WO2012084178A2 - Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant and method - Google Patents

Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant and method Download PDF

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Publication number
WO2012084178A2
WO2012084178A2 PCT/EP2011/006410 EP2011006410W WO2012084178A2 WO 2012084178 A2 WO2012084178 A2 WO 2012084178A2 EP 2011006410 W EP2011006410 W EP 2011006410W WO 2012084178 A2 WO2012084178 A2 WO 2012084178A2
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
implant
fibers
tension
present
Prior art date
Application number
PCT/EP2011/006410
Other languages
French (fr)
Other versions
WO2012084178A3 (en
Inventor
Wolfgang Goetz
Hou-Sen Lim
Original Assignee
Transcatheter Technologies Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Transcatheter Technologies Gmbh filed Critical Transcatheter Technologies Gmbh
Priority to CA2820592A priority Critical patent/CA2820592C/en
Priority to US13/996,542 priority patent/US10010415B2/en
Priority to EP15169197.9A priority patent/EP2954872B1/en
Priority to CN201180061202.1A priority patent/CN103338725B/en
Priority to JP2013543576A priority patent/JP6027540B2/en
Priority to EP11801611.2A priority patent/EP2654616B1/en
Publication of WO2012084178A2 publication Critical patent/WO2012084178A2/en
Publication of WO2012084178A3 publication Critical patent/WO2012084178A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires

