treatment catheter member with wrap-around function

专利摘要:
TREATMENT CATHETER MEMBER WITH SURROUNDING FUNCTION. A catheter member (1) for interacting with a circumferential tissue structure (10) includes an elongated primary catheter (70) which has an interior lumen (80) and which extends along a longitudinal axis (90) and has a portion. of distal end (100), first (120) and second (130) elongated secondary catheters each comprising a distal end portion (140, 150) and an inner lumen (160, 170), and each to be disposed in the inner lumen ( 80) of the primary catheter (40) to be relatively movable therein and be able to be exposed from the distal end portion thereof, and a first bending mechanism (191) for providing the distal end portion (140, 150) of the first (120) and/or second (130) secondary catheter with a tendency to assume a first secondary folded shape, wherein the distal end portion of one or both of the first and second secondary catheters is provided so as to be able to be flexed by the first mechanism of bending to form an arm portion (126, 136) substantially transverse to the direction of the longitudinal axis (90) of the primary catheter (70) so as to assume the first secondary bent shape when being exposed from the distal end portion. (100) of the primary catheter.
公开号:BR112014022075B1
申请号:R112014022075-1
申请日:2013-03-05
公开日:2021-05-25
发明作者:Georg Börtlein；Malek Nasr
申请人:Highlife Sas；
IPC主号:

专利说明:

