Medical device for a cardiac valve implant, and a method of manufacturing the medical device

A medical device (1300) for holding an annuloplasty ring (101) is disclosed comprising a support (102) defining first and second peripheral edges (103, 126) each with a curvature about which said cardiac valve implant can be fitted, wherein the support comprises a grip section (128, 129) positioned between and connected with the first and second peripheral edges at opposite sides of the grip section, the grip section defining an opening for engagement with a gripper tool in use of the support, wherein said grip section is recessed inwards from either of said first and second peripheral edges thereby defining said opening between said support and said cardiac valve implant when held in place by said support. A method of manufacturing a medical device is disclosed.

FIELD OF THE INVENTION

This invention pertains in general to the field of cardiac valve replacement and repair. More particularly the invention relates to a medical device for holding a cardiac valve implant, a kit comprising a tool for manipulation of such medical device, and a method of manufacturing the medical device.

BACKGROUND OF THE INVENTION

Diseased mitral and tricuspid valves frequently need replacement or repair. The mitral and tricuspid valve leaflets or supporting chordae may degenerate and weaken or the annulus may dilate leading to valve leak. Mitral and tricuspid valve replacement and repair are frequently performed with aid of an annuloplasty ring, used to reduce the diameter of the annulus, or modify the geometry of the annulus in any other way, or aid as a generally supporting structure during the valve replacement or repair procedure. Such annuloplasty rings or other annuloplasty implants or cardiac valve implants in general such as replacement valves, are put into position by various tools.

An assembly for holding an annuloplasty ring in place for placing a suture line and attach the ring to the annulus tissue is disclosed in U.S. Pat. No. 6,197,052. The annuloplasty ring or suture guide is releasably attached to a guide mount by sutures or threads passing through apertures disposed in the guide mount and through the ring. Once the surgeon is ready to release the ring, the sutures for fixing the ring to the mount are cut of at various locations of the mount, and the guide can subsequently be retrieved. The mount is attachable to a handle assembly which is mounted by inserting a cylindrical hub of the handle assembly into a plug of the mount.

United states patent application US2003176916 discloses a holder for an annuloplasty prosthesis having a first component, around which the prosthesis is mounted and a second component, releasably secured to the first component by sutures. Projections align the two holder components to each other, and a further rectangular projection at the second component is required to prevent deformation and reduction of the circumference of the first holder component which is an open ring. I.e. the first holder component can not satisfactory hold the prosthesis without the second holder component. In some embodiments, rather than retaining the prosthesis to the holder by means of sutures passing through the prosthesis, the prosthesis is retained by means of downwardly extending penetrating members such as barbs, pins, pegs, or needles.

Hence, a problem with prior art devices is the risk of damaging the implant due to complicated mechanisms for attachment and detachment to the holder, thereby increasing the amount of manipulation of the implant both during the positioning phase and during repositioning, which may lead to unnecessary wear and risk of damages to the implant.

During heart surgery, a premium is placed on reducing the amount of time used to replace and repair valves as the heart is frequently arrested and without perfusion. A problem with prior art devices is the time consuming attachment or detachment of the annuloplasty device, also referred to as the cardiac valve implant, or simply implant below, to the holder assembly, e.g. by using sutures. It would therefore be very useful to have a medical device for holding the implant to be positioned at the annulus that can be quickly attached or detached to such implant.

If repositioning of the cardiac valve implant becomes necessary it is also critical that the holder can engage the implant easily and quickly. The suture attachment in prior art devices is complicated and time consuming when such repositioning is required.

Another problem with prior art devices is insufficient visibility through the holder and into the annulus due to complex holder construction with elements extending across the annulus and thereby obscuring the sight. Reduced visibility makes accurate positioning more complicated and time consuming with potentially increased risk.

A further problem with prior art devices is insufficient maneuverability of the cardiac valve implant due to lack of freedom of movement between the holder and the delivery tool. Such lack of flexibility also increases the time of the replacement or repair procedure.

Another problem with prior art holders is the limited ability to adapt to implants having a wide range of sizes. It is therefore necessary to have a number of various holders which complicates the procedure further as frequent exchange of holders may be necessary to find the correct fit.

Another problem with prior art devices is the few options to manipulate the implant via the holder, once the implant is held in place by the holder, i.e. lack of versatility in handling the holder to get the desired course of positioning of the implant, while keeping the holder compact e.g. to maintaining a good view trough the holder during the positioning.

The above problems may have dire consequences for the patient and the health care system. Patient risk is increased.

Hence, an improved medical device for holding a cardiac valve implant would be advantageous and in particular allowing for increased flexibility, reducing the time of lengthy surgery procedures, cost-effectiveness, and increased patient safety. Also, a method of holding a cardiac valve implant with such medical device and a kit comprising a tool for manipulation of such medical device would be advantageous.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present invention preferably seeks to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device according to the appended patent claims.