Definitions

  • Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant and method
  • the present invention relates to an apparatus according to claim 1 for folding or unfolding an implant, and a set according to claim 11. It further relates to a method
  • implants are known that can be folded and/or unfolded by means of one or more threads transferring tension onto the implant. Furthermore, respective apparatuses for folding and unfolding are known from practice.
  • One object of the present invention is to propose a further apparatus for folding or unfolding a foldable and/or
  • an apparatus for inserting and/or folding and/or unfolding an implant by means of at least one tension thread is proposed.
  • the apparatus according to the present invention comprises a shaft.
  • the apparatus comprises at least one tensioning device for altering a form or shape, a geometry or a folding state of the foldable and/or unfoldable implant by means of the at least one tension thread.
  • the shaft of the apparatus comprises in at least one shaft section thereof a plurality of individual shaft fibers.
  • altering a form or shape of the implant means reducing or increasing a diameter, in particular an outer diameter, of the implant. Alterations of the diameter may be accompanied by any kind of alteration of the implant's length or any other alteration, or may be not.
  • folding the implant means reducing the implant's diameter.
  • folding is to be understood as increasing a diameter of the implant .
  • the implant's diameter is present in a plane perpendicular to a main flow direction of the implant, in case the implant is flown through by a fluid after its implantation.
  • the at least one tension thread is a thread or filament or yarn, respectively. It can be designed or embodied similar to a surgical sutural thread or it can be such a surgical sutural thread. It can be designed or
  • It can be designed or embodied as a chain comprising a plurality of chain members engaged with adjacent chain members.
  • the shaft of the apparatus is in at least one section thereof embodied rigidly.
  • the shaft of the apparatus is in at least one ' section thereof embodied such as to be bendable in one or more directions (i. e. it may be bent in a longitudinal direction or in a direction of the shaft' s width, in both directions or in any other direction) .
  • the shaft is embodied extendably or stretchably.
  • the shaft is embodied stiffly or inflexibly.
  • the implant during its implanted implantation state, the implant is able to be penetrated by fluids or is permeable for fluids, respectively, in its longitudinal direction.
  • the terms "permeable” or “able to be penetrated” hereby refer to the ability of the implant to be penetrated or flown through by fluids.
  • the implant in the moment of unfolding or folding, the implant is loosely arranged or attached to or at or on a receiving area of the apparatus. In some embodiments according to the present invention, the implant is thereby connected with the receiving area only by means of the tension threads.
  • the tension thread comprises or consists of a bundle or a plurality of threads or thread elements.
  • a shaft fiber of the apparatus is permeable or patent (like blood vessel) within its interior in at least sections of longitudinal direction or along its entire length.
  • the shaft fiber comprises a wall.
  • At least one of the tension threads (or all of them) is partly arranged within an inner space of the respective shaft fiber and extends from there to an outside of the shaft fiber through the shaft opening.
  • At least one of the tension threads (or all of them) exits from an inner space of the shaft fiber through one shaft opening. In other embodiments, at least one of the tension threads (or all of them) exits from the inner space through two or more shaft openings.
  • the at least one shaft opening is provided at or on the front surface of the shaft fiber. In other embodiments according to the present invention, it is arranged at or on a circumferential surface or lateral surface area of the shaft. Preferably, the shaft opening is arranged in or within a tip area of the shaft fiber or in or within a proximal area of the shaft fiber.
  • the shaft fiber comprises a plurality of shaft openings uniformly or non-uniformly distributed or arranged along or about a periphery or along or about a circumferential surface or lateral surface area of the shaft or of the shaft fiber. Additionally or alternatively, the shaft openings may be dispersed along or about a longitudinal direction of the shaft or of the shaft fiber.
  • shaft fibers may have two or more shaft openings which are arranged under different distances between the respective opening and the tip or one end of the corresponding shaft fiber.
  • At least one or all of the shaft fibers are arranged such that they do no move relatively to the apparatus according to the present invention in a longitudinal direction of the
  • tension threads for folding and/or unfolding the implant enter and/or exit through the shaft opening.
  • shaft fibers of the plurality of individual shaft fibers are always present in bundled form in at least one first section of the shaft section.
  • they are provided for moving or drifting away from each other during use of the apparatus.
  • the second section is closer to the tip of the apparatus than th first section.
  • the first section directly merges with or passes over into the second section.
  • the individual shaft fibers are arranged in contact to each othe in the first section such that there is no lumen such as, e. g., a central lumen, for example a lumen usable during the use of the apparatus for fulfilling particular functions, provided between the shaft fibers in the first section.
  • a central lumen for example a lumen usable during the use of the apparatus for fulfilling particular functions
  • the shaft fibers are arranged closely or at close quarters.
  • the term "individual shaft fibers" - when used discretely - comprises all shaft fibers present of the plurality of the entirely present individual shaft fibers; in other
  • the number of individual shaft fibers is set to two shaft fibers; in other embodiments, the number is set to three, four, five, six, seven etc.
  • the number may be a great number it may exceed ten or twenty and comprises every natural number up to at least 30 or 40.
  • a great number of individual shaft fibers advantageously allows for separating the part or rim portion of the implant (for example, the periphery of the implant) which experiences an action by means of the tension threads for
  • portions upon attaching the tension threads at or on the implant favors a uniform folding or unfolding the implant. Additionally, such dividing into a great number of sections may advantageously avoid any
  • a great number can be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present invention as well.
  • neither the individual shaft fibers nor sections thereof are arranged within the interior or material of a wall of an envelope, an outer boundary or limitation, or the like of the apparatus .
  • the individual shaft fibers are provided such that they cannot be shifted or moved relative to the
  • shaft fibers of the plurality of individual shaft fibers each comprise one or more shaft openings.
  • the one or more tension threads can enter into and/or exit from the respective shaft fiber through the shaft openings.
  • such shaft openings are solely provided for allowing tension threads to enter in or into and/or leave or exit from the respective individual shaft fiber.
  • the individual shaft fibers are designed or embodied to comprise one or more through-openings (extending into a longitudinal direction of the shaft fiber) or one or more hollow
  • These through-openings or hollow interiors may allow guiding one or more tension threads through the shaft fiber, e. g. from the tensioning device of the apparatus to a shaft opening or to an exit opening at the tip portion of the shaft fiber.
  • the tension threads are arranged within an interior of the shaft fibers such that they can be shifted or moved relative to the respective shaft fibers.
  • the individual shaft fibers and/or the tension threads do not comprise any devices for establishing a hook engagement with the implant.
  • some or all of the tension threads are connected with the implant by solely entangling or entwining the implant or a part or section or portion thereof.
  • shaft fibers of the plurality of individual shaft fibers are arranged movably in or forth from (in the direction towards the tip of the apparatus) at least the second section of the shaft respectively independently of each other and/or
  • the shaft comprises in at least one section thereof a device for bundling individual shaft fibers of the plurality of individual shaft fibers.
  • more than just one device for bundling but two, three, four, and so on, devices of this kind.
  • the device for bundling comprises not just one means, e. g.
  • the individual devices or means are provided on the shaft fibers while being spaced apart from each other.
  • the particular space or distance chosen or set may advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers. This may be true for the shaft fibers' parts arranged between the devices or means for bundling. It may also be true for the parts of the shaft fibers that are not bundled but allowed to move freely with regard to each other.
  • a (that is, one or more) core element or a (that is, one or more) interconnecting element is provided on, at or within the bundle of shaft fibers.
  • the core element or interconnecting element may also advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers.
