Patent Publication Number: US-2019183649-A1

Title: Medical securing device for securing an implant device with a securing member

Description:
TECHNICAL FIELD OF THE INVENTION 
     The invention relates to a medical securing device for securing an implant device with a securing member, and especially a cardiac implant (annuloplasty medical) device. In particularly the invention relates to a medical securing device for an open-heart-operation and for securing the cardiac implant device into an annulus of a heart valve, such as a mitral valve or tricuspid valve, comprised of valve tissue and including the annulus and a plurality of leaflets. 
     BACKGROUND OF THE INVENTION 
       FIG. 1A  illustrates a portion of the heart  12 , the mitral valve  18 , and the left ventricle  14 . 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. 2A-B  illustrate prior art cardiac implant devices and method for repairing of one or more leaflets of a heart valve as is described in the applicant&#39;s previous EP-patent (EP 1 853 199 B1), where the device  40  comprises a first and a second loop-shaped support  42 ,  44 , which are connected to each other by means of a connecting part  48  so as to form a coil-shape. The coil-shape of the device is advantageous during insertion, since the device  40  may then be rotated into position, as described in the patent in more details. One of the supports  44  may be open, e.g. C or D or any other anatomical shaped such that the support  44  presents an end to lead the movement of the support  44  when being rotated into position. The position of the supports  42 ,  44  are secured by fasteners  156 , which are inserted and fastened by hand or small screwdriver. 
     It is found that the prior art cardiac implant devices, such as depicted above, work very well, but there are still some disadvantages relating to the securing of the cardiac device into the annulus of the heart valve. The cardiac devices are typically sutured by a needle and yarns, which is time consuming, because in practise it is needed at least seven knots to be tied in order to have even some certainty that the device is secured. In addition, the device is sutured typically by one yarn, which has a drawback namely if one or more knots is/are loosen or the yarn is broken, then the whole securing will come loosen or broken. 
     The cardiac implant devices are also secured by screws. However, the screws are very small, the assembling, positioning and controlling of which are extremely difficult. The screws must be inserted through the both the first and second (upper and lower) loop-shaped support portions  42 ,  44  (tiny holes in both of the portions), which is highly demanding, because if the first screw is tightened too much, it will distort the portions little bit and thus misaligning the other holes and thereby making it impossible to inserting the other screws. Furthermore there is a huge risk to drop the small screws into the cardiac structure, because for example any safety blankets cannot be used. In addition also magnetic material cannot be used due to possible later magnetic imaging. 
     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 securing device for securing an implant device into a tissue, such as a cardiac implant device with a securing member into an annulus of a heart valve in an easy, fast and safe manner. 
     The object of the invention can be achieved by the features of independent claims. 
     The invention relates to a medical securing device for securing an implant device with a securing member into a tissue according to claim  1 . 
     According to an embodiment of the invention a medical securing device for securing an implant device with a securing member into a tissue, such as into an annulus of a heart valve, comprises at least a first elongated stem. The first stem has proximal and distal ends, and the distal end has a receiving member for receiving the securing member. The receiving member is advantageously a piston type member, which is configured to receive the securing member, such as pinch, press or lock the securing member mechanically. In addition the medical securing device is advantageously configured to under manipulation, such as during a movement of the distal end of the first stem and the receiving member in relation to each other, move, introduce and secure, such as press, bend, twist or otherwise secure the securing member to the implant device and thereby to secure the upper and/or lower portion of the implant device to the tissue with the securing member. 
     According to an embodiment the distal end of the first stem has a hollow structure, such as a conduit or channel, where the receiving member is arranged in a movable manner so that during the movement the receiving member moves and thereby introduces the securing member from the hollow structure to the implant device thereby securing the implant device to the tissue with the securing member. 
     In addition according to an embodiment the medical securing device may further comprise also a second elongated stem adjacent to the first stem. 
     The first and second stems are configured to be moved advantageously under the same manipulation or movement in relation to each other in their longitudinal direction, both stems having proximal and distal ends. The distal end of the second stem has a counterpart portion, such as a clamp and/or anvil. The counterpart portion can be used together the distal end of the first stem for clamping the implant device between the counterpart portion and the distal end, but also together the receiving member for stapling the securing member to the implant device and/or to the tissue, such as to the annulus. 
