Medical securing device for securing an object with a securing member

Abstract

A medical securing device for securing an object with a securing member into a tissue comprises an elongated sheath comprising proximal and distal ends, and a securing member introduction device having proximal and distal ends, said distal end being configured to extend from the sheath. The medical securing device comprises also a guiding trail. At least one point of the securing member introduction device is configured to travel along said first guiding trail and thereby control a defined movement of the distal end of said securing member introduction device when extending from the sheath and so to introduce the securing member to the object and to secure said object to the tissue with the securing member.

Claims

1. A medical securing device for securing an object with a securing member into a tissue comprising: an elongated sheath comprising proximal and distal ends, a securing member introduction device having proximal and distal ends, and the distal end of the securing member introduction device being configured to extend from the sheath, a retrieval device having proximal and distal ends, and the distal end of the retrieval device being configured to extend from the sheath, an actuating member for projecting the retrieval device from the sheath, a first guiding rail and a second guiding rail, said second guiding rail being arranged to the actuating member, a portion of the securing member introduction device is configured to travel along the first guiding rail and thereby control a defined movement of the distal end of the securing member introduction device so that the distal end of the securing member introduction device is configured to exhibit a non-linear movement when extending from the sheath, wherein the distal end of the securing member introduction device comprises a tip portion which comprises a pre-curved needle, and so to introduce a portion of the securing member to the object and to secure the object to the tissue with the securing member, and a portion of the retrieval device is configured to travel along the second guiding rail and thereby control a defined movement of the distal end of the retrieval device so that the distal end of the retrieval device is configured to exhibit a non-linear movement when extending from the sheath and so to capture the portion of the securing member introduced by the securing member introduction device, and to secure the portion of the securing member to the object or to the tissue.

2. The medical securing device of claim 1, wherein the first guiding rail is a non-linear guiding rail and the second guiding rail is a linear guiding rail.

3. The medical securing device of claim 1, wherein the actuating member is configured for projecting also the securing member introduction device from the sheath.

4. The medical securing device of claim 1, wherein the actuating member is configured to provide a back-and-forth movement of the retrieval device, when operated.

5. The medical securing device of claim 1, wherein the retrieval device comprises a facing element at the distal end thereof for facing the distal end of the securing member introduction device and to introduce the portion of the securing member to the distal end of the retrieval device, and thereby allowing the retrieval device to capture the portion of the securing member and to secure the portion of the securing member to the object or to the tissue.

6. The medical securing device of claim 1, wherein the retrieval device is configured to be extended from the sheath before the securing member introduction device, and wherein a facing element of the retrieval device is a hole or slit, through which the distal end of the securing member introduction device is configured to move and introduce the portion of the securing member to the hole or slit, and thereby allowing the retrieval device to capture the portion of the securing member and to secure the portion of the securing member to the object or to the tissue after the securing member introduction device is moved away from the facing element.

7. The medical securing device of claim 1, wherein the securing member introduction device is configured to be extended from the sheath before the retrieval device.

8. The medical securing device of claim 1, wherein the distal end of the retrieval device comprises a facing element and the distal end of the securing member introduction device comprises a counterpart portion, to which said portion of said securing member is attached, whereupon said counterpart portion with the portion of said securing member is configured to be captured by the facing element of said distal end of the retrieval device, thereby allowing said retrieval device to secure the portion of the securing member to the object or to the tissue.

9. The medical securing device of claim 8, wherein the counterpart portion comprises a snap locking member or a magnet.

10. The medical securing device of claim 1, wherein the distal end of the retrieval device comprises a facing element with a suction or under pressure providing element or comprises a hook-shaped portion so to engage and capture at least a portion of said securing member, by the facing element using said suction or under pressure or the hook-shaped portion, and thereby allowing said facing element of said distal end of the retrieval device to capture the portion of said securing member.

11. The medical securing device of claim 1, wherein the securing member is a suture.

12. The medical securing device of claim 3, wherein the actuating member is configured to provide a back-and-forth movement of the securing member introduction device, when operated.

13. The medical securing device of claim 1, wherein the actuating member comprises a spring, pre-stringed spring, pressure accumulator, or hydraulic or pneumatic arrangement, or wherein the actuating member comprises a push rod for providing at least one movement of the back-and-forth movement of the retrieval device.