REFERENCE FOR RELATED ORDERS
[001] The present application claims the benefit and priority of provisional application No. US 61/607,073, filed on March 6, 2012 in the United States Patent and Trademark Office, and claims the benefit and priority of German patent application Nr. 10 2012101 877.4, filed on March 6, 2012 with the German Patent and Trademark Office, the entire contents of whose applications are hereby incorporated for all purposes by this reference. TECHNICAL FIELD
[002] The invention relates generally to a catheter member for interacting with a circumferential tissue structure and a method for using a catheter member. FUNDAMENTALS
[003] Heart valve diseases are affecting approximately 300,000 people worldwide each year. These diseases translate into abnormal leaflet tissue (excess tissue growth, tissue degradation/rupture, tissue induration/calcification), or abnormal tissue position through the cardiac cycle (eg, annular dilation, ventricular remodeling) leading to a degradation of valve function such as blood leakage/reflow (valvular insufficiency) or a resistance to forward blood flow (valve stenosis) . Many of these diseases are treatable using catheter techniques.
[004] Therefore, a. catheter limb is desirable. BRIEF: DESCRIPTION
[005] A catheter member to interact with a circumference tissue structure! comprises an elongated primary catheter having at least one inner lumen and extending along a longitudinal axis and having a distal end portion, first and second elongated secondary catheters each extending along a longitudinal axis, each comprising an end portion. distal and a proximal end portion and an interior lumen, and each comprising a secondary alignment portion, which is located between the proximal and distal end portions and adjacent to the distal end portion, and each to be disposed in an interior lumen. of the primary catheter to be mobile relative to the. itself and capable of being exposed therefrom (e.g., the distal end portion thereof), a first bending mechanism for providing the distal end portion of the first and/or second secondary catheter with a tendency to assume a first shape secondary folded, and a second bending mechanism for providing the secondary alignment portion of the first and/or second secondary catheter with a tendency to assume a second secondary folded shape. The distal end portion of both the first and second secondary catheters is configured to be capable of being flexed, for example, by the first flexing mechanism to form an arm portion substantially transverse to the direction of the longitudinal axis of the primary catheter. so as to assume the first secondary bent shape when being exposed from the distal end portion of the primary catheter. The secondary alignment portion of the first and second secondary catheters may be configured to be capable of being flexed by the second bending mechanism to assume the second secondary bent shape having a predetermined curvature, optionally having a radius of substantially 30 to 70 mm and optionally describing an angle of 90° to 270°. The arm portions of the first and second secondary catheters, respectively, can extend in generally opposite directions to each other when the secondary alignment portions of the first and second secondary catheters assume the second secondary folded shape in parallel with each other.
[006] Methods are provided for encircling or capturing a structure such as a fabric structure or other hard-to-reach structure (described elsewhere herein) with a wire. or the like. The methods can include advancing a plurality of secondary catheters through one or more lumens in a primary catheter, optionally advancing respective tertiary catheters through lumens in the secondary catheters, and advancing wires or the like through the tertiary catheters. For example, methods of the invention may involve advancing secondary catheters through one or more lumens in a primary catheter such that secondary catheters are exposed in an opening on one side or end of the primary catheter, and one or more secondary catheters are bent at one or more angles to the primary catheter when secondary catheters are exposed. Tertiary catheters can be advanced through and out of the openings in the secondary catheters, preferably in such a way that the tertiary catheters bend as they are advanced out of the secondary catheters. Tertiary catheters can preferably bend in a complementary fashion to form all or part of a surrounding structure around the tissue structure or other hard-to-reach structure. One or more wires and/or capture mechanisms can then be advanced through the catheters to surround or capture the tissue structure or other hard-to-reach structure generally in the manner described in connection with the specific apparatus features herein, but without limitation to the specific device features. Catheters and/or wires or the like may be advanced with or without contact with the tissue structure or other hard-to-reach structure, and may be provided with blunt nose front features such as those described in this document in order to avoid trauma to the fabric structure or other structure difficult to reach if contact is made. BRIEF DESCRIPTION OF THE DRAWINGS
[007] In the drawings, like reference characters generally refer to the same parts throughout the different views. The drawings are not necessarily to scale, instead emphasis is generally being placed on illustrating the principles of the invention. In the following description, various embodiments are described with reference to the following drawings, in which: Figure la shows a partially schematic cross-sectional view of a distal side of a catheter member according to a variation. Figure 1b shows a schematic view of a proximal side of a catheter member according to a variation, Figure 2 shows a schematic cross-sectional view of a heart and a catheter limb according to a variation. Figures 3a and 3b show schematic cross-sectional views of a primary catheter and secondary catheters of a catheter member according to a variation, Figure 3c shows a radial cross-sectional view along CC of Figure 3b of a catheter primary and secondary catheters of a catheter member according to a variation. Figures 4a to 4c show a catheter member according to a variation, Figures 5a to 5e show detailed views of components of a catheter member according to a variation, Figures 6a to 6c show views of a bending mechanism in accordance with a variation, Figures 7a to 7c show a catheter member in accordance with a variation. Figures 8 to 12 show several exemplary method steps of a method for using a catheter member. Figures 13a. and 13b show a catheter member according to a variation. Figures 14a to 14f show views of bending mechanisms according to a variation, and method of using same according to a variation. DESCRIPTION
[008] The following detailed description refers to the accompanying drawings which show, by way of illustration, details of specific variations in which the invention may be practiced. These variations are described in sufficient detail to enable those skilled in the art to practice the invention. Other variations can be used and structural, logical and electrical modifications can be made without departing from the scope of the invention. The various variations are not mutually exclusive, as all variations can be combined with all other variations to form modalities. In this regard, all features described herein are applicable to all variants and/or embodiments of the invention and features described herein may not be applicable to certain variations or embodiments. Therefore, any feature described herein is to be understood to be disclosed by itself and/or in combination with any other feature or features. The methods discussed herein are more general, and can be performed with the exemplary apparatus specifically described or with other apparatus capable of directing the movement of features as described herein.
[009] With reference to the Figures, for example Figure la thereof, a catheter member 1 for interacting with a tissue structure (e.g. circumferential) 10 may be provided which may comprise a primary catheter (e.g., elongated) 70 which may have an interior lumen 80 and which may extend along a longitudinal axis 90 and may have a distal end portion 100. A catheter member 1 may further comprise first 120 and/or second 130 secondary catheters (e.g. elongate) which each may comprise a distal end portion 140, 150 and an inner lumen 160, 170, and each may be disposed in the inner lumen 80 of primary catheter 70 and may be movable relative thereto and may be exposed therefrom. distal end portion 100 thereof. A first bending mechanism 191 may provide the distal end portion 140, 150 of the first 120 and/or second 130 secondary catheter with a tendency to assume a first secondary folded shape. The distal end portion 140, 150 of one or both of the first and second secondary catheters 120, 130 may be provided so as to be capable of being flexed by the first bending mechanism 191 to form an arm portion 126, 136 which may being substantially transverse to the direction of the longitudinal axis 90 of the primary catheter 70 so as to assume the first secondary folded shape, at least when being exposed from the distal end portion 100 of the primary catheter 70.
[0010] An arm portion 126, 136 may be, for example, at least 4 mm or at least 5. mm or at least 8 mm or at least 10 mm or at least 12 mm, in a direction radial to the longitudinal axis 90 of primary catheter 70. A free end of the respective arm portion 126, 136 can be turned over backwards from the longitudinal axis 90 so that the respective arm portion 126, 136 can form an end face extending transversely to the longitudinal axis. 90 of primary catheter 70 which can frontally contact tissue structure 10 with catheter member 1 in a non-penetrating manner. First 120 and second secondary catheters 130 (e.g. elongated) may each extend along a longitudinal axis 125, 135 (see e.g. Figure 3a), may each comprise a distal end portion 140, 150 and an end portion proximal 180, 190 and an inner lumen 160, 170, and may each comprise a secondary alignment portion 127, 137 which may be located between distal end portions 140, 150 and proximal 180, 190 and adjacent to the distal end portion. 140, 150. The first and second secondary catheters each can be disposed in an inner lumen 80 of the primary catheter 70 and can be movable with respect thereto and can be exposed from the distal end portion 100 thereof.
[0011] A second bending mechanism 192 may provide the secondary alignment portion 120 of the first and/or second 130 secondary catheter with a tendency to assume a second secondary folded shape. A distal end portion 140, 150 of both the first and second secondary catheters 120, 130 may be provided to be able to be flexed by the first flexing mechanism 191 to form an arm port substantially transverse to the axis direction. 90 of the primary catheter 70 so as to assume the first secondary folded shape when being exposed from the distal end portion 100 of the primary catheter 70. A secondary alignment portion 127, 137 of the first 120 and second 130 secondary catheters may be provided so as to be able to be flexed by the second bending mechanism 192 to assume the second secondary bent shape which may have a predetermined curvature, optionally having a radius of substantially 30 to 70 mm and optionally describing an angle of 90 ° to 270 °. The arm portions 126, 136 of the first 120 and second 130 secondary catheters, respectively, may extend in generally opposite directions from one another when the secondary alignment portions 127, 137 of the first 120 and second 130 secondary catheters assume the second secondary folded form. , for example, in parallel with each other.
[0012] With further reference to the Figures, a catheter member 1 for interacting with an anatomical feature (e.g., surrounding, e.g., treatment) (hereinafter, for better understanding, also referred to as tissue structure, in accordance with said anatomical feature can be a tissue structure, eg a circumferential tissue structure) 10 can be provided. Tissue structure 10 may, for example, be a part of a heart, e.g., part of a heart valve, such as a ventricular valve, mitral valve, pulmonary valve and/or triscupidal valve. Referring to Figure 2, tissue structure 10 may, for example, comprise a portion or may be a heart valve having a connecting channel 20 comprising a connecting channel wall structure forming said connecting channel 20 or "port opening. ticket". The heart valve may comprise a circumferential valve ring 30, valve leaflets 40 opening and closing the connecting channel at a position close to the valve ring 30 to provide valve functionality, a generally circumferential cord structure (tendon cords) 50 connecting valve leaflets 40 and generally papillary muscle(s) 60 are referred to as papillary muscles 60. Circumferential tissue structure 10 may be referred to as connecting channel wall structure.
[0013] Catheter member 1 may comprise a primary catheter member 70 (for example, see Figure 5a). The primary catheter or primary catheter member 70 may, for example, be flexible and generally tubular in shape. Primary catheter member 70 may comprise one or more inner lumens 80 and may extend along a longitudinal axis 90. Primary catheter may comprise a distal end portion 100 and may include a proximal end portion 110 (for example, see Figure lb). The distal and/or proximal end portions 100, 110 may comprise end openings provided for connecting the inner lumen(s) 80 of primary catheter 70 to the outer/surround side of primary catheter 70 (each of the catheters described herein, for example secondary or tertiary catheter, may include end openings).
While primary catheter 70 is shown in Figure 1 to comprise an inner lumen 80, primary catheter 70 may comprise multiple inner lumens 80 that are separate from each other. The multiple inner lumens 80 can all have the same inside diameter or can have different inside diameters. The inner side of primary catheter 70 (i.e., the "outer side" of inner lumen 80) may be a smooth and/or coated surface to have a low coefficient of friction to facilitate advancement/retraction of the catheters. secondary (described in more detail below) or similar ones. In this regard, primary catheter 70 may comprise a braid-type flexible hose or a corrugated-type flexible hose (e.g., made from stainless steel) and may comprise a smooth inner liner, e.g., made of Pebax or PTFE or the like (not shown).
The primary catheter 70 may be flexible and/or rigid, and the distal end portion 100 may be flexible and/or rigid and/the proximal end portion 110 may be flexible and/or rigid. While primary catheter 70 may be generally flexible, distal 100 and/or proximal 110 end portions may be rigid to facilitate approach to tissue structure 10 and/or manipulation by an interventional cardiologist, respectively.
[0016] The primary catheter member 70 can be made from a shape memory material, for example, a shape memory alloy (such as, for example: nitinol or Fe-Mn-Si, or any metal or metal alloy with shape memory properties) or a shape memory polymer (such as Norsorex or PET crosslinked with glycerol / dimethyl-5-sulfoisophthalate or maleic anhydride or any other shape memory polymer). While the primary catheter 70 may be made of a distinctly shaped memory material ie, for example, providing material elasticity as is known in the art, it may also (additionally or alternatively) comprise structurally shaped memory properties, i.e. , can be made from a material without distinct shape memory characteristics (eg spring steel) but has shape memory characteristics due to its geometric design and/or elasticity characteristics. However, primary catheter 70 may be a conventional catheter not comprising shape memory material or structural shape memory properties. Primary catheter 70 may be flexible, for example, it may be a hose, or flexible tube, or the like.
[0017] The catheter member 1 may also comprise a first 120 and/or a second 130 (or more) secondary catheter(s) (see, for example, Figure 5b ). The first 120 and/or second 130 secondary catheters may comprise a first secondary catheter distal end portion 140 and a second secondary catheter distal end portion 150, respectively. The distal end portion 140, 150 of an or. of both the first and second secondary catheter 120, 130. may be provided to be flexible (i.e., configured to be bendable, e.g., flexible) by a first bending mechanism 191. (described, below). Thus, the distal end portion 140 of the first secondary catheter 120 e ! or the distal end portion 15.0 of the second secondary catheter 130 (or a portion of both or any of the distal end portions 140, 150) may be elastic or may be plastically deformable.