  • the core element or interconnecting element may be attached to one, two or all of the devices or means for bundling. However, it may not be attached as well.
  • the core element or interconnecting element may be provided to be extendable and to change its length, for example, when a distance between neighbouring, adjacent or interacting devices for bundling or means for bundling is changed or adapted to need.
  • Both providing more than only one device for bundling or means for bundling and providing a core element or the like may in certain embodiments of the present invention allow for keeping the shaft fibers in parallel in use along a certain or even predetermined distance. Again, this may also
  • the device for bundling is designed or embodied as a ring encompassing the individual shaft fibers to be bundled and inhibiting the shaft fibers from drifting or moving away from each other.
  • the device for bundling is designed or embodied as a clamp, a protrusion or a constriction of the apparatus, or the like.
  • the device for bundling individual shaft fibers is arranged to be shiftable along a longitudinal extension of the apparatus.
  • the device for bundling may be alterable or manipulatable or engineerable in any other way.
  • the device for bundling may be manipulated by setting or altering a gap or play between shaft fibers and the device for bundling
  • the device for bundling can be provided for being used at or on different sections of the apparatus along the longitudinal extension thereof.
  • the afore-mentioned manipulations may advantageously alter or adapt to the need, respectively, the stiffness or rigidity of the individual shaft fibers in or within the second section.
  • a device for bundling such as specified above is not provided. In some embodiments, it is not
  • individual shaft fibers are designed or embodied and provided or prepared for moving or bending or tilting, or the like, towards a rim portion of the implant when applying tension onto the implant by means of the tension thread extending through the said individual shaft fiber.
  • “Moving towards” is in some embodiments to be understood as a deviation of at least one section of the individual shaft fiber (mainly in the second section or in a tip area of the individual shaft fiber) from a position that is arranged closer to a center of a cross section of the apparatus according to the present invention into a position that is arranged more radially as compared to the first position, e. g. into a rim area or towards a rim portion.
  • the bundle of shaft fibers can be (or are) arranged in a circular manner .
  • the shaft fibers (e. g. nine shaft fibers in total) are arranged in a circular manner in both the unfolded and/or the folded state of the medical implant.
  • a rim portion is a section that is present in an area of an - in relation to the implant - exterior wall or envelope.
  • the rim portion comprises a part of the foldable material of the implant.
  • the rim portion may be a curve-shaped part of an outer limitation or of a wall (e. g. a mesh, grid, strut or bar structure) of the implant.
  • the rim portion may be a tartlike structure.
  • tension threads exiting from individual shaft fibers are connected with a rim portion of the implant for applying a force onto the implant.
  • the rim portion which is folded or unfolded by means of a
  • the rim portion does not comprise the entire periphery, whereas, in other embodiments, it indeed does .
  • tension threads exiting from individual shaft fibers are connected with a rim portion of the implant for applying a force onto the rim portion.
  • tension threads exiting from at least two or more individual shaft fibers are
  • tension threads exiting from individual shaft fibers are connected with a rim portion in an overlapping manner for applying a force onto the rim portion of the implant.
  • it is intended to fold or unfold a particular rim portion or a part thereof by means of two, three or more tension threads exiting from different individual shaft fibers. In this way, an overlap of several tension threads is achieved in an area of a particular rim portion. This may advantageously contribute to a more uniform folding of the implant.
  • tension threads exiting from individual shaft fibers are connected with differently large, broad, long or in any other way different rim portions of the implant for applying a force on the said rim portions.
  • a first rim portion may have a first arc or curve length x
  • a second rim portion may have a second arc or curve length 2x. This may advantageously allow for or contribute to a more uniform folding of the implant even in cases in which the implant does not behave in a mechanically uniform way over its entire periphery upon folding.
  • the apparatus is designed or intended for folding and/or
  • the object according to the present invention is also solved by means of the set according to the present invention.
  • the set according to the present invention comprises at least one apparatus according to the present invention and at least one implant that is connected with tension threads for the purpose of being folded and/or unfolded or that is provided or prepared for being connected therewith.
  • the implant is a stent or a heart valve
  • individual shaft fibers on the one hand and the implant on the other hand are adapted, chosen or fit to each other as regards their mechanical properties. In certain embodiments according to the present invention, this may be effected such that, during the process of folding the
  • the second force or tension is a force or tension required for effecting a folding or the beginning or an appreciable beginning of a folding of the implant by means of the tension threads connected with the implant that exit from the shaft openings. Said in a more simple manner, in some of those embodiments, upon application of tension, the
  • individual shaft fiber firstly moves in a - for example, radial - direction towards a rim portion of the implant upon applying tension by means of the tension threads exiting from the shaft fiber, prior to beginning any folding of the respective rim portion.
  • This adaptation or adjustment of properties of the individual shaft fibers (such as
  • bendability, flexibility, elasticity, or rigidity) with respect to the properties of the implant may ensure that, upon applying tension by means of the tensioning device, the individual shaft fibers firstly automatically move into a position in which the force applied or to be applied by means of the tension thread is applied onto the implant or onto the rim portion in or under a desired angle.
  • the implant is connected or intended to be interconnected with the apparatus by means of tension threads such that the tension threads (independently of each other or in an overlapping manner) interconnect with a great number of peripheral sections of the implant.
  • a great number may be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present invention as well.
  • the implant is connected or intended to be
  • tension threads interconnected with the apparatus by means of tension threads such that the tension threads may act and/or contact the medical implant not only at one end of the medical implant but at least at two or more sections of the medical implant which are longitudinally offset from each other.
  • the object according to the present invention is further solved by means of the method according to the present invention.
  • the method according to the present invention is or comprises the use of an apparatus according to the present invention or of a set according to the present invention.
  • the method comprises altering a tension applied onto the implant by means of at least one tension thread.
  • the tension is controlled by means of altering a length of the one or more tension threads exiting from the interior of the shaft or of the shaft fiber.
  • the method comprises shifting or otherwise manipulating or engineering the device for bundling
  • individual shaft fibers may be set according to need - in particular with regard to the second section.
  • the implant prior to its implantation, is
  • a great number may be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present
  • one advantage achievable according to the present invention is to advantageously reduce or even completely avoid buckling or bulging or denting of the implant resulting from applying a force onto the implant - mainly onto the periphery thereof - by means of the tension threads.
  • Another advantage is a uniform folding of the implant even in a case in which an implant is designed inhomogeneously as regards the mechanical properties of the implant along the periphery thereof.
  • the tension threads ⁇ exit from exit openings of the shaft fibers may be effected in or under angles at which the tension threads will not suffer particular friction or shear stress at the exit or shaft openings.
  • a further advantage could be that the force for folding - again due to the possibility of the individual shaft fibers to move, migrate or wander - is acting on the implant under particularly advantageous angles.
  • Fig. la shows a partial longitudinal section through an apparatus according to the present invention, a section of which is shown in a schematically simplified manner, prior to unfolding the implant ;
  • Fig. lb shows a section along the line I-I of Fig. la;
  • Fig. 2a shows a partial longitudinal section through the apparatus according to the present
  • FIG. la a section of which is shown in a schematically simplified manner, after unfolding the implant, with tension-free tension threads;
  • Fig. 2b shows a section along the line II-II of