According to a first aspect of the invention a medical device for holding a cardiac valve implant is provided comprising a support defining first and second peripheral edges each with a curvature about which said cardiac valve implant can be fitted, wherein the support comprises a grip section positioned between and connected with the first and second peripheral edges at opposite sides of the grip section, the grip section defining an opening for engagement with a gripper tool in use of the support, wherein said grip section is recessed inwards from either of said first and second peripheral edges thereby defining said opening between said support and said cardiac valve implant when held in place by said support.

According to a second aspect of the invention a kit is provided comprising a medical device according to the first aspect having a grip section and a tool comprising a grip member arranged for gripping of said grip section.

According to a third aspect of the invention a method of manufacturing a medical device for holding a cardiac valve implant is provided, the method comprises providing a sheet of bulk material such as a polymer material, providing a template of the medical device, and punching the sheet with the template to provide the medical device comprising a support defining first and second peripheral edges each with a curvature about which the cardiac valve implant can be fitted, and a grip section for engagement with a gripper tool in use of the support.

Further embodiments of the invention are defined in the dependent claims, wherein features for the second and subsequent aspects of the invention are as for the first aspect mutatis mutandis.

Some embodiments of the invention provide for less time consuming positioning of cardiac valve implants at a target site in the heart.

Some embodiments of the invention provide for less time consuming attachment and detachment of a cardiac valve implant to a medical device for efficient positioning and repositioning of such implant at the annulus.

Some embodiments of the invention provide for flexible positioning of a cardiac valve implant at a target site by conforming to varying anatomical sites in a body.

Some embodiments of the invention provide for increased visibility through the cardiac valve implant and into the annulus for accurate positioning and reducing the risk of complications.

Some embodiments of the invention also provide for a reduced risk of damaging the cardiac valve implant during a repair or replacement procedure.

Some embodiments of the invention provide for a compact holder of a cardiac valve implant with maintained flexibility of positioning.

Some embodiments of the invention provide for a flexible holder in terms of adapting to a wide range of sizes of cardiac valve implants to be positioned.

DESCRIPTION OF EMBODIMENTS

The following description focuses on an embodiment of the present invention applicable to cardiac valve implants such as annuloplasty rings. However, it will be appreciated that the invention is not limited to this application but may be applied to many other annuloplasty implants and cardiac valve implants including for example replacement valves, and other medical implantable devices.

FIGS. 1a-bshow a medical device100according to an embodiment of the invention, for holding an annuloplasty implant101(see e.g.FIG. 2andFIG. 7). The below description of the medical device100according to the embodiment as seen inFIGS. 1a-balso applies to the embodiments of the medical device1300,1400,1500,1600,1700,1800,1900,2000,2100, as seen inFIGS. 13-21. The device100comprises an elongate support102defining a peripheral edge103with a curvature about which the annuloplasty implant101can be fitted. The support102comprises a resilient portion104for resiliently holding the annuloplasty implant101in place in the medical device100. The medical device100functions as a holder for the implant, and by having a resilient portion104the implant101can be held in place without the need for any specialized means for attachment, such as sutures and/or the use of holders with several components that are required to hold the implant. Easy attachment and detachment of the implant101to the device101is thereby achieved, in a less time-consuming manner compared to e.g. using sutures. As the implant101has been positioned at a target site, e.g. to resize the annulus of a heart valve, repositioning can be achieved readily by again attaching the implant to the device due to the resilient portion104, again without the need of a special attachment means. Repeated repositioning is possible in this manner, during a narrow time frame during surgery, due to the quick attachment and detachment possible. The resilient portion104is for radially resiliently holding the implant101in place in the medical device100, and/or axially resiliently holding the implant101in place in the medical device100. Radially resiliently holding of the implant101is to be construed as the resilient portion104is resilient in the radial direction, which direction extends parallel to an axis from the center of the device100towards the peripheral edge103, and thereby providing a force in the radial direction, either radially outwards from the center or radially inwards from the center, for holding the implant101. The center of the device100may be construed as its center of mass, or geometrical center. The radial direction may also be construed as extending along an axis aligned from the position of the control member110to the peripheral edge103. The implant101is held in place against the device100by the frictional force created in the contact area between the implant101and the device100, e.g. at the peripheral edge103, which source from the radially directed force applied through the resilient portion104.

FIG. 2shows an annuloplasty ring101as an example of an annuloplasty implant101. InFIG. 3the elongate support102is resilient itself and the resilient portion104extends therefore along the peripheral edge103. The resilient portion104holds the implant101by applying the radial force (F) along the peripheral edge103. The force (F) is here applied radially outwards.

Axially resiliently holding of the implant101is to be construed as the resilient portion104is resilient in the axial direction, which direction extends substantially perpendicular to the radial direction, i.e. the vertical direction in e.g.FIG. 7showing a side view of the device100inFIGS. 1a-b. By being resilient in the axial direction the resilient portion104may exert a force in the axial direction onto the implant101that holds the implant101in place. As discussed further below with reference toFIG. 7the geometry of the implant may in this manner be changed by the applied force from the resilient portion104for facilitating insertion of the implant.