[0018] The first 120 and/or second 130 secondary catheter may comprise a first secondary catheter inner lumen 160 and a second secondary catheter inner lumen 170, respectively. The first 120 and/or second 130 secondary catheter may each comprise one or multiple: separate inner lumens 160, 170. The first secondary catheter 120 may extend along a longitudinal axis 125 (which may be an axis extending longitudinally through a point central/mid-radial of the first secondary catheter 120). Likewise, the second secondary catheter 130 may extend along a longitudinal axis 135 (which may be an axis extending longitudinally through each center/midpoint radial of the second secondary catheter 130). The first 120 and/or second 130 secondary catheter may also comprise a proximal end portion 180, 190 (see for example Figure 1b) which may be located substantially oppositely along a longitudinal axis 125, 135 of a respective secondary catheter. 120, 130 to the respective distal end portion 140, 150.
[0019] The outer diameter of the. first 120 and second 130 secondary catheter, respectively, may be smaller than a diameter of an inner lumen 80 of primary catheter 70, so that secondary catheters 120, 130 may be provided in inner lumen 80 of primary catheter 70 and may being mobile, for example, may be advanced and retractable with respect to (e.g., distal end portion 100 of) primary catheter 70. Secondary catheters 120, 130 may be longitudinally longer than primary catheter 70 so that their respective proximal end portions 180, 190 may be manipulated by a surgeon to operate (e.g., advance and/or retract) their distal end portions 140, 150 relative to the distal end portion 100 of primary catheter 70 .
The catheter member 1 may also comprise a first bending mechanism 191 (described below) to give the distal end portion 140, 150 of the first 120 and/or second 130 secondary catheter a tendency to assume a first secondary folded shape. . The first bending mechanism 191 can also provide the first secondary bent shape.
The first secondary folded shape may be a shape wherein the first and/or second secondary catheter distal end portions 140, 150 dO' 120, 130 each form an arm portion 126, 136. arm 126, 136 and/or both arm portions 126, 136 may comprise a lateral outer surface, i.e. a surface which may span a circumference (e.g. a surface which is circumferentially extending around the longitudinal axis 125, 135 of the first 120 and second 130 secondary catheters, respectively) of a respective arm portion 126, 136. For example, when using the catheter member 1, said lateral outer surface or outer surfaces may be contacting a structure which is to be surrounded using catheter member 1. The arm portion 126 of the distal end portion 140 of the first secondary catheter 120 and/or the arm portion 136 of the distal end portion 150 of the second secondary catheter 130 may extend substantially transversely to the longitudinal axis 90 of primary catheter 70, at least when the respective distal end portion 140, 150 has assumed the first secondary folded shape (e.g., shown schematically in Figure 3b). The arm portion 126, 136 (or both arm portions 126, 136 at the same time) of the distal end portion 140, 150 of the first 120 and/or second 130 secondary catheter, respectively, can be turned ashore from the shaft. 90 of the primary catheter 70 such that arm portion 126, 136 of the distal end portion 140, 150 of the first 120 and/or second 130 secondary catheter (or both arm portions 126, 136) may form an end face of blunt blunt extending transversely to the longitudinal axis 90 of primary catheter 70 and which may frontally (e.g., with respect to catheter member 1, e.g., in a direction corresponding to longitudinal axis 90 of primary catheter 70) contact tissue structure 10 in a non-penetrating manner with a lateral outer surface thereof, as the arm portion 126, 136 (see for example, Figure 11) (or both arm portions 126, 136 at the same time (for example, see Figure). 9 or Figure 13b) ) may form a blunt contact area that cannot penetrate tissue structure 10. or cause trauma damage. Both arm portions 126, 136 may extend substantially transversely to the longitudinal axis 90 of primary catheter 70. However, there can also be only one (any) arm portion 126, 136 extending transversely to the longitudinal axis 90, while at the same time the other arm portion 126, 136 may extend substantially parallel to said longitudinal axis 90 of primary catheter 70.
[0022] One or all of the arm portions 126, 136 may be straight, i.e. the respective distal end portion 140, 150 may comprise a straight arm portion 126, 136 and a. curved portion adjacent to the straight arm portion 126, 136. The curved portion may serve to give the straight arm portion 126, 136 a defined orientation relative to the respective first or second secondary catheter 120, 130.
[0023] When the catheter member 1 is in an operative position and located adjacent to a tissue structure 10, one or all of the arm portions 126, 136 may be oriented such that the longitudinal axis 125, 135 of the respective secondary catheters 120, 130 extend substantially in a straight line and transverse to the longitudinal axis 90 of primary catheter 70. Arm portion(s) 126, 136 may also extend substantially parallel to a tangent of a circumferential tissue structure 10. tangent can be the tangent that intersects a circumference of tissue structure 10 at the same point on the circumference of tissue structure 10 which is the point that intersects with the extent of longitudinal axis 90 of primary catheter 70 when in an operative position. The arm portion(s) 126, 136 may have (e.g. each) an (e.g. substantially straight) extension length of more than 4mm, more than 5mm or more than 7mm, eg 4 to 7 mm, or ü 5 to 7 mm, or 4 to 20 mm. The arm portion(s) 126, 136 can serve to reduce trauma and stress that can be induced in the circumferential tissue structure 10 by movement of the catheter member 1 by providing greater contact area in the event of physical contact. In this way, the arm portions 126, 136 (or one of the arm portions) can reduce the mechanical stress induced in the circumferential tissue structure 10 (stress equals force divided by area, and catheter member 1 provides a large contact area through the arm portions and thus reduces tension) in the event of contact between catheter member 1 and tissue structure 10, thus avoiding trauma and potentially lethal tissue damage by allowing catheter member 1 to contact tissue structure 10 of a non-penetrating form. One or both arm portion(s) 126, 136 may, due to their design/shape/orientation, also act as one. elastic cap and dissipate some energy by elastic deformation in case of contact between catheter member 1 and tissue structure 10. In addition, the arm portion(s) 126, 136 can allow the user to precisely orient one or more catheters tertiary 200, 21.0 (described in more detail below) around tissue structure 10 for providing one. greater stability and orientation capability (if one or more tertiary catheters 200, 210 are provided).
[0024] Therefore, the straight arm portion 126 of the distal end portion 140 of the first, secondary catheter 120 may define an angle o with the longitudinal axis 90 of the primary catheter 70 (for example, see Figure 4b or b), at least when the distal end portion 140 has assumed the first secondary bent shape. Likewise, the straight arm portion 136 of the distal end portion 150 of the second secondary catheter 130 may define an angle ET with the longitudinal axis 90 of the primary catheter 70, at least when the distal end portion 150 has assumed the first shape. secondary folded. Arm portion 126 of distal end portion 140 of first secondary catheter 120 may define an angle a different from arm portion 136 of distal end portion 150 of second secondary catheter 130, or both arm portions 126, 136 may define the same angle cx, at least when one or both of the distal end portions 140, 150 has assumed the first secondary bent shape, Angle a may be substantially 90' or >80° or >60° or >50° or >45° or any other angle. Angle cx can optionally be measured from the distal side of the longitudinal axis 90 to a respective straight arm portion 126, 136 (eg as shown in Figure 3b) and can optionally have a maximum value of 90° and a minimum value as described above.
[0025] As mentioned above, the catheter member 1 may comprise a first flexion mechanism 191. The first flexion mechanism 191 may serve to provide the distal end portion 140 of: first secondary catheter 120 and/or the end portion the distal 150 of the second secondary catheter 130 with a tendency to assume a first secondary folded shape, at least when the respective distal end portion 140, 150 is advanced (e.g. exposed) from the inner lumen 80 of the primary catheter 70. first bending mechanism 191 may, for example, comprise a shape memory structure provided in the distal end portion 140, 150 of the first 120 and/or the second 130 secondary catheter. The first bending mechanism 191 can be driven by elastic energy which is stored in the first bending mechanism 191 due to the deformation of the shape memory structure from a predetermined shape caused by a constraint. The restriction may be, for example, the primary catheter 70 which prevents the flexion mechanism shape memory structure 191 from assuming its predetermined shape. When the restriction is removed (for example by advancing the secondary catheter 120, 130 from the distal end portion 100 of the primary catheter 70) the shape memory structure of the first bending mechanism 191 can give the distal end portion 140, 150 of the first 120 and/or second 130 secondary catheter is the default shape.
[0026] Figure 6a shows a variant of the bending mechanism 191 comprising a pressure element 191a (eg a spring). Pressure element 191 can give the distal end portions 140, 150 of the first 120 and second 130 secondary catheter a tendency to assume the first secondary folded shape. For this, pressure element. 191a can be connected to the distal end portion 140 and to the distal end portion 140 of first 120 and second 130 primary catheters, respectively, and can bias said distal end portions 140, 150 to generally extend oppositely (e.g., in opposite directions) to each other, at least when the distal end portions 140, 150 are advanced (e.g., exposed) from an interior lumen of primary catheter 70.
[0027] Figure 6b shows another variant of a flexion mechanism 191. As shown in Figure 6b, first flexion mechanism 191 may comprise an elastic distal end portion 140, 150 at first 120 and/or second 130 Secondary catheter which, without any external restriction, may have a tendency to extend linearly (for example, along the longitudinal axes 125, 135 of the first 120 and second 130 secondary catheter, respectively). According to Figure 6b, bending mechanism 191 may further comprise one or more longitudinal elements 191b (e.g., a flexible wire or filament) which are connected with the distal end portion 140, 150 of the first 120 and/or the second 130 secondary catheter and are provided in parallel with respective secondary catheter 120, 130. The longitudinal members 191b may be provided so that they extend through the inner lumen 80 of primary catheter 70 (indicated by dots in Figure 6b) to be operable from a proximal end of catheter member 1 (eg primary catheter 70) by an operator. Operating the longitudinal elements 191b may comprise transmitting a force to the distal end portion 140, 150 of the first 120 and/or second 130 secondary catheter by moving the longitudinal elements 191b parallel to a longitudinal axis, e.g., longitudinal axis 90 of primary catheter 70 (this may, for example, comprise pulling or pushing longitudinal elements 191b). Correspondingly, the distal end portion 140, 150 of the first 120 and/or second 130 secondary catheter may be biased by the longitudinal member(s) 191b from its generally straight extended state to assume the first secondary folded shape.
[0028] Figure 6c shows another variation of the first bending mechanism 191. According to Figure 6c, bending mechanism 191 may comprise a bending frame 191c. Flexion structure 191c may be provided in a distal end portion 1.00 of the primary catheter 70 and may comprise a separate channel for each of the secondary catheters 120, 130 configured such that a respective secondary catheter 120, 13.0 may be advanced through ( for example exposed to the outside of the catheter member 1 at a distal end) of the flexion structure 191c. Each channel can be provided so that one guide. secondary catheter 120, 130 to assume the first secondary folded shape when the distal end portion 140, 150 (which may be flexible) of the first 120 and/or second 130 secondary catheter is advanced from the distal end portion 100 of the primary catheter 70 and through said bending frame channel 191c. Flexion structure 191c may comprise a distal conical end portion serving as an atraumatic tip cone to facilitate insertion of catheter member 1. In this regard, when catheter member 1 comprises a flexion structure 191c and is in a state operative adjacent to a circumferential tissue structure 10, one or more arm portions 126, 136 may extend generally transverse to the longitudinal axis 90 of primary catheter 70 longitudinally spaced from the distal conical end portion of flexion structure 191c such that a or both arm portions 126, 136 may be closer to tissue structure 10 than the distal tapered end portion. Therefore, when using the catheter member 1 having flexion structure 191c, the arm portions 126, 136 (or one of them, for example, if, for example, a configuration as shown in Figure 11 is provided) may contact a fabric structure 10 while at the same time the tapered end portion, optionally, may not contact the fabric structure. Bending structure 191c may also comprise a separate channel through which front body tube 320 (described later) may extend (not shown). Thus, flexion structure 191c may serve to facilitate atraumatic insertion of catheter member 1, while arm portion(s) 126, 136 may be allowed to contact tissue structure 10 when one or both respective distal end portions 140 , 150 of a secondary catheter 120, 130 assumed its first secondary folded shape.
[0029] It should be noted that any flexion mechanism (and, in general, any feature) that is described herein can and could be combined with any variation or modality of any catheter described here (e.g., catheter member 1 and/or secondary catheters 120, 130 and/or tertiary catheters 200, 210), unless otherwise indicated.
[0030] As shown for example in Figure 2, the first and/or second secondary catheter 120, 130 may also optionally comprise a secondary alignment portion 127, 137. The secondary alignment portion 127, 137 of the first and secondary. 120, 130 may be located between the distal end portion 140, 150 and the proximal end portion 180, 190 of the first 120 and second 130 secondary catheter, respectively. The secondary alignment portion 127, 137 of the first and/or second secondary catheter 120, 130 may be located adjacent to the distal end portion 140, 150 of the respective first or second secondary catheter 120, 130. The secondary alignment portions 127, 137 may be provided to be capable of being bent or bent or deformed by the second bending mechanism 192 (described in more detail below) to assume a second, secondary bent shape.
[0031] In addition, as mentioned above, the. Catheter member 1 may optionally comprise a second flexion mechanism 192. The second flexion mechanism 192 may be provided so as to give the secondary alignment portion 120 of the first and/or second 130 secondary caterer a tendency to assume a second shape. secondary folded. The second bending mechanism 192 may be a shape memory structure, that is, a structure that has a tendency to return elastically or plastically to a predetermined shape when deformed from this predetermined shape. Therefore, the second bending mechanism 192 may comprise a shape memory material such as Nitinol or steel or steel spring and/or may comprise a structure whose shape memory properties are primarily caused by the geometric characteristics of the shape memory structure, eg a spiral element or a spring element. The second bending mechanism 19.2 may also comprise active means for giving the secondary alignment portions 127, 137 (or any of them) a tendency to assume the second secondary folded shape in accordance with a control signal. Therefore, the second bending mechanism 192 may comprise active elements such as hydraulic actuators or material with. shape memory, in combination with controllable heating/cooling elements (eg Peltier elements) to give the secondary alignment portions 127, 137 (or one of them) the tendency to assume the second secondary folded shape. Second bending mechanism 192 can be provided by material elasticity. Any or all of the features described with reference to the second bending mechanism 192 may also be applicable to the first bending mechanism 191 and vice versa.