  • Fig. 3a shows a partial longitudinal section through the apparatus according to the present
  • FIG. la a section of which is shown in a schematically simplified manner, after unfolding the implant with tensioned tension threads;
  • Fig. 3b shows a section along the line III-III of
  • Fig. 5a, 5b in synopsis show a further advantage achievable by means of certain embodiments according to the present invention.
  • Fig. 1 shows a partial longitudinal section through an apparatus 100 according to the present invention that is shown in a schematically simplified manner and only in a section thereof.
  • the apparatus 100 comprises a shaft 1 comprising a first section 3 and a second section 5.
  • a plurality of individual shaft fibers 13 extends along or about both the first section 3 and the second section 5.
  • the first and the second section 3, 5 may be referred to as shaft section .
  • Fig. la shows two tension threads 11 and 11' each which exit from a shaft opening 9, twining or looping around a rim portion of the implant 300 shown in a folded state in Fig. la and - to be understood merely
  • One tension thread or more tension threads 11 and 11 ⁇ may exit from an interior of the shaft 1 towards the exterior of the shaft 1 through the shaft openings 9 and/or may enter in the opposite direction.
  • all threads 11 and 11' both exit and enter in a loop manner through the shaft openings 9.
  • the tension threads 11 and 11 ⁇ are provided or intended to encompass an implant not shown in Fig. la such that the implant will have an altered diameter when altering the tension applied onto the threads 11 and 11' in sections thereof .
  • the tension threads 11 and 11 ⁇ are arranged at the implant 300 under tension by means of which they inhibit an undesired opening, unfolding or expansion of the implant 300 (the latter
  • Fig. la shows only two tension threads 11 and 11' . This serves for the purpose of clarity. However, a person skilled in the art will recognize that every shaft fiber 13 can comprise one or more of such tension threads. The latter can exit from the shaft fibers 13 at different heights thereof, wherein this applies both for one the same shaft fiber 13 and, e. g., adjacent shaft fibers 13.
  • the individual shaft fibers 13 arranged on the right side (i. e. away from the tip of the apparatus 100 or within the second section 5, respectively) of a device 19 for bundling individual shaft fibers 13 are combined or concentrated in a bundle.
  • the shaft fibers 13 are arranged freely movably - relative to each other, although, in the state of the implant 300 shown in Fig. la, they also contact each other - as they do also in section 5.
  • the device 19 for bundling allows for the bundled shaft fibers 13 in Fig. la to move freely in radial direction on the left side of the device 19. Thereby, they can follow the motion or movement or geometry of the unfolded implant 300.
  • the device 19 is arranged not to hamper that movement .
  • the device 19 for bundling allows for setting the rigidity or stiffness of the shaft fiber 13 on the left side of the device 19. By shifting the device 19 along the shaft 1 to the left as indicated by arrow A in Fig. la, the rigidity or stiffness of the individual shaft fibers 13 beyond the device 19 can be increased. By shifting the device 19 in the direction indicated by arrow B (i. e. to the right side in Fig.
  • the rigidity or stiffness of the shaft fiber 13 on the left side of the device 19 can be reduced.
  • the apparatus 100 may advantageously be adapted to different features or behaviour of different implants .
  • the implant is represented in a very schematic and simplified manner.
  • the present invention may be carried out with any implant designed or embodied to be foldable and/or unfoldable by means of tension threads upon implantation .
  • Fig. lb shows a section along line I-I of Fig. la.
  • Fig. 2a shows a partial longitudinal section through the apparatus 100 according to the present invention of Fig. la that is shown in a schematically simplified manner and only in a section thereof after having entirely unfolded the implant 300 with the tension threads 11 and 11' being
  • the individual shaft fibers 13 are present in a bundled form on both sides of the device 19 (i. e. on the left side and on the right side of the device 19, i. e. both in the first section 3 and in the second section 5) . In any case they are provided in a bundle in which the individual shaft fibers 13 are close to each other or even contact each other. Due to their form which they take on while not experiencing any external tension or force, the shaft fibers 13 are present in an extended or stretched form in the second section 5. This is possible because the tension threads 11 and 11' are getting longer or stretch upon (or after) opening or
  • Fig. 2b shows a section along the line II-II of Fig. 2a.
  • the individual shaft fibers 13 are present in a bundle such as shown in Fig. lb; however, they are only bundled loosely and are not pressed against each other by an external force.
  • Tension threads 11', 11'', 11''' and 11"'' that are shown by way of example each encompass a rim portion 301', 301'', 301''' or 301''''. In an area 303 of overlap both the tension thread 11'' and the tension thread 11''' are provided.
  • such an overlap can be provided at any position, in particular along the periphery, of the implant 300. Moreover, it can be designed in any arbitrary way: based on two tension threads, three tension threads etc. In some embodiments, a more uniform application of tension force for folding the implant may be achieved by means of such an overlap. As is illustrated in Fig. 2b, the rim portions encompassed by tension threads may have different widths or lengths,
  • Fig. 3a shows a partial longitudinal section through the apparatus 100 according to the present invention of Fig. la that is shown in a schematically simplified manner and only in a section thereof after unfolding the implant 300 using tensioned tension threads.
  • four shaft fibers 13', 13'', 13''' and 13'''' are present within the implant 300.
  • Fig. 3b in which an additional cut shaft fiber 139 is shown, the number of four shaft fibers is merely chosen for improved clarity and more than four shaft fibers may be present.
  • a person skilled in the art will recognize the latter when considering the above
  • Fig. 3b shows a section along the line III-III of Fig. 3a.
  • the respective tension threads each extend between two penetration openings 305a and 305b that are present within the implant's periphery and at which the tension threads penetrate from the interior to the exterior through the "envelope" of the implant, on a more or less straight curve - together with the cross section of the shaft fiber .
  • a second device for bundling depicted as reference numeral 21 is shown. As can be seen from Fig. 3a, the shaft fibers' portions situated between the two devices 19 and 21 are kept in parallel by means of the devices 19 and 21. On the right side of device 21 for bundling, the shaft fibers can flex or bend again.
  • Fig. 4a shows how a rim portion 301 may bulge or dent inwardly when the tension thread 11 entangled around it is guided by means of a shaft fiber 13 arranged in the center o the implant - as is often the case with conventional
  • Fig. 4b shows the alteration of angle a when the shaft fiber 13 is allowed to move, wander or migrate to or towards an outer area or the rim portion 301 of the implant 300 upon biasing or tensioning the tension thread 11 Bulging or denting inwardly or outwardly or non-uniformly folding the implant may hereby in certain settings under otherwise unchanged conditions advantageously be reduced or even excluded.
  • Fig. 5a shows a further advantage achievable by means of certain embodiments according to the present invention using a sectional view similar to that of Figs, lb, 2b, 3b and 4b.
  • Fig. 5a shows the effect a tension thread 11 may have onto the periphery or the rim portion 301 of an implant 300 when applying tension onto the periphery or the rim portion 301 b means of the tension thread 11.
  • penetration areas 305a and 305b are shown.
  • the tension thread 11 penetrates through the penetration areas 305a and 305b from a center of the implant to the exterior thereof, or vice versa.
  • the penetration areas 305a and 305b may, due to the tension, bend or dent towards the center of the implant 300 or may fold non-uniformly with respect to the remaining periphery of the implant 300.
  • this effect can be seen when the shaft fiber 13 is arranged in the center of the implant 300, an arrangement that is common in the state of the art. In certain embodiments, the same effect can also be seen when the shaft fiber 13 is arranged more radially .
  • FIG. 5b A solution to the problem shown in Fig. 5a is shown in Fig 5b. If the rim portion encompassed by the tension thread i set or determined to be sufficiently narrow or short (i. e if the penetration openings 305a and 305b are arranged sufficiently close) such as proposed with respect to some embodiments according to the present invention, denting or bulging or a non-uniformly folding of the implant 300 can advantageously be avoided.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The present invention relates to an apparatus (100) for folding or unfolding at least one medical implant (300) by means of at least one tension thread (11, 11'), wherein the apparatus (100) comprises a shaft (1) and a tensioning device for altering a form or shape of the foldable and/or unfoldable implant (300) by means of the tension thread (11, 11'). In at least one shaft section thereof, the shaft (1) comprises a plurality of individual shaft fibers (13). The present invention further relates to a set and a method.

