TECHNICAL FIELD OF THE INVENTION The invention relates to a medical arrangement for introducing an object, such as an implant with spikes or other sharp protrusions into an anatomical target position. The implant may be for example a cardiac implant (like an annuloplasty medical device) and the anatomical target position an annulus of a heart valve, such as a mitral valve or tricuspid valve.

BACKGROUND OF THE INVENTION

Fig. 1A illustrates a portion of the heart 12, the mitral valve 18, and the left ventricle 14 as an example of the anatomical target position. The mitral valve is at its boundary circumferenced by an annulus 20. The valve has two cusps or leaflets 22, 24. Each of these cusps or leaflets 22, 24 are connected to a respective papillary muscle 27, 29 via their respective connecting chordae 26, 28. In normal healthy individuals the free edges of the opposing leaflets will close the valve by coaptation. However, for some individuals the closure is not complete, which results in a regurgitation, also called valvular insufficiency, i.e. back flow of blood to the left atrium making the heart less effective and with potentially severe consequences for the patient. Fig. 1B illustrates a mitral valve 18, in which the leaflets 22, 24 do not close properly. This commonly occurs when the annulus 20 becomes dilated. One surgical procedure to correct this is to remove a portion of the leaflet 24 and stitch the cut edges together with one another. The procedure will pull back the annulus 20 to a more normal position. However the strength of the leaflet 24 is altered. Similar problems with a less effective heart function occur if one or both leaflets are perforated to such an extent that blood is flowing towards the left atrium, although the leaflets close properly. In some conditions of degenerated heart function, the leaflets do not present a solid surface, as in a degenerative valve disease. The leaflet may also be ruptured, most commonly at an edge of a leaflet, resulting in an incomplete coaptation. Hence, cardiac devices and methods are developed for repairing of one or more leaflets of a heart valve, or other related anatomical structures, such as the chordae attached to the ventricular side of leaflets.

Figures 2A and 2B illustrate exemplary implants to be delivered and introduced into an anatomical target position, and in particular a cardiac implant 110. The implant may comprise one or more loop-shaped structures 111 , 112. Advantageously one first loop-shaped structure is configured to abut a first side 20A of the heart valve and one second loop-shaped structure is configured to abut a second, opposite, side 20B of the valve to thereby trap a portion of the valve tissue 20 between the second and the first support structures 111 , 112. The implant 110 may have teeth 113 in order to keep the implant in its position after introduction to the anatomical target position.

The implant is typically delivered via one or more introducers and has thus usually a delivery state, where the implant has an elongated form. The first introducer is delivered into a first extent and the second introducer to a second extend being closer or next to the anatomical target position. The first introducer provides a first curve advantageously in its distal end portion and the second introducer a second curve in its distal end portion. Also, more than two introducers can be used.

The implant comprises typically a shape memory material having a first shape, such as the elongated form of the delivery state in a first temperature, and the second shape, such as the loop-shaped form in a second temperature. The second temperature corresponds advantageously essentially to the body temperature, whereupon the implant takes the second shape, corresponding to the loop-shaped form, when introduced for example with the blood flow in the atrium.

However, some problems arise in particular when the object with sharp protrusions, such as the implant with teeth, is introduced via introducers into the anatomical target position, namely the sharp protrusions will easily claw the inner surface of the second or further (innermost) introducer. This causes that the object gets easily stuck into the second introducer and in addition the object tends to move also the second introducer. Furthermore, the object easily grates the soft inner wall surface of the second introducer, thereby releasing microscopic grains of the inner wall material, which is a highly unwanted phenomenon, because the microscopic grains might be carried to the anatomical target position of the patient. In particular, this tends to happen in a portion where there is a curve in the innermost introducer, where the introducer is bent.