[0032] The second secondary bent shape may be a predetermined shape (predetermined, for example, by features/design of the secondary alignment portion(s) 127, 137 and/or the second bending mechanism 192). The second secondary bent shape may be chosen or predetermined to match a geometric constraint that is not part of catheter member 1, for example the second secondary bent shape may correspond to an anatomical feature. In this regard, the second secondary bent shape can be chosen to resemble (e.g., match) the curvature of an anatomical feature, e.g., an aortic arch 340 of a human heart, a sheep or a porcine heart. or, generally, from a mammalian heart. Thus, the secondary alignment portion 127, 137 of the first 120 and/or second 130 secondary catheter may mate (and/or mate together) with an anatomical feature (eg, aortic arch 340) when the secondary alignment portion 127 , 137 assumed its secondary folded form.
[0033] The secondary alignment portion 127, 137 may serve to align a position and/or orientation of the respective first and/or second secondary catheter 120, 130 by having a tendency to assume the second secondary folded shape, which corresponds, for example , for an aortic arch 340, and can be induced by the second flexion mechanism 192. Thus, when the first or second secondary catheters are located, for example, in an anatomical feature, for example, in the aortic arch 340, they can assume its chosen or predetermined shape caused by the flexion mechanism 192, thus resembling the shape of the aortic arch, or in other words, mating with the natural shape of the anatomical feature. This will align the secondary alignment portion 127, 137 (and therefore the first and/or second secondary catheter 120, 130) with the anatomical feature, as the secondary alignment portion may be in a stable position (eg, energetically favorable), when it is able to assume the secondary folded shape (wherein the tendency to assume that shape is induced by the second bending mechanism 192). The second alignment portion 127, 137 and/or the second bending mechanism 192 may, for example, have a minimum of elastic energy when the second alignment portions 127, 137 have assumed their respective second folded shape. Thus, "mating" a portion of secondary alignment 127, 137 with an anatomical feature may give the respective first 120 and/or second 130 secondary catheter a defined and predetermined position and/or a defined and predetermined rotational position and , for example, can rotate a respective secondary catheter 120, 130.
[0034] Consequently, the design of the secondary alignment portion 127, 137 of the first 120 and/or second 130 secondary catheter, respectively, and/or the second flexion mechanism 192 can be chosen to give the distal end portion. 140, 150 of the first 120 and/or second 130 secondary catheter a predetermined orientation and/or rotational orientation, and therefore may also give the first 120 and/or second 13.0 secondary catheter a predetermined orientation and/or position.
[0035] In this regard, the distal end portion 140, 150 of the. the first 120 and/or second 130 secondary catheter may have a defined and predetermined orientation and position, for example, with respect to the circumferential tissue structure 10. When the respective distal end section 140, 150 takes on the first, secondary folded shape , the orientation and rotation of the arm portion 126, 136 may therefore also be defined and/or predetermined as the first and/or second secondary catheter 120, 130 may have a defined position and/or orientation, e.g. by the secondary alignment portion. As a consequence, the distal end portion 140, 150 (and/or arm portions 126, 136) can be positioned and oriented relative to an anatomical feature (eg tissue structure 10) without any additional means. Furthermore, in the alignment or mating state with an anatomical feature, some resistance against longitudinal movement of the. aligned/mated catheter, e.g. against unintentional longitudinal movement by a person handling catheter member 1 (e.g. strength may depend inter alia on the elastic properties of the respective catheter).
[0036] The arm portions 126, 136 of the first 120 and second 130 secondary catheter, respectively, :(e.g. the respective longitudinal axes 125, 135.) can define an angle β to each other (see, e.g., Figure 3c , which represents a section along CC in Figure 3b), at least when they assumed their first folded shape. Angle β can be caused and can be predetermined by designing the secondary alignment portions 127, 137 and/or the second flexion mechanism 192 as this can lead to a defined position and orientation of the first 120 and/or second 130 secondary catheter ( or the respective distal end portion 140, 150). Angles β can be approximately 180 ° or 3 170 0 or > 160 ° or > 120 ° or > 90 ° or > 4 5 ° or any other angle depending on the desired placement of the first 120 and second 130 secondary catheters in use.
[0037] Therefore, the orientation and position of an arm portion 126, 13.6 in relation to an anatomical feature (eg tissue structure 10) and/or in relation to another respective arm portion 126, 136 can be defined by first and/or second secondary alignment portions 127, 137, at least when they are in their respective second folded shape.
[0038] Furthermore, the catheter member 1 may optionally comprise a first 200 and/or a second 210 tertiary catheter (for example, see Figure 4a, 4b, 4c). Catheter member 1 may also comprise only one or more than two tertiary catheters, for example 3 to 5 tertiary catheters. The first 200 and second 210 tertiary catheters may each extend along a longitudinal axis 220 and 230, respectively. The first 200 and second 210 tertiary catheters may also each comprise one or more inner lumens 240 and 250, respectively. Furthermore, the first tertiary catheter 200' may comprise a distal end portion 260 and a proximal end portion 280 and the second tertiary catheter 210 may comprise a distal end portion 270 and a proximal end portion 290 (see for example , Figure 1b). The proximal 280, 290 and distal 260, 270 end portions of a respective tertiary catheter may be located at substantially opposite ends along the longitudinal axis 220, 230 thereof.
[0039] A tertiary catheter 200, 210 (eg a tertiary catheter and/or both tertiary catheters) can be guided by a respective secondary catheter 120, 130. In order to be guided, a tertiary catheter 200, 210 can be provided in a secondary catheter 120, 130 so that the secondary catheter 120, 130 is received in the inner lumen 240, 250 of the respective tertiary catheter 200, 210. A tertiary catheter 200, 210 can be provided in parallel with a secondary catheter 120, 130 and a parallel guide device may be provided in order to guide a tertiary catheter 200, 210 parallel (for example, with respect to the longitudinal axis 125, 135.) along a secondary catheter 120, 130. A parallel guide device may be, for example, a flexible hose that fits tightly around a secondary catheter: and a tertiary to allow parallel guidance of a tertiary catheter along the longitudinal axis 125, 135 of a secondary catheter 120, 130.
[0040] The first, tertiary catheter 200 can be provided in an inner lumen 160 of the first: secondary catheter 120 and the second tertiary catheter 210 can be provided in an inner lumen 170 of the second secondary catheter 130 so as to be mobile relative to the first 120 and second 130 secondary catheter, respectively. The first 200 and/or second 210 tertiary catheters may be configured such that their respective distal end portion 260, 270 may be advanced from and/or retracted into an inner lumen 160, 170 of the first 120 and second 130 secondary catheter , respectively, so that its respective distal end portion 260, 270 can be exposed from the distal end portion 140, 150 of the corresponding first or second secondary catheter 120, 130. Thus, an outer diameter of the first 200 and/ or second 210 tertiary catheters may be smaller than the outer diameter of the respective inner lumen 160, 170 of the respective secondary catheter 120, 130. The outer diameter of the first 200 and/or second 210 tertiary catheters may also be slightly larger than the diameter interior of its inner lumen 16.0, 170 of its secondary catheter 120, 130 so as to provide a slight press fit to maintain movement capability of the catheters, but also to provide an opposing force to any relative movement in order to facilitate precise relative movement.
[0041] Each tertiary catheter 200, 210 can be guided in the same way by a respective secondary catheter 120 130 or it can be guided in a different way. For example, the first tertiary catheter 200 may be provided into the inner lumen 160 of the first secondary catheter 120 and at the same time the second secondary catheter 130 may be received into the inner lumen 250 of the second tertiary catheter 210 such that the tertiary catheters 200, 210 are guided by secondary catheters 120, 130.
[0042] As shown, for example, in Figure 5c, first 200 and/or second 210. or tertiary catheters each may comprise a first 241, 251 and/or a second 242, 252 tertiary alignment portion. A first 241, 251 and/or a second 242, 252 tertiary alignment portion may be provided at. each or one of the tertiary catheters 200, 210, for example, located in a respective distal end portion 260, 270 or between the respective distal end portion 260, 270 and the respective proximal end portion 280, 290. The first 241, 251 and second 242, 252 tertiary alignment portion of a tertiary catheter 200 abut or may be spaced apart from each other.
[0043] The first tertiary alignment portion 241, 251 of one or both tertiary catheters 200, 210 may be provided to comprise a shape memory structure giving the first tertiary alignment portion 241, 251 a bias (e.g. , caused by the elasticity of material) to assume a first tertiary bent shape. Likewise, the second tertiary alignment portion 242, 252 of one or both of the tertiary catheters 200, 210 may be provided to include a shape memory structure giving the second tertiary alignment portion 242, 252 a tendency to assume a second tertiary bent shape. The first tertiary folded shape may correspond to (for example, resemble, for example, mate with) the first secondary folded shape. The second tertiary bent shape may correspond to the second secondary bent shape.
[0044] As a result, the first 200 and/or second 210 tertiary catheter can be aligned (for example, being in a defined and predetermined position and rotational orientation relative to a respective secondary catheter 120, 130) with the first 120 and/ or second 130 secondary catheter, respectively, when the first tertiary alignment portion 241, 251 of a tertiary catheter 200, 210 corresponds (e.g., mates) with a first secondary bent shape of a respective secondary catheter 120, 130. The first 200 and/or second 210 tertiary catheter may be aligned (e.g., being in a defined and predetermined position and relative rotational orientation for a respective secondary catheter 120, 130) with the first 120 and/or second 130 secondary catheter, respectively, when the second tertiary alignment portion 242, 252 of a tertiary catheter 200, 210 corresponds (e.g., mates) with a second secondary folded shape of a respective catheter. secondary r 120, 130. The first 241, 251 and/or the second 242, 252 tertiary alignment portion may be located in its respective tertiary catheter 200, 210 so that the alignment portion(s) of the respective tertiary catheter 200, 210 corresponds with the first and/or second secondary folded shape (of a secondary catheter 200, 210), respectively, when o. tertiary catheter 200, 210 is fully operatively exposed from the distal end portion 140, 150 of the respective secondary catheter 120, 130. The relative position and rotation of a tertiary catheter 200, 210 relative to a secondary catheter 120, 130 can be predetermined and most efficiently defined when both the first and second tertiary bent shape of a tertiary catheter mate with the first and second secondary bent shape of a respective secondary catheter 120, 130. However, the relative position and rotation of a tertiary catheter 200, 210 relative to a secondary catheter 1.20, 130 can be defined when there is only one of the tertiary bent shapes that mate with a corresponding secondary bent shape.
The alignment: tertiary portion 241, 251 of one or both of the tertiary catheters 200, 210 may be flexible and may be provided to be flexible by a third flexion mechanism (not shown). The third bending mechanism may be a shape memory structure as described above, or it may comprise any or all of the features of the first 191 and/or second 192 bending mechanism, with the difference that the respective features relate to a tertiary catheter 200, 210 instead of a secondary catheter 120, 130.
The distal end portion 260, 270 of the first 200 and/or second 210 tertiary catheter may comprise a shape memory structure. The shape memory structure can give the distal end portions 260, 270 a tendency to assume oppositely oriented arc shapes so that the distal ends 260, 270 of the tertiary catheters 200, 210 are substantially pointing toward each other when exposed, for example, fully operationally exposed from secondary catheters 120, 130 (cf Figure 1, Figure 4 or Figure 5c). Said oppositely oriented arc shapes may serve to at least partially (e.g., fully) surround the circumferential tissue structure 10, e.g., in a generally circular or elliptical shape.
[0047] Figure 5e schematically shows a single first tertiary catheter 200. As can be seen from Figure 5e, the plane in which the distal end portion 260 is extending in an arc shape may be substantially normal (i.e., it may comprise an angle of substantially 90°) with respect to the plane in which the second tertiary alignment portion 242 is extending, at least when it has assumed the second bent shape. However, there are also other possible angles between said planes, for example 80° to 90°, 30° to 60°, 700 to 80° or any other angle as appropriate for the use of the device. Although not shown in Figure 5e, it can be applied at the same time to the second tertiary catheter 210. Furthermore, it can be seen, for example, from Figure 4c, that when the first and second distal end portions 260 270 of the first 200 and second 210 tertiary catheters are exposed from the distal end portion 140, 150 of the first 120 and second 130 secondary catheters, the distal end portions 260, 270 of the first 200 and second 210 tertiary catheters each may extend substantially in a plane substantially the same, which may be transverse to the longitudinal axis 90 of primary catheter 70.
[0048] Still referring to Figures 7a, 7b and 7c, one and/or both tertiary catheters 200, 210 may also be at least partially folded, for example fully folded, at least when coated on a respective secondary catheter 120, 130. The distal end portion 260, 270 of the first 200 and/or the second 210 tertiary catheter may comprise a shape memory structure giving it a tendency to take a coil shape (e.g., a spiral shape, by example, a pig's tail shape, e.g., a helical shape, e.g., a thread shape), at least when advanced from a distal end portion 140, 150 of a secondary catheter 120, 130. The shape The coil shape can be a flat coil shape, i.e. the coil windings can be located in substantially the same plane, or the coil shape can be a helical-type and/or screw-type coil shape in which the coil windings can be willing They are spaced along an axis to form a helical-like structure. In this regard, the helical-type or thread-type coil form can have a constant pitch or variable pitch and/or a constant or variable radius of the windings. The distal end portion 260, 270 (e.g., coil shape thereof) of the first 200 and/or second 210 tertiary catheter may be bent, e.g., packaged, e.g., diametrically compressed (i.e., compressed into a radial direction of the coil shape) when coated on a respective secondary catheter 120, 130 and may deploy substantially at once (e.g., suddenly) when the folded or packaged distal end portion 260, 270 is advanced from a respective secondary catheter 120, 130. In this way, the distal end portion 260, 270 of the first 200 and/or second 210 tertiary caterer can take the form of a coil when advanced from a respective secondary catheter 120, 130 caused by the structure with shape memory of the distal end portion 260, 270 of the first and/or second tertiary catheter. 200, 210. the coil form may comprise a plurality of windings, for example 1 to 2 windings, 1 to 5 windings, 3 to 7 windings or any other number of windings. In this regard, a winding can be a full winding (ie spanning an angle of .360°) and/or a partial winding (ie spanning an angle of less than 360°). A plurality of windings may include zero or more (for example one or more) complete windings and/or zero or more (for example one or more) partial windings.