14. The medical securing device of claim 3, wherein the actuating member comprises a spring, pre-stringed spring, pressure accumulator, or hydraulic or pneumatic arrangement, or wherein the actuating member comprises a push rod for providing at least one movement of the back-and-forth movement of the securing member introduction device.

15. The medical securing device of claim 1, wherein the elongated sheath comprises a conduit between the proximal and distal ends thereof for receiving at least one guiding wire, the distal end of the guiding wire being fixed to the object and thereby for guiding a support portion of the distal end of the elongated sheath along said guiding wire and to support the support portion to the object.

16. The medical securing device of claim 15, wherein the distal end of the elongated sheath comprises a cutting member for cutting the guiding wire in the vicinity of the object or the tissue.

17. The medical securing device of claim 1, wherein the elongated sheath comprises a conduit between the proximal and distal ends thereof for introducing under pressure into the distal end or to a support portion of the elongated sheath in order to suck and thereby to support the elongated sheath or the support portion to the object or to the tissue via the force induced by the under pressure or for applying counterforce for the introduction movement of the securing member.

18. The medical securing device of claim 1, wherein the distal end of the securing member introduction device is configured to travel outside of the first guiding rail.

19. A medical securing device for securing an object with a securing member into a tissue comprising: an elongated sheath comprising proximal and distal ends, a securing member introduction device having proximal and distal ends, and the distal end of the securing member introduction device being configured to extend from the sheath, a retrieval device having proximal and distal ends, and the distal end of the retrieval device being configured to extend from the sheath, an actuating member for projecting the securing member introduction device from the sheath, a first guiding rail and a second guiding rail, said first guiding rail being arranged to the actuating member, a portion of the securing member introduction device is configured to travel along the first guiding rail and thereby control a defined movement of the distal end of the securing member introduction device so that the distal end of the securing member introduction device is configured to exhibit a non-linear movement when extending from the sheath, wherein the distal end of the securing member introduction device comprises a tip portion which comprises a pre-curved needle, wherein the distal end of the securing member introduction device is configured to travel outside of the first guiding rail, and so to introduce a portion of the securing member to the object and to secure the object to the tissue with the securing member, and a portion of the retrieval device is configured to travel along the second guiding rail and thereby control a defined movement of the distal end of the retrieval device so that the distal end of the retrieval device is configured to exhibit a non-linear movement when extending from the sheath and so to capture the portion of the securing member introduced by the securing member introduction device, and to secure the portion of the securing member to the object or to the tissue.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which:

[0027] FIGS. 1A-1B illustrate schematically a portion of a heart and mitral valve,

[0028] FIGS. 2A-2B illustrate a prior art cardiac implant device for repairing of one or more leaflets of a heart valve, and

[0029] FIGS. 3A-19 illustrate examples of medical securing devices according to advantageous embodiments of the invention.

DETAILED DESCRIPTION

[0030] FIGS. 1A-1B and 2A-2B are already discussed in more details in connection with the background of the invention portion above.

[0031] FIGS. 3A-19 illustrate examples of medical securing devices 100 for securing an object, especially a cardiac implant device 40, 400A-400B, according to advantageous embodiments of the invention. In particularly a suturing device 100 is described, even if the medical securing device can also be applied with another types of the securing members as discussed elsewhere in this document. The medical securing device 100 comprises an elongated sheath 101 extending in a longitudinal direction and having proximal 101A and distal 101B ends. The distal end of the elongated sheath comprises a support portion 101C to support the elongated sheath to the cardiac implant device directly or to the tissue 20 opposite e.g. the lower portion ring 400B of the cardiac implant device.

[0032] The medical securing 100 device comprises also a securing member introduction device 103, 113 having proximal 103A, 113A and distal 103B, 113B ends. The distal end 103B, 113B is configured to extend from the sheath 101, advantageously when operated, and to provide and introduce the securing member 102, such as a suture, to the object and/or to the tissue.

[0033] The medical securing device comprises additionally a first guiding trail 105 arranged so that at least one point 103C, 113C of the securing member introduction device 103, 113 travels along said first guiding trail 105, when operated. In this way the medical securing device can control the movement of the distal end 103B, 113B of the securing member introduction device 103, 113 in a defined manner when extending from the sheath 101, and introduce the securing member 102 to the object 400A, 400B and again to secure the object to the tissue 20 with the securing member 102. The movement or trajectory of the distal end 103B, 113B can be pre-defined by selecting the form or shape of the first guiding trail in an appropriate manner.