SUMMARY OF THE INVENTION It is an object of the invention to alleviate and eliminate the problems relating to the known prior art. Especially the object of the invention is to provide a medical arrangement for introducing an object, in particular an implant with sharp protrusions, such as teeth, into an anatomical target position in an easy, fast, safe and accurate manner. In some embodiments, a medical arrangement is provided where the object may slide easily through a catheter without getting stuck into a curve portion of the catheter. In addition, an object of the invention may be to introduce the object through the introducer so that the sharp protrusions of the object would not extract or release any inner wall material from the introducer/catheter to the anatomical target position.

The invention relates to a medical arrangement for introducing an object, such as an implant with teeth or spikes, into an anatomical target position, such as a cardiac implant into an annulus of a heart valve, according to claim 1.

A medical arrangement according to the invention is configured to introduce an object with sharp protrusions, such as an implant with teeth, into an anatomical target position. In particularly the invention is configured to introduce a cardiac implant, or an annuloplasty medical device with teeth, from a distal end of the arrangement into an anatomical target position, such as into an annulus of a heart valve. The heart valve may be a mitral valve or tricuspid valve, for example, not limiting to those only.

According to an example the object is the implant, which comprises in a use a loop shaped support portion, having either one or more loops or coils so that one first loop-shaped structure can be configured to abut a first side of the heart valve and one second loop-shaped structure to abut a second, opposite, side of the valve to thereby trap a portion of the valve tissue between the second and the first support structures. It is also possible that there is only the one first loop-shaped structure, which is configured to abut a first side of the heart valve, and not the second support structures, or vice versa. The implant is advantageously adapted to provide support for a mitral valve upon being fully delivered. Advantageously the implant comprises sharp teeth (as shown in Figure 2B), which are configured to penetrate to the tissue in the anatomical target position and thereby to keep the implant in its position during use. This might be challenging for example in a pulsating environment, such as in the heart, because if the teeth are for example inclined (not perpendicular in relation to a longitudinal axis of the implant), the pulsating movement might cause a rotation of the implant out of its position.

According to an embodiment the medical arrangement comprises a first introducer having distal and proximal ends. The introducer is advantageously configured to be delivered into the anatomical target, such as especially the mitral valve area in or near a mitral plane. In addition, the arrangement comprises also a second introducer having distal and proximal ends. The first introducer is an outer introducer and the second introducer is configured to be operated inside and guided by said first introducer. When the first introducer is delivered in or near the mitral plane, the angle of the introducer and thus also the implant is very optimal so that the introducer and thus also the implant will follow the curvature and anatomical shapes of the annulus and heart. Thus, no steep curves for the introducers or implants are needed, whereupon the additional introducers and implant are more easily delivered. This is because the steep curves increase friction between the introducers as well as inner introducer and the implant, which now can be avoided.

According to the invention at least a portion, advantageously in a distal portion, of the first introducer is configured to take a first curved shape. In addition, at least a portion, advantageously in a distal portion, of the second introducer is configured to take a second curved shape. Advantageously said first and second curved shapes are concentric curved shapes so that all the curves are curved in the same hand direction and thus form a helical loop structure.

The first introducer is advantageously configured to take said first curved shape when said first introducer is delivered towards or into said anatomical target position. The second introducer is configured to take said second curved shape to the same hand direction as the first curved shape of the first introducer when said second introducer is introduced from the distal end portion of the first introducer. Also, a third introducer can be used with same (concentric) curvature direction and so that it takes a third curved shape to the same hand direction as the previous first and second ones. The curved shape can be taken for example so that there is an operating wire (or the like) arranged to elongate between the proximal and distal ends of the introducer and along a side to which said curved shape is to be provided, whereupon when the operating wire is tightened advantageously from the proximal end of the introducer, it will cause the introducer in question to bend to that direction. There is advantageously a flexible portion arranged inside and/or outside the curve and into a casing of the introducer so that when the operating wire is tightened, said introducer is caused to take said curved shape at the point of said flexible portion and to said direction said flexible portion locates. The flexible portion can be for example a cutting, such as for example a laser cutting, but also other techniques can be used, such as material weakening, like thinning the wall of the introducer inside and/or outside the curve. Typically, the introducer (catheter) comprises a number of polycarbonate layers, for example, whereupon the weakening can be used via material technique for the layers. In addition, the operating wire is typically integrated between the layers. According to embodiment also memory materials can be used causing bending of the distal end of the introducer.