[0049] A longitudinal length of the first 200 and/or second 210 tertiary catheter may be longer than a longitudinal length of the first 120 and/or second 130 secondary catheter, respectively, so that a proximal end 280, 290 may be exposed from a proximal end 180, 190 of a respective secondary catheter 120, 130 to facilitate operation and relative movement of the catheters relative to one another. Furthermore, a longitudinal length of each tertiary catheter 200, 210 may be longer than a longitudinal length of any secondary catheter 120, 130, which length itself may be longer than a longitudinal length of a primary catheter 70.
[0050] Furthermore, as shown in Figure 4 and Figure 5d, a front body tube 320 (eg, front body catheter 320) can be provided relatively movable in an inner lumen 80 of primary catheter 70. Front body 320 may comprise a front body 330 that may be provided to serve various functions. Front body 330 may be provided to serve as a means to selectively close or open an interior lumen 80 of primary catheter 70. Therefore, front body 330 may have a cross-sectional shape that is corresponding to a cross-sectional shape (view transverse to longitudinal axis 90) of the inner lumen 80 of primary catheter 70 and a diameter that is substantially similar to the cross-sectional diameter of inner lumen 80 of primary catheter 70 or slightly larger than the diameter to provide a press fit . Front body 330 may be operable by moving front body tube 320 along a longitudinal axis 90 of primary catheter 70, thereby moving front body 330 along longitudinal axis 90 in a distal or proximal direction so as to open and close , respectively, the inner lumen 80 of the primary catheter 70. In addition, the front body 330 can serve to facilitate atraumatic insertion of the catheter member 1 by providing a curved or rounded front body 330. substantially round or curved or elliptical cross section when viewed in a lateral direction to the longitudinal axis 90 of primary catheter 70 (see, for example, Figure 4 or Figure 5d) in order to facilitate atraumatic insertion if front body 330 contacts tissue organic. Front body 330 may comprise a through opening and front body tube 320 may comprise an interior lumen that is aligned with the through opening of front body 330 so that a guide wire or the like can extend through the through opening. of the front body 330 and the inner lumen of the front body tube 320.
[0051] In what follows, possible kinematic movements of the catheter limb 1 will be described. As described above, primary catheter 70 may guide (e.g., casing) a first 120 and second 130 secondary catheters which are movable with respect thereto and which may optionally guide (e.g., casing) a first 200 and a second 210 tertiary catheter, respectively, itself, which are movable with respect thereto (and therefore also movable with respect to the primary catheter 70). In Figure la, some kinematic possibilities of relative motion are schematically indicated by arrows 5. All kinematic actions of any catheter or wire or other object described herein above or below may optionally be selectively completely and fully reversible, for example, some or all of the catheters that can be expanded and/or widened and/or moved and/or rotated and/or bent and/or flexed can selectively (eg, at the surgeon's discretion) be moved back and/or retracted and/or bent to its initial position / shape or any intermediate position / shape between and being in a stable intermediate position.
[0052] The "resistances", ie the force or tension, with which a bending mechanism 191, 192 or any structure with memory as described here attempts to induce (for example, gives a tendency to assume) a predetermined shape over a catheter described here can be chosen so that the resistance of a bending mechanism 191, 192 or shape memory structure is greater than the sum of the resistances of all catheters that are guided by that catheter. This can result in a stable bent shape of said catheter that cannot be inadvertently substantially altered by relative movements of any other catheters that are guided by said catheter.
[0053] A typical acrylic arc 340 of an adult human may have a radius of about 30 to 70 mm and define an angle of 90° to 270°. Therefore, a secondary alignment portion 127, 137 may optionally have a radius ranging from approximately 30 to 70 mm, for example 30 to 50 mm, for example 4.0 to 45 mm and/or defines an angle of 90° at 270°, for example, 90 0 to 120°, 120 0 to 160°, 160° to 200°, 200 0 to 245° and/or 245° to 270°, having assumed a second secondary folded form. However, the radius or curvature of the secondary bent shape may also be provided to be suitable (e.g., custom-made) for a specific patient's heart, whose size and geometry may have been determined using medical imaging techniques. While catheter member 1 and its features have been primarily described with reference to a mitral valve 330 as circumferential tissue structure 10 and an aortic arch 340, catheter member 1 may also be configured/designed with respect to other features or anatomical conditions . For example, the circumferential tissue structure 10 may be part or may be the entire tricuspid valve apparatus or any other valve, and the curvature of the second secondary bent shape may be designed to correspond with the curvature of a connecting channel from the vein. superior vena cava to the pulmonary artery of a mammalian heart or can be designed to match any other curvature. Catheter limb 1 can also be used to interact, for example, with a blood vessel, a gastric/digestive duct/organ and/or a tracheal/pulmonary duct. Catheter member 1 can also be used to interact, for example, with hard-to-reach parts of machines and so on.
[0054] In the inner lumen 240 and 250 of the first 200 or second 210 tertiary catheter a wire 300 can be provided having a free distal end 305 in which in the respective other tertiary catheter a capture wire 310 having a capture component can be provided distal 315, as shown, for example, in Figures 10 or 11. Wire 300 and/or capture wire 310 may be movable relative to its respective tertiary catheter 200, 210. Wire 300 and/or capture wire 310. can be made from the same materials or can be made from different materials, for example from metal such as steel or nitinol or from polymer such as Kevlar or polypropylene (PP) or polystyrol (PS) or from a biodegradable material, for example a material that dissolves within the human body at a substantially predetermined time.
Wire 300 and/or capture wire 310 may be advanced through inner lumen 240, 250 of its respective first or second tertiary catheter 200, 210 to a distal end portion 260, 270 thereof and may be exposed from it.
[0056] The wire 300 and/or the capture wire 310 may also serve to give the first 200 and/or the second 210 tertiary catheter a shape, for example a predetermined shape, caused by material strength, material elasticity or a shape memory structure of the wire 300 and/or the capture wire 310. Thus, a wire 300 and/or a capture wire 310 may comprise material strength, material elasticity and/or a shape memory structure . The shape memory structure can give the wire 300 and/Pu the capture wire 310 a tendency to assume an arc shape (eg semicircular shape, eg elliptical) or other shape. The arc shape can have an arc shape. an arc shape having a radius that may be equal to or greater than the radius of an anatomical feature, eg, of a circumferential tissue structure 10. When wire 300 has a tendency to assume an arc shape, the capture wire 310 may have a tendency to assume an arc shape that is correspondingly oppositely oriented. In this regard, the respective arc shapes of wire 300 and capture wire 310 may form a circular shape.
[0057] Referring to Figures 7a to 7c, when a distal end portion 260, 270 of a first and/or second tertiary catheter 200, 210 is exposed from a respective secondary catheter 120, 130 and takes a coil form as described above, wire 300 and/or capture wire 310 may be advanced through a respective first and/or second tertiary catheter 200, 210 and may correspondingly unwind (e.g., further unfold, e.g. uncoil) to Coil shape of the distal end portion 260, 270 of the first and/or second tertiary catheter 200, 210. This can make the distal end portion 260, 270 of the first and/or second tertiary catheter 200, 210 at least partially , for example, fully enveloping a structure, e.g., fabric structure 10. Unwinding a bobbin shape as described above (e.g., wire 300 or capture wire 310) may allow for atraumatic positioning and/or insertion of thefirst and/or second tertiary catheter 200, 210 and/or wire 300 and/or capture wire 310 around a structure, e.g. fabric structure 10, as there can be substantially only contact between a round winding of the shape. coil and an anatomical feature.
[0058] The capture component 315 may be or comprise a capture basket 315 or a magnetic component or a hook or a trap or a loop, or any other device configured to capture and secure a free end 305 of the wire 300. To facilitate capturing and securing, the free end 305 of wire 300 may include a burr or hook (not shown).
[0059] The capture component 315 can capture and secure the free end 305 when both are exposed from a distal end portion 260, 270 of their respective tertiary catheters 200, 210. The capture component 315 of the capture wire 310 may then be retracted back into the distal end portion of its (e.g., second 210 or first 200) tertiary catheter towards a proximal end portion 290 (or 280) thereof, pulling free end 305 of wire 3.00 (and thus a portion of wire 300 as well) into, for example, second tertiary catheter 210 towards a proximal end portion 290 thereof. This can result in a wire 300 at least partially (eg fully) surrounding an anatomical feature, eg tissue structure 10.
[0060] The circumference of the inner lumen 80, 160, 170, 240, 250 of the member of primary catheter 70, secondary catheter(s) 120, 130 and/or tertiary catheter 200, 210 (and/or referred to catheters as a whole) it can be selectively gas and liquid tight so that no gas or liquid can diffuse out from the inner lumen or can diffuse into the inner lumen. However, any or all of said inner lumens may also not be gas and liquid tight and allow controlled outward diffusion of matter, eg contrast dye or other substances allowing specific visualization or a drug, from an inner lumen to the outside of catheter member 1, for example, for treatment or other purposes, or controlled inward diffusion, for example, to sample a plasmid encoding for a protein.
The catheter member 1 as described herein can also be used in combination with a medical implant. The first and/or secondary 210 tertiary catheter 200 (and/or the first 120 and/or second 130 secondary catheter) may therefore be configured to provide an implant for the circumferential tissue structure 10. The implant may be a stent or a stent-graft-like structure, a balloon or similar actively inflatable limb, a covered foam/hydrogel or otherwise passively expandable limb. The implant can be anchored by its shape, or by additional anchoring components or by interacting with another device, e.g. inserted by a different delivery catheter; the implant, for example, can be a replacement heart valve that can be delivered within tissue structure 10 (eg, between the native tricuspid or mitral leaflets).
[0062] Hereinafter, a method of using a catheter member 1 to capture a tissue structure 10 will be described in more detail with reference to Figures 8 to 12. Any feature of a catheter member 1 that is described directly or indirectly in any method step is intended to be applicable also for the catheter member "device" and any feature, or functionality described with respect to the catheter member "device" may also be applicable as a method step of a method of using the catheter member 1. In addition, devices other than those described herein can be used to carry out the method steps described herein.
Figures 8 to 12 show schematic views of the human heart as viewed from the left atrial chamber 350 at the mitral valve 360 which may be or may comprise circumferential tissue structure 10 (see also Figure 2). Catheter member 1 can be seen with a distal end portion 100 of primary catheter 70 being positioned in ventricular chamber 370 (therefore, in Figures 8 to 12 "sub"mitral valve 360, see Figure 2). The catheter member is inserted through an aortic arch 340 so that the distal end portion 100 of the primary catheter 70 can be located adjacent to the circumferential tissue structure 10. The first 120 and second 130 secondary catheters, which can be guided by the catheter primary 70 (which may be flexible), can be arranged in such a way with respect to the aortic arch 340, that the second bending mechanism 192 can cause the secondary alignment portions 127, 137 to assume their respective secondary bent shape. This can result in the secondary alignment portions of secondary catheters 120, 130 being self-aligned and/or self-oriented with the aortic arch 340, resulting in a corresponding self-alignment or self-orientation of the distal end portions 140, 150 of the first 120 and second 130 secondary catheters as described above.
[0064] In Figure 8 it can be seen that the first and second secondary catheters 120, 130 are exposed from a distal end portion 100 of the primary catheter 70. Arm portions 126, 136 extend in substantially opposite directions transverse to the longitudinal axis 90 (not shown in Figure 8) of primary catheter 70 with a corresponding arm length (i.e., straight extension length) of about 4 mm or more (as described above the arm length may, however, be longer or shorter) caused by the first bending mechanism 191.
[0065] Figure 9 shows the first 210 and second 220 tertiary catheters being exposed from a distal end portion 140, 150 of the first 120 and second 130 secondary catheters, respectively, so as to substantially expand into oppositely oriented arc shapes toward each other to surround a mitral valve circumference 360 (or any other circumferential tissue structure 10).
[0066] Figure 10 shows the exposed free end 305 of wire 300 captured by capture component 315 of capture wire 310. Here, capture component 315 is a capture basket. Wire 300 and capture wire 310 are advanced through the inner lumen 240, 250 of the first 200 and second 210 tertiary catheters, respectively, from a proximal end portion 280, 290 (e.g., from the outside of a body) of the first 200 and second 210 catheters. tertiary, respectively, to be exposed from distal end portions 260, 270 thereof, so that the free end 305 of wire 300 can be reliably captured by capture member 315 of capture wire 310.
[0067] Figure 11 is similar to Figure 10, but shows an alternative/different arrangement of second secondary catheter 130 and second tertiary catheter 210. Here, second secondary catheter 130 and second tertiary catheter 210 are shaped so as to be substantially parallel to a longitudinal axis 90 (not shown in Figure 11) of primary catheter 70 and first secondary catheter 120 and first tertiary catheter 200 comprise an arm portion 126 as described above with reference to, for example, Figure 10 which is substantially transverse to the axis. longitudinal 90 or primary catheter 70. This results in catheter member 1 only partially surrounding a circumferential structure of a mitral valve 360 or other structure. As can be seen from Figure 11, arm portion 126 is provided substantially transverse to longitudinal axis 90 of primary catheter 70, while arm portion 136 is provided substantially parallel to longitudinal axis 90. as can be seen in Figure 11, in order for the capture member 315 to reliably capture the free end 305 of wire 300, it may not be necessary for distal end portions 260, 270 of the first and/or second tertiary catheters 200, 210, respectively. , are oriented in a certain way or angle relative to each other, nor is it necessary to touch or touch each other.
[0068] Figure 12 shows a further step of a method for using catheter member 1. The arrangement of catheter member 1 of Figure 12 is based on that shown in Figure 11, but all the principles described in Figure 12 or with reference to Figure 12 may also be applicable for the arrangement shown in Figure 10. In Figure 12, the capture wire 310 with the free end 305 of the wire 300 being captured in the capture member 315 is retracted into the interior lumen 250 of the second tertiary catheter 210, thus drawing wire 300 around part of mitral valve 360 and into inner lumen 250 of second tertiary catheter 210 as well. Furthermore, in Figure 12, the first and second tertiary catheters 200, 210 and the first and second secondary catheters 120, 130 are retracted into the inner lumen 90 of primary catheter 70. This can result in wire 300: circling a circumference of a mitral valve 360 (in Figure 12 partially, however when using a catheter member 1 as shown in Figure 10, fully).