[0034] The medical securing device 100 comprises advantageously also a retrieval device 104, 114 for capturing at least portion of the securing member 102 introduced by the securing member introduction device 103, 113. The retrieval device 104, 114 comprises proximal 104A, 114A and distal 104B, 114B ends, and the distal end 104B, 114B is configured to extend from the sheath 101. After capturing said portion the device is arranged to secure the portion of the securing member 102 to the object 400A, 400B and/or to the tissue 20. The object is advantageously an implant device 400A, 400B, but can also be for example another portion of the tissue or a portion of another tissue to be secured to the tissue.

[0035] The medical securing device comprises advantageously also a second guiding trail 106 arranged so that at least one point 104C, 114C of the retrieval device 104, 114 travels along the second guiding trail 106, when operated. In this way the medical securing device can control the movement of the distal end 104B, 114B of the retrieval device 104, 114 in a defined manner when extending from the sheath 101 and allowing the capture of the portion of the securing member 102.

[0036] The first and/or second guiding trails 105, 106 are advantageously implemented by grooves or slots or the like, which are configured to control the movement of the distal ends 103B, 113B, 104B, 114B of the securing member introduction device 103, 113 and retrieval device 104, 114 during the operation and moving of the securing member introduction device 103, 113 and retrieval device 104, 114. The first and/or second guiding trails 105, 106 are advantageously arranged into the distal end 101B or the medical securing device or the sheath 101, as can be seen especially in FIGS. 3A-3C and 4A-4D.

[0037] According to an advantageous embodiment the guiding trails 105, 106 are non-linear guiding trails, as can be seen e.g. in FIGS. 3A-3C. The guiding trails 105, 106 can be implemented, depending on the design of the medical securing device, in different ways. The form of the guiding trails 105, 106 can be for example an extended S letter or an integral sign, as is the case in FIGS. 3A-3C and where the first and second guiding trails 105, 106 cross each other and extend from the first side of the elongated sheath 101 to the second opposite side of the elongated sheath 101 (so from left to right and other from right to left, vice versa). An alternative implementation is illustrated in FIGS. 4A-4D, where the first guiding trail 105 has a curvature form or shape and the second guiding trail 106 is a linear or straightforward groove or slot. Anyway, in all cases the guiding trails 105, 106 are arranged so that when extending the distal ends 103B, 113B, 104B, 114B from the sheath 101, said defined movement of the distal ends 103B, 113B, 104B, 114B is achieved and that the movement is in addition a non-linear movement. This allows to manufacture a very narrow and small sheath portion or device. In addition to guiding trails there might also be additional guiding members for guiding especially the movements of the distal ends 103B, 113B, 104B, 114B, such as a spring 119A in FIGS. 3A-3C or a structural arrangement like a tapered canal portion 119B in FIGS. 4A-4D through which the body or arm of the securing member introduction and retrieval devices 113, 114 must travel.

[0038] The retrieval device 104, 114 comprises also a facing element 115, 116 at the distal end 104B, 114B of it for facing or receiving the distal end 103B, 113B of the securing member introduction device 103, 113 and thereby for guiding said distal ends 103B, 113B, 104B, 114B to meet each other. During facing the portion of the securing member 102 is introduced to the distal end 104B, 114B of the retrieval device 104, 114B, thereby allowing the retrieval device 104, 114 to capture the portion of the securing member 102 and to secure the portion of the securing member 102 to the object 400A, 400B and/or to the tissue 20. The facing element 115, 116 at the distal end 104B, 114B may be e.g. a hole or through hole or a slit or gap 115. Also other types of facing elements can be applied, such as tip portion 116 with thick or expansion circumference area. In addition it is to be noted that the facing element 115, 116 can be provided with an additional element for guiding and facilitating the receiving of the securing member, such as with a suction or under pressure providing element 125 (see FIG. 10A) or with a hook-shaped portion 126 (see FIG. 10B) so to engage and capture at least a portion of said securing member 102, such as advantageously the suture.

