DE102012101877A1 - Catheter device - Google Patents

Abstract

A catheter device for interacting with a circumferential tissue structure comprising an elongated primary catheter having an inner lumen extending along a longitudinal axis and having a distal end portion, first and second elongated secondary catheters each having a distal end portion and a distal one inner lumen, and each intended to be disposed in the inner lumen of the primary catheter so as to be movable relative thereto and exposed from a distal end portion thereof, and a first bending mechanism to engage the distal end portion of the first and / or the second second secondary catheter having a tendency to tend to assume a first secondary curved shape, wherein the distal end portion of one or both of the first and second secondary catheters is provided so as to be bendable by the first bending mechanism an arm area too form substantially transverse to the direction of the longitudinal axis of the primary catheter so as to assume the first secondary curved shape, the respective arm region being 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 that is radial to the longitudinal axis of the primary catheter, and wherein a free end of the respective arm portion points away from the longitudinal axis such that the respective arm portion, with a lateral outer surface thereof, forms a blunt end face extends transversely to the longitudinal axis of the primary catheter, and makes it possible to contact the tissue structure with the catheter device in a non-penetrating manner.

Description

Technical area

The invention generally relates to a catheter device for interacting with a circumferential tissue structure and a method of using a catheter.

background

Heart valve diseases affect about 300,000 people worldwide each year. These diseases manifest themselves in abnormal leaflets (excessive tissue growth, tissue degradation / tear, tissue hardening / calcification) or in an abnormal position during the cardiac cycle (ie, annular dilatation, ventricular remodeling), leading to a decrease in valve function such as leakage / blood reflux (valvular insufficiency) ) or a resistance to the blood forward flow (valve stenosis) leads. Many of these diseases are treatable by catheter techniques.

Accordingly, a catheter device is desirable.

Short description

The invention provides a catheter device according to claim 1 and / or claim 2. Further embodiments are described in the dependent claims.

Brief description of the drawings

In the drawings, the same reference numbers generally refer to the same parts throughout the various views. The drawings are not necessarily to scale, generally it is more important to illustrate the principles of the invention. In the following description, various embodiments are described with reference to the following drawings, in which:

1a 12 shows a schematic, partially sectioned cross-sectional view of a distal side of a catheter device according to a variation,

1b Fig. 3 shows a schematic view of a proximal side of a catheter device according to a variation,

2 2 shows a schematic cross-sectional view of a heart and a catheter device according to a variation,

3a and 3b show schematic cross-sectional views of a primary catheter and secondary catheter of a catheter device according to a variation,

3c shows a radial cross-sectional view of a primary catheter and secondary catheter of a catheter device according to a variation,

4a to 4c show a catheter device according to a variation

5a to 5e show detailed views of components of a catheter device according to a variation,

6a to 6c show a bending mechanism according to a variation

7a to 7c show a catheter device according to a variation

8th to 12 show various exemplary method steps of a method of using a catheter device, and

13a and 13b show a catheter device according to a variation.

description

The following detailed description refers to the accompanying drawings which show, by way of illustration, specific details and variation 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 may be used and structural, logical and electrical variations may be made without departing from the scope of the invention. The various variations are not necessarily mutually exclusive, as all variations can be combined with all other variations to form new embodiments. In this regard, all features disclosed herein may be applied to all variations and / or embodiments of the invention, and no feature disclosed herein may not be applicable to any variation or embodiment. Accordingly, each feature disclosed herein must be understood as being disclosed in combination with any other feature or feature.

With reference to the figures, a catheter device 1 for interacting with a (eg, circumferential) tissue structure 10 be provided having a (eg elongated) primary catheter 70 may have an inner lumen 80 You can have it along a longitudinal axis 90 can extend and the one distal end portion 100 may have. A catheter device 1 may further comprise a first 120 and / or a second one 130 (eg elongated) secondary catheters, each of which has a distal end portion 140 . 150 and an inner lumen 160 . 170 and each of which is in an inner lumen 80 of the primary catheter 70 may be arranged and may be movable relative thereto and exposed from a distal end portion 100 this can be, and a first bending mechanism 191 that the distal end area 140 . 150 of the first 120 and / or the second 130 secondary catheter having a tendency to assume a first secondary curved shape. The distal end area 140 . 150 one or both of the first and second secondary catheters 120 . 130 can be provided so that it passes through the first bending mechanism 191 Can be bent to an arm area 126 . 136 to form substantially transverse to the direction of the longitudinal axis 90 of the primary catheter 70 so as to assume the first secondary curved shape, at least when viewed from a distal end region 100 of the primary catheter 70 is exposed. An arm area 126 . 136 may extend at least 4 mm or at least 5 mm or at least 8 mm or at least 10 mm or at least 10 mm in a direction that is radial to the longitudinal axis 90 of the primary catheter 70 is, and a free end of the respective arm area 126 . 136 can be from the longitudinal axis 90 Show away, so that the respective arm area 126 . 136 can form a blunt end face, which is transverse to the longitudinal axis 90 of the primary catheter 70 extends and it can allow the tissue structure 10 frontally with the catheter device 1 to touch in a non-pentrating manner. The first 120 and the second 130 Secondary (eg, elongated) catheters can move along a longitudinal axis 125 . 135 extend and each may have a distal end portion 140 . 150 , a proximal end region 180 . 190 and an inner lumen 160 . 170 and each of them may have a secondary alignment section 127 . 137 which is between the distal 140 . 150 and the proximal one 180 . 190 End region and adjacent to the distal end region 140 . 150 may be arranged, and which may be provided, in the inner lumen 80 of the primary catheter 70 to be arranged and movable with respect thereto and from a distal end region 100 to be exposed to this. A second bending mechanism 192 may be the secondary alignment section of the first 120 and the second 130 secondary catheter with a tendency to assume a second secondary curved shape. A distal end area 140 . 150 one or both, the first and second secondary catheters 120 . 130 , may be provided to by means of the first bending mechanism 191 to be bent to form an arm region substantially transverse to the direction of the longitudinal axis 90 of the primary catheter 70 is to assume the first secondary curved shape, at least when it is from the distal end region 100 of the primary catheter 70 is exposed from. An arm region may be 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 that is radial to the longitudinal axis 90 of the primary catheter 90 extend and a free end of the respective arm area 126 . 136 can be from the longitudinal axis 90 show away, leaving the respective arm area 126 . 136 can form a blunt end face, which is transverse to the longitudinal axis 90 of the primary catheter 70 extends and it can enable the tissue structure 10 with the catheter device 1 to touch in a non-penetrating manner. The first 120 and the second 130 (eg, elongated) secondary catheters can each extend along a longitudinal axis 125 . 135 extend and each of them can have a distal end area 140 . 150 , a proximal end region 180 . 190 and an inner lumen 160 . 170 and each may have a secondary alignment section 127 . 137 between the distal 140 . 150 and the proximal one 180 . 190 End region and adjacent to the distal end region 140 . 150 can be arranged, and each of them can be provided in the inner lumen ( 80 ) of the primary catheter ( 70 ) so as to be movable relative thereto and from a distal end region (Fig. 100 ) this is exposed. A second bending mechanism ( 192 ) can the secondary alignment section of the first ( 120 ) and / or second ( 130 Secondary catheter give a tendency to assume a second curved shape. The distal end region ( 140 . 150 ) of both, the first and the second ( 120 . 130 ), secondary catheters may be provided to be deformed by the first bending mechanism ( 191 ) can be bent to an arm area ( 126 . 136 ) which is substantially transverse to the direction of the longitudinal axis (FIG. 90 ) of the primary catheter ( 70 ) so as to assume the first secondary curved shape as it moves from the distal end region (FIG. 100 ) of the primary catheter ( 70 ) is exposed from. A secondary alignment section 127 . 137 of the first 120 and the second 130 Catheter may be provided to by means of the second bending mechanism 192 to be bent so as to assume the second secondary curved shape, which may have a predetermined curvature, optionally in a radius of substantially 30 to 70 mm and which may optionally describe an angle of 90 ° to 270 °. The arm areas 126 . 136 of the first 120 or the second 130 secondary catheters can become essentially one another extend opposite directions when the second alignment sections 127 . 137 of the first 120 and the second 130 secondary catheter adopt the second secondary curved shape, z. B. next to each other.