Returning toFIGS. 1a-b, the support104has an expanded circumference (C) in a first configuration (FIG. 1a), and a reduced circumference (C′) in a second configuration (FIG. 1b). The circumference is to be construed in its usual meaning, as the dimension of the device100around the peripheral edge103. When the elongate support is discontinuous, e.g. with two free ends as illustrated inFIGS. 1a-b, the circumference is measured as the shortest distance between the free ends at the periphery, as indicated by the dashed line (C, C′). Radial movement of the support102between the second and first configuration cause the curvature of the peripheral edge103to conform at least partly to the annuloplasty implant101to hold the annuloplasty implant101in place. The radial movement is due to the resilience of the resilient portion104. Radial movement between the second and first configuration is to be construed as movement from second to first configuration, or movement from first to second configuration, i.e. radially outward and radially inward. The elongate support102may therefore apply a force to the implant101in both radially outward and radially inward directions to hold the implant in place. A self-holding action is thereby provided which allows easy removal of the implant from the device100and re-insertion if desired. By having an elongate support that is self-holding the disadvantageous prior art solutions with several components for holding the implant are avoided, and no sutures are needed.

The first configuration of expanded circumference (C) may be the relaxed configuration of the device100, and the second configuration of reduced circumference may be the compressed configuration of the device100. The resilient portion104is unloaded in the relaxed configuration and is loaded, i.e. being tensioned, in the compressed configuration. Hence, as was illustrated inFIG. 3, the radial movement is radial expansion from the second configuration to the first configuration, which causes the curvature of the peripheral edge103to conform to the implant101and exert a force (F) in the radially outward direction to hold the implant101in place. The configuration of the device100inFIG. 3is therefore not the fully expanded circumference, i.e. not fully relaxed, in order to exert the force (F) on the implant101. Thus, once the device100is put into place in the implant101, it provides a firm support and the implant101and the device100can be manipulated without loosing the self-holding contact between the two. An elongate support with a circumference that merely can be changed is not sufficient to solve the aforementioned problems. Previous solutions still rely on having multiple component holder members that must be connected lock the implant in place, and to prevent collapsing of the holder members. The resilient portion104of the device100being radially expandable between to configurations, as discussed above, avoids such complex mounting systems.

In case of the device100apply a radially inward force to the implant (not shown),FIG. 1billustrates the relaxed configuration, and the resilience of the portion104allows expansion of the device100to expanded circumference inFIG. 1a. The implant101may then conform to the inward edge of the device100, opposite to peripheral edge103to hold it in place.

The resilience of the device100in embodiments may be due to the resilient portion104being made of a flexible material with shape memory properties, such as a shape memory polymer or metal. Alternatively, the device configurations of expanded and reduced circumference may be achieved by a material of the device100having other shape memory properties, such as temperature dependent shapes.

The elongate support102may be ring-shaped with at least one central opening105. As seen inFIG. 1a, the central opening105has a substantial area due to the cross-section of the material of the elongate support102being substantially smaller than the diameter of the device100at any point. This improves the visibility of through the device100, which is important during the implantation procedure.

In embodiments such as inFIG. 1athe ring-shape is discontinuous so that the elongate support102comprises two free ends106,107. The free ends106,107, allow movement in relation to each other, hence allowing the circumference of the device100to be varied to conform to the implant101. The general shape of the elongate support102may be D-shaped, C-shaped, or shaped suitably to allow conforming to the implant101while permitting varying of the circumference. In case of not having a discontinuous ring-shape, i.e. a closed ring of any shape, the circumference may be reduced by pulling or compressing the resilient portion104inwards and towards the center of the device100, e.g. as seen in the embodiments inFIGS. 18-19, where first engagement surface108may be forced in a direction towards second engagement surface109. The circumference of the device100, which would be reduced by said pulling action, should in that case be construed as the shortest path around the periphery, i.e. a circular/oval path without following portions of the edges103being pulled towards the center, i.e. extending towards the center. Hence, this would effectively be the cross-section of the device100, which would decrease by the pulling action. The device100may have struts crossing the opening105that are arranged so that compressing the struts towards each other the cross-section of the device100would be reduced.

As mentioned above, the entire elongate support102may be flexible to define the resilient portion104. This may simplify manufacturing of the device100, or provide a sufficiently uniform flexibility around the peripheral edge103to allow the entire elongate support102to conform to the implant101, as illustrated inFIG. 3, thereby leaving no openings between the edge103and the implant101for secure attachment. Alternatively, a limited portion of the elongate support may be flexible, and/or the flexibility me be provided by other means such as a spring (not shown) arranged to join two parts of the elongate support102together, thereby allowing flexibility between the two parts for varying the circumference of the device100.

