A MEDICAL ARRANGEMENT FOR INTRODUCING AN OBJECT INTO AN ANATOMICAL TARGET POSITION

A medical arrangement for introducing an implant into an anatomical target position comprises a first introducer and a guide wire. The guide wire is configured to be introduced before the implant into or towards the anatomical target position. The implant is configured to be delivered along the guide wire into the anatomical target position. The guide wire is configured to be retracted after the implant has been introduced into said anatomical target position so that said object essentially maintains the shape taken when introduced into said anatomical target position.

TECHNICAL FIELD OF THE INVENTION

The invention relates to a medical arrangement for introducing an object, such as an implant into an anatomical target position, such as a cardiac implant (like an annuloplasty medical device) into an annulus of a heart valve, such as a mitrel valve or tricuspid valve.

BACKGROUND OF THE INVENTION

FIG. 1Aillustrates a portion of the heart12, the mitral valve18, and the left ventricle14as an example of the anatomical target position. The mitrel valve is at its boundary circumferenced by an annulus20. The valve has two cusps or leaflets22,24. Each of these cusps or leaflets22,24are connected to a respective papillary muscle27,29via their respective connecting chordae26,28. 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. 1Billustrates a mitral valve18, in which the leaflets22,24do not close properly. This commonly occurs when the annulus20becomes dilated. One surgical procedure to correct this is to remove a portion of the leaflet24and stitch the cut edges together with one another. The procedure will pull back the annulus20to a more normal position. However the strength of the leaflet24is 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.

FIG. 2illustrates an exemplary implant to be delivered and introduced into an anatomical target position, and in particularly a cardiac implant110. The implant may comprise one or more loop-shaped structures111,112. Advantageously one first loop-shaped structure is configured to abut a first side of the heart valve and one second loop-shaped structure is configured to abut a second, opposite, side of the valve to thereby trap a portion of the valve tissue20between the second and the first support structures111,112.

The implant is typically delivered via a catheter and has thus typically a delivery state, where the implant has an elongated form. In said delivery state the implant can be transferred advantageously through a catheter having diameter 7-10 mm, for example. 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.

In addition, some problems arise due to a catheter system having both inner and outer catheters, usually steerable catheters, sometimes numerous inner catheters, where the inner catheter(s) locating inside the outer catheter limit(s) space from the implant.

It is found that the prior art cardiac implants, such as depicted above, work very well, but there are still some disadvantages relating to the introduction devices, such as catheter type devices, to deliver the implant into the anatomical target position, such as into the annulus of the heart valve. The catheter based systems are based for delivering a relatively thick main catheter having a first curve portion into a first portion of the anatomical target position, such as to an atrium, then a second catheter having a second curve portion into a second portion of the anatomical target position, such as next to annulus or leaflets of the heart valve, and then a third catheter having a third curve portion into a third portion of the anatomical target position, such as around the annulus of the heart valve. In some systems there might be even further catheters with further curve portions to be delivered before the implant can be delivered and introduced into its position. The third or further catheter if used, is called as a delivery catheter. The implant is then delivered to its position inside the feeding catheters, which is delivered to its position inside the other catheters.

There are some drawbacks related to the prior art catheter based systems, such as at least the main catheter must be thick (7-10 mm or even more) so that it can carry the further catheters inside. In addition, also the delivery catheter must be relatively thick so that the implant can be delivered inside the delivery catheter. When the catheters are relatively thick, it is very hard to insert the catheters into the anatomical target position. For example, a sub-annular space below the annulus, so between the chordae and wall or septum, is very narrow, whereupon the best channel for the thick catheters is very difficult to find and deliver, in particular when the maneuverability and steerability of the catheters is poor. Furthermore, the surface of the inner wall is rough, having additionally numerous attachment points of chordae, which easily causes stuck of the catheters. Additional challenges arise when the catheters, especially also the delivery catheter, have memory properties or predetermined shapes, which might activate too early and thereby raising possibility to stuck the catheter into the wall or other structures of the anatomical target position, such as the heart. Thus, the time limit to insert the catheters, in particularly the delivery catheter, having memory properties, is very limited so that the catheters can be inserted into their right and accurate position before the memory property will be activated by the temperature of the anatomical target position, such as the heart.

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 implant into an anatomical target position in an easy, fast, safe and accurate manner with a high degree of control. In addition, the object of the invention is to minimize the sizes of the catheters used and at the same time minimize stuck of the catheters and thereby minimize stress introduced for the anatomical target position.

The object of the invention can be achieved by the features of independent claim.