With continued reference to the figures, a catheter device 1 for interacting with (eg, surrounding, eg, treating) an anatomical feature (hereinafter also referred to as a tissue structure for better understanding, accordingly, said anatomical features may also be a tissue structure, eg, a circumferential tissue structure) 10 to be provided. The fabric structure 10 may be part of a heart, e.g. B. part of a heart valve such. The ventricular valve, the mitral valve, the pulmonary valve and / or the tricuspid valve. With reference to the 2 can the tissue structure 10 have a part of a heart valve or be a heart valve, which has a connecting channel 20 having a connection channel wall structure, the said connection channel 20 or the "passage opening" forms. The heart valve may include a circumferential valve annulus 30 , Flap sails 40 connecting the communication passage at a position close to the valve annulus 30 open or close to provide valve functionality, a generally circumferential tendon structure (chordae tendinae) 50 holding the flap sails 40 and essentially the papillary muscle (s) 60 connects, and the said papillary muscles. The extensive fabric structure 10 may be the aforementioned connection channel wall structure.

The catheter device 1 may be a primary cathether device 70 (see eg 5a ) exhibit. The primary catheter device, also called the primary catheter 70 is designated, z. B. be flexible and have a substantially tubular shape. The primary catheter device 70 can be an inner lumen 80 can and can be along a longitudinal axis 90 extend. The primary catheter may have a distal end portion 100 and may have a proximal end portion 110 exhibit. The distal 100 and / or the proximal one 110 End region may have end openings provided to the inner lumen 80 of the primary catheter with the outside / periphery of the primary catheter 70 (any of the catheters described herein, e.g., secondary or tertiary catheters, may have end openings).

Although the primary catheter 70 in the 1 with an inner lumen 80 shown can be the primary catheter 70 also several inner lumens 80 have, which are separated from each other. The several inner lumens 80 can all have the same inner diameter or can have different inner diameters. The inside of the primary catheter 70 (ie the "outside" of the inner lumen 80 ) may be a smooth surface and / or coated to have a low coefficient of friction to facilitate the forwarding and / or retraction of the secondary catheters (described in more detail below) or the like. In this regard, the primary catheter 70 a flexible hose of the winding hose type or a flexible hose of the corrugated hose type (eg made of stainless steel) and may have a smooth inner lining, for example made of Pebax or PTFE or the like (not shown).

The primary catheter 70 may be flexible and / or rigid, and the distal end region 100 may be flexible and / or stiff and / or proximal end region 110 can be flexible and / or stiff. Although the primary catheter 70 In general, the distal can be flexible 100 and / or the proximal one 110 End area should be stiff to access the fabric structure 10 or to facilitate the handling by an interventional cardiologist.

The primary catheter 70 may be made of a shape memory material, for. For example, a shape memory alloy (such as nitinol, Fe-Mn-Si of any metal or alloy having shape memory properties) or a shape memory polymer (such as, for example, Norsorex or PET crosslinked with glycerine / dimethyl 5-sulfoisophthalate or melanic anhydride or any other shape memory polymer). Although the primary catheter 70 from a characteristic shape memory material, the z. B. Material elasticity, as it is known in the art can provide, it may also (additionally or alternatively) have structural shape memory properties, ie it may consist of a material without characteristic shape memory properties (eg spring steel), but shape memory properties have due to its geometric structure or its elasticity properties. The primary catheter 70 however, it may also be a conventional catheter having no shape memory material or structural shape memory properties. The primary catheter 70 can be flexible or z. B. a flexible tube or hose or something similar.

The catheter device 1 can also be a first 120 and / or a second one 130 have (or more) secondary catheters (see e.g. 5b ). The first 120 and / or the second 130 secondary catheters may include a first secondary catheter distal end portion 140 or a second-to-secondary catheter distal end region 150 , The distal end area 140 . 150 from one or both of the first 120 and of second 130 Secondary catheter may be provided so that it is bendable (ie, configured, for example, to be bendable, eg, flexible) by a first bending mechanism 191 (described below). Accordingly, the distal end portion 140 of the first secondary catheter 120 and / or the distal end region 150 of the second secondary catheter 130 (or a part of the two or any of the distal end portions 140 . 150 ) be elastically or plastically deformable. From the first 120 and / or the second 130 Secondary catheters can each have a lumen 160 . 170 or have a plurality of separate inner lumens. The first secondary catheter 120 can be along a longitudinal axis 125 (which may be an axis extending longitudinally through a radial center / midpoint of the first secondary catheter 120 extends). Similarly, the second secondary catheter may be 130 along a longitudinal axis 135 (which may be an axis that extends longitudinally through a radial center / midpoint of the second secondary catheter 130 extends). The first 120 and / or the second 130 secondary catheters can also each have a proximal end region 180 . 190 along a longitudinal axis 125 . 135 of the respective secondary catheter 120 . 130 essentially opposite the respective distal end region 140 . 150 can be arranged.

The outer diameter of the first 120 or the second 130 secondary catheter may be smaller than a diameter of an inner lumen 80 of the primary catheter 70 so the secondary catheter 120 . 130 in the inner lumen 80 of the primary catheter 70 may be provided and may be movable, for. B. forward-bringable and retractable, with respect to the primary catheter 70 (eg the distal end region 100 whose). The secondary catheters 120 . 130 can be longer in length than the primary catheter 70 so that their respective proximal end area 180 . 190 by a surgeon can be touched to their distal end areas 140 . 150 relative to the distal end region 100 of the primary catheter 70 to operate (eg to bring forward and / or withdraw).

The catheter device 1 can also be a first bending mechanism 191 (described below) around the distal end portions 140 . 150 of the first 120 and / or the second 130 secondary catheter to give a tendency to assume a first secondary curved shape. The first bending mechanism 191 can also provide the first secondary curved shape.

The first secondary curved shape may be a shape in which the distal end portion 140 . 150 the first and / or the second secondary catheter 120 . 130 each one arm area 126 . 136 forms. An arm area 126 . 136 and / or both arm areas 126 . 136 may have a lateral outer surface, ie a surface which is a periphery of a respective arm region 126 . 136 span (eg, an area that extends circumferentially about the longitudinal axis 125 . 135 of the first 120 or the second 130 secondary catheter extends around). The arm area 126 of the distal end region 140 of the first secondary catheter 120 and / or the arm area 136 of the distal end region 150 of the second secondary catheter 130 can be essentially transverse to the longitudinal axis 90 of the primary catheter 70 extend, at least when the respective distal end portion 140 . 150 the first secondary curved shape (schematically eg in 5b shown). The arm area 126 . 136 (or both arm areas 126 . 136 at the same time) of the distal end portion 140 . 150 of the first 120 or the second 130 secondary catheter may be from the longitudinal axis 90 of the primary catheter 70 Show off, leaving the arm area 126 . 136 of the distal end region 140 . 150 of the first 120 and / or the second 130 secondary catheter (or both arm areas 126 . 136 ) can form a blunt end face which is transverse to the longitudinal axis 90 of the primary catheter 70 extends, and it can allow the tissue structure 10 frontally (eg, with respect to the catheter device 1 , z. In a direction parallel to the longitudinal axis 90 of the primary catether 70 corresponds) to touch in a non-penetrating manner with a side surface thereof, since the arm portion 126 . 136 (or both arm areas 126 . 136 at the same time) can form a blunt contact surface, which is the tissue structure 10 can not penetrate or cause trauma.

Both arm areas 126 . 136 can be essentially transverse to the longitudinal axis 90 of the primary catheter 70 However, it may also only one (any) arm area 126 . 136 give, which is transverse to the longitudinal axis 90 extends while at the same time the other arm area 126 . 136 substantially parallel to said longitudinal axis 90 of the primary catheter 70 can extend.

One or all of the arm areas 126 . 136 may be rectilinear, ie the respective distal end region 140 . 150 can be a straight arm area 126 . 136 and a curved part adjacent to the rectilinear arm region 126 . 136 , The curved part may serve to the rectilinear arm area 126 . 136 relative to the respective first or second secondary catheter 120 . 130 to give a defined orientation.

