MEDICAL SECURING DEVICE FOR SECURING AN IMPLANT DEVICE WITH A SECURING MEMBER

Abstract

A medical securing device for securing an implant device, such as a cardiac implant device with a securing member into a tissue, such an annulus of a heart valve comprises a first elongated stem having proximal and distal ends. The distal end of the first stem has a receiving member for receiving the securing member. During a mutual movement of the distal end of the first stem and the receiving member, the distal end of the first stem is configured to introduce with the receiving member the securing member to the implant device to secure the implant device to the tissue with the securing member.

Claims

1. A medical securing device for securing an implant device with a securing member into a tissue, where the implant device comprises a upper or lower portion, whereby, in use, a portion of the tissue is coupled with the upper or lower portion, or trapped between the upper and lower portions of the implant device, wherein the medical securing device comprises: a first elongated stem having proximal and distal ends, where the distal end of the first stem has a receiving member for receiving the securing member, whereupon during a movement of the distal end of the first stem and the receiving member in relation to each other, the distal end of the first stem with the receiving member is configured to introduce the securing member to the implant device to secure the implant device to the tissue with the securing member.

2. The medical securing device of claim 1, wherein the distal end of the first stem has a hollow structure, and where the receiving member is arranged to the distal end in a movable manner in relation to the cavity so that during the movement the receiving member is configured to introduce the securing member from the cavity of the distal end to the implant device to secure the implant device to the tissue with the securing member.

3. The medical securing device of claim 1, wherein the medical securing device further comprises: a second elongated stem adjacent to the first stem, where said first and second stems are configured to be moved in relation to each other in their longitudinal direction, both stems having proximal and distal ends, where the distal end of the second stem has a counterpart portion for the distal end of the first stem or for the receiving member of the first stem, the distal end of the second stem is configured to be introduced to the opposite portion of the tissue than the distal end of the first stem and to produce counterforce via the counterpart portion to the distal end of the first stem and thereby clamping the implant device between the distal ends of the first and second stems when the distal end of the first or second stems is/are moved in the longitudinal direction towards the implant device, and wherein in addition during the movement the distal end of the first stem with the receiving member is configured to introduce the securing member to the implant device to secure the implant device to the tissue with the securing member.

4. The medical securing device of claim 3, wherein the mutual design of the distal end portions of the first and second stems are so that a space is formed between the distal end portions of the first and second stems, whereupon, in use, the space is configured to receive at least portion of the tissue.

5. The medical securing device of claim 3, wherein the second stem has a protrusion portion in the distal end portion forming the space between the first and second stems.

6. The medical securing device of claim 3, wherein the distal end of the second stem has an angle, towards the extension line of the distal end of the first stem so that the counterpart portion of the second stem locates essentially in the extension line in the longitudinal direction of the first stem distal end portion.

7. The medical securing device of claim 2, wherein the proximal end of the first stem comprises an operation member for moving the distal end of the first stem, or the receiving member towards the cardiac implant device and thereby introducing the securing member to the cardiac implant device.

8. The medical securing device of claim 3, wherein the proximal end of the first stem comprises an operation member during an operation of which the following operations are configured to happen either simultaneously or in sequentially by the same operation of the operation member: the movement of the distal ends of the first and second stems in relation to each other and towards to each other in their longitudinal direction and thereby to clamp implant device between the distal ends of the first and second stems, the movement of the distal end of the first stem, or the movement of the receiving member towards the implant device, positioning the implant device in the securing position, or introduction of the securing member to the implant device to secure the implant device to the tissue with the securing member.

9. The medical securing device of claim 7, wherein the first stem has a conduit via which the operation member is functionally coupled with the receiving member.

10. The medical securing device of claim 3, wherein the distal end of the first stem or the receiving member is configured to press or bend a first end of the securing member at least partially around or partially into the upper or lower portion of the implant device, when the distal end of the first stem is pressed against the counterpart portion of the second stem.

11. The medical securing device of claim 1, wherein the distal end of the first stem or the counterpart portion of the second stem configured to press or bend a second end of the securing member at least partially around or partially into the lower portion of the implant device or into the tissue, when the distal end of the first stem is pressed against the counterpart portion of the second stem.

12. The medical securing device of claim 3, wherein the counterpart portion comprises an anvil for receiving and bending the securing device at least partially around or partially into the implant device or to the tissue during the movement of the distal end of the first stem towards the implant device.

13. The medical securing device of claim 1, wherein the distal end of the first stem with the receiving member is configured to introduce the securing device at least partially through or via the implant device into the tissue during the movement of the distal end of the first stem or the receiving member in relation the implant device.

14. The medical securing device of claim 1, wherein the distal end of the first stem comprises a recess for supporting the distal end of the first stem to the upper portion of the implant device or the distal end of the second stem comprises a recess for supporting the distal end of the second stem to the lower portion of the implant device during the introduction of the securing member.

15. The medical securing device of claim 1, wherein the medical securing device comprises a storage for receiving a number of securing members, whereupon the medical securing device is arranged to feed a new securing member from the storage when the previous one is introduced to the implant device.

