Apparatus and set for folding or unfolding a medical implant comprising a clamping mechanism, implant and method
09795479 · 2017-10-24
Assignee
Inventors
Cpc classification
A61F2002/9511
HUMAN NECESSITIES
A61F2/95
HUMAN NECESSITIES
A61F2/9522
HUMAN NECESSITIES
International classification
A61F2/95
HUMAN NECESSITIES
Abstract
The present invention relates to an apparatus (100) for folding or unfolding at least one medical implant (300) by using at least one tension thread (11, 11′), wherein the apparatus (100) includes a shaft (1) including a reception area for receiving the implant (300), a tensioning device for altering a shape of the foldable and/or unfoldable implant (300) by the tension thread (11, 11′), and a clamping mechanism for clamping at least one section of at least one of the tension threads (11, 11′). The present invention further relates to a set and a method.
Claims
1. An apparatus for folding or unfolding at least one medical implant by using one or more tension threads, wherein the apparatus includes: a shaft including a reception or retaining area for receiving the implant; a tensioning device for altering a shape of the foldable and/or unfoldable implant by using at least one of the one or more tension threads or by using at least one first string connected to the one or more tension threads; and a clamping mechanism configured for engaging and clamping at least one section of at least one of the one or more tension threads.
2. An apparatus according to claim 1, comprising: a releasing device for releasing the clamped section of the one or more tension threads from the implant or from the clamping mechanism by releasing the clamping mechanism.
3. An apparatus according to claim 2, wherein the clamping mechanism is adapted for clamping the at least one section of at least one of the one or more tension threads between a first clamping section of the apparatus and a second clamping section of the apparatus, or wherein the clamping mechanism consists of the first and second clamping sections.
4. An apparatus according to claim 1, wherein the clamping mechanism is adapted for clamping the at least one section of at least one of the one or more tension threads between a first clamping section and a second clamping section, or wherein the clamping mechanism consists of the first and second clamping sections.
5. An apparatus according to claim 4, wherein the first clamping section and the second clamping section are arranged such that at least one of them is slidable relatively to the other.
6. An apparatus according to claim 4, wherein the first clamping section and the second clamping section are arranged such that they are inclined relative to the longitudinal axis of the apparatus, the shaft, and/or the reception or retaining area for receiving the implant.
7. An apparatus according to claim 4, wherein the second clamping section is arranged in an inner space of the first clamping section.
8. An apparatus according to claim 4, wherein the first clamping section and the second clamping section are arranged such that at least one of them may slide relatively to the other.
9. An apparatus according to claim 4, wherein the first clamping section and the second clamping section are arranged such that they are inclined relative to the longitudinal axis of the apparatus the shaft, and/or the reception or retaining area for receiving the implant.
10. An apparatus according to claim 4, wherein the second clamping section is arranged in an inner space of the first clamping section.
11. An apparatus according to claim 1, wherein an interior of the shaft is permeable or may be passed in at least sections thereof in the longitudinal direction of the shaft, wherein the shaft has a wall, wherein the shaft includes at least one shaft aperture, through which the one or more tension threads for folding and/or unfolding the implant may enter and/or exit.
12. An apparatus according to claim 1, wherein the implant is a stent or a cardiac valve assembly.
13. An apparatus according to claim 1, wherein the apparatus and the at least one medical implant are connected with the one or more tension threads or with a set of tension threads for folding or unfolding the at least one medical implant.
14. An apparatus according to claim 13, wherein the set of tension threads comprises at least one first string, at least a first tension thread, and at least a second tension thread, wherein the first string comprises a first guiding element for guiding through the first tension thread and a second guiding element for guiding through the second tension thread, and wherein both the first tension thread and the second tension thread are attached with the first string.
15. An apparatus according to claim 14, wherein at least one of the first guiding element and the second guiding element is a ring.
16. An apparatus according to claim 14, wherein the first string is connected to at least six tension threads, at least three of the at least six tension threads being guided through the first guiding element, and at least three of the at least six tension threads being guided through the second guiding element.
17. An apparatus according to claim 14, wherein the first tension thread is connected to the first string at a first end section of the first string, and the second tension thread is connected to the first string at a second end section of the first string.
18. A medical implant comprising a set of tension threads for folding or unfolding the medical implant or being connected or provided herewith, the set of tension threads being designed as set forth claim 13.
19. An apparatus according to claim 1, wherein the clamping mechanism is configured to release the one or more tension threads such that the one or more tension threads are removable from the at least one medical implant.
20. An apparatus according to claim 1, wherein the clamping mechanism includes a first clamping surface and a second clamping surface, the at least one section of at least one of the one or more tension threads being sandwiched between the first clamping surface and the second clamping surface.