Each of the free ends106,107, may comprise an engagement portion106,107, having an engagement surface108,109, as illustrated inFIG. 1a. The engagement surfaces108,109, are adapted to receive a tool for compressing the free ends106,107, towards each other in the compressed configuration of the elongate support102. The direction of compression is indicated for the free ends106,107, inFIG. 1b, and is for one end107indicated as a first direction119, and being reversed for the opposite free end106. Alternatively, if the configuration of reduced circumference (C′) would be the relaxed shape, as elucidated above, the free ends may be forced apart by engaging with a tool200the surfaces opposite to that of the engagement surfaces108,109, for each of the free ends106,107. By having engagement surfaces108,109, the free ends106,107, may be manipulated to achieve the desired shape of the elongate support102to be able to conform to the cardiac valve implant101and hold it in place. This is an efficient and quick way of manipulating the device100. Due to the free ends106,107, being manipulated directly a compact device100is realized. Visibility through the elongate support102is optimized due to manipulation at the periphery of the elongate support102. Alternatively or in addition, the free ends106,107, may have apertures123,124, with corresponding engagement surfaces108,109, for allowing insertion with a tool to manipulate the free ends106,107, as illustrated inFIG. 10. It may be advantageous to engage with the tool as close to the elongate support as possible, i.e. either by apertures123,124, or by the control member110, discussed further below, being displaced from the center of the support102and positioned close to the peripheral edge103. Such positioning can improve the ability to position the implant101at the target site. Further, improved visibility through the implant101is obtained.

The engagement portion106,107, and the engagement surface108,109, may extend in a radial direction from the peripheral edge103of the elongate support102. InFIGS. 1a-bthe engagement surfaces108,109, extend radially inwards from the edge103. A compact device100is thereby provided. Alternatively, the engagement surfaces108,109, may extend radially outwards from the edge103. The spatial extent of the engagement surfaces108,109, may be optimized for allowing sufficient grip with a tool200while visibility is maintained by being confined largely to the periphery of the elongate support102.

The device100may comprise a control member110for engagement with a positioning tool200as seen inFIGS. 11a-c. The control member110may comprise a spherical surface117, as illustrated in the perspective view of the device100inFIG. 4. By having a spherical surface117the device100may pivot in a mating spherical recess201of the positioning tool200. Such pivoting allows the device100to be rotated in any desired direction in relation to the positioning tool200, see e.g.FIG. 11a, which for example allows insertion into the body in a minimally invasive manner, such as through the ribs of the body, and subsequent reorientation when being positioned for implantation at the target site.

The positioning tool200inFIGS. 11a-cmay be used as a combination instrument. The distal end202of the tool200is arranged for manipulation of the free ends106,107, of the device100, by contacting the engagement surfaces108,109. Also, the spherical recess201mates with the spherical surface117for pivotable positioning of the device100. The spherical recess201is illustrated inFIG. 11cwhich is a magnification of the distal end202seen inFIGS. 11a, and 11b. InFIG. 11cthe device100holding the implant101is pivotably held with the tool200via control member110having the spherical surface117. Positioning of the device100onto the implant101and delivering of the implant101to the target site is thereby achieved with the same tool200. Other types of tools having a spherical recess201and/or engagement members for the free ends106,107, and can be used with the device according to the above.

The control member110may be fixed to one of the free ends106,107, off-center from the central opening105. InFIG. 1a, the control member110is fixed to the free end107, and is positioned slightly above the center of the opening in vertical direction. This may provide increased visibility through the opening105. At the same time the control member110may be positioned slightly towards the center, and alternatively at the center of the device100, so that rotation of the device100around an axis extending through the control member110, i.e. substantially perpendicular to the plane spanned by the curvature of the elongate support102, corresponds to a rotation of the device100substantially around it central axis without lateral displacement. This may ease the positioning at the target site if the implant101is to be turned into position, as in the case of having a helical implant101as illustrated inFIG. 6. Further, the device100may be used to hold helical downsizing tools, such as disclosed in WO2009/080801.

InFIG. 1athe engagement portions106,107, extend radially inwards from the peripheral edge103, and the control portion110is fixed to an end111of the engagement portion107. By having the control member110fixed to an end of one of the engagement portions106,107, it is easy to switch mode from attaching or detaching the device100to/from the implant101by engaging the contact surfaces108,109, and to engaging the control member110for moving the device100to or from the target site. The switch can be made in one fluent motion, by using the combination tool200, and reduces the time of the procedure and generally provides an increased degree of control. As mentioned above, the device100can be made compact in this manner, e.g. no additional fixation structures for the control member110extending across the opening105are necessary, improving visibility.

The elongate support102may comprise a radially outwardly opening or groove112along the peripheral edge103dimensioned to receive the annuloplasty implant101. This is illustrated inFIGS. 5a-bwhich corresponds to side views of the device100inFIGS. 1a-b, with and without holding of the implant101inFIGS. 5aand 5b, respectively. The groove112provides efficient retaining of the implant101by the device100. The groove112may have a curvature similar to that of the implant101, so that the contact surface between the implant101and the device is increased, thereby allowing a further increased retaining force of the implant101. Upon expansion of the elongate support102from the configuration of reduced circumference (C′) to the configuration of increased circumference (C) the groove112conforms to the implant101as seen inFIG. 5b.