Description

Description
Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant and method
The present invention relates to an apparatus according to claim 1 for folding or unfolding an implant, and a set according to claim 11. It further relates to a method
according to claim 14.
From practice, implants are known that can be folded and/or unfolded by means of one or more threads transferring tension onto the implant. Furthermore, respective apparatuses for folding and unfolding are known from practice.
-One object of the present invention is to propose a further apparatus for folding or unfolding a foldable and/or
unfoldable implant by means of a tension thread. Furthermore, an appropriate set comprising such an apparatus, as well as a method for folding and/or unfolding an implant are to be proposed.
This object is solved by means of an apparatus having the features of claim 1.
Thus, according to the present invention, an apparatus for inserting and/or folding and/or unfolding an implant by means of at least one tension thread is proposed. The apparatus according to the present invention comprises a shaft.
Furthermore, the apparatus comprises at least one tensioning device for altering a form or shape, a geometry or a folding state of the foldable and/or unfoldable implant by means of the at least one tension thread.
The shaft of the apparatus comprises in at least one shaft section thereof a plurality of individual shaft fibers.
Advantageous embodiments or developments of the apparatus according to the present invention are each subject matter of the dependent claims.
Embodiments according to the present invention may each comprise one or more of the following features in any
arbitrary combination. In some embodiments of the apparatus according to the present invention, altering a form or shape of the implant means reducing or increasing a diameter, in particular an outer diameter, of the implant. Alterations of the diameter may be accompanied by any kind of alteration of the implant's length or any other alteration, or may be not.
In certain embodiments of the apparatus according to the present invention, folding the implant means reducing the implant's diameter.
In some embodiments according to the present invention, folding is to be understood as increasing a diameter of the implant . In certain embodiments according to the present invention, the implant's diameter is present in a plane perpendicular to a main flow direction of the implant, in case the implant is flown through by a fluid after its implantation. In some embodiments of the apparatus according to the
present invention, the at least one tension thread is a thread or filament or yarn, respectively. It can be designed or embodied similar to a surgical sutural thread or it can be such a surgical sutural thread. It can be designed or
embodied as a rope or a cord or twine or string,
respectively. It can be designed or embodied as a chain comprising a plurality of chain members engaged with adjacent chain members.
In the following, whenever reference is made to a thread or tension thread, the terms may include a plurality of threads or tension threads as well insofar as a person skilled in the art recognizes the exchangeability of the terms.
In certain embodiments, the shaft of the apparatus is in at least one section thereof embodied rigidly. In some
embodiments, the shaft of the apparatus is in at least one ' section thereof embodied such as to be bendable in one or more directions (i. e. it may be bent in a longitudinal direction or in a direction of the shaft' s width, in both directions or in any other direction) . In some embodiments, the shaft is embodied extendably or stretchably. In other embodiments, the shaft is embodied stiffly or inflexibly.
In one embodiment of the apparatus according to the present invention, during its implanted implantation state, the implant is able to be penetrated by fluids or is permeable for fluids, respectively, in its longitudinal direction. The terms "permeable" or "able to be penetrated" hereby refer to the ability of the implant to be penetrated or flown through by fluids. In some embodiments of the apparatus according to the present invention, in the moment of unfolding or folding, the implant is loosely arranged or attached to or at or on a receiving area of the apparatus. In some embodiments according to the present invention, the implant is thereby connected with the receiving area only by means of the tension threads.
In certain embodiments of the apparatus according to the present invention, the tension thread comprises or consists of a bundle or a plurality of threads or thread elements.
In some embodiments according to the present invention, a shaft fiber of the apparatus is permeable or patent (like blood vessel) within its interior in at least sections of longitudinal direction or along its entire length. In tho embodiments, the shaft fiber comprises a wall.
In certain embodiments, at least one of the tension threads (or all of them) is partly arranged within an inner space of the respective shaft fiber and extends from there to an outside of the shaft fiber through the shaft opening.
In some embodiments, at least one of the tension threads (or all of them) exits from an inner space of the shaft fiber through one shaft opening. In other embodiments, at least one of the tension threads (or all of them) exits from the inner space through two or more shaft openings.
In certain embodiments according to the present invention, the at least one shaft opening is provided at or on the front surface of the shaft fiber. In other embodiments according to the present invention, it is arranged at or on a circumferential surface or lateral surface area of the shaft. Preferably, the shaft opening is arranged in or within a tip area of the shaft fiber or in or within a proximal area of the shaft fiber.
In certain embodiments according to the present invention, the shaft fiber comprises a plurality of shaft openings uniformly or non-uniformly distributed or arranged along or about a periphery or along or about a circumferential surface or lateral surface area of the shaft or of the shaft fiber. Additionally or alternatively, the shaft openings may be dispersed along or about a longitudinal direction of the shaft or of the shaft fiber. For example, in some embodiments according to the present invention, shaft fibers may have two or more shaft openings which are arranged under different distances between the respective opening and the tip or one end of the corresponding shaft fiber.
In certain embodiments according to the present invention, at least one or all of the shaft fibers are arranged such that they do no move relatively to the apparatus according to the present invention in a longitudinal direction of the
apparatus upon folding or unfolding the medical implant.
In some embodiments according to the present invention, tension threads for folding and/or unfolding the implant enter and/or exit through the shaft opening.
In certain embodiments according to the present invention of the apparatus, during the use of the apparatus, shaft fibers of the plurality of individual shaft fibers are always present in bundled form in at least one first section of the shaft section. In contrast, in a second section, they are provided for moving or drifting away from each other during use of the apparatus.
In some embodiments according to the present invention, the second section is closer to the tip of the apparatus than th first section.
In certain embodiments according to the present invention, the first section directly merges with or passes over into the second section.
In some embodiments according to the present invention, the individual shaft fibers are arranged in contact to each othe in the first section such that there is no lumen such as, e. g., a central lumen, for example a lumen usable during the use of the apparatus for fulfilling particular functions, provided between the shaft fibers in the first section.
Spoken differently, the shaft fibers are arranged closely or at close quarters.
In some embodiments according to the present invention, the term "individual shaft fibers" - when used discretely - comprises all shaft fibers present of the plurality of the entirely present individual shaft fibers; in other
embodiments, it only comprises some of them.
In certain embodiments according to the present invention, the number of individual shaft fibers is set to two shaft fibers; in other embodiments, the number is set to three, four, five, six, seven etc. The number may be a great number it may exceed ten or twenty and comprises every natural number up to at least 30 or 40. A great number of individual shaft fibers advantageously allows for separating the part or rim portion of the implant (for example, the periphery of the implant) which experiences an action by means of the tension threads for
folding/unfolding, that exit from the individual shaft fibers into a great number of subunits. The inventors of the present invention have recognized that, for example, dividing the periphery into many but small or short sectors or rim
portions upon attaching the tension threads at or on the implant, in certain embodiments, favors a uniform folding or unfolding the implant. Additionally, such dividing into a great number of sections may advantageously avoid any
buckling or bulging or denting of the periphery.
A great number can be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present invention as well.
In some embodiments according to the present invention, neither the individual shaft fibers nor sections thereof are arranged within the interior or material of a wall of an envelope, an outer boundary or limitation, or the like of the apparatus .
In certain embodiments according to the present invention of the apparatus, the individual shaft fibers are provided such that they cannot be shifted or moved relative to the
remainder of the apparatus in a longitudinal direction thereof . In some embodiments according to the present invention of the apparatus, shaft fibers of the plurality of individual shaft fibers each comprise one or more shaft openings. The one or more tension threads can enter into and/or exit from the respective shaft fiber through the shaft openings.
In certain embodiments according to the present invention, such shaft openings are solely provided for allowing tension threads to enter in or into and/or leave or exit from the respective individual shaft fiber.
In some embodiments according to the present invention, the individual shaft fibers are designed or embodied to comprise one or more through-openings (extending into a longitudinal direction of the shaft fiber) or one or more hollow
interiors. These through-openings or hollow interiors may allow guiding one or more tension threads through the shaft fiber, e. g. from the tensioning device of the apparatus to a shaft opening or to an exit opening at the tip portion of the shaft fiber.
In some embodiments according to the present invention, the tension threads are arranged within an interior of the shaft fibers such that they can be shifted or moved relative to the respective shaft fibers.
In some embodiments according to the present invention, the individual shaft fibers and/or the tension threads do not comprise any devices for establishing a hook engagement with the implant.
In some embodiments according to the present invention, some or all of the tension threads are connected with the implant by solely entangling or entwining the implant or a part or section or portion thereof.
In certain embodiments according to the present invention of the apparatus, during a state of use of the apparatus, shaft fibers of the plurality of individual shaft fibers are arranged movably in or forth from (in the direction towards the tip of the apparatus) at least the second section of the shaft respectively independently of each other and/or
independently of the position of the implant relative to the apparatus for folding or unfolding. Differently spoken, they can move away from each other and/or move towards each other in or within the second section.
In some embodiments according to the present invention of the apparatus, the shaft comprises in at least one section thereof a device for bundling individual shaft fibers of the plurality of individual shaft fibers.
In certain embodiments according to the present invention, there are provided more than just one device for bundling (but two, three, four, and so on, devices of this kind) .
Additionally or alternatively, in some embodiments, the device for bundling comprises not just one means, e. g.
having the shape of a collar, but more than one means (e. g., two, three, four, and so on, means) .