When the catheter device 1 in an operative position and adjacent to the tissue structure 10 can be placed, one or all Arm portion (s) 126 . 136 be oriented so that the longitudinal axis 125 . 135 of the respective secondary catheter 120 . 130 essentially in a straight line and transverse to the longitudinal axis 90 of the primary catheter 70 extends. The arm area 126 . 136 may also be substantially parallel to a tangent of the circumferential tissue structure 10 extend. The tangent may be the tangent, which is a perimeter of the tissue structure 10 at the same point on the perimeter of the fabric structure 10 also cuts the extension of the longitudinal axis 90 of the primary catheter 70 cuts when it is in an operating position. The arm area (s) 126 . 136 can (eg, each) have an (eg, substantially rectilinear) extension length greater than 4 mm, greater than 5 mm, greater than 7 mm, e.g. B. 4 to 7 mm or 5 to 7 mm or 4 to 20 mm. The arm area (s) 126 . 136 may / may serve to reduce trauma and stress caused by movement of the catheter device 1 on the extensive tissue structure 10 can be introduced by providing a larger area of contact in the case of physical contact. This allows the arm areas 126 . 136 (or one of the arm areas) the mechanical stress (voltage equals force divided by area and the catheter device 1 provides a large contact area through the arm regions, thus reducing the stress on the circumferential fabric structure 10 is applied in the event of contact between the catheter device 1 and the tissue structure 10 By doing so, they avoid trauma and potentially deadly tissue damage by turning it into the catheter device 1 enable the tissue structure 10 to touch in a non-penetrating manner. One or both arm area (s) 126 . 136 Because of their construction / shape / orientation, they can also act as an elastic buffer and dissipate some energy through elastic deformation in the event of contact between the catheter device 1 and the tissue structure 10 , Furthermore, the arm area (s) can / 126 . 136 allow one or more tertiary catheters 200 . 210 (described in more detail below) precisely around the tissue structure 10 by providing improved stability and guiding ability (when one or more tertiary catheters 200 . 210 is provided).

Accordingly, the rectilinear arm portion 126 of the distal end region 140 of the first secondary catheter 120 an angle α with the longitudinal axis 90 of the primary catheter 70 define (see eg 3b or 4b ), at least when the distal end region 140 assumed the first secondary curved shape. Likewise, the rectilinear arm area 136 of the distal area 150 of the second secondary catheter 130 an angle α with the longitudinal axis 90 of the primary catheter 70 define, at least when the distal end region 150 assumed the first secondary curved shape. The arm area 126 of the distal end region 140 of the first secondary catheter 120 can define a different angle α than the arm area 136 of the distal end region 150 of the second secondary catheter 130 or both arm areas 126 . 136 may define the same angle α, at least when one or both of the distal end portions 140 . 150 has assumed the first secondary curved shape. The angle α may be substantially 90 ° or ≥ 80 ° or ≥ 60 ° or ≥ 50 ° or ≥ 45 °, or it may be any other angle. The angle α may optionally be a distal side of the longitudinal axis 90 to a respective rectilinear arm area 126 . 136 be measured (as it is eg in 3b is shown) and may optionally have a maximum value of 90 ° and a minimum value as stated above.

As mentioned above, the catheter device 1 a first bending mechanism 191 exhibit. The first bending mechanism 191 can serve the distal end area 140 of the first secondary catheter 120 and / or the distal end region 150 of the second secondary catheter 130 having a tendency to assume a first secondary arcuate shape, at least when the respective distal end region 140 . 150 from the inner lumen 80 of the primary catheter 70 brought to the front (eg is exposed). The first bending mechanism 191 can z. B. a shape memory structure, at a distal end portion 140 . 150 of the first 120 and / or the second 130 secondary catheter is provided. The first bending mechanism 191 can through the elastic. Energy powered in the first bending mechanism 191 is stored due to the deformation of the shape memory structure from a predetermined shape due to a constraint condition. The constraint can z. B. the primary catheter 70 be that of the shape memory structure of the bending mechanism 191 prevents it from assuming its predetermined shape. When the constraint condition is removed (eg, by bringing the secondary catheter forward 120 . 130 from a distal end region 100 of the primary catheter 70 ), the shape memory structure of the first bending mechanism 191 the distal end region 140 . 150 of the first 120 and / or the second 130 give secondary catheter its predetermined shape. The 6a shows a variation of the bending mechanism 191 that is a biasing element 191a (eg a spring). The biasing element 191a can be the distal end areas 140 . 150 of the first 120 and the second 130 secondary catheters give a tendency to assume a first secondary curved shape. For this purpose, the biasing element 191a with the distal end region 140 and with the distal end region 150 of the first 120 or the second 130 secondary Catheter may be connected and may be said distal end portions 140 . 150 so that they extend substantially opposite each other (eg, in opposite directions) to each other, at least when the distal end portions 140 . 150 from an inner lumen 80 of the primary catheter are brought forward (eg, exposed). The 6b shows a further variation of a bending mechanism 191 , As it is in the 6b can be shown, the first bending mechanism 191 an elastic distal end region 140 . 150 at the first 120 and / or second 130 secondary catheters, which may, without any constraint, have a tendency to extend rectilinearly (for example, along the longitudinal axes 125 . 135 of the first 120 or the second 130 secondary catheter). According to the 6b can the bending mechanism 191 further comprise one or more longitudinal elements 191b (eg, a flexible wire or thread) with the distal end portion 140 . 150 of the first 120 and / or the second 130 secondary catheter are connected and next to the respective secondary catheter 120 . 130 are provided. The longitudinal elements 191b may be provided so that they pass through the inner lumen 80 of the primary catheter 70 extend (indicated by dots in the 6b ), allowing it from a proximal end of the catheter device 1 (eg, the primary catheter 70 ) are operated by a surgeon. Operation of longitudinal elements 191b may include transmitting a force to the distal end region 140 . 150 of the first 120 and / or the second 130 secondary catheter by moving the longitudinal elements 191b parallel to a longitudinal axis, e.g. B. the longitudinal axis 90 of the primary catheter 70 (This may include, for example, pushing or pulling the longitudinal elements 191b exhibit). Accordingly, the distal end portion 140 . 150 of the first 120 and / or second 130 secondary catheter by the longitudinal element (s) 191b from its state of generally rectilinear extent, be forced to assume the first secondary curved form. The 6c shows a further variation of the first bending mechanism 191 , According to the 6c can the bending mechanism 191 have a bending structure 191c , The bending structure 191c can be at a distal end area 100 of the primary catheter 70 be provided and may have a separate channel for each of the secondary catheters 120 . 130 arranged to be a respective secondary catheter 120 . 130 can thereby be brought forward (eg, to the outside of the catheter device 1 may be exposed at a distal end portion thereof). Each of the channels may be provided so that it has a secondary catheter 120 . 130 which assumes the first secondary curved shape when the distal end portion 140 . 150 (which can be flexible) of the first 120 and / or the second 130 secondary catheter is brought forward from the distal end portion 100 of the primary catheter 70 and through said channel of the bending structure 191c , The bending structure 191c may have a distal conical end portion serving as an atraumatic anterior cone to facilitate insertion of the catheter device 1 to simplify. In this regard, if the catheter device 1 a bending structure 191c and in an operative condition adjacent to a circumferential fabric structure 10 is, can have one or more arm areas 126 . 136 generally at a longitudinal distance from the distal conical end portion of the flexure structure 191c transverse to the longitudinal axis 90 of the primary catheter 70 extend so that one or more arm areas 126 . 136 closer to the tissue structure 10 may be than the distal conical end region. The bending structure 191c may also have a separate channel through which a front body tube 320 (described below) may extend (not shown). Accordingly, the bending structure 191c serve to atraumatic insertion of the catheter device 1 while the arm area (s) 126 . 136 it can / may allow a fabric structure 10 to touch if one or both distal end portion 140 . 150 one of the secondary catheters 120 . 130 assumed its first secondary curved shape.

It should be noted that each bending mechanism (and generally, each feature) described herein is compatible with any variation or embodiment of any catheter described herein (e.g., catheter device 1 and / or secondary catheters 120 . 130 and / or tertiary catheters 200 . 210 ) and may, unless otherwise described.

The first and / or the second secondary catheter 120 . 130 Optionally, each can have a secondary alignment section 127 . 137 exhibit. The secondary alignment section 127 . 137 of the first 120 and / or the second 130 secondary catheter may be between the distal end portion 140 . 150 and the proximal end region 180 . 190 of the first 120 or the second 130 secondary catheter may be arranged. The secondary alignment section 127 . 137 of the first 120 and / or the second 130 secondary catheter may be adjacent to the distal end region 140 . 150 of the respective first or second secondary catheter 120 . 130 be arranged. The secondary alignment sections 127 . 137 can be provided so that they by means of the second bending mechanism 192 (described in more detail below) may be bent, flexed or deformed to assume a second secondary curved shape.

Furthermore, as mentioned above, the catheter device 1 optionally a second bending mechanism 192 exhibit. The second bending mechanism 192 may be provided to the second alignment portion of the first 120 and / or the second 130 secondary catheter to give a tendency to adopt a second secondary curved shape. The second bending mechanism 192 may be a shape memory structure, that is, a structure having a tendency to elastically or plastically return to a predetermined shape when deformed from this predetermined shape. This may be the second bending mechanism 192 have a shape memory material such as. Nitinol or spring steel or steel and / or it may have a structure whose shape memory properties mainly by geometric features of the shape memory structure, eg. B. a spiral element or a spring element caused. The second bending mechanism 192 may also include active means to the secondary alignment sections 127 . 137 (or one of these) has a tendency to accept the second secondary shape according to a control signal. Accordingly, the second bending mechanism 192 have active elements, such as. Hydraulic actuators or shape memory material having controllable heat / cool elements (eg, Peltier elements) around the secondary alignment sections 127 . 137 (or one of these) the tendency to adopt the second secondary curved shape. The second bending mechanism 192 can be provided by material elasticity. Any or all features related to the second bending mechanism 192 can also be described on the first bending mechanism 191 be applicable and vice versa.