[0069] The wire 300 extending around the circumferential tissue structure of the mitral valve 360 can enable further valve treatment, similar fixation, For example, it can be used to fix an artificial heart valve as described in PCT Publication No. WO 2012/004679 , the entire contents of which are incorporated herein by reference and/or may be used to serve as an outer member or to position an outer member or other circumferential implant support structure or the like as described in PCT application No. PCT / EP2012 / 067801, all contents of which are incorporated herein by reference.
[0070] Although the above method has been described on the basis of a 360 mitral valve for better illustration of the general principles, it can generally refer to involving any tissue structure 10 and still involve any circumferential structure, eg hard-to-reach parts of the machine or other circumferential structures in confined spaces.
[0071] Still referring to Figure 13, the catheter member 1 may be configured to surround the circumferential tissue structure 10 from a side of the circumferential tissue structure 10 that is opposite the aortic arch 340. distal end 100 of primary catheter 70 may be placed on the other side of circumferential tissue structure 10 with reference to aortic arch 340. Thus, the first 120 and/or the second 130 and the secondary catheter and/or the first 200 and/or the second 210 tertiary catheter may be configured to enclose tissue structure 10 (at least partially, e.g., completely) from a location on circumferential tissue structure 10 that is located opposite aortic arch 340. catheter 1 can be configured to envelop tissue structure 10 from any location with respect to aortic arch 340.
[0072] Figures 14a to 14f further show variations of the first bending mechanism (see also Figure 6). According to Figure 14a and 14b, the first bending mechanism 191 can be implemented by (and therefore comprising) one (e.g. 1) connecting member 191d and two joining members 191e. Each joint members 191e may be provided at the distal end portion 140, 150 of the first 120 and second 130 secondary catheters (e.g., at or near the distal end thereof), respectively. The connecting member 191d may be a rigid or rigid or flexible longitudinal member comprising two longitudinal end portions which each can be connected with one of the two joining members 191e. The connection between a joint member 191 and the connecting member 191d may be configured to allow rotational movement between the connecting member 191d and the first 120 or second 130 secondary catheter. In this regard, a joint member 191e may be implemented as a hinge between a longitudinal end of the connecting member 191d and the first 120 or second 130 secondary catheter. Therefore, as shown in Figure 14a, when the first 120 and second 130 secondary catheters are coated in the inner lumen 80 of primary catheter 70, a longitudinal axis of connecting member 191d may be substantially aligned with longitudinal axis 90 of primary catheter 70 , wherein the distal end portions 140, 150 of the first and second secondary catheters 120, 130 have a distance along the longitudinal axis 90 of the primary catheter 70 from each other that corresponds to the distance between the two joint members 191e ( and therefore also corresponds to the longitudinal length of the connecting member 191d). That is, the distal end portions 140, 150 of the first and second secondary catheters 120, 130 may be distanced from each other in one direction along the longitudinal axis. 90 of primary catheter 70 (and therefore may also have a distance along longitudinal axes 1.25, 135 of secondary catheters 120, 130). When, as shown in Figure 14b, the first and second secondary catheters 120, 13.0, which have a distance from each other that corresponds to a length, of the connecting member 191d while coated onto the primary catheter 70, are advanced from the portion of distal end 100 of primary catheter 70, and then the first and/or second secondary catheters 120, 130 are/is moved so that the axial (axial to longitudinal axis 90 of primary catheter 70) distance between the portion of the distal end 140 of the first secondary catheter 120 and the distal end portion 150 of the second secondary catheter 130 is altered (e.g., reduced), the connecting member 191d, which is rotatably connected to the first and second secondary catheters 120, 130 by through the board members. 191e, will cause a lateral deflection (with respect to the longitudinal axis 90 of the primary catheter 70) of the distal end portions 140, 150 of the secondary catheters 120, 130. Therefore, the arm portions 126, 136 are formed by the interaction of connecting member 191d and joint members 191e (constituting first bending mechanism 191 as shown in Figures 14a and 14b) with the distal end portions 140, 150 of the first and second secondary catheters 120, 130.
[0073] Figures 14c and 14d show a new variation of the first bending mechanism 191 comprising link members 191d and joint members 191e. Here, a first connecting member 191d is connected with the first secondary catheter 120 (e.g., the distal end portion 140 thereof) through a first connecting member 191c, and a second connecting member 191d is connected with the second secondary catheter 130 (e.g., distal end portion 150 thereof) through a second gasket member 191e. Furthermore, the end portions of the first and second attachment members 191d that are opposed to the respective end portions of the first and second attachment members 191d, which are connected with the first and second, respectively, secondary catheters 120, 130, are rotatably interconnected by a third joint member 191e. In addition, a longitudinal operating member 191j can be connected with a (longitudinal) end thereof to the first connecting member, the second connecting member 191d and/or the third connecting member 191e (as shown in Figures 14c and I4d ) . Operating member 191j may be (partially) coated in the inner lumen 80 of primary catheter 70 and may be movable with respect thereto. The other longitudinal end of operating member 191j may extend to proximal end 110 of primary catheter 70 and may not be outwardly exposed to be operable, for example, by a surgeon or actuation mechanism or the like.
[0074] As shown in Figure 14d, operation of operating member 191j can move the third joint member 11 and (or the first or second connecting member) in a longitudinal direction: of primary catheter 70 and can therefore flex the first and second catheter members 120r 130 (e.g., distal end portions 140, 150 thereof.) through first and second connecting members 191d and first, second and third joint members 191e, whereby the portion the distal end 100 of the primary catheter 70 can serve as a "benchtop" support for flexing the secondary catheters. In addition, or alternatively, optionally, as shown in Figure 14c and 14d., other connecting members 191d and joint members 191e may also be provided. For example, a fourth connecting member 191c may be connected to the first and second secondary catheters 120, 130 through the fourth and fifth joint members 191e (which may provide a rotatable connection or a rigid connection) which are provided spaced apart in a proximal direction. from the first and second board members 191e. Therefore, the fourth connecting member 191e can serve as a "countertop" support by flexing the first and second secondary catheters 120, 130 to form arm portions 126, 136. Optionally, also a fifth connecting member 19 can be provided connecting between first joint member 191e and fourth joint member 191e (connecting first secondary catheter 120 and fifth connecting member) and/or a sixth connecting member 191e may be provided connecting between second joint member 191e and fifth member of joint 191e (connecting second secondary catheter 130 and fifth connecting member) in order to further improve the efficiency of the first bending mechanism 191.
[0075] Another variant of the first bending mechanism 191 is shown in Figures 14e and 14f. Here, the first and second secondary catheters 120, 130 can be connected via a hinge member 191h. The pivot member 191h may connect the distal end portions 140, 150 of the secondary catheters 120, 130, or may connect portions having a longitudinal distance (along the longitudinal axes 125, 135) from the distal end portions 140, 150 The pivot member 191h may be configured to allow rotation of the secondary catheters 120, 130 relative to one another along a rational axis that may be substantially perpendicular to the longitudinal axes 125, 135 of the secondary catheters. In addition to the hinge member 191h, the first flexion mechanism 191 according to a variant may also comprise an inflatable/deflated member 191f (hereinafter referred to as "inflatable member") and an inflatable limb catheter 191g which is connected to inflatable member 191f. The inflatable limb catheter 191g and the inflatable limb 191f may be (at least for the time being) coated in the inner lumen 80 of the primary catheter 70. The inflatable limb catheter 191g and the inflatable limb 191f may be (at least partially) longitudinally movable with respect to primary catheter 70. Inflatable member 191f may have an inflated state characterized by a reduced diameter in a direction perpendicular to the longitudinal axis 90 of primary catheter 70 and may have an inflated state characterized by an enlarged diameter in a direction perpendicular to the axis. 90 of the primary catheter 70. When the inflatable member 191f is coated onto the primary catheter 70, it may be in its deflated state. In order to flex the distal end portions 140, 150 of the secondary catheters 120, 130, said distal end portions (which can be connected by a hinge member, 191h) can be advanced and exposed from the primary catheter 70. then, the inflatable member 191f can be positioned by the inflatable catheter member 191g in a position proximally spaced from the pivot member 191h. The inflatable member 191f can then be brought to its inflated state so that it applies an outward force to the first and second secondary catheters, resulting in their rotation about the pivot member 191h. As a consequence, the distal end portions (or parts thereof) 140, 150 of the secondary catheters 120, 130 that are located distally from the pivot member 191h can be moved outwardly in a radial direction (relative to, for example, longitudinal axis 90 of primary catheter 76) to form arm portions 126, 136. The inflatable member 191f may be implemented as a balloon or a membrane to and/or from which a substance such as a. gas or a liquid can be supplied in order to achieve the inflated and/or deflated state or any intermediate state. In this way, the shape and position of arm portions 126, 136 can be controlled via the inflated/deflated/intermediate state of the inflatable member 191f and/or via the distance from the inflatable member 191f to the pivot member 191h. (which can be adjusted by moving the inflatable limb 191f and the secondary catheters 120, 130 relative to each other, e.g. through the inflatable limb catheter 191g). Note that the inflatable member 191f can also or alternatively be implemented as a shape memory structure and/or an elastic structure which can have a reduced or enlarged diameter state which are realized without supply of liquid or gas or the like. In this regard, the inflatable member 191f may be in a compressed state having a reduced diameter when coated in the inner lumen 80 of primary catheter 70, and may be in an uncompressed state having an enlarged diameter when advanced from the inner lumen 80 of the primary catheter 70. The uncompressed state can, for example, be achieved by the elasticity of material which can enlarge the diameter once the restriction is placed by the inner lumen 80 of the primary catheter. 70 is removed by exposing an inflatable limb 191f from the primary catheter 70. It is further noted that the inflatable limb 191f and the inflatable limb catheter 19.1g may also at the same time serve as the blunt front body 330 and the front body tube 320, respectively. In this regard, the inflatable member may close the proximal end of primary catheter 70 (e.g., when having an "intermediate" or reduced diameter state, as described above and being in a position that is distal from the pivot member. 191h), e.g. when catheter member 1 is advanced into a tissue structure), and may then serve as the first bending mechanism 191 (e.g. when having the enlarged diameter state and being moved to the proximal position from of the articulating member 191h). In this regard, inflatable member 191f may be configured such that it can pass hinge member 191h in a longitudinal direction of primary catheter 70, at least when it is in a deflated/reduced diameter state).
[0076] With respect to Figures 15a to Figure 15e, a variation of a catheter member 1 and a method of using the same are described. Note that all features described herein (such as the first and/or second flexion mechanism 191, 192, arm portions, etc.) can be applied also to the catheter member 1 and the method described with reference to Figures 15a to 15e, and therefore features not yet described above will be described with reference to Figures 15a to 15e. Primary catheter 70 may include an opening 75 that may be located in the distal end portion 100 thereof or between the proximal end portion 110 and the distal end portion 100 thereof (e.g., near the distal end portion 100) . The opening 75 may be connected to the or an inner lumen 80 of the primary catheter 70 with the environment/exterior of the primary catheter member 70. In this regard, the opening may be opened in a lateral direction relative to the longitudinal axis 90 of the: catheter. primary 70 or you can define an angle for it (eg between 30 to 80 degrees, for example 40 to 60 degrees, for example substantially 45 degrees, where the angle is counted from a direction perpendicular to the axis. lengthwise 90 in a direction toward the distal end (portion) of primary catheter 70).
[0077] The catheter member variation 1 that is shown in Figure 15a to 15e may be provided with a capture mechanism 450. The capture mechanism 450 may be configured to be movable relative to the primary catheter 70 in a proximal and /or distal longitudinally thereof. Capture mechanism 450 may be advanced (and/or retracted) from the or one (e.g., a separate) inner lumen 80 of primary catheter 70 via opening 75 to the outside of primary catheter 70 to be exposed. Capture mechanism 450 or a portion thereof (see below) may also be movable relative to primary catheter 70 when capture mechanism 450 is advanced and exposed from primary catheter 70.
[0078] The capture mechanism 450 may be configured to capture one or more (e.g. two) wires and/or catheters (such as the first and/or second tertiary catheter) or the like. For example, capture mechanism 450 may be configured to capture wire 300 and/or capture wire 3101 (which may be provided with or without a distal capture component 315), e.g., the distal ends thereof. The capture mechanism 450 may also be configured to capture one or more (e.g., both) tertiary catheters 200, 210, e.g., the distal end portions 260, 270 thereof. Capture mechanism 450 may be configured to capture any single or two wire(s) or catheter(s) described herein. Capture mechanism 450 may also be configured to capture capture mechanism 315, which can be used to capture free distal end 305 of wire 300, as described above. As indicated, capture wire 310 may also be provided without capturing component 315, and capture mechanism 450 may accordingly capture the distal ends of wire 300 and capture wire 310 which may or may not comprise a capture component 315 when it is caught by a capture mechanism 450. (In this regard, note that wire 300 and capture wire 310 here may also be designated as first wire 300 and second wire 310 (corresponding to capture wire 310 which is supplied without a capture component 315), respectively, here).
[0079] The capture mechanism 450 may be configured to selectively and controllably move the capture wire(s) and/or catheter(s) and/or components relative to the primary catheter 70. This may, for example, serve to move wire 300 (which may be partially or fully involving an anatomical feature as described above) and/or wire 315 and/or tertiary catheters 200, 210 in relation to primary catheter 70 and, consequently, also in relation to said anatomical feature (by example, fabric structure 10) as described in more detail below.
