and would reduce the force needed to release the carrier 8 from the loading cone (cf.
Furthermore, as indicated in
According to
Furthermore, as indicated in
As illustrated in
Alternatively, as shown in
Further, as indicated in
As illustrated in
Alternatively, a prosthesis mounting tool 85 can be used as shown in
According to yet another alternative, the medical implant (e.g. prosthesis) 2 can be arranged on the base plate 81 before placing the posts 80 on the base plate 81. Furthermore, the medical implant (e.g. prosthesis) 2 could be placed on the base plate 81 and the posts 80 could be arranged in place afterwards. This can mean that the posts 80 are bent during mounting or mounted at an angle and then tilted upwards. Similarly, the medical implant (e.g. prosthesis) 2 could be placed after mounting one or two posts 80 wherein the remaining posts are mounted after placement of the implant 2. The medical implant (e.g. prosthesis) 2 could also be placed by spreading the posts 80 by hand.
Furthermore, as shown in
Furthermore, as shown in
According to an alternative embodiment, the posts 80 can be omitted and the three slots 43 in the body 40 of the loading cone 4 could be removed and the prosthesis carrier 8 would be fully rotatable in the loading cone 4. Furthermore, in case of a solution without an expandable loading tube 5 the cylindrical area 45 and the ledge 42a at the outflow side of the cone 4 could be potentially omitted. Furthermore, different shapes and numbers of spacer bridges 44 are possible to improve visibility of the connector 33. Furthermore, a solution without spacer bridges 44 and loading tube guide 45 could be feasible, where the loading tube 5 inserts directly into the loading cone 4. Furthermore, different angles of the inner surface 40a of the loading cone 4 are possible. The cone 4 does not necessarily have to have a conical inner surface 40a (decreasing uniformly in diameter). A trumpet shape or other tapering shapes would also be feasible.
Furthermore,
According to an alternative configuration, the loading tube 5 could be attached to the loading cone 4 in the mounting configuration by screwing, bayonet, magnetic, wedge, press fit or snapping mechanism. Furthermore, alternatively, the axial fixation of the capsule 226 (which prevents the capsule 226 from diving into the loading cone 4 and the distal end from deforming) with the ledge 5c and the radially expandable end 5b of the loading tube 5 can be replaced by a fixation of the outer sheath or capsule on another level. For example, the outer sheath 202 could axially fixed in the packaging 6. This would also prevent the capsule 226 from diving into the loading cone 4. Furthermore, an additional step could be added, where the medical implant (e.g. prosthesis) 2 is first pulled into the loading tube 5 and then encapsulated within the loading tube 5.
Furthermore,
According to
Furthermore,
Furthermore,
The present invention offers the advantages according to which the delivery catheter can be loaded in a safe manner by a single person. No additional packaging is required. The (loading) system is stored within the packaging 6 of the medical implant (e.g. prosthesis) 2 and the delivery catheter 3. Furthermore, less tools are needed for the loading procedure (only a syringe for flushing of the respective lumen is needed). Furthermore, the mounting system 1 protects the distal end of the delivery catheter 3.
While specific embodiments of the present invention have been shown and described, it should be understood that other modifications, substitutions and alternatives are apparent to one of ordinary skill in the art. Such modifications, substitutions and alternatives can be made without departing from the spirit and scope of the invention, which should be determined from the appended claims.
Various features of the invention are set forth in the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 22156699.5 | Feb 2022 | EP | regional |
This application is a 35 U.S.C. 371 US National Phase and claims priority under 35 U.S.C. § 119, 35 U.S.C. 365 (b) and all applicable statutes and treaties from prior PCT Application PCT/EP2023/050840, which was filed Jan. 16, 2023, which application claimed priority from EP Application Serial No. 22151791.5, which was filed Jan. 17, 2022.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2023/053372 | 2/10/2023 | WO |