The second secondary curved shape may be a predetermined shape (predetermined by, for example, the characteristics / structure of the secondary alignment step / alignment section and / or the second bending mechanism 192 ). The second secondary curved shape may be chosen or predetermined so that it becomes a geometric constraint that is not part of the catheter device 1 is, corresponds, z. For example, the second secondary shape may be selected to resemble (eg, correspond to) the curvature of an anatomical feature, e.g. B. the aortic arch 340 a human heart, a bovine or pig heart, or generally a mammalian heart. Accordingly, the secondary alignment section 127 . 137 of the first 120 and / or the second 130 Secondary catheter mesh (and / or match) with an anatomical feature (eg, the aortic arch 340 ) when the secondary alignment section 127 . 137 has adopted the respective second curved shape.

The secondary alignment section 127 . 137 may serve to provide a position and / or orientation of the respective first and / or second secondary catheter 120 . 130 in that it has a tendency to adopt the second secondary curved shape, e.g. B. an aortic arch 340 corresponds and by the second bending mechanism 192 can be induced. Thereby, if the first or second secondary catheter z. B. in an anatomical feature, for. B. in an aortic arch 340 are arranged, they can their chosen or predetermined shape by means of the bending mechanism 192 whereby they are similar to the shape of the aortic arch, or, in other words, interlock with the natural shape of the anatomical feature. This directs the secondary alignment section 127 . 137 (and corresponding to the first and / or second secondary catheters 120 . 130 ) with the anatomical feature, since the secondary alignment section can be in a stable (eg, energetically favorable) position if it can assume its secondary curved shape (the tendency to assume this shape by means of the second bending mechanism 192 is induced). The second alignment section 127 . 137 and / or the second bending mechanism 192 For example, they may have a minimum of elastic energy when the second alignment sections 127 . 137 have assumed their respective second curved shape. Accordingly, the "meshing" of a secondary alignment section 127 . 137 with an anatomical feature the respective first 120 and / or second 130 secondary catheter give a defined and predetermined position and / or a defined and predetermined rotational position and can, for. B. a respective secondary catheter 120 . 130 rotate.

Accordingly, the structure of the secondary alignment section 127 . 137 of the first 120 and / or the second 130 secondary catheter, and / or the construction of the second bending mechanism 192 be chosen so that they are the distal end 140 . 150 of the first 120 and / or second 130 secondary catheter give a predetermined orientation and or rotational orientation and therefore can also the first 120 and / or the second 130 secondary catheter to give a predetermined orientation and / or position.

In this regard, the distal end region 140 . 150 of the first 120 and / or the second 130 secondary catheter have a defined and predetermined orientation and position, z. B. with respect to the circumferential tissue structure 10 , If the respective distal end area 140 . 150 The first secondary curved shape may also assume the orientation and rotation of the arm regions 126 . 136 defined and / or predetermined, since the first and / or second secondary catheter 120 . 130 may have a defined orientation and position caused z. B. by a secondary alignment section. As a consequence, the distal end region 140 . 150 (and / or arm areas 126 . 136 ) relative to an anatomical feature (eg, the tissue structure 10 ) and be oriented without any additional means. Further, some resistance to longitudinal movement of the aligned / intermeshing catheter may also be provided in a state of alignment and engagement with an anatomical feature, for example, against inadvertent longitudinal movement by a person receiving the catheter device 1 operated (the resistance may, among other things, depend on the elastic properties of the respective catheter).

The arm areas 126 . 136 of the first 120 or second 130 secondary catheter (eg, the respective longitudinal axes 125 . 135 ) can define an angle β between each other (see eg 3c ), at least when they have taken their first curved shape. The angle β may be caused and predetermined by the structure of the secondary alignment sections 127 . 137 and / or the second bending mechanism 192 as this leads to a defined position and orientation of the first 120 and / or second 130 secondary catheter (or the respective distal end portion 140 . 150 ) can lead. The angle β may be about 180 ° or ≥ 170 ° or ≥ 160 ° or ≥ 120 ° or ≥ 90 ° or ≥ 45 ° or may be any other angle.

Accordingly, the orientation and position of an arm area 126 . 136 relative to an anatomical feature (eg, the tissue structure 10 ) and / or relative to the respective other arm region 126 . 136 through the first and second secondary alignment sections 127 . 137 be defined, at least when they are in their respective second curved shape.

Furthermore, the catheter device 1 optionally a first 200 and / or a second one 210 tertiary catheters (see, for example, also 5c ). The catheter device 1 may also have only one or more than two tertiary catheters, e.g. B. three to five tertiary catheters. The first 200 or the second 210 Tertiary catheters can each go along a longitudinal axis 220 respectively 230 extend. The first 200 and the second 210 Tertiary catheters can also have one or more inner lumens 240 respectively 250 exhibit. Furthermore, the first tertiary catheter 200 a distal end region 260 and a proximal end portion 280 and the second tertiary catheter 210 can have a distal end area 270 and a proximal end portion 290 exhibit. The proximal ones 280 . 290 and distal 260 . 270 End regions of a respective tertiary catheter may be at substantially opposite sides along the longitudinal axis 220 . 230 this be arranged.

A tertiary catheter 200 . 210 (ie, a tertiary catheter and / or both tertiary catheters) may be delivered by means of a respective secondary catheter 120 . 130 be guided. To be guided, a tertiary catheter may be used 200 . 210 on a secondary catheter 120 . 130 be provided so that the secondary catheter 120 . 130 in the inner lumen 240 . 250 of the respective tertiary catheter 200 . 210 is included. A tertiary catheter 200 . 210 can be next to a secondary catheter 120 . 130 be provided and a parallel guide device may be provided to a tertiary catheter 200 . 210 parallel (eg in relation to the longitudinal axis 125 . 135 ) along a secondary catheter 120 . 130 respectively. For example, a parallel guide device may be a flexible tube that fits tightly around a secondary and a tertiary catheter to guide a tertiary catheter parallel along the longitudinal axis 125 . 135 a secondary catheter 120 . 130 to enable.

The first tertiary catheter 200 can be in an inner lumen 160 of the first secondary catheter 120 be provided and the second tertiary catheter 210 can be in an inner lumen 170 of the second secondary catheter 130 be provided so that they are relative to the first 120 or the second 130 secondary catheters are movable. The first 200 and / or the second 210 Tertiary catheters may be set up so that their respective distal end portions 260 . 270 Can be brought forward and / or withdrawn into an inner lumen 160 . 170 of the first 120 or the second 130 secondary catheter, leaving its respective distal end 260 . 270 from the distal end region 140 . 150 of the corresponding first or second secondary catheter 120 . 130 can be exposed. Accordingly, an outer diameter of the first 200 and / or the second 210 tertiary catheter smaller than the inner diameter of the respective inner lumen 160 . 170 of the respective secondary catheter 120 . 130 to provide a slight press fit to maintain the relative movability of the catheters but also to provide a counterforce to any relative movement to facilitate precise relative movement.

Every tertiary catheter 200 . 210 can work the same way through a respective secondary catheter 120 . 130 be led or can be led in another way. For example, the first tertiary catheter 200 in the inner lumen 160 of the first secondary catheter 120 be deployed while at the same time the second secondary catheter 130 in the inner lumen 250 of the second tertiary catheter 210 may be included, so the tertiary catheter 200 . 210 through the secondary catheters 120 . 130 be guided.

The first 200 and / or the second 210 tertiary catheters can each give a first 241 . 251 and / or a second one 242 . 252 tertiary alignment section have. A first 241 . 251 and / or a second one 242 . 252 tertiary alignment section may be on each or on one of the tertiary catheters 200 . 210 be provided, for. B. arranged on a respective distal end portion 260 . 270 or between the respective distal end region 260 . 270 and the respective proximal end region 280 . 290 , The first 241 . 251 and the second 242 . 252 Tertiary alignment sections may adjoin one another or may be spaced from each other.