     Advantageously the first elongated stem is made of one piece of material, as well as especially the second elongated stem is also made of one piece of material, whereupon very strong and stable securing device structure can be achieved. This is very advantageous e.g. when the securing member, such as a stable, is pushed through the tissue and bent by the counterpart portion of the second elongated stem, such as the clamp or anvil, because the dimensions of the annulus and the implant device are small. The unstable device structure, especially the second elongated stem, might bend or twist and thus being unable to guide the securing member correctly through the tissue or guide and bend the securing member around or into the contact with the cardiac implant device and/or to the annulus, when introduced by the first elongated stem and receiving member. 
     The distal end of the second stem is advantageously configured to be introduced to the opposite portion of the tissue, such as to the valve tissue than the distal end of the first stem or to the lower portion of the implant device, when lower portion is used. In addition the distal end is configured to produce counterforce via the counterpart portion to the distal end of the first stem, for example when the second stem is pulled, and thereby clamping the implant device between the distal ends of the first and second stems when the distal end of the first and/or second stems is/are moved in the longitudinal direction towards the implant device. In addition during the additional movement the distal end of the first stem with the receiving member or the receiving member as such is configured to introduce the securing member to the implant device to secure at least portion of the implant device to the tissue, such as to the annulus of the valve with the securing member. 
     The securing member may be e.g. a staple the one end of which is bendable at least partially around or into the implant device under the pressing force induced by the distal end of the first stem and/or counterpart portion of the second stem. The securing member may also be e.g. a staple having at least one hook-shaped end to be introduced at least partially around or into the implant device. In addition the securing member may be also a helical clip, locking clip, pointed screw, spring clip, skin staple, pin, or circular clip, as an example. The securing member may comprise for example shape memory material, metal or polymer or any other material with memory function, as an example. In addition the second end or both ends of the securing member may be sharpened (atraumatic) so to help the penetration of the securing member into the annulus tissue. 
     It is to be noted in connection with the heart valve that the heart valve is for example a mitral valve or tricuspid valve, and comprises valve tissue including the annulus and a plurality of leaflets. In addition it is to be noted that the implant device used in the invention may comprise an upper or lower portion, or both. The portions are advantageously as loops and at least one of them can be open loop, such as C or D shaped portion (or any other suitable anatomical shape), whereby, in use, a portion of the valve tissue is coupled with the upper or lower portion, or trapped between the upper and lower portions of the cardiac implant. 
     In addition it is to be noted that the medical securing device described in this document can be used for securing different kinds of implant devices to the tissue, but particularly cardiac implant devices to the annulus of the valve. Thus even if the cardiac implant devices are described below and in this document in more details, it is be understood that the same inventive principle of the medical securing device can be applied by securing also other types of implant devices into different tissues, such as tissue or skin transplant beneath the skin or the like. 
     The present invention offers advantages over the known prior art, such as an easy, safe and time saving manner to reliable securing the cardiac implant device to the annulus of the valve with the securing member. In addition the securing process including both the clamping and positioning of the cardiac implant device, as well as the securing the cardiac implant device in a reliable manner into the right position can be performed in a very natural way and advantageously by one movement. Most advantageously the movement can be just one continuous movement, such as for example by pressing or pulling the operation member(s) in the handle bar of the medical securing device. 
     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, 
         FIGS. 2A-2B  illustrate a prior art cardiac implant device for repairing of one or more leaflets of a heart valve, and 
         FIGS. 3A-13  illustrate examples of medical securing devices according to advantageous embodiments of the invention. 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1A-1B and 2A-2B  are already discussed in more details in connection with the background of the invention portion above. 
       FIGS. 3A-13  illustrate examples of medical securing devices  100  according to advantageous embodiments of the invention, where the medical securing device  100  comprises at least a first elongated stem  103 . The first stem has proximal  103 A and distal  103 B ends ( FIG. 12 ), and the distal end  103 B has a receiving member  104  for receiving the securing member  102 . The distal end  103 B of the first stem and the receiving member  104  can be moved in relation to each other, whereupon they are configured to introduce and secure the securing member  102  to the cardiac implant device  101  and thereby to secure the upper and/or lower portion  101 A,  101 B of the cardiac implant device  101  to the annulus  20  of the valve with the securing member  102 . 