[0039] The securing member introduction device 103, 113 and/or the retrieval device 104, 114 may be operated by using an operation arm 124, which is advantageously in the proximal end 101A of the medical securing device 100 or the sheath 101. The operation arm 124 is advantageously coupled with an actuating members 117, 118, and configured to cause during an operation of it back-and-forth movements 110 of the actuating members and thereby a back-and-forth movements (out-in movements in relation to the sheath) of the securing member introduction device 103, 113 and/or the retrieval device 104, 114, correspondingly.

[0040] Depending on the embodiment an order of the securing member introduction device 103, 113 and/or the retrieval device 104, 114 can vary. For example in relation to the medical securing device 100 illustrated in FIGS. 3A-3C, the retrieval device 104 is configured to be extended from the sheath 101 before the securing member introduction device 103. In more details, during the operation, the retrieval device 104 is configured to move at first out from the sheath 101 so that the distal end 104B of it makes advantageously a non-linear movement so that it is able to curve into the “back side” of the object 400A, 400B, as can be seen in FIG. 3B. Right after this the securing member introduction device 103 is configured to move out from the sheath 101 so that the distal end 103B of it makes advantageously a non-linear movement so that it is also able to curve into the “back side” of the object 400A, 400B, as can be seen in FIG. 3C, and additionally to meet the facing element 115 of the retrieval device 104.

[0041] In this particular embodiment (FIGS. 3A-3C) the facing element 115 of the retrieval device 104 comprises a hole or a slot 115 through which the distal end 103B of the securing member introduction device 103 moves in a back-and-forth manner. According to an example the securing member introduction device 103 moves at first into or through the facing element 115 and introduces the portion of the securing member 102 to the facing element 115, such as for example a knot or other expansion portion of the suture to the edge portion of the hole or slit type facing element 115. The retrieval device may move little bit back, thereby capturing the portion of the securing member 102, such as the knot or expansion portion of the suture to the edge portion of the hole or slit. After this the securing member introduction device 103 moves back and away from the hole or slit type facing element 115.

[0042] Next, depending on the application, either the securing member introduction device 103 and the retrieval device 104 with the portion of the securing member 102 may both move essentially at the same time back to the sheath 101, or alternative the securing member introduction device 103 may move as first and the retrieval device 104 as a second. If the both are moving back in the same time, a forming of a possible loop of a suture 102 can be avoided, which can otherwise even cause damages to the tissue or making damages to the suture itself, if e.g. the securing member introduction device 103 is moved back first, and letting thereby the suture make an additional loop (between the distal ends 103B, 104B), before the retracting of the retrieval device 104.

[0043] When retracting the securing member introduction and retrieval devices 103, 104, the portion of the securing member 102 is advantageously secured to the object 400A, 400B and/or to the tissue 20.

[0044] Another example is illustrated in FIGS. 4A-4D, where the securing member introduction device 113 is configured to be extended from the sheath 101 before the retrieval device 114. In more details, during the operation, the securing member introduction device 113 is configured to move at first out from the sheath 101 so that the distal end 113B of it makes advantageously a non-linear movement so that it is able to curve into the “back side” of the object, as can be seen in FIG. 4B. Right after this the retrieval device 114 is configured to move out from the sheath 101 so that the distal end 114B of it makes advantageously a non-linear movement so that it is also able to curve into the “back side” of the object 400A, 400B, as can be seen in FIG. 4C, and additionally to allow the facing element 116 of the retrieval device 114 to meet the distal end 113B portion of the securing member introduction device 113.

[0045] When meeting the distal end 113B portion of the securing member introduction device 113, the retrieval device is configured to capture the portion of the securing member 102, such as the suture, as is illustrated in FIG. 4D. When retracting the securing member introduction and retrieval devices 113, 114, the portion of the securing member 102 is advantageously secured to the object 400A, 400B and/or to the tissue 20.

[0046] It is to be noted that the securing member introduction device 113 and the retrieval device 114 may both move essentially at the same time back to the sheath 101, or alternative the retrieval device 114 may move as first and the securing member introduction device 103 as a second. If the both are moving back in the same time, a forming of a possible loop of a suture can also be avoided, as is the case with embodiment illustrated in FIGS. 3A-3C.