The invention relates to a medical arrangement for introducing an implant into an anatomical target position, such as a cardiac implant into an annulus of a heart valve, according to claim1.

A medical arrangement according to the invention is configured to introduce an object, such as an implant, and in particularly such as a cardiac implant, or an annuloplasty medical device, 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 mitrel valve or tricuspid valve, for example, not limiting to those only. It is to be understood that the object can be also some other object, such as medicine, for example.

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 at least one first loop-shaped structure can be configured to abut a first side of the heart valve and at least 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 support a mitrel valve upon being fully delivered.

According to an embodiment the medical arrangement comprises a first introducer, such as an outer steerable introducer or catheter, and a guide wire. The first introducer is advantageously an outer steerable catheter, which is delivered for example to the atrium or ventricle, but not to the anatomical target end position as such, where the implant is to be introduced. According to an embodiment the guide wire is configured to be introduced into or towards said anatomical target position via the first introducer but before the implant (meaning that the guide wire is delivered beforehand so that it can guide the delivery of implant). When the guide wire is delivered into the right position, the implant is then delivered along and guided by the guide wire (and inside the first introducer) into the anatomical target position.

The guide wire can be also introduced partly from the distal end portion of the first introducer, after which also the implant can be delivered partly along the guide wire (i.e. not to a final end target position at once but rather step by step), and after which the guide wire may be further delivered and followed by the implant and thereby introducing the guide wire and implant sequentially. According to an embodiment the guide wire and implant can be delivered at the same time, but however so that the guide wire guides the route to the anatomical target position.

The implant is advantageously a hollow tubular structure, whereupon the implant can be delivered into said anatomical target position so that it travels around or over the guide wire. This offers clear advantages over the known prior art solutions namely because the guide wire is very thin compared to the catheters, it is remarkable easy, fast, safe and accurate to insert via very small and narrow channels of the anatomical target position to the correct place. When the guide wire is delivered to the correct position, the implant with the hollow tubular structure can be easily delivered along the guide wire to the correct end position. Alternatively, the implant may also have loops, stitches or turns coupled with it whereupon the implant, even a solid implant, can be delivered to the position so that the loops or turns travel around the guide wire. In addition, it is to be noted that the implant can be also made from fabric, polyurethane or polyester and there is no need for the implant to have any memory property. The implant can be delivered to the position for example by a pusher coupled to the proximal end of the implant, whereupon the implant can be pushed to the position by the pusher. In the case of a non-rigid implant, for example if the implant is made of textile or the like compressible material, the pusher can be coupled to the distal end of the implant and thereby to draw the implant to the position.

According to an embodiment the implant may have at least a first curved shape having a preformed shape and capable of being delivered in a straightened configuration through the first introducer, whereupon the implant is activated of guided to at least a first curved shape within or near the anatomical target position, such as in the atrium or ventricle proximate the mitral valve of the heart. The implant may comprise e.g. a shape memory property and biased to said curved shape. However, it is to be noted that according to the invention, in particularly the implants without any memory property can be delivered and guided by the guide wire, which is delivered to the position first.

It is to be noted that the implant is configured to follow said guide wire and said first curved shape of the guide wire into said anatomical target position. When the implant has been introduced into said anatomical target position, the guide wire can be retracted and the implant essentially maintains the shape taken when introduced into said anatomical target position, corresponding to the shape of the guide wire in the anatomical target position. It is to be noted that the implant can be attached, such as sutured, into its position for example by keeping the implant in its position during the attaching by the guide wire. The implant can also be a self-attaching version having e.g. teeth, whereupon when the introducer or catheter over the implant is retracted, the teeth can dig into the tissue and thereby attach the implant into its position.

The guide wire is advantageously retracted only after the implant is secured. This makes the attaching of the implant very safe because the implant can be retracted away as long as the guide wire is in the anatomical target position. In addition it is to be noted that when the guide wire is inside the implant and in the anatomical target position, the position of the implant can still be adjusted by manipulating the guide wire, such as by dragging and/or turning the guide wire and thereby adjusting the position or orientation of the implant (a whole packet of the guide wire and the implant), which is very advantageous in many situations. In addition, if something goes wrong, the implant can still be retracted away by the guide wire. After the implant is attached to the anatomical target position the guide wire can be retracted away from the anatomical target position.