21. A set of tension threads for folding or unfolding at least one medical implant, the set of tension threads comprising: at least one first string, at least a first tension thread and at least a second tension thread, wherein the first string comprises at least a first guiding element for guiding through the first tension thread and a second guiding element for guiding through the second tension thread, the first guiding element being configured to be moveable relative to the second guiding element and wherein both the first tension thread and the second tension thread are attached with the first string.
Description
(1) In the following, examples of the present invention will be described with reference to the accompanying figures wherein similar or identical assemblies or elements are denoted by same reference numbers.
(2)
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(21)
(22) A first tension thread 11 and a second tension thread 11′ are arranged around the implant 300. As can be seen from
(23) In the exemplary embodiment of
(24) Also by way of example, two, three or more posts 305 are arranged between the first guiding structure 303 and the second guiding structure 303′. The posts 305 each comprises one, two or more openings 307 for letting pass the first or second tension threads 11, 11′ from an inside of the implant 300 to on outside thereof.
(25) The posts 305 may be configured to keep the distance between the first guiding structure 303 and the second guiding structure 303′.
(26) In the example of
(27) The apparatus 100 has a shaft 1 having a lumen covered by a wall (depicted with reference numeral “3” in, e.g.,
(28) The pulling threads 17 are integral with or interconnected to threads 11 and 11′ which are guided along the circumference of implant 300 at different levels—by the first and the second guiding structure 303 and 303′—thereof such that pulling or releasing the pulling threads 17 makes the threads 11 and 11′ to exert more or less force on the implant 300 as it is also described in the patent application published under WO 2011/063972 A1This way, operating the pulling threads 17 may provide for a change in one or more cross-section dimensions of the implant 300. The respective disclosure of WO 2011/063972 A1 is incorporated into the present specification by reference.
(29) The threads 11 and 11′ enter into the lumen of shaft 1 by apertures 9 not shown in
(30) The expansion of implant 300 may benefit in the present exemplary embodiment from the internal stress or from shape-memory capacities of implant 300. The implant 300 may be manufactured from Nitinol or comprise such material. In order to expand the implant 300, the pulling threads 17 need, however, to be sufficiently released. For folding the implant 300 again, the pulling threads 17 are tightened again.
(31)
(32) In
(33)
(34)
(35) Shown in part section is an outer protective sleeve 53 which gives protection to a retaining area 55 for the implant 300. In the example of
(36) The implant 300 is held by the threads 11 and 11′ in a restrained or folded state in which it is not expanded.
(37)
(38)
(39) Shaft 1 features an arbitrary number of apertures 9, at one, two (as shown in
(40) The shaft apertures 9 extend through the entire thickness of the wall of shaft 1 and, hence, interconnect the lumen or inner space of shaft 1 with the exterior of shaft 1.
(41) The shaft apertures 9 may be evenly spaced from each other around the circumference of shaft 1. Alternatively, they may be divided with at least two different distances from each other around the circumference.
(42)
(43) In
(44) For example, the first clamping section 61 may be slid or moved towards the tip 51 into a clamping position in a direction indicated by the arrow C (for clamping). In this position, the section of the not shown thread would be clamped between the first and the second clamping section. In this particular and exemplary embodiment, the second clamping section 63 may be slid away from the tip 51 into a release position in a direction indicated by the arrow R (for releasing). In this position, the section of the not shown thread would not be clamped any longer between the first and the second clamping section. In the particular exemplary embodiment of
(45) As discussed above, in
(46) In
(47) By way of example, for the ease of moving the first clamping section 61 into the release position shown in
(48) It goes without saying that everything that has been stated herein for the first clamping section 61 may in further exemplary embodiments according to the present invention which are not shown in the figures also hold true for the second clamping section 63, and vice versa. For example, it may be the second clamping device 63 that is retractable or movable (in whatsoever direction) with regard to the first clamping device 61, in contrast to what is depicted in
(49) In the example of
(50) Further, the shaft 1, the first clamping section 61 or any other part of the apparatus 100 and the retracting device, or release device interconnected with the first clamping section 61 by the thread 67 (shown in
(51) Furthermore, the shaft 1 may have a further groove, sliding block guiding, slotted guide or the like to avoid twisting or rotation of retracting device, or release device with regard to the shaft.
(52)
(53)
(54) In
(55)
(56)
(57) The first clamping section 61 comprises two indentations 75 which together form a groove in which a bulge 77 may be moved in a direction perpendicular to the plane of projection of
(58)
(59) In the exemplary embodiment of
(60) The inclined surface 63′ of the second clamping section 61′ may be part of a collar 79 of the second clamping section 61′.
(61) In the particular embodiment of
(62)
(63) The set 200 of tension threads comprises in the exemplary embodiment of
(64) The first string 201 comprises a first guiding element 203 for guiding through the first tension thread 211 and a second guiding element 203′ for guiding through the second tension thread 211′. Both the first tension thread 211 and the second tension thread 211′ are attached to the first string 201.