[0047] In this particular embodiment (FIGS. 4A-4D) the facing element 116 of the retrieval device 114 may comprise different implementations, as described elsewhere in this document, especially in FIGS. 7, 8, 9 and 10A-10B. The facing element 116 may comprises e.g. the extension portion, and the distal end 113B of the securing member introduction device 113 a counterpart portion 107, such as a snap locking member with a tongue 107A to catch the extension portion 116, or a magnet, to which said portion of said securing member 102 is caught and attached. In this case the counterpart portion 107 with the portion of the securing member 102 is advantageously captured by the facing element 116, like the extended tip portion of the retrieval device 114 thereby allowing the retrieval device 114 to capture the portion of the securing member 102. As an example the capturing is performed during in a single back-and-forth movement of the retrieval device 104, but it is to be noted, that depending on the implementation, also number of successive back-and-forth movements can be performed.

[0048] In addition or alternatively the facing element 116 of the retrieval device 114 may comprise a suction or under pressure providing element 125 (as described in FIG. 10A), whereupon when facing with the distal end 113B securing member introduction device 113, the facing element 116 may capture the portion of the securing member, such as the suture, by the suction or under pressure. Still in addition the facing element 116 of the retrieval device 114 may comprise a hook-shaped portion 126 so to engage and capture at least a portion of said securing member 102, such as the suture, as described in FIG. 10B.

[0049] An additional example of the hook-shaped portion 126 is illustrated in FIG. 10C, where the securing member introduction device 113 (advantageously at its distal end) comprises radially displaceable arms 127A, 127B holding the suture 102. The radially displaceable arms 127A, 127B can be pushed out from the securing member introduction device 113 (e.g. a catheter type), thus resiliently biased to diverge and to form an extended shape and to introduce the suture so to form a looped form, or a protrusion portion with a portion of the suture 102, as can be seen in FIG. 10C. The hook-shaped portion 126 can thereby engage and capture the portion of said looped shape suture 102.

[0050] It is to be noted that the facing element 116 with the suction or under pressure providing element 125 or with the hook-shaped portion 126 may also be actuated without any counterpart portion 107.

[0051] According to an embodiment the actuating member 117, 118 may comprise or at least be coupled with a spring and/or pre-stringed spring 128, pressure accumulator 129 or hydraulic or pneumatic arrangement 130 for facilitating or providing at least one direction of the movement of said back-and-forth movement of the securing member introduction device 103, 113 and/or retrieval device 104, 114. For example, a first pre-stringed spring 128 or pressure accumulator 129 may trigger the out-movement of the securing member introduction device and/or retrieval device, whereupon the back-movement (in) is triggered by the spring or pre-stringed spring 128. Naturally, also other combination can be applied and the force transmission to the actuating member 117, 118 or the securing member introduction and/or retrieval devices can be applied via hydraulic arrangement 130 including also hydraulic hose 131.

[0052] FIGS. 6A and 6B illustrate examples of the medical securing device 100 and especially of the sheath portion 101, where the opening angle α or distance d between the securing member introduction device 113 and retrieval device 114 can be controlled via an hinge 132 or a rail 135, such as opening or closing the angle or the distance. Advantageously the controlling of the opening angle α or distance d can be operated by the operation arm 124. In addition, as can be seen in FIG. 6B, also the distance d between the securing member introduction device 113 and retrieval device 114 can be controlled so that the distance d of both the distal and proximal ends of the sheath 101 can be changed. These allow to control the amount of the tissue to be received between the devices, and thus also the settling and locating of the securing member, like the suture, can be accurately controlled. In addition also the trajectory of the distal ends 103B, 113B, 104B, 114B can be controlled by manipulating the opening angle α or distance d.

[0053] In addition it is to be noted that according to an embodiment also the form or at least one point of the guiding trail 105, 106, such as the proximal end 105A, 106A of the guiding trail can be adjusted 133, controlled or otherwise manipulated and thereby the movement track or trajectory of the distal end of the securing member introduction device and/or retrieval device can be changed in an appropriate manner in view of the object. The medical securing device 100 comprises advantageously an adjusting device 134 for adjusting 133 the form or shape or other parameters of the guiding trail.