The guide wire has advantageously an activated shape and an inactivated shape, wherein in said inactivated shape the guide wire can be delivered in a straightened configuration through the first introducer and in said activated shape the guide wire takes at least a first curved shape within or near the anatomical target position, such as in the atrium or ventricle or proximate the mitral valve. The guide wire advantageously has a preformed shape so to take the activated shape when introduced to the anatomical target position. According to an embodiment the guide wire is at least partially formed from a shape memory material and thereby operable to assume said activated shape when meeting the temperature of the anatomical target position. The activated shape can be achieved also via another techniques known by the skilled person. When the guide wire is activated to said at least first curved shape and delivered to the anatomical target position (or at least towards the position), after which the implant is delivered along the guide wire to the anatomical target position, as is described elsewhere in this document.

In addition, the distal end of the guide wire may comprise a curvature tip portion, such as a J-shape, in order to allow smooth delivery of the distal end of the guide wire and to prevent the distal end of the guide wire from getting tangled into tissue. The curvature tip portion may have a preformed shape or being at least partially formed from a shape memory material and thereby taking the shape of the curvature tip portion when introduced into the anatomical target position.

According to an embodiment the arrangement may additionally comprise a second introducer, such as a catheter and in particular an inner steerable catheter. The second introducer is arranged to be operable between the first introducer and the guide wire. The second introducer is configured to be introduced from the distal end portion of the first introducer. According to an embodiment, the second introducer is an optional introducer and can be used for example to bypass the leaflets of the heart or other anatomical portion in or near the anatomical target position. However, according to an embodiment at least a distal portion of the second introducer is configured to be introduced from the distal end portion of the first introducer before the guide wire, and thereby guide or instruct the guide wire to bypass for example a certain anatomical portion, such as leaflets.

If the second introducer is used, the implant may then be delivered inside the second introducer (and also inside the first introducer), and again along the guide wire, into or towards the anatomical target position after at least the distal portion of the second introducer is introduced from the distal end portion of the first introducer.

However, the second introducer is advantageously configured to be retracted after said guide wire is introduced into said anatomical target position and/or before said implant is introduced into said anatomical target position. This is not mandatory but by this more space can be provided for the implant.

In addition, according to an embodiment, the arrangement may additionally comprise also a guiding catheter, which could also be called a third introducer, where said guiding catheter is arranged to be operable between the first introducer and the guide wire, and if the second introducer is used, also between the second introducer and the guide wire. The guiding catheter can be used as a delivering catheter for delivering the implant into the anatomical target position inside the guiding catheter but still around the guide wire. When the implant is delivered inside the guiding catheter, it additionally protects the anatomical portions from the implant. The guiding catheter is configured to be introduced from the distal end portion of the first introducer (and from the distal end portion of the second introducer, if used). It is to be noted that at least a distal portion of the guiding catheter is introduced from the distal end portion of the first introducer (and from the distal end portion of the second introducer, if used) only after the guide wire is introduced into or towards said anatomical target position.

The guiding catheter is advantageously a flexible catheter, which is configured to be delivered along the guide wire into or towards said anatomical target position after the guide wire is at least partially introduced from the distal end portion of the first introducer. Most advantageously the guiding catheter is delivered to the anatomical target position when the guide wire is fully delivered to the anatomical target position, in particular when the guiding catheter is flexible. The guiding catheter can be used to protect the tissue and other anatomical portions in the anatomical target position from the implant during delivering the implant into the anatomical target position. It is to be noted that the implant is configured to be delivered inside the guiding catheter into or towards said anatomical target position. This can be done after at least the distal portion of the guiding catheter is introduced from the distal end portion of the first and second introducers into or towards said anatomical target position, but most advantageously when the distal end of the guiding catheter is delivered into the anatomical target position.

According to an embodiment the second introducer is retraced before the implant is delivered into the anatomical target position inside the guiding catheter. This is not mandatory but by this more space can be provided for the implant, and especially when the guiding catheter is flexible so that it can expand for the implant during delivering. In addition, the guiding catheter is configured to be retracted after the guide wire and implant have been introduced into said anatomical target position.

Still in addition, the arrangement may also comprise a cooling arrangement for cooling the guide wire for example during retracting the guide wire, but also in other phases. When the guide wire is cooled down it can be easily reshaped and for example retracted out essentially easily transformable state. The cooling arrangement may be arranged so that there is an inlet for a cooling agent, such as cool water, in the proximal end of the first introducer, second introducer and/or guiding catheter, whereupon the cooling agent can flow between the walls of the first introducer, second introducer and/or guiding catheter from the proximal ends towards the distal ends, for example. According to an embodiment the distal ends may have openings so that the cooling agent can flow out.