In certain of the embodiments comprising more than one device for bundling or means for bundling, the individual devices or means are provided on the shaft fibers while being spaced apart from each other. The particular space or distance chosen or set may advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers. This may be true for the shaft fibers' parts arranged between the devices or means for bundling. It may also be true for the parts of the shaft fibers that are not bundled but allowed to move freely with regard to each other.
In some of the embodiments comprising more than one device for bundling or means for bundling, a (that is, one or more) core element or a (that is, one or more) interconnecting element is provided on, at or within the bundle of shaft fibers. The core element or interconnecting element may also advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers. The core element or interconnecting element may be attached to one, two or all of the devices or means for bundling. However, it may not be attached as well. The core element or interconnecting element may be provided to be extendable and to change its length, for example, when a distance between neighbouring, adjacent or interacting devices for bundling or means for bundling is changed or adapted to need.
Both providing more than only one device for bundling or means for bundling and providing a core element or the like may in certain embodiments of the present invention allow for keeping the shaft fibers in parallel in use along a certain or even predetermined distance. Again, this may also
advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers, both in the vicinity of core element or device or means for bundling and also in the second section of the shaft in which the shaft fibers are intended to move, wander or migrate freely in case of need. In certain embodiments according to the present invention, the device for bundling is designed or embodied as a ring encompassing the individual shaft fibers to be bundled and inhibiting the shaft fibers from drifting or moving away from each other. In some embodiments according to the present invention, the device for bundling is designed or embodied as a clamp, a protrusion or a constriction of the apparatus, or the like.
In certain embodiments according to the present invention of the apparatus, the device for bundling individual shaft fibers is arranged to be shiftable along a longitudinal extension of the apparatus. Additionally or alternatively, the device for bundling may be alterable or manipulatable or engineerable in any other way. For example, the device for bundling may be manipulated by setting or altering a gap or play between shaft fibers and the device for bundling
limiting or encircling the shaft fibers. Additionally or alternatively, the device for bundling can be provided for being used at or on different sections of the apparatus along the longitudinal extension thereof. The afore-mentioned manipulations may advantageously alter or adapt to the need, respectively, the stiffness or rigidity of the individual shaft fibers in or within the second section.
In other embodiments, a device for bundling such as specified above is not provided. In some embodiments, it is not
possible to distinguish a first section from a second section (such as specified above and below) or required.
In some embodiments according to the present invention of the apparatus, individual shaft fibers are designed or embodied and provided or prepared for moving or bending or tilting, or the like, towards a rim portion of the implant when applying tension onto the implant by means of the tension thread extending through the said individual shaft fiber.
"Moving towards" is in some embodiments to be understood as a deviation of at least one section of the individual shaft fiber (mainly in the second section or in a tip area of the individual shaft fiber) from a position that is arranged closer to a center of a cross section of the apparatus according to the present invention into a position that is arranged more radially as compared to the first position, e. g. into a rim area or towards a rim portion.
In certain embodiments according to the present invention the bundle of shaft fibers can be (or are) arranged in a circular manner .
In some embodiments according to the present invention, the shaft fibers (e. g. nine shaft fibers in total) are arranged in a circular manner in both the unfolded and/or the folded state of the medical implant.
In certain embodiments according to the present invention, a rim portion is a section that is present in an area of an - in relation to the implant - exterior wall or envelope.
In some embodiments according to the present invention, the rim portion comprises a part of the foldable material of the implant. The rim portion may be a curve-shaped part of an outer limitation or of a wall (e. g. a mesh, grid, strut or bar structure) of the implant. The rim portion may be a tartlike structure. In certain embodiments according to the present invention of the apparatus, tension threads exiting from individual shaft fibers are connected with a rim portion of the implant for applying a force onto the implant.
In some embodiments according to the present invention, the rim portion which is folded or unfolded by means of a
particular shaft fiber or by means of the one or more tension threads of the shaft fiber, respectively, is only a part of the foldable and/or unfoldable periphery of the implant. In those embodiments, the rim portion does not comprise the entire periphery, whereas, in other embodiments, it indeed does .
In certain embodiments according to the present invention of the apparatus, tension threads exiting from individual shaft fibers are connected with a rim portion of the implant for applying a force onto the rim portion. In certain embodiments according to the present invention, tension threads exiting from at least two or more individual shaft fibers are
connected with the said rim portion, or parts thereof.
In some embodiments according to the present invention of the apparatus, tension threads exiting from individual shaft fibers are connected with a rim portion in an overlapping manner for applying a force onto the rim portion of the implant. In those embodiments, it is intended to fold or unfold a particular rim portion or a part thereof by means of two, three or more tension threads exiting from different individual shaft fibers. In this way, an overlap of several tension threads is achieved in an area of a particular rim portion. This may advantageously contribute to a more uniform folding of the implant.
In certain embodiments according to the present invention of the apparatus, tension threads exiting from individual shaft fibers are connected with differently large, broad, long or in any other way different rim portions of the implant for applying a force on the said rim portions. Thus, a first rim portion may have a first arc or curve length x, a second rim portion may have a second arc or curve length 2x. This may advantageously allow for or contribute to a more uniform folding of the implant even in cases in which the implant does not behave in a mechanically uniform way over its entire periphery upon folding.
In some embodiments according to the present invention, the apparatus is designed or intended for folding and/or
unfolding an implant designed as a stent or a heart valve arrangement .
The object according to the present invention is also solved by means of the set according to the present invention. The set according to the present invention comprises at least one apparatus according to the present invention and at least one implant that is connected with tension threads for the purpose of being folded and/or unfolded or that is provided or prepared for being connected therewith.
In some embodiments of the set according to the present invention, the implant is a stent or a heart valve
arrangement . In certain embodiments of the set according to the present invention, individual shaft fibers on the one hand and the implant on the other hand are adapted, chosen or fit to each other as regards their mechanical properties. In certain embodiments according to the present invention, this may be effected such that, during the process of folding the
implant, a first force or tension required for moving the shaft fibers in a section thereof, in particular in an area of a shaft opening for tension threads, from their
longitudinal alignment or in a direction of the radial extension of the implant is lower than a second force or tension. The second force or tension is a force or tension required for effecting a folding or the beginning or an appreciable beginning of a folding of the implant by means of the tension threads connected with the implant that exit from the shaft openings. Said in a more simple manner, in some of those embodiments, upon application of tension, the
individual shaft fiber firstly moves in a - for example, radial - direction towards a rim portion of the implant upon applying tension by means of the tension threads exiting from the shaft fiber, prior to beginning any folding of the respective rim portion. This adaptation or adjustment of properties of the individual shaft fibers (such as
bendability, flexibility, elasticity, or rigidity) with respect to the properties of the implant may ensure that, upon applying tension by means of the tensioning device, the individual shaft fibers firstly automatically move into a position in which the force applied or to be applied by means of the tension thread is applied onto the implant or onto the rim portion in or under a desired angle.
In some embodiments according to the set according to the present invention of, the implant is connected or intended to be interconnected with the apparatus by means of tension threads such that the tension threads (independently of each other or in an overlapping manner) interconnect with a great number of peripheral sections of the implant. A great number may be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present invention as well.
In some embodiments of the set according to the present invention, the implant is connected or intended to be
interconnected with the apparatus by means of tension threads such that the tension threads may act and/or contact the medical implant not only at one end of the medical implant but at least at two or more sections of the medical implant which are longitudinally offset from each other.
The object according to the present invention is further solved by means of the method according to the present invention. The method according to the present invention is or comprises the use of an apparatus according to the present invention or of a set according to the present invention.
In certain embodiments of the method according to the present invention, the method comprises altering a tension applied onto the implant by means of at least one tension thread. The tension is controlled by means of altering a length of the one or more tension threads exiting from the interior of the shaft or of the shaft fiber.
In some embodiments of the method according to the present invention, the method comprises shifting or otherwise manipulating or engineering the device for bundling
individual shaft fibers. In this way, the rigidity,
stiffness, elasticity, or the like, of the respective
individual shaft fibers may be set according to need - in particular with regard to the second section.
In some embodiments of the method according to the present invention, prior to its implantation, the implant is
connected with the apparatus by means of tension threads such that the tension threads (independently of each other or in an overlapping manner) interconnect with a great number of peripheral sections of the implant. A great number may be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present
invention as well.
The advantages achievable by means of some or all embodiments of the apparatus according to the present invention may also be obtained by means of the set according to the present invention and the method according to the present invention.
Some or all of the following advantages and the advantages mentioned above can be achieved in some, certain or all embodiments according to the present invention.
In some embodiments according to the present invention, one advantage achievable according to the present invention is to advantageously reduce or even completely avoid buckling or bulging or denting of the implant resulting from applying a force onto the implant - mainly onto the periphery thereof - by means of the tension threads. Another advantage is a uniform folding of the implant even in a case in which an implant is designed inhomogeneously as regards the mechanical properties of the implant along the periphery thereof.