[0080] The capture mechanism 450 may comprise a capture device configured to capture wires, catheters or other elements such as capture component 315). Said catching device may be or comprise a catching basket 470 (as shown) and/or a magnetic component and/or a hook and/or a trap and/or a loop or a combination thereof.
The capture mechanism 450 may optionally comprise a capture mechanism controller 460 (hereinafter referred to as controller 460). Controller 460 may be configured to control the position of wires, catheters, or other elements/components that are captured with/by capture mechanism 450 (e.g., the capture device thereof) as described in more detail below.
[0082] According to an exemplary variation, controller 460 may comprise a control catheter 400 that may comprise one or more inner lumens and may be movable relative to primary catheter 70 while being coated thereon (e.g., inner lumen coated 80 or an inner lumen separate from the primary catheter 70). A proximal end of control catheter 480 may be exposed from proximal end portion 110 of primary catheter 70 to be operable. Operating control catheter 480 may include moving control catheter 480 relative to primary catheter 70 in a longitudinal direction thereof.
[0083] A control wire 490 may be coated on the control catheter 480 and may be movable relative thereto. A distal end of the control wire 490 may be connected to the capture device, i.e. to the capture basket 470 (as shown) or a magnetic component or a hook or a trap or a loop or the like. The proximal end of the control wire 390 may be exposed from the proximal end portion 110 of the primary catheter 70 to be operable. Thus, by operating the control wire 490, the control wire 490 and the capture device (e.g., capture basket 470 as shown) connected thereto can be moved relative to the control catheter 480.
[0084] For example, when the capture mechanism 450 is implemented as a capture basket 470 (for example, made of elastic metal or plastic wire or a shape memory material or the like), the controller 460 can be implemented as a 490 control wire that is coated onto a 480 control catheter. The 470 capture basket, which can be provided in a folded/compressed state within the 480 control catheter, can be moved proximally and/or distally with respect to the opening 75 of primary catheter 70 by moving control catheter 480 and/or control wire 490 relative to primary catheter 70. Therefore, capture basket 470 can be advanced to the outside of primary catheter 70 via opening 75 ( and control catheter 480) or can be retracted therethrough from the outside into control catheter 480 and/or primary catheter 70 by operating control wire 490 and control catheter 480.
[0085] When the capture basket 470 is exposed from the control caterer 480 (and primary catheter 70), it can be unfolded from its folded compressed state, for example, using its elastic and/or memory properties of way. When the capture basket 470 is retracted into the control catheter 480, it can be compressed / folded to assume its compressed / folded state, for example, through the geometric restriction that is formed by the control catheter 470 (for example, through the distal end opening of a lumen thereof). When said capture basket 470 is advanced from control catheter 480 and primary catheter 70 (i.e. when it is exposed to the external environment of catheter member 1), it may be movable relative to primary catheter 70 while being exposed to the outside of the primary catheter 70 and, for example, while being in its deployed/uncompressed state. The capture device (e.g., capture basket 470 as exemplified above) can be moved with respect to primary catheter 70 while the position of control catheter 480 remains substantially constant with respect to primary catheter 70 (i.e., the delivery device capture can be shifted by control wire movement 490). However, in addition or alternatively, the capture device can also be moved by moving control catheter 480 and control wire 490 correspondingly so that the position of the capture device remains substantially constant with respect to the control catheter. 480, but capture device and control catheter 480 positions are changed from primary catheter 70.
[00861 When the capture mechanism 450 comprises a magnetic component as a capture device (not shown), the controller 460 may optionally further comprise an electrical wire that can be connected with the magnetic component and an external power source (by example, provided at the proximal end portion 110 of primary catheter 70, eg spaced: from a patient) in order to supply a current/polarization to the magnetic component to increase a magnetic force of the magnetic component. Additionally or optionally, when the 460 controller is electrically conductive, it can be used directly to transmit a current/voltage to the magnetic component without the need for a separate wire or the like. The magnetic component is not necessarily implemented as an electromagnet, but it can also be implemented as a conventional magnet, such as a neodymium-iron-boron magnet or a permanent iron-magnet or the like.
[0087] Next, an exemplary method for using a catheter limb 1 has. a capture mechanism 450 as described above will be explained. It is intended that features that are described relating to the catheter "device" may also be applicable as method steps and that features described relating to method steps may also be applicable to the catheter "device".
[0088] Figure 15a shows a cross-sectional view of a human heart that is substantially similar to the views shown in Figure 12 or Figure 13a. Here, catheter member 1 has an opening 75 as described above provided with primary catheter 70. Catheter member 1 is advanced through aortic arch 340 so that the distal end portion 100 of primary catheter 70 extends into ventricular chamber 370 and is placed on one side of tissue structure 10 that is substantially opposite aortic arch 340 (for example, using an alignment portion and a flexion mechanism as described above). Opening 75 is provided in primary catheter 70 so that it is generally located at the same axial level as the distal end portion 100 of primary catheter 70 when primary catheter 70 is in its operative position. The axial level can be defined with respect to an axis 500 connecting mitral and ventricular chambers 350, 370 through the valve ring 30 / connecting channel wall structure (e.g., a midpoint thereof). In addition, opening 75 is provided radially in primary catheter 70 so that opening 75 is generally facing distal end portion 100 thereof. It should be noted that "generally on the same level" can refer to positions spaced slightly proximally or distally (for example, equal to or less than 0.01 or 0.1 or 0.3 or 0.5 or 1 or 2 or 3 or 4 or 5 cm or 7 cm or a different distance spaced proximally or distally, wherein the distance is counted along the longitudinal axis 90 of primary catheter 70) in primary catheter 70 from the level of distal end portion 100 relative to to the 500 axis.
[0089] As shown in Figure 15b, capture mechanism 450 (here comprising capture basket 470 as a capture device) can be advanced and exposed from primary catheter 70, for example, using controller 460 (implemented herein as a control wire 490 and control catheter 480 which is (partially) coated on primary catheter 70) so that capture basket 470 assumes its unfolded/uncompressed state, as indicated by arrow 5 in Figure 15b.
[0090] As shown in Figure 15c, the distal end 305 of wire 300 can be captured by a capture mechanism 450. In order to be captured, the distal end 305 can, for example, be advanced so that it is extending across of the capture mechanism 450 when it is implemented as a capture basket 470 or may, for example, be magnetically attracted to the capture device when it comprises a magnetic component. In this regard, wire 300 can be advanced to extend (at least partially) around tissue structure 10 and to be captured by a capture mechanism 450, for example, using a secondary catheter 120, 130 and/or tertiary catheter 200, 210 substantially as described above, or by other means. Capture basket 470 may optionally also be made from a magnetic material and/or may be implemented comprising an electromagnet in order to further improve capture performance. If secondary and tertiary catheters as described above are used to advance thread 300 so that it extends (at least partially) circumferentially around tissue structure 10, these are retracted back to primary catheter 70 after thread 300 is advanced. and therefore are not visible in Figure 15c.
[0091] Additionally, or alternatively, the free distal end 305 of wire 300 may be captured by the distal capture component 315 provided with capture wire 310 as described above (see, for example, Figure 10) after or during or before of wire 300 (eg, distal end 305 thereof), capture member 315 and/or capture wire 310 are captured by capture mechanism 450. In addition, for example, also, the loop formed by wire 300, which is formed, for example, by capturing distal end 305 of wire 300 by using capture member 315 provided with capture wire 310 and then retracting distal end 305 of wire 300 back to primary catheter 70, can be captured by the mechanism. capture 450 (which results in wire 300 being captured by capture engine 450 (eg, the capture device thereof).
[0092] As shown in Figure 15d, the second wire/capture wire 310 can be advanced from the distal end portion 100 of the primary catheter 70, which is positioned on one side of the circumferential tissue structure 10 that is opposite the aortic arch 340, in order to extend (at least partially) around tissue structure 10 so that the distal end portion of second strand/capture wire 310 is captured by capture mechanism 450, which is positioned opposite the portion. of distal end 100 of primary catheter 70 with respect to circumferential tissue structure 10, using a secondary catheter 120, 130 and/or tertiary catheter 200, 210 as described above, or by other means. As in Figure 15c, in Figure 15d any secondary catheter 120, 130 or tertiary catheter 200, 210 that may have been used previously is shown in a retracted state into primary catheter 70 and, accordingly, not visible in Figure 15d. As further shown in Figure 15d, wire 300 [which may also be referred to as first wire 300) and capture wire/second wire 310 both may be extending from distal end portion 100 of primary catheter 70 to capture mechanism 450, wherein both strands 300, 310 may extend on radially opposite sides of fabric structure 10 so that a loop extending (e.g., fully extending) circumferentially around fabric structure 10 is formed and the distal ends of both. wires 300, 310 are captured by capture mechanism 450 (for example, using a capture device such as capture basket 470 which is shown in Figure 15d). When the distal ends of threads 300, 310 (and/or capture member 315) are firmly captured by the capture mechanism 450, the position of threads 300, 310 (e.g., the loop extending circumferentially around the fabric structure 10) it can be selectively shifted axially with respect to axis 500, as indicated by arrow 5 in Figure 15e, by moving the capture mechanism. 450 (and therefore the capture wire(s) or other elements) with respect to the primary catheter 70. Consequently, the loop formed by a wire 300 and/or wire 310 can be accurately positioned with respect to the tissue structure 10 and/or a medical cal implant such as an artificial heart valve or the like which may, for example, be provided within tissue structure 10.
[0093] As exemplified in Figure 15e, when a capture basket 4 70 is used as the capture device, capture mechanism 450, wires 300, 310 and/or capture component 315 can be more securely captured by the capture basket 470 when the capture basket 470 is (at least partially) retracted back to the control catheter 480 (e.g., one or the inner lumen thereof), so that wire 300, wire 310 and/or capture component 315 may be securely attached by a snap fit between capture basket 470 and control catheter 480 (e.g., the distal end thereof) and/or may be partially drawn into the control catheter 480 inner lumen in order to be captured more securely. Thereafter, the position of wire 300, wire 310 and/or capture component 315 can be accurately controlled by movement of control catheter 480 relative to primary catheter 70 while keeping the position of control wire 490 constant with respect to catheter control 480.
[0094] With respect to, for example, Figures 13a, 13b and 15a to 15e. catheter member 1 may be shaped such that the distal end portion of primary catheter 70 is located on a side of tissue structure 10 that is substantially radially opposite from aortic arch 340 when catheter member 1 is advanced. to the mitral valve 360 via an approach through the aortic arch 340. This shape can be obtained by correspondingly pre-molding the catheter member 1 or by using the second flexion portion and second flexion mechanism as described herein and/ or by pushing a distal end portion 100 of primary catheter 70 into ventricular chamber 370 substantially along papillary muscle 60 so that distal end portion 100 is located substantially radially opposite circumferential tissue structure 10.
[0095] According to another exemplary embodiment, a catheter member 1 for interacting with a circumferential tissue structure 10 is provided, the catheter member 1 comprising: an elongated primary catheter 70 having an inner lumen 80 and extending to the along a longitudinal axis 90 and has a distal end portion 100, first 120 and second 130 elongated secondary catheters each comprising a distal end portion 140, 1.50 and an inner lumen 160, 170, and each configured to be disposed in the lumen. interior 80 of primary catheter 70 to be movable relative thereto and capable of being exposed from distal end portion 100 thereof, and a first bending mechanism 191 for providing distal end portion 140, 150 of the first. 120 and/or second 130 secondary catheters have a tendency to assume a first secondary folded shape, wherein the distal end portion 140, 150 of one or both of the first and second secondary catheters 120, 130 is configured to be capable of being flexed by the first bending mechanism 191 to form an arm portion 126, 136 substantially transverse to the direction of the longitudinal axis 90 of the primary catheter 70 so as to assume the first secondary folded shape when being exposed from the distal end portion 100 of the primary catheter 70, and wherein the respective arm portion 126, 136 extends at least 4 mm or at least 5 mm or at least 8 mm or at least 10 mm or at least 12 mm in a direction radial to the longitudinal axis ( 90) of the primary catheter 70 with a free end of the respective arm portion rearwardly from the longitudinal axis 90 so that the respective arm portion 126, 136, with a lateral outer surface of the it formed a blunt end face extending transversely to the longitudinal axis 90 of primary catheter 70 and allowing the blunt end face to frontally contact fabric structure 10 with catheter member 1 in a non-penetrating manner.
[0096] In said additional exemplary embodiment, optionally the first 120 and second 130 secondary catheters may each comprise a secondary alignment portion 127, 137, which is located between the distal end portions 140, 150 and proximal end portions 180, 190 and adjacent to the distal end portion 140, 150 thereof, wherein the catheter member 1 further comprises a second bending mechanism 192 for providing the secondary alignment portion 127, 137 of the first 120 and/or second 130 secondary catheter with a tendency to assume a second secondary folded shape, wherein the secondary alignment portion 127, 137 of the first 120 and second 130 secondary catheters is configured to be capable of being flexed by the second bending mechanism 192 to assume the second secondary folded shape having a predetermined curvature, optionally with a radius of substantially 30 to 70 mm and optionally describing an angle of 90° to 270 °, and wherein the first secondary catheter 120 has a longitudinal axis 125 and the second secondary catheter 130 has a longitudinal axis 135, wherein the arm portions 126, 136 of the first 120 and second 130 secondary catheters, respectively, and the portion The distal end portions 100 of the primary catheter 70 are with respect to their respective longitudinal axes 90, 125, 135 extending in the same predetermined plane as the secondary, aligning portions 127, 137 of the first 120 and second 130 secondary catheters assume the second secondary folded shape. in parallel with each other. Said additional exemplary embodiment can also be combined with the subject matter of any one or several or all of claims 2 to 24 as attached.