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, such as an implant to the anatomical target position, like to the annulus of the valve. Still, the guide wire is very convenient to deliver to the target position, namely it is very thin compared to the catheters and thus it does not tangle to the tissue. When the guide wire is delivered into the target position, the subsequent catheters, even flexible catheters, can be delivered easily along and guided by the guide wire. Further, the guide wire can be used as a rescue device during securing the object, like the implant, namely if something goes wrong in securing, any device used for pulling out the implant can be delivered to the proximal end of the implant along and guided by the guide wire, because the guide wire can be kept in the target position as long as the implant is secured.

In addition, the present invention provides for a compact arrangement for delivering the object. The compact medical device allows minimally invasive procedure. Furthermore, when using the compact catheter-operated medical device, risks for having any medical drawbacks or symptoms are much lower than e.g. in the traditional open-heart operation. Also, the patient recovery process is much faster.

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.

DETAILED DESCRIPTION

FIGS. 1A-1B and 2are already discussed in more details in connection with the background of the invention portion above.

In addition, it is to be noted that the implant110comprises advantageously a hollow structure so that it can be passed along the guide wire103so that the guide wire103is inside the hollow structured implant110. However, the implant110may also have loops, stitches or turns113coupled with it, as can be seen inFIG. 2, whereupon the implant, even a solid implant, can be delivered to the position so that the loops or turns113travel around the guide wire103.

FIGS. 3-23illustrate a medical arrangement100for introducing an implant into a heart as an example of the anatomical target position20according to advantageous embodiments of the invention. InFIG. 3the first introducer101is delivered next to the annulus20of the heart, and the second introducer102is introduced from the distal end portion101A of the first introducer101. It is to be noted that the second introducer is an optional introducer, but it is still illustrated in Figures as an example. The second introducer can be used for example to bypass the leaflets22,24of the heart, as well as to achieve a turn to a specific direction by turning the distal end102A of the second introducer102(namely turnability of the introducers are limited). In addition, it is to be noted that at least a distal portion102A of the second introducer102is introduced from the distal end portion101A of the first introducer101before the guide wire, and may thereby guide or instruct the guide wire103to bypass the leaflets, for example, as can be seen inFIG. 4.

When the second introducer has bypassed the leaflets22,24, the guide wire103can be delivered into or towards the position20. It is to be noted that the guide wire103is delivered into the position before the implant110.

The guide wire103has advantageously an activated shape and an inactivated shape, wherein in said inactivated shape the guide wire103can be delivered in a straightened configuration1031through the first introducer101, as can be seen inFIG. 4. In said activated shape the guide wire103takes at least a first curved shape103B within or near the anatomical target position20. When the guide wire103is activated to said at least first curved shape103B, it is delivered to or at least towards the position. According to an example the distal end103A of the guide wire103may comprise a curvature tip portion103J, such as a J-shape, in order to allowing smooth delivery of the distal end103A of the guide wire103and to prevent the distal end103A of the guide wire103from getting tangled into tissue.

The arrangement may additionally comprise also a guiding catheter104, as can be seen inFIGS. 5-11, where the guiding catheter104is operated between the first introducer101and the guide wire103, and if the second introducer is used, also between the second introducer102and the guide wire103. The guiding catheter104is introduced from the distal end portion101A of the first introducer101(and from the distal end portion102A of the second introducer102, if used). It is to be noted that at least a distal portion104A of the guiding catheter104is introduced from the distal end portion101A of the first introducer101(and from the distal end portion102A of the second introducer102, if used) only after the guide wire103is introduced into or towards said anatomical target position20.

The guiding catheter104is delivered along the guide wire103into or towards said anatomical target position20after the guide wire103is at least partially introduced from the distal end portion101A of the first introducer101, as can be seen inFIGS. 5-8. Most advantageously the guiding catheter104is delivered to the anatomical target position20when the guide wire is fully delivered to the anatomical target position, in particular when the guiding catheter104is flexible, whereupon the guiding catheter104is guided by the guide wire103.

When the guide wire103and the guiding catheter104are delivered into the position, the second introducer102is retracted and it is retracted advantageously before delivering the implant110into the anatomical target position20, as is the case inFIG. 9. This is not mandatory but by this more space can be arranged for the implant. It is to be noted that also the first introducer can be retracted before delivering the implant110or even right after the delivering of the second introducers, even if this is not shown in the Figures. By this even more space can be arranged for the implant.