According to an embodiment of the invention at least the curved portion of the second introducer (or further, advantageously the innermost and nearest introducer to the anatomical target position during use) comprises a tubular member inside the introducer. The tubular member may advantageously comprise a circular profile, such as C-profile or O-profile. The tubular member may be a separate tubular tube or trough (C-profile), which is introduced into the second introducer before introducing the implant, so before the use. Alternatively, the tubular member may be integrated, such as coated, laminated, glued or welded, into an inner wall of the second introducer and in particularly into an area of the second curve shape of the second introducer. The tubular member may be for example integrated as a laminated layer during a manufacturing process of the introducer to its inner wall surface.

According to one embodiment of the invention, the second introducer may be configured to receive a tubular member, such that the tubular member may be introduced into the second introducer before or after the second introducer has been delivered to a respective anatomical target position. A respective anatomical target position may refer to a position into which each portion of the medical arrangement is configured to be delivered in order to e.g. supply the object into its own anatomical target position, such as the mitral valve annulus region.

If a tubular member is introduced into the second introducer after the second introducer has been delivered to its respective anatomical target position, advantageously with the object being introduced into the tubular member before its introduction into the second introducer, the object may be more efficiently delivered to its anatomical target position in a more controlled manner.

In one embodiment, the tubular member is configured to receive the object before the tubular member is introduced into the second introducer. In various embodiments, the tubular member may be configured to extend to different lengths along the second introducer.

In one embodiment, the tubular member may be configured to extend into the second introducer so that the distal end of the tubular member does not extend beyond the first curved portion.

In one embodiment, the tubular member may be configured to extend into the second introducer so that the distal end of the tubular member does not extend beyond the second curved portion.

If a tubular member does not extend to or does not reach a first or second curved portion, the tubular member may have a smooth inner surface (no cutting section), and thus be simple and easy to manufacture.

A medical arrangement according to one embodiment of the invention may additionally comprise or be used with a cooling arrangement, wherein the cooling arrangement is configured to cool at least the tubular member and/or the object. A cooling arrangement may additionally or alternatively cool the first and/or second introducer or there may be separate cooling arrangements for the first and second introducers, as well as to the tubular member. When the first and/or second introducers are also cooled, they form as an insulating arrangement around the tubular member minimizing heat transfer between the environment and the object, whereupon the object is easier to keep in a stable cooled state by the cooled tubular member.

The tubular member may be configured to be cooled and receive a preferably cooled object. The second introducer may be configured to receive the cooled tubular member with the cooled object within it. The tubular member may be connected to the cooling arrangement by a suitable connecter, such as a tyohy borst connector, wherepon the cooling of the tubular member can be performed, advantageously in a controlled manner, also during introducing the tubular member into the second introducer. When the tubular member and the object are introduced to the desired position, the cooling of the tubular member can be decreased, whereupon the temperature of the object will be increased so to allow the object to take its memory shape, such as an implant to take its shape corresponding to the anatomical shape of the anatomical target position.

A medical arrangement may additionally comprise or be used with a pusher for pushing/delivering the object into its anatomical target position within the tubular member or second introducer.

The tubular member comprises advantageously a metallic or carbon fibre inner surface at least at the portion of the second introducer to which the tubular member is configured to be delivered, for instance at the second curved shape and at least on the outer, upper and/or lower curve portion of the tubular member when curved along the second curved shape of said second introducer. According to an example the tubular member is a metallic tube or metallic trough (C-profile). Also, other suitable hard material can be used, such as carbon fibre, so that the sharp protrusions of the object is not able to penetrate through the inner surface layer of the introducer and get thereby stuck and in addition is not able to release inner wall material of the introducer.