     In addition the medical securing device  100  may also comprise a second elongated stem  107  adjacent to the first stem, as is described in more details in  FIG. 12 , but also in  FIGS. 3, 4, 6, 7, 8 . The first  103  and second  107  stems are configured to be moved advantageously under the same manipulation or movement in relation to each other in their longitudinal direction  108 . The distal end  107 B of the second stem  107  is advantageously configured to be introduced to the opposite portion of the valve tissue than the distal end  103 B of the first stem  103  or to the lower portion  101 B of the cardiac implant device  101 , when the cardiac implant device  101  comprises the lower portion  101 B. 
     The distal end  107 B of the second stem  107  has advantageously a counterpart portion  109 , which can be used for clamping and thereby controlling the cardiac implant device  101  between the counterpart portion  109  and the distal end  103 B of the first stem for further operation, namely for introduction the securing member  102 . In addition the counterpart portion  109  can be used, together with the receiving member  104 , for securing, such as stapling the securing member  102  to the cardiac implant device  101  and/or to the annulus  20 . As can be seen in Figures the counterpart portion  109  can be used as an anvil to guide and bend the securing member  102  around or into the contact with the cardiac implant device  101  and/or to the annulus  20 , when introduced by the receiving member  104 . 
     Especially the distal end  107 B is configured to produce counterforce via the counterpart portion  109  to the distal end  103 B of the first stem  103 , for example when the second stem  107  is pulled ( 107 A,  114 ). For example the operation member illustrated in  FIG. 13  can be arranged so that when the proximal end  103 A,  107 A of the first and/or second stem(s)  103 ,  107  and/or the operation member  114  are pressed against each other, the distal end of the first and/or second stems is/are moved in the longitudinal direction  108  towards the cardiac implant device  101 , and the cardiac implant device  101  is then clamped between the distal ends  103 B,  107 B of the first and second stems  103 ,  107 . In addition during the additional movement  108  the distal end  103 B of the first stem  103  with the receiving member  104  or the receiving member  104  as such is configured to introduce the securing member  102  to the cardiac implant device  101  to secure at least portion of the cardiac implant device  101  to the annulus  20  of the valve with the securing member  102 . 
     The distal end  103 B of the first stem  103  or the receiving member  104  is configured to press and/or bend a first end  102 A of the securing member at least partially around or partially into the upper and/or lower portion  101 A,  101 B of the cardiac implant device  101 , when the distal end  103 B of the first stem  103  and/or the receiving member  104  is pressed against the counterpart portion  109  of the second stem  107 . As can be seen e.g. in  FIGS. 3A and 3B  the ends  102 A,  102 B of the securing member  102  are pressed and bended into the slots  117  in the cardiac implant device  101 . The securing member  102  may be as a nail or having H-form (see. e.g.  FIG. 3C ), and the first end  102 A of it can have a hook shape originally, whereupon the second end  102 B can be bend by the counterpart portion  109  functioning as an anvil. Alternatively the securing member  102  can be introduced around the upper and lower portions  101 A,  101 B of the cardiac implant device  101 , as is illustrated in  FIG. 4A-4C . Also in this example the first end  102 A of the securing member  102  comprises a hook shape originally, and the second end  102 B is formed and guided around the lower portion  101 B of the cardiac implant device  101  by the counterpart portion  109  functioning as the anvil. 
     It also should be noted that the distal end  103 B of the first stem  103  (advantageously with the receiving member ( 104 )) as such or together with the counterpart portion  109  of the second stem  107  may also be configured to press and/or bend the second end  102 B of the securing member  102  at least partially into the annulus  20  of the valve, as is described in  FIG. 9A-9D , or  FIG. 10A-10B . In particularly in  FIG. 9A-9B  the receiving member  104  can be arranged so that when it is pulled upwards it will raise the centre portion of the securing member  102  (as a staple), whereupon the ends of the securing member  102  will bend downwards and are thereby introduced into the cardiac implant device  101  and the annulus tissue  20 . In  FIG. 9C-9D  the receiving member  104  (such as a piston type member) is pushed downwards, whereupon it will bend at least one end of the securing member  102  (as a staple) downwards and is thereby introduced into the cardiac implant device  101  and the annulus tissue  20 . The securing member  102  may also comprise shape memory material, which additionally helps to achieve the form and securing of the securing member e.g. to the annulus as is described in  FIG. 10A-10B . 