16. The medical securing device of claim 1, wherein the medical securing device is a cardiac implant device for an open-heart-operation, and the tissue is an annulus of the heart valve.

17. The medical securing device of claim 1, wherein the securing member is one of the following: a staple, the one end of which is bendable at least partially around or into the cardiac implant device under the pressing force induced by the distal end of the first stem or counterpart portion of the second stem, a staple having at least one hook-shaped end to be introduced at least partially around or into the cardiac implant device, a helical clip, a locking clip, a pointed screw, a spring clip, a skin staple, or a circular clip.

18. The medical securing device of claim 1, wherein the securing member comprises shape memory material, metal or polymer.

19. The medical securing device of claim 1, wherein the implant device comprises the upper or lower portion, which are advantageously loop-shaped portions arranged to form a coil-shape so that during an insertion the implant device is rotated into the position, and wherein at least one of the portion is at least partially open shaped.

20. The medical securing device of claim 3, wherein the first elongated stem is made of one piece of material, and wherein the second elongated stem is made of one piece of material.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which:

[0023] FIGS. 1A-1B illustrate schematically a portion of a heart and mitral valve,

[0024] FIGS. 2A-2B illustrate a prior art cardiac implant device for repairing of one or more leaflets of a heart valve, and

[0025] FIGS. 3A-13 illustrate examples of medical securing devices according to advantageous embodiments of the invention.

DETAILED DESCRIPTION

[0026] FIGS. 1A-1B and 2A-2B are already discussed in more details in connection with the background of the invention portion above.

[0027] 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 103A and distal 103B ends (FIG. 12), and the distal end 103B has a receiving member 104 for receiving the securing member 102. The distal end 103B 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 101A, 101B of the cardiac implant device 101 to the annulus 20 of the valve with the securing member 102.

[0028] 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 107B of the second stem 107 is advantageously configured to be introduced to the opposite portion of the valve tissue than the distal end 103B of the first stem 103 or to the lower portion 101B of the cardiac implant device 101, when the cardiac implant device 101 comprises the lower portion 101B.

[0029] The distal end 107B 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 103B 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.

[0030] Especially the distal end 107B is configured to produce counterforce via the counterpart portion 109 to the distal end 103B of the first stem 103, for example when the second stem 107 is pulled (107A, 114). For example the operation member illustrated in FIG. 13 can be arranged so that when the proximal end 103A, 107A 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 103B, 107B of the first and second stems 103, 107. In addition during the additional movement 108 the distal end 103B 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.

[0031] The distal end 103B of the first stem 103 or the receiving member 104 is configured to press and/or bend a first end 102A of the securing member at least partially around or partially into the upper and/or lower portion 101A, 101B of the cardiac implant device 101, when the distal end 103B 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 102A, 102B 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 102A of it can have a hook shape originally, whereupon the second end 102B 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 101A, 101B of the cardiac implant device 101, as is illustrated in FIG. 4A-4C. Also in this example the first end 102A of the securing member 102 comprises a hook shape originally, and the second end 102B is formed and guided around the lower portion 101B of the cardiac implant device 101 by the counterpart portion 109 functioning as the anvil.

[0032] It also should be noted that the distal end 103B 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 102B 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.

[0033] It is to be noted that in the embodiment illustrated in FIG. 9A-9D the first end 102A of the securing member 102 is introduced into or coupled with the cardiac implant device 101 and the second end 102B 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 102A 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 102B of the securing member 102 is introduced directly to the annulus tissue 20.

[0034] 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 103B 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 103B 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.

[0035] However when the first end 102A 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 102B of the securing member 102 is introduced directly to the the annulus tissue 20), huge advantage can be achieved, namely when the end (102A) 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.

[0036] 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 103B 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 101A of the cardiac implant device 101 and again so that the second end 102B of the hook shaped securing member 102 is bend into the slots of the lower portion 101B of the cardiac implant device 101.

[0037] The distal end 103B of the first stem 103 may also comprise a recess 116 for supporting the distal end 103B of the first stem 103 to the upper portion 101A of the cardiac implant device 101. The distal end 107B of the second stem 107 may also comprise a recess 117 for supporting the distal end 107B of the second stem 107 to the lower portion 101B 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.

[0038] As can be seen especially in FIG. 12 the mutual design of the distal end portions 103B, 107B 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 107B 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 107B 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 103B 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 103B.

[0039] The distal end 103B 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 103B, 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.

[0040] 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.

[0041] 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 103A of the first stem 103. The operation member 114 is advantageously configured for moving the distal end 103B 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 103B 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.

[0042] 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: [0043] the movement of the distal ends 103B, 107B 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 103B, 107B of the first and second stems 103, 107, [0044] the movement of the distal end 103B of the first stem 103, and/or the movement of the receiving member 104 towards the cardiac implant device 101, [0045] 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 [0046] 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.

[0047] As can be seen in Figures the cardiac implant device 101 comprises the upper and/or lower portion 101A, 101B, 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 101A, 101B is an open shaped, such as a C or D shaped portion.

[0048] 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.

[0049] 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.

[0050] The features recited in dependent claims are mutually freely combinable unless otherwise explicitly stated.