The tubular member may in some embodiments comprise shape memory material, advantageously at least at its distal end. This may facilitate the delivering of the object to the anatomical target position, in particular when also the object comprises shape memory material.

It is to be noted that also C-profile tubular member can be used so that it covers outer, upper and lower walls of the second introducer, e.g. at a curve portion. The opening of the C-profile can be pointed towards the inner curve, namely the sharp distal end of the implant will hit the outer curve, and the sharp teeth of the implant (as described in Figure 2B, for example) will touch upper and lower walls of the curve portion (the teeth of the implant described in Figure 2B are arranged both in the upper and lower portions of the implant). The tubular member enables introducing the object, such as the implant with teeth, through the tubular member and thereby over at least a portion of the second introducer, namely the sharp protrusions of the object are not able to penetrate to the inner wall of the tubular member, which is much hard coating than the introducer, which is typically soft and sloppy.

It is to be noted that even if the second introducer is described here to receive the tubular member, it might also be another introducer, such as third or fourth etc. introducer, depending on an application how many introducers are applied. In practise, the introducer in question to receive the tubular member is the innermost one whose distal end is nearest to the anatomical end target portion during use, and which guides the implant to the utmost anatomical end target portion.

According to an embodiment the tubular member comprises a cutting section having cuttings, such as laser cuttings, allowing the tubular member bend into the same centric direction as the second introducer, so i.e. the distal end portion of the innermost introducer. The cuttings are advantageously arranged at least outside of the curve of the tubular member into an area, which will be curved along the second curved shape of the second introducer during use. Yet, in embodiments where shape memory material is used for the tubular member, the cutting sections may not be needed. The discussed cuttings are however particularly advantageous in embodiments where the tubular member is configured to extend in the second introducer over a curved portion. In some embodiments the tubular member may comprise both the shape memory material as well as cutting sections.

According to an embodiment, the ends of two adjacent cuttings in a first side of the tubular member are non-aligned so that they are not in the same level in the axial plane of the tubular member, where the axial plane is a plane being parallel with the longitudinal axis of the tubular member and the second introducer. In addition, according to an embodiment the ends of every second or third cuttings of the tubular member are aligned.

However, in the second opposite side of the tubular member, the ends of the cuttings are aligned so to form a longitudinal non-cut portion. The longitudinal non-cut portion is parallel with the longitudinal axis of the tubular member. The longitudinal non-cut portion forms advantageously a spinal column allowing the tubular member to bend in a first direction (the same hand direction as the curve shape of the second introducer), but resist the bending to the opposite direction.

It is to be noted that the cutting section, as the whole tubular member, is advantageously non-stretchable. In addition, the tubular member may comprise a smooth cutting section, as a transition section, next to the cutting section and towards the proximal end of the second introducer. This will provide smoother transition from the essentially non-flexible tubular member portion to more flexible portion offered by the cuttings, whereupon e.g. stresses induced to the tubular member in the curve portion can be kept minimal, thereby improving durability of the tubular member and avoiding sharp edge between the non-flexible and flexible portions. In addition, the object will slide even more smoother when the flexibility of the tubular member in the curve area changes with smaller steps.

According to an embodiment the cuttings are inclined from a radial plane of the tubular member being perpendicular to the longitudinal axis of the tubular member. The inclination is advantageously between 5°-20° and is advantageously about 10°. The inclination allows or forces the distal end of the tubular member to turn downwards or upwards from the axial plane of the transition section of the tubular member, such as downwards or upwards from a mitral plane, when used in mitral valve operations.

As an example, the anatomical target position is a left atrium or left ventricle or an annulus area of a mitral valve. In this case the first introducer is advantageously delivered into a first side of the annulus of the mitral valve and essentially in the mitral plane or in an angle less than in relation to the mitral plane. The second (or further) introducer is then delivered to the second side of the annulus of the mitral valve between leaflets said second side of the annulus being opposite to said first side.