The first tertiary alignment section 241 . 251 from one or both tertiary catheters 200 . 210 may also be provided so as to have a shape memory structure corresponding to the first tertiary alignment section 241 . 251 There is a tendency (eg caused by material elasticity) to assume a first tertiary curved shape. Similarly, the second tertiary alignment region 242 . 252 one or both of the tertiary catheters may be provided to have a shape memory structure corresponding to the second tertiary alignment region 242 . 252 there is a tendency to assume a second tertiary curved shape. The first tertiary curved shape may correspond to (eg, be similar to, eg mesh with) the first secondary curved shape. The second tertiary curved shape may correspond to the second secondary curved shape.

Accordingly, the first 200 and / or the second 210 tertiary catheters with the first 120 or the second 130 secondary catheters (eg, in a defined and predetermined position and rotational orientation relative to a respective secondary catheter 120 . 130 ) when the first tertiary alignment section 241 . 251 a tertiary catheter 200 . 210 the first secondary curved form of a respective secondary cathether 120 . 130 corresponds (eg with this interlocking). The first 200 and / or the second 210 Tertiary catheters can match the first one 120 or the second 130 secondary catheters (eg, in a defined and predetermined position and rotational orientation relative to a respective secondary catheter 120 . 130 when the second tertiary alignment section 242 . 252 a tertiary catheter 200 . 210 the second secondary curved form of a respective secondary cathether 120 . 130 corresponds (eg with this interlocking). The first 241 . 251 and / or the second 242 . 252 Tertiary alignment area may be on their respective tertiary catheter 200 . 210 be arranged so that the alignment region (s) of the respective tertiary catheter of the first and the second secondary curved shape (a secondary catheter 200 . 210 ) when the tertiary catheter 200 . 210 completely operative from a distal end area 140 . 150 of the respective secondary catheter 120 . 130 is exposed. The relative position and rotation of a tertiary catheter 200 . 210 relative to a secondary catheter 120 . 130 may be more efficiently predetermined and defined when both the first and second tertiary curved shapes of a tertiary catheter with the first and second secondary curved shapes of a respective secondary catheter 120 . 130 mesh. However, the relative position and rotation of a tertiary catheter 200 . 210 relative to a secondary catheter 120 . 130 be defined if there is only one of the tertiary curved shapes that matches a corresponding secondary curved shape.

The tertiary alignment section 241 . 251 one or both tertiary catheters may be bendable and may be provided to be bendable by a third bending mechanism (not shown). The third bending mechanism may be a shape memory structure as described above, or may include any or all of the features of the first 191 and / or the second bending mechanism, with the difference that the respective features on a tertiary catheter 200 . 210 rather than a secondary catheter 120 . 130 are related.

The distal end area 260 . 270 of the first 200 and / or the second 210 tertiary catheter may have a shape memory structure. The shape memory structure may be at the distal end portions 260 . 270 have a tendency to assume oppositely oriented arch forms, so that the distal ends 260 . 270 the tertiary catheter 200 . 210 Essentially, when exposed to each other (eg fully exposed) are of the secondary catheters 120 . 130 (see. 1 . 4 or 5c ). The aforesaid oppositely oriented arch molds may serve to provide the circumferential fabric structure 10 at least partially (eg, completely), for example in a generally circular or elliptical shape.

The 5e shows a single first tertiary catheter 200 schematically. As it is in the 5e can be seen, the plane in which the distal end 260 in an arch shape extends, may be substantially normal (ie, may have an angle of substantially 90 °) to the plane in which the second tertiary alignment region 242 extends, at least when it has adopted the second curved shape. However, other angles between these levels are possible, for. B. 80 ° to 90 °, 30 ° to 60 °, 70 ° to 80 ° or any other angle. Although it is in the 5e not shown, the same at the same time also on the second tertiary catheter 210 hold true. Furthermore, it may be in the 4c be seen that when the first and the second distal end region 260 . 270 of the first 200 and second 210 tertiary catheter from the distal end region 140 . 150 of the first 120 and second 130 secondary catheters are exposed to the distal end portions 260 . 270 of the first 200 and second 210 tertiary catheter may extend in the substantially same plane, which may be transverse to the longitudinal axis 90 of the primary catheter 70 ,

With further reference to the 7a to 7c may be one and / or both tertiary catheters 200 . 210 also be at least partially folded, z. B. completely folded, at least when from a respective secondary catheter 120 . 130 are sheathed. The distal end area 260 . 270 of the first 200 and / or the second 210 The tertiary catheter may have a shape memory structure that gives it a tendency to adopt a coil shape (eg, spiral shape, eg, ringlet shape, eg, helix shape, eg, helical shape), at least when from a distal end region 140 . 150 a secondary catheter 120 . 130 brought out to the front. The coil shape may be a flat coil shape, ie, the turns of the coil may be disposed in substantially the same plane, or the coil shape may be a helical and / or helical coil shape in which the turns of the coil may be spaced along an axis to form a helical type structure. In this context, the helical or helical coil shape may have a constant pitch or have a variable pitch and / or a constant or variable radius of the turns. The distal end area 260 . 270 (eg, the coil shape of this) of the first 200 and / or the second 210 tertiary catheter can be folded, z. B. packed, z. Diametrically compressed (ie, compressed in a radial direction of the coil form) when it is from a respective secondary catheter 120 . 130 is sheathed and may unfold substantially instantaneously (eg, suddenly) when the folded or packed distal end portion 260 . 270 from a respective secondary catheter 120 . 130 brought out to the front. Accordingly, the distal end portion 260 . 270 of the first 200 and / or the second 210 secondary catheter adopt the coil shape when coming from a respective secondary catheter 120 . 130 is brought forward, caused by the shape memory structure of the distal end portion 260 . 270 the first and / or the second tertiary catheter 200 . 210 , The coil form may comprise a plurality of turns, e.g. 1 to 2 turns, 1 to 5 turns, 3 to 7 turns or any number of turns. In this context, a turn may be one full turn (ie span an angle of 360 °) and / or be a partial turn (ie span an angle of less than 360 °). A plurality of turns may have one or more (eg, one or more) full turns and / or have one or more (eg, one or more) partial turns.

A longitudinal length of the first 200 and / or the second 210 tertiary catheter may be longer than a longitudinal length of the first 120 or the second 130 secondary catheter, leaving a proximal end 280 . 290 from a proximal end 180 . 190 a respective secondary catheter 120 . 130 may be exposed to facilitate actuation and relative movement of the catheters relative to one another. Also a longitudinal length of each tertiary catheter 200 . 210 may be longer than a longitudinal length of each secondary catheter 120 . 130 whose length itself is longer than a longitudinal length of a primary Katethers 70 can be.

In addition, as it is in the 4 and 5d shown can be a front body tube 320 (eg, front body catheter 320 ) relatively movable in an inner lumen 80 of the primary catheter 70 be provided. The front body tube can be a front body 330 which may be provided to serve multiple purposes. The front body 330 may be provided as a means for selectively closing or opening an inner lumen 80 of the primary catheter 70 , This can be the front body 330 have a cross-sectional shape with a cross-sectional shape of the inner lumen 80 of the primary catheter 70 (transverse to the longitudinal axis 90 seen), and a diameter substantially similar to a cross-sectional diameter of the inner lumen 80 of the primary catheter 70 or slightly larger than this diameter to provide a press fit. The front body 330 may be operable by moving the front body tube 320 along a longitudinal axis 90 of the primary catheter 70 , whereby the front body 330 along the longitudinal axis 90 is moved in a distal or proximal direction to the inner lumen 80 of the primary catheter 70 to open or close. Furthermore, the front body 330 serve to atraumatic insertion of the catheter device 1 to facilitate by providing a curved or rounded front body 330 , But the front body can do this have substantially round or curved or elliptical cross-sectional shape when in a direction transverse to the longitudinal axis 90 of the primary catheter is considered (see eg. 4 or 5d ) to facilitate atraumatic insertion when the fore body 330 comes into contact with organic tissue. The front body 330 may have a through hole and the front body tube 320 may have an inner lumen with the passage opening of the front body 330 is aligned, so that a guidewire or something similar through the passage opening of the front body 330 and the inner lumen of the front body tube 320 can extend.

The following are possible kinematic movements of the catheter device 1 described. As has been described above, the primary catheter 70 a first 120 and a second 130 secondary catheters (eg sheathing), which are movable relative to this and also optionally a first 200 or a second one 210 Tertiary catheters can lead (eg sheath), which are movable relative to these (and thus also relative to the primary catheter 70 are movable). In 1 are some kinematic relative motion possibilities schematically by arrows 5 indicated. Any kinematic actions of any catheter or wire or other object described hereinbefore or hereinafter may optionally be complete and fully reversible, that is, all catheters that expand and / or expand and / or move and / or rotated and / or or may be bent and / or flexed, optionally (eg, at the discretion of a surgeon), moved backward and / or withdrawn, and / or brought to its initial position / shape or any intermediate position / shape therebetween, and can be in a stable intermediate position.