According to yet another advantage - due to the capacity of the individual shaft fibers to move, migrate or wander - the tension threads λ exit from exit openings of the shaft fibers may be effected in or under angles at which the tension threads will not suffer particular friction or shear stress at the exit or shaft openings. In connection therewith, a further advantage could be that the force for folding - again due to the possibility of the individual shaft fibers to move, migrate or wander - is acting on the implant under particularly advantageous angles.
In the following, the present invention will be exemplarily described with respect to the appended drawing. In the drawing, same reference numerals refer to same or identical elements. In the drawing:
Fig. la shows a partial longitudinal section through an apparatus according to the present invention, a section of which is shown in a schematically simplified manner, prior to unfolding the implant ;
Fig. lb shows a section along the line I-I of Fig. la;
Fig. 2a shows a partial longitudinal section through the apparatus according to the present
invention of Fig. la, a section of which is shown in a schematically simplified manner, after unfolding the implant, with tension-free tension threads; Fig. 2b shows a section along the line II-II of
Fig. 2a;
Fig. 3a shows a partial longitudinal section through the apparatus according to the present
invention of Fig. la, a section of which is shown in a schematically simplified manner, after unfolding the implant with tensioned tension threads; Fig. 3b shows a section along the line III-III of
Fig. 3a;
Fig. 4a, 4b in synopsis show an advantage achievable by
means of some embodiments according to the present invention; and
Fig. 5a, 5b in synopsis show a further advantage achievable by means of certain embodiments according to the present invention.
Fig. 1 shows a partial longitudinal section through an apparatus 100 according to the present invention that is shown in a schematically simplified manner and only in a section thereof. The apparatus 100 comprises a shaft 1 comprising a first section 3 and a second section 5. A plurality of individual shaft fibers 13 extends along or about both the first section 3 and the second section 5. The first and the second section 3, 5 may be referred to as shaft section .
The individual shaft fibers 13 comprise shaft openings 9. Merely exemplarily, Fig. la shows two tension threads 11 and 11' each which exit from a shaft opening 9, twining or looping around a rim portion of the implant 300 shown in a folded state in Fig. la and - to be understood merely
exemplarily as well - which re-enter into the same or into another shaft opening 9 of the same shaft fiber 13.
One tension thread or more tension threads 11 and 11 λ may exit from an interior of the shaft 1 towards the exterior of the shaft 1 through the shaft openings 9 and/or may enter in the opposite direction. In Fig. la, all threads 11 and 11' both exit and enter in a loop manner through the shaft openings 9.
The tension threads 11 and 11 Λ are provided or intended to encompass an implant not shown in Fig. la such that the implant will have an altered diameter when altering the tension applied onto the threads 11 and 11' in sections thereof . In the state of the implant 300 shown in Fig. la, the tension threads 11 and 11 λ are arranged at the implant 300 under tension by means of which they inhibit an undesired opening, unfolding or expansion of the implant 300 (the latter
resulting, e. g., from a memory shape property of the
implant) .
Fig. la shows only two tension threads 11 and 11' . This serves for the purpose of clarity. However, a person skilled in the art will recognize that every shaft fiber 13 can comprise one or more of such tension threads. The latter can exit from the shaft fibers 13 at different heights thereof, wherein this applies both for one the same shaft fiber 13 and, e. g., adjacent shaft fibers 13.
As can be seen from Fig. la, the individual shaft fibers 13 arranged on the right side (i. e. away from the tip of the apparatus 100 or within the second section 5, respectively) of a device 19 for bundling individual shaft fibers 13 are combined or concentrated in a bundle. In the second section 5 (i. e. on the left side of the device 19 or towards the tip of the apparatus 100, respectively) , the shaft fibers 13 are arranged freely movably - relative to each other, although, in the state of the implant 300 shown in Fig. la, they also contact each other - as they do also in section 5.
On the one hand, the device 19 for bundling allows for the bundled shaft fibers 13 in Fig. la to move freely in radial direction on the left side of the device 19. Thereby, they can follow the motion or movement or geometry of the unfolded implant 300. The device 19 is arranged not to hamper that movement . , On the other hand, the device 19 for bundling allows for setting the rigidity or stiffness of the shaft fiber 13 on the left side of the device 19. By shifting the device 19 along the shaft 1 to the left as indicated by arrow A in Fig. la, the rigidity or stiffness of the individual shaft fibers 13 beyond the device 19 can be increased. By shifting the device 19 in the direction indicated by arrow B (i. e. to the right side in Fig. la), the rigidity or stiffness of the shaft fiber 13 on the left side of the device 19 can be reduced. In this way, the apparatus 100 may advantageously be adapted to different features or behaviour of different implants . It is obvious that the implant is represented in a very schematic and simplified manner. The present invention may be carried out with any implant designed or embodied to be foldable and/or unfoldable by means of tension threads upon implantation .
Fig. lb shows a section along line I-I of Fig. la.
Fig. 2a shows a partial longitudinal section through the apparatus 100 according to the present invention of Fig. la that is shown in a schematically simplified manner and only in a section thereof after having entirely unfolded the implant 300 with the tension threads 11 and 11' being
completely or substantially released or free from tension. The individual shaft fibers 13 are present in a bundled form on both sides of the device 19 (i. e. on the left side and on the right side of the device 19, i. e. both in the first section 3 and in the second section 5) . In any case they are provided in a bundle in which the individual shaft fibers 13 are close to each other or even contact each other. Due to their form which they take on while not experiencing any external tension or force, the shaft fibers 13 are present in an extended or stretched form in the second section 5. This is possible because the tension threads 11 and 11' are getting longer or stretch upon (or after) opening or
unfolding of the implant 300. The latter can be achieved by correspondingly actuating the tensioning device not shown in the figures. Fig. 2b shows a section along the line II-II of Fig. 2a. As can be recognized, the individual shaft fibers 13 are present in a bundle such as shown in Fig. lb; however, they are only bundled loosely and are not pressed against each other by an external force.
Tension threads 11', 11'', 11''' and 11"'' that are shown by way of example each encompass a rim portion 301', 301'', 301''' or 301''''. In an area 303 of overlap both the tension thread 11'' and the tension thread 11''' are provided.
According to the present invention, such an overlap can be provided at any position, in particular along the periphery, of the implant 300. Moreover, it can be designed in any arbitrary way: based on two tension threads, three tension threads etc. In some embodiments, a more uniform application of tension force for folding the implant may be achieved by means of such an overlap. As is illustrated in Fig. 2b, the rim portions encompassed by tension threads may have different widths or lengths,
yielding the advantages mentioned above.
Fig. 3a shows a partial longitudinal section through the apparatus 100 according to the present invention of Fig. la that is shown in a schematically simplified manner and only in a section thereof after unfolding the implant 300 using tensioned tension threads. For example, four shaft fibers 13', 13'', 13''' and 13'''' are present within the implant 300. As can be seen from Fig. 3b in which an additional cut shaft fiber 139 is shown, the number of four shaft fibers is merely chosen for improved clarity and more than four shaft fibers may be present. However, a person skilled in the art will recognize the latter when considering the above
specification .
Fig. 3b shows a section along the line III-III of Fig. 3a.
It can readily be seen that, due to the tension applied by means of the respective tension threads 11' , 11' ' , 11' ' ' and 11'"', the shaft fibers 13', 13", 13'" and 13"" have moved from the center of the implant 300 towards a rim area of the implant 300 or at least in a radial direction. One effect of this motion or movement is explained in detail with respect to Figs. 4 and 5 below. However, without any further explanation, a person skilled in the art will yet be aware from Fig. 3b that the respective tension threads exit from the shaft fibers 13', 13", 13"' and 13"" via the shaft openings in a substantially diametrical manner. Further, it can be recognized that the respective tension threads each extend between two penetration openings 305a and 305b that are present within the implant's periphery and at which the tension threads penetrate from the interior to the exterior through the "envelope" of the implant, on a more or less straight curve - together with the cross section of the shaft fiber . In Fig. 3a, only by way of example, a second device for bundling depicted as reference numeral 21 is shown. As can be seen from Fig. 3a, the shaft fibers' portions situated between the two devices 19 and 21 are kept in parallel by means of the devices 19 and 21. On the right side of device 21 for bundling, the shaft fibers can flex or bend again.
In synopsis with Fig. 4b, Fig. 4a shows one advantage
achievable by means of some embodiments according to the present invention using a sectional view similar to that of Figs, lb, 2b and 3b.
Fig. 4a shows how a rim portion 301 may bulge or dent inwardly when the tension thread 11 entangled around it is guided by means of a shaft fiber 13 arranged in the center o the implant - as is often the case with conventional
arrangements in certain constellations or apparatus-implant- arrangements. The inventors of the present invention have realized that such a bulging or denting - both inwardly and outwardly - including any undesired non-uniform folding of the implant as well largely depends on the angle a shown in Fig. 4a.
In contrast, Fig. 4b shows the alteration of angle a when the shaft fiber 13 is allowed to move, wander or migrate to or towards an outer area or the rim portion 301 of the implant 300 upon biasing or tensioning the tension thread 11 Bulging or denting inwardly or outwardly or non-uniformly folding the implant may hereby in certain settings under otherwise unchanged conditions advantageously be reduced or even excluded.
In synopsis with Fig. 5b, Fig. 5a shows a further advantage achievable by means of certain embodiments according to the present invention using a sectional view similar to that of Figs, lb, 2b, 3b and 4b.
Fig. 5a shows the effect a tension thread 11 may have onto the periphery or the rim portion 301 of an implant 300 when applying tension onto the periphery or the rim portion 301 b means of the tension thread 11. In Fig. 5a, as in Fig. 3b, penetration areas 305a and 305b are shown. The tension thread 11 penetrates through the penetration areas 305a and 305b from a center of the implant to the exterior thereof, or vice versa. As can be seen in Fig. 5a, the penetration areas 305a and 305b may, due to the tension, bend or dent towards the center of the implant 300 or may fold non-uniformly with respect to the remaining periphery of the implant 300. As shown in Fig. 5a, this effect can be seen when the shaft fiber 13 is arranged in the center of the implant 300, an arrangement that is common in the state of the art. In certain embodiments, the same effect can also be seen when the shaft fiber 13 is arranged more radially .
A solution to the problem shown in Fig. 5a is shown in Fig 5b. If the rim portion encompassed by the tension thread i set or determined to be sufficiently narrow or short (i. e if the penetration openings 305a and 305b are arranged sufficiently close) such as proposed with respect to some embodiments according to the present invention, denting or bulging or a non-uniformly folding of the implant 300 can advantageously be avoided.