The present invention offers advantages over the known prior art, such as an easy, safe, precise and time saving manner to reliable delivering the object with sharp protrusions, such as an implant with teeth to the anatomical target position, like to the annulus of the heart valve. Due to the tubular member the object can be delivered in a precise and smooth way into its respective anatomical target position.

In one embodiment, the tubular member provides a way of delivering the object over the curves of the catheter(s) so that any sharp protrusions of the object do not grab to the wall structure of the innermost catheter, in particularly in any curve portion.

The exemplary embodiments presented in this text are not to be interpreted to pose limitations to the applicability of the appended claims. The verb "to comprise" is used in this text as an open limitation that does not exclude the existence of also un-recited features. The features recited in depending claims are mutually freely combinable unless otherwise explicitly stated.

The novel features which are considered as characteristic of the invention are set forth in particular in the appended claims. The invention itself, however, both as to its construction and its method of operation, together with additional objects and advantages thereof, will be best understood from the following description of specific example embodiments when read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which: Figures 1A-1B illustrate schematically a portion of a heart and mitral valve,

Figures 2A-2B illustrates exemplary implants

Figures 3-6 illustrate a medical arrangement for introducing an implant into an anatomical target position according to advantageous embodiments of the invention.

DETAILED DESCRIPTION

Figures 1 A-1 B and 2A-2B are already discussed in more details in connection with the background of the invention portion above. Figures 3-6 illustrate a medical arrangement 100 for introducing an implant 110 into an anatomical target position according to advantageous embodiments of the invention, where the medical arrangement 100 comprises a first introducer 101 having distal and proximal ends 101 A, 101 B. The introducer is advantageously configured to be delivered into the mitral valve area in a mitral plane 105 or in an angle 101 E advantageously less than 45° and more advantageously less than less than 30° in relation to the mitral plane 105. In addition, the arrangement comprises also a second introducer 102 having distal and proximal ends 102A, 102B.

The first introducer 101 is delivered first in a straightened configuration 101 F until the distal end 101 A of the first introducer 101 reaches its extent towards the anatomical target position, whereupon the distal portion is configured to take the first curved shape 101 C, advantageously following the anatomical shapes of the anatomical target position. It is to be noted that the first introducer 101 does not typically go further, but after this the second introducer 102 is delivered inside the first introducer 101 in a straightened configuration 102F. The second introducer 102 follows the shapes of the first introducer 101 until it comes out from the distal end 101 A of the first introducer 101 , after which the second introducer 102 is still delivered further until the distal portion of the second introducer 102 is configured to take the second curved shape 102C, as can be seen in Figure 3.

According to an example the second introducer 102 can still be delivered further until the distal portion of the second introducer 102 is configured to take the additional curved shape 102G, as can be seen in Figure 4. The additional curved shape 102G locates to the direction of the proximal end 102B from the second curved shape 102C. However, it is to be noted that the additional curved shape 102G is optional, for example if third or more introducers are used (not shown in this document).

Advantageously the second introducer 102 (possibly also the first introducer 101) comprises a flexible portion 106 so that said introducer 101 , 102 takes said curved shape 101 C, 102C at the point of said flexible portion 106 to the direction where the flexible portion 106 locates. The flexible portion 106 can be a cutting, in particularly a laser cutting, for example or achieved by material weakening, like thinning. The flexible portion 106 is arranged into a casing of the introducer 101 , 102 and so that it is left inside the curve when the introducer takes said curve shape. It is to be noted that the first and second curved shapes turn the first and second introducers 101 , 102 concentrically essentially in the mitral plane 105. However, as can be seen in Figures 3, 4 and 6, for example, the first and second introducers 101 , 102 are also configured to tilt or bank downwards 108 and thereby form an angle 109A, 109B also downwards 108. Therefore, when the introducers are delivered for example to the left ventricle, the introducers take a helical loop form due to said first and second and additional curved shapes 101 C, 102C, 102G, but in addition to this the distal end portion of the first introducer 101 , and advantageously also the second introducer 102 takes the angle downwards 108, whereupon at least the second (or third , if used) introducer 102 can be delivered to the opposite side of the annulus and so that the introducers still follow smoothly the shapes of the anatomical target position.