The "strengths", ie the force or tension, with which a bending mechanism 191 . 192 or any shape memory structure described herein attempts to induce (eg, tend to assume) a predetermined shape in a catheter described herein, may be chosen to be the strength of a flexure mechanism 191 . 192 or a shape memory structure is greater than the sum of the strengths of all catheters guided by that catheter. This can result in a stably curved shape of this catheter which can not be altered inadvertently by relative movement of any other catheter guided by that catheter.

A typical aortic arch 340 An adult human may have a radius of about 30 to 70 mm and may describe an angle of 90 ° to 270 °. Therefore, a secondary alignment section 127 . 137 optionally a radius of about 30 to 70 mm, z. B. 30 to 50 mm, z. B. 40 to 45 mm and / or an angle of 90 ° to 270 °, z. From 90 ° to 120 °, 120 ° to 160 °, 160 ° to 200 °, 200 ° to 245 ° and / or 245 ° to 270 ° if it has adopted a second secondary curved shape. However, the radius or curvature of the secondary arcuate shape may also be provided to match (e.g., custom made) to a specific heart of a patient whose size and geometry may be determined by medical imaging techniques. Although the catheter device 1 and their features mainly in relation to a mitral valve 330 as the circumferential tissue structure 10 and an aortic arch 340 described, the catheter device 1 also set up / constructed with regard to other anatomical features or conditions. For example, the circumferential tissue structure 10 may be part or all of a trisplum valve apparatus or other valve, and the curvature of the secondary curved shape may be designed to mate with the curvature of the connecting channel from the superior vena cava to the pulmonary artery of a mammalian heart, or may be designed to be with any other Curvature interlock. The catheter device 1 can also be used to B. to interact with a blood vessel, a gastric / digestive connection channel / organ and / or a tracheal / pulmonary connection channel. The catheter device 1 can also be used to B. to interact with hard-to-reach parts of machines or the like.

In the inner lumen 240 and 250 of the first 200 or the second 210 tertiary catheter can be a wire 300 be provided having a free distal end 305 has, wherein in the respective other tertiary catheter a safety wire 310 may be provided, which is a distal catch component 315 having. The wire 300 and / or the safety wire 310 may be relative to their respective tertiary catheter 200 . 210 be movable. The wire 300 and / or the safety wire 310 may be made of the same material or made of different materials, eg. B. from a metal such as steel or Nitinol or from a polymer such as Kevlar or PP or PS or from a biodegradable material, eg. A material that dissolves within the human body in a substantially predetermined time.

The wire 300 and / or the safety wire 310 can through the inner lumen 240 . 250 their respective first or second tertiary catheter 200 . 210 to a distal end region 260 . 270 this one after be brought forward and be exposed from there.

The wire 300 and / or the safety wire 310 can also serve the first 200 and / or the second 210 tertiary catheters a form, for. A predetermined shape, caused by material strength, material elasticity or shape memory structure of the wire 300 and / or the safety wire 310 , Accordingly, a wire 300 and / or a safety wire 310 Material strength, material elasticity and / or have a shape memory structure. The shape memory structure can be the wire 300 and / or the safety wire 310 have a tendency to adopt an arc shape (eg, a semicircular shape, eg, an elliptical shape) or other shape. The arch form may be an arch form having a radius equal to or greater than a radius of an anatomical feature, e.g. B. a circumferential tissue structure 10 , can be. If the wire 300 has a tendency to adopt a bow shape, the catch wire can 310 have a tendency to assume an arc shape which is oriented accordingly opposite. In this regard, the arched forms of the wire 300 and the safety wire 310 form a circular shape. With reference to the 7a to 7c can the wire 300 and / or the safety wire 310 through a respective first and / or second tertiary catheter 200 . 210 can be brought forward and can the coil shape of the distal end portion 260 . 270 of the first and / or second tertiary catheter correspondingly unwind (e.g., continue to deploy, eg, unwind) if a distal end portion 260 . 270 a first and / or second tertiary catheter 200 . 210 from a respective secondary catheter 120 . 130 is exposed and has assumed the coil shape as described above. This can cause the distal end area 260 . 270 of the first and / or second tertiary catheter 200 . 210 a fabric structure, e.g. B. the tissue structure 10 , at least partially (eg completely) surrounds. Developing a coil shape (eg through the wire 300 or the safety wire 310 ), as described above, atraumatic placement and / or insertion of the first and / or second tertiary catheter 200 . 210 and / or wire 300 and / or catching wire 310 around a structure, e.g. B. a tissue structure 10 , because essentially there can only be contact between a round coil winding coil and an anatomical feature.

The catch component 315 can a catcher 315 or a magnetic component or a hook or a sling or a lasso or any other device adapted to have a free end 305 of the wire 300 to catch, hold, or be such. To simplify catching and holding, the free end can be 305 of the wire 300 a hook or barbs (not shown).

The catch component 315 can the free end 305 catch and hold when both from a distal end area 260 . 270 their respective tertiary catheter 200 . 210 are exposed. The catch component 315 of the safety wire 310 can then be withdrawn into the distal end region of its tertiary catheter (eg the second 210 or the first 200 ) to a proximal end region 290 (or 280 ) this, leaving the free end 305 of the wire in the, z. B. second, tertiary catheter 210 to a proximal end region 290 this pulls (and thereby also a part of the wire 300 ). This can cause the wire 300 at least partially (eg, completely) surrounding an anatomical feature, e.g. B. the tissue structure 10 ,

The circumference of the inner lumen 80 . 160 . 170 . 240 . 250 of the primary catheter 70 , Secondary Kateter (s) 120 . 130 and / or the tertiary catheter (s) 200 . 210 (or said catheters as a whole) may be selectably gas and liquid tight so that no gas or liquid can diffuse out of the inner lumen or diffuse into the inner lumen. However, any or all of the said lumens may also be non-liquid-tight or non-gas tight, and the controlled outward diffusion of matter, e.g. From a contrasting color or other substances that allow for specific visualization, or a drug, from an inner lumen to the exterior of the catheter device 1 allow, for. For treatment or other purposes, or to allow controlled inward diffusion, e.g. To take a sample of a plasmid encoding a protein.

The catheter device 1 as described herein may also be used in combination with a medical implant. The first 200 and / or the second 210 tertiary catheters (and / or the first 120 and / or the second 130 secondary catheters) may accordingly be configured to attach an implant to the circumferential tissue structure 10 bring to. The implant may be a stent or a stent graft-like structure, a balloon or similar, actively inflatable device, or a foam / hydrogel covered or otherwise passively expandable device. The implant may be anchored by its shape or by additional anchor components or by interaction with another device, e.g. B. is introduced with another delivery catheter. The implant can z. B. be a replacement heart valve that in the interior of the tissue structure 10 can be brought, for. Between the natural mitral or trisci-lateral sails).

The following is a method of using a catheter device 1 around a fabric structure 10 to catch more detail with respect to the 8th to 12 described. Each feature of a catheter device 1 , which is described directly or indirectly in any method step, is intended to be applicable also to the catheter device "device" and any feature or functionality described with reference to the catheter device "device" may also be referred to as a method step of a method of using the catheter device 1 be applicable.

The 8th to 12 show schematic views of a human heart with a view from the left atrial chamber 350 on the mitral valve 360 which are the or part of the circumferential flap structure 10 (see also 2 ) can be. The catheter device 1 is shown with one in the ventricular chamber 370 placed distal end region 100 of the primary catheter 70 (therefore in the 8th to 12 "Under" the mitral valve 360 , see. 2 ). The catheter device 1 is over the aortic arch 340 introduced so that the distal end 100 of the primary catheter 70 (which can be flexible) relative to the aortic arch 340 may be arranged such that the second bending mechanism 192 can cause so the secondary alignment sections 127 . 137 assume their respective secondary curved shape. This can cause the secondary alignment sections 127 . 137 with the aortic arch 340 self-aligned and / or self-oriented, resulting in a corresponding self-alignment or self-orientation of the distal end regions 140 . 150 of the first 120 and second 130 secondary catheter results as described above.

The 8th shows that the first and second secondary catheters 120 . 130 from a distal end region 100 of the primary catheter 70 are exposed from. The arm areas 126 . 136 extend in substantially opposite directions transverse to the longitudinal axis 90 of the primary catheter 70 with a corresponding arm length (ie, the length of the rectilinear extent) of about 4 mm or more (as described above, the arm length may also be longer or shorter) caused by the first bending mechanism 191 ,

The 9 also shows the first 210 and the second 220 tertiary catheter extending from a distal end 140 . 150 of the first 120 or the second 130 secondary catheters are exposed so that they extend in substantially oppositely-oriented arcuate shapes to each other about a perimeter of the mitral valve 360 to surround (or any other extensive tissue structure 10 ).