The recessed surface of the groove112may have other shapes to fit other types of implants, such as triangular, rectangular or oval. The groove112has side edges120,121, between which the recessed surface of the groove112extends. The side edges120,121, extend along the groove around the elongate support102, and may be offset in relation to each other in the radial direction. I.e. inFIG. 5athe first side edge120extending on the side of the elongate support102opposite to that side of which the control member110extends from, i.e. the distal side, has a shorter radial extent than the second side edge121. This may provide for an easier positioning of the implant101into the groove112, as the circumference of the elongate support102at the location of the first side edge120at the distal side is smaller than that of the second side edge121. Hence, less compression of the resilient member104of the elongate support102becomes necessary for the curvature to conform to the implant101, when inserted from the distal side.

FIG. 4shows a perspective view of the device100. The groove112extends around the elongate member102, which is shown in further detail inFIG. 9, which is a top down view, similar to that inFIGS. 1a-b, of the device100. Also indicated inFIG. 9is the different radius of curvature (R1, R2) of the elongate support102. As mentioned above, the shape of the elongate support may vary, and the radius of curvature may vary along the elongate support102.

The curvature of the peripheral edge103of the elongate support102may generally follow a three-dimensional path118such that the curvature conforms to an annuloplasty implant101extending in a corresponding three-dimensional path. Various implants101having different shapes can thereby be held in place by the device100. An example is illustrated inFIG. 7, where the peripheral edge103follows the path118of the implant101, seen inFIG. 6, which is marked by dashed lines. Here the discontinuous ring-shape of the elongate support102generally follows a three-dimensional path118such that the free ends106,107, are axially off-set113. The off-set113is in the axial direction which is substantially perpendicular to the plane spanned by the elongate support102in the radial direction. The off-set118is such that the curvature of peripheral edge103follows the helix-shaped implant101. The off-set113may be adjusted to fit the helix-shaped implant101if the distance between adjacent turns of the helix is varied. Alternatively the free ends106,107, way be aligned without off-set113, but the peripheral edge103at other parts of the elongate member102may follow a curvature or path118in the axial direction, e.g. at a mid-section of the elongate support102between the free ends106,107. For example, implants101may have the posterior side125, as indicated inFIG. 2, elevated in the axial direction from the other parts of the implant101, and the elongate member102may be elevated at the corresponding portion to conform to the entire curvature of the implant101. Other implants101may be saddle-shaped, i.e. convex or concave, or be asymmetrical in various configurations, whereby the elongate member102has the corresponding saddle shape or asymmetry.

The spatial extent of the path118may also provide for modifying the geometry of the implant101. For example, the off-set113may be increased to force the rings of a helical implant101, inFIG. 6, apart when the implant101is held in place by the device100. This may facilitate insertion of the implant100through the annulus at the target site, as friction against the tissue may be reduced. When the device100is removed from the implant101, the helical rings may assume their unstrained condition. By being resilient in the axial direction the resilient portion104, which may be defined by the entire elongate support102being resilient, the geometry of the implant101may be modified by first compressing the device100in the axial direction and fit it to the implant101, and then let the device100relax, whereby the implant101, in this case being flexible, follows the expansion of the device101. The groove112provides for locking the implant101in place and thereby forcing the rings of the implant101to follow the path118of the elongate support102when the elongate support102assumes its relaxed configuration.

The elongate support102may comprise a retainer pin114extending axially in a direction substantially perpendicular to a plane spanned by the curvature of the peripheral edge103, as illustrated inFIGS. 4 and 5a. The retainer pin114is arranged to exert a radial force on the annuloplasty implant101to stop radial movement of the annuloplasty implant101when held in place by the device100. The implant101is thereby prevented from slipping off the device100, as radial movement is prevented by the pin114. In particular, when the device100and the implant101is rotated, the force exerted on the implant101by surrounding tissue may cause a displacement in the radial direction, which now is prevented by the pin14. A safer procedure and an improved grip of the implant is therefore achieved. As seen inFIG. 7, the retainer pin114extends from the distal side of the elongate support, i.e. in relation to the control member110, and is placed such that it is in abutment with the implant101, i.e. one of the helical rings of the implant101. The position of the retainer pin114is seen also in the perspective view inFIG. 4, however it may be positioned at any part of the elongate support102provided it prevents radial movement of the implant101.

The elongate support102may comprise a friction reducing sheath115along the peripheral edge103which extends in a radial direction to cover a portion of the annuloplasty implant101when held in place by the device100. By covering a part of the implant101when held in position by the sheath the friction is reduced between the implant101and the surrounding tissue. This allows the implant101to be more easily positioned without getting stuck on the tissue, for example when rotating the implant101into place at a target site such as through the leaflets of a valve.FIG. 8ashows a detail part of the elongate support102at the peripheral edge103with the implant held in place at the edge103.FIG. 8billustrates the friction reducing sheath115extending in the radial direction and covering a part of the implant101. The sheath115may extend along the entire edge103of the elongate support102. The sheath115will now prevent the tissue from contacting part of the implant101. The amount of coverage of the implant101by the sheath115may be varied by increasing or decreasing the length of the sheath115. More coverage may be suitable in some applications where low friction is particularly required. The sheath115may conform to the curvature of the cross-section of the implant101, or may have other shapes to provide protection from tissue while allowing sufficient ease of insert of the device100to the implant101. The sheath may be made of any material such as a polymer or a metal alloy providing low friction.