As can be seen in Figures 4 and 6, the second introducer 102 is configured to receive a tubular member 120 or comprises a a tubular member 120 inside the introducer (not shown in other Figures).

The tubular member may be introduced into the second introducer before or after the second introducer has been delivered to or towards the anatomical target position.

Thus, the first and second introducer may first be delivered to the anatomical target position, such that the distal end of the second introducer is provided to the anatomical target position in a controlled manner. Then, the object may be introduced into the tubular member before its introduction into the second introducer.

The tubular member and advantageously also the object are cooled before the object is introduced into the tubular member. The tubular member (and object) may then be introduced into the second introducer so as to extend to a selected length along the second introducer. The tubular member may be configured to extend along the second introducer from the proximal end of the second introducer to an end point residing e.g. be before the first curved shape, before the second curved shape, or the end point may be after the second curved portion, such as essentially coinciding with the proximal end of the second introducer.

A cooling arrangement 129 may be used to cool the tubular member, the object, the first introducer, and/or the second introducer. The tubular member and/or the object may be cooled prior to introduction into the second introducer and they may be cooled while being positioned inside the second introducer, prior to the object being fully delivered to the target anatomical position.

Figures 5A and 5B illustrate exemplary tubular members 120 with an optional cutting section 121 having cuttings 123. The cuttings 123 may be arranged perpendicular to the longitudinal axis 124 of the tubular member 120, as is the case in Figure 5A, or the cuttings 123 may be inclined or tilted from a radial plane 125 of the tubular member, where the radial plane 125 is perpendicular to the longitudinal axis 124 of the tubular member 120. The inclination is advantageously between 5°-20° and is advantageously about 10° .

The tubular member advantageously comprises also a smooth cutting section, as a transition section 122, next to the cutting section 121 and towards the proximal end of the second introducer during use.

Figure 5C illustrates a first side of the tubular member 120, where the ends of two adjacent cuttings 123 are non-aligned so that they are not in the same level 127 in the axial plane 126 of the tubular member, where the axial plane 126 is a plane being parallel with the longitudinal axis 124 of the tubular member 120 and the second introducer. In the example of Figures 5C and 5D the ends 123A, 123B of every second cuttings 123 of the tubular member 120 are aligned.

Figure 5D illustrates a second opposite side of the tubular member 120, where the ends of the cuttings 123C, 123D are aligned so to form a longitudinal non-cut portion 128 parallel with the longitudinal axis 124 of the tubular member 120. The longitudinal non-cut portion 128 forms a spinal column allowing the tubular member to bend in a first direction (the same hand direction as the curve shape of the second introducer) but resist the bending to the opposite direction.

In addition, the tubular member may comprise for example a C-profile (as shown in Figure 5F) or an O-profile (as shown in Figure 5E).

The invention has been explained above with reference to the aforementioned embodiments, and several advantages of the invention have been demonstrated. It is clear, that the invention is not only restricted to these embodiments but comprises all possible embodiments within the spirit and scope of the inventive thought and the following patent claims.

In addition, it is to be noted that even if the implant is described in this document as an example to be delivered, also other kinds of object with sharp protrusions can be delivered according to the invention. Furthermore, even if the heart is described in many embodiments, it is to be understood that the heart is only an example of the anatomical target and the invention can be applied also with organ or target positions. Furthermore, it is to be understood that the cuttings may comprise at least two different lengths, or the cutting may be the same length.