Patent Application
20220226118
The invention relates to a medical arrangement for introducing an object, such as an implant or medicament 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.
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.
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 the body temperature, whereupon the implant takes the second shape, corresponding 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 relative 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 possibly 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 to 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 relative 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 particularly 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.
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 or medicament 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 object, such as an implant or medicament, 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, such as a medicament or an implant, into an anatomical target position. In particularly the invention is configured to introduce 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 mitral 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 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 support for a mitral valve upon being fully delivered.
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 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 annulus and heart. Thus, no steep curves for the introducers or implants are needed, whereupon the additional introducers and implant are more easily to delivered. This is because the steep curves will increase friction between the introducers as well as inner introducer and the implant. In particularly the friction might be problem, when the implant with memory property is tried to deliver by the curves and if the memory property of the implant will already start to affect.
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 curvature direction (concentric) 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 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 the curve. According to embodiment also memory materials can be used.
The concentric way to deliver the introducers has advantages, namely when the introducers and implant is delivered concentric or so that the introducers and implant have a similar curvature direction, there is no need to change the direction of concentric movement of the introducers and implant, which again decreases possible friction or other resistance.
Further, according to an embodiment the portion of the first and/or second introducer taking said curved shape is also configured to form an angle essentially perpendicular to said first and second curved shape directions or to the mitral plane. Thus, the first and second curved shapes turn the introducers concentrically in one plane or circularly, but in addition to this the portion of the first and/or second introducer forms the angle in another perpendicular plane so downwards. Therefore, when the introducer is delivered for example to the left ventricle, the introducer takes a helical loop form due to said first and second curved shapes. In addition to this the distal end portion of the first introducer takes the angle downwards so towards the leaflets, whereupon it alleviates the delivering of the second introducer so that the distal end of the second introducer is pointed towards the leaflets, or the gap between the leaflets, already when the distal end of the second introducer is delivered from the distal end of the first introducer. In addition, also the distal end portion of the second introducer takes the angle downwards so towards the gap of the leaflets, whereupon it is easy to deliver the second or additional introducers between the leaflets and into the opposite side (underside) the annulus.
According to embodiment, a cross-section of the second and/or third introducer is expandable. For example, at least portion of the housing of the introducer can be made expansible, such as made for example of flexible or stretchable material. This allows to deliver a bigger implant, for instance, and especially if the previous introducers are retracted before delivering the implant, whereupon the expandable introducer can take the space of the previous introducers, but still without overtaking any extra space.
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.
In one embodiment, the first introducer is advantageously delivered into a first side of the annulus of the mitral valve in an angle less than 45°, more advantageously less than 30°, most advantageously less than 15° in relation to the mitral plane.
When the first introducer is delivered into a first side of the annulus of the mitral valve in an angle in relation to the mitral plane that is preferably as small as possible, there may be an axial torsional effect on an implant that is reduced. Such an advantageous delivery angle of the first introducer may allow more precise position control when introducing an implant into the target position.
In addition, the invention relates to a method for introducing an object, such as an implant or medicament, into an anatomical target position, wherein in the method
wherein said first and second curved shapes are concentric curved shapes.
The present invention offers advantages over the known prior art, such as an easy, safe, precise and time saving manner to reliable delivering the implant to the anatomical target position such as to the annulus of the valve. In addition, the present invention provides for a compact arrangement for delivering the implant. 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 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.
Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which:
The first introducer 101 is delivered first in a straightened configuration 101F until the distal end 101B of the first introducer 101 reaches the anatomical target position, whereupon the distal portion is configured to take the first curved shape 101C, 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 101B 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
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
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 101C, 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. 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
As can be seen in
By this a bigger implant can be delivered without any needs for bigger introducers, namely because when the first introducer 101 is retracted and the second introducer is expandable, the cross-section 107 of the second introducer 102 can expand and take the space needed for the implant. The second introducer can be manufactured for example of flexible or stretchable material. It is to be understood that also the third introducer 103 can be expandable in the cases where the third introducer 103 is used.
However, the third introducer 103 is configured to take the third curved shape 103C to the same hand direction as the first and second curved shapes 101C, 102C of the first and second introducers 101, 102 when the third introducer 103 is introduced from the distal end portion 102A of the second introducer 102 so that said first, second and third curved shapes 101C, 102C, 103C are concentric curved shapes.
As is the case also with two introducers in
The introducers 101, 102, 103 comprises advantageously also third portions 101D, 102D, 103D between the distal ends 101C, 102C, 103C and said distal portions taking said curved shapes 101C, 102C, 103C. The third portions 101D, 102D, 103D have different curvature radius than the portions taking said curved shapes 101C, 102C, 103C. In some case the third portion 101D, 102D, 103D may be even essentially a direct portion. This will guide the next inner introducer 102, 103 or the implant 110 to take better orientation and direction in relation to the surrounding anatomical environment, because in this way the distal end 102A, 103B, 110B of the outcoming inner introducer 102, 103 or the implant 110 will follow better the shapes of the anatomical target position, i.e. otherwise it will easily hit the tissue of the anatomical environment, such as the annulus.
The distal ends 101A, 102A of the first and second introducers 101, 102 comprise advantageously a reinforcement ring 114 to which said the operating wire 113 is coupled with. Thus, when the operating wire 113 is tightened advantageously from the proximal end of the introducer 101B, 102B, it will cause the introducer 101, 102 in question to bend to that direction. There flexible portion is arranged inside 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 the curve. According to embodiment also memory materials can be used.
In addition, it is to be noted that when the operating wire 113 is coupled to the reinforcement ring 114 in an angle 115, the tightening of the operating wire 113 will also tilt or bank the distal end 101A, 102A of the introducer in question to the downward direction 108, as depicted in
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 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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19175644.4 | May 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/064015 | 5/20/2020 | WO | 00 |