FIG. 8cshows an alternative configuration of the friction reducing sheath115, covering the entire implant101. The sheath115may be applied to the implant101before engaging with the device100and then, after being engaged and held in place by the device100, removed when the implant101has been positioned at the target site. The sheath115may have an opening or discontinuity122which allows easy removal. InFIG. 8c, the sheath115may be fixated into the device100after the implant101is engaged with the edge103, for example by a weld or glue portion between the sheath and the elongate member102. When the implant101is inserted at the target site and the device100is removed, the sheath115will disengage from the implant101and be retracted together with the device100. The opening or discontinuity122may allow for such disengagement.

The device100may comprise an indicator mark116being positioned at a first side of the elongate member102to mark a geometric feature of the implant101on a second opposite side of the elongate member102, which may not be visible when the implant101is held in place at a target site. This allows easier maneuvering e.g. when an end of a helical implant101, shown inFIG. 6, must be positioned at an opening of the annulus, but being obscured by the elongate support102. Such indicator116is shown inFIG. 1a, and may be positioned anywhere on the device to facilitate the implantation procedure. Indicator marks may also be placed to mark anatomical features, such as the commissures. The indicator mark116may be made of a material visible in X-ray. The device100may have other indicators visible in X-ray or other imaging techniques, or the device100may be made in part or entirely of such material. The device100may have a channel or void containing a gas such as air as an indicator. Such indicators allow determination of the position and orientation of the device100in the body.

FIG. 12shows a flow diagram of a method300of positioning an annuloplasty implant101at a target site at an annulus with a medical device100having an elongate support102comprising a resilient portion104. The method300comprises resiliently holding301the annuloplasty implant101in place in the device100, positioning303the implant101at the target site, and loading305the resilient portion104for releasing the annuloplasty implant101from the device100.

Resiliently holding the annuloplasty implant101may comprise loading302the resilient portion104for transforming the elongate support102from a first configuration to a second configuration, whereby radial movement of the elongate support102between the second and first configuration cause resiliently holding the annuloplasty implant101in place in the device100.

Positioning the device100may comprise pivoting304the device100having a spherical surface117in a spherical recess201of a tool200for insertion into a body in a minimally invasive manner. The pivoting allows the device while held in place by the tool200to adapt to various anatomies to reach the target site. The pivoting304may comprise positioning the device100such that a plane spanned by the elongate support is substantially parallel to a longitudinal axis of the tool200for minimally invasive insertion. This is illustrated inFIG. 11a, where the device100is parallel to the longitudinal direction of the tool200. This allows for example for insertion trough the ribs of a body.

Holder with Improved Grip Section

FIGS. 13a-b, illustrates a medical device1300according to another embodiment of the invention for holding a cardiac valve implant101. The device1300comprises a support102defining first and second peripheral edges103,126, respectively, each with a curvature about which the cardiac valve implant can be fitted. The support102further comprises a grip section128positioned between and connected with the first and second peripheral edges103,126, at opposite sides of the grip section128, in a manner such that the grip section128defines an opening130for engagement with a gripper tool400in use of the support102. The holder1300thereby allows easy manipulation, e.g. by gripping the grip section128at any time during the procedure and applying twisting or pushing/pulling action on the grip section. At the same time, the device1300maintains a compact shape and visibility is provided through the opening130at the periphery during the procedure of positioning the implant101. The opening130separates the first and second peripheral edges103,126. The grip section128may be directly connected at its opposite ends to the first and second peripheral edges103,126. This allows for a compact holder and a minimum of structural elements to interfere with the view through the holder, while means for manipulation in all directions, such as along several points close to the periphery, is improved. The support102may further comprise a resilient portion104for resiliently holding the cardiac valve implant101in place in the device1300. The support102may function as described above in relation to any ofFIGS. 1-12. The shape of the support102can be changed, due to resilient properties, to provide a temporary hold of the implant101. For example, with respect toFIG. 1b, a force as indicated by arrows137may be applied on engagement surfaces108,109, respectively, to compress the support102which bends in direction of arrows138in order to assume a reduced circumference for positioning inside the implant101. Once the force is released the support assumes the relaxed expanded configuration where first and second peripheral edges103,126, and further a third peripheral edge127may conform to the curvature of the implant101to hold it in place. The grip section128positioned between first and second peripheral edges103,126, allows the support102to freely conform to the implant101while providing an integral means for manipulating the support, and thereby the implant, thereby dispensing with the need for separate manipulation means.