权利要求:
Claims (15)
[0001]
1. Catheter member (1) for interacting with a circumferential tissue structure (10) characterized in that it comprises: an elongated primary catheter (70) having at least one inner lumen (80) and extending along an axis longitudinal (90) and has a distal end portion (100), first (120) and second (130) elongated secondary catheters each extending along a longitudinal axis (125, 135), each comprising a distal end portion (140 , 150) and a proximal end portion (180, 190) and an interior lumen (160, 170), and each comprising a secondary alignment portion (127, 137) that is located between the distal end portions (140, 150) and proximal end portions (180, 190) and adjacent to the distal end portion (140, 150), and each positionable in an interior lumen (80) of the primary catheter (70) to be movable relative thereto and can be exposed from it, a first bending mechanism (191) for f provide the distal end portion (140, 150) of one or both of the first (120) and second (130) secondary catheters with a tendency to assume a first secondary bent shape, and a second bending mechanism (192) to provide the secondary alignment portion (127, 137) of the first (120) and second (130) secondary catheters with a tendency to assume a second secondary bent shape, wherein the distal end portion (140, 150) of the one or both of the first and second secondary catheters (120, 130) is configured to be able to be flexed by the first flexing mechanism (191) to form an arm portion (126, 136) transverse to the direction of the longitudinal axis (90) of the primary catheter ( 70) so as to assume the first secondary folded shape when being exposed from the distal end portion (100) of the primary catheter (70), wherein the secondary alignment portion (127, 137) of the first (120) and second (130) secondary catheters is configured to be able to be flexed by the second bending mechanism (192) to assume the second secondary bent shape having a predetermined curvature, and wherein the arm portion (126, 136) of one of the first (120) and second ( 130) secondary catheters, extend transversely towards the longitudinal axis (90) of the primary catheter (70), while at the same time the distal end portion (140, 150) of the other one of the first (120) and second (130) secondary catheters remain straight when the secondary alignment portions (127, 137) of the first (120) and second (130) secondary catheters assume the second secondary folded shape extending parallel to each other, or the arm portions of both of the first (120) and second (130) secondary catheters extend in generally opposite directions to each other when the secondary alignment portions (127, 137) of the first (120) and second (130) secondary catheters take the second shape. secondary fold extending parallel to each other.
[0002]
2. Catheter member (1) according to claim 1, further comprising first (200) and second (210) elongated tertiary catheters to be guided by first (120) and second (130) secondary catheters, respectively, each extending along a longitudinal axis (220, 230) and each comprising a distal end portion (260, 270) and a proximal end portion (280, 290) and each to be movable relative to the first (120) and second (130) secondary catheters, respectively, and can be exposed from the distal end portions (140, 150) thereof.
[0003]
3. Catheter member (1) according to claim 2, characterized in that the first (200) and second (210) tertiary catheters each have a first (241, 251) and/or a second (242, 252 ) tertiary alignment portion between respective distal end portions (260, 270) and proximal end portions (280, 290) thereof, each with a shape memory structure providing the first (241, 251) and/or the second (242, 252) tertiary alignment portions with a tendency to assume a first and/or second tertiary folded shape, respectively, corresponding to the first and/or second secondary folded shape, respectively.
[0004]
4. Catheter member (1) according to claim 2 or 3, characterized in that the distal end portions (260, 270) of the first (200) and second (210) tertiary catheters comprise a memory structure shaped by providing them with a tendency to assume a respective arcuate shape when exposed from the distal end portion (140, 150) of the first and second secondary catheters (120, 130), respectively.
[0005]
5. Catheter member (1) according to claim 3 or 4, characterized in that the shape memory structure of the distal end portions (260, 270) of the first (200) and second (210) catheters tertiary is such that when the first (241, 251) and/or second (242, 252) tertiary alignment portion of the first (200) and second (210) tertiary catheters are located so as to mate with the tertiary portions. distal end and/or the secondary alignment portions (127, 137) of the first and second secondary catheter (120, 230), assuming their respective first and/or second folded shape, respectively, the distal end portions (260, 270) of the first (200) and second (210) tertiary catheters are provided with a tendency to assume arcuate shapes extending oppositely to each other so as to form a loop shape.
[0006]
6. Catheter member (1) according to any one of claims 3, 4 or 5, characterized in that when the first (241, 251) and/or the second (242, 252) tertiary alignment portion of the first (200) and second (210) tertiary catheters are located so as to mate with the distal end portions (140, 150) and/or the secondary alignment portions (127, 137) of the first and second secondary catheter (120 , 130), assuming their respective first and/or second folded shape, respectively, the distal end portions (260, 270) of the first (200) and second (210) tertiary catheters are fully operatively exposed from the end portions distal (140, 150) of the first (120) and second (130) secondary catheters.
[0007]
7. Catheter member (1) according to any one of claims 2, 3, 4, 5 or 6, characterized in that the first (200) and second (210) tertiary catheters each comprise an interior lumen (240, 250), wherein a wire (300) having a free distal end (305) is provided in the inner lumen (240) of the first tertiary catheter (200) and a capture wire (310) optionally with a capture component (315) at a distal end thereof it is provided in the inner lumen (250) of the second tertiary catheter (210), and wherein both the wire (300) and the capture wire (310) are provided to be movable relative to their respective catheter tertiary (200, 210) and can be exposed from and retractable on a distal end portion (260, 270) thereof, so that the free distal end (305) of the wire (300) can be captured with the component of capture (315) to form a cycle.
[0008]
8. Catheter member (1) according to any one of claims 1, 2, 3, 4, 5, 6 or 7, characterized in that the curvature of the second form of secondary bend matches the curvature of an arch (340) of a mammalian heart and the circumferential tissue structure (10) is part or all of the mitral valve apparatus.
[0009]
9. Catheter member (1) according to any one of claims 1, 2, 3, 4, 5, 6 or 7, characterized in that the curvature of the second secondary bent shape matches the curvature of a channel of connection between the superior vena cava to the pulmonary artery of a mammalian heart and the circumferential tissue structure (10) is part or all of the tricuspid valve apparatus.
[0010]
10. Catheter member (1) according to any one of claims 2, 3, 4, 5, 6, 7, 8 or 9, characterized in that one or both of the first (200) and second (210) tertiary catheters are received in the inner lumen (160, 170) of the first (120) and second (130) secondary catheter, respectively, so as to be guided by them.
[0011]
11. Catheter member (1) according to any one of claims 2, 3, 4, 5, 6, 7, 8, 9 or 10, characterized in that the first (200) and/or second (210) tertiary catheter comprises an inner lumen (240, 250) and wherein one or both of the first (120) and second (130) secondary catheter, respectively, are received in the inner lumen (240, 250) of the first (200) and/or second (210) tertiary catheter, respectively, so that the first (200) and/or second (210) tertiary catheter are guided by the first (120) and/or second (130) secondary catheter, respectively.
[0012]
12. Catheter member (1) according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11, characterized in that the first flexion mechanism (191) and/or the second bending mechanism (192) comprises a shape memory structure (191a), a bending structure having an atraumatic tip cone (191c) and/or filaments (191b) attached to the distal end portion (140 , 150) of the first (120) and/or second (130) secondary catheter and/or an articulating member (191h) rotatably connecting the first (120) and second (130) secondary catheters and an inflatable member (191f) that is provided between the first (120) and second (130) secondary catheters, and/or at least one connecting member (191d) and at least two joint members (191e) interconnecting first (120) and second (130) secondary catheters, and/or at least two connecting members (191d) and at least three joining members (191e) and a longitudinal operating member (191j) which is millstone. capable in a longitudinal direction of primary catheter (70), wherein the first secondary catheter (120) is connected to a first connecting member (191d) by means of a first joint member (191e), the second secondary catheter (130 ) is connected to a second bonding member (191d) through a second joint member (191e) and the first and second bonding members are connected through a third joint member (191e), and wherein the third joint member joint (191) or the first connecting member (191d) or the second connecting member (191d) is connected to the operating member (191j) to be movable in the longitudinal direction of the primary catheter (70).
[0013]
13. Catheter member (1), according to any one of claims 3, 4, 5 or 12, characterized in that the shape memory structure is provided by the elasticity of material.
[0014]
14. Catheter member (1) according to any one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or 13, characterized in that the respective portion arm (126, 136) extends at least 5 mm or at least 8 mm or at least 10 mm or at least 12 mm in a radial direction to the longitudinal axis (90) of the primary catheter (70) with a free end of the respective arm portion (126, 136) facing away from the longitudinal axis (90) so that the respective arm (126, 136) forms a blunt face end extending transversely to the longitudinal axis (90) of the primary catheter (70 ) and allowing frontally contacting the tissue structure (10) with the catheter member (1) in a non-penetrating manner.
[0015]
15. Catheter member (1) according to any one of claims 2, 3, 6, 7, 8, 9, 10, 11, 12, 13 or 14, characterized in that the distal end portion (260 , 270) of the first (200) and/or second (210) tertiary catheter has a shape memory structure giving a tendency to assume a coil shape having a plurality of windings, at least when the distal end portion (260, 270) of the first and/or second tertiary catheter (200, 210) is exposed from the distal end portion (140, 150) of the first (120) and/or second (130) secondary catheter, respectively, and in which, optionally , the coil shape of the distal end portion (260, 270) of the first and/or second (200, 210) of the tertiary catheter is diametrically compressed when coated in the inner lumen (160, 170) of the first (120) and/or second (130) secondary catheter.

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同族专利:

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JP2015510782A|2015-04-13|

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US9770332B2|2017-09-26|

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AU2013229583A1|2014-08-21|

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法律状态:
2018-03-13| B25G| Requested change of headquarter approved|Owner name: HIGHLIFE SAS (FR) |

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2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-12-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-04-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-05-25| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201261607073P| true| 2012-03-06|2012-03-06|

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US61/607,073|2012-03-06|

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DE102012101877.4|2012-03-06|

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DE102012101877A|DE102012101877A1|2012-03-06|2012-03-06|Catheter device|

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PCT/EP2013/054442|WO2013131925A1|2012-03-06|2013-03-05|Treatment catheter member with encircling function|

---