The 10 additionally shows the exposed free end 305 of the wire 300 that of the catch component 315 of the safety wire 310 is captured. Here is the catch component 315 a catcher. The wire 300 and the catching wire 310 be through the inner lumens 240 . 250 of the first 200 or second 210 tertiary catheter from a proximal end region 280 . 290 (eg from outside the body) of the first 200 or the second 210 tertiary catheter brought forward to from the distal end regions 260 . 270 to be exposed, leaving the free end 305 of the wire 300 reliable through the catch component 315 of the safety wire 300 can be caught.

The 11 is similar to the 10 but shows a different / alternative arrangement of the second secondary catheter 130 and the second tertiary catheter 210 , Here are the second secondary catheter 130 and the second tertiary catheter 210 a shape so that it is substantially parallel to a longitudinal axis 90 of the primary catether 70 are, and the first secondary catheter 120 and the first tertiary catheter 200 have an arm area 126 on how he related to the above 10 described, which is substantially transverse to the longitudinal axis 90 of the primary catheter 70 is. This causes the catheter device 1 only partially a circumferential structure of a mitral valve 360 surrounds. As it is in the 11 is shown is the arm area 126 substantially transverse to the longitudinal axis 90 of the primary catheter 70 deployed while the arm area 136 substantially parallel to the longitudinal axis 90 is provided. As it is further in 11 It must be shown that it is the catch component 315 the free end 305 of the wire 300 can reliably catch, not necessary, that the distal end portions 260 . 270 of the first and second tertiary catheters, respectively 200 . 210 are arranged in a certain way or at a certain angle relative to each other or that they touch or abut each other.

The 12 shows a further method step of a method for using a catheter device 1 , The arrangement of the catheter device 1 of the 12 based on in the 11 shown, but all the principles in the 12 are shown or described with respect to these, may also be applied to the arrangement shown in the 10 shown to be applicable. In the 12 is the catch wire 310 with the in the catch component 315n caught free end 305 of the wire 300 into the inner lumen 250 of the second tertiary catheter 210 withdrawn, which also causes the wire 300 around a part of the mitral valve 360 and into the inner lumen 250 of the second tertiary catheter 210 draws. Furthermore, in the 12 the first and second tertiary catheters 200 . 210 and the first and second secondary catheters 120 . 130 into the inner lumen 80 of the primary catheter 70 withdrawn. This can cause the wire 300 a circumference of a mitral valve 360 surrounds (in the 12 partially, but with a catheter device 1 as they are in the 10 is shown, is used completely),

The wire 300 , which concerns the circumferential tissue structure of the mitral valve 360 may allow further treatment of the valve, the attachment of other catheters or artificial heart valves or the like.

Although the above procedure based on a mitral valve 360 In order to better illustrate the general principles, it may generally be the surrounding of any fabric structure 10 and also surrounding each perimeter structure, e.g. Hard-to-reach parts of machines or other peripheral structures in confined spaces).

With further reference to the 13 can the catheter device 1 be set up to the extensive tissue structure 10 from one side of the circumferential fabric structure 10 out, the aortic arch 340 opposite to surround. Accordingly, a distal end region 100 of the primary catheter 70 on a with respect to the aortic arch 340 distant side of the circumferential tissue structure 10 be placed. Accordingly, the first 120 and / or the second 130 secondary catheter and / or the first 200 and / or second 210 Tertiary catheters may be set up so that they have the tissue structure 10 (at least partially, eg completely) surrounded by a location on top of the circumferential tissue structure 10 opposite the aortic arch 340 is arranged. In this regard, the catheter device may 1 be set up to the tissue structure 10 from any place in relation to the aortic arch 340 to surround.

Claims (21)