FIG. 13aillustrates an embodiment that the grip section126is recessed radially inwards from the first and second peripheral edges thereby defining the opening130between the support102and the cardiac valve implant101, when the latter is held in place by the support. Hence, there is an open void from the grip section128radially outwards towards the implant101, and the borders defining the opening130is given by the implant and the grip section, and walls139that join the peripheral edges103,126, with the grip section. The recess, i.e. opening130, which is created by the recessed grip section128may have different shapes. For example, the recess or opening130may have any elongate shape. This allows manipulation of the support102close to its periphery while at the same time allowing good visibility at the periphery. Manipulation close to the periphery with a gripper tool may improve the degree of control during certain stages of the implant insertion procedure. This also allows a compact device, e.g. minimizing the amount of material, that ease manufacturing and also ease control of e.g. shape-changing properties of the support, such as obtaining the required spring force constants for setting the proper resilience properties of the support102. Also, as the grip section128join the first and second peripheral edges103,126, in this manner, with an opening130that shifts the periphery of the support102radially inwards, the bending radius of the support can be more freely chosen with respect to a D-shaped support by varying the position and shape of the grip section128, as the grip section may define the periphery, i.e. outer border, of the support102between the first and second peripheral edges103,126. This in turn may allow particular customization of the dynamics of fitting the implant101to the support102, such as easier to snap in the support102place and also remove from the implant. The grip section128may comprise an elongate portion that extends at least partly along the longitudinal direction of a portion of the implant that extends between said first and second peripheral edges, when held in place by said support. For example, as seen inFIG. 13a, grip section128follows generally the direction of the implant along portion136that extends between said first and second peripheral edges, i.e. the portion radially outside opening130.

As illustrated inFIGS. 13a-b, the support102may comprise a third peripheral edge127with a curvature about which said cardiac valve implant can be fitted, and where the third peripheral edge127is connected to either of the first and second peripheral edges103,126, by a second grip section129. InFIGS. 13a-b, the third peripheral edge127is connected to the second peripheral edge126. This allows a second position for engagement with a grip tool during a procedure, with the same advantages as described above in relation to the first grip section126.

The grip section126may be elongate as seen inFIGS. 13a-b, and positioned off-center from a center point135of the support102and at a distance from the implant101, when held in place by the support, where that distance corresponds substantially to the width of the opening130. The grip section126may extend substantially parallel to a portion136of the implant101, which portion defines the border of the opening130together with the grip section. The same may apply to the second grip section129and opening131, as seen inFIGS. 13a-b. The shape of the grip section126,129, and the angle relative to the implant101, when held in place by the support102, may be optimized for engagement with a particular grip tool.

As described in relation to device100, the support102may have an expanded circumference (C) in a first configuration, and a reduced circumference (C′) in a second configuration, wherein radial movement of the support102between the second and first configuration cause the curvature to conform at least partly to the cardiac valve implant101to hold the cardiac valve implant in place, and wherein the first configuration is relaxed and the second configuration is compressed, and the radial movement is radial expansion from the second configuration to the first configuration.

As illustrated inFIGS. 13a-b, the medical device1300may comprise a first engagement surface108adapted to receive a tool200for compressing the first engagement surface108towards an opposite second engagement surface109of the support101in a compressed second configuration. Also as illustrated inFIGS. 13a-b, the support may comprise two free ends106,107, where one of the free ends, such as a first end106comprises the first engagement surface108. Here, the second engagement surface109is provided between the first and third peripheral edges103,127. At least one of the first and second engagements surfaces may be defined by the inside surface of an engagement aperture132,133. This may allow for a more easy, safe and controllable positioning with an engagement tool at the support102.

The grip section128,129, may be flexible to define the resilient portion of the medical device1300-1900. Portions of the support102may be made differently resilient in order to optimize the function of the device1300-1900as a temporary holder for the implant101. For example, the portions defining the peripheral edges103,126,127, may be more rigid than the grip sections128,129, to define a solid contact with the implant101, which may be provided by having either of the grip sections128,129, of a smaller cross-section than the aforementioned portions103,126,127. Substantially the entire support may be flexible to define the resilient portion of the medical device1300-1900, as previously described with reference to device100.

The width (W) of the first or second grip sections128,129, may be chosen to set a predetermined spring force constant of the support102, to thereby optimize the response of the support102when applying a desired amount of force with an engagement tool at the engagement surfaces108,109. The support102may be comprised of a monolithic piece of a polymer material. This allows for easy mass-production, where the entire support can be extracted out of a bulk material, such as a polymer with suitable elasticity module (E), by punching out the support from a sheet of material, by laser or wire sawing, or by molding or extrusion.FIG. 23illustrates a method of manufacturing500a medical device for holding a cardiac valve implant101, such as a device1300-2100, and is described in more detail below. The support may also be made from a Titanium alloy.

The medical device1300-1900may comprise a locking mechanism134(not shown) for fixating the support102in a first expanded configuration. This may allow for a more forceful handling of the support102, without risking that the support is compressed and becomes displaced with respect to the implant101.