The implant110is then delivered around (and guided by) the guide wire103and inside the guiding catheter104into or towards said anatomical target position, as can be seen inFIGS. 10-12. This can be done after at least the distal portion104A of the guiding catheter104is introduced from the distal end portion101A of the first and second introducers101,102into or towards said anatomical target position, but most advantageously when the distal end of the guiding catheter104is delivered into the anatomical target position.

The guiding catheter104is then retracted after the implant110is introduced into the anatomical target position20after which the implant can be secured to the tissue by securing members114, as can be seen inFIG. 14. The securing can be done for example by suturing or stabling or by other securing methods known by the skilled person. In addition, the guiding catheter104can be retracted sequentially, uncovering only a part of the implant for securing, and after securing said uncovered part the guiding catheter104can be retracted more, thereby uncovering an additional portion of the implant for securing.

When the implant110is introduced and secured into the position20(and also the guiding catheter is retracted), as is the case inFIG. 10, the guide wire103can be retracted and the implant110essentially maintains the shape taken when introduced into said anatomical target position20, corresponding to the shape of the guide wire in the anatomical target position, as can be seen inFIGS. 15-18.

FIG. 13illustrates the order of the introducers101and102, guiding catheter104, guide wire103and the implant110.

In addition,FIG. 8illustrates also a cooling arrangement115for supplying a cooling agent (arrow) and thereby cooling the guide wire103. It is to be noted that the arrangement may comprise one or more cooling arrangements115and arranged in connection with the first introducer, second introducer and/or guiding catheter. In addition, even if the cooling arrangement115is illustrated only in connection withFIG. 8, it should be understood, that it may also be comprised by other embodiments and arrangements100illustrated in other Figures.

FIGS. 19-23illustrate a further example of the medical arrangement100to introduce the implant110into a mitral valve20(as an example of the anatomical target position) so that at least one loop-shaped structure111of the implant110abuts a first side of the heart valve and one second loop-shaped structure112abuts a second, opposite, side of the valve to thereby trap a portion of the valve tissue20between the second and the first support structures111,112. InFIGS. 19-23the first introducer110has a first curve shape and the second introducer102has a second curve shape to the same curvature direction as the first curve shape of the first introducer101so to form a concentric system100. As can be seen inFIG. 21, the arrangement may also have an additional second introducer102x, which again has third curve shape but still to the same curvature direction as the first and second curve shapes of the first and second introducers, wherein said first, second and third curved shapes are concentric curved shapes. In addition, the additional second introducer102xmay also be a steerable catheter or having pre-curved structure so that it has ability to seek said third curve shape at least and advantageously when delivered into or towards the anatomical target position.

It is to be noted that the first introducer is introduced next to the annulus and the second as well as additional second introducers102,102xare used to bypass the leaflets22,24and to be introduced to the opposite side of the annulus as the first introducer is delivered.

FIGS. 22 and 23illustrate the arrangement100, where the guiding catheter104and also the guide wire103are introduced into or at least towards the position for delivering the implant. As can be seen inFIG. 23, the second as well as additional second introducers102,102xcan be retracted before introducing the implant. The implant and the steps for delivering it are not shown, but the fundamental principles are the same as described elsewhere in this document.

It is to be noted that according to an embodiment the first introducer101can be retracted already after the second introducer102is delivered and before the delivery of the additional second introducer102xand guiding catheter104and implant, and the second introducer102can be retracted after the additional second introducer102xis delivered and before the delivery of the guiding catheter104and implant, and that the additional second introducer102xcan be retracted after the guiding catheter104is delivered toward or into the anatomical target position and before the delivery of the implant110. In this way a maximum space can be provided for the delivering catheter104, or the guiding catheter104, and in particularly when the guiding catheter104in an expandable catheter104, whereupon a relatively big implant can be delivered into the anatomical target position. Previously, the diameter of the all additional introducers or catheters must have been smaller and smaller, whereupon the diameter of the last delivering catheter is particularly small, which remarkably limits also the size of the object, such as the implant, to be delivered.

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. For example the guide wire is at least partially formed from a shape memory material operable to assume an activated shape and an inactivated shape, wherein in said inactivated shape the guide wire is configured to be delivered in a straightened configuration through said first introducer and in said activated shape the guide wire is configured to take said at least a first curved shape within or near the anatomical target position. The guide wire is advantageously configured to be introduced before the implant into or towards the anatomical target position. However, it is to be noted that the guide wire should at least reach the target position before the implant.

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 can be delivered according to the invention, such as medicaments, for example. 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. Still, in addition it is to be noted that the implant can be rigid or flexible.