Patent Publication Number: US-2022226118-A1

Title: A Medical Arrangement for Introducing an Object into an Anatomical Target Position

Description:
TECHNICAL FIELD OF THE INVENTION 
     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. 
     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. 
       FIG. 2  illustrates an exemplary implant to be delivered and introduced into an anatomical target position, and in particularly 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  20 A of the heart valve and one second loop-shaped structure is configured to abut a second, opposite, side  20 B 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 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. 
     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 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
         a first introducer is delivered towards or into the anatomical target position, where at least a portion of first introducer takes a first curved shape,   a second introducer is delivered towards or into the anatomical target position inside said first introducer, where at least a portion of the second introducer takes a second curved shape when said second introducer is introduced from a distal end of the first introducer,       

     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. 
    
    
     
       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: 
         FIGS. 1A-1B  illustrate schematically a portion of a heart and mitral valve, 
         FIG. 2  illustrates an exemplary implant, 
         FIGS. 3-13  illustrate a medical arrangement for introducing an implant or medicament into an anatomical target position according to advantageous embodiments of the invention. 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1A-1B and 2  are already discussed in more details in connection with the background of the invention portion above. 
       FIGS. 3-13  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 second introducer  102  having distal and proximal ends  102 A,  102 B. 
     The first introducer  101  is delivered first in a straightened configuration  101 F until the distal end  101 B of the first introducer  101  reaches 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  102 F. The second introducer  102  follows the shapes of the first introducer  101  until it comes out from the distal end  101 B 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  102 C, as can be seen in  FIG. 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  102 G, as can be seen in  FIG. 4 . The additional curved shape  102 G locates to the direction of the proximal end  102 B from the second curved shape  102 C. However, it is to be noted that the additional curved shape  102 G is optional, for example if third or more introducers are used, as is illustrated in  FIGS. 8-12 . 
     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,  102 C 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  FIGS. 3, 4 and 7 , for example, the first and second introducers  101 ,  102  are also configured to tilt or bank downwards  108  and thereby form an angle  109 A,  109 B 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,  102 C,  102 G, 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  FIGS. 5-6 , at least the distal portion  101 A (or even the whole introducer) of the first introducer  101  is retracted before the implant  110  is introduced into the anatomical target position  20  via the second introducer  102 , whereupon more space can be arranged for delivering of the implant, especially if the second introducer is expandable  107 . The distal portion  101 A of the first introducer  101  is retracted however advantageously after the second introducer  102  is delivered into the anatomical target position  20 . If the third introducer  103  is used, as is the case in  FIGS. 8-12 , then at least the distal portion  102 A of the second introducer  102  is advantageously retracted before the implant  110  is introduced into the anatomical target position  20  and also advantageously after said third introducer  103  is delivered into said anatomical target position  20 . In this case also at least the first introducer is retracted. 
     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. 
       FIGS. 8-12  illustrate the medical arrangement  100  with third introducer having distal and proximal ends  103 A,  103 B, where in  FIG. 8  the first introducer  101  is delivered so that it takes the first curve shape  101 C and the first angle  109 A to the downward  108 . Next the second introducer  102  is delivered inside the first introducer  101  and from the distal end  101 A of the first introducer  101  so that it takes the second curve shape  102 C and the second angle  109 B to the downward direction  108 , as is the case in  FIG. 9 . Then the third introducer  103  is delivered inside the first and second introducers  101 ,  102  and from the distal end  102 A of the second introducer  102 , as can be seen in  FIG. 10 . It is to be noted that the third introducer  103  does not advantageously take any angle  109 B to the downward direction  108 , because advantageously the third introducer is already delivered to the opposite side of the annulus (between the leaflets) and there is no need to go downwards anymore. Thus, it is advantageous that the third (or any additional) introducer  103 ,  104  will follow the anatomical target environment, such as the annulus essentially in the mitral plane  105 . 
     However, the third introducer  103  is configured to take the third curved shape  103 C to the same hand direction as the first and second curved shapes  101 C,  102 C of the first and second introducers  101 ,  102  when the third introducer  103  is introduced from the distal end portion  102 A of the second introducer  102  so that said first, second and third curved shapes  101 C,  102 C,  103 C are concentric curved shapes. 
     As is the case also with two introducers in  FIGS. 3-7 , the first introducer  101  is delivered first and said second introducer  102  is delivered secondly and then the third introducer  103  last. As can be seen in  FIG. 11 , there might be also still additional introducers  104 , where the operational principle is analogous with three introducers. In addition, also in this embodiment at least the distal portion  102 A of the second introducer  102  is retracted before the implant  110  is introduced into the anatomical target position  20 , but anyway after the third introducer  103  is introduced into the anatomical target position. This is for protecting the tissue of the anatomical target position and environment, when the third introducer can be delivered inside the second introducer as far as possible. Same naturally applies to other situations, where for example at least the distal end  101 A of the first introducer  101  is retracted after introduction of the third introducer  103  and so on.  FIG. 12  illustrates an example with four introducers  101 - 104 , where the second and third introducers  102 ,  103  are retracted and the additional introducer  104  is left to protect the tissue about the delivering of the implant  110 . It is to be understood that the additional introducer  104  is illustrated in  FIG. 12  so that it is already retracted a certain length towards the proximal end so that the implant delivered can be seen better. In addition, it is to be noted that also the first introducer could have been retracted. 
     The introducers  101 ,  102 ,  103  comprises advantageously also third portions  101 D,  102 D,  103 D between the distal ends  101 C,  102 C,  103 C and said distal portions taking said curved shapes  101 C,  102 C,  103 C. The third portions  101 D,  102 D,  103 D have different curvature radius than the portions taking said curved shapes  101 C,  102 C,  103 C. In some case the third portion  101 D,  102 D,  103 D 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  102 A,  103 B,  110 B 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. 
       FIG. 13  illustrates an example of the first and second introducers  101 , 102  how to control the formation of the curved shapes  101 C,  102 C. The introducer may for example comprise an operating wire  113  (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 so advantageously the same side where the flexible portion  106  is provided. 
     The distal ends  101 A,  102 A 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  101 B,  102 B, 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  101 A,  102 A of the introducer in question to the downward direction  108 , as depicted in  FIGS. 3, 4 and 7 , for example. 
     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.