(65) In the exemplary embodiment of
(66) For example, the first tension thread and/or the second tension 11, 11′ thread may be knotted to or integral with the first string 201.
(67) Both the first and the second tension thread 11, 11′ are folded into loops 13 and 13′. By these loops 13, 13′ the threads 11, 11′ may be inserted into the guiding structures 303 and 303′ (not shown in
(68) In the exemplary embodiment of
(69) As can be seen in
(70) As can be further seen in
(71) Finally, as can also be seen in
(72)
(73) As can be seen, all free ends of the six tension threads 11, 14, 15, 11′, 14′, 15′ (i.e., those ends which are not fixedly connected with the first string 201) are clamped by the common first and second clamping sections 61, 63. However, some of the tension threads may as well be clamped by a first clamping mechanism that is different from a second clamping mechanism as this is shown, e.g., in
(74)
(75)
(76) As can be seen in
(77) For moving the first clamping section 61 along the longitudinal axis, a first connecting device 81 is provided. The first connecting device 81 may have a crown-shaped end, it may comprise a gear pattern, it may have teeth or any other engagement device, due to space constraints preferably at its front surface (not on its sided surface), configured to be engageable with a second, rotably arranged connecting device (not shown) of the apparatus 100 (not of the tip) in a manner such that via rotating the second connecting device the first connecting device 81 may be rotated.
(78) The first connecting device 81 comprises threads on an outer surface thereof. Also, there are matching threads on an inner surface of the first clamping section 61.
(79) Any rotation of the first clamping section 61 is precluded or avoided by a longitudinal, straight slot provided in a (preferably inner) side or on a circumferential surface of the first clamping section 61 (e. g. by cutting) and a protrusion such as a pin that is arranged within this slot: the first clamping section 61 can only pass by the pin while the pin is guided inside the slot. That way, the first clamping section 61 can be moved to or away from the second clamping section 63 simply by rotating the first connecting device 81. The last named element may be considered as a rotational clamping mechanism. By the rotational clamping mechanism, the clamping surfaces do not rotate in relation to each other. The advantage that comes along with this is that the tension threads to be clamped do neither become damaged nor displaced because of any rotation of the clamping surfaces.
(80) Instead of the slot, a groove might also be provided.
(81) Also, the protrusion such as the pin might as well be a recession whereas the instead of the slot a protrusion might be arrange. In other words, it does not matter whether the first clamping section 61 comprises the slot and the wall 3 comprises the pin, or the other way round.
(82) In the particular exemplary embodiment of
(83) The first connecting device 81 comprising the crown is a tube with inner threads that engages the outer threads of 61. When the first connecting device 81 is rotated, it remains at its place with regard to the longitudinal axis of the tip. Its distance to the second clamping section 63 does never change. It does not move in translation. Only, because of the threads the first clamping section 61 is moved towards the clamping hole 65 or away from it. The first connecting device 81 is arranged on an outside of the first clamping section 61, whereas the first clamping section 61 is arranged on an outside of the wall 3.
(84) In other words, the tip of the apparatus 100 comprises a rotational clamping mechanism while the clamping surface as such are arranged so as not to be rotated.
(85) In
(86) As can be seen in
(87) As can be seen in
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(92) By means of the rotational mechanism any longitudinal actuations by the user in order to unclamp the tension threads can be avoided. This is of advantage because longitudinal operations hampers precise positioning of the device: If one of the clamping sections has to be push or pulled (instead of rotated), a counteracting force on the apparatus or the main catheter is required. That counteracting force may result in that the desired position of the implant will change due to this action. This is avoided by the rotational clamping.
REFERENCE NUMERALS
(93) 100 apparatus 200 set 201 first string 203 first guiding element of the first string 203′ second guiding element of the first string 205 first end section of the first string 205′ second end section of the second string 300 implant 303 first guiding structure of the implant 303′ second guiding structure of the implant 305 post 307 opening 1 shaft 3 wall of shaft 1 9 apertures 11 first tension thread(s), also 14, 15 11′ second tension thread(s), also 14′, 15′ 12 first end section of first tension thread 12′ first end section of second tension thread 13 loop of the first tension thread 13′ loop of the second tension thread 17 pulling thread 51 tip 53 external protective sleeve 55 reception/retaining area 57 collar 61 first clamping section 63 second clamping section 65 clamping holes 67 thread 69 bayonet coupling 71 handle of releasing device 75 indentations 77 bulge 79 collar 81 first connecting device 83 thread L longitudinal direction C direction of clamping R direction of release or unclamping I space for the first guiding structure of the implant II space for the second guiding structure of the implant