Catheter Device ( 1 ) for interacting with a circumferential tissue structure ( 10 ) comprising an elongated primary catheter ( 70 ), which is an inner lumen ( 80 ), along a longitudinal axis ( 90 ) and a distal end region (FIG. 100 ), a first ( 120 ) and a second ( 130 ) elongated secondary catheter, each having a distal end portion ( 140 . 150 ) and an inner lumen ( 160 . 170 ), and each provided, in the inner lumen ( 80 ) of the primary catheter ( 70 ) so as to be movable relative thereto and from a distal end region (Fig. 100 ) this is exposable, and a first bending mechanism ( 191 ) to the distal end region (FIG. 140 . 150 ) of the first ( 120 ) and / or the second ( 130 ) secondary catheter having a tendency to assume a first secondary curved shape, the distal end region ( 140 . 150 ) of one or both of the first and second secondary catheters ( 120 . 130 ) is provided in such a way that by means of the first bending mechanism ( 191 ) can be bent to an arm area ( 126 . 136 ) substantially transverse to the direction of the longitudinal axis (FIG. 90 ) of the primary catheter ( 70 ) so as to assume the first secondary curved shape, the respective arm region ( 126 . 136 ) 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 which is radial to the longitudinal axis ( 90 ) of the primary catheter ( 90 ), and wherein a free end of the respective arm region ( 126 . 136 ) from the longitudinal axis ( 90 ) away, so that the respective arm area ( 126 . 136 ), with a lateral outer surface thereof, forms a blunt end face extending transversely to the longitudinal axis ( 90 ) of the primary catheter ( 70 ) and allows the tissue structure ( 10 ) with the catheter device ( 1 ) to touch frontally in a non-penetrating manner. Catheter Device ( 1 ) for interacting with a circumferential tissue structure ( 10 ) comprising an elongated primary catheter ( 70 ), which is an inner lumen ( 80 ) extending along a longitudinal axis ( 90 ) and a distal end region (FIG. 100 ), a first ( 120 ) and a second ( 130 ) elongate secondary catheters, each of which extends along a longitudinal axis ( 125 . 135 ), each having a distal end portion (Fig. 140 . 150 ), a proximal end region ( 180 . 190 ) and an inner lumen ( 160 . 170 ), and each having a secondary alignment section ( 127 . 137 ) located between the distal ( 140 . 150 ) and the proximal ( 180 . 190 ) End portion and adjacent to the distal end portion (FIG. 140 . 150 ), and each of which is intended to be located in the inner lumen ( 80 ) of the primary catheter ( 70 ) so as to be movable relative thereto and from a distal end region (Fig. 100 ) that is exposed, a first bending mechanism ( 191 ) to the distal end region (FIG. 140 . 150 ) of the first ( 120 ) and / or the second ( 130 secondary catheter have a tendency to assume a first secondary curved shape, a second bending mechanism ( 192 ) to the secondary alignment section ( 127 . 137 ) of the first ( 120 ) and / or second ( 130 secondary catheter have a tendency to adopt a second curved shape, with the distal end portion (FIG. 140 . 150 ) of both, the first and the second ( 120 . 130 ), secondary catheters is provided so as to be fixed by means of the first bending mechanism ( 191 ) can be bent to an arm area ( 126 . 136 ) which is substantially transverse to the direction of the longitudinal axis (FIG. 90 ) of the primary catheter ( 70 ) so as to assume the first secondary curved shape as it moves from the distal end region (FIG. 100 ) of the primary catheter ( 70 ) is exposed, the secondary alignment section ( 127 . 137 ) of the first ( 120 ) and the second ( 130 ) secondary catheter is provided in such a way that by means of the second bending mechanism ( 192 ) can be bent to assume the second secondary curved shape having a predetermined curvature, optionally with a radius of substantially 30 up to 70 mm and optionally an angle between 90 ° and 270 °, and wherein the arm regions ( 126 . 136 ) of the first ( 120 ) or the second ( 130 ) extend in substantially opposite directions to each other when the secondary alignment sections ( 127 . 137 ) of the first ( 120 ) and second ( 130 ) secondary catheter adopt the second secondary curved shape parallel to each other. Catheter Device ( 1 ) according to claim 1 or 2, further comprising a first ( 200 ) and a second ( 210 ) elongated tertiary catheters, each of which is intended to be connected by means of the first ( 120 ) or second ( 130 secondary catheter, each of which is guided along a longitudinal axis (FIG. 220 . 230 ) and each having a distal end portion (FIG. 260 . 270 ) and a proximal end region ( 280 . 290 ) and each is provided to be relative to the first ( 120 ) or the second ( 130 ) secondary catheter movable and from a distal end region ( 140 . 150 ) to be exposed to this. Catheter Device ( 4 ) according to claim 3, wherein the first ( 200 ) and the second ( 210 ) tertiary catheters each a first ( 241 . 251 ) and / or a second ( 242 . 252 ) tertiary alignment section between the respective distal ( 260 . 270 ) and the proximal end region ( 280 . 290 ), each of them having a shape memory structure comprising the first ( 241 . 251 ) and / or the second ( 242 . 252 ) tertiary alignment sections have a tendency to assume a first and / or a second tertiary curved shape that corresponds to the first and / or the second secondary curved shape. Catheter Device ( 1 ) according to claim 3 or 4, wherein the distal end region ( 260 . 270 ) of the first ( 200 ) and the second ( 210 ) tertiary catheter have a shape memory structure which gives them a tendency to adopt a respective arc shape when viewed from a distal end region (FIG. 140 . 150 ) of the first and second secondary catheters ( 120 . 130 ) are exposed. Catheter Device ( 1 ) according to claims 4 and 5, wherein the shape memory structure of the distal end region ( 260 . 270 ) of the first ( 200 ) and the second ( 210 ) tertiary catheter is such that when the first ( 241 . 251 ) and / or second ( 242 . 252 ) tertiary alignment section of the first ( 200 ) and the second ( 210 ) tertiary catheter are arranged so that they are connected to the distal end regions and / or the secondary alignment regions ( 127 . 137 ) of the first and second secondary catheters ( 120 . 130 ), which assume their respective first and / or second curved shape, intermesh the distal end regions ( 260 . 270 ) of the first ( 200 ) and the second ( 210 ) are provided with a tendency to assume arcuate shapes that extend oppositely to each other to form a loop shape. Catheter Device ( 1 ) according to any one of claims 4 to 6, wherein; when the first ( 241 . 251 ) and / or the second ( 242 . 252 ) tertiary alignment section of the first ( 200 ) and second ( 210 ) tertiary catheters are arranged so that they are connected to the distal end regions ( 140 . 150 ) and / or the secondary alignment sections ( 127 . 137 ) of the first and second secondary catheters ( 120 . 130 ), which assume their respective first and / or second curved form, intermesh the distal end regions ( 260 . 270 ) of the first ( 200 ) and second ( 210 ) tertiary catheter fully operational from the distal end regions ( 140 . 150 ) of the first ( 120 ) and second ( 130 ) secondary catheters are exposed from. Catheter Device ( 1 ) according to claim 6 or 7, wherein when the first and the second distal end region ( 260 . 270 ) of the first ( 200 ) and the second ( 210 ) tertiary catheter from the distal end region ( 260 . 270 ) of the first ( 200 ) and the second ( 210 secondary catheter are exposed, the distal end portions ( 260 . 270 ) of the first ( 200 ) and the second ( 210 ) tertiary catheter both in the substantially same plane extending transversely to the longitudinal axis ( 90 ) of the primary catheter ( 70 ). Catheter Device ( 1 ) according to one of claims 3 to 8, wherein the first ( 200 ) and the second ( 210 ) tertiary catheters each an inner lumen ( 240 . 250 ), wherein a wire ( 300 ), which has a free end ( 305 ), in the inner lumen ( 240 ) of the first tertiary. Catheter ( 200 ) and wherein a catching wire ( 310 ) with a catch component ( 315 at a distal end thereof in the inner lumen ( 250 ) of the second tertiary catheter ( 210 ) and both, the wire ( 300 ) and the catching wire ( 310 ) are provided so that they can be delivered to their respective tertiary catheter ( 200 . 210 ) are movable and from a distal end region ( 260 . 270 ) that are exposable and retractable there, leaving the free end ( 305 ) of the wire ( 300 ) with the catch component ( 315 ) can be caught to form a loop. Catheter Device ( 1 ) according to claim 9, wherein the capture component ( 315 ) is a collecting basket and / or a lasso and / or a sling. Catheter Device ( 1 ) according to one of claims 2 to 10, wherein the curvature of the second secondary curved shape of the curvature of an aortic arch ( 340 ) of a mammalian heart and the peripheral tissue structure is part or all of a mitral valve apparatus. Catheter Device ( 1 ) according to one of claims 2 to 10, wherein the curvature of the second secondary curved shape corresponds to the curvature of a connecting channel from the superior vena cava to the pulmonary artery of a mammalian heart and the circumferential tissue structure (FIG. 10 ) is part or all of a tricuspid valve apparatus. Catheter Device ( 1 ) according to any one of the preceding claims, wherein the primary catheter ( 70 ) further comprises a front body tube ( 320 ) which is movable in its inner lumen ( 80 ), and wherein the front body tube ( 320 ) at its distal end portion a blunt front body ( 330 ) arranged to engage the distal end portion (Fig. 100 ) of the primary catheter ( 70 ) optionally to open or close by the movement of the front body tube ( 320 ) in a distal or proximal direction of the primary catheter ( 70 ). Catheter Device ( 1 ) according to one of claims 3 to 13, wherein one or both of the first ( 200 ) and the second ( 210 ) tertiary catheter in the inner lumen ( 160 . 170 ) of the first ( 120 ) or the second ( 130 ) are received secondary catheter to be guided by this. Catheter Device ( 1 ) according to one of claims 3 to 14, wherein the first ( 200 ) and / or second ( 210 ) tertiary catheters an inner lumen ( 240 . 250 ), and one or both of the first ( 120 ) or second ( 130 ) secondary catheters in the inner lumen ( 240 . 250 ) of the first ( 200 ) and / or second ( 210 ) tertiary catheter is added so that the first ( 200 ) and / or second ( 210 ) tertiary catheters by means of the first ( 120 ) or second ( 130 ) secondary catheter. Catheter Device ( 1 ) according to one of the preceding claims, wherein the first bending mechanism ( 191 ) and / or the second bending mechanism ( 192 ) a shape memory structure ( 191a ), a bending structure with an atraumatic front cone ( 191c ) and / or threads ( 191b ) located at the distal end region (FIG. 140 . 150 ) of the first ( 120 ) and / or the second ( 130 ) are attached to the secondary catheter. Catheter Device ( 1 ) according to one of claims 4 to 5 or 16, wherein the shape memory structure is provided by material elasticity. Catheter Device ( 1 ) according to any one of claims 2 to 17, wherein the respective arm region ( 126 . 136 ) 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 which is radial to the longitudinal axis ( 90 ) of the primary catheter ( 90 ), and wherein a free end of the respective arm region ( 126 . 136 ) from the longitudinal axis ( 90 ) away, so that the respective arm area ( 126 . 136 ), with a lateral outer surface thereof, forms a blunt end face extending transversely to the longitudinal axis ( 90 ) of the primary catheter ( 70 ) and allows the tissue structure ( 10 ) with the catheter device ( 1 ) to touch frontally in a non-penetrating manner. Catheter Device ( 1 ) according to one of claims 1 to 18 in combination with an implant, wherein one or both of the first ( 200 ) and second ( 210 ) tertiary catheter is / are set so that he / she an implant to the circumferential tissue structure ( 10 ) feeds. Catheter Device ( 1 ) according to any one of claims 3 to 4 and / or 7 to 19, wherein a distal end region ( 260 . 270 ) of the first ( 200 ) and / or second ( 210 ) tertiary catheter has a shape memory structure which gives it a tendency to assume a coil shape having a plurality of turns, at least when the distal end portion (FIG. 260 . 270 ) of the first and / or second tertiary catheter ( 200 . 210 ) from the distal end region ( 140 . 150 ) of the first ( 120 ) and / or second ( 130 Secondary catheter is exposed from, and where optionally the coil shape of the distal end portion ( 260 . 270 ) of the first and / or second ( 200 . 210 ) tertiary catheter is compressed diametrically when moving from the inner lumen ( 160 . 170 ) of the first ( 120 ) and / or second ( 130 ) is surrounded by a secondary catheter. Catheter Device ( 1 ) according to claim 20 and claim 9, wherein the wire ( 300 ) and / or the safety wire ( 310 ) has a shape memory structure giving it a tendency, an arch shape assuming the strength of the shape memory structure of the wire ( 300 ) and / or the safety wire ( 310 ) greater than a thickness of a shape memory structure of the distal end region ( 260 . 270 ) of the first ( 200 ) and / or second ( 210 ) tertiary catheter, so that the wire ( 300 ) and / or the safety wire ( 310 ) the coil shape of the distal end region ( 260 . 270 ) of the first and / or second tertiary catheter ( 200 . 210 ) escapes if it passes through the first ( 200 ) and / or second ( 210 ) tertiary catheters are brought forward so that the distal end region ( 260 . 270 ) of the first and / or second tertiary catheter, the arc shape of the wire ( 300 ) and / or the safety wire ( 310 ) and where optionally the catching wire ( 310 ) a catch component ( 315 ) does not have.

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