Claims

Claims
1. An apparatus (100) for folding or unfolding at least one medical implant (300) by means of at least one tension thread (11, 11', 11", 11"', 11""), wherein the
apparatus (100) comprises: a shaft ( 1 ) ; a tensioning device for altering a form or shape of the foldable and/or unfoldable implant (300) by means of the tension thread (11, 11', 11", 11'", 11""); and wherein the shaft (1) comprises in at least one shaft section thereof a plurality of individual shaft fibers (13, 13', 13", 13'", 13"").
2. The apparatus (100) according to claim 1, wherein, during use of the apparatus (100), shaft fibers (13, 13', 13", 13"', 13"") of the plurality of individual shaft fibers (13, 13', 13", 13"', 13"") are always present in bundled form in at least one first section (3) of the shaft section, whereas, in a second section (5), the shaft fibers (13, 13', 13", 13"', 13"") are provided or intended for moving away from each other during use of the apparatus ( 100 ) .
3. The apparatus (100) according to claim 1 or 2, wherein
shaft fibers (13, 13', 13", 13"', 13"") of the
plurality of individual shaft fibers (13, 13', 13",
13"', 13'"') each comprise one or more shaft openings (9) by means of which the one or more tension threads (11, 11', 11'', 11"', 11'"') can exit from and/or enter into the respective shaft fiber (13, 13',
13" , 13" ' , 13" " ) .
4. The apparatus (100) according to anyone of the preceding claims, wherein, during a state of use of the
apparatus (100), shaft fibers (13, 13', 13", 13"', 13"") of the plurality of individual shaft fibers (13, 13' , 13' ' , 13' ' ' , 13' ' " ) are arranged movably in or forth from at least the second section (5) of the shaft (1) independently of each other and/or independently of the position of the implant (300) relative to the
apparatus (100) for folding or unfolding.
5. The apparatus (100) according to anyone of the preceding claims, wherein the shaft (1) comprises in at least one section thereof at least one device (19, 21) for bundling individual shaft fibers (13, 13', 13", 13"', 13"") of the plurality of individual shaft fibers (13, 13', 13", 13" ' , 13" " ) .
6. The apparatus (100) according to claim 5, wherein the at least one device (19, 21) for bundling individual shaft fibers (13, 13', 13", 13"', 13"") is arranged to be shiftable or movable along a longitudinal extension of the apparatus (100) or is otherwise alterable or manipulatable or engineerable and/or is provided or intended for being used at or on different sections of the apparatus (100) along the longitudinal extension thereof.
7. The apparatus (100) according to anyone of the preceding claims, wherein individual shaft fibers (13, 13', 13", 13' ' ' , 13' " ' ) are designed or embodied and intended or provided for moving towards a rim portion (301', 301'', 301"', 301"") of the implant (300) when applying tension onto the implant (300) by means of the tension threads (11, 11', 11", 11"', 11"") extending through these individual shaft fibers (13, 13', 13", 13'", 13" " ) .
8. The apparatus (100) according to anyone of the preceding claims, wherein tension threads (11, 11', 11", 11'", 11"") exiting from individual shaft fibers (13) are connected with a rim portion (301', 301", 301'",
301"") of the implant (300) for applying a force onto the rim portion, in particular wherein the rim
portion (301', 301", 301'", 301"") only comprises a part of the foldable and/or unfoldable periphery of the implant (300) .
9. The apparatus (100) according to anyone of the preceding claims, wherein tension threads (11, 11', 11", 11'", 11"") exiting from individual shaft fibers (13, 13', 13", 13'", 13"") are connected with a rim portion for applying a force onto the rim portion (301', 301",
301"', 301"") of the implant (300), in particular wherein tension threads (11, 11', 11", 11"', 11"") exiting from at least two individual shaft fibers (13, 13', 13", 13"', 13'"') are connected with the rim portion (301', 301", 301"', 301"") or parts thereof.
10. The apparatus (100) according to anyone of the preceding claims designed or embodied as a catheter, in particular a heart catheter, or comprising such a catheter.
11. A set, comprising: at least one apparatus (100) according to anyone of the preceding claims; and at least one implant (300) connected with tension threads (11, 11', 11", 11"', 11"") for the purpose of folding and/or unfolding or provided or prepared for being connected with tension
threads (11, 11', 11", 11"', 11"").
12. The set according to claim 11, wherein the implant (300) is a stent or a heart valve arrangement.
13. The set according to claim 11 or 12, wherein individual shaft fibers (13, 13', 13", 13'", 13"") and the implant (300) are adapted such that, during a process of folding the implant, a first force required for moving the shaft fibers (13, 13', 13", 13"', 13"") in a section thereof, in particular in a section comprising shaft openings (9) for tensions threads (11, 11', 11", 11'", 11""), from their longitudinal alignment or for moving them in a direction of radial extension of the
implant (300), is lower than a second force required for effecting folding of the implant (300) by means of the tension threads (11, 11', 11", 11"', 11"") connected with the implant (300) and which exit from the shaft openings ( 9 ) .
14. A method, comprising the step: using an apparatus (100) according to anyone of claims 1 to 10 or a set according to anyone of claims 11 to 13.
15. The method according to claim 14, comprising the step: altering a tension applied onto the implant (300) by means of at least one tension thread (11, 11', 11'', 11' ' ' , 11' ' ' ' ) by altering a length of the tension thread (11, 11', 11", 11"', 11"") exiting from an interior of the shaft (1) or of the shaft fiber (13, 13' , 13" , 13" ' , 13" " ) .
The method according to anyone of claims 14 or 15, comprising the step: shifting or otherwise manipulating or engineering the at least one device (19, 21) for bundling individual shaft fibers (13, 13', 13", 13"', 13"").
PCT/EP2011/006410 2010-12-20 2011-12-19 Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant and method WO2012084178A2 (en)

Priority Applications (6)

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CA2820592A CA2820592C (en) 2010-12-20 2011-12-19 Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant and method
US13/996,542 US10010415B2 (en) 2010-12-20 2011-12-19 Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant and method
EP15169197.9A EP2954872B1 (en) 2010-12-20 2011-12-19 Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant
CN201180061202.1A CN103338725B (en) 2010-12-20 2011-12-19 Comprise the device of axle fiber out of the ordinary and cover group and the method for folding or launch medical implant
JP2013543576A JP6027540B2 (en) 2010-12-20 2011-12-19 Device comprising individual axial fibers and combined device for folding or deploying medical implants
EP11801611.2A EP2654616B1 (en) 2010-12-20 2011-12-19 Apparatus comprising individual shaft fibers and set for folding or unfolding a medical implant

Applications Claiming Priority (4)

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US201061424706P 2010-12-20 2010-12-20
US61/424,706 2010-12-20
DE102010061371.1 2010-12-20
DE102010061371A DE102010061371A1 (en) 2010-12-20 2010-12-20 Individual shaft fiber device and kit for folding or deploying a medical implant and method

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WO2012084178A2 true WO2012084178A2 (en) 2012-06-28
WO2012084178A3 WO2012084178A3 (en) 2012-08-16

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JP6027540B2 (en) 2016-11-16
EP2954872A1 (en) 2015-12-16
CN103338725A (en) 2013-10-02
EP2654616A2 (en) 2013-10-30
CN103338725B (en) 2016-04-20
CA2820592A1 (en) 2012-06-28
CA2820592C (en) 2019-03-05
EP2654616B1 (en) 2015-05-27
US10010415B2 (en) 2018-07-03
WO2012084178A3 (en) 2012-08-16
EP2954872B1 (en) 2019-05-15
JP2014508548A (en) 2014-04-10
US20130338755A1 (en) 2013-12-19
DE102010061371A1 (en) 2012-06-21

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