[0054] In addition the medical securing device 100, in particularly the sheath 101 may also comprise a conduit 108 between the proximal and distal ends 100A, 100B (101A, 101B) for receiving at least one guiding wire 109 coupled with the object to be secured (optional feature), as is described in FIGS. 13 and 16. If the object to be secured is provided with the guiding wire 109, the distal end 109B of is advantageously fixed to the object 400A, 400B so to guide the device along said guiding wire and to support a support portion 101C or a special recess 121 of the distal end 101B of the elongated sheath 101 to the object 400A, 400B to be secured. In addition the medical securing device 100 may also comprise a cutting member 123 for cutting the guiding wire 109 in the vicinity of the object 400A, 400B or the tissue 20. The device 100 may also comprise a cutting member 123 for cutting the suture (as the securing member) by which the object is secured.

[0055] Moreover medical securing device 100, in particularly the sheath 101 may also comprise a conduit 108 between the proximal and distal ends thereof for introducing under pressure into the distal end 101B or to a support portion 101C, 121 of the elongated sheath 101 as is described in FIG. 12. The under pressure is provided in order to suck and thereby to support the elongated sheath 101 or the support portion 101C, 121 to the object 400A, 400B or to the tissue 20 via the force induced by the under pressure and/or for applying counterforce for the introduction movement 110 of the securing member 102.

[0056] The medical securing device 100 or more precisely the distal end 101B of the elongated sheath 101 may also comprise a locking member 111, which is advantageously configured to lock the distal end 101B of the elongated sheath 101 to the object 400A, 400B or to the tissue 20, as can be seen in FIG. 17. The locking member 111 can be implemented e.g. by a finger or spring, and it might be made of or comprise shape memory material. It may be operable also from the proximal end of the elongated sheath so via operation arm 124, for example. In addition, as can be seen in FIGS. 15 and 17, the elongated sheath can be bendable (like a bendable and controllable catheter), whereupon it can be more easily directed into a right position, as well as that the securing member introduction device 103, 113 and retrieval device 104, 114 can be retracted into the sheath 101 so that no tip portion is located outside the sheath 101, thereby avoiding or at least minimizing any damage to the artery or other anatomical structures of the patient in question during inserting the distal end of the medical securing device 100.

[0057] FIG. 11 illustrates an example of the medical securing device 100 with the proximal and distal ends 100A, 100B. It is to be noted that the medical securing device 100 may comprise a catheter type shield 134 structure in connection with the elongated sheath 101, for example to provide the secure members, such as the suture, so that it is covered during the operation.

[0058] In addition, according to an embodiment the distal end 101B of the elongated sheath 101 may also comprises a guiding trail 112, such as a groove or slot or the like, as is described in FIG. 18. Respectively the tip portion of the securing member introduction device 103, 113 and/or the retrieval device 104, 114 may also comprise a projection 120 as a counterpart for the guiding trail (or vice versa). The guiding trail 112 and projection 120 thereby guide the tip portion of the securing member introduction device and/or the retrieval device so to pierce the tissue 20 without substantive twisting around the longitudinal axis of the tip portion of the device. By this it can be ensured that the position or angle of the distal portions 1038, 1138, 1048, 114B of the securing member introduction device 103, 113 and/or the retrieval device 104, 114 is in a right or suitable position in relation to the object 400A, 400B, for example.

[0059] The invention has been explained above with reference to the aforementioned embodiments, and several advantages of the invention have been demonstrated. It is clear that the invention is not only restricted to these embodiments, but comprises all possible embodiments within the spirit and scope of the inventive thought and the following patent claims. For example the object to be secured may be e.g. the cardiac implant (for example annuloplasty ring) device, but also other type of object can be secured, as is demonstrated and described in the description, In addition different kinds of securing members can be used, even if the suture is mentioned in the connection with most applications. In particularly it is to be understood that the invention can be applied as a catheter-operated or cannula-operated medical securing device 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. However, the principle of the invention can also be applied for an open-heart operated medical securing device, as well as securing also other object as only the cardiac implant devices, such as tissue or skin transplant beneath the skin or the like. In addition the invention can also be used for securing an artificial heart valve, for example.

[0060] Further, even if the facing elements 115, 116 are described to be located in connection with the retrieval device 104, 114, it should be understood that the facing elements 115, 116 can also be provided into the distal end 1038, 1138 of the securing member introduction device 103, 113, correspondingly.

[0061] The features recited in dependent claims are mutually freely combinable unless otherwise explicitly stated.