     It is to be noted that in the embodiment illustrated in  FIG. 9A-9D  the first end  102 A of the securing member  102  is introduced into or coupled with the cardiac implant device  101  and the second end  102 B of the securing member  102  is introduced into or coupled with the annulus tissue  20  (or bend via the annulus tissue towards or into the cardiac implant device  101 ). Again it is to be noted that in the embodiment illustrated in  FIG. 9E-9H  the first end  102 A of the securing member  102  is introduced into or coupled with the cardiac implant device  101  and then bend towards and further into the annulus tissue  20 , and the second end  102 B of the securing member  102  is introduced directly to the annulus tissue  20 . 
     As can be seen in the embodiment and drawings, the present invention offer many advantageously features and ways to secure the cardiac implant device into the annulus. For example, the embodiment illustrated in  FIG. 9E-9H  offer clear advantage, namely at first the introduction of the securing member  102  as well as the securing of the cardiac implant  101  can be done by the medical securing device  100  having only the first stem  103  (either “upper”  103  or “lower”  107  stem. In this embodiment the distal end  103 B of the first stem  103  (or  107 ) with the receiving member ( 104 ) is configured to introduce the securing device  102  at least partially through or via the cardiac implant device  101  into the annulus  20  of the valve during the movement of the distal end  103 B of the first stem  103  (or  107 ) and/or the receiving member  104  in relation to the cardiac implant device  101 . The movement can be e.g. downwards so towards the cardiac implant device  101  or upwards so away from the cardiac implant device  101 . 
     However when the first end  102 A of the securing member is  102  is introduced into or coupled with the cardiac implant device  101  and then bend towards and further into the annulus tissue  20  (and the second end  102 B of the securing member  102  is introduced “directly” to the the annulus tissue  20 ), huge advantage can be achieved, namely when the end ( 102 A) of the securing member  102  to be introduced into the annulus tissue  20  is bend before introduction, the tensile stress, as well as any other further tissue tearing caused to the tissue can be remarkably reduced. 
     In addition it is to be noted that the securing member  102  may be as a locking clip or pointed screw or the like as is described in  FIG. 11A, 11B , whereupon the receiving member  104  can be turned e.g. via manipulation of the operation member  114  so to introduce and turn (screw) the securing member  102  into the cardiac implant device  101 . Moreover, as can be seen in  FIG. 5A, 5B , the securing member  102  may be as a helical spring  102 , whereupon the receiving member  104  possibly together the distal end  103 B of the first stem  103  is configured to introduce the helical spring  102  so to penetrate a possible hollow or hole structure in the cardiac implant device  101  as well as to penetrate into the annulus  20  tissue of the valve structure. The cardiac implant device  101  may also comprise a textile structure around it to which the helical spring  102  can be secured. Still in  FIG. 6A, 6B  is shown a locking clip  102 , which can be just pushed through the first hole in the upper portion of the cardiac implant device  101  and again into the receiving securing hole in the lower portion of the cardiac implant device  101 , where the securing hole locks the locking clip  102  in its securing position. Additionally  FIG. 7A-7C  illustrates a hook shaped securing member  102  which is pressed by the receiving member  104  thought the holes in the upper portion  101 A of the cardiac implant device  101  and again so that the second end  102 B of the hook shaped securing member  102  is bend into the slots of the lower portion  101 B of the cardiac implant device  101 . 
     The distal end  103 B of the first stem  103  may also comprise a recess  116  for supporting the distal end  103 B of the first stem  103  to the upper portion  101 A of the cardiac implant device  101 . The distal end  107 B of the second stem  107  may also comprise a recess  117  for supporting the distal end  107 B of the second stem  107  to the lower portion  101 B of the cardiac implant device  101  during the introduction of the securing member  102 . This helps and guides the securing device  100  to be positioned in an appropriate position for clamping as well as for introducing the securing member and thereby for securing the cardiac implant device  101  into the annulus. 