The embodiments illustrated inFIGS. 14-21, of medical device1400-2100share generally the same features and advantages as described above. More particularly,FIGS. 14a-bshow a device1400with a support102having an engagement surface109at the grip section128, that can be compressed towards opposite engagement surface108at the free end106of the support102.

FIGS. 15a-b—discloses a medical device1500having a support102that has a further third grip section140partly parallel to the first grip section128, thereby forming an aperture141between aforementioned grip sections128,140. This may allow further versatility in achieving the correct grip at a certain stage during an insertion procedure. Further, this provides a further mode for providing the support102in the compressed configuration, by contacting and compressing a third engagement surface142at the third grip section140in first direction towards the first engagement surface108of the opposite free end106. In addition, the free end106can be compressed towards second engagement surface109in a second direction, substantially perpendicular to the aforementioned first direction. The free end106may have an aperture or an angled portion to allow for engagement and compression with a tool in more than one direction.

FIGS. 16a-billustrates a further embodiment of a medical device1600according to an embodiment of the invention. The grip sections128,129are displaced further inwards from the peripheral edges103,126,127, of the support102. Increased view at the peripheral edges is thus provided. Solid temporary hold of the implant101is still provided by the engagement surfaces103,127, that extend along sections of the interior of the implant. The grip sections128,129, may also be shaped to allow for optimized path of movement of the support102when compressed and expanded, e.g. curved grip sections128,129, as seen inFIGS. 16a-b.

FIGS. 17a-billustrates a further embodiment of a medical device1700according to an embodiment of the invention. The grip sections128,129, form an elongate opening143in the central portion of the device1700. The shape of the support102may be optimized to allow for particularly easy manufacturing. First and second engagement surfaces108,109, may be compressed towards each other, as in the previously described embodiments.

The device1800illustrated inFIGS. 18a-baccording to another embodiment of the invention comprise an elongate aperture144formed by the boundaries of the first, second and third grip section103,128,129. The third grip section140may comprise the engagement surface108for being compressed towards the opposite second engagement surface109, whereby the peripheral edges103,127, connected with the third grip section140are moved towards each other and inwards in a direction towards a center of the support102, in order to release from the implant101.

FIGS. 19a-billustrates a device1900according to another embodiment of the invention, where the peripheral edges103,127, of the support102are partly spherical, oval, or in a shape that conforms to the implant101over a substantial portion of the circumference of the implant101. The engagement surface108is provided at a bridge between the oval portions, and when compressed in a direction towards the opposite second engagement surface109, the circumference of either of the oval portions decreases in order to release the support102from the implant101. The embodiment provides for a support which comes into apposition with increased length of the inside circumference of the implant101, while still providing grip sections128,129,140, at the periphery of the support102for multiple choices of manipulation points during a positioning procedure.

The device2000inFIGS. 20a-bhas two oval or circular portions145, defining apertures132,133, for manipulation, e.g. via curved grip section128which forms one of the apertures133. The oval portions of the support102define both the peripheral edges103,127, that conform to the implant101and the grip sections128,129. The oval portions145can be compressed towards each other by pressing engagements surfaces108,109, at the inside surface of the oval portions.

The device2100inFIGS. 21a-bis similar to the device2000inFIGS. 20a-b, but the oval portions are open, thereby forming free ends146, forming substantially semi-circular portions of the support102that comprise the engagement edges103,127. As inFIGS. 20a-bthe semi-circular portions functions as grip sections128,129, for a tool to e.g. twist, push or pull the support102and thereby the implant101, and as engagement portions108,109, for manipulating the size of the support102, and further as portions of the support102that conforms to the implant101, i.e. via the peripheral edges103,127.

FIGS. 22a-dillustrates a gripper tool400according to an embodiment of the invention, that comprises a first and second grip member401,402, that are moveable in relation to each other to thereby clamp a grip section128,129,140, of the medical device1300-2100. The first and second grip members401,402may be pivotable around a common pivoting point403in order to be movable in relation to each other and provide the clamping action to hold the support102of the medical device1300-2100in place. The first and second grip members401,402, may have a suitable groove along the distal edges of the grip members to conform to the curvature of the support102for a solid hold. The grip tool400may be used as a combination tool, likewise as described for tool200, and can thereby both grip the grip sections128,129,140, to manipulate the implant101once the support102holds the implant in place, and to change the shape of the support102by engaging the engagement surfaces108,109, to attach or release the support102from the implant101.

FIG. 23illustrates a method of manufacturing500a medical device for holding a cardiac valve implant101, such as a device1300-2100. The method comprises providing501a sheet of bulk material such as a polymer material, and providing502a template of the medical device, and further punching503the sheet with the template to provide the medical device, which medical device comprises a support102defining first and second peripheral edges103,126, each with a curvature about which the cardiac valve implant101can be fitted, and a grip section128for engagement with a gripper tool400in use of the support102.

The present invention has been described above with reference to specific embodiments. However, other embodiments than the above described are equally possible within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims.

More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used.