     As can be seen especially in  FIG. 12  the mutual design of the distal end portions  103 B,  107 B of the first and second stems  103 ,  107  are so that a space  110  is formed between the distal end portions. As an example, the space  111  the second stem  107  may comprise a protrusion portion  111  in the distal end portion  107 B  110  between the first and second stems  103 ,  107 . In a use the space  110  is configured to receive at least portion of the valve tissue and/or leaflets  18 . In addition the distal end  107 B of the second stem may have an angle  112 , such as inclined or rectangular portion, which extends towards the extension line  113  of the distal end  103 B of the first stem  103  so that the counterpart portion  109  of the second stem  107  locates essentially in the extension line  113  in the longitudinal direction  108  of the first stem distal end portion  103 B. 
     The distal end  103 B of the first stem  103  has a hollow structure  106 , such as a conduit or channel, where the receiving member  104  is arranged in a movable manner. In addition the first stem  103  has a hollow structure  106  via which the operation member  114  is functionally coupled with the receiving member  104 . During the movement the receiving member  104  moves and when it is moved towards the output of the distal end  103 B, it thereby introduces the securing member from the hollow structure to the cardiac implant device  101  and secures the cardiac implant device (or at least part of it) to the annulus  20  of the valve with the securing member. 
     The medical securing device may also comprise a storage (not shown in Figures) for receiving number of securing members  102 . The storage is advantageously arranged to feed a new securing member  102  when the previous one is introduced to the cardiac implant device  101 . 
     The receiving member  104  can be a piston type, for example, such as is described e.g. in  FIGS. 6A, 6B, 7A, 7B, 8A, 8B, 9A-9H . The piston type receiving member  104  can be operated e.g. by operating, such as pulling an operation member  114 , which is advantageously comprised by or in the proximal end  103 A of the first stem  103 . The operation member  114  is advantageously configured for moving the distal end  103 B of the first stem  103 , or especially the receiving member  104  towards the cardiac implant device  101  and thereby introducing the securing member  102  to the cardiac implant device  101 . Most advantageously the operation member  114  moves the piston type receiving member  104  so that the securing device  102  is outputted at least partially from the distal end  103 B or from the hollow structure  106  and against the cardiac implant device  101 , after which and advantageously during the same movement the second stem  107  is pulled thereby clamping the cardiac implant device  101  and after this introducing the securing device  102  further and around or into the contact with cardiac implant device  101  and thereby securing said cardiac implant device  101  into the annulus  20 . 
     The operation member  114  advantageously together with the first and/or second stems  103 ,  107  is/are arranged so that during an operation the following operations are configured to happen either simultaneously or in sequentially by the same operation or movement of the operation member  114 :
         the movement of the distal ends  103 B,  107 B of the first and second stems  103 ,  107  in relation to each other and towards to each other (pull e.g. the second stem) in their longitudinal direction  108  and thereby to clamp cardiac implant device  101  between the distal ends  103 B,  107 B of the first and second stems  103 ,  107 ,   the movement of the distal end  103 B of the first stem  103 , and/or the movement of the receiving member  104  towards the cardiac implant device  101 ,   positioning the cardiac implant device  101  in the securing position so i.e. pulling or pushing the cardiac implant device  101  or its lower or upper portion around or over the annulus  20  in its proper securing position, and/or   introduction the securing member  102  to the cardiac implant device  101  to secure the cardiac implant device  101  to the annulus  20  of the valve with the securing member  102 .       

     As can be seen in Figures the cardiac implant device  101  comprises the upper and/or lower portion  101 A,  101 B, which are advantageously loop-shaped portions. They may form a coil-shape portion so that during an insertion the cardiac implant device  101  can be rotated into the position. In an advantageous embodiment at least one of the portions  101 A,  101 B is an open shaped, such as a C or D shaped portion. 
     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 when it is stated that it is the first elongated stem having proximal, which is used to introduce the securing member to the cardiac implant device to secure the cardiac implant device to the annulus of the valve with the securing member, it should be understood that this first stem (if no other stem is mentioned or needed) can be functionally either the “upper” stem ( 103 ) or the “lower” stem ( 107 ), by which the introduction and securing can be performed. In addition it is to be noted that the medical securing device according to the invention can be used in trancatheter applications, such as for example trancatheter mitral valve implantation. In particularly the first and second elongated stems can be used together with a steering catheter, which is big enough. 
     The features recited in dependent claims are mutually freely combinable unless otherwise explicitly stated.